chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: chills; With 2nd shot in series, I have large swollen, painful lymph nodes in my neck/collarbone and under arm.  Additionally, I had body aches and chills.; I had body aches; This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 25May2021 at 11:30 as dose 2, single (at the age of 39-years-old) for COVID-19 immunization at Pharmacy or Drug Store. Medical history included known allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19, and not received any other vaccines within 4 weeks. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included Escitalopram and Metoprolol within two weeks. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0170) via an unspecified route of administration, administered in left arm on 28Apr2021 at 02:30 as dose 1, single (at the age of 39-years-old) for COVID-19 immunization. On 26May2021 at 14:00, after 2nd vaccination, the patient experienced chills, large swollen, painful lymph nodes in my neck/collarbone and under arm and also had body aches. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 17May2021. No treatment received for adverse event. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: Shingles left lower abd. 2 cold sores on face; Shingles left lower abd. 2 cold sores on face; This is a spontaneous report from a contactable Nurse (Patient). A 46-year-old non pregnant female patient received BNT162B2 (PFIZER-BIOTECH COID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Right on 14May2021 (age at vaccination 46-year-old) 12:15 as single dose for covid-19 immunization. Medical history included known allergies PCN, Sulfa, ongoing eosinophilic oesophagitis (EoE), allergies, The patient had covid-19 prior to vaccination. Concomitant medication included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) at 80 mg daily taken for EoE. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 12:00 the patient experienced shingles left lower and, 2 cold sores on face. Since the vaccination, patient was not been tested for COVID-19. Therapeutic measures were taken as a result of the events with Acyclovir. The outcome for the evens was reported as recovering.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Localised infection, Nail disorder
Clinical narrative: Horrible infection in my thumb; losing my thumb nail; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 07Apr2021 (Batch/Lot Number: EP6955, at 60 years old) as DOSE 1, SINGLE for covid-19 immunisation. No Medical history. No concomitant medications. On 07Apr2021, patient got a horrible infection in his thumb had to see doctor and have drained. The first infection was in his right thumb and patient is still losing his thumb nail. The outcome of the events was recovering. 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 has not been tested for COVID-19. No Known Allergies. Vaccination facility information available. Device Date: 29May2021. Treatment: Yes; Drain infection prescribed sulfamethoxazole.  Follow up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: sore arm; extreme fatigue; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 12-years-old patient of unspecified gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number, expiration date were not reported) via an unspecified route of administration on un unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm, extreme fatigue, 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Joint swelling, Lip swelling, Peripheral swelling, Swelling face
Clinical narrative: Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; This is a spontaneous report from a contactable consumer.  A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0177), dose 1 via an unspecified route of administration, administered in left arm on 30May2021 at 12:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. Medical history included orange allergy. The patient was not pregnant at the time of vaccination. The patient had not been tested for COVID-19 nor before neither since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. No concomitant medications was reported. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced swollen eyes, face, lips, hands, left leg and ankle on 30May2021 at 17:00. Treatment include Benadryl. The outcome of the events were not recovered.   Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Feeling abnormal, Nausea, Vertigo, Vomiting
Clinical narrative: Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; This is a spontaneous report received from a contactable consumer (patient himself). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: Ew0164) via an unspecified route of administration in left arm on 05May2021 10:00 for COVID-19 immunization. Patient medical history included High blood pressure and acid reflux. Concomitant medications included amlodipine besilate, benazepril hydrochloride (LOTREL) and esomeprazole magnesium (NEXIUM) 40mg. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE and lot number: Ew0164) administered in left arm on 01May2021 10:00 for COVID-19 immunization. On 29May2021 06:00 patient was experienced with Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting. Patient was went to physician office/clinic visit, Emergency room/department or urgent care. Patient was treated with Steroid shot and prednisone 50mg from urgent care. Outcome of events was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes zoster
Clinical narrative: Developed shingles; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient (pregnant: no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0168), dose 2 via an unspecified route of administration, administered in arm right on 11May2021 12:00 (age at vaccination: 62-years-old and pregnancy at vaccination: no) as dose 2, single for covid-19 immunisation. Medical history included osteoporosis and the patient was allergic to penicillin. The patient previously took with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), dose 1 via an unspecified route of administration, administered in arm right on 20Apr2021 at 11:30 AM (age at vaccination: 62-years-old) as dose 1, single for covid-19 immunisation. The patient's concomitant medications included alendronate sodium (FOSAMAX). On 14May2021 at 12:00, the patient developed shingles 3 days of the second vaccination. The patient read a report that states that 1% of the patients that received MRN vaccine were developing shingles. The patient was received treatment with anti viral and nerve support medications for the event of shingles. The patient did not receive any other vaccine within 4 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of the event was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pyrexia, Sleep disorder
Clinical narrative: Developed fever up to 102; On the next day after my second shot I started to feel weakness; However I still have some sleeping problems; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 21May2021 at 10:45 AM (vaccinated at the age of 42 years) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19, prior to vaccination. The most recent COVID-19 vaccine was administered at hospital. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date (vaccinated at the age of 42 years) as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, next day after the shot patient felt weakness, developed fever up to 102 but the day after that, she came to normal (however she still had some sleeping problems). The case was reported as non-serious. The outcome of all events was recovering.  Device Date : 31May2021  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Product use issue, SARS-CoV-2 test
Clinical narrative: Shortness of breath and mild chest pain; Shortness of breath and mild chest pain; other vaccine same date details; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:30 (Batch/Lot Number: ER8735) (at the age of 34 years old) and dose 2 via an unspecified route of administration, administered in Arm Left on 17Apr2021 (Batch/Lot Number: EW0170) (at the age of 34 years old) as single for COVID-19 immunization. The patient's medical history included high blood pressure, myocarditis. The patient had no known allergies. The patient did not have COVID-19 prior vaccination. The patient did not test for COVID-19 post vaccination. The patient's concomitant medication included amlodipine besilate (AMLODIPINE BESILATE), valsartan (VALSARTAN), hydrochlorothiazide (HYDROCHLOROTHIAZIDE) all taken for an unspecified indication, start and stop date were not reported. On 13May2021 at 07:00, the patient experienced shortness of breath and mild chest pain. The AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received unspecified steroids as treatment medication for the lungs. On 18May2021, the patient underwent nasal swab test which shown negative result. The patient was not recovered from the events.  No follow up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the left arm on 19Apr2021 13:30 (batch/lot number ER8729 and expiry date unknown) at 63 years of age as dose 2, single for covid-19 immunization administered in a clinic ( health clinic/ facility). The patient medical history and concomitant medications were none. The patient previously received dose 1 of BNT162B2, intramuscular, administered in the left arm on 29Mar2021 13:00 (batch/lot number ER8732) at 63 years of age for covid-19 immunization. On 16May2021, the patient experienced shingles. The patient informed that he didn't know if the company has any history of this, but he got his second COVID-19 shot and he got shingles after that. The event required visit to emergency room. The event was reported serious as an important medical event. The patient received treatment of acyclovir, gabapentin due to the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Herpes zoster
Clinical narrative: 2.5 weeks after first shot developed Shingles.; cellulitis; This is a spontaneous report from a contactable other-health care professional (Patient). A 45-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0162 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 21Apr2021 15:45 (at the age of 45 years) as single for covid-19 immunisation. Medical history included HTN and asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included candesartan taken for an unspecified indication, start and stop date were not reported. Patient had known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 08May2021 the patient experienced shingles 2.5 weeks after first shot and cellulitis. The adverse event result in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. Patient received Valtrex and antibiotics for cellulitis. The outcome of the events was recovered on unspecified date of 2021.   Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (Patient). A 60-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 (age at the time 60-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: FN6205) via an unspecified route of administration in the left arm on 09Mar2021 (age at the time 60-year-old) as dose 1, single for covid-19 immunisation. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination reported as some. On 14Apr2021, the patient experienced shingles. The patient visited the doctor or other healthcare professional office/clinic visit for the adverse event. Therapeutic measures were taken as a result of shingles. The outcome of the event was not recovered.  Follow-up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: Changes in menstrual cycle - the period wasn't supposed to start for another 7-10 days but it started on 31May2021; Two days after my 2nd vaccination and heavier flows noticed as well; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ENOM) via an unspecified route of administration, administered in Left arm on 29May2021 at 15:00 as Dose 2,Single for COVID-19 immunization. The patient's medical history included none. Other Medical history- No.Concomitant medications(received within 2 weeks of vaccination) included amoxicillin (AMOXICILLIN) taken for an unspecified indication from 29May2021 to an unspecified stop date. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient hasn't been tested for COVID-19. On 31May2021 at 16:00,the patient experienced changes in menstrual cycle - the period wasn't supposed to start for another 7-10 days but it started two days after my 2nd vaccination and heavier flows noticed as well. No treatment was received. No prolonged hospitalization. The outcome for the events was Unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Vaccination site pain
Clinical narrative: Tingling and numbness of tongue about 2 hrs after injection; Tingling and numbness of tongue about 2 hrs after injection; Soreness at site of injection for 1 day; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection), via an unknown route of administration on 28Jan2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tingling and numbness of tongue about 2hrs after injection and soreness at site of injection for 1 day on 28Jan2021. The outcome of the event tingling and numbness of tongue about 2hrs after injection was recovered on 28Jan2021 and soreness at site of injection for 1 day was recovered on 29Jan2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear discomfort, Ear disorder, Ear infection, Fatigue
Clinical narrative: fatigue; chills; malaise; began to experience symptoms consistent with a sinus infection (nasal congestion, headache, runny nose, cough, sore throat); ears filled with fluid; ear is still feeling clogged; hearing in the left ear is impaired; ear infection in the left ear; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0182), via an unspecified route of administration, administered in the right arm on May2021 (also reported as '18Apr2021'), dose 2, single for COVID-19 immunization.  Medical history included allergy to sulfa antibiotics and asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number: EW0170, expiry date unknown) on 18Apr2021 (at 35-years-old) at 14:30 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. On 10May2021 at 08:00, approximately 18 hours after the second shot, the patient began to experience fatigue, chills and malaise lasting for approximately 8 hours.  Following those 8 hours, the patient's initial symptoms eased and were gone within 36 hours after the shot on an unspecified date in May2021.  However, around the same point, on an unknown date in May2021, the patient began to experience symptoms consistent with a sinus infection (nasal congestion, headache, runny nose, cough, sore throat). The symptoms persisted for approximately 1 week.  Around day 8/9, following a trip to higher altitude, the patient's ears filled with fluid and within 12 hours she had developed an ear infection in the left ear. This was treated with steroids and a course of antibiotics (amoxicillin). A week later, approximately 18 days after the shot, the infection has cleared but her ear is still feeling clogged and her hearing in the left ear is impaired. The events resulted to a clinic visit and an emergency room or urgent care visit. The patient received antibiotics, steroids and OTC medications as treatment for the events.  The outcome of the event fatigue, chills and malaise recovered in May2021. The outcome of the events ear infection in the left ear and began to experience symptoms consistent with a sinus infection (nasal congestion, headache, runny nose, cough, sore throat) recovered with sequel in May2021. The outcome of the events ears filled with fluid, ear is still feeling clogged and hearing in the left ear is impaired recovered with sequel on an unknown date.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Malaise, Sinusitis
Clinical narrative: fatigue; chills; malaise; began to experience symptoms consistent with a sinus infection (nasal congestion, headache, runny nose, cough, sore throat); ears filled with fluid; ear is still feeling clogged; hearing in the left ear is impaired; ear infection in the left ear; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0182), via an unspecified route of administration, administered in the right arm on May2021 (also reported as '18Apr2021'), dose 2, single for COVID-19 immunization.  Medical history included allergy to sulfa antibiotics and asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number: EW0170, expiry date unknown) on 18Apr2021 (at 35-years-old) at 14:30 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. On 10May2021 at 08:00, approximately 18 hours after the second shot, the patient began to experience fatigue, chills and malaise lasting for approximately 8 hours.  Following those 8 hours, the patient's initial symptoms eased and were gone within 36 hours after the shot on an unspecified date in May2021.  However, around the same point, on an unknown date in May2021, the patient began to experience symptoms consistent with a sinus infection (nasal congestion, headache, runny nose, cough, sore throat). The symptoms persisted for approximately 1 week.  Around day 8/9, following a trip to higher altitude, the patient's ears filled with fluid and within 12 hours she had developed an ear infection in the left ear. This was treated with steroids and a course of antibiotics (amoxicillin). A week later, approximately 18 days after the shot, the infection has cleared but her ear is still feeling clogged and her hearing in the left ear is impaired. The events resulted to a clinic visit and an emergency room or urgent care visit. The patient received antibiotics, steroids and OTC medications as treatment for the events.  The outcome of the event fatigue, chills and malaise recovered in May2021. The outcome of the events ear infection in the left ear and began to experience symptoms consistent with a sinus infection (nasal congestion, headache, runny nose, cough, sore throat) recovered with sequel in May2021. The outcome of the events ears filled with fluid, ear is still feeling clogged and hearing in the left ear is impaired recovered with sequel on an unknown date.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chest scan, Chills, Fear of disease, Fibrin D dimer
Clinical narrative: 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; Doctor thought I either had a virus of some sort; elevated D Dimer test; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was sensitive to estrogen birth controls. Facility type vaccine was other. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination. Post vaccination covid tested was unknown. Reported, 9 days after first dose (4/7) sudden chills, fever followed by severe chest pain on 07Apr2021. Resulted in ER trip fearing heart event on Apr2021. continued chest pain and multiple clinic visits with Doctor/chest scan w/ contrast after elevated D Dimer test, doctor thought patient either had a virus of some sort on Apr2021 and advised not to skip her second dose of covid vaccine. Chest pain had started to subside. Treatment 2x physical therapy was received for adverse events. Adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken for all the events. The outcome of event was resolving for chest pain and for other events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Pyrexia, Viral infection
Clinical narrative: 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; Doctor thought I either had a virus of some sort; elevated D Dimer test; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was sensitive to estrogen birth controls. Facility type vaccine was other. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination. Post vaccination covid tested was unknown. Reported, 9 days after first dose (4/7) sudden chills, fever followed by severe chest pain on 07Apr2021. Resulted in ER trip fearing heart event on Apr2021. continued chest pain and multiple clinic visits with Doctor/chest scan w/ contrast after elevated D Dimer test, doctor thought patient either had a virus of some sort on Apr2021 and advised not to skip her second dose of covid vaccine. Chest pain had started to subside. Treatment 2x physical therapy was received for adverse events. Adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken for all the events. The outcome of event was resolving for chest pain and for other events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Hypoaesthesia, Hyporeflexia, Neck pain
Clinical narrative: 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; Doctor thought I either had a virus of some sort; elevated D Dimer test; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was sensitive to estrogen birth controls. Facility type vaccine was other. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination. Post vaccination covid tested was unknown. Reported, 9 days after first dose (4/7) sudden chills, fever followed by severe chest pain on 07Apr2021. Resulted in ER trip fearing heart event on Apr2021. continued chest pain and multiple clinic visits with Doctor/chest scan w/ contrast after elevated D Dimer test, doctor thought patient either had a virus of some sort on Apr2021 and advised not to skip her second dose of covid vaccine. Chest pain had started to subside. Treatment 2x physical therapy was received for adverse events. Adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken for all the events. The outcome of event was resolving for chest pain and for other events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Viral infection
Clinical narrative: 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; Doctor thought I either had a virus of some sort; elevated D Dimer test; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was sensitive to estrogen birth controls. Facility type vaccine was other. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination. Post vaccination covid tested was unknown. Reported, 9 days after first dose (4/7) sudden chills, fever followed by severe chest pain on 07Apr2021. Resulted in ER trip fearing heart event on Apr2021. continued chest pain and multiple clinic visits with Doctor/chest scan w/ contrast after elevated D Dimer test, doctor thought patient either had a virus of some sort on Apr2021 and advised not to skip her second dose of covid vaccine. Chest pain had started to subside. Treatment 2x physical therapy was received for adverse events. Adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken for all the events. The outcome of event was resolving for chest pain and for other events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Period came earlier than usual after vaccine.; Period came earlier than usual after vaccine. Very heavy.; This is a spontaneous report received from a contactable (patient). A 48-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ee0186), via an unspecified route of administration in left arm on 22Apr2021 at 15:00 (at the age of 48 years old) as single for covid-19 immunisation. Medical history included no just bipolar but have been taking tegretol and Wellbutrin over 25 years daily with no unusual side effects. Concomitant medications the patient received within 2 weeks of vaccination included carbamazepine (TEGRETOL); bupropion hydrochloride (WELLBUTRIN) have been taking over 25 years daily with no unusual side effects. 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 hasn't been tested for COVID-19. On 21May2021 at 13:00, patient experienced period came earlier than usual after vaccine. Very heavy. The outcome of the events was unknown.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Supraventricular tachycardia, Ventricular extrasystoles
Clinical narrative: I have been having frequent PVCs and some runs of SVT starting a week post my second dose of Pfizer. Some dizziness and shortness of breath.; I have been having frequent PVCs and some runs of SVT starting a week post my second dose of Pfizer. Some dizziness and shortness of breath.; I have been having frequent PVCs and some runs of SVT starting a week post my second dose of Pfizer. Some dizziness and shortness of breath.; I have been having frequent PVCs and some runs of SVT starting a week post my second dose of Pfizer. Some dizziness and shortness of breath.; This is a spontaneous report from a contactable Nurse (other hcp). A 33-years-old female patient received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: ER8279), via an unspecified route of administration, administered in Arm Left on 19Apr2021 12:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EN6208) in left arm on 17Mar2021 (at the age of 33-years-old) for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 25Apr2021, patient reported that she had been having frequent PVCs and some runs of SVT starting a week post her second dose of Pfizer. Some dizziness and shortness of breath. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event with Propranolol and further testing. 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.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Stopped menstrual cycle; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 18Mar2021 00:15 (at the age of 47-years-old) as dose number unknown, single for covid-19 immunization. Medical history included fibromyalgia, spondylolisthesis, cervicalgia, cervical spondylosis, lumbar canal stenosis, chronic constipation, insomnia from an unknown date and unknown if ongoing. Concomitant medications included cyclobenzaprine; duloxetine; linaclotide (LINZESS); losartan.  The patient previously took lyrica and experienced allergy. 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. On 18Mar2021, the patient experienced stopped menstrual cycle. The patient visited physician office for the adverse event. Therapeutic measures were taken as a result of adverse event was blood tests. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 103 degree F after her 1st dose; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient medical history, concomitant medication or past drug reaction were not reported. On an unspecified date, after first dose of vaccination, patient experienced a high fever of 103-degree F which lasted about 48-72 hours before patient got back to her normal self. Reporter asked if this was normal for her daughter as everyone in their family (blood related) got the vaccine but only her daughter had these effects. Outcome of the event was resolved on an unspecified date.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: ear pain; This is a spontaneous report from a contactable consumer reported for a female patient (sister). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took 1st shot of bnt162b2 for COVID-19 immunisation and she might experience pain in her arm but there was nothing about no ear nothing. The patient experienced ear pain on an unspecified date. The clinical course of the event was reported as her sister had her second dose of the Pfizer COVID vaccine over a month ago (did not know the date) and she had ear pain since then. Her sister's physician stated that ear pain had been reported with (university name) and a side effect of the vaccine. The reporter wanted to know if this was true and what should the patient do. The reporter stated that she herself took the Pfizer shot and she was a veteran and got it at the hospital and had no problems and her sister got hers from a drug store. The reporter stated what the doctor told her and that it was doing that was not right and that was why she was calling and a lot of people did not want to get it. The reporter stated that she went to an ear doctor and they could not find anything and then she went to her primary doctor and he found a study that found that it caused ear pain. She stated her husband also had the shot and did not have any problems. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis, Computerised tomogram, Full blood count
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable other health care professional.  A 63-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL8982), dose 2 intramuscular, administered in left upper arm on 14Jan2021 at 16:00 (at the age 63-years-old) as dose 2, single for COVID-19 immunization. Medical history included Meniere from 2019 and its ongoing. Patient had no family medical history relevant to adverse event. Historical vaccine included 1st of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284) as 1st single dose intramuscular, administered in left upper arm on 23Dec2021 at 15.00 (at the age 63-years-old) as dose 1, single for COVID-19 immunization. Patient had no prior vaccination. It was reported that, patient not had COVID-19 itself. No concomitant medication was reported. Vaccination facility type at Hospital not at other facility. The patient experienced an appendicitis and patient had no illnesses until appendicitis. Seriousness criteria include Hospitalization/ Prolongation of Hospitalization, Important medical event. Adverse event required Emergency room visit. The outcome of the event was recovering. The patient underwent lab tests and procedures which included computerized tomogram: positive, CT showed appendicitis and Full blood count: wbc 15 increased on 25May2021. Treatment include appendectomy performed on 25May2021. The outcome of the event was recovered on 25May2021.  Information about lot/batch number has been requested.  Follow-up(25Jun2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: Patient age at time of vaccination, dose 1 and 2 lot number, administration site were update. Family medical history and other medical history added. Lab data was update. Outcome of the event reported.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Appendicitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: menstrual changes; she had heavy period for several months now; This is a spontaneous report from a contactable nurse (Patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK9231, Expiration Date: Apr2021), via an unspecified route of administration on 10Jan2021 as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Lot/Batch number: EK5730, expiration: Mar2021) on 20Dec2020 for covid-19 immunization. She was wondering if there had been studies about menstrual changes or if Pfizer is getting a lot of complaint about women having menstrual changes after the Pfizer COIVD-19 vaccine. She said that after taking the two doses of the vaccine she had heavy period for several months now. She received her first dose on 20Dec2020 and second dose on 10Jan2021. She wanted to know heavy period she is experiencing is one of the side effects of the vaccine. The outcome for the events was reported as not resolved.   Follow up information requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: I have been spotting now since May 16th; I have had two menstrual periods since March 18th; This is a spontaneous report from a contactable other hcp (patient). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 06Mar2021 (Batch/Lot Number: EN6206) as dose 1, single for covid-19 immunisation and medroxyprogesterone acetate (DEPO-PROVERA, suspension for injection), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was reported as multiple. Concomitant medication included too many. The patient experienced she have had two menstrual periods on 18Mar2021, and she have been spotting now on 16May2021. The reporter stated that she had two menstrual periods since 18Mar2021. She has already applied 2 Mexican Depo Provera injections, also made by Pfizer, hoping to make it stop. She should mention she have been using these injections for about 10 years. she has been spotting now since 16May2021. She can no longer deny this is vaccine related when my sister is having similar symptoms but is not on any meds or birth control. If someone knows what she can do to make this stop she would appreciate some information as she doesn't see anything on your site. The patient was not a hospitalization prolonged. The patient did not receive any treatment for the events. the patient was not diagnosed with COVID-19 prior to vaccination and have not been tested for covid 19. The action taken in response to the event, for medroxyprogesterone acetate was unknown. The seriousness of the events was reported as non-serious. The outcome of the events was reported as not resolved.   No follow-up attempts are possible. No further information is expected.