1336296,05/21/2021,NJ,,,,F,,"Hospitalized with a major surgery/ Some blood leakage in brain; Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Brain operation in March 2021. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine). The patient was hospitalized on 01-Mar-2021 due to CEREBRAL HAEMORRHAGE. At the time of the report, CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) and PRODUCT DOSE OMISSION ISSUE (Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were provided. Patient had received the first dose of the Moderna Covid-19 vaccine and ended up being hospitalized in March with a major surgery that involved some blood leakage in brain. Patient had essentially missed the second Moderna Covid-19 dose scheduled in mid-March and at the time of reporting patient was about 90 days after receiving the first Moderna Covid-19 vaccine. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow up received on 11-May-2021 Updated the Reporter, patient information and serious event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provided at this time. Further information has been requested.",,,,,Y,,,,U,02/15/2021,03/01/2021,14,,UNK,,,,Medical History/Concurrent Conditions: Brain operation,,"USMODERNATX, INC.MOD20211",2,05/21/2021,,,,
1336297,05/21/2021,PA,74.0,74,,M,,"Hallucination; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (Hallucination) had not resolved. No concomitant medications were provided. No treatment drugs were reported. It was reported that patient refuses to see a doctor and says that everyone else is crazy. Company comment: Limited information regarding the second vaccination dose has been provided at this time and insufficient to assess the temporal association. No follow up is possible. A causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received on 09 May 2021 included no new information.; Sender's Comments: Limited information regarding the second vaccination dose has been provided at this time and insufficient to assess the temporal association. No follow up is possible. A causal relationship cannot be excluded.",,,,,,,,,N,04/01/2021,04/08/2021,7,,UNK,,,,,,"USMODERNATX, INC.MOD20211",2,05/21/2021,,,,
1336298,05/21/2021,AZ,75.0,75,,M,,"Brain embolism; Missed second dose (51 days since first dose); Feeling a little weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL ARTERY EMBOLISM (Brain embolism) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced CEREBRAL ARTERY EMBOLISM (Brain embolism) (seriousness criteria hospitalization, medically significant and life threatening). On 09-May-2021, the patient experienced ASTHENIA (Feeling a little weak). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (51 days since first dose)). The patient was hospitalized until 08-May-2021 due to CEREBRAL ARTERY EMBOLISM. On 08-May-2021, CEREBRAL ARTERY EMBOLISM (Brain embolism) had resolved. At the time of the report, ASTHENIA (Feeling a little weak) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed second dose (51 days since first dose)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products included cholesterol medication, high blood pressure medication, anxiety medication, allergies medication, and medication for brain embolism. Company comment:This case concerns a 51-year-old male who experienced cerebral artery embolism and asthenia and missed second dose (51 days since first dose) (missed dose). Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events of cerebral embolism and asthenia, a causal relationship cannot be excluded. The event of missed dose is assessed as not applicable.; Sender's Comments: This case concerns a 51-year-old male who experienced cerebral artery embolism and asthenia and missed second dose (51 days since first dose) (missed dose). Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events of cerebral embolism and asthenia, a causal relationship cannot be excluded. The event of missed dose is assessed as not applicable.",,,Y,,Y,,,,N,03/20/2021,04/17/2021,28,,UNK,,,,Comments: No medical history reported.,,"USMODERNATX, INC.MOD20211",2,05/21/2021,,,,
1336299,05/21/2021,OH,37.0,37,,M,,"Bell's Palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). On 07-May-2021, BELL'S PALSY (Bell's Palsy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. Patient stated, he was given 2 medications of unknown names for treatment of bells palsy and symptoms gone way after a week of taking those meds. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Event start date, stop date and outcome updated. Vaccine given date updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",,,,,,,,,Y,04/13/2021,04/26/2021,13,,UNK,,,,,,"USMODERNATX, INC.MOD20211",2,05/21/2021,,,,
1336300,05/21/2021,OH,,,,F,,"acute anaphylactic shock; A.fib; blurry vision; swollen lips; Numbing sensation in her hands and lips; tingling sensation in her hands and lips; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (acute anaphylactic shock) and ATRIAL FIBRILLATION (A.fib) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced ANAPHYLACTIC SHOCK (acute anaphylactic shock) (seriousness criterion medically significant), ATRIAL FIBRILLATION (A.fib) (seriousness criterion medically significant), VISION BLURRED (blurry vision), LIP SWELLING (swollen lips), HYPOAESTHESIA (Numbing sensation in her hands and lips) and PARAESTHESIA (tingling sensation in her hands and lips). At the time of the report, ANAPHYLACTIC SHOCK (acute anaphylactic shock), ATRIAL FIBRILLATION (A.fib), VISION BLURRED (blurry vision), LIP SWELLING (swollen lips), HYPOAESTHESIA (Numbing sensation in her hands and lips) and PARAESTHESIA (tingling sensation in her hands and lips) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment for the events included diphenhydramine, metoclopramide, ketorolac, prochlorperazine and prednisone. The patient was advised not to receive the second dose of vaccine by her healthcare provider. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",,,,,,,,,U,05/11/2021,05/11/2021,0,,UNK,,,,,,"USMODERNATX, INC.MOD20211",2,05/21/2021,,,,