chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, UNK
Symptoms: Thrombosis
Clinical narrative: TWO BLOOD CLOTS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient had an unspecified surgery before three weeks of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The patient received rivaroxaban (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. 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 after vaccination, the patient developed blood clots. The patient was taking rivaroxaban (Xarelto) and went to his physician and found out that he had two blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The patient had not recovered from two blood clots. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210653162- covid-19 vaccine ad26.cov2.s- two blood clots. This event(s) is considered un-assessable. 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: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, high cholesterol, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN)frequency 1 total,  dose was not reported, administered on 26-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-JUN-2021, the patient reported that she had Antibody test which came out negative (Confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000184012. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210654376-Covid-19 vaccine ad26.cov2.s-Confirmed immunological 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
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Arthralgia, Headache, Intentional underdose, Off label use
Clinical narrative: ITCHING; JOINT PAIN; HEADACHE; ADMINISTERED HALF DOSE OF JANSSEN COVID-19 VACCINE; OFF LABEL USE; ANAPHYLACTIC SHOCK; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast cell activation syndrome, non smoker, and non alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with moxifloxacin hydrochloride, azithromycin, methylprednisolone, phenelzine, and bupropion hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on right deltoid on 17-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Benadryl continuous IV - 300 mg/24 hours for drug used for unknown indication and takes rescue Benadryl - 50 mg as needed for drug used for unknown indication. On 17-JUN-2021, Doctor administered half dose of vaccine because of patient's condition (mast cell activation syndrome). On 17-JUN-2021, patient went into anaphylactic shock 3 minutes later after vaccination and was administered Epi-pen (epinephrine). On 17-JUN-2021, the patient experienced headache. On 19-JUN-2021, the patient experienced itching and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic shock, and headache on 17-JUN-2021, was recovering from itching, had not recovered from joint pain, and the outcome of administered half dose of Janssen covid-19 vaccine and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210660183- Covid-19 vaccine ad26.cov2.s- Anaphylactic shock, itching. 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 20210660183- Covid-19 vaccine ad26.cov2.s- Joint pain, headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING; JOINT PAIN; HEADACHE; ADMINISTERED HALF DOSE OF JANSSEN COVID-19 VACCINE; OFF LABEL USE; ANAPHYLACTIC SHOCK; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast cell activation syndrome, non smoker, and non alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with moxifloxacin hydrochloride, azithromycin, methylprednisolone, phenelzine, and bupropion hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on right deltoid on 17-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Benadryl continuous IV - 300 mg/24 hours for drug used for unknown indication and takes rescue Benadryl - 50 mg as needed for drug used for unknown indication. On 17-JUN-2021, Doctor administered half dose of vaccine because of patient's condition (mast cell activation syndrome). On 17-JUN-2021, patient went into anaphylactic shock 3 minutes later after vaccination and was administered Epi-pen (epinephrine). On 17-JUN-2021, the patient experienced headache. On 19-JUN-2021, the patient experienced itching and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic shock, and headache on 17-JUN-2021, was recovering from itching, had not recovered from joint pain, and the outcome of administered half dose of Janssen covid-19 vaccine and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210660183- Covid-19 vaccine ad26.cov2.s- Anaphylactic shock, itching. 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 20210660183- Covid-19 vaccine ad26.cov2.s- Joint pain, headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold
Clinical narrative: CHILLS; FEELING COLD; FEELING TIRED; This spontaneous report received from a consumer concerned a 35 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: 1808982 expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced feeling cold. On 25-JUN-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feeling tired, and feeling cold. This report was non-serious. This case, from the same reporter is linked to
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED SIDE EFFECTS; 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, intramuscular, 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 subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Discomfort, Dizziness, Hot flush
Clinical narrative: UNSPECIFIED SIDE EFFECTS; 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, intramuscular, 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 subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush
Clinical narrative: UNSPECIFIED SIDE EFFECTS; 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, intramuscular, 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 subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event
Clinical narrative: HOT FLASHES; LIGHT HEADED; GENERAL DISCOMFORT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included blood disorder.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 27-JUN-2021 17:30 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On 27-JUN-2021, the subject experienced hot flashes. On 27-JUN-2021, the subject experienced light headed. On 27-JUN-2021, the subject experienced general discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, light headed, and general discomfort. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Discomfort, Dizziness, Hot flush
Clinical narrative: HOT FLASHES; LIGHT HEADED; GENERAL DISCOMFORT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included blood disorder.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 27-JUN-2021 17:30 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On 27-JUN-2021, the subject experienced hot flashes. On 27-JUN-2021, the subject experienced light headed. On 27-JUN-2021, the subject experienced general discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, light headed, and general discomfort. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush
Clinical narrative: HOT FLASHES; LIGHT HEADED; GENERAL DISCOMFORT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included blood disorder.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 27-JUN-2021 17:30 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On 27-JUN-2021, the subject experienced hot flashes. On 27-JUN-2021, the subject experienced light headed. On 27-JUN-2021, the subject experienced general discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, light headed, and general discomfort. This report was non-serious.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Product administered to patient of inappropriate age, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; SORENESS IN THE ARM; TIRED AT NIGHT; This spontaneous report received from a parent concerned a 16 year old female. The patient's height, and weight were not reported. The patient was diagnosed with Lyme disease when she was 10 or 11 years old but no after effects and she is fine now. The patient have just seasonal allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm on 12-MAY-2021 (coded as inappropriate age at vaccine administration) for prophylactic vaccination. No concomitant medications were reported. After vaccination, the patient had soreness in the arm for a couple of days and felt tired at night which cleared in 24-48 hours. The patient work at a camp, where somebody came down with Covid and there have been couple of cases of Covid-19. The patient exhibited symptoms of Covid and was tested by rapid test on 13-JUN-2021, which was negative. Laboratory data included: SARS-CoV-2 test (NR: not provided) negative. The patient was subsequently tested twice on 14-JUN-2021, both positive (suspected clinical vaccination failure and suspected covid-19 infection). The patient's father did not know the specifics of the tests that were done. The patient was quarantined in the camp and was till under quarantine in the camp. The patient also presented with Covid symptoms such as Covid cough and pain in the chest for coughing. The patient felt fine now (as reported). The patient's father mentioned that the camp had to make a report to the health authorities but did not think that the patient visited a physician. Laboratory data included SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the arm, and tired at night on 14-MAY-2021, and the outcome of suspected covid-19 infection, suspected clinical vaccination failure and inappropriate age at vaccine administration was not reported. This report was serious (Other Medically Important Condition). This case is associated with the Product quality complaint (PQC): 90000184104.; Sender's Comments: V0 - 20210660267- 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: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; SORENESS IN THE ARM; TIRED AT NIGHT; This spontaneous report received from a parent concerned a 16 year old female. The patient's height, and weight were not reported. The patient was diagnosed with Lyme disease when she was 10 or 11 years old but no after effects and she is fine now. The patient have just seasonal allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm on 12-MAY-2021 (coded as inappropriate age at vaccine administration) for prophylactic vaccination. No concomitant medications were reported. After vaccination, the patient had soreness in the arm for a couple of days and felt tired at night which cleared in 24-48 hours. The patient work at a camp, where somebody came down with Covid and there have been couple of cases of Covid-19. The patient exhibited symptoms of Covid and was tested by rapid test on 13-JUN-2021, which was negative. Laboratory data included: SARS-CoV-2 test (NR: not provided) negative. The patient was subsequently tested twice on 14-JUN-2021, both positive (suspected clinical vaccination failure and suspected covid-19 infection). The patient's father did not know the specifics of the tests that were done. The patient was quarantined in the camp and was till under quarantine in the camp. The patient also presented with Covid symptoms such as Covid cough and pain in the chest for coughing. The patient felt fine now (as reported). The patient's father mentioned that the camp had to make a report to the health authorities but did not think that the patient visited a physician. Laboratory data included SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the arm, and tired at night on 14-MAY-2021, and the outcome of suspected covid-19 infection, suspected clinical vaccination failure and inappropriate age at vaccine administration was not reported. This report was serious (Other Medically Important Condition). This case is associated with the Product quality complaint (PQC): 90000184104.; Sender's Comments: V0 - 20210660267- COVID-19 VACCINE AD26.COV2.S -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Feeling cold, Headache
Clinical narrative: BODY SORENESS; LOSS OF APPETITE; FEELING COLD; WEAKNESS; FEVER-LIKE; HEADACHE; DIZZY; NAUSEATED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, 8782021 expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced dizzy. On JUN-2021, the subject experienced nauseated. On 26-JUN-2021, the subject experienced headache. On 27-JUN-2021, the subject experienced body soreness. On 27-JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced feeling cold. On 27-JUN-2021, the subject experienced weakness. On 27-JUN-2021, the subject experienced fever-like. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, weakness, body soreness, feeling cold, loss of appetite, fever-like, dizzy and nauseated was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: BODY SORENESS; LOSS OF APPETITE; FEELING COLD; WEAKNESS; FEVER-LIKE; HEADACHE; DIZZY; NAUSEATED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, 8782021 expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced dizzy. On JUN-2021, the subject experienced nauseated. On 26-JUN-2021, the subject experienced headache. On 27-JUN-2021, the subject experienced body soreness. On 27-JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced feeling cold. On 27-JUN-2021, the subject experienced weakness. On 27-JUN-2021, the subject experienced fever-like. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, weakness, body soreness, feeling cold, loss of appetite, fever-like, dizzy and nauseated was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold
Clinical narrative: CHILLS; FEELING COLD; FEELING TIRED; This spontaneous report received from a consumer concerned a 28 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced feeling cold. On 25-JUN-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feeling cold, and feeling tired. This report was non-serious. This case, from the same reporter is linked to
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia
Clinical narrative: DIFFICULTY TURNING HEAD FROM LEFT TO RIGHT; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty turning head from left to right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of difficulty turning head from left to right was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapy partial responder
Clinical narrative: LOW ANTIBODY TITER; This spontaneous report received from a physician concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) 1 total 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. Physician reported that after patient received Janssen COVID-19 vaccine (date unspecified), on 25-JUN-2021, laboratory data included: Antibody test (NR: not provided) antibody titer levels were at 45000000000 which was low. Physician was concerned that these levels may be low and patient may need to be revaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low antibody titer. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210660717-covid-19 vaccine ad26.cov2.s -Low antibody titer. 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy prostate, Body temperature, Chills, Eye pain, Pain
Clinical narrative: BODY ACHES; CHILLS; FEVER/TEMPERATURE DECREASED FROM 102.8 TO 101.5; EYES HURTING; This spontaneous report received from a patient concerned a 60 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: 201A24A, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced eyes hurting. Laboratory data included: Biopsy prostate (NR: not provided) Not reported. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever/temperature decreased from 102.8 to 101.5. On 27-JUN-2021, Laboratory data included: Body temperature (NR: not provided) Decreased from 102.8 to 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever/temperature decreased from 102.8 to 101.5, and had not recovered from eyes hurting, chills, and body aches. This report was non-serious. This case, from the same reporter is linked to 20210661848.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER/TEMPERATURE DECREASED FROM 102.8 TO 101.5; EYES HURTING; This spontaneous report received from a patient concerned a 60 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: 201A24A, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced eyes hurting. Laboratory data included: Biopsy prostate (NR: not provided) Not reported. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever/temperature decreased from 102.8 to 101.5. On 27-JUN-2021, Laboratory data included: Body temperature (NR: not provided) Decreased from 102.8 to 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever/temperature decreased from 102.8 to 101.5, and had not recovered from eyes hurting, chills, and body aches. This report was non-serious. This case, from the same reporter is linked to 20210661848.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS ADMINISTERED FROM A PUNCTURED VIAL 18 HOURS AFTER BEING USED INITIALLY.; INCORRECT PRODUCT STORAGE; 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: 201A21A, expiry: 07-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced vaccine was administered from a punctured vial 18 hours after being used initially. On 24-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered from a punctured vial 18 hours after being used initially. and incorrect product storage was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: SHOOTING PAIN DOWN THE ARM; HEADACHE; FEVER; This spontaneous report received from a consumer concerned an 18 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: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced shooting pain down the arm. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting pain down the arm, headache, and fever on JUN-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Accident, Pyrexia
Clinical narrative: ACCIDENT; HIGH FEVER 104; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced accident, and high fever 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from accident, and high fever 104. This report was non-serious.; Sender's Comments: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Taste disorder, Throat irritation
Clinical narrative: TASTE OF MEDICINE AT THE BACK OF THROAT; BURNING SENSATION BACK OF THROAT; FEELING VERY FATIGUE; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was  pounds, and height was  inches. 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 27-JUN-2021 09:30:00 for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the subject experienced taste of medicine at the back of throat. On 27-JUN-2021, the subject experienced burning sensation back of throat. On 27-JUN-2021, the subject experienced feeling very fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling very fatigue, and taste of medicine at the back of throat, and the outcome of burning sensation back of throat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, C-reactive protein, Gait inability, Pain in extremity, Skin discolouration
Clinical narrative: DECOLORIZATION; COULDN'T WALK; RIGHT THIGH STARTED PAINING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced decolorization. On JUN-2021, the subject experienced couldn't walk. On JUN-2021, the subject experienced right thigh started paining. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, C-reactive protein (NR: not provided) Normal, and X-ray (NR: not provided) Normal. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right thigh started paining, and decolorization, and the outcome of couldn't walk was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: DECOLORIZATION; COULDN'T WALK; RIGHT THIGH STARTED PAINING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced decolorization. On JUN-2021, the subject experienced couldn't walk. On JUN-2021, the subject experienced right thigh started paining. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, C-reactive protein (NR: not provided) Normal, and X-ray (NR: not provided) Normal. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right thigh started paining, and decolorization, and the outcome of couldn't walk was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE; 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: 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 subject experienced out of specification product use, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-hodgkin's b cell lymphoma, immunocompromised, non-alcoholic, and non-smoker. The patient had no known allergies.  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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JUN-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative.  The consumer said the patient's team of oncologists are aware of the results of the antibody testing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with the RA number 90000184174.; Sender's Comments: V0 20210660913-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine 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: UNDERLYING DISEASE, SPECIAL SITUATIONS.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Tenderness
Clinical narrative: ACHY; CHILLS; TENDERNESS ON TOP OF THE HEAD; SORE ARM; This spontaneous report received from a patient concerned a 60 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced tenderness on top of the head. On 18-JUN-2021, the subject experienced sore arm. On 19-JUN-2021, the subject experienced achy. On 19-JUN-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on top of the head on 21-JUN-2021, achy, and chills on JUN-2021, and sore arm on 26-JUN-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Injection site pain, Limb mass, Muscle spasms, Muscular weakness
Clinical narrative: BACK PAIN GOT WORSE; BODY ACHES AND PAIN; SPASM IN LEGS AND BACK; PAIN IN RIGHT ARM  WHERE GOT INJECTION AND GOT WORSE; FEVER; WEAKNESS IN LEG; MASS IN ARM LIKE LUMP; This spontaneous report received from a patient concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included back injury, and bulging discs in back. The patient was previously treated with stem cells nos for back injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced weakness in leg. On JUN-2021, the subject experienced mass in arm like lump. On 04-JUN-2021, the subject experienced body aches and pain. On 04-JUN-2021, the subject experienced spasm in legs and back. On 04-JUN-2021, the subject experienced pain in right arm where got injection and got worse. On 04-JUN-2021, the subject experienced fever. On 07-JUN-2021, the subject experienced back pain got worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches and pain, and fever on JUN-2021, had not recovered from back pain got worse, pain in right arm where got injection and got worse, and spasm in legs and back, and the outcome of weakness in leg and mass in arm like lump was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BACK PAIN GOT WORSE; BODY ACHES AND PAIN; SPASM IN LEGS AND BACK; PAIN IN RIGHT ARM  WHERE GOT INJECTION AND GOT WORSE; FEVER; WEAKNESS IN LEG; MASS IN ARM LIKE LUMP; This spontaneous report received from a patient concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included back injury, and bulging discs in back. The patient was previously treated with stem cells nos for back injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced weakness in leg. On JUN-2021, the subject experienced mass in arm like lump. On 04-JUN-2021, the subject experienced body aches and pain. On 04-JUN-2021, the subject experienced spasm in legs and back. On 04-JUN-2021, the subject experienced pain in right arm where got injection and got worse. On 04-JUN-2021, the subject experienced fever. On 07-JUN-2021, the subject experienced back pain got worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches and pain, and fever on JUN-2021, had not recovered from back pain got worse, pain in right arm where got injection and got worse, and spasm in legs and back, and the outcome of weakness in leg and mass in arm like lump was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Injection site swelling, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; INJECTION SITE FULLNESS; This spontaneous report received from a patient concerned a 79 year old female  Initial information was processed with the additional information received on 28-JUN-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to antibiotics, allergic to food, non-alcohol user, and non-smoker. The patient had no history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 for prevention of COVID-19. No concomitant medications were reported.  On 02-APR-2021, the patient experienced injection site fullness with administration. The patient had titers drawn to assess for immunity. The physician ordered the wrong lab test at first. In JUN-2021 (2 and a half weeks ago from report time), the patient had a quantitative study drawn and results of lab were stated as 25 (units not provided) and it should be over 250 (units not provided). The patient had a confirmed immunological vaccine failure. The test was ordered by primary care doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site fullness on 02-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184220.; Sender's Comments: V0: 20210661118-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: NAUSEA/COULDNT EAT ANYTHING; HEADACHES; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included restless leg syndrome, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient is not a drug abuse or illicit drug user. antiemetics flares up restless leg syndrome. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. Concomitant medications included tramadol for restless leg syndrome. On 20-MAY-2021, the subject experienced nausea/couldnt eat anything. On 20-MAY-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: bismuth subsalicylate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea/couldnt eat anything, and had not recovered from headaches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test, Sneezing
Clinical narrative: SNEEZING; DRY COUGHING; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had not been infected with Covid in the past. 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 subject experienced sneezing, and dry coughing. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sneezing, and dry coughing. This report was non-serious. This case, from the same reporter is linked to 20210665584.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: FELT LIKE SHIT FOR 2 DAYS; CHILLS; FEVER; HEADACHE; MUSCULAR PAIN; 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: unknow) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt like shit for 2 days, chills, fever, headache, and muscular pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like shit for 2 days, chills, fever, headache, and muscular pain. This report was non-serious.