chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral atrophy, Computerised tomogram head abnormal, Confusional state, Cryptococcus test, Culture urine positive
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cytology abnormal, Cytomegalovirus test negative, Differential white blood cell count normal, Electroencephalogram abnormal, Encephalopathy
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Endotracheal intubation, Enterovirus test negative, Escherichia test negative, Full blood count normal, Fungal test negative
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Gram stain negative, Haemophilus test, Herpes simplex test negative, Immunoglobulin therapy, Intensive care
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Listeria test, Lumbar puncture abnormal, Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Mechanical ventilation
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Mycobacterium test negative, Neisseria test negative, Nervous system disorder, Neurological symptom
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil count, Periventricular leukomalacia, SARS-CoV-2 test negative, Streptococcus test negative, Tremor
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Treponema test negative, Varicella virus test negative, Venogram normal, Viral test, Vitamin B12 normal
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cells urine positive, White matter lesion
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: 1st dose about a year and a half ago, has not received 2nd dose because of COVID; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about a year and a half ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of the Shingrix vaccine yet because of covid, which led to social problem. The reporter was requesting information regarding the recommendation for patients who did not receive the second dose within two to six months after the first dose. The reporter did not consent to follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Starting in late August 2021. I have been bleeding every week in different amounts and lengths. In November 2021, I bled for 14 days straight. This Sunday, Jan 23, 2022, I started hemorrhaging. I am now on day 5 and it has slowed. I had to go to Emergency room on Monday. I followed up at Gyn on Wednesday Jan 26, 2022. Medication was prescribed to manage the bleeding.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Asthenopia, Dyspnoea, Dyspnoea exertional
Clinical narrative: Extreme Sinus pressure/teeth pain  Pain so severe leads to suicidal thoughts Adrenaline dumps Fatigue/ legs feel out of shape and cramp Slightly out of breath after minor activity Anxiety Cold hands Shoulder tendonitis Tired eyes Burning eyes Soreness in joints (feet, knees, hands) Lower back popping when bending over Fatigue Faster heart rate Faster breathing Yawning Stiff neck muscles where skull meets top of neck Cracking knees
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Fatigue, Heart rate increased, Muscle spasms, Muscular weakness
Clinical narrative: Extreme Sinus pressure/teeth pain  Pain so severe leads to suicidal thoughts Adrenaline dumps Fatigue/ legs feel out of shape and cramp Slightly out of breath after minor activity Anxiety Cold hands Shoulder tendonitis Tired eyes Burning eyes Soreness in joints (feet, knees, hands) Lower back popping when bending over Fatigue Faster heart rate Faster breathing Yawning Stiff neck muscles where skull meets top of neck Cracking knees
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paranasal sinus discomfort, Peripheral coldness, Rotator cuff syndrome
Clinical narrative: Extreme Sinus pressure/teeth pain  Pain so severe leads to suicidal thoughts Adrenaline dumps Fatigue/ legs feel out of shape and cramp Slightly out of breath after minor activity Anxiety Cold hands Shoulder tendonitis Tired eyes Burning eyes Soreness in joints (feet, knees, hands) Lower back popping when bending over Fatigue Faster heart rate Faster breathing Yawning Stiff neck muscles where skull meets top of neck Cracking knees
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Suicidal ideation, Toothache, Yawning
Clinical narrative: Extreme Sinus pressure/teeth pain  Pain so severe leads to suicidal thoughts Adrenaline dumps Fatigue/ legs feel out of shape and cramp Slightly out of breath after minor activity Anxiety Cold hands Shoulder tendonitis Tired eyes Burning eyes Soreness in joints (feet, knees, hands) Lower back popping when bending over Fatigue Faster heart rate Faster breathing Yawning Stiff neck muscles where skull meets top of neck Cracking knees
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered Hiberix after it was reconstituted with sterile water; administered Hiberix after it was reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 5p244, expiry date 21st March 2023) for prophylaxis.   On 25th January 2022, the patient received Hiberix. On 25th January 2022, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that a patient was administered Hiberix after it was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Hypoaesthesia, Migraine, Pain, Paraesthesia
Clinical narrative: ACHY; SLEPT 12 HOURS; SPLITTING MIGRAINE; TINGLING 2 FOREFINGERS AND THUMB; NUMB/PINS AND NEEDLES IN LEFT THUMB; This spontaneous report received from a patient concerned a 41 year old White, non Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included: smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient had no drug abuse or illicit drug usage. The patient previously received 2 doses of bnt 162 (Dose number in series was 1) (form of admin, route of admin, and batch number were not reported) dose and therapy start date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with bnt 162 (Pfizer) (Dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-JAN-2022 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 10-JAN-2022, after vaccine, patient slept 12 hours, woke up with splitting migraine, numb/pins and needles in left thumb, tingling 2 forefingers and thumb, and very achy lasted until 12-JAN-2022 (Dose number in series was 2). On 13-JAN-2022, the patient was feeling achy (mild) (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept 12 hours on 10-JAN-2022, and splitting migraine, tingling 2 forefingers and thumb, and numb/pins and needles in left thumb on 12-JAN-2022, and was recovering from achy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative through social media concerned two patients of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported. On an unspecified date, the patient's experienced suspected clinical vaccination failure, and suspected covid-19 infection. Reporter stated that "know this 1st hand, three of us covid-19 positive, sick for 10 plus days, despite pfizer, moderna and jnj news vaccines."  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000212249. This case, from the same reporter is linked to 20220130649.  Version created to amend previously reported information on 17-JAN-2022. Upon review following information was amended: Case was processed as valid.; Sender's Comments: V1: Version created to make case valid. This information does not alter the previous causality assessment. 20220130852-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age and ethnicity. Initial information processed with additional information received from central complaint vigilance department on 26-JAN-2022. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) 1 total, dose was not reported administered at left arm on 13-MAR-2021 for prophylactic vaccination.  On 01-NOV-2021, the patient received additional booster of non-company vaccine included: mrna 1273 (Moderna) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 033F21A and expiry: unknown) 1 total, dose was not reported for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with mrna 1273 (dose number in series 2). No concomitant medications were reported.  On 16-JAN-2022, the patient experienced stuffy nose, dry cough, fatigue and body aches and had 2 antigens rapid test which were inconclusive and he took an antigen rapid test (BinaxNOW) that was positive on same day (coded as suspected clinical vaccination failure and suspected covid-19 infection) (all events in dose number series 1). On 18-JAN-2022, the patient had a telehealth consultation with primary care physician (PCP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from suspected covid-19 infection and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority. The suspected regulatory authority has been confirmed to be the reported allegation was not confirmed. The root cause was determined to be not manufacturing related based on the Regulatory Authority evaluation/investigation performed.; Sender's Comments: V0 - 20220136238- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON WHOLE BODY; This spontaneous report received from a patient concerned a 54 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received 2 doses of bnt 162 (Pfizer) (Dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown), dose was not reported, administered for prophylactic vaccination. No adverse events were reported following vaccination with bnt 162 (Pfizer) (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: 213021A, expiry: unknown) dose was not reported, 1 total administered on 11-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-DEC-2021, the patient experienced rash on whole body (Dose number in series: 2). On 17-DEC-2021, treatment medications included: prednisone used for rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on whole body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  The patient was tested positive for Covid-19 via PCR laboratory test (Polymerase chain reaction) on 31-DEC-2021. The patient had a cough, chest congestion (suspected covid-19 infection and suspected clinical vaccination failure) and flu symptoms and that the patient took medications for symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000213265.; Sender's Comments: V0: 20220139637-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: 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 request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid was not reported. This report was non-serious.
Age: 52.0
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 health care professional concerned a 52 year old  male. Initial information was processed along with the additional information received on 25-JAN-2022. 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: 1802068, and expiry: UNKNOWN) dose was not reported, 1 total administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-NOV-2021, patient received a positive covid-19 test result from his physician's office, unsure of what type of test was performed but stated that the physician diagnosed him with covid-19 (confirmed covid-19 infection, and confirmed clinical vaccination failure). The patient had symptoms of shortness of breath, muscle aches, body aches, and fever. On 26-NOV-2021, the patient was given monoclonal antibody therapy and since then the patient had been doing much better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from 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 regulatory authority.; Sender's Comments: V0: 20220143954- JANSSEN 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. 20220143954- CONFIRMED COVID-19 INFECTION- JANSSEN COVID-19 VACCINE Ad26.COV2.S-. 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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, SARS-CoV-2 test, Taste disorder
Clinical narrative: TIRED; SPORADIC LOW GRADE FEVER; BAD TASTE IN MOUTH; 102 DEGREE FEVER; This spontaneous report received from a patient concerned a 63 year old white female with unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included: left bundle branch block for heart and was not on pacemaker. The patient will be visiting cardiology in march. 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: 31-DEC-2021) dose was not reported, 1 total, administered on 06-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced 102 degree fever. (Dose number in series 1). Laboratory data included: Body temperature (NR: not provided) 102 degree Celcius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 102 degree fever was not reported. The patient received additional booster non-company suspect vaccine mrna 1273 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 23-OCT-2021 in right arm for prophylactic vaccination.  On 24-OCT-2021, next day after moderna, the patient experienced bad taste in mouth. It had happened several times. On an unspecified date, the patient experienced tired, and sporadic low grade fever (all events in dose number series 2). The patient was not sure if she was immune enough because they said if patient got 2 doses of vaccine so will get immunity. She asked doctor if she need another dose, but he did not respond. Before christmas trip she called to health Department and the man said she would not be eligible for next shot till 23-JAN-2022. She got PCR tests negative The patient lay on couch for a minute and after 3 minutes get back up from couch. The patient was going to visit cardiology in March The patient had not recovered from tired, bad taste in mouth, and sporadic low grade fever. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Laboratory test, Pertussis, Pulmonary embolism
Clinical narrative: HEMOPERTUSSIS; PULMONARY EMBOLISM; ELEVATED FURITAN; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient had no pertinent history and was healthy up to now. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 06-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2022, patient had fever, then cough and all the symptoms like covid but tested negative. On 10-JAN-2022 or 11-JAN-2022, he got tested again and the result was negative. On JAN-2022, the patient then went to a mass Polymerase Chain Reaction (PCR) drive through testing and the result came out to be negative. He then went to a doctor and underwent a lung X-ray which was fine, but was still coughing. The patient's fever kind of went away, but around 100 (no unit). On 19-JAN-2022, the patient suddenly started coughing with blood consistently for 2 days. On 21-JAN-2022, the patient went to the emergency room, where they collected his cough with blood sample and run some tests and X-rays and found blood clots in both the lungs, pulmonary embolism, hemo pertussis and elevated furitan. According to the doctors, it looked like the health issues were caused by the vaccine. The reporter stated that the patient was almost paralyzed and was on blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, hemo pertussis, and elevated furitan. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213715.; Sender's Comments: 20210738088- Covid-19 vaccine ad26.cov2.s- pulmonary embolism, hemo pertussis,. 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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Serum ferritin, Serum ferritin increased, X-ray
Clinical narrative: HEMOPERTUSSIS; PULMONARY EMBOLISM; ELEVATED FURITAN; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient had no pertinent history and was healthy up to now. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 06-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2022, patient had fever, then cough and all the symptoms like covid but tested negative. On 10-JAN-2022 or 11-JAN-2022, he got tested again and the result was negative. On JAN-2022, the patient then went to a mass Polymerase Chain Reaction (PCR) drive through testing and the result came out to be negative. He then went to a doctor and underwent a lung X-ray which was fine, but was still coughing. The patient's fever kind of went away, but around 100 (no unit). On 19-JAN-2022, the patient suddenly started coughing with blood consistently for 2 days. On 21-JAN-2022, the patient went to the emergency room, where they collected his cough with blood sample and run some tests and X-rays and found blood clots in both the lungs, pulmonary embolism, hemo pertussis and elevated furitan. According to the doctors, it looked like the health issues were caused by the vaccine. The reporter stated that the patient was almost paralyzed and was on blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, hemo pertussis, and elevated furitan. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213715.; Sender's Comments: 20210738088- Covid-19 vaccine ad26.cov2.s- pulmonary embolism, hemo pertussis,. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED AFTER BEING STORED IN THE FREEZER; VACCINE PLACED IN THE FREEZER UPON RECEIPT ABOUT 1 WEEK LATER; This spontaneous report received from a health care professional concerned multiple male patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: 20-MAR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine administered after being stored in the freezer, and vaccine placed in the freezer upon receipt about 1 week later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after being stored in the freezer and vaccine placed in the freezer upon receipt about 1 week later was not reported. This report was non-serious. This case, from the same reporter is linked to 20220146840.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Laboratory test, Pericarditis
Clinical narrative: MILD PERICARDITIS; This spontaneous report received from a patient concerned a 31 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and abstains from alcohol, and other pre-existing medical conditions included: The patient had no known allergies and no history drug abuse or illicit drug usage. Patient was in military and had received many vaccines and never had a reaction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 202A21A, and expiry: Unknown) dose was not reported, 01 total administered in left arm on 03-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUL-2021 evening and 06-JUL-2021 morning, the patient experienced on his heart region hot feeling and kind achy. He stated feeling remained regardless of positioning (sitting, standing, Et Cetera). Symptom seemed to ease a little with physical activity, but came back after he would go back to normal state. Patient stated he thought it was a temporary discomfort but symptom was none stop. On 13-JUL-2021, he went to Emergency Room as symptom had not subsided. Stated electrocardiogram (EKG) and most of the labs came back clean. ER doctor diagnosed him with abnormal chest pain due to mild pericarditis. Prescribed Mobic (meloxicam) for 2 week, which as per patient did ease symptoms to manageable levels. 1 week after end of 2-week treatment, symptoms disappeared (unspecified date). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild pericarditis on JUL-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220146919-COVID-19 VACCINE AD26.COV2.S-Mild Pericarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: WHOLE BODY SHAKING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced whole body shaking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of whole body shaking was not reported. This report was non-serious. This case, from the same reporter is linked to 20220146346 and 20220147068.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: HAVING SYMPTOMS OF COVID AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; This spontaneous report received from a consumer concerned a 21 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: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced having symptoms of covid after receiving the janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having symptoms of covid after receiving the janssen covid 19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220150229.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: NECK PAIN (SOME DAYS IT HURTS MORE THAN OTHERS); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, and other pre-existing medical conditions included: Patient never had this neck pain until received the janssen covid-19 vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-SEP-2021, the patient experienced neck pain (some days it hurts more than others). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain (some days it hurts more than others). This report was non-serious.
Age: 61.0
Sex: U
Vaccine: TD
Symptoms: Cellulitis, Dehydration, Fatigue, Feeling abnormal, Hypoaesthesia
Clinical narrative: Unable to function; Cellulities; Felt Awful; Dehydrated; Swelling; Numbness; Fatigue; Muscle Aches; Trigger finger; Intermittent pain in the lower right arm; Scabbiness; Initial Telephone Call, 14 Jun 2021 Pt. reported that was administered TDVAX (MassBiologics lot #A125A) in her left arm on 11 Apr 2021 for wound management after cutting her left ring finger on a can. On the same day, pt. was prescribed the antibiotic, amoxicillin, by her doctor for wound management. Pt. stated that the vaccine site was not appropriately cleaned prior to the injection and that she was unsure if the TDVAX was administered via an intramuscular injection. On 12 Apr 2021, she felt "awful", dehydrated and fatigued. She also reported muscle aches in her lower back, and noticed that cellulitis had started to develop at the injection site.   Pt. stated that over the couple of weeks post-vaccination she developed swelling in her feet and left hand.  Due to this, she could not exercise and felt tired all the time. Pt. stated that she has Epstin-Barr Virus and that could have played a role in her reaction to the vaccine.  During this call, she also mentioned that she still feels numbness in the left hand and pain at the wound site. In addition, she could feel little lump on the injection site which was painful if she applies pressure. She added that overall, her adverse reactions were getting better as of 6/14/2021 though she was not completely recovered.  Follow-up Telephone Call, 25 Jun 2021 During this call, pt. provided more information on the diagnosis of her cellulitis - A week after vaccination, her infectious disease doctor confirmed that she had cellulitis in her left arm and mentioned that the antibiotic which she is taking for the wound management would take care of the cellulitis as well. Therefore, Dr did not prescrib treatment to address the cellulitis.  However, Dr. prescribed Meloxicam to treat her inflammation and pain.  Pt. mentioned that she was feeling better; however, the AEs she reported were not fully recovered. She also mentioned that she had some numbness in her left hand and was feeling achy.  Further, pt. reported that she had recently developed a trigger finger (her right thumb) within the past week.  Follow-up Telephone Call, 15 Jul 2021 Pt. mentioned that the cellulitis in her left arm was no longer present but that numbness in her left hand, which she believes was the result of nerve damage, was worsening. She was planning to visit the neurologist for the numbness.  Further Follow-up After this call, MassBiologics attempted to reach out to pt. several times to check the status of the numbness of her left arm and to learn about her overall health but pt. did not answer calls on 10 Aug 2021, 18 Aug 2021, email on 31 Aug 2021. Thus, MassBiologics closed this case.; Sender's Comments: The adverse event reported in this case was assessed as follow: 1) Cellulitis, Generalised muscle aches, and Swelling was assesed as Non-serious and Labeled. 2) Rest of the AEs were assessed as Non-serious and Unexpected.