chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature exersion; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   there are no treatment or concomitant medications provided.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Muscular weakness, Oral pain, Syncope
Clinical narrative: Started with weakness and complained ?his mouth hurt?, we checked his mouth and everything was fine. He wouldnt respond all questions as if he didnt have the strenght to do it. Started holding his head and eyes began to close. We called our doctor, he said to stop somewhere and observe closely his reactions and if something was wrong go to an ER. He didnt want to walk, his legs were weak. We carried him, gave him tylenol? order a soda for him to drink and some food. He was fainting. After 20 minutes he started to recover strenght and smiling again.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Started with weakness and complained ?his mouth hurt?, we checked his mouth and everything was fine. He wouldnt respond all questions as if he didnt have the strenght to do it. Started holding his head and eyes began to close. We called our doctor, he said to stop somewhere and observe closely his reactions and if something was wrong go to an ER. He didnt want to walk, his legs were weak. We carried him, gave him tylenol? order a soda for him to drink and some food. He was fainting. After 20 minutes he started to recover strenght and smiling again.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site irritation, Injection site rash, Photophobia, Vomiting
Clinical narrative: Severe vomiting for several hours and a headache/light sensitivity.  Also irritation/rash at the site
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Haemorrhage, Musculoskeletal pain, Pain
Clinical narrative: Severe traveling chest pain for 5 days that traveled from my sternum area, left chest, then right chest and then behind my rear shoulder blade. Shortness of breath, painful breathing, and an exhalation that sounded like my chest was congested. Blood in my phlegm on the 3rd and 4th day. Nights were the hardest and on the 3rd night I had the most intense chest pain at the center of my chest I?ve ever felt. It lasted for 2 hours and then subsided. Doctor advised a treatment that moved from Aspirin to Ibuprofen. I started drinking hot teas as well and a Vapor Rub was extremely helpful.   Physical activity was not possible and I stayed in bed for 4 days straight. 7th or 8th day lingering pain was gone.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Painful respiration, Productive cough
Clinical narrative: Severe traveling chest pain for 5 days that traveled from my sternum area, left chest, then right chest and then behind my rear shoulder blade. Shortness of breath, painful breathing, and an exhalation that sounded like my chest was congested. Blood in my phlegm on the 3rd and 4th day. Nights were the hardest and on the 3rd night I had the most intense chest pain at the center of my chest I?ve ever felt. It lasted for 2 hours and then subsided. Doctor advised a treatment that moved from Aspirin to Ibuprofen. I started drinking hot teas as well and a Vapor Rub was extremely helpful.   Physical activity was not possible and I stayed in bed for 4 days straight. 7th or 8th day lingering pain was gone.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac arrest, Cardiac pacemaker insertion, Electrocardiogram, Loss of consciousness
Clinical narrative: Heart stopped, passed out and heart restarted several times over the course of 5 days until a Medtronic pacemaker was implanted.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Cough
Clinical narrative: 12/01/21 ID note: "Multifocal pneumonia due to COVID-19 virus with hypoxia;  Fever on admission to 102.7, now afebrile, was on 2 LPM NC, now weaned down to 1 LPM; Onset cough on 11/25; FLU a/b negative; Covid + PCR on 12/1;   Cxray 12/1: Asymmetric reticular densities, right greater than left which may reflect atypical/viral pneumonitis, including potentially Covid pneumonia. Acute leukocytosis, trending down. S/p azithromycin x1  11/30. PMH:  DM type 2, HTN, COPD, PVD s/p R BKA, subdural hematoma s/p mechanical fall, CAD s/p PCI, HFrEF (LVEF 40%), atrial fib on apixaban, CKD stage 3, depression. COVID vaccinations- was at nursing home, no records in I-CARE noted. Continue dexamethasone day, continue remdesevir day 1/5, continue anticoagulation".
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoxia, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Leukocytosis
Clinical narrative: 12/01/21 ID note: "Multifocal pneumonia due to COVID-19 virus with hypoxia;  Fever on admission to 102.7, now afebrile, was on 2 LPM NC, now weaned down to 1 LPM; Onset cough on 11/25; FLU a/b negative; Covid + PCR on 12/1;   Cxray 12/1: Asymmetric reticular densities, right greater than left which may reflect atypical/viral pneumonitis, including potentially Covid pneumonia. Acute leukocytosis, trending down. S/p azithromycin x1  11/30. PMH:  DM type 2, HTN, COPD, PVD s/p R BKA, subdural hematoma s/p mechanical fall, CAD s/p PCI, HFrEF (LVEF 40%), atrial fib on apixaban, CKD stage 3, depression. COVID vaccinations- was at nursing home, no records in I-CARE noted. Continue dexamethasone day, continue remdesevir day 1/5, continue anticoagulation".
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lung opacity, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 12/01/21 ID note: "Multifocal pneumonia due to COVID-19 virus with hypoxia;  Fever on admission to 102.7, now afebrile, was on 2 LPM NC, now weaned down to 1 LPM; Onset cough on 11/25; FLU a/b negative; Covid + PCR on 12/1;   Cxray 12/1: Asymmetric reticular densities, right greater than left which may reflect atypical/viral pneumonitis, including potentially Covid pneumonia. Acute leukocytosis, trending down. S/p azithromycin x1  11/30. PMH:  DM type 2, HTN, COPD, PVD s/p R BKA, subdural hematoma s/p mechanical fall, CAD s/p PCI, HFrEF (LVEF 40%), atrial fib on apixaban, CKD stage 3, depression. COVID vaccinations- was at nursing home, no records in I-CARE noted. Continue dexamethasone day, continue remdesevir day 1/5, continue anticoagulation".
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: Abnormal behaviour, Crying, Erythema, Insomnia, Irritability
Clinical narrative: Fever at 102.7 both arms red and swollen, he?s crying and fussy. Irritable and making weird noises. Staying up can?t sleep. Both arms are very hot. I?ve traced the red circle it?s getting bigger. These shots are stupid. He had a strong immune system before getting any shots, now he?s sick all the time. I?m waiting 6 months til the next ONE shot required for school.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: Malaise, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever at 102.7 both arms red and swollen, he?s crying and fussy. Irritable and making weird noises. Staying up can?t sleep. Both arms are very hot. I?ve traced the red circle it?s getting bigger. These shots are stupid. He had a strong immune system before getting any shots, now he?s sick all the time. I?m waiting 6 months til the next ONE shot required for school.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever and swollen lymph node in armpit on arm where vaccine was given starting 2 days post vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Headache, Muscular weakness, Nausea
Clinical narrative: Heart rate in the  130s for a number of hours, weakness to the point my knees started to buckle, headache, extreme nausea, inability to urinate for a number of hours. Started to improve but later had a temp of 104.1, used ibuprofen to lower temp
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary retention
Clinical narrative: Heart rate in the  130s for a number of hours, weakness to the point my knees started to buckle, headache, extreme nausea, inability to urinate for a number of hours. Started to improve but later had a temp of 104.1, used ibuprofen to lower temp
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion). On 19-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided. 6 patients were administered a dose of the Moderna COVID-19 vaccine after a temperature excursion at the frozen range reaching a temperature less than minus 50 degree Celcius. This vaccine was then placed in a different freezer which experienced a temperature excursion on 19NOV2021, reaching a maximum of  10.8°F for 5 hours and 31 minutes.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Interchange of vaccine products, Pruritus, Rash, Rash erythematous
Clinical narrative: I received the Covid-19 vaccine originally on 3/17/2021 and 4/7/2021 (Pfizer) without any issue. I took the Moderna vaccine for my booster on 11/17/2021, and by 11/20/2021 I had a minor rash on the nape of my neck (within my hair). I then noticed itchiness and a minor rash/bumps on my right breast a couple days after that. By Thanksgiving Day (11/25/2021), I was so itchy and the rash/bumps had spread to my hips/upper thighs and arms. On Friday 11/26/2021, I went back to the dermatologist and was prescribed betamethasone cream. By Sunday 11/28/2021, my husband used the rest of the tube I was prescribed to help coat almost my entire body in an attempt for relief. I went to the dermatologist again on Wednesday 12/1/2021, as I was getting no relief and the rash/bumps were now everywhere except my palms, soles of feet, and face.   The bumps sort of look like pimples in some places (arms/wrists/shoulders/knuckles/ankles). In other areas, it?s more rash-like (breasts/hips/thighs). If I scratch an area, the bumps turn very red, raise significantly, become like welts, and the itching becomes unbearable.   I received a betamethasone injection at 3:00pm on 12/1/2021 in my right hip (40mg/1cc solution) and noticed some relief within the first 15 minutes. I also have a 1 lb tub of triamcinilone acetonide cream USP 0.1% for use twice a day. I am not yet feeling much relief or difference but am hopeful for more relief in the coming days.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Scratch, Urticaria
Clinical narrative: I received the Covid-19 vaccine originally on 3/17/2021 and 4/7/2021 (Pfizer) without any issue. I took the Moderna vaccine for my booster on 11/17/2021, and by 11/20/2021 I had a minor rash on the nape of my neck (within my hair). I then noticed itchiness and a minor rash/bumps on my right breast a couple days after that. By Thanksgiving Day (11/25/2021), I was so itchy and the rash/bumps had spread to my hips/upper thighs and arms. On Friday 11/26/2021, I went back to the dermatologist and was prescribed betamethasone cream. By Sunday 11/28/2021, my husband used the rest of the tube I was prescribed to help coat almost my entire body in an attempt for relief. I went to the dermatologist again on Wednesday 12/1/2021, as I was getting no relief and the rash/bumps were now everywhere except my palms, soles of feet, and face.   The bumps sort of look like pimples in some places (arms/wrists/shoulders/knuckles/ankles). In other areas, it?s more rash-like (breasts/hips/thighs). If I scratch an area, the bumps turn very red, raise significantly, become like welts, and the itching becomes unbearable.   I received a betamethasone injection at 3:00pm on 12/1/2021 in my right hip (40mg/1cc solution) and noticed some relief within the first 15 minutes. I also have a 1 lb tub of triamcinilone acetonide cream USP 0.1% for use twice a day. I am not yet feeling much relief or difference but am hopeful for more relief in the coming days.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Electrocardiogram, Myocarditis, Troponin
Clinical narrative: Pt diagnosed with acute myocarditiits. Admitted for monitoring. No signs of clinical decompensation at this time.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Pt diagnosed with acute myocarditiits. Admitted for monitoring. No signs of clinical decompensation at this time.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Electrocardiogram, Myocarditis, Troponin
Clinical narrative: Myocarditis
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea exertional, Fatigue, Myalgia, Oedema
Clinical narrative: 10 hours post-injection  experienced 20 hours of fever, shaking chills, near syncope, severe myalgia,.  2-3 weeks later 1 week of pitting edema .  chronic fatigue for 10 months, dyspnea on exertion, for 3 months
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: 10 hours post-injection  experienced 20 hours of fever, shaking chills, near syncope, severe myalgia,.  2-3 weeks later 1 week of pitting edema .  chronic fatigue for 10 months, dyspnea on exertion, for 3 months
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Loss of consciousness, Vomiting
Clinical narrative: Extremely high heart rate from a heart rate at rest. One incident resulted in my almost passing out and throwing up. This happened about three different times.  My significant other was going to the hospital but I asked him not to take me.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Tremor
Clinical narrative: I'm cold, shaking just can't stop
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block complete, Cardiac pacemaker insertion, Catheterisation cardiac abnormal, Echocardiogram, Left ventricular failure
Clinical narrative: Complete heart block with left ventricular insufficiency
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Shingles outbreak side, chest & breast with arm redness, heat, itch & sore
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Acarodermatitis, Pruritus, Purpura, Rash, Sleep disorder
Clinical narrative: Three or four days after my second shot, I began to itch.  With it being "dry air season" I didn't think much of it.  Day by day, no matter what I was doing, the itching was getting uncontrollably worse.  After about day7 or 8 , I began to have outbreaks of rash in a multiple, random areas on my body.  I bough some creams still thinking it was dry skin.  Nothing was helping,  the rash was spreading, it was keepin me up at night.  After a few more days of treating, assuming that I was losing this battle,  I went to the doctor.  After inspection of all of the spots of bleeding rash all over my body I went through the standard array of questions,  trying to narrow down a possible exposure to the possible source of the itch.  Not a single question I answered even provided an avenue for discovery.  Didn't stay in a bed other than my own, no house guests, hotels, clothing donations, laundry soap change,  nothing at all.  Even asked how often I washed my bedding.  Once a week was the answer...   So,  based on the lack of available information the doctor said she believed that it was Scabies.  I don't have scabies.  I don't believe that for a moment.  I was given some creams and steroids which have relieved the itch somewhat but it still exists and at this moment I am not sure how it will be after I am off the meds.  Tomorrow will be the first day for that so we shall see.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging abnormal, Myocarditis, Troponin abnormal
Clinical narrative: MRI confirmed myocarditis with positive troponin
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm (delayed by a few days) with first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm (delayed by a few days) with first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives. Family history included Skin reaction (hives, etc.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm (delayed by a few days) with first shot). At the time of the report, VACCINATION SITE REACTION (COVID arm (delayed by a few days) with first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-395795 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: had "reactions"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (had "reactions") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (had "reactions"). At the time of the report, VACCINATION SITE REACTION (had "reactions") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication were reported. no treatment medication were reported.   This case was linked to MOD-2021-396523 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Nausea, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 13Oct2021 10:45 (Lot number: EW0217) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 09Mar2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 30Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Oct2021 14:00, outcome "recovered" (Oct2021), described as "Sore upper arm of injection"; LYMPHADENOPATHY (non-serious) with onset 13Oct2021 14:00, outcome "recovered" (Oct2021), described as "swollen lymph nodes arm of injection "; NAUSEA (non-serious) with onset 13Oct2021 14:00, outcome "recovered" (Oct2021), described as "Nausea"; PAIN (non-serious) with onset 13Oct2021 14:00, outcome "recovered" (Oct2021), described as "full body aches "; IMMUNISATION (non-serious) with onset 13Oct2021 10:45, outcome "unknown", described as "third dose". Therapeutic measures were taken as a result of pain in extremity, lymphadenopathy, nausea, pain.Additional information: The patient also takes concomitant medications of Omega-3 methyl esters and multivitamins.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: After her first dose, her hair started falling out. After her second dose, her hair started to fall out even more then it stopped; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 26Feb2021 (Lot number: EN6203) at the age of 68 years as dose 1, single and administration date 19Mar2021 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "A little anemic" (unspecified if ongoing), notes: she is a little anemic, but her diet is crap and she lived alone for a year.; "Borderline diabetic" (unspecified if ongoing), notes: She is a borderline diabetic, but is not a diabetic. There were no concomitant medications. The following information was reported: ALOPECIA (medically significant) with onset 2021, outcome "recovered" (2021), described as "After her first dose, her hair started falling out. After her second dose, her hair started to fall out even more, then it stopped". Clinical course: The hair loss has been so significant that it has caused her vacuum cleaner to be clogged twice.  Her dogs are even ingesting it and pooping out long grey hair.  she noticed the hair failing about within a month of first dose. She noticed hair everywhere. Certainly after second dose it was like woah. Caller has had children and been under stress in her life and never lost hair like this before. Compared to what her hair normally looks like she has lost a third of hair volume easily.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported alopecia cannot be excluded.  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. ,Linked Report(s) : -PFIZER INC-202101596809 same reporter/drug/AE, different patients
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood test, Cardiac flutter, Dizziness, Dizziness postural
Clinical narrative: Got very dizzy next day while standing; felt like I was going to pass out/woozy feeling; Then I would get fluttering heart; sweaty; This is a spontaneous report from a contactable consumer. The reporter is the patient. A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) Pfizer BioNTech, administered in arm left, administration date 24MAR2021 08:45 (Lot number: EN6207) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Graves Disease" (unspecified if ongoing), "Laytex allergy" (unspecified if ongoing). Concomitant medications included: LEVOXYL; ATORVASTATIN CALCIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; YUVAFEM.  Past drug history included: Synthroid reaction: "Allergy". The following information was reported: DIZZINESS POSTURAL (hospitalization) with onset 25Mar2021, outcome "recovered", described as "Got very dizzy next day while standing"; DIZZINESS (hospitalization) with onset 25Mar2021, outcome "recovered", described as "felt like I was going to pass out"/ "woozy feeling"; CARDIAC FLUTTER (hospitalization) with onset 25Mar2021, outcome "recovered", described as "Then I would get fluttering heart"; HYPERHIDROSIS (hospitalization) with onset 25Mar2021, outcome "recovered", described as "sweaty". Clinical course was the patient was very dizzy next day while standing and felt like she was going to pass out. Then she would get fluttering heart, sweaty, and woozy feeling that would just wash over her while sitting at her desk. She went to the doctor. Blookwork was normal, sugar level normal, EKG was affected. Sent her to Cardiologist.  The patient was hospitalized for dizziness postural, dizziness, cardiac flutter, hyperhidrosis, dizziness (hospitalization duration: 1 day(s)). The events "got very dizzy next day while standing", "felt like i was going to pass out", "then i would get fluttering heart", "sweaty" and "woozy feeling" were evaluated at the emergency room visit.  The patient underwent the following laboratory tests and procedures: Nasal Swab sars-cov-2 test: (Oct2021) negative; blood test: (unspecified date) normal; blood glucose: (unspecified date) normal; electrocardiogram: (unspecified date) affected. Therapeutic measures were taken as a result of dizziness postural, dizziness, cardiac flutter, hyperhidrosis, dizziness.  Treatment included nitroglycerin and cardiac catheterization. The patient received the second dose of bnt162b2, brand Pfizer BioNTech, lot number=EWz158, administration date was 14Apr2021, administration time was 09:15 AM, vaccine location was left arm.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Hyperhidrosis, SARS-CoV-2 test
Clinical narrative: Got very dizzy next day while standing; felt like I was going to pass out/woozy feeling; Then I would get fluttering heart; sweaty; This is a spontaneous report from a contactable consumer. The reporter is the patient. A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) Pfizer BioNTech, administered in arm left, administration date 24MAR2021 08:45 (Lot number: EN6207) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Graves Disease" (unspecified if ongoing), "Laytex allergy" (unspecified if ongoing). Concomitant medications included: LEVOXYL; ATORVASTATIN CALCIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; YUVAFEM.  Past drug history included: Synthroid reaction: "Allergy". The following information was reported: DIZZINESS POSTURAL (hospitalization) with onset 25Mar2021, outcome "recovered", described as "Got very dizzy next day while standing"; DIZZINESS (hospitalization) with onset 25Mar2021, outcome "recovered", described as "felt like I was going to pass out"/ "woozy feeling"; CARDIAC FLUTTER (hospitalization) with onset 25Mar2021, outcome "recovered", described as "Then I would get fluttering heart"; HYPERHIDROSIS (hospitalization) with onset 25Mar2021, outcome "recovered", described as "sweaty". Clinical course was the patient was very dizzy next day while standing and felt like she was going to pass out. Then she would get fluttering heart, sweaty, and woozy feeling that would just wash over her while sitting at her desk. She went to the doctor. Blookwork was normal, sugar level normal, EKG was affected. Sent her to Cardiologist.  The patient was hospitalized for dizziness postural, dizziness, cardiac flutter, hyperhidrosis, dizziness (hospitalization duration: 1 day(s)). The events "got very dizzy next day while standing", "felt like i was going to pass out", "then i would get fluttering heart", "sweaty" and "woozy feeling" were evaluated at the emergency room visit.  The patient underwent the following laboratory tests and procedures: Nasal Swab sars-cov-2 test: (Oct2021) negative; blood test: (unspecified date) normal; blood glucose: (unspecified date) normal; electrocardiogram: (unspecified date) affected. Therapeutic measures were taken as a result of dizziness postural, dizziness, cardiac flutter, hyperhidrosis, dizziness.  Treatment included nitroglycerin and cardiac catheterization. The patient received the second dose of bnt162b2, brand Pfizer BioNTech, lot number=EWz158, administration date was 14Apr2021, administration time was 09:15 AM, vaccine location was left arm.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Blood pressure measurement, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: feel dizzy and faint; feel dizzy; felt so bad; couldn't breath; sick; irregular heart rhythm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 03Aug2021 (Lot number: EVEL64) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant) with onset Aug2021, outcome "unknown", described as "irregular heart rhythm"; SYNCOPE (medically significant) with onset 03Aug2021, outcome "unknown", described as "feel dizzy and faint"; ILLNESS (non-serious) with onset Aug2021, outcome "unknown", described as "sick"; DIZZINESS (non-serious) with onset 03Aug2021, outcome "unknown", described as "feel dizzy"; FEELING ABNORMAL (non-serious) with onset 03Aug2021, outcome "unknown", described as "felt so bad"; DYSPNOEA (non-serious) with onset 03Aug2021, outcome "unknown", described as "couldn't breath". The events "feel dizzy and faint", "feel dizzy", "felt so bad" and "couldn't breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) kept going up and down; electrocardiogram: (2021) abnormal; heart rate: (2021) was up. Clinical course: Caller stated that 5 min after his first dose of the Pfizer Covid Vaccine he began to feel dizzy and faint. He was kept at his Dr. office until they closed. Caller said when he left he had to try and drive slowly home but had to pull over because he felt so bad. Caller said he felt dizzy and like he couldn't breath for almost an hour sitting in his car. He said a police office stopped and drove him home. Caller said he later went to the hospital and his blood pressure kept going up and down his heart rate was up and he had an abnormal EKG. Caller said he previously went online and made report to Pfizer. Reported everything through the app. Ended up having to go to the hospital. Now has an irregular heart rhythm. Caller was sick for so long, he doesn't want to die. Clarified caller was referring to the COVID-19 Vaccine. Had the reaction after the first dose. Did not get second dose.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Illness, Syncope
Clinical narrative: feel dizzy and faint; feel dizzy; felt so bad; couldn't breath; sick; irregular heart rhythm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 03Aug2021 (Lot number: EVEL64) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant) with onset Aug2021, outcome "unknown", described as "irregular heart rhythm"; SYNCOPE (medically significant) with onset 03Aug2021, outcome "unknown", described as "feel dizzy and faint"; ILLNESS (non-serious) with onset Aug2021, outcome "unknown", described as "sick"; DIZZINESS (non-serious) with onset 03Aug2021, outcome "unknown", described as "feel dizzy"; FEELING ABNORMAL (non-serious) with onset 03Aug2021, outcome "unknown", described as "felt so bad"; DYSPNOEA (non-serious) with onset 03Aug2021, outcome "unknown", described as "couldn't breath". The events "feel dizzy and faint", "feel dizzy", "felt so bad" and "couldn't breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) kept going up and down; electrocardiogram: (2021) abnormal; heart rate: (2021) was up. Clinical course: Caller stated that 5 min after his first dose of the Pfizer Covid Vaccine he began to feel dizzy and faint. He was kept at his Dr. office until they closed. Caller said when he left he had to try and drive slowly home but had to pull over because he felt so bad. Caller said he felt dizzy and like he couldn't breath for almost an hour sitting in his car. He said a police office stopped and drove him home. Caller said he later went to the hospital and his blood pressure kept going up and down his heart rate was up and he had an abnormal EKG. Caller said he previously went online and made report to Pfizer. Reported everything through the app. Ended up having to go to the hospital. Now has an irregular heart rhythm. Caller was sick for so long, he doesn't want to die. Clarified caller was referring to the COVID-19 Vaccine. Had the reaction after the first dose. Did not get second dose.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, SARS-CoV-2 test, Tinnitus
Clinical narrative: Constant tinnitus; noticeable loss of hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23May2021 (Lot number: EW0185) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sulfonamides" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 24Apr2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: TINNITUS (disability) with onset May2021, outcome "not recovered", described as "Constant tinnitus"; DEAFNESS (disability) with onset May2021, outcome "not recovered", described as "noticeable loss of hearing". The events "constant tinnitus" and "noticeable loss of hearing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jul2021) negative. Therapeutic measures were not taken as a result of tinnitus, deafness. Addition information: The patient didn't received other vaccine in four weeks. Other medications in twoweeks included men's mutivitamin, solgar brand. The patient covid prior vaccination was none. Known allergy included sulfonamides. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; contracted COVID; contracted COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An 81-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing); "dementia" (unspecified if ongoing). The patient took multiple concomitant medications in two weeks. Unknown if other vaccine in four weeks. No Covid prior vaccination. The following information was reported: IMMUNISATION (medically significant), outcome "recovering", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) both with onset 15Nov2021, outcome "recovering" and all described as "contracted COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results, notes: post vaccination. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Event did not result in death, hospitalized, life-threatening, congenital anomaly, disability. Also reported that at least 19 patients in this nursing home have recently contracted COVID after receiving booster. Reporter mother-in-law believes patients were given Pfizer vs Moderna vaccine but reporter had not confirmed with nursing home.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had a breakthrough with Covid; had a breakthrough with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (consumer's daughters friends mom) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had a breakthrough with Covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypersomnia, Mental impairment
Clinical narrative: Complaining about a disconnect between head and body; Noticed a downward trend in strength; Sleeping a lot more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer.  A 81 year-old male patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) at the age of 81 years as dose 1, single and administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL IMPAIRMENT (medically significant) with onset 2021, outcome "not recovered", ASTHENIA (non-serious) with onset 2021, outcome "unknown", HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "since the caller's husband received the Pfizer Covid 19 Vaccines, the caller has noticed a downward trend in the patient's strength, the patient is sleeping a lot more and the patient is complaining about a disconnect between head and body. The patient states the disconnect between head and body feels like the patient is in a control tower, something is going on down there but a long ways away and not like it use to be. The patient's ability to do anything is limited to 3 or 4 hours a day". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: had a heart attack 5 days after taking the Pfizer COVID-19 vaccine; This is a spontaneous report received from a non-contactable consumer from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "had a heart attack 5 days after taking the Pfizer COVID-19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with Covid Virus; diagnosed with Covid Virus; This is a spontaneous report received from a contactable consumer.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid Virus".  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Immunisation
Clinical narrative: Brain fog; Tired; booster dose; This is a spontaneous report received from a contactable Consumer via COVID-19 Adverse Event Self-Reporting Solution. The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 12:00 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster dose), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 30Mar2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Leg Left, Vaccine Administration Time: 12:30 PM), administration date: 09Mar2021, when the patient was 57 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 03Nov2021 12:00, outcome "unknown", described as "booster dose"; FEELING ABNORMAL (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Brain fog"; FATIGUE (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Tired". Therapeutic measures were not taken as a result of feeling abnormal, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Palpitations, SARS-CoV-2 test, Ventricular arrhythmia, Ventricular extrasystoles
Clinical narrative: Sustained ventricular heart arrhythmia; bigeminy of PVCs; shortness of breath with mild exertion; palpitations; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 19:15 (Lot number: 301U58A) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (received within 2 weeks of vaccination) included: MYRBETRIQ; OMEPRAZOLE; AMBIEN; ALLEGRA; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Erythromycin, reaction(s): "known allergies: erythromycin". The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The following information was reported: VENTRICULAR ARRHYTHMIA (medically significant) with onset 08Oct2021 13:00, outcome "not recovered", described as "Sustained ventricular heart arrhythmia"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 08Oct2021 13:00, outcome "not recovered", described as "bigeminy of PVCs"; DYSPNOEA EXERTIONAL (non-serious) with onset 08Oct2021 13:00, outcome "not recovered", described as "shortness of breath with mild exertion"; PALPITATIONS (non-serious) with onset 08Oct2021 13:00, outcome "not recovered", described as "palpitations". The events "sustained ventricular heart arrhythmia", "bigeminy of pvcs", "shortness of breath with mild exertion" and "palpitations" were evaluated at the physician office visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Oct2021) negative. Therapeutic measures were taken as a result of ventricular arrhythmia, ventricular extrasystoles, dyspnoea exertional, palpitations. Clinical course: Within less than 48 hours of receiving the vaccine, the patient has developed a sustained ventricular heart arrhythmia where the patient is experiencing bigeminy of PVCs, palpitations and shortness of breath with mild exertion. The patient is seeing a cardiologist now.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and 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.