chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient tested negative for antibodies, and experienced suspected immunological vaccine failure.  Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210805141.; Sender's Comments: V0-20210805266-COVID-19 VACCINE aD26.Cov2.s-Suspected Immunological Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Headache, Infrequent bowel movements
Clinical narrative: COULDN'T GO TO THE BATHROOM FOR SEVERAL DAYS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced couldn't go to the bathroom for several days, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and couldn't go to the bathroom for several days was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced adverse symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse symptoms was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Nausea, Swelling face
Clinical narrative: DIZZINESS AND LIGHTHEADEDNESS; FACIAL SWELLING; TRIPPED; SLIGHT SENSE OF QUEASINESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced anaphylaxis and drug allergy when treated with macrogol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced dizziness and lightheadedness. On 07-APR-2021, the subject experienced facial swelling. On 07-APR-2021, the subject experienced tripped. On 07-APR-2021, the subject experienced slight sense of queasiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness and lightheadedness on 09-APR-2021, facial swelling on 08-APR-2021, and tripped, and slight sense of queasiness on 07-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: SEVERE BODY ACHES; RUNNING FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced severe body aches, running fever, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, running fever, fatigue, and headache. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PUNCTURED VIAL STORED IN FRIDGE FOR 24 HOURS; RECEIVED A DOSE OF VACCINE DRAWN FROM A VIAL THAT WAS HELD IN THE FRIDGE FOR NEARLY 24 HOURS; This spontaneous report received from a pharmacist concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced punctured vial stored in fridge for 24 hours. On 29-JUL-2021, the subject experienced received a dose of vaccine drawn from a vial that was held in the fridge for nearly 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial stored in fridge for 24 hours and received a dose of vaccine drawn from a vial that was held in the fridge for nearly 24 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210804947 and 20210804917.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Fatigue, Hypersomnia, Myocardial infarction
Clinical narrative: Heart attack; Weakness; Wanted to sleep a lot; Fatigue; COVID-19; Did not receive 2 nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2 nd dose). On 08-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant), ASTHENIA (Weakness), HYPERSOMNIA (Wanted to sleep a lot) and FATIGUE (Fatigue). The patient was treated with Surgery (Received heart stent in June 2021) for Myocardial infarction and Immunotherapy (Received antibody infusion on 10 Apr 2021) for COVID-19. In March 2021, PRODUCT DOSE OMISSION ISSUE (Did not receive 2 nd dose) had resolved. At the time of the report, MYOCARDIAL INFARCTION (Heart attack), HYPERSOMNIA (Wanted to sleep a lot), COVID-19 (COVID-19) and FATIGUE (Fatigue) outcome was unknown and ASTHENIA (Weakness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test: positive (Positive) tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Patient was informed that second dose cant be received for 90 days after infusion.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Myocardial infarction as the event started over four (4) months after the vaccination and the causality is unlikely.   This case was linked to MOD-2021-213417 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Case has been upgraded to serious with the addition of event heart attack. New treatment was reported.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Myocardial infarction as the event started over four (4) months after the vaccination and the causality is unlikely.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Heart attack; Weakness; Wanted to sleep a lot; Fatigue; COVID-19; Did not receive 2 nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2 nd dose). On 08-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant), ASTHENIA (Weakness), HYPERSOMNIA (Wanted to sleep a lot) and FATIGUE (Fatigue). The patient was treated with Surgery (Received heart stent in June 2021) for Myocardial infarction and Immunotherapy (Received antibody infusion on 10 Apr 2021) for COVID-19. In March 2021, PRODUCT DOSE OMISSION ISSUE (Did not receive 2 nd dose) had resolved. At the time of the report, MYOCARDIAL INFARCTION (Heart attack), HYPERSOMNIA (Wanted to sleep a lot), COVID-19 (COVID-19) and FATIGUE (Fatigue) outcome was unknown and ASTHENIA (Weakness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test: positive (Positive) tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Patient was informed that second dose cant be received for 90 days after infusion.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Myocardial infarction as the event started over four (4) months after the vaccination and the causality is unlikely.   This case was linked to MOD-2021-213417 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Case has been upgraded to serious with the addition of event heart attack. New treatment was reported.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Myocardial infarction as the event started over four (4) months after the vaccination and the causality is unlikely.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Pain in extremity, Postmenopausal haemorrhage, Smear cervix normal
Clinical narrative: Menstrual period after menopause; Pain; inflammation; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Menstrual period after menopause) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN for an unknown indication.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Menstrual period after menopause) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain), INFLAMMATION (inflammation) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Menstrual period after menopause), PAIN IN EXTREMITY (Pain), INFLAMMATION (inflammation) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Smear cervix normal: normal (normal) it was normal to try to discard cancer.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took a vaccine after 2 week later had menstruation after being menopause and one week later had another episode of menstruation. She did not have menstruation again.  Company Comment  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.; 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.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Concussion, Dizziness, Electrocardiogram
Clinical narrative: passed out; felt light-headed; possibly a "light concussion" when fell; a few sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), DIZZINESS (felt light-headed), CONCUSSION (possibly a "light concussion" when fell) and MYALGIA (a few sore muscles). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out), DIZZINESS (felt light-headed), CONCUSSION (possibly a "light concussion" when fell) and MYALGIA (a few sore muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal.         No relevant concomitant medications were reported  Patient reported the nurses at the vaccination facility suggested that  passing out  after vaccination may have been due to not eating enough or maybe anemia.  Patient stated that he was prescribed with strong Advil but  he took over the counter ibuprofen .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  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.; 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.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging, Myalgia
Clinical narrative: passed out; felt light-headed; possibly a "light concussion" when fell; a few sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), DIZZINESS (felt light-headed), CONCUSSION (possibly a "light concussion" when fell) and MYALGIA (a few sore muscles). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out), DIZZINESS (felt light-headed), CONCUSSION (possibly a "light concussion" when fell) and MYALGIA (a few sore muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal.         No relevant concomitant medications were reported  Patient reported the nurses at the vaccination facility suggested that  passing out  after vaccination may have been due to not eating enough or maybe anemia.  Patient stated that he was prescribed with strong Advil but  he took over the counter ibuprofen .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  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.; 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic active Epstein-Barr virus infection, Illness, Product dose omission issue
Clinical narrative: chronic condition due to Epstein- bar virus; got very sick; didn't get to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC ACTIVE EPSTEIN-BARR VIRUS INFECTION (chronic condition due to Epstein- bar virus) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC ACTIVE EPSTEIN-BARR VIRUS INFECTION (chronic condition due to Epstein- bar virus) (seriousness criterion medically significant), ILLNESS (got very sick) and PRODUCT DOSE OMISSION ISSUE (didn't get to get the second dose). At the time of the report, CHRONIC ACTIVE EPSTEIN-BARR VIRUS INFECTION (chronic condition due to Epstein- bar virus) and ILLNESS (got very sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (didn't get to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  The caller was a patient who received the first dose of the Moderna COVID-19 Vaccine on the right arm,  and didn't get to get the second dose as it got very sick. The patient had a chronic condition due to Epstein- bar virus ( the episode happened after the first dose).  Company Comment: Very limited information regarding these events have been provided at this time. No further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Bacteraemia
Clinical narrative: Patient developing bacteremia after receiving the Moderna COVID-19 vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACTERAEMIA (Patient developing bacteremia after receiving the Moderna COVID-19 vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACTERAEMIA (Patient developing bacteremia after receiving the Moderna COVID-19 vaccine.) (seriousness criterion medically significant). At the time of the report, BACTERAEMIA (Patient developing bacteremia after receiving the Moderna COVID-19 vaccine.) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No concomitant medications were reported.  No treatment information was provided by the reporter.  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.; 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.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: diagnosed with Lymphoma; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (diagnosed with Lymphoma) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced LYMPHOMA (diagnosed with Lymphoma) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (diagnosed with Lymphoma) outcome was unknown.            No Concomitant Medications were provided. No Treatment Medications were provided.   As a medical student and hospital volunteer during COVID, the patient received the Moderna 1st dose in Dec 2020 and 2nd dose January 2021. Unfortunately she was diagnosed with Lymphoma in May and had undergone 6 cycles of chemotherapy. Thankfully she had now finished with her treatment however, the chemo wiped out her COVID vaccine and she no longer had the COVID antibody. The Oncologist explained this had been the case with most cancer patients. The Oncologist would like her and all cancer patients to be revaccinated once their treatment was completed but they had been unable to help get this approved.  Company comment: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia, Myalgia, Pyrexia, Rectal haemorrhage
Clinical narrative: passed about 1 cup of blood in her stool from her rectum; passed about 1 cup of blood in her stool from her rectum; sore arm; temperature/fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (passed about 1 cup of blood in her stool from her rectum) and RECTAL HAEMORRHAGE (passed about 1 cup of blood in her stool from her rectum) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATOCHEZIA (passed about 1 cup of blood in her stool from her rectum) (seriousness criterion medically significant), RECTAL HAEMORRHAGE (passed about 1 cup of blood in her stool from her rectum) (seriousness criterion medically significant), PYREXIA (temperature/fever) and MYALGIA (sore arm). At the time of the report, HAEMATOCHEZIA (passed about 1 cup of blood in her stool from her rectum), RECTAL HAEMORRHAGE (passed about 1 cup of blood in her stool from her rectum), PYREXIA (temperature/fever) and MYALGIA (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HAEMATOCHEZIA (passed about 1 cup of blood in her stool from her rectum), RECTAL HAEMORRHAGE (passed about 1 cup of blood in her stool from her rectum), PYREXIA (temperature/fever) and MYALGIA (sore arm) to be possibly related.    Concomitant medication included was Sedatives for the colonoscopy. No treatment medication was provided by the reporter. Lab test included was Colonoscopy performed - No results were provided.  The patient received her second dose of the Moderna COVID-19 vaccine by injection at the end of May. After receiving the vaccine, that day she had a sore arm and fever which lasted about 4 hours. She also went to the restroom that night and passed about 1 cup of blood in her stool from her rectum. The patient talked to her primary care doctor and sent a picture. She was referred to a gastroenterologist who performed a colonoscopy. The gastroenterologist stated that her symptoms were likely vaccine related. Besides sedatives for the colonoscopy, no medications or treatments were given.  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.; 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.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood cholesterol, Bone pain, Feeling abnormal, Gait disturbance
Clinical narrative: legs so swollen and full of water he could not walk/Swelling of feet; he can hardly walk; having a hard time seeing; bones ache and hurt; ankles swollen and blue and black; massive pain in both ankles; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs so swollen and full of water he could not walk/Swelling of feet), GAIT DISTURBANCE (he can hardly walk), FEELING ABNORMAL (having a hard time seeing), BONE PAIN (bones ache and hurt), JOINT SWELLING (ankles swollen and blue and black) and ARTHRALGIA (massive pain in both ankles) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, LISINOPRIL, ARIPIPRAZOLE and ATORVASTATIN for an unknown indication.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (legs so swollen and full of water he could not walk/Swelling of feet) (seriousness criterion hospitalization), GAIT DISTURBANCE (he can hardly walk) (seriousness criterion hospitalization), FEELING ABNORMAL (having a hard time seeing) (seriousness criterion hospitalization), BONE PAIN (bones ache and hurt) (seriousness criterion hospitalization), JOINT SWELLING (ankles swollen and blue and black) (seriousness criterion hospitalization) and ARTHRALGIA (massive pain in both ankles) (seriousness criterion hospitalization). At the time of the report, PERIPHERAL SWELLING (legs so swollen and full of water he could not walk/Swelling of feet), GAIT DISTURBANCE (he can hardly walk), FEELING ABNORMAL (having a hard time seeing), BONE PAIN (bones ache and hurt), JOINT SWELLING (ankles swollen and blue and black) and ARTHRALGIA (massive pain in both ankles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: high (High) Cholesterol levels spiked.         No treatment information was provided.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: legs so swollen and full of water he could not walk/Swelling of feet; he can hardly walk; having a hard time seeing; bones ache and hurt; ankles swollen and blue and black; massive pain in both ankles; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs so swollen and full of water he could not walk/Swelling of feet), GAIT DISTURBANCE (he can hardly walk), FEELING ABNORMAL (having a hard time seeing), BONE PAIN (bones ache and hurt), JOINT SWELLING (ankles swollen and blue and black) and ARTHRALGIA (massive pain in both ankles) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, LISINOPRIL, ARIPIPRAZOLE and ATORVASTATIN for an unknown indication.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (legs so swollen and full of water he could not walk/Swelling of feet) (seriousness criterion hospitalization), GAIT DISTURBANCE (he can hardly walk) (seriousness criterion hospitalization), FEELING ABNORMAL (having a hard time seeing) (seriousness criterion hospitalization), BONE PAIN (bones ache and hurt) (seriousness criterion hospitalization), JOINT SWELLING (ankles swollen and blue and black) (seriousness criterion hospitalization) and ARTHRALGIA (massive pain in both ankles) (seriousness criterion hospitalization). At the time of the report, PERIPHERAL SWELLING (legs so swollen and full of water he could not walk/Swelling of feet), GAIT DISTURBANCE (he can hardly walk), FEELING ABNORMAL (having a hard time seeing), BONE PAIN (bones ache and hurt), JOINT SWELLING (ankles swollen and blue and black) and ARTHRALGIA (massive pain in both ankles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: high (High) Cholesterol levels spiked.         No treatment information was provided.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: patient received the 1st dose of the Moderna vaccine and right after had throat tightening up and had to go to the ER; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (patient received the 1st dose of the Moderna vaccine and right after had throat tightening up and had to go to the ER) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced THROAT TIGHTNESS (patient received the 1st dose of the Moderna vaccine and right after had throat tightening up and had to go to the ER) (seriousness criteria hospitalization and life threatening). At the time of the report, THROAT TIGHTNESS (patient received the 1st dose of the Moderna vaccine and right after had throat tightening up and had to go to the ER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No treatment medication details was reported.  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.; 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.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac fibrillation
Clinical narrative: heart fibrillation so bad that he also went to the clinic; he was very weak; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FIBRILLATION (heart fibrillation so bad that he also went to the clinic) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FIBRILLATION (heart fibrillation so bad that he also went to the clinic) (seriousness criterion medically significant) and ASTHENIA (he was very weak). At the time of the report, CARDIAC FIBRILLATION (heart fibrillation so bad that he also went to the clinic) and ASTHENIA (he was very weak) outcome was unknown.            No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.   Patient  had heart fibrillation so bad that he also went to the clinic to get checked. He's a farmer and is generally healthy, but he was very weak after the vaccines.    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.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Pulmonary congestion
Clinical narrative: chest congestion; chest heaviness; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (chest congestion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY CONGESTION (chest congestion) (seriousness criterion medically significant) and CHEST DISCOMFORT (chest heaviness). At the time of the report, PULMONARY CONGESTION (chest congestion) and CHEST DISCOMFORT (chest heaviness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment details were provided.  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.  Further information is expected.; 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.  Further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Haemoptysis, Thrombosis
Clinical narrative: Multiple blood clot in both lungs; Having a hard time breathing / , breathing got more and more labor; Coughing blood; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Multiple blood clot in both lungs) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Multiple blood clot in both lungs) (seriousness criterion medically significant) and HAEMOPTYSIS (Coughing blood). an unknown date, the patient experienced DYSPNOEA (Having a hard time breathing / , breathing got more and more labor). The patient was treated with RIVAROXABAN (XARELTO) for Adverse reaction, at a dose of 20 mg twice a day and RIVAROXABAN (XARELTO) for Adverse reaction, at a dose of 15 mg twice a day. At the time of the report, THROMBOSIS (Multiple blood clot in both lungs), DYSPNOEA (Having a hard time breathing / , breathing got more and more labor) and HAEMOPTYSIS (Coughing blood) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Computerised tomogram: abnormal (abnormal) CT scan result indicated that patient had multiple blood clot in both.         Concomitant medication use information was not provided by reporter.  After 2nd dose patient had severe breathing difficulties, later started coughing blood. CT scan result found blood clots this clots are deep so patient had done echogram of heart and CT scan of leg because of showing legs problems and the results were unknown.  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.   This case was linked to MOD-2021-273692 (Patient Link).; 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Computerised tomogram head, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Bell's palsy; Hypoaesthesia; Injected limb mobility decreased; Muscular weakness; Paraesthesia; Injection site swelling; This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0352c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Meniere's disease. Concurrent medical conditions included Shellfish allergy, Bee sting, Drug allergy (aspirin), Penicillin allergy and Adhesive tape allergy. Concomitant products included IBUPROFEN, VITAMIN C [ASCORBIC ACID] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), HYPOAESTHESIA (Hypoaesthesia), INJECTED LIMB MOBILITY DECREASED (Injected limb mobility decreased), MUSCULAR WEAKNESS (Muscular weakness), PARAESTHESIA (Paraesthesia) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, BELL'S PALSY (Bell's palsy), HYPOAESTHESIA (Hypoaesthesia), INJECTED LIMB MOBILITY DECREASED (Injected limb mobility decreased), MUSCULAR WEAKNESS (Muscular weakness), PARAESTHESIA (Paraesthesia) and INJECTION SITE SWELLING (Injection site swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, Computerised tomogram head: abnormal (abnormal) diagnosed with bells palsy. On 19-Jul-2021, Computerised tomogram: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient was diagnosed with bells palsy and patient will see a neurologist.  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.; 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Muscular weakness, Paraesthesia
Clinical narrative: Bell's palsy; Hypoaesthesia; Injected limb mobility decreased; Muscular weakness; Paraesthesia; Injection site swelling; This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0352c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Meniere's disease. Concurrent medical conditions included Shellfish allergy, Bee sting, Drug allergy (aspirin), Penicillin allergy and Adhesive tape allergy. Concomitant products included IBUPROFEN, VITAMIN C [ASCORBIC ACID] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), HYPOAESTHESIA (Hypoaesthesia), INJECTED LIMB MOBILITY DECREASED (Injected limb mobility decreased), MUSCULAR WEAKNESS (Muscular weakness), PARAESTHESIA (Paraesthesia) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, BELL'S PALSY (Bell's palsy), HYPOAESTHESIA (Hypoaesthesia), INJECTED LIMB MOBILITY DECREASED (Injected limb mobility decreased), MUSCULAR WEAKNESS (Muscular weakness), PARAESTHESIA (Paraesthesia) and INJECTION SITE SWELLING (Injection site swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, Computerised tomogram head: abnormal (abnormal) diagnosed with bells palsy. On 19-Jul-2021, Computerised tomogram: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient was diagnosed with bells palsy and patient will see a neurologist.  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.; 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough exposure and positive test with the first vaccination; Breakthrough exposure and positive test with the first vaccination; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration in Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 (mild exposure) from Mar2020. The patient's concomitant medications were not reported. The patient reported that he is an essential employee. His wife and daughter are nurses in (city name). All three of them had a mild exposure from COVID-19 in Mar2020. The patient had a breakthrough exposure and positive test in Feb2021 with the first Pfizer vaccination in Feb2021. The patient mentioned that he is exposed in his job to over 25 people a day, he would like to volunteer for the Pfizer 3rd booster study. The patient was vaccinated with the 2nd Pfizer vaccine in Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chronic lymphocytic leukaemia, SARS-CoV-2 antibody test
Clinical narrative: She has a diagnosis of CLL; This is a spontaneous report from a Pfizer sponsored program, from a contactable female consumer (patient). A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on an unknown date, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on an unknown date, as a single dose for covid-19 immunization. On an unknown date, after taking both doses of the Pfizer covid-19 Vaccine, patient was diagnosed with CLL. She mentioned that she was not immune. The patient underwent lab test and procedure which included antibody test and it came back negative because of her Lymphoma & T-Cells and doctor recommends getting third shot of the covid vaccine and wanted to know if Pfizer can approve for her to receive a third Pfizer Covid 19 Vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.