chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nerve injury, Pain, Rash, Thrombosis
Clinical narrative: BLOOD CLOTS; NERVE DAMAGE; SEVERE PAIN; RASHES; This spontaneous report received from a patient via a company representative from social media 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: not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots, nerve damage, severe pain and rashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots, nerve damage, severe pain and rashes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210922003-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clots . 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).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Colonoscopy, Dizziness, Full blood count, Metabolic function test
Clinical narrative: LIGHT HEADED; COLITIS FLARE; This spontaneous report received from a patient via a company representative concerned a 57 year old male. Initial information was processed with the additional information received on 12-SEP-2021. The patient's height, and weight were not reported. As past history, patient had a colonoscopy in 2020 (a year and half ago). The patient's concurrent conditions included: ulcerative colitis that had been under control, reaction to penicillin, allergy to tree pollen, alcohol user (may be 6 beers in a year), and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered to right arm on 10-SEP-2021 16:45 for prophylactic vaccination. Concomitant medications included sulfasalazine for ulcerative colitis.  On 10-SEP-2021, patient felt washed out for 8-10 hours. On 11-SEP-2021, after 14 to 15 hours of received the vaccine the patient had rectal mucus and an hour later the blood started but had no diarrhea and the patient had blood in stool. Patient stated that It was the fastest time that had happened to patient from going mucus to bleeding. Patient was also light-headed and On 11- SEP-2021, patient went to the emergency room around 15:00. The patient started with blood work. On 11-SEP-2021, patient waited till 01:30 (at night) at hospital but doctor was busy. Patient had sips of water to kept hydrated. Patient was waited during the patient started getting colon pain on the left side and the right side groin area that come and go. The patient was diagnosed with colitis flare up (and possibly due to the vaccination). Patient still had lower groin pain (lower colon) and not higher up the mid-stomach area (patient knew that, patient would in trouble). The patient had reluctant to get the vaccine but decided to got it. Treatment medications (12- SEP-2021) included: prednisone. Laboratory data (11-SEP-2021) included: Complete blood count (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, and Rectal examination (NR: not provided) Rectal bleeding and colitis flare up.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headed, and colitis flare, and had not recovered from lower groin pain/pain on the right side groin area that come and go.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210922028-COVID-19 Vaccine AD26.COV2.S-Colitis Flare. 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: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rectal examination
Clinical narrative: LIGHT HEADED; COLITIS FLARE; This spontaneous report received from a patient via a company representative concerned a 57 year old male. Initial information was processed with the additional information received on 12-SEP-2021. The patient's height, and weight were not reported. As past history, patient had a colonoscopy in 2020 (a year and half ago). The patient's concurrent conditions included: ulcerative colitis that had been under control, reaction to penicillin, allergy to tree pollen, alcohol user (may be 6 beers in a year), and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered to right arm on 10-SEP-2021 16:45 for prophylactic vaccination. Concomitant medications included sulfasalazine for ulcerative colitis.  On 10-SEP-2021, patient felt washed out for 8-10 hours. On 11-SEP-2021, after 14 to 15 hours of received the vaccine the patient had rectal mucus and an hour later the blood started but had no diarrhea and the patient had blood in stool. Patient stated that It was the fastest time that had happened to patient from going mucus to bleeding. Patient was also light-headed and On 11- SEP-2021, patient went to the emergency room around 15:00. The patient started with blood work. On 11-SEP-2021, patient waited till 01:30 (at night) at hospital but doctor was busy. Patient had sips of water to kept hydrated. Patient was waited during the patient started getting colon pain on the left side and the right side groin area that come and go. The patient was diagnosed with colitis flare up (and possibly due to the vaccination). Patient still had lower groin pain (lower colon) and not higher up the mid-stomach area (patient knew that, patient would in trouble). The patient had reluctant to get the vaccine but decided to got it. Treatment medications (12- SEP-2021) included: prednisone. Laboratory data (11-SEP-2021) included: Complete blood count (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, and Rectal examination (NR: not provided) Rectal bleeding and colitis flare up.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headed, and colitis flare, and had not recovered from lower groin pain/pain on the right side groin area that come and go.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210922028-COVID-19 Vaccine AD26.COV2.S-Colitis Flare. 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: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: STARTED USING THE JANSSEN COVID-19 VACCINE AS A SECOND DOSE WHO HAD ALLERGIC REACTION UPON RECEIVING PFIZER OR MODERNA AS FIRST DOSE; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic reaction upon receiving pfizer or moderna. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162, and mrna 1273.  On an unspecified date, the patient experienced started using the janssen covid-19 vaccine as a second dose who had allergic reaction upon receiving pfizer or moderna as first dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of started using the janssen covid-19 vaccine as a second dose who had allergic reaction upon receiving pfizer or moderna as first dose was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; PATIENT WAS ADMINISTERED VACCINE AFTER THE VIAL UNDERWENT MULTIPLE TEMPERATURE EXCURSIONS; This spontaneous report received from a health care professional 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, and batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient experienced patient was administered vaccine after the vial underwent multiple temperature excursions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient was administered vaccine after the vial underwent multiple temperature excursions and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death, Respiratory arrest
Clinical narrative: DEATH; SUDDENLY STOPPED BREATHING; This spontaneous report received from a consumer concerned a 34 year old female of unknown 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, Expiry: Unknown) dose was not reported, 1 total, administered on unspecified date in AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified in AUG-2021, after one week of vaccination, the patient suddenly stopped breathing at home. The patient was trying to be brave and tough it out and she decided not to go to the emergency room (ER). On an unspecified date in 2021, the patient died from unknown cause of death at home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 2021, and the outcome of suddenly stopped breathing was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210921562.; Sender's Comments: V0: 20210923692-covid-19 vaccine ad26.cov2.s -Death, Suddenly stopped breathing . 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: Feeding disorder, Insomnia, Lymphadenopathy, Pyrexia, Tachycardia
Clinical narrative: THYROID PROBLEMS; TACHYCARDIA/UNCONTROLLED RAPID HEART  RATE; UNABLE TO SLEEP; UNABLE TO EAT; ENLARGED LYMPHNODES; FEVER; This spontaneous report received from a consumer concerned a 29 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 administration not reported, batch number: Unknown expiry: Unknown) dose was not reported,  1 total was administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported On 12-SEP-2021, the patient experienced tachycardia/uncontrolled rapid heart rate, and was hospitalized on same day. On an unspecified date and month in 2021, the patient had ongoing signs and symptoms related to thyroid problems and was hospitalized on 12-SEP-2021.On an unspecified date, the patient was unable to sleep, unable to eat, had enlarged lymphnodes, and fever. The patient was hospitalized for 1 day and was discharged on 12-SEP-2021 The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thyroid problems, and the outcome of unable to sleep, unable to eat, enlarged lymphnodes, tachycardia/uncontrolled rapid heart rate and fever was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210923706-covid-19 vaccine ad26.cov2.s-tachycardia/uncontrolled rapid heart rate, Thyroid problems. 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: Thyroid disorder
Clinical narrative: THYROID PROBLEMS; TACHYCARDIA/UNCONTROLLED RAPID HEART  RATE; UNABLE TO SLEEP; UNABLE TO EAT; ENLARGED LYMPHNODES; FEVER; This spontaneous report received from a consumer concerned a 29 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 administration not reported, batch number: Unknown expiry: Unknown) dose was not reported,  1 total was administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported On 12-SEP-2021, the patient experienced tachycardia/uncontrolled rapid heart rate, and was hospitalized on same day. On an unspecified date and month in 2021, the patient had ongoing signs and symptoms related to thyroid problems and was hospitalized on 12-SEP-2021.On an unspecified date, the patient was unable to sleep, unable to eat, had enlarged lymphnodes, and fever. The patient was hospitalized for 1 day and was discharged on 12-SEP-2021 The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thyroid problems, and the outcome of unable to sleep, unable to eat, enlarged lymphnodes, tachycardia/uncontrolled rapid heart rate and fever was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210923706-covid-19 vaccine ad26.cov2.s-tachycardia/uncontrolled rapid heart rate, Thyroid problems. 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: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 48 year old  female of unspecified 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: 1802072 and expiry: 23-AUG-2021) dose was not reported, 1 total administered to left arm on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient underwent antibody test: SARS-CoV-2 IgG antibody test, SARS-CoV-2 IgM antibody test (Immunoglobulin SARS-CoV-2 IgG and IgM immunoassay) and results were found to be no antibodies (confirmed immunological vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000193209.; Sender's Comments: V0: 20210923714- Covid-19 vaccine ad26.cov2.s- Confirmed immunological 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: Chills, Feeling abnormal, Pain, Tremor, Vomiting
Clinical narrative: ACHES; SHAKES; NEVER FELT SO BAD EVER; UNCONTROLLABLE CHILLS; VOMITING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced aches, shakes, never felt so bad ever, uncontrollable chills, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, uncontrollable chills, shakes, vomiting and never felt so bad ever was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: MILD COLD SYMPTOMS; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and no alcohol use, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug use and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: 23-AUG-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced mild cold symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild cold symptoms. This report was non-serious.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Rash pruritic, Sleep disorder, Urine analysis
Clinical narrative: SLEEP IS WORSE; RASH ALL OVER HIS BODY, FACE, NECK, SHOULDERS, LEGS, THIGHS, STOMACH, BACK AND SHOULDERS; This spontaneous report received from a patient concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart condition, high blood pressure, and arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: 11-SEP-2021) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced rash all over his body, face, neck, shoulders, legs, thighs, stomach, back and shoulders. On JUL-2021, treatment medications included: menthol/zinc oxide. On AUG-2021, Laboratory data included: Blood test (NR: not provided) not reported, and Urine analysis (NR: not provided) not reported. On an unspecified date, the patient experienced sleep is worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash all over his body, face, neck, shoulders, legs, thighs, stomach, back and shoulders, and sleep is worse. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Intracardiac thrombus, Suspected COVID-19, Vaccination failure
Clinical narrative: BLOOD CLOT IN HEART; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via social media concerned a patient of unspecified age and sex. 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 not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from getting covid (suspected covid-19 infection and suspected clinical vaccination failure) and having a blood clot in heart. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint (PQC).; Sender's Comments: V0.20210923766-covid-19 vaccine ad26.cov2.s -blood clot in heart, suspected 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).   20210923766-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; Reported Cause(s) of Death: BLOOD CLOT IN HEART; SUSPECTED COVID-19 INFECTION
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: PASSED OUT 3 MINUTES AFTER RECEIVING THE VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-SEP-2021, the patient passed out 3 minutes after receiving the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passed out 3 minutes after receiving the vaccine was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210923877.; Sender's Comments: V0: 20210923780- Covid-19 vaccine ad26.cov2.s-passed out 3 minutes after receiving the vaccine. 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: M
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: DEATH; BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. Initial information was processed along with the additional information received on 14/Sep/2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported, expiry: unknown) dose, start therapy date were not reported, administered 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough infection after vaccination (suspected covid 19 infection) and suspected clinical vaccine failure. On an unspecified date, the patient died from unknown cause  It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of breakthrough infection and suspected clinical vaccine failure was not reported. This report was serious (Death, and Other Medically Important Condition). This case is associated with product quality complaint number 90000193360; Sender's Comments: V0: 20210923788-COVID-19 VACCINE AD26.COV2.S-Death, Breakthrough infection. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210923788-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fungal skin infection
Clinical narrative: FUNGAL INFECTION IN THE FACE; PERSISTENT PAIN IN THE LEFT SHOULDER; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-SEP-2021, the patient experienced fungal infection in the face. On 03-SEP-2021, the patient experienced persistent pain in the left shoulder. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from persistent pain in the left shoulder, and the outcome of fungal infection in the face was not reported.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: AN ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced an adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of an adverse event was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 SEP-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint:90000193147
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: ARM TENDERNESS OVER 4 TO 5 DAYS; MASSIVE HEADACHE; This spontaneous report received from a patient concerned a 61 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: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced arm tenderness over 4 to 5 days. On 02-SEP-2021, the patient experienced massive headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tenderness over 4 to 5 days on 06-SEP-2021, and massive headache on 05-SEP-2021. This report was non-serious. This case, from the same reporter is linked to 20210923780.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia, Rash erythematous
Clinical narrative: GENERALIZED MALAISE; ONE BIG RASH (TURNED RED ALL OVER); FELT FEVERISH/ FEVER; This spontaneous report received from a patient via a company representative concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, non alcohol user, and mildly overweight, and other pre-existing medical conditions included: The patient had no known drug allergies, did not have any history of drug abuse or illicit drug use, no known past reactions from vaccines or medication and did not have any breathing issues. The patient was doing well overall with no significant past medical history. The patient not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-SEP-2021, the patient experienced generalized malaise. On 11-SEP-2021, the patient experienced one big rash (turned red all over). On 11-SEP-2021, the patient experienced felt feverish/ fever. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications included: diphenhydramine hydrochloride. On 12-SEP-2021, treatment medications included: ibuprofen, and paracetamol. On 13-SEP-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from one big rash (turned red all over) on 13-SEP-2021, and had not recovered from felt feverish/ fever, and generalized malaise. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Cough, Diarrhoea, Dyspnoea
Clinical narrative: BAD SHORTNESS OF BREATH; COUGH / DRY COUGH; TIGHTNESS ON CHEST (TIGHTNESS LASTS 30 MIN); FEELS WEAK; DIARRHEA; THROWING UP; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: overweight, rheumatoid arthritis, high blood pressure, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had no known drug allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced diarrhea. On MAR-2021, the patient experienced throwing up. On MAY-2021, the patient experienced bad shortness of breath. On MAY-2021, the patient experienced cough / dry cough. On MAY-2021, the patient experienced tightness on chest (tightness lasts 30 min). On MAY-2021, the patient experienced feels weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and throwing up, had not recovered from bad shortness of breath, cough / dry cough, and tightness on chest (tightness lasts 30 min), and the outcome of feels weak was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: BAD SHORTNESS OF BREATH; COUGH / DRY COUGH; TIGHTNESS ON CHEST (TIGHTNESS LASTS 30 MIN); FEELS WEAK; DIARRHEA; THROWING UP; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: overweight, rheumatoid arthritis, high blood pressure, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had no known drug allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced diarrhea. On MAR-2021, the patient experienced throwing up. On MAY-2021, the patient experienced bad shortness of breath. On MAY-2021, the patient experienced cough / dry cough. On MAY-2021, the patient experienced tightness on chest (tightness lasts 30 min). On MAY-2021, the patient experienced feels weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and throwing up, had not recovered from bad shortness of breath, cough / dry cough, and tightness on chest (tightness lasts 30 min), and the outcome of feels weak was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: TINNITUS ON LEFT SIDE OF HEAD; 4 OR 5 DAYS OF BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-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 patient experienced tinnitus on left side of head, and 4 or 5 day of bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 4 or 5 day of bad headache, and had not recovered from tinnitus on left side of head. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Injection site pain, Pain in extremity
Clinical narrative: ARMS WERE HURTING; HEADACHE; EXHAUSTED; PAIN IN THE ARM AT THE SITE OF INJECTION; SOME LOWER BACK PAIN; This spontaneous report received from a health care professional concerned a 57 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced some lower back pain. On SEP-2021, the patient experienced pain in the arm at the site of injection. On 03-SEP-2021, the patient experienced headache. On 03-SEP-2021, the patient experienced exhausted. On 04-SEP-2021, the patient experienced arms were hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and exhausted on 03-SEP-2021, and the outcome of some lower back pain, pain in the arm at the site of injection and arms were hurting was not reported. This report was non-serious. This case, from the same reporter is linked to 20210924065.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED PUNCTURED VACCINE LEFT AT ROOM TEMPERATURE FOR 5.5 HOURS; PUNCTURED VACCINE STORED AT ROOM TEMPERATURE FOR 5.5 HOURS; This spontaneous report received from a pharmacist concerned a 38 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, intramuscular, batch number: 041A21A expiry: 19-SEP-2021) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced administered punctured vaccine left at room temperature for 5.5 hours. On 10-SEP-2021, the patient experienced punctured vaccine stored at room temperature for 5.5 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the administered punctured vaccine left at room temperature for 5.5 hours and punctured vaccine stored at room temperature for 5.5 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: SEVER MIGRAINE; ARMS WERE HURTING SO MUCH / ARM PAIN; HEADACHES; EXHAUSTED; PAIN AT SITE OF INJECTION; LOWER BACK PAIN; TWITCHING ON LOWER RIGHT HIP OR AS IF SOMETHING WAS KICKING HER; BODY WAS IN A FIGHT MODE; This spontaneous report received from a patient concerned a 51 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 not reported, batch number: 201A21A, expiry: 05-SEP-2021) dose was not reported, administered on 03-SEP-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced lower back pain. On SEP-2021, the patient experienced twitching on lower right hip or as if something was kicking her. On SEP-2021, the patient experienced body was in a fight mode. On SEP-2021, the patient experienced pain at site of injection. On 03-SEP-2021, the patient experienced headaches. On 03-SEP-2021, the patient experienced exhausted. On 04-SEP-2021, the patient experienced arms were hurting so much / arm pain. On 12-SEP-2021, the patient experienced sever migraine. Laboratory data included: COVID-19 virus test (not provided) Negative, and Pain scale (not provided) 8/10, and Vital signs measurement (not provided) stable. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever migraine on SEP-2021, lower back pain, arms were hurting so much / arm pain, and exhausted, and headaches on 03-SEP-2021, and the outcome of twitching on lower right hip or as if something was kicking her, pain at site of injection and body was in a fight mode was not reported. This report was non-serious. This case, from the same reporter is linked to 20210924029.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle twitching, Pain assessment, Pain in extremity, SARS-CoV-2 test
Clinical narrative: SEVER MIGRAINE; ARMS WERE HURTING SO MUCH / ARM PAIN; HEADACHES; EXHAUSTED; PAIN AT SITE OF INJECTION; LOWER BACK PAIN; TWITCHING ON LOWER RIGHT HIP OR AS IF SOMETHING WAS KICKING HER; BODY WAS IN A FIGHT MODE; This spontaneous report received from a patient concerned a 51 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 not reported, batch number: 201A21A, expiry: 05-SEP-2021) dose was not reported, administered on 03-SEP-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced lower back pain. On SEP-2021, the patient experienced twitching on lower right hip or as if something was kicking her. On SEP-2021, the patient experienced body was in a fight mode. On SEP-2021, the patient experienced pain at site of injection. On 03-SEP-2021, the patient experienced headaches. On 03-SEP-2021, the patient experienced exhausted. On 04-SEP-2021, the patient experienced arms were hurting so much / arm pain. On 12-SEP-2021, the patient experienced sever migraine. Laboratory data included: COVID-19 virus test (not provided) Negative, and Pain scale (not provided) 8/10, and Vital signs measurement (not provided) stable. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever migraine on SEP-2021, lower back pain, arms were hurting so much / arm pain, and exhausted, and headaches on 03-SEP-2021, and the outcome of twitching on lower right hip or as if something was kicking her, pain at site of injection and body was in a fight mode was not reported. This report was non-serious. This case, from the same reporter is linked to 20210924029.
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: SEVER MIGRAINE; ARMS WERE HURTING SO MUCH / ARM PAIN; HEADACHES; EXHAUSTED; PAIN AT SITE OF INJECTION; LOWER BACK PAIN; TWITCHING ON LOWER RIGHT HIP OR AS IF SOMETHING WAS KICKING HER; BODY WAS IN A FIGHT MODE; This spontaneous report received from a patient concerned a 51 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 not reported, batch number: 201A21A, expiry: 05-SEP-2021) dose was not reported, administered on 03-SEP-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced lower back pain. On SEP-2021, the patient experienced twitching on lower right hip or as if something was kicking her. On SEP-2021, the patient experienced body was in a fight mode. On SEP-2021, the patient experienced pain at site of injection. On 03-SEP-2021, the patient experienced headaches. On 03-SEP-2021, the patient experienced exhausted. On 04-SEP-2021, the patient experienced arms were hurting so much / arm pain. On 12-SEP-2021, the patient experienced sever migraine. Laboratory data included: COVID-19 virus test (not provided) Negative, and Pain scale (not provided) 8/10, and Vital signs measurement (not provided) stable. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever migraine on SEP-2021, lower back pain, arms were hurting so much / arm pain, and exhausted, and headaches on 03-SEP-2021, and the outcome of twitching on lower right hip or as if something was kicking her, pain at site of injection and body was in a fight mode was not reported. This report was non-serious. This case, from the same reporter is linked to 20210924029.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: PAIN SECONDARY TO TOOTHACHE WORSENED; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: toothache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced pain secondary to toothache worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain secondary to toothache worsened. This report was non-serious. This case, from the same reporter is linked to 20161001746 and 20160930945.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod sting, Diarrhoea, Peripheral swelling, Therapeutic response unexpected
Clinical narrative: BEE STING ON RIGHT WRIST AROUND 4PM (NO KNOWN ALLERGY); SWELLING ON THE HAND FELT LIKE 3 BRICKS, SWELLING GOING TO FOREARM AND REACHED ELBOW; DIARRHEA; UNEXPECTED THERAPEUTIC EFFECT (EXACTLY 72 HOURS AFTER THE VACCINATION, FELT NO MORE PAIN FROM PAST INJURIES AND HAD BEST SLEEP EVER); This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 158 pounds, and height was 66 inches. The patient's past medical history included: pre-vaccine broken injuries, wrist brace, and pre-vaccine pain, and concurrent conditions included: seafood allergy, non-alcohol user, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the patient experienced unexpected therapeutic effect (exactly 72 hours after the vaccination, felt no more pain from past injuries and had best sleep ever). On 26-AUG-2021, the patient experienced bee sting on right wrist around 4pm (no known allergy). On 26-AUG-2021, the patient experienced swelling on the hand felt like 3 bricks, swelling going to forearm and reached elbow. On 26-AUG-2021, the patient experienced diarrhea. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unexpected therapeutic effect (exactly 72 hours after the vaccination, felt no more pain from past injuries and had best sleep ever), had not recovered from bee sting on right wrist around 4pm (no known allergy), and swelling on the hand felt like 3 bricks, swelling going to forearm and reached elbow, and the outcome of diarrhea was not reported. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: ADMINISTERED THE COVID-19 VACCINE TO A 17 YEAR OLD PATIENT; This spontaneous report received from a pharmacist concerned a 17 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: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-SEP-2021, the patient experienced administered the covid-19 vaccine to a 17 year old subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered the covid-19 vaccine to a 17 year old patient was not reported. This report was non-serious.