chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED TWO DAYS AFTER TAKING VACCINE; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age. 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 (dose number in series1)(suspension for injection, route of admin were not reported, batch number: unknown, expiry: unknown) dose,1 total, administered ,start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died two days after vaccine was taken due to unknown cause. It was unspecified if an autopsy was performed. The reporter stated, "My uncle died two days after taking your VAX(vaccine)" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 20211263315-COVID-19 VACCINE AD26.COV2.S- died two days after taking vaccine. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age and sex, race and ethnicity. 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, and batch number were not reported, expiry; unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. (Dose number in series 1). 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 patient died. On an unspecified date, from unknown cause of death. It was unspecified if an autopsy was performed. The reporter reported that "Yes, I agree. There is something in it that is causing all kinds of problems. Only one news channel gives stats. I know of someone who died from it. It is pathetic. The government want is not telling us everything. It is evil. Prayers for the United States of America. We are going at down at a fast pace." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211263332- covid-19 vaccine ad26.cov2.s -Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: TESTED POSITIVE; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive was not reported. This report was non-serious. This report was associated with product quality complaint : 90000209406.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED PAST THE ACCEPTABLE 6 HOUR REFRIGERATION TIME LIMIT; INCORRECTLY STORED VACCINE ADMINISTRATED; This spontaneous report received from a pharmacist 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, and batch number were not reported) dose, 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 experienced vaccine administered past the acceptable 6 hour refrigeration time limit, and incorrectly stored vaccine administrated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered past the acceptable 6 hour refrigeration time limit and incorrectly stored vaccine administrated was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a parent concerned a male of unspecified age. 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, and batch number were not reported) dose, 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 24-DEC-2021, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20211261116.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SAME COMPLICATIONS; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced same complications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of same complications was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Haemoptysis, Headache, Pain in extremity
Clinical narrative: SINUS DRAINAGE; COUGH FROM SINUS DRAINAGE WITH BLOOD; FELT DRUGGED/FUZZY; SORE ARM; LOW ENERGY; 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, and concurrent conditions included: penicillin allergy, drug allergy, ex-smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced sore arm, low energy, and headache. On 24-DEC-2021, the patient experienced felt drugged/fuzzy. On 28-DEC-2021, the patient experienced sinus drainage, and cough from sinus drainage with blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 25-DEC-2021, was recovering from felt drugged/fuzzy, low energy, and sore arm, and had not recovered from sinus drainage, and cough from sinus drainage with blood. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus hypersecretion
Clinical narrative: SINUS DRAINAGE; COUGH FROM SINUS DRAINAGE WITH BLOOD; FELT DRUGGED/FUZZY; SORE ARM; LOW ENERGY; 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, and concurrent conditions included: penicillin allergy, drug allergy, ex-smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced sore arm, low energy, and headache. On 24-DEC-2021, the patient experienced felt drugged/fuzzy. On 28-DEC-2021, the patient experienced sinus drainage, and cough from sinus drainage with blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 25-DEC-2021, was recovering from felt drugged/fuzzy, low energy, and sore arm, and had not recovered from sinus drainage, and cough from sinus drainage with blood. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional 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: 1855835, and expiry: 27-APR-2022) dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-DEC-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's family members were tested positive for covid-19 and patient was exposed by his son who was unvaccinated and was currently experiencing severe covid-19 symptoms. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-DEC-2021, the patient was asymptomatic during the day until he had chills at night. The patient had symptoms of light headedness, fatigue, lower part of back was hurting and little congestion (coded as suspected covid-19 infection, suspected clinical vaccination failure). The patient took cold and flu medications and Mucinex which had helped him for a couple of hours. It was reported that the patient has not had any booster dose of any vaccine. On 29-DEC-2021, the patient was tested positive for covid-19 with a home kit test. The patient had not taken polymerase chain reaction (PCR) test yet. (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with regulatory authority.; Sender's Comments: V0: 20211264179-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fear, Rectal neoplasm
Clinical narrative: GROWTH START ON HIS RECTUM  AFTER HIS VAX; WORRIED; AFRAID TO ASK; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced growth start on his rectum after his vax, worried, and afraid to ask. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the growth start on his rectum after his vax, worried and afraid to ask was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Mouth ulceration, Swelling face
Clinical narrative: an episode of anaphylaxis where patient went to emergency room; experiencing mouth ulcers; facial swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (an episode of anaphylaxis where patient went to emergency room) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced MOUTH ULCERATION (experiencing mouth ulcers) and SWELLING FACE (facial swelling). On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (an episode of anaphylaxis where patient went to emergency room) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; HYDROXYZINE for Adverse event, at an unspecified dose and frequency and FAMOTIDINE for Adverse event, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (an episode of anaphylaxis where patient went to emergency room), MOUTH ULCERATION (experiencing mouth ulcers) and SWELLING FACE (facial swelling) had not resolved.            Patient reported that she was released from ER after an overnight stay. .  No relevant concomitant medications were reported. Company Comment This case concerns a 47-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of anaphylactic reaction. The event occurred 24 days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 47-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of anaphylactic reaction. The event occurred 24 days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: his temperature 102°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (his temperature 102°F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (his temperature 102°F). At the time of the report, PYREXIA (his temperature 102°F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Body temperature: 102°f (High) 102 degree Fahrenheit.         No concomitant medications were reported. No treatment details were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient contracted COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient contracted COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced COVID-19 (patient contracted COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with CASIRIVIMAB, IMDEVIMAB (REGEN COV) on 02-Sep-2021 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (patient contracted COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive for COVID-19.         Patient does not takes any daily medications. The patient had no known drug or food allergies and had no risk factors for COVID-19 infection. The patient was not hospitalized for COVID-19.  The reported had heard that the Moderna booster dose might be made less effective after receiving REGEN-COV infusion. The patient has not yet received the booster dose of Moderna vaccine.; Sender's Comments: This case concerns a 68-year-old female patient with no relevant medical history, who experienced the unexpected events of COVID-19 and Drug Ineffective. The events occurred approximately 7 months  2 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The two doses were administered at approximately 30 days interval. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) in not affected by this report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VERAPAMIL, ALLOPURINOL, EZETIMIBE (ZETIA), ROSUVASTATIN CALCIUM (CRESTOR), TERIZIDONE, CALCITONIN, SALMON and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No treatment information was provided by the reporter.  Patient wanted to get the Moderna COVID-19 booster vaccine but ended up testing positive again for COVID.; Sender's Comments: This case concerns a 80-year-old male patient with no relevant medical history, who experienced the unexpected events of COVID-19 and Drug Ineffective. The events occurred approximately 8 months after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) in not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). In 2021, ATRIAL FIBRILLATION (atrial fibrillation) had resolved.            Patient was not taking any concomitant medication at the moment of the event.  He had no history of COVID-19 infection nor Myocarditis/Pericarditis. Patient did not required hospitalization.  Back in March and April the patient received two Moderna shots, however, a week after the first shot he woke up in the morning and felt that he had irregular heartbeat. His family doctor diagnosed him with Atrial Fibrillation, which initially kept coming and going, but never went away, got worse and became persistent over the following weeks. At first, he was told by several doctors that it was unlikely that the Covid vaccine would have caused the atrial fibrillation, however, a cardiologist told him that it could not be excluded. He had to undergo a cardioversion to bring his heart back into normal sinus rhythm. He was treated with was blood thinner before electroshocks. After that, he was recovered to normal heart rhythm and symptoms were not ongoing.   Company Comment - This case concerns a 54 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of atrial fibrillation (AESI). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine and had resolved at the time of this report. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Age of the patient and Start date of vaccine updated On 17-Dec-2021: No new information updated.; Sender's Comments: This case concerns a 54 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of atrial fibrillation (AESI). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine and had resolved at the time of this report. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Vaccination complication
Clinical narrative: faint; has an adverse reaction to Moderna/happened again this afternoon, and didn't go away for like the same time 20 to 30 minutes.; started falling very dizzy/happened again this afternoon, and didn't go away for like the same time 20 to 30 minutes.; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (faint) 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.     No Medical History information was reported.    On 17-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant), VACCINATION COMPLICATION (has an adverse reaction to Moderna/happened again this afternoon, and didn't go away for like the same time 20 to 30 minutes.) and DIZZINESS (started falling very dizzy/happened again this afternoon, and didn't go away for like the same time 20 to 30 minutes.). At the time of the report, SYNCOPE (faint), VACCINATION COMPLICATION (has an adverse reaction to Moderna/happened again this afternoon, and didn't go away for like the same time 20 to 30 minutes.) and DIZZINESS (started falling very dizzy/happened again this afternoon, and didn't go away for like the same time 20 to 30 minutes.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  Patient stated that she has an adverse reaction to Moderna, she received it yesterday and started falling very dizzy and faint, that lasted about 20- 30 minutes and went away, and today patient woke up felling Okay and it wasn't, and happened again this afternoon, and didn't go away for like the same time 20 to 30 minutes.  Company Comment This case concerns a female patient of an unknown age with no reported medical history, who experienced the serious expected event of Syncope. The event occurred the same day after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age with no reported medical history, who experienced the serious expected event of Syncope. The event occurred the same day after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Loss of consciousness, Seizure
Clinical narrative: he had one episode of seizure where he passed out for a little bit and he started convulsing for 7 seconds; Passed out for a little; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (he had one episode of seizure where he passed out for a little bit and he started convulsing for 7 seconds) and LOSS OF CONSCIOUSNESS (Passed out for a little) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced SEIZURE (he had one episode of seizure where he passed out for a little bit and he started convulsing for 7 seconds) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Passed out for a little) (seriousness criterion medically significant). On 04-Jul-2021, SEIZURE (he had one episode of seizure where he passed out for a little bit and he started convulsing for 7 seconds) and LOSS OF CONSCIOUSNESS (Passed out for a little) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal.         Concomitant product use was not provided by the reporter.   No treatment information was provided.  On 04-Jul-2021, the patient had one episode of seizure where he passed out for a little bit and he started convulsing for 7 seconds. He consulted with a neurologist at the end of Jul-2021.  Company Comment - This case concerns a 50 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of loss of consciousness and seizure. The events occurred approximately 3 months after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to (Patient Link).; Sender's Comments: This case concerns a 50 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of loss of consciousness and seizure. The events occurred approximately 3 months after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Pain in extremity
Clinical narrative: Arrhythmias; Arm is hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmias) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Acid reflux (oesophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), METOPROLOL for Blood pressure high.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is hurting). On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmias) (seriousness criteria hospitalization and medically significant). At the time of the report, ARRHYTHMIA (Arrhythmias) outcome was unknown and PAIN IN EXTREMITY (Arm is hurting) had not resolved.        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 treatment medications were provided. The patient has not been infected with COVID-19. The patient doesn´t have a history of Myocarditis/pericarditis.  Company Comment - This case concerns a 44 year old female patient with medical history of blood pressure high, who experienced the serious unexpected event of arrhythmia. The event arrhythmia occurred on an unknown date after the first dose of mRNA-1273 vaccine. Patient's medical history of blood pressure high remains a confounder. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-418012, MOD-2021-418016 (Patient Link).; Sender's Comments: This case concerns a 44 year old female patient with medical history of blood pressure high, who experienced the serious unexpected event of arrhythmia. The event arrhythmia occurred on an unknown date after the first dose of mRNA-1273 vaccine. Patient's medical history of blood pressure high remains a confounder. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up"; Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up"; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") and LOSS OF CONSCIOUSNESS (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 030A21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced SEIZURE (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") (seriousness criterion medically significant). At the time of the report, SEIZURE (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") outcome was unknown and LOSS OF CONSCIOUSNESS (Today, 17Dec2021, a day after he had the booster dose, he claims that he had the same feeling as before - he " was out for under a minute and just woke up") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  On  17-Dec-2021, a day after patient had the booster dose, patient  claim that he had the same feeling as before - he  was out for under a minute and just woke up.   This case was linked to MOD-2021-417226 (Patient Link).; Sender's Comments: This case concerns a 50-year-old, male patient with no relevant medical history, who experienced the unexpected events of Seizure and Loss of Consciousness. The events occurred approximately 1 day after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after booster dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Product dose omission issue
Clinical narrative: did not receive his second dose yet because of this reaction; Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a 42-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.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). On 21-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive his second dose yet because of this reaction). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 21-Jan-2021, PRODUCT DOSE OMISSION ISSUE (did not receive his second dose yet because of this reaction) had resolved. In 2021, BELL'S PALSY (Bells Palsy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient developed Bell's Palsy after 28-30 hours of vaccination and was recovered almost after a month and a half. Patient did not receive dose 2 as patient's primary care doctor said the risk may be too much.  Company Comment: This is a spontaneous case concerning a 42-year-old, male patient with no reported medical history, who experienced the expected, serious, AESI event of Bell's palsy. The event occurred 28- 30 hours after the first dose of mRNA-1273 vaccine. The patient developed Bell's Palsy after 28-30 hours of vaccination and was recovered almost after a month and a half, so patient did not receive dose 2 as patient's primary care doctor said the risk may be too much, Product dose omission issue is also noted in the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 42-year-old, male patient with no reported medical history, who experienced the expected, serious, AESI event of Bell's palsy. The event occurred 28- 30 hours after the first dose of mRNA-1273 vaccine. The patient developed Bell's Palsy after 28-30 hours of vaccination and was recovered almost after a month and a half, so patient did not receive dose 2 as patient's primary care doctor said the risk may be too much, Product dose omission issue is also noted in the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Dermatitis bullous, Pemphigoid
Clinical narrative: largest fluid filled blisters was the size of a dime; Bullous episode; Diagnosed with bullous pemphigoid/areas affected include the hands, arms and under arm area of chest/recent outbreaks on right lower leg; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS BULLOUS (Bullous episode) and PEMPHIGOID (Diagnosed with bullous pemphigoid/areas affected include the hands, arms and under arm area of chest/recent outbreaks on right lower leg) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PEMPHIGOID (Diagnosed with bullous pemphigoid/areas affected include the hands, arms and under arm area of chest/recent outbreaks on right lower leg) (seriousness criterion medically significant). On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DERMATITIS BULLOUS (Bullous episode) (seriousness criterion medically significant). On an unknown date, the patient experienced BLISTER (largest fluid filled blisters was the size of a dime). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and DOXYCYCLINE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DERMATITIS BULLOUS (Bullous episode), PEMPHIGOID (Diagnosed with bullous pemphigoid/areas affected include the hands, arms and under arm area of chest/recent outbreaks on right lower leg) and BLISTER (largest fluid filled blisters was the size of a dime) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-417920 (Patient Link).; Sender's Comments: This case concerns a 72-year-old, male patient with no relevant medical history, who experienced the unexpected event of Bullous Pemphigus. The event occurred approximately 7 days after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incision site inflammation, Pain, Postoperative wound infection
Clinical narrative: infection in the surgical incision site; inflammation in the surgical incision site; Pain; This spontaneous case was reported by a consumer and describes the occurrence of POSTOPERATIVE WOUND INFECTION (infection in the surgical incision site) in a 59-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.     The patient's past medical history included Surgery. Concurrent medical conditions included Immunocompromised.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTOPERATIVE WOUND INFECTION (infection in the surgical incision site) (seriousness criterion medically significant), INCISION SITE INFLAMMATION (inflammation in the surgical incision site) and PAIN (Pain). At the time of the report, POSTOPERATIVE WOUND INFECTION (infection in the surgical incision site), INCISION SITE INFLAMMATION (inflammation in the surgical incision site) and PAIN (Pain) outcome was unknown.            No concomitant medication was reported. The Patient was immunocompromised, in turn, Patient told the caller that patient had surgery three weeks ago. After receiving the vaccine (on 17DEC2021, LOT NUMBER: Not Provided), Patient began to experience severe inflammation and infection in the surgical incision site.  The patient has a lot of pain. Consent given to follow up with safety. Treatment medication was not provided by the reporter.; Sender's Comments: This case concerns a 59-year-old, female patient with relevant medical history of immunodeficiency and recent surgery, who experienced the unexpected events of Postoperative Wound Infection and Incision Site Inflammation. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after the third dose. However, the recent surgical history in this immunocompromised patient remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: effected her asthma; ended up testing positive/had COVID-19 in November; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (effected her asthma), COVID-19 (ended up testing positive/had COVID-19 in November) and DRUG INEFFECTIVE (Lack of drug effect) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient went to urgent care 2-3 times) and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), LOSARTAN, MONTELUKAST, SERTRALINE, PRAVASTATIN, ALBUTEROL [SALBUTAMOL], LEVOCETIRIZINE, PROBIOTICS NOS, MELATONIN, MIRABEGRON (MYRBETRIQ) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (ended up testing positive/had COVID-19 in November) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced ASTHMA (effected her asthma). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHMA (effected her asthma), COVID-19 (ended up testing positive/had COVID-19 in November) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In November 2021, SARS-CoV-2 test: positive (Positive) ended up testing positive.Concomitant product included Resmipat 1.25 taken 2 sprays daily, Ristela spray taken twice a day and nebulizer taken as the circumstances arises.Treatment medication included monoclonal antibodies on 23 Nov 2021 and antibiotics. Sender's Comments: This case concerns a 79-year-old female patient with relevant medical history of Asthma, who experienced the unexpected event of COVID-19, Drug Ineffective, and Asthma. The events of COVID-19 and Drug Ineffective occurred approximately 8 months after the second dose of mRNA-1273 (Moderna covid-19 vaccine); while Asthma occurred at unspecified interval. The rechallenge was not applicable as events occurred after second dose. Patient's underlying medical condition remains a confounder.The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) in not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve compression, Vaccination site mass, Vaccination site movement impairment
Clinical narrative: Had a knot in her arm, it looks like a lump where she got the shot; Cannot stick her arm above her chest; Pinched nerve in the neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Had a knot in her arm, it looks like a lump where she got the shot), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot stick her arm above her chest) and MUSCULOSKELETAL DISCOMFORT (Pinched nerve in the neck) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 031M20A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Was taking asthma medicines).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION SITE MASS (Had a knot in her arm, it looks like a lump where she got the shot) (seriousness criterion hospitalization), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot stick her arm above her chest) (seriousness criterion hospitalization) and MUSCULOSKELETAL DISCOMFORT (Pinched nerve in the neck) (seriousness criterion hospitalization). At the time of the report, VACCINATION SITE MASS (Had a knot in her arm, it looks like a lump where she got the shot), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot stick her arm above her chest) and MUSCULOSKELETAL DISCOMFORT (Pinched nerve in the neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product included asthma medications. It was reported that she had a knot in her arm, it looked like a lump where she got the shot. She cannot stick her arm above her chest, she had a pinched nerve in the neck. Had to go to the hospital and everything was okay besides her arm.