chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Renal disorder, Thrombosis, Weight decreased, X-ray
Clinical narrative: Blood clots; vaccine is attacking her kidneys; Lost 20 pounds; The blood looks like merlot wine; The blood looks like merlot wine. This is painful; Mentally distraught; I have lost 20 pounds and cannot work.; This is a spontaneous report from a contactable consumer (patient reported for herself). A 41-years-old female patient received her second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 27Mar2021, as single for covid-19 immunisation. Medical history included Bladder biopsy and hysterectomy in 2016. The patient concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 06Mar2021, as single for covid-19 immunisation and between 06Mar- 13Mar2021, she had all the side effects: night sweats, colds, nauseated, sore arm, fever, I was sick. On 18Mar, she began urinating blood and was not stopped. On an unspecified date in Mar2021, after the second dose the patient experienced blood clots and the vaccine is attacking her kidneys, lost 20 pounds and cannot work, the blood looks like merlot wine and mentally distraught. The clinical course of the events as follows: She went to the emergency room, when the blood first started. She stated that the vaccine was attacking her kidneys and they did not know why. On an unspecified date in Jan2021, she got a clean bill of health at her annual checkup. She had a hysterectomy in 2016, so this was not vaginal bleeding. She had passing blood clots at this point and this was painful. She mentioned, no one was able to figure out what the vaccine was doing to her. She had seen a nephrologist, a urologist and her primary care physician for the events. She had an appointment with a clinic scheduled. She stated she had lost 20 pounds and could not work. She stated that her blood looks like merlot wine and she was mentally distraught. Her MD said he had read about this in a journal about other patients. She had been to 4 different hospitals, had 3 CAT (computerized tomography) scans for which the result was unknown. She has had x-rays and was in and out of the emergency room. On an unspecified date, the patient underwent lab tests biopsy bladder: unknown, computerized tomogram: unknown, x-ray: unknown. She had her blood drawn every 2 weeks. The outcome of the events was unknown at the time of this report. The patient was Referred to HCP and provided info on the countermeasures Injury Compensation Program  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Heart rate, Palpitations, Vomiting
Clinical narrative: AFIB/flutter; threw up; Threw up and saying that her heart was racing/have bouts of palpitations/heart rate was out of control; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right at age of 22 years on 28Apr2021 (lot number: EN6199) as single dose for covid-19 immunisation. Medical history included extreme immune system, described that patient was 3 weeks post term (as reported) and had issues when she was born, she was adopted and when all the kids would get sick she would always get the sickest; had seizures that only lasted about 2 years (not ongoing) when she was a baby. Family medical history relevant to AE was none. Concomitant medications were none. No vaccines administered on same date or within four weeks prior to the first administration date of the suspect vaccine. The patient previous took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 via an unspecified route of administration, administered in arm right at age of 22 years on 07Apr2021 (Lot no: : EN6205) for covid-19 immunisation, few days later she felt something and thought it was anxiety. On 15May2021, 8:30 in the morning patient threw up and was saying that her heart was racing, so she got their finger monitor, and heart rate was out of control so they took her to the emergency room. They tried to get her heart rate down with medications and sent her to an electro physicist, and the rest was history. The only reason attributed this to the vaccine was because this occurred 17 days after her second shot and patient was has been an athlete her whole life, has been in great shape with no heart problems. They captured flutter on the EKG, and saw AFIB when she was under, on 15May2021. Patient ended up having to have cardiac surgery (for AFIB) on 16Jun2021 13:00 in hospital from 16Jun2021 to 17Jun2021. Patient was doing really well, they had to do an ablation. Patient will recover completely, but it will take about 3 months. She will have to be followed by a cardiologist. Saw the cardiologist, patient may have bouts of palpitations, but has had nothing since 3 days after the surgery (19Jun2021). The outcome of the events palpitations was recovered on 19Jun2021, other events was recovering.  Follow-up actions are needed. Further information has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Joint lock, Pain in extremity, SARS-CoV-2 test, Trigger finger
Clinical narrative: he said I have trigger figure; The night of the first injection I woke up with pain in my right thumb area; My thumb was what I though sticking in a locked position; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 05Apr2021 (at the age of 52-year-old) (Batch/Lot Number: Ew0176) as dose 2, single for covid-19 immunisation. Medical history included known allergies to hormones patch. The patient was not pregnant. The patient's concomitant medications were not reported.  The patient received first dose of bnt162b2 for covid-19 immunisation on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the night of the first injection, the patient woke up with pain in her right thumb area. Her thumb was what she thought sticking in a locked position. She wasn't sure what was going on so she massaged it and went back to sleep and it continued to stick. After a month, she saw her primary doctor who referred her to a hand specialist and he said the patient had a trigger "figure". The events resulted in doctor or other healthcare professional office/clinic visit. Therapy for the events included a cortisone shot in right thumb. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. The patient underwent a nasal swab (rapid covid) on 15May2021 with negative results. Outcome of events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone density decreased, Finger deformity, Myalgia
Clinical narrative: Severe joint and muscle pain; Severe joint and muscle pain; Fingers becoming deformed very rapidly; Bones deteriorating rapidly; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3246) via an unspecified route of administration administered in left arm on 19Jan2021 at 11:00 (at 65 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. The patient medical history was not reported. Concomitant medications included hctz, bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium, esomeprazole magnesium (NEXIUM), and alprazolam (XANAX) modified-release tablet; all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced severe joint and muscle pain, fingers becoming deformed very rapidly, and bones deteriorating rapidly on 22Jan2021. All events resulted to physician office visit. Treatment received for the adverse events included prednisone. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL9265) via an unspecified route of administration administered in left arm on 09Feb2021 at 11:00 as single dose for COVID-19 immunization. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: fever of 101.2 for about 8 hours/feeling like she was coming down with the flu; fever of 101.2 for about 8 hours/feeling like she was coming down with the flu; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received second dose of BNT162B2, via an unspecified route of administration at arm left on 19May2021 (Batch/Lot Number: EW0179) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus and known allergies: penicillin. The patient received first dose of BNT162B2 at arm left on 27Apr2021 (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. The patient's concomitant medications were not reported.  The patient was not diagnosed with COVID-19 prior to vaccination, did not tested for COVID-19 since the vaccination. The patient had a fever of 101.2 for about 8 hours from 20May2021 09:00. It occurred the next morning after receiving the vaccine. The patient was feeling like she was coming down with the flu or something else. The event was recovered on 20May2021 17:00.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash, Scab, Skin haemorrhage, Skin mass
Clinical narrative: My skin has bumps and rashes all over it that have t gone away since the second vaccine. They scab and bleed.; My skin has bumps and rashes all over it that have t gone away since the second vaccine. They scab and bleed.; My skin has bumps and rashes all over it that have t gone away since the second vaccine. They scab and bleed.; My skin has bumps and rashes all over it that have t gone away since the second vaccine. They scab and bleed.; Date of start of drug: 24Mar2021, Dose number 1, date of start of drug: 10Apr2021, Dose number 2; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 10Apr2021 12:00 (at the age of 34-year-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient received first dose of bnt162b2 on 24Mar2021 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021, the patient experienced skin bumps and rashes all over it and it have not gone away since the second vaccine. They scab and bleed. The patient reported having five different kinds of rashes and she can't even shave her legs anymore. Therapy for the events included creams and steroids that don't work. The events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: had a fever of 103.4F; Still ill; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old male patient (reporter's son) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in arm left on 24Jun2021 13:45 (Lot Number: EW0217) as dose 2, single (at age of 16-year-old) for covid-19 immunisation. Medical history included Celiac disease. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EW0197) administered in the Left Arm on 03Jun2021 for Covid-19 immunization. The patient experienced fever started around 23:00 on 24Jun2021. The patient had a fever of 103.4F and he was still ill after the second vaccine on 24Jun2021. The reporter asked when she can expect he will feel better and when she should take him to the doctor. The reporter was told by nurse that his temperature was normal. The patient had been treated his fever with medication, otherwise it went back, the reporter had to even give him a tepid bath. When medication wear off, the fever came back. Outcome of the events was not recovered.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Extrasystoles, Mononuclear cell count, Supraventricular tachycardia
Clinical narrative: cardiac arrhythmias, including SVT and ectopic beats; cardiac arrhythmias, including SVT and ectopic beats; cardiac arrhythmias, including SVT and ectopic beats; This is a spontaneous report from a contactable Physician (patient). A 66-year-old female BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via unspecified route of administration, administered in left arm deltoid, on 18Jan2021 (Age at vaccination: 66) as DOSE 2, SINGLE for Covid-19 immunization. Patient took first dose of vaccine (lot number: unknown, expiry date: unknown), via unspecified route of administration, on 26Dec2020 (at the age of 66-years-old) as Dose 1, single for Covid-19 immunization. NDC number of Covid-19 Vaccine: Unknown. Patient medical history and concomitant medications were not reported. On 17Feb2021 after second vaccination, patient developed cardiac arrhythmias, including SVT and ectopic beats. He was otherwise healthy and was just calling to report that with the recent cardiac report. His question was if they had information or were aware of any long term cardiac events. The patient underwent lab test which included Holter Monitor test on 17Feb2021, results of which showed it was cardiac arrhythmia. Treatment regimen was not given as a result of the adverse events. The outcome of events was recovered on an unspecified date. ; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious event Cardiac arrhythmia cannot be totally 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.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Pneumonitis
Clinical narrative: Chest XRay. Result Pneumonitis; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp.  A 60-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose1 (Lot number EN6202, expiry date was not reported) via unspecified route of administration at Left arm on 01Mar2021 at 12:00 PM as a single dose for COVID-19 immunisation. dose 2 (Lot Number: ER8727 expiry date was not reported) via an unspecified route of administration at Arm Left on an unspecified date as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient known allergies included Demerol, Morphine, Codiene. The patient previously took demerol apap and, morphine and, codeine and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Adverse event treatment chest XRay. Result Pneumonitis - Proair inhaler ve. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced, result pneumonitis on an unspecified, shortness of breath on 23Mar2021. patient underwent lab tests chest X-ray witch result pneumonitis. Therapeutic measures were taken as a result of shortness of breath Proair inhaler for (pneumonitis). The outcome of the event pneumonitis was unknown, shortness of breath was recovered on an unspecified date 2021.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: Bilateral pulmonary embolisms; DVT in right leg from groin to behind knee; This is a spontaneous report from a contactable consumer or other non health care professional (Patient).  A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 08:00 (Batch/Lot Number: ER8727) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Right on 18Mar2021 (Batch/Lot Number: ER8729) as DOSE 2, SINGLE for covid-19 immunization at Hospital.. The patient past Medical history included Migraine and treated with topimax. Concomitant medication included topiramate (Topimax) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 09Apr2021, at 19:00, the patient experienced Bilateral pulmonary embolisms and DVT in right leg from groin to behind knee. The patient visited Doctor or other healthcare professional office/clinic visit and went to emergency room and Hospitalized for 5 days. The patient underwent lab tests which included: On 31Mar2021 sars-cov-2 test Result: Negative (Nasal Swab mako PCR). On 17Apr2021 Nasal Swab: Result: Negative and on 30Apr2021 Nasal Swab: Result: Negative. The patient treated with Heparin IV, Díaz CT, ultrasounds, echo, endo and colo. The event outcome was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea
Clinical narrative: Difficulty breathing; Chest pain; Upper back pain; This is a spontaneous report from a contactable consumer (patient).   A 24-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0191, expiration date: un-known) via an unspecified route of administration in Arm Right on 21Jun2021 at 04:30 PM (at the age of 24-year-old) as single dose for covid-19 immunization. Medical history included Congenital anamoly (ARSA), and No known allergies reported. Concomitant medications (taken within 2 weeks of vaccination) included Sertraline and Hydroxyzine. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. On 25Jun2021 at 10: PM, the patient experienced difficulty breathing, chest pain, and upper back pain. No therapeutics measures were taken for events. The events resulted to visit Emergency room/department or urgent care. Device Date: 27Jun2021. The outcome of the events was reported as not recovered.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menopause, Premenstrual pain
Clinical narrative: Had some bleeding; I am on my fourth time of break through bleeding since than; Doctor thought it might be pre menopause; Have break through bleeding every two an half weeks before after a period; It might be pre menopause; I thought may be just you know cramping or whatever before my periods; This is a spontaneous report from a non-contactable consumer(patient). A 35-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) and also received second dose of BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date in Apr2021 (Batch/Lot number was not reported) as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. About two and half weeks after her first vaccination, she had some bleeding and she thought may be just a cramping or whatever before her periods. Now she was on her fourth time of break through bleeding since then and it was, her doctor thought it might be pre menopause. She had both the doses and ever since than she had the break through bleeding every two to two an half weeks before after a period. So is that now a side effect of the Pfizer vaccination. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: The first 2-3 days and had maybe one or two clots; My periods have been extremely heavy and extremely clotty; My periods have been extremely heavy and extremely clotty; Im also experiencing more cramping.; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old non-pregnant female patient (not pregnant at time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 22Apr2021 (at the age of 38-years-old) as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 28Apr2021, after first dose her periods had been extremely heavy and extremely clotty. She was on her 3rd cycle at the time of reporting and no improvements. She was also experiencing more cramping. She had to change a super-sized tampon every 2 hours for the first 2-3 days of period. Her period was never like this before. Prior to being vaccinated she did change a super tampon every 6-8 hours for the first 2-3 days and had maybe one or two clots. The patient did not receive any treatments for the events. Reporter considered events as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Body temperature, Fatigue, Feeling cold, Hyperhidrosis
Clinical narrative: rarely leaving bed.; Checked oral temp: 100.6 F.; Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding.; 5/20-Woke in AM drenched in sweat, blankets wet, and freezing.; Fatigued; Muscle aches; Feeling extremely cold and always waking drenched in sweat with wet blankets. 5/21- rarely leaving bed; Woke up during night freezing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 19May2021 at 16:00 (at the age of 37 year) as DOSE 2, SINGLE for COVID-19 immunization at School or Health Clinic. Medical history included idiopathic hypersomnolence, anxiety, depression, excessive daytime sleepiness, chronic fatigue, constipation, internal and external bleeding haemorrhoids and non-celiac gluten enteropathy. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate and dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within four weeks of vaccination. Patient received Adderall XR 40 mg twice per day within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW 0172), via an unspecified route of administration, administered in Right arm on 28Apr2021at 15:00 as single dose for covid-19 immunization. On 19May2021 at 08 PM, patient woke up during night freezing. Applied more blankets and fell back asleep. On 20May2021, woke in AM drenched in sweat, blankets wet and freezing. Able to sit up for about 2 hours total throughout day watching TV. Otherwise in bed, fatigued, muscle aches, feeling extremely cold and always waking drenched in sweat with wet blankets. On 21May2021, rarely leaving bed. Checked oral temp: 100.6 F. Seemingly constant cycle of waking freezing, drenched in sweat with wet blankets. Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding. Last day of symptoms was on 03Jun2021. Patient tested for COVID-19 after vaccination. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit in May2021 and SARS-COV-2 test/ Nasal Swab: negative on 25May2021. This case assessed as non-serious by reporter. Patient visited to doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as recovering.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: rarely leaving bed.; Checked oral temp: 100.6 F.; Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding.; 5/20-Woke in AM drenched in sweat, blankets wet, and freezing.; Fatigued; Muscle aches; Feeling extremely cold and always waking drenched in sweat with wet blankets. 5/21- rarely leaving bed; Woke up during night freezing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 19May2021 at 16:00 (at the age of 37 year) as DOSE 2, SINGLE for COVID-19 immunization at School or Health Clinic. Medical history included idiopathic hypersomnolence, anxiety, depression, excessive daytime sleepiness, chronic fatigue, constipation, internal and external bleeding haemorrhoids and non-celiac gluten enteropathy. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate and dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within four weeks of vaccination. Patient received Adderall XR 40 mg twice per day within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW 0172), via an unspecified route of administration, administered in Right arm on 28Apr2021at 15:00 as single dose for covid-19 immunization. On 19May2021 at 08 PM, patient woke up during night freezing. Applied more blankets and fell back asleep. On 20May2021, woke in AM drenched in sweat, blankets wet and freezing. Able to sit up for about 2 hours total throughout day watching TV. Otherwise in bed, fatigued, muscle aches, feeling extremely cold and always waking drenched in sweat with wet blankets. On 21May2021, rarely leaving bed. Checked oral temp: 100.6 F. Seemingly constant cycle of waking freezing, drenched in sweat with wet blankets. Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding. Last day of symptoms was on 03Jun2021. Patient tested for COVID-19 after vaccination. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit in May2021 and SARS-COV-2 test/ Nasal Swab: negative on 25May2021. This case assessed as non-serious by reporter. Patient visited to doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as recovering.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Insomnia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: rarely leaving bed.; Checked oral temp: 100.6 F.; Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding.; 5/20-Woke in AM drenched in sweat, blankets wet, and freezing.; Fatigued; Muscle aches; Feeling extremely cold and always waking drenched in sweat with wet blankets. 5/21- rarely leaving bed; Woke up during night freezing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 19May2021 at 16:00 (at the age of 37 year) as DOSE 2, SINGLE for COVID-19 immunization at School or Health Clinic. Medical history included idiopathic hypersomnolence, anxiety, depression, excessive daytime sleepiness, chronic fatigue, constipation, internal and external bleeding haemorrhoids and non-celiac gluten enteropathy. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate and dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within four weeks of vaccination. Patient received Adderall XR 40 mg twice per day within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW 0172), via an unspecified route of administration, administered in Right arm on 28Apr2021at 15:00 as single dose for covid-19 immunization. On 19May2021 at 08 PM, patient woke up during night freezing. Applied more blankets and fell back asleep. On 20May2021, woke in AM drenched in sweat, blankets wet and freezing. Able to sit up for about 2 hours total throughout day watching TV. Otherwise in bed, fatigued, muscle aches, feeling extremely cold and always waking drenched in sweat with wet blankets. On 21May2021, rarely leaving bed. Checked oral temp: 100.6 F. Seemingly constant cycle of waking freezing, drenched in sweat with wet blankets. Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding. Last day of symptoms was on 03Jun2021. Patient tested for COVID-19 after vaccination. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit in May2021 and SARS-COV-2 test/ Nasal Swab: negative on 25May2021. This case assessed as non-serious by reporter. Patient visited to doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as recovering.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pruritus, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: rarely leaving bed.; Checked oral temp: 100.6 F.; Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding.; 5/20-Woke in AM drenched in sweat, blankets wet, and freezing.; Fatigued; Muscle aches; Feeling extremely cold and always waking drenched in sweat with wet blankets. 5/21- rarely leaving bed; Woke up during night freezing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 19May2021 at 16:00 (at the age of 37 year) as DOSE 2, SINGLE for COVID-19 immunization at School or Health Clinic. Medical history included idiopathic hypersomnolence, anxiety, depression, excessive daytime sleepiness, chronic fatigue, constipation, internal and external bleeding haemorrhoids and non-celiac gluten enteropathy. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate and dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within four weeks of vaccination. Patient received Adderall XR 40 mg twice per day within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW 0172), via an unspecified route of administration, administered in Right arm on 28Apr2021at 15:00 as single dose for covid-19 immunization. On 19May2021 at 08 PM, patient woke up during night freezing. Applied more blankets and fell back asleep. On 20May2021, woke in AM drenched in sweat, blankets wet and freezing. Able to sit up for about 2 hours total throughout day watching TV. Otherwise in bed, fatigued, muscle aches, feeling extremely cold and always waking drenched in sweat with wet blankets. On 21May2021, rarely leaving bed. Checked oral temp: 100.6 F. Seemingly constant cycle of waking freezing, drenched in sweat with wet blankets. Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding. Last day of symptoms was on 03Jun2021. Patient tested for COVID-19 after vaccination. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit in May2021 and SARS-COV-2 test/ Nasal Swab: negative on 25May2021. This case assessed as non-serious by reporter. Patient visited to doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as recovering.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: rarely leaving bed.; Checked oral temp: 100.6 F.; Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding.; 5/20-Woke in AM drenched in sweat, blankets wet, and freezing.; Fatigued; Muscle aches; Feeling extremely cold and always waking drenched in sweat with wet blankets. 5/21- rarely leaving bed; Woke up during night freezing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 19May2021 at 16:00 (at the age of 37 year) as DOSE 2, SINGLE for COVID-19 immunization at School or Health Clinic. Medical history included idiopathic hypersomnolence, anxiety, depression, excessive daytime sleepiness, chronic fatigue, constipation, internal and external bleeding haemorrhoids and non-celiac gluten enteropathy. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate and dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within four weeks of vaccination. Patient received Adderall XR 40 mg twice per day within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW 0172), via an unspecified route of administration, administered in Right arm on 28Apr2021at 15:00 as single dose for covid-19 immunization. On 19May2021 at 08 PM, patient woke up during night freezing. Applied more blankets and fell back asleep. On 20May2021, woke in AM drenched in sweat, blankets wet and freezing. Able to sit up for about 2 hours total throughout day watching TV. Otherwise in bed, fatigued, muscle aches, feeling extremely cold and always waking drenched in sweat with wet blankets. On 21May2021, rarely leaving bed. Checked oral temp: 100.6 F. Seemingly constant cycle of waking freezing, drenched in sweat with wet blankets. Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding. Last day of symptoms was on 03Jun2021. Patient tested for COVID-19 after vaccination. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit in May2021 and SARS-COV-2 test/ Nasal Swab: negative on 25May2021. This case assessed as non-serious by reporter. Patient visited to doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blister, Breast pain, Herpes zoster, Neuralgia
Clinical narrative: Shingles; Outbreak back & right breast with intense pain over 48 hrs; Outbreak back & right breast with intense pain over 48 hrs; itching & pain within 24 hrs; itching & pain within 24 hrs; tingling in chest right side; Blisters; Scars on back; nerve pain; This is a spontaneous report from a contactable consumer (Patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 27Jan2021 at 14:30 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. The most recent facility where the COVID-19 vaccine was administered was reported as other. Medical history included arthritis, IBS, dermatitis and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID) and ibuprofen, both 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 vaccination or on the same day of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that patient does not had any previous shingles before vaccination. On 27Jan2021 at 15:45 (minutes after vaccination), patient experienced tingling in chest right side, blisters, scars on back and nerve pain. On 28Jan2021, patient had itching & pain within 24 hrs. On 29Jan2021, patient experienced an outbreak back & right breast with intense pain over 48 hrs. The patient had tried to call doctor, who was unable to see patient till Tuesday (reported as 02Jan), and on an unspecified date in Feb2021, patient was diagnosed with Shingles. However, it was too late to administer any medication that would help clear up quickly. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The events were assessed as Serious (Disability/Incapacitating/permanent damage). The blisters took over 10 weeks to clear and the event nerve pain was continuing at the time of report (27Jun2021). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures included gamapentin for pain. The outcome all the events except nerve pain was recovered with sequel. The event nerve pain was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pruritus, Scar
Clinical narrative: Shingles; Outbreak back & right breast with intense pain over 48 hrs; Outbreak back & right breast with intense pain over 48 hrs; itching & pain within 24 hrs; itching & pain within 24 hrs; tingling in chest right side; Blisters; Scars on back; nerve pain; This is a spontaneous report from a contactable consumer (Patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 27Jan2021 at 14:30 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. The most recent facility where the COVID-19 vaccine was administered was reported as other. Medical history included arthritis, IBS, dermatitis and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID) and ibuprofen, both 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 vaccination or on the same day of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that patient does not had any previous shingles before vaccination. On 27Jan2021 at 15:45 (minutes after vaccination), patient experienced tingling in chest right side, blisters, scars on back and nerve pain. On 28Jan2021, patient had itching & pain within 24 hrs. On 29Jan2021, patient experienced an outbreak back & right breast with intense pain over 48 hrs. The patient had tried to call doctor, who was unable to see patient till Tuesday (reported as 02Jan), and on an unspecified date in Feb2021, patient was diagnosed with Shingles. However, it was too late to administer any medication that would help clear up quickly. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The events were assessed as Serious (Disability/Incapacitating/permanent damage). The blisters took over 10 weeks to clear and the event nerve pain was continuing at the time of report (27Jun2021). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures included gamapentin for pain. The outcome all the events except nerve pain was recovered with sequel. The event nerve pain was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Disorientation, Dizziness, Fear, Hallucination
Clinical narrative: hallucinating; blood sugar very low; very dizzy; disorientated; I wasn't able to hold conversation; very scary; sweaty; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 37-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0217), dose 2 via an unspecified route of administration in arm left on 25Jun2021 at 17:00 (at the age of 37-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included liver disease from an unknown date and unknown if ongoing. The concomitant medications of the patient included rifaximin (XIFAXAN), propranolol (PROPRANOLOL), bupropion hydrochloride (WELLBUTRIN), celecoxib (CELEXA [CELECOXIB]) and ursodiol (URSODIOL) all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0178), via an unspecified route of administration in arm left on 04Jun2021 at 15:00 (at the age of 37-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient experienced reported that on 25Jun2021 at 18:00 approx 30 min after injection, while shopping, I became very dizzy, sweaty and disorientated. I wasn't able to hold conversation and was rolling and running in circles. I did not know where I was and was hallucinating, very scary and all happened very quickly. Was taken to ER for observation, was told my blood sugar very low. I've never had glucose problems and am not diabetic. The patient underwent lab tests and procedures which included blood glucose decreased was low on 25Jun2021. Therapeutic measures were taken as a result of events that included ate food and observed. The outcome of all the events was reported as resolving.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Speech disorder
Clinical narrative: hallucinating; blood sugar very low; very dizzy; disorientated; I wasn't able to hold conversation; very scary; sweaty; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 37-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0217), dose 2 via an unspecified route of administration in arm left on 25Jun2021 at 17:00 (at the age of 37-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included liver disease from an unknown date and unknown if ongoing. The concomitant medications of the patient included rifaximin (XIFAXAN), propranolol (PROPRANOLOL), bupropion hydrochloride (WELLBUTRIN), celecoxib (CELEXA [CELECOXIB]) and ursodiol (URSODIOL) all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0178), via an unspecified route of administration in arm left on 04Jun2021 at 15:00 (at the age of 37-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient experienced reported that on 25Jun2021 at 18:00 approx 30 min after injection, while shopping, I became very dizzy, sweaty and disorientated. I wasn't able to hold conversation and was rolling and running in circles. I did not know where I was and was hallucinating, very scary and all happened very quickly. Was taken to ER for observation, was told my blood sugar very low. I've never had glucose problems and am not diabetic. The patient underwent lab tests and procedures which included blood glucose decreased was low on 25Jun2021. Therapeutic measures were taken as a result of events that included ate food and observed. The outcome of all the events was reported as resolving.