chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anal incontinence, COVID-19, Constipation, Diarrhoea, Dizziness
Clinical narrative: STRICTURE OF COLON; DIZZINESS; URINARY INCONTINENCE; BOWEL INCONTINENCE; FALL; DIARRHEA; CONSTIPATION; NAUSEA; VOMITING; COVID-19; This spontaneous report received from a patient via other manufacturer concerned a 68 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Crohn's disease and there was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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, expiry: unknown) 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 stricture of colon, dizziness, urinary incontinence, bowel incontinence, and fall. On an unspecified date in JAN-2022, the patient experienced covid-19. On 21-JAN-2022, the patient experienced covid vaccine issue nausea, and vomiting. On an unspecified date in MAR-2022, the patient experienced constipation, and diarrhea.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the dizziness, urinary incontinence, bowel incontinence, constipation, stricture of colon, fall, diarrhea, nausea, vomiting and covid-19 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220916246-covid-19 vaccine ad26.cov2.s-stricture of colon. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fall, Large intestinal stenosis, Nausea, Urinary incontinence, Vomiting
Clinical narrative: STRICTURE OF COLON; DIZZINESS; URINARY INCONTINENCE; BOWEL INCONTINENCE; FALL; DIARRHEA; CONSTIPATION; NAUSEA; VOMITING; COVID-19; This spontaneous report received from a patient via other manufacturer concerned a 68 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Crohn's disease and there was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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, expiry: unknown) 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 stricture of colon, dizziness, urinary incontinence, bowel incontinence, and fall. On an unspecified date in JAN-2022, the patient experienced covid-19. On 21-JAN-2022, the patient experienced covid vaccine issue nausea, and vomiting. On an unspecified date in MAR-2022, the patient experienced constipation, and diarrhea.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the dizziness, urinary incontinence, bowel incontinence, constipation, stricture of colon, fall, diarrhea, nausea, vomiting and covid-19 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220916246-covid-19 vaccine ad26.cov2.s-stricture of colon. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hypertension, Psoriatic arthropathy, Sinusitis, Swelling face
Clinical narrative: BLOATING; BACTERIAL INFECTION; SWELLING FACE; BLOOD PRESSURE HIGH; SINUS INFECTION; PSORIATIC ARTHRITIS AGGRAVATED/PSORIATIC ARTHRITIS  OUTBREAK FOR TWO FINGERS AND TOES; UNSPECIFIED DISORDER OF INTESTINE/EXPLOSIVE INTESTINAL PROBLEM; GAS; This spontaneous report received from a patient via other manufacturer concerned an 88 year old female of an unspecified race and ethnicity. 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 was not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: Humira/adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from 10-AUG-2022 for psoriatic arthritis.  No concomitant medications were reported.  On AUG-2022, the patient experienced gas.  On 12-AUG-2022, the patient experienced psoriatic arthritis aggravated/psoriatic arthritis outbreak for two fingers and toes. On 12-AUG-2022, the patient experienced unspecified disorder of intestine/explosive intestinal problem.  On 20-AUG-2022, the patient experienced sinus infection.  On 26-AUG-2022, the patient experienced blood pressure high, bacterial infection, and swelling face. Laboratory data included: Blood pressure Over 200/100.  On an unspecified date, the patient experienced bloating.  Treatment medications (dates unspecified) included: Augmentin (amoxicillin trihydrate/clavulanate potassium). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from blood pressure high, and swelling face on 26-AUG-2022, unspecified disorder of intestine/explosive intestinal problem on 16-AUG-2022, and gas on 2022, was recovering from sinus infection, and the outcome of psoriatic arthritis aggravated/psoriatic arthritis outbreak for two fingers and toes, bloating and bacterial infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220916512-covid-19 vaccine ad26.cov2.s-Psoriatic Arthritis Aggravated/Psoriatic Arthritis  Outbreak For Two Fingers And Toe. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related. 20220916512-covid-19 vaccine ad26.cov2.s -Blood pressure high. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: FELT LUMP WHERE RECEIVED VACCINE/VACCINATION SITE LUMP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced felt lump where received vaccine/vaccination site lump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt lump where received vaccine/vaccination site lump. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 61 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Drug name not reported), and other pre-existing medical conditions included: The patient stated he was not taking any other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 1808980, expiry: unknown) dose was not reported, 1 in total was administered on 30-MAR-2021 13:00 to left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events 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: 1822811 expiry: UNKNOWN) dose was not reported, 1 total administered on 26-NOV-2021 10:00 to left arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 61 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received non-company suspect vaccine Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 3) (form of administration, route of administration not reported, batch number: FK9893 expiry: UNKNOWN), dose was not reported, administered on 18-APR-2022 13:00 to left arm for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 3). On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 3). For which the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported administered on 19-AUG-2022 to 23-AUG-2022. On 25-AUG-2022 20:00, the patient experienced rebounded with flu like symptoms, congestion and sniffles, low grade fever and chills (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and with Paxlovid was drug discontinued.  The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Therapeutic product effect decreased
Clinical narrative: CONDITION RETURNED WITH SKYRIZI (RISANKIZUMAB); NEGATIVE REACTION/NULLIFIED THE EFFECTS OF SKYRIZI (RISANKIZUMAB); This spontaneous report received from a patient concerned a 6 decade old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 04-JUN-2021 for covid-19 prophylaxis. 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 an unspecified indication. Age at time of vaccination 58 years old. No concomitant medications were reported. On an unspecified date, the patient experienced condition returned with skyrizi (risankizumab), and negative reaction/nullified the effects of skyrizi (risankizumab). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient had not recovered from condition returned with skyrizi (risankizumab), and negative reaction/nullified the effects of skyrizi (risankizumab). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: erythromycin 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: 1802072 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 10-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (dose number in series: 1). The patient received, Non-company suspect vaccine tozinameran (Pfizer Biontech covid-19 vaccine) (dose number in series: 2) (form of admin, route of admin were not reported, batch number: FH8030 and expiry: UNKNOWN) dose was not reported, administered to left arm on 24-NOV-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). On an unspecified date of 2022, the patient had covid-19 symptoms which was Suspected covid-19 infection (dose number in series 2). The patient was treated with Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported administered from 18-AUG-2022 to 22-AUG-2022 for treatment of covid-19. It was reported that patient symptoms had resolved after 5 days of Paxlovid. The patient continued to isolate/work from home. On 26-AUG-2022; 06:00 symptoms returned (Suspected covid-19 infection) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s and tozinameran (Pfizer Biontech covid-19 vaccine) was not applicable, and treatment with Paxlovid was discontinued. The outcome of the revaccination with different covid-19 vaccine and suspected covid-19 infection was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Urticaria
Clinical narrative: HIVE/SKIN RASH; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: glaucoma, and drug allergy (unspecified drug), and other 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: 1822811 expiry: UNKNOWN) dose was not reported, administered on 25-OCT-2021 12:00 for covid-19 prophylaxis. Age at time of vaccination 60 years old. Concomitant medications included dorzolamide hydrochloride for drug used for unknown indication. On 2022, the patient experienced suspected covid-19 infection. On 26-AUG-2022 14:00, the patient experienced hive/skin rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hive/skin rash, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Disturbance in attention, Eye pain, Gastrointestinal disorder
Clinical narrative: PROGRESSION OF RHEUMATOID ARTHRITIS; MEMORY IMPAIRMENT; POOR CONCENTRATION; GASTROINTESTINAL DISORDER; WATERING EYES; EYE PAIN; TREMOR OF HANDS; GENERALIZED SPASM; BACK PAIN; SHOULDER PAIN; PAIN IN EXTREMITY; URTICARIA AGGRAVATED/BREAKOUT IN HIVES; This spontaneous report received from a patient via other manufacturer concerned an adult female with unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: crohn's disease, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) 1 total, dose, start therapy date were not reported for covid-19 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, Humira was wearing off two days before injection (wearing off effect) due/experiences eye watering pain a few days before Humira shot (watering eyes, eye pain). 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, and moderate to severe rheumatoid arthritis.  On an unspecified date, the patient experienced progression of rheumatoid arthritis, memory impairment, poor concentration, gastrointestinal disorder, tremor of hands, generalized spasm, back pain, shoulder pain, pain in extremity, and urticaria aggravated/breakout in hives. 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 gastrointestinal disorder, and urticaria aggravated/breakout in hives, and had not recovered from memory impairment, poor concentration, watering eyes, eye pain, shoulder pain, pain in extremity, back pain, progression of rheumatoid arthritis, tremor of hands, and generalized spasm. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220918276-covid-19 vaccine ad26.cov2.s- Progression of rheumatoid arthritis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY( Rheumatoid arthritis) . Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lacrimation increased, Memory impairment, Muscle spasms, Pain in extremity, Rheumatoid arthritis
Clinical narrative: PROGRESSION OF RHEUMATOID ARTHRITIS; MEMORY IMPAIRMENT; POOR CONCENTRATION; GASTROINTESTINAL DISORDER; WATERING EYES; EYE PAIN; TREMOR OF HANDS; GENERALIZED SPASM; BACK PAIN; SHOULDER PAIN; PAIN IN EXTREMITY; URTICARIA AGGRAVATED/BREAKOUT IN HIVES; This spontaneous report received from a patient via other manufacturer concerned an adult female with unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: crohn's disease, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) 1 total, dose, start therapy date were not reported for covid-19 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, Humira was wearing off two days before injection (wearing off effect) due/experiences eye watering pain a few days before Humira shot (watering eyes, eye pain). 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, and moderate to severe rheumatoid arthritis.  On an unspecified date, the patient experienced progression of rheumatoid arthritis, memory impairment, poor concentration, gastrointestinal disorder, tremor of hands, generalized spasm, back pain, shoulder pain, pain in extremity, and urticaria aggravated/breakout in hives. 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 gastrointestinal disorder, and urticaria aggravated/breakout in hives, and had not recovered from memory impairment, poor concentration, watering eyes, eye pain, shoulder pain, pain in extremity, back pain, progression of rheumatoid arthritis, tremor of hands, and generalized spasm. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220918276-covid-19 vaccine ad26.cov2.s- Progression of rheumatoid arthritis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY( Rheumatoid arthritis) . Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tremor, Urticaria
Clinical narrative: PROGRESSION OF RHEUMATOID ARTHRITIS; MEMORY IMPAIRMENT; POOR CONCENTRATION; GASTROINTESTINAL DISORDER; WATERING EYES; EYE PAIN; TREMOR OF HANDS; GENERALIZED SPASM; BACK PAIN; SHOULDER PAIN; PAIN IN EXTREMITY; URTICARIA AGGRAVATED/BREAKOUT IN HIVES; This spontaneous report received from a patient via other manufacturer concerned an adult female with unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: crohn's disease, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) 1 total, dose, start therapy date were not reported for covid-19 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, Humira was wearing off two days before injection (wearing off effect) due/experiences eye watering pain a few days before Humira shot (watering eyes, eye pain). 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, and moderate to severe rheumatoid arthritis.  On an unspecified date, the patient experienced progression of rheumatoid arthritis, memory impairment, poor concentration, gastrointestinal disorder, tremor of hands, generalized spasm, back pain, shoulder pain, pain in extremity, and urticaria aggravated/breakout in hives. 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 gastrointestinal disorder, and urticaria aggravated/breakout in hives, and had not recovered from memory impairment, poor concentration, watering eyes, eye pain, shoulder pain, pain in extremity, back pain, progression of rheumatoid arthritis, tremor of hands, and generalized spasm. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220918276-covid-19 vaccine ad26.cov2.s- Progression of rheumatoid arthritis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY( Rheumatoid arthritis) . Therefore, this event(s) is considered not related.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Dysgeusia
Clinical narrative: METALLIC TASTE; COVID-19; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: iron deficiency, and lower back pain, and concurrent conditions included: codeine allergy. The patient was not pregnant at the time of the report. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-MAR-2021 on left arm for covid-19 prophylaxis. Age at time of vaccination 56 years old. Concomitant medications included omeprazole (from 01-APR-2016) and zolpidem tartrate (Ambien, from JAN-2006) for unknown indication. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 1). The patient received non-company suspect vaccine elasomeran (Moderna covid-19 vaccine, Spikevax) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 033F21A expiry: UNKNOWN) dose was not reported, administered on 30-NOV-2021 on left arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine. On an unspecified date in 2022, the patient experienced metallic taste (which lasted 5 days), and covid-19 (fatigue, headache, diarrhea and night sweats) (Dose number in series 2). The patient received non-company suspect drug Nirmatrelvir/ritonavir (Paxlovid) (form of admin, route of admin were not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, administered from 22-AUG-2022 to 27-AUG-2022 for covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable and with paxlovid treatment withdrawn on 27-AUG-2022. The patient recovered from metallic taste, and covid-19, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA (PROSTATIC SPECIFIC ANTIGEN) NUMBERS WENT UP; TIRED BY THE END OF THE DAY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 83.45 kilograms, and height was not reported. The patient's concurrent conditions included: prostate cancer. 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 covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: enzalutamide (tablet, oral, batch number: EJ6677 expiry: 31-MAY-2024, batch number: 1861177 expiry: 31-AUG-2024) dose was not reported, 1 time every 1 day, from 17-AUG-2021, and dose was not reported, 1 time every 1 day, therapy dates were not reported for prostate cancer. Concomitant medications included leuprorelin acetate. On an unspecified date, the patient experienced psa (prostatic specific antigen) numbers went up, and tired by the end of the day. Laboratory data (dates unspecified) included: Prostatic specific antigen went up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with enzalutamide was not reported. The patient had not recovered from psa (prostatic specific antigen) numbers went up, and tired by the end of the day. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: HEAVY VAGINAL BLEEDING OVER A YEAR. NOT JUST HEAVY MENSTRUAL BLEEDING, HEAVY VAGINAL BLEEDING. OFF AND ON, BUT MORE OFTEN ON.; This spontaneous report received from a health care professional concerned a 4 decade old female. 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 07-SEP-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 2021, the patient experienced heavy vaginal bleeding over a year, not just heavy menstrual bleeding, heavy vaginal bleeding off and on, but more often on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy vaginal bleeding over a year, not just heavy menstrual bleeding, heavy vaginal bleeding off and on, but more often on. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Thrombosis
Clinical narrative: DEATH; STROKE; BLOOD CLOTS; This spontaneous report received from a consumer via a social media via a company representative concerned a male of an unspecified age, race and ethnicity. 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: Unknown and expiry: Unknown) dose was not reported, 1 total , administered on an unspecified date of 2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient got blood clots and had a stroke, and passed away (death) from unknown cause of death on mother's day (Date unspecified). It was unknown if an autopsy was performed. It was reported that "My husband got that J J shot last year and he got blood clods and then had a stroke and passed away on mother's day". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause of death on an unspecified date, and the outcome of blood clots and stroke was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:20220919319- covid-19 vaccine ad26.cov2.s -Death, stroke. 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). Therefore, this event(s) is considered unassessable.  20220919319- covid-19 vaccine ad26.cov2.s -Blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VERY SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20220925320.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Cardiac disorder, Electrocardiogram, Electrocardiogram abnormal, Thyroid disorder
Clinical narrative: HEART NOT WORKING RIGHT; THYROID DIDN'T WORK CORRECTLY ANYMORE; BAD EKG (ELECTROCARDIOGRAM); BOTTOM PART OF HAIR FELL OUT; 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 concurrent conditions included: rare disability (No cure). 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced heart not working right, thyroid didn't work correctly anymore, bad ekg (electrocardiogram), and bottom part of hair fell out. Laboratory data (dates unspecified) included: Electrocardiogram Bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart not working right, thyroid didn't work correctly anymore, bad ekg (electrocardiogram) and bottom part of hair fell out was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS FOR COUPLE OF DAYS; 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: Patient gets normal flu shot every year. The patient experienced tiredness for couple of days when treated with influenza vaccine. 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced tiredness for couple of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness for couple of days. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administrated, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced clots. The reporter stated that "My friend got clots from vax as well. Not good" The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220920781 -covid-19 vaccine ad26.cov2.s-Clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Tinnitus, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; TINNITUS; This spontaneous report received from a consumer concerned a 74 year old male. Initial information was processed with the additional information received from complaint department on 07-SEP-2022. 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: 1802072 and expiry: 20-JAN-2022) dose was not reported, 1 total administered to the left arm on 09-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 73 years old.  No concomitant medications were reported. On an unspecified date in about MAY-2022, the patient experienced some adverse side effects of tinnitus and in the same month (MAY-2022), the patient had a constant runny nose that was clear and dripped all day long.  On an unspecified date in JUL-2022, the patient tested positive for covid-19 (coded as confirmed covid-19 infection and confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, and confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000249350. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this report indicates medical adverse event for the patient. There is no product quality issue described. While the reporter states he was vaccinated, there is no report of covid related symptoms or statement indicating the vaccine did not work) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220910881.; Sender's Comments: V0: 20220922379.-covid-19 vaccine ad26.cov2.s- Confirmed Clinical Vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Fear of death, Feeling abnormal, Panic attack, Pharyngeal swelling, Tremor
Clinical narrative: STRONG BURNING SENSATION IN THE HEART; FEAR OF DEATH; PANIC; FEELING THAT THE BLOOD HAD STOPPED FLOWING TO THE BRAIN; SOMETHING SWOLLEN IN THE THROAT; SUFFOCATION; ALMOST LOST CONSCIOUSNESS; STRONG TREMOR (RECURRENT); SWOLLEN STOMACH; FELT A PRICKLING SENSATION IN THE HEART; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. 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 and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered in OCT-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  In OCT-2021, an hour after the injection, felt a prickling sensation in the heart, which lasted for several seconds. Patient had not experienced anything for two weeks. In NOV-2021, After two weeks, a strong tremor (recurrent) began in the evening and patient got scared and went outside. Before the tremor, the stomach was very swollen. and after that, with a frequency every other day, a tremor began in the evening.  On DEC-2021, three weeks later, the patient was on holiday and woke up at night from suffocation and panic began. Patient went out into the street and almost lost consciousness on the street. At that time, patient had a feeling that the blood had stopped flowing to the brain and lasted for 15 minutes, later it was all over. The patient had something swollen in the throat which lasted for a month.  In Feb, two months later, closer to the night, patient felt a strong burning sensation in the heart, experienced the fear of death and after that the tremor began again. After two months, the tremor stopped and the swelling in the throat went away. But the stomach began to swell constantly. Three weeks before, the tremor began again, closer to the night before going to bed. The tremor always lasted about five minutes. Also at the time of report, patient felt discomfort in the area of the heart.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suffocation, almost lost consciousness, panic and feeling that the blood had stopped flowing to the brain on DEC-2021, felt a prickling sensation in the heart on OCT-2021, and something swollen in the throat on JAN-2022, had not recovered from strong tremor (recurrent), swollen stomach, and strong burning sensation in the heart, and the outcome of fear of death was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220922815-Covid-19 vaccine ad26.cov2.s-suffocation,almost lost consciousness. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: RED RASH THAT COVERED ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced red rash that covered arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of red rash that covered arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20220924450.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: COULDN'T GET OUT OF CHAIR FOR DAY (HOURS); FELT NUMB LIKE HAVING A STROKE; HEAD ACHE; This spontaneous report received from a patient via a company representative via media (J and J corporate concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced, red rash that covered arm (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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, it was reported that, "2nd covid shot felt numb, head ache, couldn't get out of chair for day (hours) felt numb like having a stroke (dose number in series 2). Won't get another shot." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt numb like having a stroke, head ache and couldn't get out of chair for day (hours) was not reported. This report was non-serious. This case, involving the same patient is linked to 20220924365.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19 immunisation, Pain in extremity, Unevaluable event
Clinical narrative: ALMOST KILL; ARM HURTS FOR A DAY; DOWN FOR 6 WEEKS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company (on behalf of moderna) concerned a female patient of unspecified age. The patient's height was 5.4 (units not given), and weight were not reported.  The patient's concurrent conditions included: thyroid problem, and autoimmune system issue, and other pre-existing medical conditions included: The patient had no allergies (medications, food and other products), the patient did not have COVID positive test or diagnosis ever, and did not take other vaccines within 1 month prior to moderna COVID-19 vaccine. The patient received first dose as covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1805075 /1805025) dose was not reported, 1 total, administered on 25-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced almost kill and was down for 6 weeks and reported to her doctor (physician office) (Dose number in series 1). The patient also received second and third dose as moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin was not reported, Intramuscular, batch number:019F21A (second dose) and 017F21A (third dose) , expiry: Unknown) dose was not reported, second dose (first of moderna) administered on 24-SEP-2021 and third dose (second of moderna) on 22-OCT-2021 for covid-19 prophylaxis (revaccination with different COVID-19 vaccine).  On an unspecified date, the patient arm hurts for a day after first and second dose of moderna covid-19 vaccine (elasomeran) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from arm hurts for a day, and down for 6 weeks, and the outcome of almost kill and revaccination with different COVID-19 vaccine was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and other pre-existing medical conditions included: The patient had never got covid-19. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total administered on 30-MAR-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient previously received dose 2 (first booster) with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 total administered on 26-OCT-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received dose 3 (second booster) with covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, 1 total administered on 24-MAY-2022 to left arm for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 3). The drug was associated with Off label use. Age at time of vaccination 71 years old. No concomitant medications were reported. The patient had not reported any side effects after vaccination (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.