chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Intentional product misuse, Off label use, Product administered to patient of inappropriate age
Clinical narrative: PRODUCT ADMINISTERED to PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; INTENTIONAL MISUSE; This spontaneous report received from a lawyer via a company representative and concerned a 17 year old patient (sex unspecified).  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, batch number: 1855835, expiry date 27-APR-2022) 0.5 ml, on an unspecified date for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date the vaccine was administered by a non-medical professional (a biology teacher) to the patient, without the parents permission. The patient was 17 at the time of vaccination which constituted off label use (product administered to patient of inappropriate age). The biology teacher who administered the vaccine was arrested on 31-DEC-2021 and charged with unauthorized practice of a profession, after police determined that she was not a medical professional (intentional misuse). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age, off label use, and intentional misuse was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT PRETTY SICK; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced got pretty sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got pretty sick was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: RAPID COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to over 35 medications, allergic to eggs, no alcohol use, non-smoker and tooth infection. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported,1 total administered to the left arm on 18-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: UNKNOWN) dose was not reported,1 total administered to the left arm on 17-NOV-2021 for prophylactic vaccination. It was reported that on 03-JAN-2022 the patient had taken a rapid covid-19 test after contact with her Covid-19 positive grandson and that the rapid test showed positive although the patient had no symptoms. The patient stated that during the time that she tested positive she was being treated with azithromycin and prednisone for a tooth infection and mentioned perhaps these medications were the reason she had no symptoms (dose number in series 2). On 03-JAN-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) positive. On 03-JAN-2022, the patient experienced rapid covid-19 test positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rapid covid-19 test positive was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Feeling hot, Joint stiffness
Clinical narrative: MUSCLES OF UPPER BODY (NECK, SHOULDERS, ARMS AND BACK, NOT SO MUCH LEGS) GETTING VERY HOT/WARM, PERIODICALLY AND SPORADICALLY; STIFF MUSCLES OF UPPER BODY (NECK, SHOULDERS, ARMS AND BACK, NOT SO MUCH LEGS); HANDS (SPECIFICALLY IN JOINTS) FELT SWOLLEN AND VERY DIFFICULT TO MAKE A FIST; STIFF UPPER BODY JOINTS; LIMITING BOTH SIDES OF THE UPPER BODY; UPPER BODY JOINTS VERY ACHY; ACHY MUSCLES OF UPPER BODY (NECK, SHOULDERS, ARMS AND BACK, NOT SO MUCH LEGS), PERIODICALLY AND SPORADICALLY; FEELING WEAKER; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was a very active person. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced muscles of upper body (neck, shoulders, arms and back, not so much legs) getting very hot/warm, periodically and sporadically, stiff muscles of upper body (neck, shoulders, arms and back, not so much legs), hands (specifically in joints) felt swollen and very difficult to make a fist, stiff upper body joints, limiting both sides of the upper body, upper body joints very achy, achy muscles of upper body (neck, shoulders, arms and back, not so much legs), periodically and sporadically, and feeling weaker. Laboratory data (dates unspecified) included: Blood test (NR: not provided) all normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff muscles of upper body (neck, shoulders, arms and back, not so much legs), upper body joints very achy, achy muscles of upper body (neck, shoulders, arms and back, not so much legs), periodically and sporadically, muscles of upper body (neck, shoulders, arms and back, not so much legs) getting very hot/warm, periodically and sporadically, hands (specifically in joints) felt swollen and very difficult to make a fist, feeling weaker, stiff upper body joints, and limiting both sides of the upper body. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: MUSCLES OF UPPER BODY (NECK, SHOULDERS, ARMS AND BACK, NOT SO MUCH LEGS) GETTING VERY HOT/WARM, PERIODICALLY AND SPORADICALLY; STIFF MUSCLES OF UPPER BODY (NECK, SHOULDERS, ARMS AND BACK, NOT SO MUCH LEGS); HANDS (SPECIFICALLY IN JOINTS) FELT SWOLLEN AND VERY DIFFICULT TO MAKE A FIST; STIFF UPPER BODY JOINTS; LIMITING BOTH SIDES OF THE UPPER BODY; UPPER BODY JOINTS VERY ACHY; ACHY MUSCLES OF UPPER BODY (NECK, SHOULDERS, ARMS AND BACK, NOT SO MUCH LEGS), PERIODICALLY AND SPORADICALLY; FEELING WEAKER; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was a very active person. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced muscles of upper body (neck, shoulders, arms and back, not so much legs) getting very hot/warm, periodically and sporadically, stiff muscles of upper body (neck, shoulders, arms and back, not so much legs), hands (specifically in joints) felt swollen and very difficult to make a fist, stiff upper body joints, limiting both sides of the upper body, upper body joints very achy, achy muscles of upper body (neck, shoulders, arms and back, not so much legs), periodically and sporadically, and feeling weaker. Laboratory data (dates unspecified) included: Blood test (NR: not provided) all normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff muscles of upper body (neck, shoulders, arms and back, not so much legs), upper body joints very achy, achy muscles of upper body (neck, shoulders, arms and back, not so much legs), periodically and sporadically, muscles of upper body (neck, shoulders, arms and back, not so much legs) getting very hot/warm, periodically and sporadically, hands (specifically in joints) felt swollen and very difficult to make a fist, feeling weaker, stiff upper body joints, and limiting both sides of the upper body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Eye irritation, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; BURNING EYES; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JAN-2022, the patient experienced confirmed covid-19 infection, and burning eyes. 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 outcome of the confirmed covid-19 infection and burning eyes was not reported. This report was non-serious. This case, from the same reporter is linked to 20220112654, 20220112293 and 20220112632.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: PAINFUL KNEE; HAND PAIN; GASTROINTESTINAL INFECTION; COVID-19; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, intramuscular, batch number :unknown, expiry: unknown) dose was not reported, 1 total, administered on 20-MAR-2021. It was unknown if patient experienced any adverse reactions following administration of covid-19 vaccine ad26.cov2.s. (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, intramuscular, batch number :unknown, expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination which reported for off label use and inappropriate schedule of vaccine administered. (dose number in series 2). On DEC-2021, the patient experienced gastrointestinal infection. (dose number in series 2). On an unspecified date, the patient had covid-19, Patient got covid after left hospital. Missed doses of Humira while in hospital and during covid and had painful knee and hand pain(dose number in series 2). The patient was hospitalized on an unknown date for five days. The patient received adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date therapy with adalimumab was discontinued. No concomitant medications were reported.  Patient received additional dose of Moderna (dose number in series was 3) (form of admin, intramuscular, and batch number were not reported) dose was not reported, administered on 04-DEC-2021 for covid-19 vaccination. It was unknown if patient experienced any adverse reactions following vaccination with Moderna vaccine (dose number in series was 3).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; treatment with adalimumab was withdrawn; and action taken with mrna 1273 was not reported. The patient was recovering from painful knee, gastrointestinal infection, and covid-19, and the outcome of hand pain, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220152328-COVID-19 VACCINE AD26.COV2.S-gastrointestinal 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). 20220152328-COVID-19 VACCINE AD26.COV2.S-painful knee, hand pain. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, 1 total administered on 08-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-JAN-2022, the patient started to experience cough, sore throat, nasal congestion, light headedness and fatigue and later that same day tested positive using the Bi Nax covid-19 antigen test (suspected clinical vaccination failure, and suspected covid-19 infection). Symptoms had peaked but were still there as of 27-JAN-2022.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000214161.; Sender's Comments: V0:20220152330-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: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Reporter stated that "My mother received a vax and was dead the next morning". On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220152346 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- DIED. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation, Oxygen saturation decreased, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; OXYGEN SATURATION DECREASED; This spontaneous report received from a patient concerned a patient of unspecified age and sex and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, 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 20-DEC-2021, the patient experienced oxygen saturation decreased, suspected covid-19 infection and suspected clinical vaccination failure and was hospitalized (date unspecified). Laboratory data (dates unspecified) included: Oxygen saturation (not provided) 87. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and oxygen saturation decreased was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint. This case, involving the same patient is linked to 20220161291.; Sender's Comments: V0:20220152367-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 20220152367-COVID-19 VACCINE AD26.COV2.S-Suspected covid-19 infection, Oxygen saturation decreased 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: Illness
Clinical narrative: PREETY SICK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 preety sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of preety sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220151884.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Rash, Rhinorrhoea, Thrombosis
Clinical narrative: SEVERE BLOOD CLOT IN EYE; SLEEPING DIFFICULTY; LOT OF MUCUS; SEVERE RASH ON NECK WHICH WENT DOWN THE ARMS TO THE ELBOW/RASH ON BACK AND PART OF THE HEAD; This spontaneous report received from a patient concerned a 7 decade old female of unspecified 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 (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient developed a severe blood clot in the eye and a severe rash on the neck which went down the arms to the elbow. The patient had visited the dermatologist and had started to get better. The rash had lasted for several months. The patient also had difficulty sleeping (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe blood clot in her eye, severe rash on neck which went down the arms to the elbow/rash on back and part of the head, and sleeping difficulty was not reported. On 10-NOV-2021, the patient received booster of non-company suspect vaccine MRNA 1273 (dose number in series: 2) (form of admin, and route of admin, were not reported, batch number: 033F21A expiry: UNKNOWN) dose was not reported, administered to the left arm shoulder deltoid muscle for prophylactic vaccination. On an unspecified date, following vaccination with MRNA 1273, the patient developed a rash on the back, neck and part of the head. The patient had seen the doctor for the rash and was prescribed with cortisone tablets, antihistamine, ointments and liquids to put on the rash. The patient was also prescribed with clobetasol propionate (Clobetasol 0.05%). The patient also noticed a lot of mucus after the booster vaccine and stated that the rash was not as severe as it was after the covid-19 vaccine ad26.cov2.s. (Dose number in series: 2). The outcome of the lot of mucus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220152554 COVID-19 VACCINE AD26.COV2.S- severe blood clot in her eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dyspnoea, Headache, Nausea
Clinical narrative: SEVERE SINUS HEADACHE; ACHEY; DRY COUGH; WINDED; SORE THROAT; SINUS CONGESTION; FEVERISH; HEADACHE; NAUSEA; DIARRHEA; This spontaneous report received from a patient concerned a White, Not Hispanic or Latino male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: unknown) dose was not reported, 1 total administered on 05-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced severe sinus headache, achey, dry cough, winded, sore throat, sinus congestion, feverish, headache, nausea, and diarrhea. (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe sinus headache, achey, and feverish, had not recovered from headache, diarrhea, nausea, dry cough, sore throat, and sinus congestion, and the outcome of winded was not reported. The patient received additionally booster BNT 162 (Pfizer) vaccine (dose number in series 2) (Form of admin not reported, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, administered on 18-DEC-2021 for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with BNT162 (Pfizer). (Dose number in series 2). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Sinus congestion, Sinus headache
Clinical narrative: SEVERE SINUS HEADACHE; ACHEY; DRY COUGH; WINDED; SORE THROAT; SINUS CONGESTION; FEVERISH; HEADACHE; NAUSEA; DIARRHEA; This spontaneous report received from a patient concerned a White, Not Hispanic or Latino male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: unknown) dose was not reported, 1 total administered on 05-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced severe sinus headache, achey, dry cough, winded, sore throat, sinus congestion, feverish, headache, nausea, and diarrhea. (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe sinus headache, achey, and feverish, had not recovered from headache, diarrhea, nausea, dry cough, sore throat, and sinus congestion, and the outcome of winded was not reported. The patient received additionally booster BNT 162 (Pfizer) vaccine (dose number in series 2) (Form of admin not reported, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, administered on 18-DEC-2021 for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with BNT162 (Pfizer). (Dose number in series 2). This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 79 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included: non-smoker, non-alcoholic and other pre-existing medical conditions included: Patient did not had known drug allergies and drug abuse or illicit drug use. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin was not reported. batch number: 202A21A  and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 on left arm for prophylactic vaccination. It was unknown if the patient had any adverse events with covid-19 vaccine ad26. cov2. s (dose number series1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin was not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered, 17-Nov-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experience body aches, chills, fever, cough, heavy congestion, sore throat and headache(dose number in series 2) .On 25-JAN-2022 , the patient diagnosed with suspected covid-19 infection which lead to suspected clinical vaccination failure. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.6.(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20220153760-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: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: CHILLS; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, headache, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, fatigue and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT (HAVE NOT HAD AN OUTBREAK (HERPES AND SHINGLES); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: terrible, horrific cold sores (literally no exaggeration), and shingles, and other pre-existing medical conditions included: The patient had cold sores and shingles outbreak occurred up to 3 times a year. The patient had indescribable pain, itch, fever, chills due to shingles and had received shingles shot series. The patient was previously treated with valaciclovir hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced unexpected therapeutic benefit (have not had an outbreak (herpes and shingles). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit (have not had an outbreak (herpes and shingles) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: REALLY SICK FOR 2 WEEKS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, lupus, gastrooesophageal reflux disease, heartburn, polycystic ovarian syndrome, migraine headaches, nausea, allergies, dry eyes, off balance, thyroid nodules, pain, and multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included azelastine, bupropion hydrochloride/naltrexone hydrochloride, cannabidiol, cetirizine hydrochloride, cimetidine, diphenhydramine hydrochloride, erenumab, lisinopril, methylprednisolone sodium succinate, montelukast sodium, ocrelizumab, omeprazole, ondansetron, steroids, and.  On an unspecified date, the patient experienced really sick for 2 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of really sick for 2 weeks was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20220152301.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK IN BED FOR MONTHS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sick in bed for months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick in bed for months was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Feeling abnormal, Headache, Pruritus
Clinical narrative: BELLS PALSY; TERRIBLE ITCH; OTHER STRANGE THINGS; HEADACHES; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, and ethnicity with race as other. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total 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.  It was reported that on an unspecified date, "J and J gave patient bells palsy, headaches, terrible itch and among other strange things".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bells palsy, headaches, terrible itch and other strange things was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220155234-covid-19 vaccine ad26.cov2.s- Bells Palsy.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: EPISODES OF HEADACHES; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high cholesterol, high blood pressure, non smoker, and no alcohol use, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, and expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced episodes of headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from episodes of headaches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Muscular weakness, Vision blurred
Clinical narrative: BLURRED VISION; METAL TASTE IN MOUTH; MUSCULAR WEAKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blurred vision, metal taste in mouth, and muscular weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the metal taste in mouth, blurred vision and muscular weakness was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 54 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and expiry: unknown) dose was not reported,1 total administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-JAN-2022, Patient had symptoms of runny nose and cough symptoms (suspected covid-19 infection) which were ongoing at the time of reporting. On 28-JAN-2022, the patient tested Covid positive from rapid antigen test (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0- 20220156414-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Foot deformity, Gout
Clinical narrative: GREAT AMOUNT OF HAIR LOSS; BUNION IN THE SECOND TOE OF RIGHT FOOT; GOUT; This spontaneous report received from a patient concerned a 74 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced gout. On an unspecified date, the patient experienced great amount of hair loss, and bunion in the second toe of right foot. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from great amount of hair loss, and gout, and the outcome of bunion in the second toe of right foot was not reported. This report was non-serious. This case, from the same reporter is linked to 20220157663.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE REACTIONS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Thrombosis
Clinical narrative: BLOOD CLOT; TINGLING SENSATION IN HIS LEG; SHARP PAIN AND NUMBING SENSATION IN HIS RIGHT FOOT; This spontaneous report received from a parent concerned a 34 year old male. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number, expiry were not reported) dose, start therapy date were not reported, dose number in series was 01, 01 in total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient developed blood clot. After the shot, he felt a tingling sensation in his leg and then sharp pains and numbing sensation in his right foot. He was rushed to an emergency room (ER) and then transferred to another facility that was better to equipped to handle the situation and underwent surgery (dose number in series was 01). On an unspecified date patient was hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot, and the outcome of tingling sensation in his leg, sharp pains and numbing sensation in his right foot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220156613 - covid-19 vaccine ad26.cov2.s - blood clot. 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).  20220156613 -covid-19 vaccine ad26.cov2.s- tingling sensation in his leg, sharp pains and numbing sensation in his right foot. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chest discomfort, Pain, Pyrexia
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; HEAVINESS IN UPPER CHEST AREA, FELT LIKE BRONCHITIS; ACHES AFTER BOOSTER; FEVER AFTER BOOSTER; 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: bronchitis, aspirin allergy (irritates stomach), and iodine allergy (rash). The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: Unknown) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination on her right arm (dose number in series 1). It was unknown if patient experienced any adverse events after primary vaccination.(dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D2 expiry: Unknown) dose was not reported, 1 in total, administered on 08-DEC-2021 for prophylactic vaccination on her right arm (dose number in series 2). No concomitant medications were reported.  On 08-DEC-2021 after vaccination with booster dose, patient experienced fever and aches for three days.  On 08-JAN-2022, the patient experienced symptoms which included sore throat, fatigue, headache, smell bothered her throat, aches, fever of 99F, patient felt very much higher and body aches (confirmed covid-19 infection). Laboratory data included: Body temperature (NR: not provided) 99 F. The patient felt heaviness in upper chest area which felt like bronchitis. On 14-JAN-2022, the patient tested Covid positive (confirmed clinical vaccination failure). Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive (dose number in series 2). The patient reported that she had no symptoms at the time of report.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and heaviness in upper chest area, felt like bronchitis on 21-JAN-2022, and aches after booster, and fever after booster on 11-DEC-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20220156699. This report was associated with product quality complaint.  It was determined that Manufacturer Case Number (20220156699) was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number (20220156981).; Sender's Comments: V0-20220156981- covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; HEAVINESS IN UPPER CHEST AREA, FELT LIKE BRONCHITIS; ACHES AFTER BOOSTER; FEVER AFTER BOOSTER; 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: bronchitis, aspirin allergy (irritates stomach), and iodine allergy (rash). The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: Unknown) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination on her right arm (dose number in series 1). It was unknown if patient experienced any adverse events after primary vaccination.(dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D2 expiry: Unknown) dose was not reported, 1 in total, administered on 08-DEC-2021 for prophylactic vaccination on her right arm (dose number in series 2). No concomitant medications were reported.  On 08-DEC-2021 after vaccination with booster dose, patient experienced fever and aches for three days.  On 08-JAN-2022, the patient experienced symptoms which included sore throat, fatigue, headache, smell bothered her throat, aches, fever of 99F, patient felt very much higher and body aches (confirmed covid-19 infection). Laboratory data included: Body temperature (NR: not provided) 99 F. The patient felt heaviness in upper chest area which felt like bronchitis. On 14-JAN-2022, the patient tested Covid positive (confirmed clinical vaccination failure). Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive (dose number in series 2). The patient reported that she had no symptoms at the time of report.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and heaviness in upper chest area, felt like bronchitis on 21-JAN-2022, and aches after booster, and fever after booster on 11-DEC-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20220156699. This report was associated with product quality complaint.  It was determined that Manufacturer Case Number (20220156699) was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number (20220156981).; Sender's Comments: V0-20220156981- covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS