chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: blistered on her cheeks and chin; entire face and chest and neck got all rashed out really severely/rash all over the body and face; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 51-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Jun2021 10:45 (age at vaccination: 51-year-old) as single dose for covid-19 immunization. (Vaccination facility: Pharmacy). Vaccine Administered at Facility: No. Medical history included Seizures ongoing stated states she has been having seizures her whole life. No concomitant medications were not reported. patient did not receive any other vaccinations within four weeks prior to vaccination. Patient had tetanus shot and she never had any reactions to tetanus. It was reported that she got the first shot on the 15th and she got a severe reaction. her entire face and chest and neck all was rashed out really severely and had blistered on her cheeks and chin and she went to the emergency room and the dermatologist and they did not know what to do so they put her on some antibiotics. she was scarring up from this, this was ridiculous. stated yeah its viscious bad, it wont go away. stated her symptoms began 16Jun2021 and are ongoing. went to the emergency room, dermatologist and her primary care just for a minute to get a referral. they put her on doxycycline 100mg twice a day and he gave her a 3 month prescription, also gave medicated antibiotic ointment but she was not using it it because it burns too bad. her face was on fire, it burns, it stings, it hurts. The outcome for the event was reported as not resolved.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Rash
Clinical narrative: Rash; they thought maybe it was yeast, looked yeasty to them they said; This is a spontaneous report from a contactable consumer or other non hcp. A 43-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: ER8736), via intramuscular, administered in Arm Right on 02Jun2021 (at the age of 43-year-old) as dose 1, single and dose 2 via intramuscular, administered in Arm Right on 24Jun2021 (Batch/Lot Number: EW0168) (at the age of 43-year-old) as dose 2, single for covid-19 immunisation. Medical history included vaginal herpes from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (FLUOXIBENE) taken for depression, start and stop date were not reported; acyclovir taken for genital herpes, start and stop date were not reported. Patient did not took any other vaccines within for weeks prior to vaccination. On 05Jun2021, the patient experienced rash. After the second dose patient got more of a rash. On an unknown date in Jun2021, Patient went to her husband's clinic for his job and they prescribed, a cream because they thought maybe it was yeast, looked yeasty to them they said. Patient stated that "so they gave me that and then they gave me Diflucan which just did nothing". The events resulted in health care professional visit. Therapeutic measures were taken as a result of events. Patient considered the event rash as non serious. The outcome of the events were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: he got really sick, but he didn't wax out or anything; This is a spontaneous report from a contactable consumer (Step Daughter). This consumer (Step Daughter) reported for (step-father) patient.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, caller unwilling to complete the report. Caller reporting an AE and mentions step-father received the Pfizer Covid 19 Vaccine and he got really sick, but he didn't wax out or anything. Caller declines to complete safety report for her dad stating he would have to do that. On an unspecified date, the patient experienced he got really sick, but he didn't wax out or anything. Reporter seriousness for he got really sick, but he didn't wax out or anything was unspecified. Outcome of the event was unknown.  PSCC Communication: Report 2 of 2. Details documented as provided by caller. Caller declines to complete a safety report for her dad, therefore, no further details obtained at this time.
Sex: M
Vaccine: COVID19
Symptoms: Orthostatic hypotension, Pain in extremity
Clinical narrative: sore arm; chronic orthostatic hypotension; This is a spontaneous report from a Pfizer-sponsored program . This consumer reported (Reporter's father) that a 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7534), dose 2 via an unspecified route of administration on 20Mar2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient took first dose of BNT162B2 on 27Feb2021 for covid-19 immunization. On an unspecified date, the patient experienced sore arm and chronic orthostatic hypotension. Wanted to know what EH6205 means. States it says that or EN6205. States in a row on his dads card it says 1st dose Covid 19 and has that number then the 2nd dose is also stamped Pfizer EP7534. Outcome of the events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report based on information from a contactable consumer received by Pfizer manufacturer, [manufacturer control number 4365306].    A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 03Jun2021 via an unknown route at 56-year-old for Covid-19 immunization. Patient's concurrent condition included relapsing remitting multiple sclerosis, increased falls, broken foot, anxiety worse, lymphatic colitis, allergy to aspirin, allergy to penicillin, allergy to sulfa drugs, allergy to tecfidera, emphysema, Von Willebrand's disease, depression, acid reflux, high blood pressure, dizziness, and nausea. Patient's concomitant medication included ocrelizumab, diazepam (VALIUM), duloxetine hydrochloride (CYMBALTA), omeprazole (PROTONIX), diltiazem, vitamin D3, vitamin B complex, meclizine, hydrocodone bitartrate, paracetamol (NORCO), ondansetron hydrochloride (ZOFRAN), loperamide, budesonide (ENTOCORT), and salbutamol sulfate (ALBUTEROL). On an unknown date (reported as Jul2020), patient experienced pneumonia. The outcome of the reported event was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, SARS-CoV-2 antibody test, Thyroid function test, Thyroiditis acute, Weight decreased
Clinical narrative: diagnosed with Acute Thyroiditis; Patient has Crone's disease; Patient has lost 25 pounds; white count dropped/  white blood cell count was 6000 but today it is 2.6; This is a spontaneous report from a contactable physician (patient parent). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization in Mar2021, at 47-year-old. Medical history and concomitant medication were not reported. Patient got two COVID tests, and they were both negative. The patient was tested for COVID antibodies, and he did not have any antibodies in response to the COVID vaccine received in March. Patient had acute thyroiditis, hospitalization from 28Jun2021 and ongoing. The patient had been getting thyroid function checked on yearly basis for several years. Prior to the vaccination he got it checked and it was normal. Patient had a week-long history of a serious fever, and profound sweating. His thyroid function was up, and his PCH was down to zero. Patient's symptoms began about a week and a half ago (Jun2021). Patient was diagnosed with acute thyroiditis. Physician office visited, he went to see his doctor about a week and half ago and was started on medication, but he had gotten progressively worse; finally, last night (28Jun2021) he was admitted to hospitalization. Patient saw a doctor that was covering for his primary care doctor and started him metronidazole. Methimazole he started to take 10mg daily; then a week and half ago increased to 15mg; starting yesterday in the emergency room it was 20mg twice a day. Patient went to the emergency room on 26Jun2021. He had been in the emergency room. Last night, 28Jun2021, patient was admitted to the hospital and moved to a room. The white count dropped yesterday (28Jun2021). The patient's white blood cell count was 6000 but today it was 2.6. Now he was on medication provided by the hospital. Patient had Crone's disease. Patient had lost 25 pounds. Outcome of the event acute thyroiditis was not resolved; outcome of the other events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: diagnosed with Acute Thyroiditis; Patient has Crone's disease; Patient has lost 25 pounds; white count dropped/  white blood cell count was 6000 but today it is 2.6; This is a spontaneous report from a contactable physician (patient parent). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization in Mar2021, at 47-year-old. Medical history and concomitant medication were not reported. Patient got two COVID tests, and they were both negative. The patient was tested for COVID antibodies, and he did not have any antibodies in response to the COVID vaccine received in March. Patient had acute thyroiditis, hospitalization from 28Jun2021 and ongoing. The patient had been getting thyroid function checked on yearly basis for several years. Prior to the vaccination he got it checked and it was normal. Patient had a week-long history of a serious fever, and profound sweating. His thyroid function was up, and his PCH was down to zero. Patient's symptoms began about a week and a half ago (Jun2021). Patient was diagnosed with acute thyroiditis. Physician office visited, he went to see his doctor about a week and half ago and was started on medication, but he had gotten progressively worse; finally, last night (28Jun2021) he was admitted to hospitalization. Patient saw a doctor that was covering for his primary care doctor and started him metronidazole. Methimazole he started to take 10mg daily; then a week and half ago increased to 15mg; starting yesterday in the emergency room it was 20mg twice a day. Patient went to the emergency room on 26Jun2021. He had been in the emergency room. Last night, 28Jun2021, patient was admitted to the hospital and moved to a room. The white count dropped yesterday (28Jun2021). The patient's white blood cell count was 6000 but today it was 2.6. Now he was on medication provided by the hospital. Patient had Crone's disease. Patient had lost 25 pounds. Outcome of the event acute thyroiditis was not resolved; outcome of the other events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse
Clinical narrative: This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 at 57-year-old, via an unspecified route of administration on 22Jun2021 at single dose for COVID-19 immunization. Medical history included broke wrist, exhausted from walking, fall, and ongoing multiple sclerosis. Concomitant medications included ocrelizumab (OCREVUS), and fampridine (AMPYRA). The patient experienced MS flare up on an unspecified date with outcome of resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Productive cough
Clinical narrative: The patient s niece stated her uncle is coughing up phlegm; he is really tired; his arm hurting; This is a spontaneous report from a contactable consumer. This consumer (Patient's niece) reported for a patient (Reporter's uncle)   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Patient also received SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) via unspecified route of administration for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient's niece stated her uncle is coughing up phlegm, his arm hurting, and he is really tired. The patient just got the Covid shot when these symptoms took place while being on Entresto. The outcome of all the events were not recovered.   Information about lot/batch number is Requested
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstrual disorder
Clinical narrative: Menstrual bleeding.; Horrible headache.; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EW0198 ), dose 1 intramuscular on 25Jun2021 at 11:35 AM as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have other vaccinations prior to 4 weeks of COVID vaccine. The patient experienced horrible headache on 27Jun2021. and she had menstrual bleeding on 28Jun2021. Patient reported that menstrual bleeding stopped and she haven't any bleeding that day so it's just yesterday. The outcome of the event menstrual bleeding was recovered on 28Jun2021 and the outcome of horrible headache was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Feeling abnormal
Clinical narrative: They barely got anything into me. I am not sure if I am really vaccinated properly; They barely got anything into me. I am not sure if I am really vaccinated properly; This is a spontaneous report from a Non-contactable consumer (patient). A patient of unspecified age and gender received unknown dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Jun2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated "Do you know about how Pfizer Vaccine is actually administered tons of people being, you know having the thing put into your arm? Can you guys tell me something about how it supposed to be administered? I got it at hospital yesterday. From then I am watching television, they barely got anything into me. I am not sure if I am really vaccinated properly and I try get to the phone, nothing. Their phone does not work. I mean I can't find anybody to talk to about what's supposed to normal inject in the arm. Anybody who can actually tell me how it supposed to be administered, is it supposed to be a light jab or is it supposed to be little bit more into the to the underneath of your arm. I got a flu shot, it is a very light jab. I saw it on television, how people receive the first shot after flu shot, COVID-19 shot you know anything about it, no?" You have somebody there who actually is involved with proper administration of the Vaccine, who knows how to give it in people's arms? I need to talk to somebody like that. The outcome of the events were unknown.  Regulatory Authority Comment: AE Filed conservatively  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Somnolence
Clinical narrative: Sleepy; Just weak in general; Tired; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 25Jun2021 as single dose for covid-19 immunization. No Medical history and no medications were not reported. patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunization. It was reported that patient received second dose on 25th and after got the dose has been feeling really tired, sleepy and just weak in general. Patient wanted to know if there is anything can do or take to help with that and if not how long, how much longer will take this feeling like this and patient have been having this quite randomly. The outcome for the events was reported as unknown.   Information about lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: shriveled down and lost it; This is a spontaneous report from a contactable consumer (patient's daughter). An 80-year-old female patient received the second dose of BNT162b2 (PFIZER-BIOTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date, at patient age of 80-year-old, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had to go into the emergency room and have 4 bags of potassium pumped into her because she just shriveled down and lost it and they didn't know what was wrong with her at one hospital so she went to another hospital and was there for 3 days. The reported wanted to know if these are side effects or something else. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Heart inflammation or Myocarditis/Pericarditis; Heart inflammation or Myocarditis/Pericarditis; Chest pain; Abnormal heart rhythms; Fever on and off for almost 3 days; Mild diarrhea; Fatigue; Shortness of breath; Lightheadedness; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; lot number was reported as EWOM), via an unspecified route of administration on the left arm on 09Jun2021 14:45 (at the age of 37-years-old) as dose 2, single for COVID-19 immunisation. Medical history included gallbladder polyp. Concomitant medication included an unspecified vitamin (other medications the patient received within 2 weeks of vaccination). The patient previously received to first dose of BNT162B2 (Lot number: EW0178,) via an unspecified route of administration on the left arm on 19May2021 03:15 AM (at the age of 37-years-old) as dose 1, single for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 09Jun2021 at 22:00, the patient experienced fever on and off for almost 3 days, heart inflammation of myocarditis/pericarditis; more specifically, chest pain, abnormal heart rhythms, mild diarrhea, fatigue, shortness of breath, and lightheadedness. No treatment was received by the patient. The outcome of the event fever was recovered in Jun2021; while for the other events was recovering.  Information about batch/lot number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Myocarditis, Pericarditis, Pyrexia
Clinical narrative: Heart inflammation or Myocarditis/Pericarditis; Heart inflammation or Myocarditis/Pericarditis; Chest pain; Abnormal heart rhythms; Fever on and off for almost 3 days; Mild diarrhea; Fatigue; Shortness of breath; Lightheadedness; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; lot number was reported as EWOM), via an unspecified route of administration on the left arm on 09Jun2021 14:45 (at the age of 37-years-old) as dose 2, single for COVID-19 immunisation. Medical history included gallbladder polyp. Concomitant medication included an unspecified vitamin (other medications the patient received within 2 weeks of vaccination). The patient previously received to first dose of BNT162B2 (Lot number: EW0178,) via an unspecified route of administration on the left arm on 19May2021 03:15 AM (at the age of 37-years-old) as dose 1, single for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 09Jun2021 at 22:00, the patient experienced fever on and off for almost 3 days, heart inflammation of myocarditis/pericarditis; more specifically, chest pain, abnormal heart rhythms, mild diarrhea, fatigue, shortness of breath, and lightheadedness. No treatment was received by the patient. The outcome of the event fever was recovered in Jun2021; while for the other events was recovering.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced blood clot after receiving Pfizer COVID vaccine on an unspecified date. Event took place after use of product. The outcome of event was unknown.   Information about lot/batch number is requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she did have pain at the injection site with the first vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0180, expiration: unknown) via an unspecified route of administration in arm left on 05Jun2021 17:00 (at the age of 62 years) as single dose for COVID-19 immunization. Medical history includes high cholesterol, high blood pressure and still ongoing from last 3 years, Acid reflux: About 2 years ago patient started using this medication and still ongoing. Prior to vaccination (within 4weeks) patient didn't had any other vaccination. No adverse event prior vaccination. Concomitant medications included simvastatin (ZOCOR) taken 10 mg tablet by mouth once a day for high cholesterol: she has been on it for more than 3 years, lisinopril (LISINOPRIL) taken 10 mg tablet by mouth once a day for high pressure: she started it 2 years ago, omeprazole (PROTONIX [OMEPRAZOLE]) taken 40mg tablet by mouth once a day for acid reflux: she started it about 2 hours ago. Patient really had no issues with first vaccine. But she did have pain at injection site with first vaccine and with second vaccine too. Patient received treatment for the event. The outcome of the event is unknown.  PSCC Communication:   Caller not answering questions directly, in adverse event section.  Details are as provided by caller with clarifying attempts.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Swelling, Vaccination site erythema
Clinical narrative: feels hot to touch; Swollen; Having the redness on the arm/tiny redness; Arm feels hard inside like its inside the muscle; Redness on her arm (where the injection was given)/bit of redness, tiny redness, the size of a penny; This is a spontaneous report from a contactable consumer or other non-HCP. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Left Arm on 27Jun2021 10:00 as DOSE 2, SINGLE (at the age of 60-year-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180) administered in Left Arm on 06Jun2021 at 12:00 for covid-19 immunization and had a little bit of tiredness and sleepiness. On 27Jun2021 the patient experienced redness on her arm (where the injection was given) and bit of redness, tiny redness, the size of a penny. On 28Jun2021 the patient experienced feels hot to touch, swollen, having the redness on the arm/tiny redness, arm feels hard inside like its inside the muscle. The patient's arm feels hot to the touch and swollen: The next morning, 28Jun2021, in the morning, the caller finds out that her arm is swollen, not the whole arm, but the area where the caller received the second dose Pfizer Covid Vaccine, it was maybe 5 to 6 centimeters that it was swollen. The patient arm feels hard inside like its inside the muscle. Her arm was hard when touching the muscle, will feel hardness inside when touching arm. Her arm feels hot to the touch and swollen: The arm felt hot, warm, and swollen. Her arm feels hot to the touch and swollen: In the night hours, maybe about 2000, the callers arm swelling was already 9.5 centimeters, the swelling grew. All day on 28Jun2021, the caller was putting a little ice pack and wet and cold things onto the arm.  Today, 29Jun2021, in the morning the caller finds out the size is the same. Her arm feels hard inside like its inside the muscle: The hardness in the caller's arm muscle is a little less. The caller doesn't feel the big chunk inside of the arm. There is a little less hardness. Her arm feels hot to the touch and swollen: The swelling is the same. The size is the same on the arm. Her Has redness on arm where the second dose Pfizer Covid Vaccine was given: The color is the same on the arm.  Therapeutic measures were taken as a result of swollen. The outcome of event arm feels hard inside like its inside the muscle was recovering. The outcome of rest all events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypokinesia, Muscle spasms, Piriformis syndrome
Clinical narrative: Piriformis syndrome; muscle spasms; both legs going numb to toes; Could barely move for weeks; This is a spontaneous report from a contactable consumer(patient). A 52-years-old-female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number Ew0169), via an unspecified route of administration at Arm Left on 05Apr2021 at the 52 years old at single dose for COVID-19 immunization.  The medical history was none. The concomitant medications were not reported. There were no known allergies. The patient was not pregnant. The Historical Vaccine was first dose BNT162B2(lot number=Er8733) in 2021(08:30 AM) at 52 years old at Left arm for Covid-19 immunization. On 10Apr2021 08:30 the patient experienced Piriformis syndrome, muscle spasms and both legs going numb to toes, Could barely move for weeks. All of the events caused Emergency Room Visit and Physician Office Visit. The patient received Cortisone anti inflammatory and physical therapy as treatment. 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 had not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Diarrhoea, Dizziness, Nausea, Palpitations
Clinical narrative: Increase of blood pressure; Heart palpitations; Dizziness; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer. This 31-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration into the right arm on 18Jun2021 at 08:30 PM as single dose for COVID-19 immunisation. The patient medical history included Covid-19 an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop dates were not reported. On 23Jun2021, the patient experienced increase of blood pressure three days after, heart palpitations, dizziness, nausea and diarrhoea. The events lead to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests which showed sars-cov-2 test as positive. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatments received. No covid tested post vaccination. Device date was reported as 29Jun2021. Outcome was resolving for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Increase of blood pressure; Heart palpitations; Dizziness; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer. This 31-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration into the right arm on 18Jun2021 at 08:30 PM as single dose for COVID-19 immunisation. The patient medical history included Covid-19 an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop dates were not reported. On 23Jun2021, the patient experienced increase of blood pressure three days after, heart palpitations, dizziness, nausea and diarrhoea. The events lead to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests which showed sars-cov-2 test as positive. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatments received. No covid tested post vaccination. Device date was reported as 29Jun2021. Outcome was resolving for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Depression, Dizziness, Emotional disorder, Fatigue
Clinical narrative: don't feel right; getting dizzy spells; feel tired all the time; feeling really depressed and emotional; feeling really depressed and emotional; crying; stressful; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 59-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 59-years) on 08Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 59-years) on an unknown date as dose 1, single for COVID-19 immunization and experienced slight heart palpitations that only lasted briefly and then she stated, but that could have been stress. After second dose first she felt great, she did not feel anything wrong at all. Then she reported around the beginning of May2021, she noticed that she just do not feel right, she was getting dizzy spells, she feel tired all the time. Patient feeling really depressed and emotional. During this report the she started crying. She stated that she just wanted to feel normal again. She was calling because her doctor advised her to call Pfizer or look on the website to see if anything similar has been reported regarding these emotional side effects. She stated that it was hard for her to know what was the true cause behind why she was feeling this way because she also opened her own business during this time and that has been really stressful as well, however, she stated that she just has not felt the same after receiving the second dose of the vaccine. She also mentioned it was hard to know what to believe about side effects with the Pfizer COVID-19 vaccine based on all of the different media reports. She also had a customer tell her that they have friends who have permanent seizures now because of the vaccine and she was unsure of what to believe. She was asking if these type of side effects (emotional) have been reported with the Pfizer COVID-19 vaccine. The clinical outcome of the events was reported as unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Stress
Clinical narrative: don't feel right; getting dizzy spells; feel tired all the time; feeling really depressed and emotional; feeling really depressed and emotional; crying; stressful; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 59-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 59-years) on 08Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 59-years) on an unknown date as dose 1, single for COVID-19 immunization and experienced slight heart palpitations that only lasted briefly and then she stated, but that could have been stress. After second dose first she felt great, she did not feel anything wrong at all. Then she reported around the beginning of May2021, she noticed that she just do not feel right, she was getting dizzy spells, she feel tired all the time. Patient feeling really depressed and emotional. During this report the she started crying. She stated that she just wanted to feel normal again. She was calling because her doctor advised her to call Pfizer or look on the website to see if anything similar has been reported regarding these emotional side effects. She stated that it was hard for her to know what was the true cause behind why she was feeling this way because she also opened her own business during this time and that has been really stressful as well, however, she stated that she just has not felt the same after receiving the second dose of the vaccine. She also mentioned it was hard to know what to believe about side effects with the Pfizer COVID-19 vaccine based on all of the different media reports. She also had a customer tell her that they have friends who have permanent seizures now because of the vaccine and she was unsure of what to believe. She was asking if these type of side effects (emotional) have been reported with the Pfizer COVID-19 vaccine. The clinical outcome of the events was reported as unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cancer
Clinical narrative: High-grade solid serous endometrioid-like transitional variant; This is a spontaneous report from a contactable physician. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not provided) via unspecified route of administration on an unknown date in Jan2021, as unknown dose, single for COVID-19 immunisation.The patient medical history included COVID infection in Jan2020. Concomitant medications were not provided. The patient reported that in Jan2020 she had covid infection, after that in Jan2021 she received BNT162B2 and on an unknown date, she was diagnosed with high-grade solid serous endometrioid-like transitional variant. Recently she reviewed the below mentioned article. Comorbidities and inflammation associated with ovarian cancer and its influence on SARS-CoV 2 infection. She cited an article and asked "is in your expertise could be a direct correlation between my ovarian cancer and my covid history. how it will be the effect of chemotherapy in further management ovarian cancer do I have to get coming winter in immunization again". Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events ovarian cancer and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Panic attack
Clinical narrative: Panic attack; received 2 of COVID vaccine dose, 14 days after the first dose; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: FA6780; Expiration Date: Sep2021), via an unspecified route of administration in left arm on 18Jun2021 (Age at Time of Vaccination in Years: 27) as dose 2, single for COVID-19 immunization. Historical vaccine included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0217; Expiration Date: Sep2021), via an unspecified route of administration in left arm on 04Jun2021 for COVID-19 immunization. Medical history included anaemia. There were no concomitant medications. Other products was not reported. The patient experienced received 2 of covid vaccine dose, 14 days after the first dose on 18Jun2021. Patient wanted to be vaccinated, to go home to their country. Additional Vaccines was not administered on same date of the Pfizer Suspect. AE(s) did not required a visit to emergency room or physician office. In Jun2021, the patient was in the hospital recently but it was for a panic attack due to a paperwork issue as far as the caller knows. Nobody had followed up if there any relation to the vaccine and caller is assuming it is just a panic attack. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The outcome of the events was unknown.  Amendment: This follow-up report is being submitted to amend previously reported information: Added event panic attack and upgraded to serious (hospitalization).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021810425 Same reporter/ drug, different patient/ AE
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Menstrual spotting after first dose that repeatedly came and went.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received bnt162b2 (Covid 19, Brand Pfizer), dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 13:45 (Lot Number: ER8730) as single for COVID-19 immunization. Medical history included amenorrhoea and allergy to birth control pills from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced menstrual spotting on 12Apr2021 after first dose that repeatedly came and went with outcome of not recovered. Case reported as serious due to disability. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was given for event includes birth control. The patient was not diagnosed with covid prior vaccination and has not been tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Endocrine disorder, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: After the second dose, spotting was continual but light and not overly worrisome; After a couple a couple months of this spotting I had a period of about eight hours with large clots and very heavy bleeding.; probably hormones; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant (including at the time of vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization at the public health clinic/veterans administration facility.  Medical history included amenorrhoea. Concomitant medications were not reported.  The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE  on 08Apr2021 01:45 PM (lot # ER8730) at the age of 33-year-old as 0.3 mL for COVID-19 immunization. She had menstrual spotting  after first dose that repeatedly came and went in 2021. Then, had the 2nd dose in 2021. After the second dose, spotting was continual but light and not overly worrisome. After a couple of months of this spotting, she had a period of about eight hours with large clots and very heavy bleeding. After this episode clots became more persistent and went to have doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. They said it was probably hormones and put the patient on birth control to make it stop. However, she now have hives due to the birth control pills which she have stopped taking and back to daily bleeding and clotting. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. The events were considered as serious (disabling) and not yet recovered from the events.  Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Benign hydatidiform mole, Maternal exposure during pregnancy, SARS-CoV-2 antibody test
Clinical narrative: molar pregnancy; pregnant while taking BNT162B2; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is a maternal report. A 32-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0217), via an unspecified route of administration on 08Jun2021 11:00 AM (at 32-year-old, pregnant at time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history included allergies and COVID prior vaccination. Concomitant medication included vitamin D NOS. No other vaccines within four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EE0185), via an unspecified route of administration on 18May2021 11:00 AM (at 32-year-old, pregnant at time of vaccination) as dose 1, single for COVID-19 immunization, and experienced maternal exposure during pregnancy, first trimester. The patient experienced pregnancy fine then turned into a molar pregnancy shortly following second injection on 23Jun2021. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event), congenital anomaly or birth defect. The mother reported she became pregnant while taking BNT162B2. The mother was 7 weeks pregnant at the onset of the event molar pregnancy, 5 weeks pregnant at the vaccination of dose 2. The mother was due to deliver on 07Feb2022. The patient had COVID tested post vaccination, included Nasal Swab: negative on 26Jun2021. Therapeutic measures were taken as a result of molar pregnancy included surgery. The outcome of the event molar pregnancy was not recovered, outcome of the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021810841 fetus case