chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Malaise, Nausea
Clinical narrative: RED MARK ON LEFT ARM; FELT SICK; NAUSEA; This spontaneous report received from a patient concerned a 75 year old white female of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with  covid-19 vaccine ad26.cov2.s for prophylactic vaccination on unspecified date (dose number in series 1) (unspecified manufacturer). No adverse events reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 08-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On 08-NOV-2021, the patient received the booster shot of the Janssen Covid-19 vaccine and had a red mark on her arm (left arm), that would not be go away (not resolved). She also reported feeling nauseous (resolved) and sick 15 mins after receiving the vaccine (resolved) (all events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sick, and nausea (date unspecified) and had not recovered from red mark on left arm. This report was non-serious. This case, from the same reporter is linked to 20211133681.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: FATIGUE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 35 year old male.  The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and other pre-existing medical conditions included: Patient had no known drug allergies and no relevant medical history.  The patient received first dose (dose number in series 1) of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 30- MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. The batch number was not reported.  On an unspecified date, the patient experienced fever, headache and fatigue. (dose number in series 1)  The patient received additional dose (dose number in series 2) of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 30-OCT-2021 for prophylactic vaccination.  The Company is unable to perform follow-up to request batch/lot numbers.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from fatigue and the outcome of fever and headache was not recovered   This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anal incontinence, Decreased appetite, Dysgeusia, Fatigue, Migraine
Clinical narrative: LOST CONTROL OF THEIR BOWELS; METALLIC TASTE; VERTIGO; LOST THEIR APPETITE; FATIGUE; SEVERE MIGRAINE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease, and other pre-existing medical conditions included: The patient had inner inner ear disease, osteoporosis, vitamin b complex deficiency, unspecified allergy and anxiety. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802072, and  expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. On unspecified date the patient experienced severe migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. outcome of severe migraine was not reported. Non-company suspect vaccine included: mrna 1273 (dose number in series 2) ( batch number: 034F21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination.  Concomitant medications included pregabalin for chronic migraine, citalopram for drug used for anxiety, ergocalciferol for drug used for unknown indication, vitamin b nos for for a deficiency, calcium/colecalciferol for osteoporosis, and cetirizine hydrochloride for year round allergies.  On 08-NOV-2021, the patient experienced severe migraine, metallic taste, vertigo, lost their appetite and fatigue.  On 09-NOV-2021, the patient experienced lost control of their bowels. The action taken with mrna 1273, was not applicable The patient recovered from metallic taste and lost control of their bowels on 09-NOV-2021 and severe migraine, vertigo, lost their appetite, and fatigue on 10-NOV-2021. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: LOST CONTROL OF THEIR BOWELS; METALLIC TASTE; VERTIGO; LOST THEIR APPETITE; FATIGUE; SEVERE MIGRAINE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease, and other pre-existing medical conditions included: The patient had inner inner ear disease, osteoporosis, vitamin b complex deficiency, unspecified allergy and anxiety. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802072, and  expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. On unspecified date the patient experienced severe migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. outcome of severe migraine was not reported. Non-company suspect vaccine included: mrna 1273 (dose number in series 2) ( batch number: 034F21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination.  Concomitant medications included pregabalin for chronic migraine, citalopram for drug used for anxiety, ergocalciferol for drug used for unknown indication, vitamin b nos for for a deficiency, calcium/colecalciferol for osteoporosis, and cetirizine hydrochloride for year round allergies.  On 08-NOV-2021, the patient experienced severe migraine, metallic taste, vertigo, lost their appetite and fatigue.  On 09-NOV-2021, the patient experienced lost control of their bowels. The action taken with mrna 1273, was not applicable The patient recovered from metallic taste and lost control of their bowels on 09-NOV-2021 and severe migraine, vertigo, lost their appetite, and fatigue on 10-NOV-2021. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included: fibromyalgia, and concurrent conditions included: non-alcohol user, non-smoker, and blood pressure. The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (unspecified manufacturer) (Dose Number In Series 1) and experienced drug allergy when treated with hydrocodone (for fibromyalgia), duloxetine hydrochloride, fluconazole, diltiazem, doxycycline (received only for 7 days), famotidine, fluticasone, irbesartan, gabapentin, carisoprodol, budesonide/formoterol fumarate and topiramate.  The patient received booster dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination (Dose Number In Series 2). No concomitant medications were reported.  On 17-NOV-2021, the patient experienced headache. Treatment medications (dates unspecified) included: hydrocodone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-NOV-2021. This report was non-serious. This case, from the same reporter is linked to 20211142554.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an Unspecified date the patient was previously treated with covid-19 vaccine ad26. cov2.s from unspecified manufacturer (Dose Number in Series: 1) for prophylactic vaccination and did not report any adverse events.  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, (Dose Number in Series: 2) 1 total administered on 17-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s booster dose the patient experienced expired vaccine used. (Dose Number in Series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of expired vaccine used was not reported.  This report was non-serious.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: VERY BAD HEADACHE; This spontaneous report received from a consumer concerned an 86 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history was not reported. Concurrent conditions are non-alcohol user, quit smoking (patient quit smoking in 1980's) and glaucoma. The patient was previously treated with covid-19 vaccine ad26. cov2. s. (manufacturer not specified) (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 in total, for prophylactic vaccination (dose series 1).  The patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: UNKNOWN) dose was not reported, 1 in total, on right arm administered on 16-NOV-2021 for prophylactic vaccination. (dose series 2). Concomitant medications included brimonidine tartrate/brinzolamide and latanoprost for glaucoma; and famotidine, losartan, metformin, metoprolol succinate, and pravastatin for unknown indications.  On 17-NOV-2021, the patient experienced very bad headache after he woke up (dose series 2). The headache lasted all day.  Tylenol (Paracetamol) did not help to reduce the headache. Patient did not experience the headache on the night of 17-NOV-2021, and it went away during sleep. Headache was gone on 18-NOV-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very bad headache on 18-NOV-2021. This report was non-serious. This case, from the same reporter is linked to 20211142267.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM HURT TERRIBLE; This spontaneous report received from a patient concerned a 57 year old female.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient experienced terrible headache when treated with covid-19 vaccine ad26. cov2. s for prophylactic 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: 1855194, and batch number: 1855194 expiry: 09-APR-2022) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination.(Dose number in series 2) No concomitant medications were reported.   On 11-NOV-2021, the patient experienced arm hurt terrible.(Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of arm hurt terrible was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211145104 (Dose number in series 1).  This case, from the same reporter is linked to 20211144980.
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood potassium, Diarrhoea, Haemorrhoids, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohns disease.  The patient was previously treated with covid-19 vaccine ad26. cov2. s  (suspension for injection, intramuscular, batch number was not reported) for prophylactic vaccination. (Dose number in series 1)   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 2). Non-company suspect drugs included: 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 adult crohn's disease. No concomitant medications were reported.   On an unspecified date, the patient experienced hemorrhoids, diarrhea, and fever (Dose number in series 2). Laboratory data (dates unspecified) included: Magnesium (NR: not provided) low, Potassium (NR: not provided) low, and Vitamin B12 (NR: not provided) decreased. Treatment medications (dates unspecified) included: zopiclone.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported.  The patient recovered from fever, and was recovering from hemorrhoids, and diarrhea.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12
Clinical narrative: This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohns disease.  The patient was previously treated with covid-19 vaccine ad26. cov2. s  (suspension for injection, intramuscular, batch number was not reported) for prophylactic vaccination. (Dose number in series 1)   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 2). Non-company suspect drugs included: 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 adult crohn's disease. No concomitant medications were reported.   On an unspecified date, the patient experienced hemorrhoids, diarrhea, and fever (Dose number in series 2). Laboratory data (dates unspecified) included: Magnesium (NR: not provided) low, Potassium (NR: not provided) low, and Vitamin B12 (NR: not provided) decreased. Treatment medications (dates unspecified) included: zopiclone.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported.  The patient recovered from fever, and was recovering from hemorrhoids, and diarrhea.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: SHOT KILLED; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose  (dose number series 1), 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 consumer stated "shot killed my loved one" (death). On an unspecified date, the patient died from unknown cause. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211164482-COVID-19 VACCINE AD26.COV2.S-shot killed. 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: F
Vaccine: COVID19
Symptoms: Blepharitis
Clinical narrative: INFLAMMATION OF EYE LIDS; 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 pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced inflammation of eye lids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammation of eye lids. This report was non-serious.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned an 82 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rare blood cancer (since 1995). The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, route of admin not reported, batch number: 1708609, expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm in late afternoon between 16:00 or 17:00 on 23-MAR-2021 for prophylactic vaccination. Concomitant medications included special flu shot (influenza vaccine).  On 08-NOV-2021, the patient diagnosed with Covid-19, patient did not hospitalized or ventilated, stayed in bed at home. The patient was getting over quarantine as of 18-NOV-2021. On 08-NOV-2021, the patient's Covid test was done, took nose swab. The patient received results on 09-NOV-2021, who said his test was positive, and this results in confirmed clinical vaccination failure. On 08-NOV-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The patient just received his 2nd special flu shot and would like to get a Janssen Covid-19 vaccine booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000205266.; Sender's Comments: V0: 20211208454 -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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF VACCINE AS THE INITIAL DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 65 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: 213D21A, and expiry: 11-APR-2022) (Dose number in series: 1) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced received less than 0.5ml of vaccine as the initial dose (0.3ml). On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as the initial dose (0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF THE VACCINE AS THE INITIAL DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 26 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: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced received less than 0.5ml of the vaccine as the initial dose. On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the vaccine as the initial dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210058, 20211210160, 20211210409, 20211210610, 20211209679, 20211209706, 20211209740, 20211209775, 20211209782, 20211209843, 20211209874, 20211209880, 20211209884, 20211209912, 20211209921, 20211210019, 20211210067, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210159, 20211210165, 20211210165, 20211210180, 20211210350, 20211210385, 20211210408, 20211210549, 20211210555, 20211210588, 20211210733, 20211209551, 20211209976, 20211209798 and 20211210334.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: MALAISE; FEW HOURS OF MILD FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 malaise, and few hours of mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from malaise, and few hours of mild fever. This report was non-serious. This case, from the same reporter is linked to 20211210219 and 20211210699.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Fatigue, Sensory disturbance
Clinical narrative: LIFE HASN'T BEEN THE SAME; TROUBLE WITH LEGS AND FEET GOING TO SLEEP; LEGS AND FEET ARE CONSTANTLY FATIGUED; 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 pre-existing medical conditions included: Before the shot patient was an active person. 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 patient experienced life hasn't been the same, trouble with legs and feet going to sleep, and legs and feet are constantly fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the life hasn't been the same, trouble with legs and feet going to sleep and legs and feet are constantly fatigued was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: BLACKING OUT; LIGHT HEADEDNESS; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 in APR-2021, and concurrent conditions included: celiac disease, and gluten allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: Unknown) dose was not reported, 1 total,  administered on left arm on 03-DEC-2021 for prophylactic vaccination (dose number series is 1). No concomitant medications were reported.  On 03-DEC-2021, after the injection, the patient experienced light headedness. On 04-DEC-2021, in the morning while in kitchen, the patient started to black out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blacking out, and light headedness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211212231-covid-19 vaccine ad26.cov2.s- Blacking out. This event(s) is considered unassessable. The event(s) has a compatible/ suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Night sweats, Palpitations, Thyroid disorder, Tremor
Clinical narrative: LOSS OF VISION; THYROID STOPPED WORKING PROPERLY; TREMORS; HEART POUNDING; NIGHT SWEATS; This spontaneous report received from a patient on social media  via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. The patient's pre-existing medical conditions included: Patient had normal thyroid in June. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on NOV-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On NOV-2021, the patient experienced tremors, heart pounding, loss of vision, night sweats, thyroid stopped working properly and patient stated that this happened 4 weeks after the shot and the covid shot ruined the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the tremors, heart pounding, loss of vision, night sweats and thyroid stopped working properly was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211212519-COVID-19 VACCINE AD26.COV2.S-Loss of vision. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Feeling abnormal
Clinical narrative: FELT LIKE SHE WAS IN FOG; LIKE NOT TOO QUICK TO THINK; This spontaneous report received from a patient via a company representative concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for psoriatic arthritis.  On 20-MAR-2021, the patient experienced felt like she was in fog. On 20-MAR-2021, the patient experienced like not too quick to think. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like she was in fog and like not too quick to think was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm, Cerebrovascular accident
Clinical narrative: MULTIPLE STROKES; ANEURYSM; This spontaneous report received from a consumer via social media concerned a 42 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died from an aneurysm and multiple strokes. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of aneurysm and multiple strokes on an unspecified date. This report was serious (Death).; Sender's Comments: V0:20211212714-COVID-19 VACCINE AD26.COV2.S-Multiple stroke, Aneurysm. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ANEURYSM; MULTIPLE STROKES
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Peripheral coldness, Pyrexia
Clinical narrative: ACHINESS; COLD HANDS; FEVER; TINGLING HANDS; 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 (series 1, 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 patient experienced achiness, cold hands, fever, and tingling hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold hands, and tingling hands, and the outcome of fever and achiness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Coordination abnormal, Diplopia, Fine motor skill dysfunction, Injury
Clinical narrative: PRETTY SEVERE VACCINE INJURY; LOSS OF COORDINATION; LOSS OF FINE MOTOR SKILLS; DOUBLE VISION; LOSS OF STRENGTH; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 patient experienced pretty severe vaccine injury, loss of coordination, loss of fine motor skills, double vision, and loss of strength. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pretty severe vaccine injury, loss of strength, loss of coordination, loss of fine motor skills and double vision was not reported. This report was non-serious. This case, from the same reporter is linked to 20211212714.
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery occlusion, Myocardial infarction
Clinical narrative: HEART ATTACK; MASSIVE BLOCKAGES IN HEART; This spontaneous report received from a consumer concerned an 84 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had perfect health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack 2 weeks later after the vaccination and had massive blockages in heart and doctors did not do anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and massive blockages in heart was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211213021-COVID-19 VACCINE AD26.COV2.S- heart attack, massive blockages in heart. 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: Body temperature, Pyrexia
Clinical narrative: ELEVATED TEMPERATURE FOR TWO DAYS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 number. No concomitant medications were reported. On an unspecified date, the patient experienced elevated temperature for two days. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated temperature for two days. This report was non-serious. This case, from the same reporter is linked to 20211212497.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEELING LIKE DYING EVERYDAY; 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 feeling like dying everyday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling like dying everyday was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood test, Tinnitus
Clinical narrative: RINGING IN THE EARS, CANNOT LISTEN TO ANYTHING WITHOUT THE RINGING; 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 pre-existing medical conditions included: The doctor said his ears were normal. The patient had no temporomandibular joint disorder (TMJ). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 23-AUG-2021) dose was not reported, administered on 19-MAR-2021 11:23 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the patient experienced ringing in the ears, cannot listen to anything without the ringing. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported, and Hearing test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in the ears, cannot listen to anything without the ringing. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood cholesterol, Blood cholesterol decreased, Influenza like illness, Low density lipoprotein
Clinical narrative: FLU LIKE SYMPTOMS/FEVER/CHILLS/HEADACHE; CHOLESTEROL LOW; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: tumor in neck/ benign lipoma on the neck, non smoker, alcohol user, nuts allergy, and low density lipoprotein was high, and other pre-existing medical conditions included: Codeine allergy manifestated by face, tounge and feet swelling. Nut allergy was manifestated by anaphylactic reaction, tingling sensation on lips and tounge and scratchy throat. The patient was previously treated with prednisone for drug used for unknown indication; and experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) 15 mg, 1 time every 1 day, from APR-2021 for moderate to severe rheumatoid arthritis. Concomitant medications included rosuvastatin calcium for high density lipoprotein, and epinephrine for rheumatoid arthritis. On 2021, the patient experienced cholesterol low. Laboratory data included: Cholesterol (NR: not provided) low. On 01-APR-2021, the patient experienced flu like symptoms/fever/chills/headache. Laboratory data (dates unspecified) included: Low density lipoprotein (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient recovered from flu like symptoms/fever/chills/headache on 02-APR-2021, and had not recovered from cholesterol low. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hypoacusis
Clinical narrative: PERIOD CAME 6 DAYS EARLY; CHILLS; ARM PAIN; HEADACHE; EXTREME TIREDNESS; FEVER; PAINFUL SHOT; STRANGE TASTE IN MOUTH WHEN GETTING SHOT; TROUBLE WITH WORDS; TROUBLE WITH HEARING; TROUBLE WITH SMELL, BURNT TOAST; 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 not reported, batch number: Unknown) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-OCT-2021, the patient experienced strange taste in mouth when getting shot, trouble with words, trouble with hearing, trouble with smell, burnt toast, experienced chills, arm pain, headache, extreme tiredness, fever, and painful shot. Laboratory data included: Body temperature (NR: not provided) 100.7, 96.6 shortly after shot. On an unspecified date, the patient experienced period 6 days early. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and the outcome of strange taste in mouth when getting shot, painful shot, fever, trouble with words, trouble with hearing, trouble with smell burnt toast, chills, headache, arm pain and period 6 days early was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Language disorder, Menstruation irregular, Pain in extremity, Parosmia
Clinical narrative: PERIOD CAME 6 DAYS EARLY; CHILLS; ARM PAIN; HEADACHE; EXTREME TIREDNESS; FEVER; PAINFUL SHOT; STRANGE TASTE IN MOUTH WHEN GETTING SHOT; TROUBLE WITH WORDS; TROUBLE WITH HEARING; TROUBLE WITH SMELL, BURNT TOAST; 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 not reported, batch number: Unknown) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-OCT-2021, the patient experienced strange taste in mouth when getting shot, trouble with words, trouble with hearing, trouble with smell, burnt toast, experienced chills, arm pain, headache, extreme tiredness, fever, and painful shot. Laboratory data included: Body temperature (NR: not provided) 100.7, 96.6 shortly after shot. On an unspecified date, the patient experienced period 6 days early. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and the outcome of strange taste in mouth when getting shot, painful shot, fever, trouble with words, trouble with hearing, trouble with smell burnt toast, chills, headache, arm pain and period 6 days early was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Taste disorder
Clinical narrative: PERIOD CAME 6 DAYS EARLY; CHILLS; ARM PAIN; HEADACHE; EXTREME TIREDNESS; FEVER; PAINFUL SHOT; STRANGE TASTE IN MOUTH WHEN GETTING SHOT; TROUBLE WITH WORDS; TROUBLE WITH HEARING; TROUBLE WITH SMELL, BURNT TOAST; 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 not reported, batch number: Unknown) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-OCT-2021, the patient experienced strange taste in mouth when getting shot, trouble with words, trouble with hearing, trouble with smell, burnt toast, experienced chills, arm pain, headache, extreme tiredness, fever, and painful shot. Laboratory data included: Body temperature (NR: not provided) 100.7, 96.6 shortly after shot. On an unspecified date, the patient experienced period 6 days early. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and the outcome of strange taste in mouth when getting shot, painful shot, fever, trouble with words, trouble with hearing, trouble with smell burnt toast, chills, headache, arm pain and period 6 days early was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: PAIN WHEN RAINING; FEELING TIRED; ARM HURT; 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: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, series 1, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: 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. Concomitant medications included leflunomide. On JUL-2021, the patient experienced arm hurt. On an unspecified date, the patient experienced pain when raining, and feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from arm hurt, and was recovering from feeling tired, and pain when raining. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.