chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Bad side effect in her lymph node right now; Little bit of sore in her arm; This is a spontaneous report from a Pfizer . A contactable consumer (patient) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 16Apr2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on unspecified date, at single dose, for COVID-19 immunization. The patient had had the 2nd shot of the vaccine on 16Apr2021. She was experiencing bad side effect in her lymph node right now but she did not stated the exact side effect. Also, patient stated that she had a little bit of sore in her arm. Other than these she did not have any symptoms. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Trigeminal neuralgia; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: er8729), via an unspecified route of administration, administered in right arm on 11Apr2021 17:30 as single dose for COVID-19 immunisation. Medical history included known allergies to shellfish, PCN (Penicillin), and iodine from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. There were no concomitant medications. The patient previously took prochlorperazine edisylate (COMPAZINE) and experienced drug allergy. On 12Apr2021, the patient has had very bad nerve issues in left side of face/ eye. She saw an eye specialist and a primary doctor and was diagnosed with Trigeminal neuralgia. The event resulted in a doctor or healthcare professional office/clinic visit. The patient has not recovered from the event.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Body temperature, Body temperature increased, Heart rate, Heart rate increased
Clinical narrative: Extremely heavy menstrual period right after vaccine.; Fast heart rate; Warm body temperature; Nausea; Bloated; Left arm pain; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) received  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported. The patient did not have COVID prior to vaccination. Concomitant medication(s) included ibuprofen taken for an unspecified indication, start and stop date were not reported; benzylpenicillin (PENICILLINE [BENZYLPENICILLIN]) taken for an unspecified indication, start and stop date were not reported.  It was reported that patient experienced "extremely heavy menstrual period right after vaccine, same day of given shot, heavy clotting, non-stop bleeding for hours", fast heart rate, warm body temperature, nausea, bloated and left arm pain on 12Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature was warm and heart rate was fast on 12Apr2021. The patient was not tested for COVID post vaccination.  Information on the lot/ batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Nausea, Pain in extremity
Clinical narrative: Extremely heavy menstrual period right after vaccine.; Fast heart rate; Warm body temperature; Nausea; Bloated; Left arm pain; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) received  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported. The patient did not have COVID prior to vaccination. Concomitant medication(s) included ibuprofen taken for an unspecified indication, start and stop date were not reported; benzylpenicillin (PENICILLINE [BENZYLPENICILLIN]) taken for an unspecified indication, start and stop date were not reported.  It was reported that patient experienced "extremely heavy menstrual period right after vaccine, same day of given shot, heavy clotting, non-stop bleeding for hours", fast heart rate, warm body temperature, nausea, bloated and left arm pain on 12Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature was warm and heart rate was fast on 12Apr2021. The patient was not tested for COVID post vaccination.  Information on the lot/ batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Investigation, Rash, SARS-CoV-2 test
Clinical narrative: Rash over entire body; This is a spontaneous report from a contactable consumer (patient). This 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Mar2021 16:30 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications were not reported.  The patient experienced rash over entire body on 20Mar2021 07:00 with outcome of not recovered. The patient was hospitalized for rash over entire body for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Apr2021 and multiple lab / blood tests on unknown date with results unknown. Therapeutic measures were taken as a result of rash over entire body included IV antibiotics.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash pruritic
Clinical narrative: Itchy rash with a few blisters all over body, but mostly on trunk front/back and left side of neck and under arms where shot was given; blisters were few and on my legs; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 16:00 (Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient didn't 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. Medical history included renal cancer, allergies to Pennicillin, sulfa drugs, codeine. Concomitant medications included zinc; cyanocobalamin (B12-VITAMIIN); ascorbic acid (VITAMIIN C); olopatadine hydrochloride (PATADAY); fluticasone propionate (ALLER FLO), all taken for an unspecified indication, start and stop date were not reported. The patient experienced Itchy rash with a few blisters all over body, but mostly on trunk front/back and left side of neck and under arms where shot was given. The blisters were few and on legs. An itchy bump appeared under left arm after 4 days and a few days later the rash was very itchy and appeared every where else. The events onset date was reported as 06Apr2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. Patient I was told to take allegra, use calamine lotion. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lethargy
Clinical narrative: Swollen lymph node in left underarm; Body ache; nausea; lethargy; chills; joint pain; tiredness; headache; This is a spontaneous report from a contactable consumer (Patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:00 (Batch/Lot Number: Unknown) at the age of 31-years-old as single dose for covid-19 immunisation. Medical history included the patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were None, the patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node in left underarm, body ache, lethargy, chills, joint pain, tiredness, headache, nausea on 20Apr2021 05:00. No treatment received for the events. Since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain
Clinical narrative: Swollen lymph node in left underarm; Body ache; nausea; lethargy; chills; joint pain; tiredness; headache; This is a spontaneous report from a contactable consumer (Patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:00 (Batch/Lot Number: Unknown) at the age of 31-years-old as single dose for covid-19 immunisation. Medical history included the patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were None, the patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node in left underarm, body ache, lethargy, chills, joint pain, tiredness, headache, nausea on 20Apr2021 05:00. No treatment received for the events. Since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: Nauseous; vomiting; fever of 101; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscularly administered in Arm Left on 19Apr2021 at 10:30 (Batch/Lot number was not reported) at the age of 32 years old as single dose for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. Concomitant medication received within 2 weeks of vaccination was methadone. The patient previously received the first dose of bnt162b2 intramuscularly on 29Mar2021 at 10:45 at the age of 32 years old in arm left for covid-19 immunisation and about 36 hours after the first dose the patient got extremely nauseous, diarrhea so bad she thought she was going to pass out. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Other. In Apr2021, about 36 hours after the second dose the patient got extremely nauseous. Second time was more vomiting and a fever of 101- this still happened 36 hours after injection (Apr2021). Treatment was not received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Two very large red, itchy rashes above and below injection site. Size about 5 inches in diameter.; Two very large red, itchy rashes above and below injection site. Size about 5 inches in diameter.; Two very large red, itchy rashes above and below injection site. Size about 5 inches in diameter.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were was not reported), via an unspecified route of administration in left arm on an 12Apr2021 at 18:30 (age at vaccination was 68-year-old) as a single dose for COVID-19 immunization. Patient was unable to locate or read the details of lot number. Patient took historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were was not reported), via an unspecified route of administration in right arm on an 22Mar2021 at 14:00 as a single dose for COVID-19 immunization. The patient had a medical history of Rheumatoid Arthritis, Diverticulosis, Osteo Arthritis, and allergy to Penicillin and Septra. Patient took other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and patient has not been tested for COVID-19 since the vaccination. On 21Apr2021 at 14:00 patient experienced two very large red, itchy rashes above and below injection site. Size about 5 inches in diameter. No treatment was received for adverse event. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pyrexia, Vaccination site nodule
Clinical narrative: caught a fever but got past that; I developed a knot up on my left arm where I got the shot.; developed a knot under his arm and his arm is sore, like the lymph node is inflamed; reported that his whole arm was sore, but now it is just right under the armpit like a lymph node or cyst.; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left as single dose on 16Apr2021 11:30 for COVID-19 immunization. The patients medical history included unspecified blood pressure condition diagnosed probably 10 years ago and is ongoing. The patients concomitant medication included losartan (LOSARTAN, unspecified formulation) 50 mg once daily taken for blood pressure and is ongoing. Complained that they does not have the product with them at the time of call. Patient had not received any vaccines within 4 weeks. On 18Apr2021, the patient experienced fever, developed a knot up on his left arm where he got the shot and experienced a knot under his arm like the lymph node is inflamed. He reported that his whole arm was sore, but now it is just right under the armpit like a lymph node or cyst. Treatment medication for pain in arm included Tylenol. The outcome for all the events was reported as recovering. The seriousness of all the events was unspecified.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Kindly review the events coded, seriousness and listedness.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Paraesthesia
Clinical narrative: stomach cramps; Tingling in hands; This is a spontaneous report from a non-contactable consumer. A 79-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 27Feb2021 10:00 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Patient received the first dose of vaccine intramuscular on 06Feb2021 10:00 (Batch/Lot Number: EM9810) for covid-19 immunization, and experienced numbness in hands/arms, excruciating cramps in stomach. Medical history included ongoing diabetes, ongoing high blood pressure (BP), ongoing high cholesterol. None concomitant medication. The patient experienced stomach cramps on 03Mar2021 AM with outcome of unknown, it required visit to Physician Office, doctor stated lack of H2O but didn't receive treatment. Patient also experienced tingling in hands on 03Mar2021 with outcome of unknown. The events were reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Oral pain, Vaccination site pain
Clinical narrative: cold sores every week on my mouth; continual Zoster outbreaks; my childhood shingles site reactivated with burning pain/injection spot on right deltoid still has a sore spot in the center; This is a spontaneous report from a contactable nurse (patient herself). A 49-years-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 22Dec2020 at 15:00 (at the age of 49-year-old) as SINGLE DOSE in Arm Right for covid-19 immunization. Medical history included asthma since childhood (well controlled without meds). Allergies to medications, food, or other products: reported as many things, not foods. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination reported as none. Prior to the vaccination the patient was not diagnosed with COVID-19. On 05Jan2021 (approximately 2 weeks after the injection), the patient experienced childhood shingles site reactivated with burning pain and had cold sores every week on mouth since then (going on 4 months). This is very unusual for her and had no immunity issues normally. Whenever she had a cold sore, it was in the same location and lasted about a week, then could be gone for years. These are on other areas than usual and keep reappearing week after week, sometimes in new areas. The burning sensation at the old site (right lateral upper ribs) keeps coming and going as well without any blisters-just the burning sensation. The patient's injection spot on right deltoid still has a sore spot in the center, but ignorable most of the time. She was mainly concerned about these continual Zoster outbreaks. Nothing else was changed-not diet, sleep, stress, etc. So, this is extremely strange for her. Acyclovir ointment is not helping, which is also very unusual. The patient did not receive any treatment received for the adverse events. Since the vaccination the patient was not diagnosed with COVID-19. The outcome of the event cold sores every week on my mouth and continual zoster outbreaks was unknown and not recovered for other event.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Photosensitivity reaction, Urticaria
Clinical narrative: out in the sun and broke out in hives; pain in her back; a headache; out in the sun and broke out in hives; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's concomitant medications and medical history were not reported. It was reported that, on an unknown date, her friend got the second shot and two days later was out in the sun and broke out in hives and took benadryl and it went away but every time she is in the sun she broke out in hives. It was also reported that, when the hives come out it gives her an adrenaline rush, pain in her back and a headache. Her friend was driving in her car and the sun hitting her hands and forearms made her break out in hives and she had to turn around and go home and her friend has had photosensitivity for at least four weeks. Also enquired that, how long the photosensitivity will last. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Rash erythematous, Skin irritation
Clinical narrative: Severe rash on the face and neck. It looks severe skin irritation, redness and inflammation.; Severe rash on the face and neck. It looks severe skin irritation, redness and inflammation.; Severe rash on the face and neck. It looks severe skin irritation, redness and inflammation.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in left arm on 13Apr2021 (Lot Number: ER7533) as single dose for covid-19 immunisation. Medical history included Controlled arterial hypertension, NSAIDs allergy. Concomitant medications included Amlodipine, Vitamins C and D, Magnesium. The patient previously received the first dose of bnt162b2, at the age of 65-year-old, via an unspecified route of administration, administered in left arm on 23Mar2021 13:00 (Lot Number: ER 8730) as single dose for covid-19 immunisation. The patient experienced severe rash on the face and neck. It looks severe skin irritation, redness and inflammation. No treatment received. No pregnant at the time of vaccination. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Pain
Clinical narrative: A female patient received bnt162b2 (reported as Covid-19 Vaccine), dose 2 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Non-vaccine suspect product included etanercept (ENBREL), via an unspecified route of administration from an unspecified date (Batch/Lot Number: 1123166; Expiration Date: 31Aug2023) to an unspecified date, at unspecified dose for ankylosing spondylitis. Medical history included ongoing ankylosing spondylitis and ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. Historical vaccine included receiving the first dose of Covid-19 Vaccine for COVID-19 immunisation on unknown date. With the first COVID vaccine she stated she was very tired and fatigued, her arm hurt, and she had a headache. The patient stated the second day after the vaccine, she felt even worse. On 12Apr2021, the patient received her second vaccine and stated her arm never got sore but she had a bad headache, felt a little achy and fatigued but she was not sure if that was from the vaccine or not taking her Enbrel. The patient Enbrel was due days ago. The patient was informed by one of her physicians that the COVID vaccine would not be as effective due to her immune disorder. The patient asked if there was any information pertaining to when she should take her next Enbrel dose following her vaccination. The action taken in response to the events for etanercept was post-therapy. The outcome of events was unknown.  Pfizer is a marketing authorization holder of Covid-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Covid-19 Vaccine has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular
Clinical narrative: rash on her legs. She had (1) rash on each leg, on her thighs, on the outer parts of her thighs; rash on her legs. She had (1) rash on each leg, on her thighs, on the outer parts of her thighs/One had a tiny bump; This is a spontaneous report from a contactable consumer (patient reported for herself). A 42-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Apr2021 11:30 (Batch/Lot number was not reported) at the age of 42 years old as single dose for covid-19 immunisation. Medical history included Horrible allergies to mold, crab meat, chicken hot dogs. The patient had never taken the flu shot because she couldn't digest eggs properly. Concomitant medication received within 2 weeks of vaccination included valaciclovir hydrochloride (VALAREX) sporadically. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Apr2021 10: 00, the patient had what appeared to be a rash on her legs. She had (1) rash on each leg, on her thighs, on the outer parts of her thighs. One had a tiny bump. It basically looked like one put blue dye on a golf ball and then stamped her thigh. Treatment was not received for the adverse events. This report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Arrhythmia; headache; hypersexuality; worsened muscle/join pain; fatigue; chills; vomiting; worsened muscle/join pain; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 22Apr2021, at 14:45 (Lot Number: ER8736) as SINGLE DOSE for covid-19 immunization. Medical history included bipolar I disorder from an unknown date, allergy to cilantro, pollen, and lactose from an unknown date. Concomitant medication included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Apr2021 at 16:00, the patient experienced arrhythmia, headache, hypersexuality, worsened muscle/join pain, fatigue, chills and vomiting. No corrective measures were taken by the patient for the reported events. The outcome was reported as not recovered for the reported events at the time of reporting.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersexuality, Myalgia, Vomiting
Clinical narrative: Arrhythmia; headache; hypersexuality; worsened muscle/join pain; fatigue; chills; vomiting; worsened muscle/join pain; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 22Apr2021, at 14:45 (Lot Number: ER8736) as SINGLE DOSE for covid-19 immunization. Medical history included bipolar I disorder from an unknown date, allergy to cilantro, pollen, and lactose from an unknown date. Concomitant medication included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Apr2021 at 16:00, the patient experienced arrhythmia, headache, hypersexuality, worsened muscle/join pain, fatigue, chills and vomiting. No corrective measures were taken by the patient for the reported events. The outcome was reported as not recovered for the reported events at the time of reporting.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Erythema, Fatigue, Feeling abnormal
Clinical narrative: A 32 male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:30 (Lot Number: EW0170) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. The patient medical history was not reported. Concomitant medications included amoxicillin, daily multivitamin, probiotic supplement. The patient previously received the first dose  at arm left on 30Mar2021 14:00  as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling, reddened skin, and itchiness at vaccination site, low- grade fever for 36 hours, slight cough, headaches, extreme tiredness, brain fog from 19Apr2021 19:00. No treatment received for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Outcome of the events was reported as recovering.    No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Swelling, Vaccination site pruritus
Clinical narrative: A 32 male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:30 (Lot Number: EW0170) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. The patient medical history was not reported. Concomitant medications included amoxicillin, daily multivitamin, probiotic supplement. The patient previously received the first dose  at arm left on 30Mar2021 14:00  as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling, reddened skin, and itchiness at vaccination site, low- grade fever for 36 hours, slight cough, headaches, extreme tiredness, brain fog from 19Apr2021 19:00. No treatment received for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Outcome of the events was reported as recovering.    No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Complete deafness in right ear; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: eng199), via an unspecified route of administration, in left arm on 24Mar2021 09:00 (at the age of 56-years-old) as single dose for COVID-19 immunization. Medical history included known allergy to penicillin. The patient received other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant at the time of vaccination. Patient received vaccine at the Pharmacy or Drug Store. The patient experienced complete deafness in right ear on 11Apr2021. Hearing loss was not regained with current aggressive medical care. The event resulted in physician or other healthcare professional office or clinic visit and considered as serious due to disability. Since the vaccination, patient has not been tested for COVID-19. The patient was treated with steroids, several other medications and oxygen. Outcome of the event was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Migraine
Clinical narrative: Migraines; Tired; Headache; Felt unwell; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt unwell and tired but she always feels this way, she also had a headache and migraines too on an unspecified date. The outcome of these events was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: The patient had a first time seizure a few minutes after having the vaccine; This is a spontaneous report from a contactable physician. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown), dose 1, intramuscularly on 25Apr2021 at 12:00 PM (at the age of 17-years-old) as a single dose for covid-19 immunisation. The patient's medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. No other medication was received within 2 weeks of the vaccination. On an unspecified date, the patient had a first time seizure a few minutes after having the vaccine. No therapeutic measures were taken as a result of the event. The event seizure did result in an emergency room/department or urgent care visit. Clinical outcome of the event first time seizure a few minutes after having the vaccine was resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Follow up attempts needed. Further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of seizure  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EEG and Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Developed bell's palsy on the left side of my face; My mouth and side of my face started to feel numb within a half hour of receiving the vaccine; My mouth and side of my face started to feel numb within a half hour of receiving the vaccine; Within 24 hours the entire side of my face from my jaw to my eye was numb; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN0164 and expiry date was not provided), via an unspecified route of administration, in Arm Left, on 15Apr2021 at 10:00 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included bee venom (known allergies). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 15Apr2021 at 10:30 AM, she developed bell's palsy on the left side of her face. Her mouth and side of her face started to feel numb within a half hour of receiving the vaccine. Within 24 hours the entire side of her face from her jaw to her eye was numb. The patient received Medrol 4 mg dosepak and Valtrex - 7-day dose as treatment for the events. The events resulted in physician office visit. Outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Myalgia, Nasal congestion
Clinical narrative: tired; Muscle ache; stuffy nose; got cold, so cold; Chills/so cold her teeth were chattering; uncontrollable shaking; sore arm; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 22Apr2021 at 06:20 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included sinus infection and colonoscopy from an unknown date and unknown if ongoing. The patient's concomitant medication included daily vitamin (unspecified). The patient previously took bnt162b2 for COVID-19 immunisation on 18Mar2021 (at the age of 53-years-old) and experienced sore arm, muscle aches, tired, stuffy nose, had been exposed to COVID, an upset stomach, chills, worst headache and had no energy. The patient also previously took oxytocin (PITOCIN) and experienced uncontrollable shaking. It was reported that her arm got sore pretty quickly after the second dose on 22Apr2021. The sore arm is ongoing. Her arm is killing her. It was ok, she took the Advil. She didn't think she felt that bad. She could tell she would be tired last night from it. Then she got cold. The heat was on 70 and she got cold and had chills and shaking and couldn't stop. When she woke up this morning (23Apr2021), she had other muscle aches and stuffy nose. She feels a little tired this morning. She thinks that will be gone in a day or so. The patient underwent lab tests and procedures which included oxygen saturation: fine on an unspecified date. Therapeutic measures were taken as a result of chills/so cold her teeth were chattering and sore arm. The outcome of the event sore arm was not recovered; chills/so cold her teeth were chattering and uncontrollable shaking was recovered on 22Apr2021, while of the rest was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pain in extremity, Tremor
Clinical narrative: tired; Muscle ache; stuffy nose; got cold, so cold; Chills/so cold her teeth were chattering; uncontrollable shaking; sore arm; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 22Apr2021 at 06:20 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included sinus infection and colonoscopy from an unknown date and unknown if ongoing. The patient's concomitant medication included daily vitamin (unspecified). The patient previously took bnt162b2 for COVID-19 immunisation on 18Mar2021 (at the age of 53-years-old) and experienced sore arm, muscle aches, tired, stuffy nose, had been exposed to COVID, an upset stomach, chills, worst headache and had no energy. The patient also previously took oxytocin (PITOCIN) and experienced uncontrollable shaking. It was reported that her arm got sore pretty quickly after the second dose on 22Apr2021. The sore arm is ongoing. Her arm is killing her. It was ok, she took the Advil. She didn't think she felt that bad. She could tell she would be tired last night from it. Then she got cold. The heat was on 70 and she got cold and had chills and shaking and couldn't stop. When she woke up this morning (23Apr2021), she had other muscle aches and stuffy nose. She feels a little tired this morning. She thinks that will be gone in a day or so. The patient underwent lab tests and procedures which included oxygen saturation: fine on an unspecified date. Therapeutic measures were taken as a result of chills/so cold her teeth were chattering and sore arm. The outcome of the event sore arm was not recovered; chills/so cold her teeth were chattering and uncontrollable shaking was recovered on 22Apr2021, while of the rest was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site swelling
Clinical narrative: tired; his arm swollen at vaccine site, couldn't lift as high; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the Pfizer second dose, got tired, his arm swollen at vaccine site, couldn't lift as high, was gone by the second day. The outcome of the events were resolved on unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, Chills and achiness within the first 12-14 hours after the second shot; Fever, Chills and achiness within the first 12-14 hours after the second shot; It was like a horrible sunburn reaction on arm that got the vaccine it hurt, burned and itch/Fever, Chills and achiness within the first 12-14 hours after the second shot; Fatigue that was more than she usually get with rheumatoid arthritis; This is a spontaneous report from a contactable consumer based on information received by Pfizer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 2 intramuscularly on an unspecified date as single dose for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient historical vaccine included first shot of COVID-19 vaccine for COVID-19 immunisation and seven to eight days after the first shot it was like a horrible sunburn reaction on the arm that got the vaccine it hurt, burned and itch. Subsequently, the patient followed treatment with ice and Tylenol (paracetamol). It lasted for three days before it went away. The patient concomitant medication included etanercept (Enbrel, solution for injection in pre-filled syringe, lot number was 1120647 and expiration date was 31Mar2023) at 50 mg weekly for rheumatoid arthritis, start and stop date were not reported. On an unknown date, the patient had fever, chills and achiness within the first 12-14 hours after the second shot. On an unknown date, three days later, the patient had fatigue that was more than she usually gets with rheumatoid arthritis. The outcome of the events was unknown.   The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) Same patient for different vaccine dose/events
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient previously received dose 1 of  BNT162B2 on 19Mar2021. Reporter stated she did not have the typical reactions but she had dizziness, weakness, and overall not feeling well. She saw in the FactSheet that this was an allergic reaction to the vaccine. She reported her dizziness only occurred when she was walking and not sitting. She did not have a fever and she did not drive at first but she was driving now. The dizziness was starting to go away but then came back and intensified after she received the second dose on 10Apr2021.  She called her primary care doctor and she also went to a neurologist who did not know what to do about it, but the neurologist would like to do some test for some things that have been on her brain for 30 years. She has had many CT scans in the past. She will be going to an allergist on Monday who also told her prior to receiving the COVID vaccine that she would have a reaction to any COVID vaccine due to her list of other allergies. She was thinking of putting off her neurologist test until after she sees the allergist. The outcome of the events was not recovered. She would like to know how long will this dizziness last and what should she do about it.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). The 87-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 19:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization at the age of 87 years old. Medical history included Pacemaker for bradycardia x 20 years, myocarditis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Same meds for years. The patient experienced atrial fibrillation on an unspecified date. The event was reported as serious with seriousness criteria disability. Reported as: Been seeing a cardiologist for 20+ years every 6 months, now first visit since vaccine and now I have atrial fibrillation. A-FIB. Never had it in 87 years of life. I see a country is reporting a link between Pfizer and myocarditis.. I look up does myocarditis cause AFIB ? YES. I pray it is temporary. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient received amiodarone for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.  Follow up attempts are possible, information about lot/batch number cannot be obtained.