chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Feeling hot, Flushing
Clinical narrative: FEEL WARM FROM MY HEAD TO MY NECK /WARMTH SENSATION ALL OVER/ LIGHT WARM SENSATION IN CHEST AREA; ANXIETY; ELEVATED BLOOD PRESSURE; FLUSHED FACE/GOT RED IN THE FACE; SHAKY LEGS; This spontaneous report received from a patient concerned a 79-year-old elderly female. The patient's weight was 180 kilograms, and height was 67 centimeters. The patient's past medical history included: constipation (the patient stated that Cholestyramine 4g gave her horrendous Constipation), and concurrent conditions included: hernias, Crohn's symptoms, and irritable bowel symptoms (IBS), and other pre-existing medical conditions included: The patient had no known allergies. The Patient added that her stomach started going bad when COVID hit, and that currently she was in remission from Crohn's/IBS and was currently undergoing GI diagnostic testing for her recent reappearance of GI (gastro intestinal) symptoms. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) 1 total, dose not reported, administered on 18-MAR-2021 for prophylactic vaccination (dose number in series 1), and reported no side effects at all. The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) 1 total, dose was not reported, administered at right arm on 15-DEC-2021 at 10:30 for prophylactic vaccination (dose number in series 2).  Concomitant medications included Cholestyramine Oral powder 4g (colestyramine) for Chron's symptoms (For stomach issues, not for Cholesterol). The patient skipped the medication as per her HCP (Health care provider) at the day of reporting. On 15-Dec-2021, the patient reported that she started getting warm, started in feet, went to neck too, all over, like getting IV dye, but not internal, more like in the skin- she got red in the face, flushed, became anxious after the 10-minute observation period was over and they had kept her there for another 45 minutes and then she got really anxious. The patient stated that there was 4 separate episodes of this, they started about 5'' after, occurring every 5-10''. The patient added that her blood pressure was elevated, no temperature was taken, and she had "shaking legs". The patient stated that vaccine facility suggested her to go to Emergency room but the episodes subsided, nothing else happened, so she went home. The patient was reporting that she was still having light warm sensation in chest area (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, flushed face/got red in the face, and shaky legs on 15-DEC-2021, was recovering from anxiety, and had not recovered from feel warm from my head to my neck /warmth sensation all over/ light warm sensation in chest area. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: FEEL WARM FROM MY HEAD TO MY NECK /WARMTH SENSATION ALL OVER/ LIGHT WARM SENSATION IN CHEST AREA; ANXIETY; ELEVATED BLOOD PRESSURE; FLUSHED FACE/GOT RED IN THE FACE; SHAKY LEGS; This spontaneous report received from a patient concerned a 79-year-old elderly female. The patient's weight was 180 kilograms, and height was 67 centimeters. The patient's past medical history included: constipation (the patient stated that Cholestyramine 4g gave her horrendous Constipation), and concurrent conditions included: hernias, Crohn's symptoms, and irritable bowel symptoms (IBS), and other pre-existing medical conditions included: The patient had no known allergies. The Patient added that her stomach started going bad when COVID hit, and that currently she was in remission from Crohn's/IBS and was currently undergoing GI diagnostic testing for her recent reappearance of GI (gastro intestinal) symptoms. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) 1 total, dose not reported, administered on 18-MAR-2021 for prophylactic vaccination (dose number in series 1), and reported no side effects at all. The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) 1 total, dose was not reported, administered at right arm on 15-DEC-2021 at 10:30 for prophylactic vaccination (dose number in series 2).  Concomitant medications included Cholestyramine Oral powder 4g (colestyramine) for Chron's symptoms (For stomach issues, not for Cholesterol). The patient skipped the medication as per her HCP (Health care provider) at the day of reporting. On 15-Dec-2021, the patient reported that she started getting warm, started in feet, went to neck too, all over, like getting IV dye, but not internal, more like in the skin- she got red in the face, flushed, became anxious after the 10-minute observation period was over and they had kept her there for another 45 minutes and then she got really anxious. The patient stated that there was 4 separate episodes of this, they started about 5'' after, occurring every 5-10''. The patient added that her blood pressure was elevated, no temperature was taken, and she had "shaking legs". The patient stated that vaccine facility suggested her to go to Emergency room but the episodes subsided, nothing else happened, so she went home. The patient was reporting that she was still having light warm sensation in chest area (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, flushed face/got red in the face, and shaky legs on 15-DEC-2021, was recovering from anxiety, and had not recovered from feel warm from my head to my neck /warmth sensation all over/ light warm sensation in chest area. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Intervertebral discitis, Peripheral artery thrombosis
Clinical narrative: DISCITIS; BLOOD CLOT IN FEMORAL ARTERY; BAD SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number were not reported and expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced bad side effect. On an unspecified date, blood clot in femoral artery, and discitis (dose number in series 1). The patient clarified that discitis was infections of discs in their back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in femoral artery, discitis and bad side effect was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211233462 (booster case with both dose numbers in series information).; Sender's Comments: -20211235699-covid-19 vaccine ad26.cov2.s-Discitis, Blood clot in femoral artery. 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, COVID19
Symptoms: Adverse drug reaction, Intervertebral discitis, Peripheral artery thrombosis
Clinical narrative: DISCITIS; BLOOD CLOT IN FEMORAL ARTERY; BAD SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number were not reported and expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced bad side effect. On an unspecified date, blood clot in femoral artery, and discitis (dose number in series 1). The patient clarified that discitis was infections of discs in their back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in femoral artery, discitis and bad side effect was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211233462 (booster case with both dose numbers in series information).; Sender's Comments: -20211235699-covid-19 vaccine ad26.cov2.s-Discitis, Blood clot in femoral artery. 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).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Leg amputation, Muscle strain, Nausea, SARS-CoV-2 test
Clinical narrative: BLOOD CLOT IN LEG; LEFT LEG AMPUTATION; PULLED MUSCLE; CORONAVIRUS 19; CONFIRMED CLINICAL VACCINATION FAILURE; FELT QUEASY; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non alcohol user, and non-smoker. The patient experienced dystonic and muscle spasms on the neck when treated with prochlorperazine.  The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced felt queasy. On an unspecified date of JUN-2021, (at the beginning of month) the patient experienced coronavirus 19 and had confirmed clinical vaccination failure. Laboratory data included: COVID-19 PCR (coronavirus-19 polymerase chain reaction) test (NR: not provided) positive. On an unspecified date, the patient went to urgent care for foot was limp and there was no blood flow getting to patient leg. At first it diagnosed with pulled muscle. A week after the patient again went to emergency room and they stated pulling blood clots out. After that on next day the patient was hospitalized with diagnosis of blood clots in leg. The patient stayed in the hospital for about a month. On an unspecified date of AUG-2021, during hospitalization, the patient had left leg amputation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coronavirus 19 on 30-JUN-2021, and felt queasy on 11-APR-2021, and the outcome of left leg amputation, pulled muscle, blood clot in leg and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with regulatory authority 90000207277.; Sender's Comments: V0: 20211235762-COVID-19 VACCINE AD26.COV2.S-Blood clot in leg, Left leg amputation. 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). 20211235762-COVID-19 VACCINE AD26.COV2.S-Confirmed 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
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Vaccination failure
Clinical narrative: BLOOD CLOT IN LEG; LEFT LEG AMPUTATION; PULLED MUSCLE; CORONAVIRUS 19; CONFIRMED CLINICAL VACCINATION FAILURE; FELT QUEASY; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non alcohol user, and non-smoker. The patient experienced dystonic and muscle spasms on the neck when treated with prochlorperazine.  The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced felt queasy. On an unspecified date of JUN-2021, (at the beginning of month) the patient experienced coronavirus 19 and had confirmed clinical vaccination failure. Laboratory data included: COVID-19 PCR (coronavirus-19 polymerase chain reaction) test (NR: not provided) positive. On an unspecified date, the patient went to urgent care for foot was limp and there was no blood flow getting to patient leg. At first it diagnosed with pulled muscle. A week after the patient again went to emergency room and they stated pulling blood clots out. After that on next day the patient was hospitalized with diagnosis of blood clots in leg. The patient stayed in the hospital for about a month. On an unspecified date of AUG-2021, during hospitalization, the patient had left leg amputation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coronavirus 19 on 30-JUN-2021, and felt queasy on 11-APR-2021, and the outcome of left leg amputation, pulled muscle, blood clot in leg and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with regulatory authority 90000207277.; Sender's Comments: V0: 20211235762-COVID-19 VACCINE AD26.COV2.S-Blood clot in leg, Left leg amputation. 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). 20211235762-COVID-19 VACCINE AD26.COV2.S-Confirmed 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: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Blood pressure increased, Mobility decreased, Visual acuity reduced
Clinical narrative: EYESIGHT DETERIORATED; LEGS WERE IMMOBILE; BLOOD PRESSURE WAS SKY HIGH; MANY OTHER SIDE EFFECTS; This spontaneous report received from a patient concerned a 26 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and never had any type of illness or hospitalization before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (dose series 1, suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered 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 eyesight deteriorated, legs were immobile, blood pressure was sky high, and many other side effects. After receiving vaccine last spring and one week later patient was hospitalized. The patient had a number of different side effects which she believes was from the vaccine and none of which patient had before the vaccine. After more than a week got discharged from hospital. It was an awful event for patient and her family. Number of days hospitalized was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the eyesight deteriorated, legs were immobile, blood pressure was sky high and many other side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211236040-Covid-19 vaccine ad26.cov2.s - Eyesight deteriorated, legs were immobile, blood pressure was sky high ,many other side effects. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: Suspected COVID-19, Vaccination failure
Clinical narrative: COVID PNEUMONIA (SUSPECTED COVID-19 INFECTION); SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via social media via 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 (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 06-JUN-2021 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 20-NOV-2021, the patient experienced covid pneumonia (suspected covid-19 infection) and (suspected clinical vaccination failure). It was reported that "was vaxxed with your vaccine on 06-JUN-2021. was hospitalized with covid pneumonia on 28-NOV-2021 for 5 days after battling it for 8 days at home. Thanks for the failed vaccine and astronomical medical bills".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid pneumonia (suspected covid-19 infection) and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint 90000207499.; Sender's Comments: V0: 20211237564-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. V0: 20211237564-Covid-19 vaccine ad26.cov2.s -Covid pneumonia. 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: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, age group, 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, batch number: Unknown and expiry: Unknown) dose was not reported,1 total, administered on an unspecified date in Mar-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. On 15-Dec-2021, the patient experienced cough (confirmed covid-19 infection). On 16-Dec-2021, Thursday, the patient stated that he woke up in the morning with fever, fatigue, body aches. Patient took the home test twice (Laboratory test COVID-19 test), both the test reports were positive. The Patient went to medical facility and took another test there (it was a swab) (SARS-CoV-2 PCR test). The patient stated that he received text stating results were positive (confirmed clinical vaccination failure). At the time of reporting the patient stated he was at another facility (Emergency room) where he was awaiting treatment with monoclonal antibodies and he was not around anyone who has tested positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207469.; Sender's Comments: V0:20211237727-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; RUNNY NOSE; SORE THROAT; FEVER; TIREDNESS; This spontaneous report received from a patient 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: 206A21A and expiry: unknown) dose was not reported, (dose number in series 1), 1 total administered on 10-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-JUN-2021, the patient experienced runny nose, sore throat, fever, tiredness that lasted 3 days (13-JUN-2021) after vaccination. The Patient stated he had shortness of breath and cough since 25-NOV-2021 (reported since thanksgiving day). Also, the patient reported since 13-DEC-2021 (reported as Monday), he had chills, fever and sore throat. On 15-DEC-2021 (reported as last night), the patient underwent a covid-19 antigen rapid test, which came positive (suspected clinical vaccination failure, suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, sore throat, fever, and tiredness (on 13-JUN-2021), had not recovered from suspected covid-19 infection, 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: 90000207555. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0: 20211237796 -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: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; RUNNY NOSE; SORE THROAT; FEVER; TIREDNESS; This spontaneous report received from a patient 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: 206A21A and expiry: unknown) dose was not reported, (dose number in series 1), 1 total administered on 10-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-JUN-2021, the patient experienced runny nose, sore throat, fever, tiredness that lasted 3 days (13-JUN-2021) after vaccination. The Patient stated he had shortness of breath and cough since 25-NOV-2021 (reported since thanksgiving day). Also, the patient reported since 13-DEC-2021 (reported as Monday), he had chills, fever and sore throat. On 15-DEC-2021 (reported as last night), the patient underwent a covid-19 antigen rapid test, which came positive (suspected clinical vaccination failure, suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, sore throat, fever, and tiredness (on 13-JUN-2021), had not recovered from suspected covid-19 infection, 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: 90000207555. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0: 20211237796 -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
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Diarrhoea, Fatigue, Headache
Clinical narrative: DIARRHEA; WEAKNESS; THREW UP EVERY TIME (VOMITING); NAUSEOUS; RIGHT KIDNEY IS HURTING; COULD NOT GET OUT OUT OF BED; SUPER ACHY; HEADACHES; FATIGUE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: history of chronic urinary tract infection, penicillin allergy (rash and hives), macrodantin allergy (rash, hives, captured as drug allergy), bactrim (rash and hives, captured as drug allergy) non-smoker, and non-alcoholic The patient had no drug abuse or illicit drug usage.  The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number 206A21A, expiry: Unknown) dose was not reported,1 total, administered on 03-SEP-2021 for prophylactic vaccination on her right arm. No adverse events were reported (dose number in series 1).  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, 1 total, administered on 14-DEC-2021 at noon (12:00) for prophylactic vaccination as a booster dose on her left arm (dose number in series 2). No concomitant medications were reported.  On 14-DEC-2021, the patient experienced headaches, and fatigue in evening (dose number in series 2). Patient reported that super achy and headache worsened throughout that evening (dose number in series 2). On 15-DEC-2021, the patient could not get out out of bed (dose number in series 2). Patient was nauseous and threw up every time (vomiting) (dose number in series 2). Patient could drink water, but would gag and throw it back up and claimed that her right kidney was hurting (dose number in series 2). On 16-DEC-2021, the patient experienced diarrhea, and weakness.(dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from threw up every time (vomiting), and nauseous on 15-DEC-2021, and headaches on DEC-2021, and had not recovered from fatigue, could not get out out of bed, right kidney is hurting, weakness, diarrhea, and super achy. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Renal pain, Vomiting
Clinical narrative: DIARRHEA; WEAKNESS; THREW UP EVERY TIME (VOMITING); NAUSEOUS; RIGHT KIDNEY IS HURTING; COULD NOT GET OUT OUT OF BED; SUPER ACHY; HEADACHES; FATIGUE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: history of chronic urinary tract infection, penicillin allergy (rash and hives), macrodantin allergy (rash, hives, captured as drug allergy), bactrim (rash and hives, captured as drug allergy) non-smoker, and non-alcoholic The patient had no drug abuse or illicit drug usage.  The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number 206A21A, expiry: Unknown) dose was not reported,1 total, administered on 03-SEP-2021 for prophylactic vaccination on her right arm. No adverse events were reported (dose number in series 1).  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, 1 total, administered on 14-DEC-2021 at noon (12:00) for prophylactic vaccination as a booster dose on her left arm (dose number in series 2). No concomitant medications were reported.  On 14-DEC-2021, the patient experienced headaches, and fatigue in evening (dose number in series 2). Patient reported that super achy and headache worsened throughout that evening (dose number in series 2). On 15-DEC-2021, the patient could not get out out of bed (dose number in series 2). Patient was nauseous and threw up every time (vomiting) (dose number in series 2). Patient could drink water, but would gag and throw it back up and claimed that her right kidney was hurting (dose number in series 2). On 16-DEC-2021, the patient experienced diarrhea, and weakness.(dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from threw up every time (vomiting), and nauseous on 15-DEC-2021, and headaches on DEC-2021, and had not recovered from fatigue, could not get out out of bed, right kidney is hurting, weakness, diarrhea, and super achy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypertrophic cardiomyopathy, Visual impairment
Clinical narrative: HEART WARMING HYPERTROPHIC CARDIOMYOPATHY; PARTIAL LOSS OF SIGHT; 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 experienced recurrent migraines (dose number in series 1) when treated with BNT162 for prophylactic vaccination (Dose number in series 1). The outcome for recurrent migraines was not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that "PII You're gonna love that new one by Johnson & Johnson #3. Feeling even better when you mix-up! It embrace heart warming hypertrophic cardiomyopathy, partial loss of sight but sadly no recurrent migraines like Pfizer #6". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart warming hypertrophic cardiomyopathy and partial loss of sight was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211238271-covid-19 vaccine ad26.cov2.s -Heart warming hypertrophic cardiomyopathy. 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).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fall, Fear, Feeling hot, Headache
Clinical narrative: This spontaneous report received from a patient concerned a 34-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 (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced sweating, felt hot, feverish, and headache. On 11-APR-2021, the patient experienced woke up in the middle of the night, face puffy and inflamed, right arm inflammation, she tripped on the stairs/almost fell, pinched nerve, could not feel right leg, leg and arm on right side felt heavy, and face numbness right cheek. On 14-APR-2021, Laboratory data included: CT scan (NR: not provided) Not reported, and MRI (NR: not provided) Not reported. On an unspecified date, the patient experienced nerve issue, scary, and stressful. The action taken with covid-19 vaccine was not applicable. The patient was recovering from feverish, felt hot, headache, sweating, could not feel right leg, leg and arm on right side felt heavy, face numbness right cheek, face puffy and inflamed, right arm inflammation, she tripped on the stairs/almost fell, pinched nerve, and woke up in the middle of the night, and the outcome of stressful, scary and nerve issue was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Inflammation, Limb discomfort, Magnetic resonance imaging
Clinical narrative: This spontaneous report received from a patient concerned a 34-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 (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced sweating, felt hot, feverish, and headache. On 11-APR-2021, the patient experienced woke up in the middle of the night, face puffy and inflamed, right arm inflammation, she tripped on the stairs/almost fell, pinched nerve, could not feel right leg, leg and arm on right side felt heavy, and face numbness right cheek. On 14-APR-2021, Laboratory data included: CT scan (NR: not provided) Not reported, and MRI (NR: not provided) Not reported. On an unspecified date, the patient experienced nerve issue, scary, and stressful. The action taken with covid-19 vaccine was not applicable. The patient was recovering from feverish, felt hot, headache, sweating, could not feel right leg, leg and arm on right side felt heavy, face numbness right cheek, face puffy and inflamed, right arm inflammation, she tripped on the stairs/almost fell, pinched nerve, and woke up in the middle of the night, and the outcome of stressful, scary and nerve issue was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Middle insomnia, Nerve compression, Nervous system disorder, Pyrexia, Sensory loss
Clinical narrative: This spontaneous report received from a patient concerned a 34-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 (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced sweating, felt hot, feverish, and headache. On 11-APR-2021, the patient experienced woke up in the middle of the night, face puffy and inflamed, right arm inflammation, she tripped on the stairs/almost fell, pinched nerve, could not feel right leg, leg and arm on right side felt heavy, and face numbness right cheek. On 14-APR-2021, Laboratory data included: CT scan (NR: not provided) Not reported, and MRI (NR: not provided) Not reported. On an unspecified date, the patient experienced nerve issue, scary, and stressful. The action taken with covid-19 vaccine was not applicable. The patient was recovering from feverish, felt hot, headache, sweating, could not feel right leg, leg and arm on right side felt heavy, face numbness right cheek, face puffy and inflamed, right arm inflammation, she tripped on the stairs/almost fell, pinched nerve, and woke up in the middle of the night, and the outcome of stressful, scary and nerve issue was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Swelling face
Clinical narrative: This spontaneous report received from a patient concerned a 34-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 (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced sweating, felt hot, feverish, and headache. On 11-APR-2021, the patient experienced woke up in the middle of the night, face puffy and inflamed, right arm inflammation, she tripped on the stairs/almost fell, pinched nerve, could not feel right leg, leg and arm on right side felt heavy, and face numbness right cheek. On 14-APR-2021, Laboratory data included: CT scan (NR: not provided) Not reported, and MRI (NR: not provided) Not reported. On an unspecified date, the patient experienced nerve issue, scary, and stressful. The action taken with covid-19 vaccine was not applicable. The patient was recovering from feverish, felt hot, headache, sweating, could not feel right leg, leg and arm on right side felt heavy, face numbness right cheek, face puffy and inflamed, right arm inflammation, she tripped on the stairs/almost fell, pinched nerve, and woke up in the middle of the night, and the outcome of stressful, scary and nerve issue was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED  VACCINE; This spontaneous report received from a health care professional concerned a 59 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: 1820095, expiry: 02-OCT-2021) dose was not reported, administered on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211239223 and 20211238177.
Sex: M
Vaccine: COVID19
Symptoms: Appendicectomy
Clinical narrative: EMERGENCY SURGERY TO REMOVE APPENDIX; This spontaneous report received from a parent via a company representative concerned a 35 year old male of an unspecified 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 (Dose number in series 1) (suspension for injection, route of administration was not reported, 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 numbers. No concomitant medications were reported.  On 17-DEC-2021, a post was shared by a parent stated "Not getting booster, however I chose to get my shots because of my age and weight, no one forced me. That's immoral Wish I had not gotten the jabs. My 35 year old military son got jab, 38 hours later was in emergency surgery to remove appendix, Side effect ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of emergency surgery to remove appendix was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211240198-COVID-19 VACCINE AD26.COV2.S- Emergency surgery to remove appendix . 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: Poor quality product administered
Clinical narrative: ADMINISTRATION OF VACCINE STORED OUTSIDE RECOMMENDED CONDITIONS (FOR 5 HOURS AT ROOM TEMPERATURE); 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 not reported, batch number: 1855194, and expiry: 09-APR-2022) dose was not reported, administered on 16-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-DEC-2021, the patient experienced administration of vaccine stored outside recommended conditions (for 5 hours at room temperature). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine stored outside recommended conditions (for 5 hours at room temperature) was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 72 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 (dose number in series 1) (suspension for injection, route of administration was not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 16-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, patient had covid-19 infection. On 13-SEP-2021, she tested positive via rapid test (unknown whether it was Polymerase chain reaction or Antigen) (suspected clinical vaccination failure). On 15-SEP-2021, she received an infusion. On 16-SEP-2021, She checked her pulse oximetry and it showed that her oxygen levels were 85%. On 17-SEP-2021, she presented to the hospital and was admitted. She was hospitalized for 7 days. She did not require mechanical ventilation but was on oxygen and all kinds of treatments. She was discharged home on 23-SEP-2021. She was fine but had to recover at home for a month after the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000207717, 90000207751. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20211240687.; Sender's Comments: V0- 20211240427-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  20211240427-Covid-19 vaccine ad26.cov2.s-Covid-19 infection. 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: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, 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 admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series was 1). 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 guillain barre syndrome. Consumer reported that a coworker contracted Guillain barre syndrome from the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre syndrome was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211240145.; Sender's Comments: V0-  20211240501- covid-19 vaccine ad26.cov2.s   Guillain-Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.