chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia, Palpitations
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 66-year-old female patient. A 66-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3246, Expiration date: unknown), via intramuscular route of administration, in Arm Left on 02Feb2021 at 09:00 AM (at the age of 66-years-old) as single dose for Covid-19 immunization at hospital. The patient medical history included migraines, depression, high cholesterol, melanoma, bladder carcinoma, cholecystectomy, hysterectomy. The patient received the medications within 2 weeks of vaccination included aspirin, Depakote, Lipitor, vitamin D, omega-3. The patient also received first dose of BNT162B2 (Solution for injection, Lot number: El3246) via intramuscular route, in Arm Left on 12Jan2021 at 14:00 PM (at the age of 66-years-old) as single dose for Covid-19 immunization.  Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 02Feb2021, she had her second dose of COVID-19 vaccine this morning. She was fine for 15 minutes and return to work. On 02Feb2021 at 09:15 AM, She felt flushed and her entire head felt numb. She also felt like her heart was racing. She did return to employee health, and they gave treatment as Claritin and Pepcid orally for the events. She stated that she was feeling better now. She denies any chest pain or shortness of breath. The patient went to emergency room/department or urgent care due to an adverse events. The outcome of all events was recovered on an unspecified date.  No follow-up attempts are possible, No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Consumer received first covax on 10Feb and they scheduled the second covax for 30Mar; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she received first covax on 10Feb and they scheduled the second covax for 30Mar. She is asking if this is wrong because her facts sheet says 21 days for the Pfizer covax. She has not called be-fore, read FB. Due to 13 callers ahead of us. Will fax to Pfizer DSU from Covax US Support. CEP 159558 for AE. Outcome of the event unknown.  Information on the lot/ batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Tremor
Clinical narrative: Temp up to 106.0; Uncontrollable shaking; Headache; body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809, Expiration date not reported), via an unspecified route of administration on arm left on 20Feb2021 11:00 at single dose for COVID-19 immunisation. Medical history included asthma, fibromyalgia, bp issues, hypothyroid and covid; all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient had COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had known allergies to morphine.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has received unspecified other medications in two weeks. On 20Feb2021 20:00, the patient experienced uncontrollable shaking, temp up to 106.0, headache and body aches. The patient underwent lab tests and procedures which included body temperature: up to 106.0 on an unspecified date. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 17Jan2021 at 09:00 (at the age of 68-year-old) as SINGLE DOSE for covid-19 immunization and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection,) via an unspecified route of administration, administered in Arm Right on 14Feb2021 at 08:00 as SINGLE DOSE for covid-19 immunization. Medical history included none. The patient had no known allergies. Concomitant medication(s) included in two weeks fluoxetine hydrochloride (PROZAC); colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient had no other vaccine in four weeks. The patient not had covid prior vaccination. On 06Feb2021 at 23:00, after 2 weeks, the patient experienced diarrhea for 2 weeks straight. The patient underwent lab tests and procedures which included Nasal Swab: negative on 10Feb2021: post vaccination. Therapeutic measures were taken as a result of diarrhea and treatment included with Antibiotics. The outcome of the event was unknown.  Information on lot number/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm; chills; Body aches; Headache; This is a spontaneous report received from a contactable consumer. A 36-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered on Arm Right on 17Feb2021 10:15 (Age at vaccination: 36 Years) as single dose for COVID-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. The Patient had not any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not received any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered on Arm Right on 27Jan2021 10:15 as single dose for COVID-19 immunization. On 17Feb2021 at 08:00 PM, the patient experienced Sore arm, chills, body aches, headache. The patient has not received treatment for the adverse events. The outcome of events was resolved.  No follow-up attempts are needed. No further information is expected.  Follow-up (02Mar2021): Upon follow up from contactable consumer, new information included: confirmation of awareness date as 17Feb2021.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site reaction
Clinical narrative: redness below injection site; upper arm at injection site feels heavy and tight; This is a spontaneous report from a contactable consumer (reported on herself).  The 77-year-old female patient received BNT162B2 (Solution for injection, Lot number: EN6200 expiry date: unknown) via an unspecified route of administration in left arm on 23Feb2021 9:58 am, as a single dose for Covid-19 immunization. Medical history included Diabetic since in her 30's or 40's, and problems with her spine. Concomitant PIOGLITAZONE HYDROCHLORIDE (ACTOS) 15mg daily Ongoing for Diabetes has been taking for over 10 years, HYDROCHLOROTHIAZIDE, TRIAM-TERENE (TRIAMTERENE/HCTZ) 37.5mg/25mg daily Ongoing had been taking for over 10 years for high blood pressure, LISINOPRIL 40mg daily ongoing for Blood pressure taking for over 10 years, ALENDRONATE SODIUM 35mg every Saturday from 2018 Ongoing) for bones. She would receive injections (unspecified) for back. She had one just before Covid but has had none since. She had problems with her spine. She had inflammation of the spine. She was unable to pronounce the name. On 23Feb2021, everything went ok. She waited for 15 minutes after she received the vaccine. When she got home there was a big red spot the size of a nickel down below the injection site. It had faded. She does not recall hitting her arm. The paper that they gave her mentions redness and a rash. This was down below the injection site. The redness had gone away. It looked like a bruise that had changed back to her skin tone. She could see blotches of the redness. It was a dark color but not bruised. Her upper arm felt heavy and tight. She did not have history of previous immunization with the Pfizer vaccine considered as suspect or additional Vaccines Administered on Same Date of the Pfizer Suspect. Events did not require to visit Emergency Room/ Physician Office. She did not receive prior vaccinations (within 4 weeks) and no relevant tests were performed. Outcome of the event of redness below injection site was recovering, however outcome of the event of upper arm at injection site feels heavy and tight was unknown.    No other information was reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Swollen lymph node near breast on same side as injection; Low fever (100.2); Headache; Nausea; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:30 (at the age of 33 years old) as 2nd dose, single for COVID-19 immunization. Medical history included anxiety from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE), desogestrel, ethinylestradiol (KARIVA), colecalciferol (D3), cyanocobalamin (B12 [CYANOCOBALAMIN]), fluoxetine hydrochloride (PROZAC), Welbutrin, L-Met. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 01:00 PM as 1st dose, single for COVID-19 immunization. On 23Feb2021 12:00, after 24 hours of shot, the patient experienced low fever (100.2), headache, nausea and after 36 hours of shot, swollen lymph node near breast on same side as injection on 24Feb2021. The patient did not receive any treatment for the events.The patient underwent lab tests and procedures which included body temperature: 100.2 on 23Feb2021. The clinical outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, Decreased appetite, Dehydration, Dizziness
Clinical narrative: gas; balance problems; dizziness; sensitivity to being enclosed inside warm rooms (above 66 degrees); sleeplessness; anxiety; inability to sit still; dehydration; loss of appetite; frequent urination; sensitivity to noise; This is a spontaneous report from a contactable consumer. A 83-years-old non pregnant female pa-tient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN9263, Expiration date: Unknown), dose 1 via an unspecified route of administration, in right arm on 05Feb2021 at 14:30 (at the age of 83-years-old) as single dose for COVID-19 immun-isation and the patient received second dose of BNT162B2 (Solution for injection, Lot Number: EL6203, Expiration date: Unknown), via an unspecified route of administration, in right arm on 25Feb2021 at 11:15 AM (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient medical history included arthritis and spinal stenosis. The Patient received concomitant medications in two weeks which included phytosterols nos and chondroitin sulfate sodium, glucosa-mine hydrochloride, multi-vitamins. Patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient had no known allergies. The patient had experienced gas, balance problems, dizziness, sensitivity to being enclosed inside warm rooms (above 66 degrees), sleeplessness, anxiety, inability to sit still, dehydration, loss of appetite, frequent urination and sensitivity to noise on 06Feb2021 at 19:00. There has not been any pain at the injection site or anywhere else on her body. No treatment received for events. The patient went to physician or other healthcare professional of-fice/clinic visit, Emergency room/department or urgent care due to events. The patient underwent lab tests and procedures which included nasal swab test on 05Feb2021 and 25Feb2021 result was nega-tive. The outcome of all events was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Hyperacusis, Insomnia, Pollakiuria, SARS-CoV-1 test
Clinical narrative: gas; balance problems; dizziness; sensitivity to being enclosed inside warm rooms (above 66 degrees); sleeplessness; anxiety; inability to sit still; dehydration; loss of appetite; frequent urination; sensitivity to noise; This is a spontaneous report from a contactable consumer. A 83-years-old non pregnant female pa-tient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN9263, Expiration date: Unknown), dose 1 via an unspecified route of administration, in right arm on 05Feb2021 at 14:30 (at the age of 83-years-old) as single dose for COVID-19 immun-isation and the patient received second dose of BNT162B2 (Solution for injection, Lot Number: EL6203, Expiration date: Unknown), via an unspecified route of administration, in right arm on 25Feb2021 at 11:15 AM (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient medical history included arthritis and spinal stenosis. The Patient received concomitant medications in two weeks which included phytosterols nos and chondroitin sulfate sodium, glucosa-mine hydrochloride, multi-vitamins. Patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient had no known allergies. The patient had experienced gas, balance problems, dizziness, sensitivity to being enclosed inside warm rooms (above 66 degrees), sleeplessness, anxiety, inability to sit still, dehydration, loss of appetite, frequent urination and sensitivity to noise on 06Feb2021 at 19:00. There has not been any pain at the injection site or anywhere else on her body. No treatment received for events. The patient went to physician or other healthcare professional of-fice/clinic visit, Emergency room/department or urgent care due to events. The patient underwent lab tests and procedures which included nasal swab test on 05Feb2021 and 25Feb2021 result was nega-tive. The outcome of all events was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitivity to weather change, Sitting disability
Clinical narrative: gas; balance problems; dizziness; sensitivity to being enclosed inside warm rooms (above 66 degrees); sleeplessness; anxiety; inability to sit still; dehydration; loss of appetite; frequent urination; sensitivity to noise; This is a spontaneous report from a contactable consumer. A 83-years-old non pregnant female pa-tient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN9263, Expiration date: Unknown), dose 1 via an unspecified route of administration, in right arm on 05Feb2021 at 14:30 (at the age of 83-years-old) as single dose for COVID-19 immun-isation and the patient received second dose of BNT162B2 (Solution for injection, Lot Number: EL6203, Expiration date: Unknown), via an unspecified route of administration, in right arm on 25Feb2021 at 11:15 AM (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient medical history included arthritis and spinal stenosis. The Patient received concomitant medications in two weeks which included phytosterols nos and chondroitin sulfate sodium, glucosa-mine hydrochloride, multi-vitamins. Patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient had no known allergies. The patient had experienced gas, balance problems, dizziness, sensitivity to being enclosed inside warm rooms (above 66 degrees), sleeplessness, anxiety, inability to sit still, dehydration, loss of appetite, frequent urination and sensitivity to noise on 06Feb2021 at 19:00. There has not been any pain at the injection site or anywhere else on her body. No treatment received for events. The patient went to physician or other healthcare professional of-fice/clinic visit, Emergency room/department or urgent care due to events. The patient underwent lab tests and procedures which included nasal swab test on 05Feb2021 and 25Feb2021 result was nega-tive. The outcome of all events was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness
Clinical narrative: Chills; flu-like feeling; This is a spontaneous report from a contactable consumer (reported for himself). A 60-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot unknown: Not available), dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 15:00 as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included eosinophilic granulomatosis with polyangiitis from an unknown date and unknown if ongoing.  Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) via Resp Inhalation route, montelukast, fexofenadine hydrochloride (ALLEGRA) and mepolizumab (NUCALA) taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccine in four weeks. Patient dont have covid prior vaccination. patient had not performed any covid tested post vaccination. Patient had no known allergies.The patient experienced chills and flu-like feeling on 02Mar2021 01:00. Patient had not received any treatment for the events reported. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: blood pressure was 174/106/blood pressure shot up to 198/116/blood pressure shot up to 175/106; 93 pulse/99 pulse/109 pulse; This is a spontaneous report from a contactable consumer, the patient. A 76-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration, administered in right arm on 21Feb2021 16:00 (at the age of 76-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration, administered in right arm on 31Jan2021 16:00 (at the age of 76-years-old) as a single dose for covid-19 immunization. Medical history included, blood pressure abnormal, blood cholesterol abnormal (was on blood pressure medication for many years; after losing 20 pounds did not need it anymore; take Crestor 10mg for cholesterol (total around 160)) and had allergy with rubber (latex band aids). Concomitant medication(s) included vitamin d3; rosuvastatin calcium (CRESTOR). On 21Feb2021 16:30, the patient reported about 1-2 minutes after receiving 2nd shot on 21Feb2021 "I could feel a reaction. I waited 30 minutes before leaving to make sure it wasn't anaphylaxis. When I got home my blood pressure was 174/106/93 pulse. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Feb2021 blood pressure shot up to 198/116/99 pulse. On 01Mar2021 blood pressure shot up to 175/106/109 pulse. After the first shot, the patient had slight rise in blood pressure and pulse after about 5 days but otherwise just felt tired". The patient recevied treatment with benicar 40 mg and lorazepam 5 mg, zicam. Outcome of the event was recovered with sequelae (recovered with lasting effects).   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Myalgia
Clinical narrative: Chills; joint pain; muscle aches; diarrhea; extreme fatigue; This is a spontaneous report from a contactable (Patient, self-reported). A 33-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration in Arm Left on 01Mar2021 12:00 (33-years-old, non pregnant at the time of vaccination), as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. It was reported that the patient received dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 14:00 as 1ST DOSE, SINGLE for covid-19 immunization. On 02Mar2021 04:00, the patient experienced chills, joint pain, muscle aches, diarrhea and extreme fatigue. Patient did not received treatment for an adverse events. Outcome of the events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: severe dizziness; fog fines; This is a spontaneous report from a contactable consumer (patient) via sponsored program. A 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203 and expiration date: not reported) via an unspecified route of administration, administered in arm right on 27Feb2021 12:30 as second dose, single for COVID-19 immunization at Public Health Clinic (at the age of 43years). The patient medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported and BIRTH CONTROL (both as other medications in two weeks). Previously, received PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot Number: EL9264 and expiration date: not reported) via an unspecified route of administration, administered in arm right on 06-FEB-2021 13:45 as first dose, single dose for COVID-19 immunization at Public Health Clinic (at the age of 43years). No other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. On 28Feb2021 02:15, the patient experienced severe dizziness and fog fines. The patient was on day 3 post second covid vaccine and continued to have severe dizziness and fog fines. Both adverse events resulted in Doctor or other healthcare professional office/clinic visit and no treatment was given for these. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Pain, Pain in extremity
Clinical narrative: right upper arm was really sore; my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk; my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk; my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk; This is a spontaneous report from a contactable consumer or other non hcp.     A 52-years-old non-pregnant female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Batch/Lot Number: EN6202), via an unspecified route of administration, administered on Arm Right on 26Feb2021 11:30 (age at vaccination: 52 years) at single for covid-19 immunisation. The patient medical history included COPD/Asthma and had allergies(drug hypersensitivity) to Floxin that is used in antibotics. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. Medical history included chronic obstructive pulmonary disease. Concomitant medications in two weeks included apixaban (ELIQUIS), levothyroxine sodium (SYNTHROID) taken for an unspecified indication. On 27Feb2021 04:00 ,the patient experienced, right upper arm was really sore which was to be expected, but my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk and still pretty sore and it has been 4 days now. The patient did not receive any treatment for the events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain, Pyrexia
Clinical narrative: fever; sick to stomach; diarrhea; achy; This is a spontaneous report received from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown, whether the patient was pregnant at the time of vaccination. It was unknown, whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine; prior to vaccination, the patient diagnosed with COVID-19 or since the vaccination, the patient been tested for COVID-19. On 02Mar2021, the patient experienced fever, sick to stomach, diarrhea, achy. It was unknown, whether the patient receive any treatment for the adverse event. Outcome of the event was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: having ringing in her ears; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 22Feb2021 11:30 as 2nd dose, single for covid-19 immunisation.  Medical history included occasional vertigo on and off, for the past 5-6 years. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Right on 26Jan2021 as 1st dose, single for covid-19 immunization. On 01Mar2021, the patient experienced ringing in her ears which never had that before. Patient said it was annoying but that is the only bad part about it. Patient had no intention to go to her doctor for treatment. She had not visited to emergency room and physician office. Prior Vaccinations (within 4 weeks) was reported as none.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Dyspepsia, Gastrooesophageal reflux disease, Hypoaesthesia
Clinical narrative: right arm/hand felt very tingly and numb briefly; right arm/hand felt very tingly and numb briefly; felt some chest discomfort; Gerd; indigestion; I had diarrhea; This is a spontaneous report from a contactable Other-HCP. This 50-year-old (non-pregnant) female other-HCP reported for herself that she received bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EM9810), dose 1 via an unspecified route of administration, administered in Arm Right on 13Feb2021 11:30 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included asthma, rubber sensitivity and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included tetanus vaccine taken for an unspecified indication as tetanus (vaccine 4 week/1 day prior) and Vitamins NOS for an unspecified indication start and stop date were not reported. Patient don't have covid prior vaccination. The patient experienced felt some chest discomfort, Gerd (gastrooesophageal reflux disease), indigestion and i had diarrhea on 13Feb2021 13:30 and right arm/hand felt very tingly and numb briefly on 17Feb2021. Reported as when I initially had the vaccine, I felt some chest discomfort that later felt like Gerd/indigestion. Then 2 hours later and several times throughout day I had diarrhea. 3 days after my right arm/hand felt very tingly and numb briefly. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 01Mar2021, sars-cov-2 test: unknown result on 01Mar2021. Patient had not received any treatment for the events reported. The outcome of the events was resolved on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: right arm/hand felt very tingly and numb briefly; right arm/hand felt very tingly and numb briefly; felt some chest discomfort; Gerd; indigestion; I had diarrhea; This is a spontaneous report from a contactable Other-HCP. This 50-year-old (non-pregnant) female other-HCP reported for herself that she received bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EM9810), dose 1 via an unspecified route of administration, administered in Arm Right on 13Feb2021 11:30 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included asthma, rubber sensitivity and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included tetanus vaccine taken for an unspecified indication as tetanus (vaccine 4 week/1 day prior) and Vitamins NOS for an unspecified indication start and stop date were not reported. Patient don't have covid prior vaccination. The patient experienced felt some chest discomfort, Gerd (gastrooesophageal reflux disease), indigestion and i had diarrhea on 13Feb2021 13:30 and right arm/hand felt very tingly and numb briefly on 17Feb2021. Reported as when I initially had the vaccine, I felt some chest discomfort that later felt like Gerd/indigestion. Then 2 hours later and several times throughout day I had diarrhea. 3 days after my right arm/hand felt very tingly and numb briefly. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 01Mar2021, sars-cov-2 test: unknown result on 01Mar2021. Patient had not received any treatment for the events reported. The outcome of the events was resolved on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hepatic pain, Pain in extremity
Clinical narrative: Liver is very painful; Diarrhea; arm pain; This is a spontaneous report from a contactable nurse (patient). A 37-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: unknown), via an unspecified route of administration on 09Feb2021 at 09:00 am in right arm as a single dose for covid-19 immunization Workplace clinic. The patient's medical history included allergy to tetracycline. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. No covid prior vaccination. Since the vaccination, patient had not been tested for covid-19. On 14Feb2021 at 08:00, the patient experienced Diarrhoea, arm pain. The patient stated that her liver was very painful. The patient had a physician office visit due to the events. It was unknown whether the patient was treated for the events. The outcome of the events was not resolved.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Lymphadenopathy
Clinical narrative: major swelling of lymph glands in neck jaw/continue to have minor swelling of one lymph gland on my left clavicle; patient had a maximum temperature of 101; This is a spontaneous report from a contactable Other Healthcare Professional (nurse). A 46-years-old non-pregnant female patient reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER9231), via an intramuscular route of administration, administered in left arm on 06Jan2021 08:00 (at the time of 46-year-old) at single dose for COVID-19 immunization. The patient medical history included known allergies: shellfish. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medication within 2 weeks. Facility type vaccine was Hospital. Prior to vaccination, the patient had not Covid. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received the first dose of bnt162b2 (COVID-19), on an unspecified date for COVID-19 immunization. On 07Jan2021 07:00 after the second dose vaccination, the patient experienced major swelling of lymph glands in neck jaw/continue to have minor swelling of one lymph gland on my left clavicle patient had a maximum temperature of 101. It was reported that the first week patient had a maximum temperature of 101 and major swelling of lymph glands in neck jaw. Patient continue to have minor swelling of one lymph gland on my left clavicle 8 weeks post second vaccine. The patient underwent lab tests and procedures which included body temperature increased: 101 (the first week I had a max temp of 101) on 07Jan2021. The patient did not received any treatment for events. The outcome of events was resolved with sequel.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Agitation, Eye pruritus, Fatigue, Flushing
Clinical narrative: Tired; Stomach ache; eyes were itching; itchy throat; flushing; itching; ears were hot to touch; agitation; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female non pregnant patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: en6203), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:00 (at the time of 66-years-old), as first dose, single, for covid-19 immunisation. Medical history included high bp (blood pressure) and known allergies to codine, latex, morphine, penicillin. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. The patient previously took cortisone, hydrocodone, morphine and had allergies. Concomitant medications included lisinopril at 5mg; colecalciferol (VITAMIN D, strength: 10000 IU) at 10000 iU; fish oil; curcuma longa (TURMERIC). It was reported that 24 hours after the injection patient had flushing, itching, agitation, itchy throat, my ears were hot to touch and very itchy, my eyes were itching as well on 23Fe2021 14:00. I took allergy medicine, day three horrible stomach ache (25Feb2021), not flu-like it was the pain associated with past allergic reactions to pain meds. The patient did not feel the need to throw up the fourth day was just tired (26Feb2021). Therapeutic measures were taken as a result of itchy throat, flushing, itching, ears were hot to touch, agitation, eyes were itching. The outcome of the events was resolved.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Throat irritation
Clinical narrative: Tired; Stomach ache; eyes were itching; itchy throat; flushing; itching; ears were hot to touch; agitation; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female non pregnant patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: en6203), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:00 (at the time of 66-years-old), as first dose, single, for covid-19 immunisation. Medical history included high bp (blood pressure) and known allergies to codine, latex, morphine, penicillin. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. The patient previously took cortisone, hydrocodone, morphine and had allergies. Concomitant medications included lisinopril at 5mg; colecalciferol (VITAMIN D, strength: 10000 IU) at 10000 iU; fish oil; curcuma longa (TURMERIC). It was reported that 24 hours after the injection patient had flushing, itching, agitation, itchy throat, my ears were hot to touch and very itchy, my eyes were itching as well on 23Fe2021 14:00. I took allergy medicine, day three horrible stomach ache (25Feb2021), not flu-like it was the pain associated with past allergic reactions to pain meds. The patient did not feel the need to throw up the fourth day was just tired (26Feb2021). Therapeutic measures were taken as a result of itchy throat, flushing, itching, ears were hot to touch, agitation, eyes were itching. The outcome of the events was resolved.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Pain
Clinical narrative: painful shoulder/vaccine worsened her shoulder pain and caused fatigue/pain is 9 out of 10; painful shoulder/vaccine worsened her shoulder pain and caused fatigue/pain is 9 out of 10; Painful shoulder/vaccine worsened her shoulder pain and caused fatigue/pain is 9 out of 10; This is a spontaneous report from a contactable consumer, the patient. A 67 age (unit- not specified) female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 11Feb2021 (as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a painful shoulder condition and was due to surgery one week after the second dose. Caller states she thinks the vaccine worsened her shoulder pain and caused fatigue. Caller states pain was 9 out of 10. Caller wants to know what is Pfizer saying about taking pain medications. Caller does not want to reduce the efficacy of the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Caller states that she got home and felt so cold; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 01Mar2021 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that received the first dose of the Covid vaccine yesterday and reports that she felt fine, took Tylenol and was working after the shot. Caller states that she got home and felt so cold on Mar2021. Patient reported that when she went to go to bed, she could not explain. The outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: chills; headache; nausea; This is a spontaneous report from a contactable consumer or other non hcp.     A 68-years-old female patient received first dose 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 (age at vaccination: 68 years) at single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. She received the second dose of the Covid 19 vaccine on 23Feb. On February 24th, she felt a twisting in her entire abdomen, lasted 25 minutes, it was awfully painful, but went away. She went to the ER, her lipids were elevated, they told her that it may be a side effect of the vaccine. She also had shoulder pain, bicep pain and headache. On 01Mar 2021 she experienced the same abdominal pain, lasted 15 to 20 minutes, and then subsided, she went to the ER again and they couldn't find anything abnormal. She had a follow up appointment with her doctor on (March 2nd), it happened again and lasted 15 minutes then subsided. It was an entire abdominal spasm and, in the back, too. On an unspecified date, After the first dose she experienced chills, headache and nausea. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: nausea; body aches; chills; headache; tiredness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Right on 01Mar2021 11:00 as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Vyvanse. The patients historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, administered in Arm Right on 09Feb2021 11:30 AM as 1st dose, single for covid-19 immunisation. Patient previously took Amoxicillin and experienced known allergies. It was reported that patient did not had Covid prior to vaccination nor been COVID tested post vaccination. On 02Mar2021, the patient experienced nausea, body aches, chills, headache and tiredness. Patient was not received any treatment for the events. The outcome of the events was reported as unknown. No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Depressed mood, Dizziness, Headache, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6198; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 24 Feb 2021 (at the time of 75-years-old), as first dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included unspecified product. The patient stated that he received the first dose of the Pfizer COVID vaccine on 24Feb2021. Caller states he initially had no side effects the first fifteen minutes after receiving the vaccine. Caller states a few days later on that Saturday he experienced dizziness, nausea, major aches, weakness all over the body and pains and headache (27Feb2021). He did not feel safe driving and he just felt down for the day. Caller states on Sunday he felt a little better but still had some nausea, headache and aches. Caller states he read the paperwork and thinks his symptoms were in the realm of normal. Caller would like to know if he was correct. He read that after the second shot the side effects were more severe and he would like to know if this was correct. He was actually in bed all night, was afraid to drive and was afraid to do anything. He was actually in bed all night, was afraid to drive and was afraid to do anything so, just took a day off and stayed at bed mostly, following day the Sunday felt much better and the following week, which was basically this week feel better, feel fine. Also asking should expect that his second question was could possibly be contagious being around someone else. The patient stated that stopped having these problems. The outcome of the events was resolved on 2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6198; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 24 Feb 2021 (at the time of 75-years-old), as first dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included unspecified product. The patient stated that he received the first dose of the Pfizer COVID vaccine on 24Feb2021. Caller states he initially had no side effects the first fifteen minutes after receiving the vaccine. Caller states a few days later on that Saturday he experienced dizziness, nausea, major aches, weakness all over the body and pains and headache (27Feb2021). He did not feel safe driving and he just felt down for the day. Caller states on Sunday he felt a little better but still had some nausea, headache and aches. Caller states he read the paperwork and thinks his symptoms were in the realm of normal. Caller would like to know if he was correct. He read that after the second shot the side effects were more severe and he would like to know if this was correct. He was actually in bed all night, was afraid to drive and was afraid to do anything. He was actually in bed all night, was afraid to drive and was afraid to do anything so, just took a day off and stayed at bed mostly, following day the Sunday felt much better and the following week, which was basically this week feel better, feel fine. Also asking should expect that his second question was could possibly be contagious being around someone else. The patient stated that stopped having these problems. The outcome of the events was resolved on 2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained.