chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS ADMINISTERED FROM  A VIAL THAT WAS EXPOSED TO  A TEMPERATURE OF 35 DEGREE  FAHRENHEIT FOR 4 HOURS; 5  DOSES FROM THE SAME VIAL WERE ADMINISTERED TO 5 PATIENTS; This spontaneous report received from a consumer concerned multiple patients 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: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 22-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 22-JAN-2022, the patient experienced vaccine was administered from a vial that was exposed to a temperature of 35 degree Fahrenheit for 4 hours. On 22-JAN-2022, the patient experienced 5 doses from the same vial were administered to 5 patients. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered from a vial that was exposed to a temperature of 35 degree Fahrenheit for 4 hours and 5 doses from the same vial were administered to 5 patients was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Paralysis
Clinical narrative: PARALYZED; WOULD HAVE DIED; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. 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 administration, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total administered 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 reporter reported that, "He know of a girl that after about a month suddenly became paralyzed and would have died if someone had not been there at the time." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paralyzed and would have died was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220157373-covid-19 vaccine ad26.cov2.s- Paralyzed,Would have died.This event is considered unassessable. The event 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
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR LOSS; This spontaneous report received from a consumer concerned multiple female patients of unspecified age. 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 hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair loss was not reported. This report was non-serious. This case, from the same reporter is linked to 20220156562.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: COMPLICATIONS FROM THIS VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple female patients of unknown race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, 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,15% of those who got complications from this vaccine, died. Fifteen percent of the 36 women who ended up in the ICU died. Which is 9 of 16 million people who got this vaccine. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220157677-covid-19 vaccine ad26.cov2.s-Complications from this 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: COMPLICATIONS
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a 32 year old of unspecified 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) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced death. On an unspecified date, the patient died from unknown cause of death. It was reported that reporter commented as " my 32 year old cousin too". It was unknown whether Autopsy was done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the Others is linked to 20220110646.; Sender's Comments: V0: 20220160712-Covid-19 vaccine ad26.cov2.s-Death. 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: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION TO FIRST DOSE; This spontaneous report received from a consumer concerned a female 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 an unspecified date, the patient experienced allergic reaction to first dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction to first dose was not reported. This report was non-serious. This case, from the same reporter is linked to 20220151884.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FOUR HOUR LATER INHALED A BUCKET OF CHICKEN, THEN IT HIT HIM AND FOR 8 HOURS KICKED HIS BUTT, AND HE WOKE UP LIKE SUPERMAN; This spontaneous report received from a patient concerned a 53 year old white male of unspecified ethnic origin. The patient's height, and weight were not reported. The patient was moderately healthy with no real co-morbidities. The patient was previously treated with covid-19 vaccine (dose number in series 1) (form of admin, route of admin, batch number, and expiry were not reported) dose, start therapy date were not reported for prophylactic vaccination.  On an unspecified date, by the other vaccines the patient felt super terrible for days (dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, 1 total administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included L-arginine (arginine hydrochloride) for drug used for unknown indication.  On 26-MAR-2021, 4 hours after vaccination patient inhaled a bucket of chicken, then it hit him and for 8 hours kicked his butt (dose number in series 2). Patient woke up like superman. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of four hour later inhaled a bucket of chicken, then it hit him and for 8 hours kicked his butt, and he woke up like superman was not reported (dose number in series 2). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: VACCINE WAS INEFFECTIVE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: emphysema. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reporter indicated that the patient felt vaccine was ineffective (dose number in series 1) and stated she did not have anything left to boost- referring to the level of protection that remained from Janssen vaccine. On 01-NOV-2021, the patient additionally received Moderna vaccine (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported for prophylactic vaccination. It was unknown if the patient had any adverse events after Moderna vaccine (dose number in series 2). The reporter stated that she heard the vaccine was only good for 2 months and was concerned about patient for the level of protection against COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was ineffective was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000214573. This case, from the same reporter is linked to 20220160825.; Sender's Comments: V0: 20220160740-covid-19 vaccine ad26.cov2.s- Vaccine was ineffective. 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: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension, Palpitations
Clinical narrative: HEART PALPITATIONS; HIGH BLOOD PRESSURE; RAPID PULSE; 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. The patient's pre-existing medical conditions included: Patient was a perfectly healthy athlete at the time of vaccination. 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 heart palpitations, high blood pressure, and rapid pulse. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High, and Pulse rate (NR: not provided) Rapid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations, high blood pressure, and rapid pulse. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: DESTROYED ME AND MY LIFE; 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, 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 destroyed me and my life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of destroyed me and my life was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Fatigue, Hypersomnia
Clinical narrative: SLEEPINESS/COULD HARDLY GET OUT OF BED AND SLEPT MORE THAN USUAL.; TIREDNESS; FEELING TREMENDOUS ELECTRICITY GOING THROUGH BODY AND WAS SHOCKED; 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 was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04321A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced feeling tremendous electricity going through body and was shocked. On 07-APR-2021, the patient experienced sleepiness/could hardly get out of bed and slept more than usual. On 07-APR-2021, the patient experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling tremendous electricity going through body and was shocked, and the outcome of tiredness and sleepiness/could hardly get out of bed and slept more than usual. was not reported. This report was non-serious. This case, involving the same patient is linked to 20220161445.
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Malaise, Unevaluable event
Clinical narrative: HE WAS FEELING THE SYMPTOMS THAT PEOPLE WAS FEELING BEFORE THE SHOTS; HE WAS FEELING SICK; HOT FLASHES; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient already had medical issues in the past but was fine before the shots. 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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 28-JAN-2022, the patient experienced hot flashes. On an unspecified date, the patient experienced he was feeling the symptoms that people was feeling before the shots, and he was feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hot flashes, he was feeling the symptoms that people was feeling before the shots and he was feeling sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: ALLERGIES AND COUGH ALMOST DISAPPEARED; 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, and batch number were not reported, expiry: 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 allergies and cough almost disappeared. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergies and cough almost disappeared was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: A CLOT IN BRAIN; This spontaneous report received from a consumer via a company representative via social media concerned a male of an unspecified age, race and ethnic origin. 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 administration was not reported, and batch number: unknown expiry: unknown ) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  It was reported that, on an unspecified date, Johnson and Johnson vaccine caused a blood clot in patient's brain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a clot brain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20220161645-COVID-19 VACCINE AD26.COV2.S -A clot in brain. 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).
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: PROBLEM WITH SKIN; 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. The patient's concurrent conditions included: afib. 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 problem with skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of problem with skin was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm; Achy muscles; This spontaneous report received from a patient via a company representative concerned a female 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced achy muscles, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy muscles and sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20220139574.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus headache, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; SINUS HEADACHE; This spontaneous report received from a patient concerned a 41 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: 043A21A, expiry: 19-SEP-2021) dose was not reported, 1 total administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 29-JAN-2022, the patient experienced body aches, chills, sinus headache and fever. On 30-JAN-2022, the patient was tested positive for Covid-19 by BiNax home antigen test (suspected clinical vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19, and sinus headache, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000214912.; Sender's Comments: V0:20220162392-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: U
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Malaise
Clinical narrative: DIZZINESS; NOT FEELING WELL; NUMBNESS ON THE LEFT SIDE/HAND, FACE AND LEG SOME TIME; 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, 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 dizziness, not feeling well, and numbness on the left side/hand, face and leg some time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and not feeling well, and the outcome of numbness on the left side/hand, face and leg some time was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: CHILLS; SORE ARM; This spontaneous report received from a consumer concerned an 80 year old female. 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 was not reported, administered on 29-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2022, the patient experienced chills, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a consumer 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, 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 side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side effects. This report was non-serious. This case, from the same reporter is linked to 20220200610 and 20220201530.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: LOST TWO FRIENDS; This spontaneous report received from a consumer via a company representative via social media concerned two patients of unspecified age, sex, race and ethnicity. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total, start therapy date were not reported for prophylactic vaccination. The batch number were not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, both patient died. Reporter stated that "A friend lost two friends due to the vax." On an unspecified date, both patient died due to unknown cause. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220200584.; Sender's Comments: V0 20220200610- COVID-19 VACCINE AD26.COV2.S- Lost two friends. 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: Road traffic accident
Clinical narrative: GOT IN A CAR ACCIDENT AFTER TAKING IT; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced got in a car accident after taking it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got in a car accident after taking it was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE REACTIONS; This spontaneous report received from a consumer 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, 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 severe reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20220201531.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: HAVING TREMORS; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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 patients experienced having tremors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having tremors was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a consumer concerned a 52 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: 21300DZ1A, expiry:11-APR-2022) dose was not reported, administered on 26-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 22-JAN-2022, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 26-JAN-2022, the patient experienced tested positive for covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: GOING DEAF IN ONE EAR; UNBEARABLE RINGING IN MY HEAD; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, 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 not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered 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 going deaf in one ear, and unbearable ringing in my head. On an unspecified date, the reporter stated that "Can you help me with the three months of he heck I've been through from going deaf in one ear and the unbearable ringing in my head from your safe vaccine." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the going deaf in one ear and unbearable ringing in my head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220201356-Covid-19 vaccine ad26.cov2.s-going deaf in one ear 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).
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a female 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. 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 side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side effects. This report was non-serious. This case, from the same reporter is linked to 20220200584 and 20220200610.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: WOUND UP IN THE EMERGENCY ROOM WITH CHEST  PAIN; This spontaneous report received from a parent via a company representative concerned a 19 year old female. 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 wound up in the emergency room with chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wound up in the emergency room with chest pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20220202442.
Sex: F
Vaccine: COVID19
Symptoms: Muscle disorder
Clinical narrative: MUSCLE PROBLEMS IN THE ARM; This spontaneous report received from a patient via a company representative concerned a female 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. 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 muscle problems in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle problems in the arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: ISSUES FROM A FEW DAYS AFTER SHOT; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patients were in best health. 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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced issues from a few days after shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of issues from a few days after shot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Exposure via breast milk, Gastrooesophageal reflux disease
Clinical narrative: Baby having problems going to the bathroom-moving her stools; Baby also having problems with acid reflux; vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL FAECES (Baby having problems going to the bathroom-moving her stools), GASTROOESOPHAGEAL REFLUX DISEASE (Baby also having problems with acid reflux) and EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) in a 1-month-old female infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the infant was diagnosed with ABNORMAL FAECES (Baby having problems going to the bathroom-moving her stools), GASTROOESOPHAGEAL REFLUX DISEASE (Baby also having problems with acid reflux) and EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred  on 30-Nov-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, ABNORMAL FAECES (Baby having problems going to the bathroom-moving her stools) and GASTROOESOPHAGEAL REFLUX DISEASE (Baby also having problems with acid reflux) outcome was unknown and EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported. Treatment information was not provided   This case was linked to MOD-2022-464894 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided. The vial was initially stored in the refrigerator on 16-Dec-2021. The vial didn't undergo any temperature excursions.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I broke with Covid; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2022 and was forwarded to Moderna on 29-Jan-2022.    This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (I broke with Covid) 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.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 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 COVID-19 (I broke with Covid). At the time of the report, COVID-19 (I broke with Covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient had both the vaccines in September but broke with COVID Thursday.; Sender's Comments: This spontaneous case concerns a patient of unknown age/sex with no medical history, experience the unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred on an unknown date after the second dose of mRNA-1273. The patient was tested positive for SARS-Cov-2. The dates of first and second dose were not reported. The treatment details were not reported. At the time of reporting the outcome was not known. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dyspnoea, Dysstasia, Fatigue, Gait inability
Clinical narrative: I can't walk; Out of breath/hard time keeping my breath; Can't keep my balance or anything; Can't stand up more than 6 minutes now; Tired; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (I can't walk), DYSPNOEA (Out of breath/hard time keeping my breath), BALANCE DISORDER (Can't keep my balance or anything), DYSSTASIA (Can't stand up more than 6 minutes now) and FATIGUE (Tired) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included Blood pressure high.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced GAIT INABILITY (I can't walk), DYSPNOEA (Out of breath/hard time keeping my breath), BALANCE DISORDER (Can't keep my balance or anything), DYSSTASIA (Can't stand up more than 6 minutes now) and FATIGUE (Tired). At the time of the report, GAIT INABILITY (I can't walk), DYSPNOEA (Out of breath/hard time keeping my breath), BALANCE DISORDER (Can't keep my balance or anything), DYSSTASIA (Can't stand up more than 6 minutes now) and FATIGUE (Tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After 7-10 days receiving the second dose the patient started having adverse events. The patient was being laid off from work since May 2021 and states that he had no Past medical history and reports no use of concomitant medications. He does not take any medication to help relive the possible Adverse events.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Thyroid disorder
Clinical narrative: Patient began having Thyroid problems after the 1st dose; Patient found out she was pregnant a month after 1st dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient found out she was pregnant a month after 1st dose) and THYROID DISORDER (Patient began having Thyroid problems after the 1st dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast feeding.   In February 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In February 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient found out she was pregnant a month after 1st dose). On an unknown date, the patient experienced THYROID DISORDER (Patient began having Thyroid problems after the 1st dose). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. In February 2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient found out she was pregnant a month after 1st dose) had resolved. At the time of the report, THYROID DISORDER (Patient began having Thyroid problems after the 1st dose) had not resolved.            No concomitant medication provided No treatment medication provided Patient was taking thyroid medicine for thyroid problems.   This case was linked to MOD-2022-464894 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lethargy, Nausea, Vomiting
Clinical narrative: severe nausea; Feeling lethargic; Sick every 20 minutes/sick feeling; Felt like throwing up not much came up; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Feeling lethargic), ILLNESS (Sick every 20 minutes/sick feeling), NAUSEA (severe nausea) and VOMITING (Felt like throwing up not much came up) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 02DB21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure management.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021 at 9:25 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (Felt like throwing up not much came up). On 29-Apr-2021 at 4:00 PM, the patient experienced LETHARGY (Feeling lethargic) and ILLNESS (Sick every 20 minutes/sick feeling). On 29-Apr-2021 at 5:00 PM, the patient experienced NAUSEA (severe nausea). On 30-Apr-2021, NAUSEA (severe nausea) and VOMITING (Felt like throwing up not much came up) had resolved. At the time of the report, LETHARGY (Feeling lethargic) and ILLNESS (Sick every 20 minutes/sick feeling) outcome was unknown.            It was reported that the patient drank lot of water prior to the vaccine.Patient was not able to take medication hence drank ginger tea drank all the day. Patient had Blood Pressure. Patient had no allergies.Patient not had COVID or tested Positive for COVID No treatment medication was reported.  Patient's experience feared to get booster dose. Nausea was started around 10-11 pm  non stop every 15-20 min. This went on until the following day around 5:00 and started to dissipate.Patient had 17 hour severe nausea.Felt like throwing up not much came up   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received contains start date of first dose and second dose, batch number, start date of event, patient details (age) and concomitant medication of the patient. On 01-Feb-2022: Reporter details updated.Patient demographics updated.Medical History,Concomitant product information was added.Anatomical Location was updated.Events were added.Outcome of Event was updated
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pfizer booster administered 20 days early  No negative effects observed during the administration of the vaccine nor during the 15 minutes observation period after
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nasal discomfort, Rhinorrhoea
Clinical narrative: Extreme nasal drainage  Extreme pressure when bending over or trying to exercise  Bad cramps in abdomen
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: My period was supposed to start 12/1/2021. It was delayed by two weeks, starting 12/15/2021. Cycle returned to normal the next month, starting 1/15/2022.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Brain scan normal, Cardiomegaly, Cerebral thrombosis, Computerised tomogram
Clinical narrative: Blood Clot right side of brain.  No symptoms.  Total loss of function on entire left side.  Treated for stroke(TPA Drip).  ICU 3 days.  Determined not to be stroke-no evidence on brain scan.  Heart Chamber now enlarged.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diagnostic procedure, Hemiplegia, Intensive care, Laboratory test, Magnetic resonance imaging
Clinical narrative: Blood Clot right side of brain.  No symptoms.  Total loss of function on entire left side.  Treated for stroke(TPA Drip).  ICU 3 days.  Determined not to be stroke-no evidence on brain scan.  Heart Chamber now enlarged.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature).