chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Confusion; Tinnitus; Memory issues; Fever; chills; Hives; Night sweating; Restless legs; Achy joints; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: Wagg388 FC3181), first dose via an unspecified route of administration, administered in left arm on 10Sep2021 15:00 at the age of 45-year-old as single dose for covid-19 immunization. Medical history included Covid positive in December 2020, nothing chronic, some food allergies, corn, onions, peanut, bean from an unknown date and unknown if ongoing. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications in two weeks. The patient experienced confusion, tinnitus, memory issues, fever, chills, hives, night sweating, achy joints, shortness of breath all on 12Sep2021 01:30, restless legs on 12Sep2021. Confusion for a week, tinnitus got worse and hasn't subsided memory issues, ongoing fever & chills, hives during the night three times 1st week after dose. Night sweating off and on restless legs, still ongoing achy joints, still ongoing shortness of breath, still ongoing. He had scheduled a doctor's appointment to see if he could remedy some of these. The case was reported as serious per disability. The event resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment for adverse events. No covid tested post vaccination. The patient underwent lab tests and procedures which included Covid-19: positive in Dec2020. The outcome of events was not resolved. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Since the vaccination, the patient hadn't been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hydrosalpinx, Oligomenorrhoea, Ovarian cyst, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: hydrosalpinx in the left fallopian; menstrual cycle was a week late after receiving the vaccine; Cyst on my left ovary; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 34 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 21Apr2021 17:00 (at age of 34 years old, no pregnant at time of vaccination, Lot Number: ER8732) as a single dose for covid-19 immunization. Medical history included Known allergies: Walnuts, sulfa, Benadryl; childhood asthma. Concomitant medications included diphenhydramine hydrochloride (UNISOM) and naproxen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test type post vaccination: Nasal Swab. Covid test result: Negative in 2021. On 07May2021, the patient states her menstrual cycle was a week late after receiving the vaccine. Since then have gone to gynecologist and had a cyst on left ovary and hydrosalpinx in the left fallopian. Unsure if related but in her ultrasound in 2017 neither were noted. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the events was unknown. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 15May2021 12:00 PM (Lot Number: EW0183) as a single dose for covid-19 immunization.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: deaf in one ear; This is a spontaneous report from a contactable consumer (patient's parent). This consumer reported for a 35-year-old male patient (son). A 35-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient had his first shot over a month before and is still deaf in one ear. He is 35. Reporter has stressed to all 4 of kids, DO NOT get the vaccine shots. Those need years of research, 3-5 years minimum. Add that to your list of side effects. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: It did my whole body turned blue; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: FC3180 and expiration date: not reported), via an unspecified route of administration, on 04Oct2021 (at the age of 70-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included vitamins and other unspecified drugs. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date, as DOSE 2 and DOSE 1, SINGLE for covid-19 immunization. On an unspecified date in 2021, after 3rd dose, the patient whole body turned blue. The patient would like to know if side effect was dangerous or if it was going to get worse. Therapeutic measures were taken as a result of the event included Benadryl. The outcome of the event was unknown at time of report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dysphonia, Headache, Lymphadenopathy, Pain
Clinical narrative: cough which is pneumonia; Head ache; aches and pains; swollen throat; aching teeth; swollen glands; hoarse voice; a feeling of body heaviness; runny nose; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FF2588 and expiry date not reported), via an unspecified route of administration, administered in Arm Right, on 29Sep2021 17:15 (at the age of 57-year-old), as dose 1, single, for COVID-19 immunisation in pharmacy or drug store. Medical history included diabetes, asthma, psoriasis, and COVID-19. The patient previously received pneumococcal vaccine and experienced allergy. Concomitant medications included metformin; dapagliflozin propanediol monohydrate (FARXIGA); berberine; thioctic acid (ALFA LIPOIC ACID). No other vaccine in four weeks prior to COVID vaccine. Patient was not tested for COVID post vaccination. The patient experienced headache, aches and pains, swollen throat, aching teeth, swollen glands, hoarse voice, cough which was pneumonia, a feeling of body heaviness and runny nose on 30Sep2021 07:15. The events resulted in doctor or other healthcare professional office/clinic visit. Patient was treated with antibiotics and OTC remedies. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pneumonia, Rhinorrhoea, Toothache
Clinical narrative: cough which is pneumonia; Head ache; aches and pains; swollen throat; aching teeth; swollen glands; hoarse voice; a feeling of body heaviness; runny nose; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FF2588 and expiry date not reported), via an unspecified route of administration, administered in Arm Right, on 29Sep2021 17:15 (at the age of 57-year-old), as dose 1, single, for COVID-19 immunisation in pharmacy or drug store. Medical history included diabetes, asthma, psoriasis, and COVID-19. The patient previously received pneumococcal vaccine and experienced allergy. Concomitant medications included metformin; dapagliflozin propanediol monohydrate (FARXIGA); berberine; thioctic acid (ALFA LIPOIC ACID). No other vaccine in four weeks prior to COVID vaccine. Patient was not tested for COVID post vaccination. The patient experienced headache, aches and pains, swollen throat, aching teeth, swollen glands, hoarse voice, cough which was pneumonia, a feeling of body heaviness and runny nose on 30Sep2021 07:15. The events resulted in doctor or other healthcare professional office/clinic visit. Patient was treated with antibiotics and OTC remedies. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mastitis, Off label use, Product use issue
Clinical narrative: mastitis; breastfeeding; breastfeeding; This is a spontaneous report from a non-contactable consumer (patient). The consumer reported information for both mother and baby. This is the mother case. Only this case is serious. A 30-year-old non pregnant female received patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 10Sep2021 12:45 at the age of 30-year-old as dose 1, single and second dose received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FF2588), via an unspecified route of administration, administered in Arm Left on 01Oct2021 12:30 at the age of 30-year-old as dose 2, single for covid-19 immunisation from pharmacy or drug store. The patient medical history was none and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient had a baby so patient have been breastfeeding. On 15Sep2021, 5 days after the first dose, patient got mastitis and patient took dicloxacillin (antibiotic) after the first occurrence of mastitis. Then 4 days after the second dose, patient started developing mastitis again on 05Oct2021. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event mastitis first episode was recovered, while second episode was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101329831 baby case
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant, Thrombosis
Clinical narrative: Blood clot; Cancer; This is a spontaneous report from a contactable consumer. A patient (mother's cousin) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknow, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed cancer and a blood clot at the same time on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Migraine
Clinical narrative: A-fib; migraines; shortness of breath; This is a spontaneous report from a contactable nurse (patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date (Lot Number: Ew0179) (at the age of 34-years-old) as dose 1, single for covid-19 immunisation. Medical history included covid-19 prior to vaccination. Patient had no other medical history and no known allergies. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced a-fib (atrial fibrillation), migraines and shortness of breath on 30Apr2021. The reporter considered the events medically significant. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The outcome of the events was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information(vaccination date) is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: precipitated an autoimmune condition that looks like GBS or some form thereof.; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the vaccination, the patient subsequently seems to have precipitated an autoimmune condition that looks like Gullian-barre Syndrome (GBS) or some form thereof on an unspecified date. The patient need to find a great neurologist or neuro-immunologist regarding this event. The reporter wanted to know whether any direction which can help the patient for sorting this event. The outcome of the event was unknown at the time of report.   This lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: diagnosed as polymyalgia rheumatica.; This is a spontaneous report from a contactable consumer. A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose intramuscularly on 03Mar2021 (Lot Number: EN6198, expiration date unknown) at age of 69 years old as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (lot number: EN6201) via Intramuscularly on 10Feb2021 at age of 69 years old for COVID-19 immunisation. The patient was experienced pain in joints and with movement, particularly lower body, diagnosed as polymyalgia rheumatica on 04Mar2021. Had never had similar symptoms before second vaccine dose. Therapeutic measures were taken as a result of diagnosed as polymyalgia rheumatica. The outcome of the event was resolving. The event was resulted in doctor or other healthcare professional office/clinic visit. The patient received physical therapy, steroids (had remained on steroid medication since Mar) as treatment. The patient had no known allergies. The patient had no COVID prior vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lipoma, Magnetic resonance imaging
Clinical narrative: lump in her arm below her elbow/ Lipoma; This is a spontaneous report from contactable consumer (patient) via Team. A 68 year old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6203, Expiration date and NDC number was unknown), via an unspecified route of administration on 28Feb2021 as dose 2, single (at the age of 67 years old) for COVID-19 immunisation. Patient had no medical history and received no concomitant medications. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EM9809, Expiration date and NDC number was unknown), via an unspecified route of administration on 07Feb2021 as dose 1, single (at the age of 67 years old) for COVID-19 immunisation and had no side effects. On 02Mar2021, 2 days after the vaccine, patient developed a lump in her arm below her elbow, it did not hurt or anything and this summer she was diagnosed to have a Lipoma and patient still have it. Patient had a Computerised Tomogram (CT) scan because it never went away and supposedly it was a lipoma. They also did a Magnetic resonance imaging (MRI) with contrast and said yes that was what it was, and it was not a medical concern if it did not cause any problems for her. Patient thought it was a coincidence and she still has it, popped up after the second dose. Patient stated that it got firm and hard, and she could feel. It was a muscular lipoma and maybe her muscle did something. Patient was curious as to getting the booster and wondering if that lump would get bigger. Patient thought it was just a coincidence with the lipoma in her arm but when this occurred with the booster patient was not so sure. It might be bigger, or it might not be, in her arm. On 05Oct2021 (two days ago, Tuesday morning), patient had her dose 3, booster shot of the Pfizer COVID vaccine. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy in one leg; This is a spontaneous report from a contactable Physician via Pfizer .   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced neuropathy in one leg on an unspecified date with outcome of unknown.    No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event neuropathy peripheral and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots; This is a spontaneous report from a non-contactable consumer via a Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter asked why the vaccine was causing blood clots, why and how long does it take to get a blood clot. The reporter also asked what were the ingredients in the shot. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Off label use
Clinical narrative: had shingles; had shingles; had shingles; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program support. A 70-year-old male patient received BNT162B2(PFIZER BIONTECH COVID19 vaccine, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date (At the age of 70-year-old) as dose 3(booster) single for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. The patient received BNT162B2(PFIZER BIONTECH COVID19 vaccine, Solution for injection), dose 1 and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization and experienced shingles. The patient experienced had shingles, Booster and off label use on an unspecified date. The patient also mentioned taking eye drops because it affected his vision and he would like to know when to get the booster dose since he just had shingles. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death, Tissue injury
Clinical narrative: a patient who died from the vaccine; tissue damage; This is a spontaneous report from a contactable consumer or other non-health professional received from Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.The reporter knows an immunologist who has a patient who died from the vaccine, but it was not labelled a vaccine death. The reporter knows that the vaccine causes coagulated blood and a lot of kidney damage.The reporter read that the vaccine is causing autoimmune diseases and if you are having an autoimmune disease, it means you are a vaccinated individual. A Physician the reporter knows sent a patient blood work before the vaccine, after the first shot and second shot and then after the third shot and it shows that there is tissue damage. The reporter knows that the antibodies plummet after the second dose. The booster dose is the death shot. The patient died from the vaccine on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: a patient who died from the vaccine
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Encephalomyelitis, Gait disturbance, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Encephalomyelitis; Ataxia; Gait Instability; This is a spontaneous report from a contactable consumer. This 42-year-old female Consumer (patient) reported for herself.   A 42-year-old non pregnant female patient received the second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EW0191) via unknown route administered in Arm Left on 01Jun2021 (at the age of 42 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Previously, the patient received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EW0171) via unknown route administered in Arm Left on an unspecified date in May2021 as single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient had COVID prior vaccination. On 31Jul2021, the patient experienced Encephalomyelitis, Ataxia and Gait Instability. Patient visited clinic and emergency room due to the events and hospitalized for 5 days. The patient received treatment for the event. The lab data included Multiple Tests (MRI, Lumbar Puncture, etc) IV Ster and results unknown. Patient was tested for COVID post vaccination. Nasal Swab test was negative. The outcome of the events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Encephalomyelitis; Ataxia; Gait Instability; This is a spontaneous report from a contactable consumer. This 42-year-old female Consumer (patient) reported for herself.   A 42-year-old non pregnant female patient received the second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EW0191) via unknown route administered in Arm Left on 01Jun2021 (at the age of 42 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Previously, the patient received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EW0171) via unknown route administered in Arm Left on an unspecified date in May2021 as single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient had COVID prior vaccination. On 31Jul2021, the patient experienced Encephalomyelitis, Ataxia and Gait Instability. Patient visited clinic and emergency room due to the events and hospitalized for 5 days. The patient received treatment for the event. The lab data included Multiple Tests (MRI, Lumbar Puncture, etc) IV Ster and results unknown. Patient was tested for COVID post vaccination. Nasal Swab test was negative. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Monoplegia, Muscle fatigue
Clinical narrative: My left leg will not work anymore; I can''t use my left leg; My foot started getting numb; my leg started getting tired; and then none of it wants to work right now and it kept getting progressive, progressively worse; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: ER2613 and Expiration date: Not reported), via an unspecified route of administration on 22Mar2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced left leg will not work anymore and cant use left leg, foot started getting numb and leg started getting tired. After second vaccination on an unspecified date, patient experienced left leg will not work anymore and cant use left leg, foot started getting numb and leg started getting tired and then none of it wants to work right now and it kept getting progressive, progressively worse. It was reported that, it was even worse and a week down the road, it was even worse, 2 weeks down the road, it was even more worse, it keeps getting worse. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction
Clinical narrative: I developed a severe immune reaction/She also tried Embrel, which cross-reacted as well; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), route of administration, start and stop date, batch/lot number and dose were not reported for arthritis reactive. The patient medical history was not reported. Concomitant medication(s) included etanercept (ETANERCEPT) taken for an unspecified indication, start and stop date were not reported. The patient reported that his Rheumatologist recently prescribed Coscentyx. She (Rheumatologist) did so because, after the Covid vaccination, patient developed a severe immune reaction to Humira on an unspecified date. Patient was taking Humira for reactive arthritis. She (Rheumatologist) also tried Embrel, which cross-reacted as well. The patient received treatment for adverse event as Rheumatologist recently prescribed Coscentyx. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101364904 Same reporter/patient/suspect/different event
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: Breast cancer; This is a spontaneous report from a contactable consumer (governor) reported for his wife. A female patient of an unspecified age received bnt162b2 (COVID-19 Vaccine - Manufacturer Unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced breast cancer on an unspecified date with outcome of unknown. The governor and his wife got the vaccine, didn't know what vaccine the patient received as they would have to ask the governor about that.  Pfizer is a marketing authorization holder of [COVID-19 Vaccine] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine  has submitted the same report to the regulatory authorities.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts  have been completed and no further information is expected
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Cough, Dizziness, Feeling hot
Clinical narrative: not feeling good; upper respiratory infection; high blood pressure; a 101.1 fever.; feel spaced out/light headed; slight cough; hot; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 06Oct2021 17:45 (Lot Number: FF8839, expiry date: unknown) as dose 1, single (age at vaccination:40-Year-old) for COVID-19 immunisation from Pharmacy or Drug Store. Medical history included hypertension, Gout, and Acid reflux (gastrooesophageal reflex). Concomitant medications included irbesartan (IRBESARTAN), amlodipine besylate (AMLODIPINE BESYLATE), and omeprazole (OMEPRAZOLE). No known allergies. All were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had received other medications within 2 weeks prior to the vaccination includes Irbesartan, Amlodipine Besy, Omeprazole. The patient was not diagnosed with covid-19 before vaccination, and tested post vaccination. On 07Oct2021 10:00 the patient experienced not feeling good, upper respiratory infection, high blood pressure, a 101.1 fever, feel spaced out/light headed, slight cough, and hot (feeling hot). The events resulted in emergency room visit. Event was not resulted in prolonged hospitalization. On 08Oct2021 the patient underwent lab tests and procedures which included blood pressure measurement: 176/117 (units unspecified), sars-cov-2 test nasal swab: negative and body temperature: 101.1 (units unspecified). On 11Oct2021 blood pressure measurement: 167/114 (units unspecified) and body temperature: 101.1 (units unspecified). The patient had not received treatment for all the events. The device date was 11Oct2021.The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Malaise, Pyrexia, SARS-CoV-2 test, Upper respiratory tract infection
Clinical narrative: not feeling good; upper respiratory infection; high blood pressure; a 101.1 fever.; feel spaced out/light headed; slight cough; hot; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 06Oct2021 17:45 (Lot Number: FF8839, expiry date: unknown) as dose 1, single (age at vaccination:40-Year-old) for COVID-19 immunisation from Pharmacy or Drug Store. Medical history included hypertension, Gout, and Acid reflux (gastrooesophageal reflex). Concomitant medications included irbesartan (IRBESARTAN), amlodipine besylate (AMLODIPINE BESYLATE), and omeprazole (OMEPRAZOLE). No known allergies. All were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had received other medications within 2 weeks prior to the vaccination includes Irbesartan, Amlodipine Besy, Omeprazole. The patient was not diagnosed with covid-19 before vaccination, and tested post vaccination. On 07Oct2021 10:00 the patient experienced not feeling good, upper respiratory infection, high blood pressure, a 101.1 fever, feel spaced out/light headed, slight cough, and hot (feeling hot). The events resulted in emergency room visit. Event was not resulted in prolonged hospitalization. On 08Oct2021 the patient underwent lab tests and procedures which included blood pressure measurement: 176/117 (units unspecified), sars-cov-2 test nasal swab: negative and body temperature: 101.1 (units unspecified). On 11Oct2021 blood pressure measurement: 167/114 (units unspecified) and body temperature: 101.1 (units unspecified). The patient had not received treatment for all the events. The device date was 11Oct2021.The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On 14Sep2021 the patient experienced COVID-19; On 14Sep2021 the patient experienced COVID-19; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer (manufacturer control number: 21K-163-4088161-00).  A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 01Jun2021 (Batch/Lot number was not reported) as dose 1, single, then intramuscular on 21Jun2021 (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at citrate free for psoriatic arthropathy. Medical history included non-serious ill with fatigue on Nov2020. The patient's concomitant medications were not reported.  On 14Sep2021, the patient experienced Covid-19. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The patient underwent lab tests and procedures which included Sars-cov-2 test: Covid-19 on 14Sep2021. Outcome of the event was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the information provided in the narrative, the Company considered there was not a reasonable possibility that the reported events Drug ineffective and Covid -19 were related to the suspect vaccine BNT162B2. The event Covid -19  was more likely consistent with an intercurrent condition.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 6-decade-old male patient (in in his late 50s) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)), via an unspecified route of administration on an unspecified date earlier in 2021 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with the pfizer covid-19 vaccine earlier in 2021. He just recently tested positive for covid on an unspecified date in 2021. Event took place after use of product. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 2021 tested positive for COVID. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 test, Tissue rupture
Clinical narrative: A miscarriage took place; I experienced a significant release of tissue; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received bnt162b2 (BNT162B2, Brand: Pfizer, solution for injection, Lot Number: FA7485, expiry date not reported), via an unspecified route of administration, administered in right arm on 03Aug2021 (at the age of 26 years old as reported) as dose 2, single for covid-19 immunisation. Medical history included covid-19 (prior to vaccination) from an unknown date and unknown if ongoing. Patient had nasal swab on 31May2021 (unknown results). The patient had no known allergies and other medical history. The patient had no concomitant medications and no other medications in two weeks.  Patient received dose 1 of bnt162b2 (BNT162B2, Brand: Pfizer) on 26Jun2021 (Lot number: EW0181) on 26Jun2021 administered in the right arm as COVID-19 immunization (at the age of 26 years old as reported). It was reported that a miscarriage took place on 13Aug2021. Patient experienced a significant release of tissue, and went to three different OBGYN's, two of which confirmed that the photos she presented were a miscarriage. Patient did not know that she was pregnant yet. The patient was pregnant at the time of the vaccination and of the events reported. The events was reported as serious as results in death (fetus). The event resulted in doctor or other healthcare professional office/clinic visit. It was reported that no treatments were received. The events recovered with lasting effects on an unknown date in 2021. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: know a person that died a week and half after receiving the first Pfizer vaccine and it was said it was from the vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated "I know a person that died a week and half after receiving the first Pfizer vaccine and it was said it was from the vaccine." The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: know a person that died a week and half after receiving the first Pfizer vaccine and it was said it was from the vaccine
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hordeolum, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Patient reports after receiving dose 3 (Booster) COVID vaccine 10/15/2021 she developed left sore arm, migraine headache, fever 102.5, myalgia, fatigue, right eye Hordeolum, and left arm is erythematous, warm to touch, and swollen over the site of injection after the vaccine.  Reports the onset of symptoms started approximately 12 hours after injection.  Patient has been applying ice and heat to left arm, which has not helped.  Patient reports she has been apply wet warm compresses to right eye, which has decreased the size of the Hordeolum but it is still present.    Physical exam: left arm over deltoid warm to touch, firm nodule 1 cm x 0.5 cm palpated over deltoid over injection site.  no erythema or lymphatic streaking.  right eye external hordeolum to medial canthus, no erythema, streaking, or periorbital swelling.  Tenderness upon palpation.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Migraine, Myalgia
Clinical narrative: Patient reports after receiving dose 3 (Booster) COVID vaccine 10/15/2021 she developed left sore arm, migraine headache, fever 102.5, myalgia, fatigue, right eye Hordeolum, and left arm is erythematous, warm to touch, and swollen over the site of injection after the vaccine.  Reports the onset of symptoms started approximately 12 hours after injection.  Patient has been applying ice and heat to left arm, which has not helped.  Patient reports she has been apply wet warm compresses to right eye, which has decreased the size of the Hordeolum but it is still present.    Physical exam: left arm over deltoid warm to touch, firm nodule 1 cm x 0.5 cm palpated over deltoid over injection site.  no erythema or lymphatic streaking.  right eye external hordeolum to medial canthus, no erythema, streaking, or periorbital swelling.  Tenderness upon palpation.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient reports after receiving dose 3 (Booster) COVID vaccine 10/15/2021 she developed left sore arm, migraine headache, fever 102.5, myalgia, fatigue, right eye Hordeolum, and left arm is erythematous, warm to touch, and swollen over the site of injection after the vaccine.  Reports the onset of symptoms started approximately 12 hours after injection.  Patient has been applying ice and heat to left arm, which has not helped.  Patient reports she has been apply wet warm compresses to right eye, which has decreased the size of the Hordeolum but it is still present.    Physical exam: left arm over deltoid warm to touch, firm nodule 1 cm x 0.5 cm palpated over deltoid over injection site.  no erythema or lymphatic streaking.  right eye external hordeolum to medial canthus, no erythema, streaking, or periorbital swelling.  Tenderness upon palpation.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: chills, body aches, tired, headache, loss of appetite, nausea, dizzy  (time course approximately - chills started on Friday, 10/08/2021 approximately 10 am; chills, achy, and headache subsided Saturday  AM10/09/2021; nausea /loss of appetite susbsided Sunday, 10/10/201 around 7 pm.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: chills, body aches, tired, headache, loss of appetite, nausea, dizzy  (time course approximately - chills started on Friday, 10/08/2021 approximately 10 am; chills, achy, and headache subsided Saturday  AM10/09/2021; nausea /loss of appetite susbsided Sunday, 10/10/201 around 7 pm.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Condition aggravated, Fear, Impaired work ability
Clinical narrative: None stated.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Mitral valve disease
Clinical narrative: None stated.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dizziness, Dyspnoea, Pain
Clinical narrative: Chest pain on left side, pain shooting down left arm, shortness of breath, dizzy, light headed, back pain.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Deafness, Ear pain, Swelling
Clinical narrative: Severe right ear pain, hearing loss, swelling lasting for 8 days requiring ER visit, 3 drs visits, and ct scan.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lymphadenopathy
Clinical narrative: swollen glands in neck and under arm, dry mild cough
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast tenderness, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: developed itching about 10 min after receiving the vaccine, localized to chest and no hives, thought I had dry skin. But throughout the day, the itching became more severe, primarily on scalp, eyes, arms, legs, chest and back. There is no redness or hives. Running a low grade temperature, have pain level 6/10 at the injection site, muscle pain, nausea and generally do not feel well. On the advice of a physician, I took 1000mg of Tylenol and 25mg of Benadryl.  Those symptoms continued through 1/10. On 1/11, most of the original symptoms had resolved. However, at 0800, I noticed the lymph node in the axillary area of my left arm was swollen and painful. The tenderness included the side portion of the left breast and radiated down to my elbow. It is painful to have my arm hang regularly down at my side. The pain was mildly reduced with 400mg of Advil in the morning but I did not take any additional medication. The NP stated she had never seen a reaction to a vaccine like this one and instructed me to take doxycycline tomorrow if the swelling or pain increases or does not get better by tomorrow and to continue taking Advil. The itching, which had resolved, has returned; I'm to take Benadryl.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pain in extremity, Pruritus
Clinical narrative: developed itching about 10 min after receiving the vaccine, localized to chest and no hives, thought I had dry skin. But throughout the day, the itching became more severe, primarily on scalp, eyes, arms, legs, chest and back. There is no redness or hives. Running a low grade temperature, have pain level 6/10 at the injection site, muscle pain, nausea and generally do not feel well. On the advice of a physician, I took 1000mg of Tylenol and 25mg of Benadryl.  Those symptoms continued through 1/10. On 1/11, most of the original symptoms had resolved. However, at 0800, I noticed the lymph node in the axillary area of my left arm was swollen and painful. The tenderness included the side portion of the left breast and radiated down to my elbow. It is painful to have my arm hang regularly down at my side. The pain was mildly reduced with 400mg of Advil in the morning but I did not take any additional medication. The NP stated she had never seen a reaction to a vaccine like this one and instructed me to take doxycycline tomorrow if the swelling or pain increases or does not get better by tomorrow and to continue taking Advil. The itching, which had resolved, has returned; I'm to take Benadryl.