chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: has UTI; This is a spontaneous report from a Pfizer Sponsored program support. A contactable female consumer (patient) reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The Patient medical history and concomitant medications were not reported. It was reported that, the patient has UTI and was enquiring if she could still receive her 2nd dose. The outcome for the event was unknown.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: sore arm and I have never been in a vaccine with a sore arm; Dizzy; This is a spontaneous report from a contactable consumer(patient). A 66-year-old consumer (Patient)  of an unspecified gender received first dose of BNT162B2 (formulation: Solution for injection, lot number: EN6202), via an unspecified route of administration at the left arm on 23Feb2021 08:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The Patient had sore arm, the patient had never been in a vaccine with a sore arm after 4 hours of vaccination and also the patient was feeling dizzy after 18 hours of vaccine shot on 23Feb2021. The Patient thought it would had suppressed immune reactions and took one Ibuprofen, It was 30 % controlled and took second Ibuprofen and its about 85% controlled and the patient was curious to know whether ibuprofen would be recommended for Dizziness. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Huntington's disease
Clinical narrative: presenting with symptoms identical to HD.; This is a spontaneous report from a contactable consumer (patient's daughter). A 45-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot number and Expiry date were not reported) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient presented with symptoms identical to HD (Huntington's disease) on unspecified date. The event was reported as non-serious. The outcome of the event was unknown.  Information on lot number/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Nausea; chills; This is a spontaneous report from a contactable Pharmacist (patient) reported for herself. A 62-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9269), via an unspecified route of administration, administered in left arm on 24Feb2021 10:00 AM as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took erythromycin and experienced (Known allergies: erythromycin/Allergies to medications, food, or other products and full body rash). Historical vaccine included BNT162B2, first dose (Lot number: EL9261, Administration time:10:15 AM on Left arm) on 03Feb2021 for covid-19 immunisation. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Patient experienced nausea (dry heaves) and chills, starting approximately 16 hours after the injection 25Feb2021 04:00 AM and lasting approximately 8 hours for the nausea and the chills are still occurring 12 hours (now). Patient did not receive treatment for adverse events. The outcome of the events was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site pain
Clinical narrative: body chills; Headache; Shot 2 - left arm ached 2 days; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration in left arm on 18Feb2021 as a single dose for COVID-19 immunization. The patient's medical history included osteoporosis, sleep apnea and reflux. The patient had no known allergies. The patient's concomitant medications included multivitamin, ergocalciferol (Vit D) and omeprazole (PRILOSEC [OMEPRAZOLE]). The patient previously received the dose of bnt162b2, in left arm on 28Jan2021 at 13:15 as a single dose for COVID-19 immunization and experienced left arm ached 2 days and 5 days later diarrhea for a few days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021, the patient experienced left arm ached for 2 days. On 19Feb2021, on the 2nd day, the patient experienced body chills and headache for which she slept it off. On day 3, the patient was back to baseline. The patient did not received treatment for the events. The patient did not undergo COVID test post vaccination. The outcome of the events was resolved.  Information on the lot batch number has been requested.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: on IS (immunosuppression- prednisone and myfortic); I had the sars-cov-2 total antibody test 11Feb2021, resulted negative for antibodies; This spontaneous case is report from a contactable other hcp. This is a report based on information received by Pfizer from Biontech Se 15874, license party for {BNT162B2}. A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Dec2020 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration on 10Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; prednisone (PREDNISONE), route of administration, start and stop date, batch/lot number and dose were not reported for immunosuppressant drug therapy; mycophenolate sodium (MYFORTIC), route of administration, start and stop date, batch/lot number and dose were not reported for immunosuppressant drug therapy. Medical history included autoimmune hepatitis from an unknown date and unknown if ongoing Bx documented AIH (autoimmune hepatitis) on IS (immunosuppression-Prednisone and Myfortic). The patient's concomitant medications were not reported. The patient had the sars-cov-2 total antibody test 11feb2021, resulted negative for antibodies (sars-cov-2 antibody test negative) and immunosuppresion(immunosuppression- prednisone and myfortic) (drug interaction) on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Feb2021. The outcome of the events were unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Inappropriate schedule of product administration
Clinical narrative: The appointment for her second dose is scheduled on 26Mar2021, which is 4 weeks instead of 3 weeks; tooth problem; This is a spontaneous report from a Pfizer sponsored program. A contactable 74 year-old female patient, reported for herself, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot no: not reported) on 25Feb2021 dose 1, via an unspecified route of administration (at the age of 74-year-old) as single dose for covid-19 immunization. Patient's medical history and concomitant medications were not reported. It was reported that, the patient was scheduled to receive the first dose of the Pfizer Covid 19 vaccine on 25Feb2021 and second dose was scheduled on 26Mar2021, which was 4 weeks instead of 3 weeks and had tooth problem. Also stated that, patient's 70-year-old husband also received the first dose of the Pfizer Covid 19 vaccine and was scheduled for his second dose on 25Mar2021, which was 4 weeks as well. It was stated that, the reporter mentioned it was ok to take the second dose up to 42 days after the first dose. The reporter enquired, would efficacy of the vaccine reduces if got the second dose at 4 weeks and what was the efficacy of the vaccine that was given between days 19-23 during the trial. The patient was taking penicillin for tooth problem. The outcome of the events Inappropriate schedule of vaccine administered, and dental discomfort was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, 3 to 4 days after receiving the Covid Vaccine, the patient tested positive for COVID-19. The patient wanted to know whether he had to wait furthur to receive the second dose. At the time of this report event outcome was unknown.  Information about lot and batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash macular
Clinical narrative: I have a huge red spot on one and I have the little dots, red dots on the other; I have a huge red spot on one and I have the little dots, red dots on the other; This is a spontaneous report received from a contactable consumer, the patient. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: Unknown) via an unspecified route of administration on 18Feb2021 (at the age of 76-year-old) as single dose for covid-19 immunization.  On unspecified date the patient reported to have a huge red spot on one and little dots, red dots on the other (Rash macular/Erythema). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Migraine, Musculoskeletal stiffness
Clinical narrative: extreme fatigue day after; fever of 101.2 day after; coughing 20 minutes after injection; sore/dry throat same day; migraine; Arm of inj. very sore and stiff; This is a spontaneous report received from a contactable consumer.   A 44-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, lot number: EN6205), via an unspecified route of administration, administered in left arm on 25Feb2021 17:30 at a single dose for covid-19 immunisation.  Medical history included Vascular Ehlers Danlos, Factor V Leiden deficiency and known allergies (Bee stings, coconut, cherries, red food dye). Concomitant medications taken in 2 weeks included requip, aimovig (injection), dexilant, quinine and xarelto. The patient previously took clindamycin and morphine and had known allergies. No other vaccine administered in four weeks. On 25Feb2021 17:45, the patient experienced arm of inj. very sore and stiff, migraine that started 35 minutes after injection and lasted beyond 48hrs, sore/dry throat on same day and coughing 20 minutes after injection. Day after the patient had extreme fatigue and fever of 101.2 on 26Feb2021. The patient underwent lab tests and procedures which included body temperature: 101.2 on 26Feb2021. The outcome of the events was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: extreme fatigue day after; fever of 101.2 day after; coughing 20 minutes after injection; sore/dry throat same day; migraine; Arm of inj. very sore and stiff; This is a spontaneous report received from a contactable consumer.   A 44-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, lot number: EN6205), via an unspecified route of administration, administered in left arm on 25Feb2021 17:30 at a single dose for covid-19 immunisation.  Medical history included Vascular Ehlers Danlos, Factor V Leiden deficiency and known allergies (Bee stings, coconut, cherries, red food dye). Concomitant medications taken in 2 weeks included requip, aimovig (injection), dexilant, quinine and xarelto. The patient previously took clindamycin and morphine and had known allergies. No other vaccine administered in four weeks. On 25Feb2021 17:45, the patient experienced arm of inj. very sore and stiff, migraine that started 35 minutes after injection and lasted beyond 48hrs, sore/dry throat on same day and coughing 20 minutes after injection. Day after the patient had extreme fatigue and fever of 101.2 on 26Feb2021. The patient underwent lab tests and procedures which included body temperature: 101.2 on 26Feb2021. The outcome of the events was recovering.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept most of the time; tired; chills; fever; headache; flu-like ache; muscle pain; queasiness; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 19Feb2021 at 13:15 (at the age of 77-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number E13246) on 27Jan2021 at right arm for COVID-19 immunisation. Medical history included High blood pressure (BP) and cholesterol, all managed. The patient had also history of sciatica nerve pain in in early Jan2021, resolved with 5 days of meloxicam. Concomitant medication included atenolol, hydralazine, pravastatin and budesonide/formoterol fumarate (SYMBICORT). The patient reported that 2 hours after vaccination, at home, she felt tired, quickly turned to chills and fever. Body temperature was 99.9 F. She never run temps. This was followed by headache, flu-like ache, muscle pain, queasiness, and just terrible in general. She spoke with nurse who gave her shot to see if I should take any fever reducers. She said try to hold off, but if bad, take Tylenol or Ibuprofen. On 20Feb2021 sciatic nerve just blew up. She had an episode in early January, but Meloxicam worked in 5 days and she was fine. This time it quickly turned into tremendous pain-could not walk without help, trouble getting in or out of bed and to the bathroom. She was screaming out in pain. She started taking Tylenol and then Ibuprofen. Nothing helped. She had a few Meloxicam pills left and took one 22feb2021. Temps were rising daily (101.5) chilled, no energy. She slept most of the time straight chair. Sciatica was better, but not gone. Day 9, she walked outside, temp was normal. She was sent for flu & Covid tests (nasal swab), both negative.  The outcome of events was recovering.    No follow up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Influenza like illness, Influenza virus test, Myalgia, Nausea
Clinical narrative: sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept most of the time; tired; chills; fever; headache; flu-like ache; muscle pain; queasiness; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 19Feb2021 at 13:15 (at the age of 77-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number E13246) on 27Jan2021 at right arm for COVID-19 immunisation. Medical history included High blood pressure (BP) and cholesterol, all managed. The patient had also history of sciatica nerve pain in in early Jan2021, resolved with 5 days of meloxicam. Concomitant medication included atenolol, hydralazine, pravastatin and budesonide/formoterol fumarate (SYMBICORT). The patient reported that 2 hours after vaccination, at home, she felt tired, quickly turned to chills and fever. Body temperature was 99.9 F. She never run temps. This was followed by headache, flu-like ache, muscle pain, queasiness, and just terrible in general. She spoke with nurse who gave her shot to see if I should take any fever reducers. She said try to hold off, but if bad, take Tylenol or Ibuprofen. On 20Feb2021 sciatic nerve just blew up. She had an episode in early January, but Meloxicam worked in 5 days and she was fine. This time it quickly turned into tremendous pain-could not walk without help, trouble getting in or out of bed and to the bathroom. She was screaming out in pain. She started taking Tylenol and then Ibuprofen. Nothing helped. She had a few Meloxicam pills left and took one 22feb2021. Temps were rising daily (101.5) chilled, no energy. She slept most of the time straight chair. Sciatica was better, but not gone. Day 9, she walked outside, temp was normal. She was sent for flu & Covid tests (nasal swab), both negative.  The outcome of events was recovering.    No follow up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sciatica
Clinical narrative: sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept most of the time; tired; chills; fever; headache; flu-like ache; muscle pain; queasiness; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 19Feb2021 at 13:15 (at the age of 77-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number E13246) on 27Jan2021 at right arm for COVID-19 immunisation. Medical history included High blood pressure (BP) and cholesterol, all managed. The patient had also history of sciatica nerve pain in in early Jan2021, resolved with 5 days of meloxicam. Concomitant medication included atenolol, hydralazine, pravastatin and budesonide/formoterol fumarate (SYMBICORT). The patient reported that 2 hours after vaccination, at home, she felt tired, quickly turned to chills and fever. Body temperature was 99.9 F. She never run temps. This was followed by headache, flu-like ache, muscle pain, queasiness, and just terrible in general. She spoke with nurse who gave her shot to see if I should take any fever reducers. She said try to hold off, but if bad, take Tylenol or Ibuprofen. On 20Feb2021 sciatic nerve just blew up. She had an episode in early January, but Meloxicam worked in 5 days and she was fine. This time it quickly turned into tremendous pain-could not walk without help, trouble getting in or out of bed and to the bathroom. She was screaming out in pain. She started taking Tylenol and then Ibuprofen. Nothing helped. She had a few Meloxicam pills left and took one 22feb2021. Temps were rising daily (101.5) chilled, no energy. She slept most of the time straight chair. Sciatica was better, but not gone. Day 9, she walked outside, temp was normal. She was sent for flu & Covid tests (nasal swab), both negative.  The outcome of events was recovering.    No follow up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Limb discomfort
Clinical narrative: left arm soreness; Lack of energy; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received second dose of bnt162b2 (BNT162B2 Pfizer-BioNTech COVID-19 Vaccine; Solution for injection), via an unspecified route of administration on 11Feb2021 as single dose for covid-19 immunization. Medical history included bronchitis and illness from Dec2019 to an unknown date. Concomitant medications were not reported. The patient experienced left arm soreness, lack of energy on an unspecified date. The reporter said that she become very ill in dec2019 while on vacation in (place name), went to walk-in clinic twice. no pneumonia though coughing, horrible wheezing, told me it was probably bronchitis. given numerous drugs, still doctoring when and returned home. more drugs. no energy for 2-3 months. had been told lots of sickness in (place name) when she was there. heart and lungs checked and ok. often wondered if she had covid. woman across aside from me on plane coughed all the way to (place name). 3 days later she was sick. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in my arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL). consumer stated, "I was pain in my arm in 2021 but I was wondering that with the second dose I heard that you feel worse " Consumer further stated, "I had pain a little bit just the day afterwards. My concern is, can I take Tylenol within 24 hours of getting the shot" The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (solution for injection) via an unspecified route of administration, in left arm on 09Feb2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) at single dose for covid-19 immunization. Medical history included diabetes mellitus from 2004. There were no concomitant medications. The patient said yesterday morning he had whelps on his left and right legs with some swelling, also whelps to upper left arm and left elbow. He clarified that he had slight swelling to his legs, with little whelps or hives to his legs and calves. He had done no treatment, though last night before bed he put alcohol, clarified to being Swans 70% rubbing alcohol with a swab where it was itching, it seems to be getting better, it doesn't itch as much. Swans 70% rubbing alcohol LOT: 0501407, EXP Sep2023, UPC: Number. Outcome of itching was recovering, and outcome of other events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: got a rash on the right side of my body, neck, chest, my back, my arm; Shingles and they are very painful; This is a spontaneous report received from a contactable consumer (Patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number: EL9265), via an unspecified route of administration at the left upper arm on 08Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she believes she got bad reactions because the following week on 15Feb2021 got a rash on the right side of my body, neck, chest, my back, my arm. It was reported that on unspecified date of 2021 she got shingles and patient felt it was from vaccine. The patient stated that went to doctor again and she definitely said that shingles and gave medications. she was very bothered as she got rash and shingles. she supposed to get the second dose on 01Mar2021, but she can't get it because she was afraid. Patient was fine and feeling good, and stuck with the shingles and they are very painful. Patient received treatment for Shingles. The outcome of events was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Hyperhidrosis
Clinical narrative: Started sweating real bad; It was just unusual the amount that I sweat; This is a spontaneous report from a contactable consumer.A 78-years-old male patient received First dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EL9265) via an unspecified route of administration on 12Feb2021 at a single dose for covid-19 immunization.Patient relevant medical history of ulcer from 1968, arthritis pain (about 3 months prior to receiving my vaccine, Patient was having Arthritis pain in right shoulder and a week after receiving vaccine which was 19Feb2021, he put a Heating pad on right shoulder for the Arthritis pain and that night when he went to bed he started sweating real bad, everything was wet his sheet, pillow case from sweating), neoplasm malignant from 2004, Ulcer. Concomitant medications included lisinopril (LISINOPRIL), acetylsalicylic acid (ASPIRIN) and ergocalciferol (VIT D).The patient received second dose on 05Mar2021. The patient underwent blood test and result was unknown.On 19Feb2021, patient started sweating real bad, It was just unusual the amount that he sweat and had not received any treatment. Patient did not received any treatment. The outcome of the event was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching/itching at the injection site; injection site and area around it is really red; This is a spontaneous case received report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation.  Medical history and concomitant medications were not reported. No prior vaccines were administered within 4 weeks. The patient experienced injection site and area around it was really red on 21Feb2021; itching/itching at the injection site on 22Feb2021. The patient did not undergo any lab data or investigations. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Maternal exposure during pregnancy, Pyrexia, Tremor
Clinical narrative: Fever; chills; uncontrollable shaking; itching at injection site; pain in injection site; cellulitis in right  arm; Pregnant patient; This is a spontaneous report from a contactable consumer. A 38-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 38-years-old via an unspecified route of administration, administered in arm right on 25Feb2021 23:30 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and alprazolam (XANAX), both taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to Bactrim. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on the right arm on 05Feb2021 (lot number: EM9810) 11:00 for covid-19 immunisation. The patient experienced cellulitis in right arm, fever, chills, uncontrollable shaking, itching at injection site and pain in injection site on 26Feb2021 08:00. The mother reported she became pregnant while taking bnt162b2 on 25Feb2021 23:30. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 28Oct2021. Last menstrual period was on 15Jan2021. Therapeutic measures were taken as a result of the events which included treatment with cefalexin. The outcome of maternal exposure during pregnancy was unknown while the patient was recovering from all of the other events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Fever; chills; uncontrollable shaking; itching at injection site; pain in injection site; cellulitis in right  arm; Pregnant patient; This is a spontaneous report from a contactable consumer. A 38-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 38-years-old via an unspecified route of administration, administered in arm right on 25Feb2021 23:30 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and alprazolam (XANAX), both taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to Bactrim. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on the right arm on 05Feb2021 (lot number: EM9810) 11:00 for covid-19 immunisation. The patient experienced cellulitis in right arm, fever, chills, uncontrollable shaking, itching at injection site and pain in injection site on 26Feb2021 08:00. The mother reported she became pregnant while taking bnt162b2 on 25Feb2021 23:30. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 28Oct2021. Last menstrual period was on 15Jan2021. Therapeutic measures were taken as a result of the events which included treatment with cefalexin. The outcome of maternal exposure during pregnancy was unknown while the patient was recovering from all of the other events.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: became quite ill; This is a spontaneous report from a Pfizer sponsored program. A contactable Female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient became quite ill 3 days after receiving her first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: sore arm; Stingy pain in calf; This is a spontaneous report from a Pfizer-sponsored program support. A contactable female consumer (Patient). A female patient of unspecified age received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot no. unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. it was reported that after second dose patient experienced sore arm, a Stingy pain in calf. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable other hcp. A 49-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Right on 05Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. I got Shingles within one day of the 2nd vaccination. About 2 weeks after the first vaccination, I started itching and having back and side pain. I didn't think anything of it. The week before my second vaccination I broke out with a rash. I thought something bit me. After the second vaccination within 2 days, I had full blown Shingles. On 06Feb2021, the patient experienced shingles. No treatment was received for the adverse event. The outcome of events was recovering.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia
Clinical narrative: temporary delayed loss of taste; This is a spontaneous report from a contactable Physician. This Physician reported for similar events for 4 patients. This report is 1st of 4 reports. A male patient of an unspecified age received BNT162B2(Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/batch number: Unknown, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation . Patient's medical history included covid-19. The patient's concomitant medications were not reported. The patient experienced temporary delayed loss of taste. It was reported by physician that he heard of 4 other people at his employment who had previously had COVID-19 and developed this same reaction after the vaccine, temporary delayed loss of taste.Obviously this was not a serious reaction, just a peculiar one. Physician was unable to find this on the Internet. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021205778 same drug and AE, different patient
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: temporary delayed loss of taste; This is a spontaneous report from a contactable Physician. This Physician reported for similar events for 4 patients. This report is 1st of 4 reports. A male patient of an unspecified age received BNT162B2(Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/batch number: Unknown, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation . Patient's medical history included covid-19. The patient's concomitant medications were not reported. The patient experienced temporary delayed loss of taste. It was reported by physician that he heard of 4 other people at his employment who had previously had COVID-19 and developed this same reaction after the vaccine, temporary delayed loss of taste.Obviously this was not a serious reaction, just a peculiar one. Physician was unable to find this on the Internet. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021205778 same drug and AE, different patient
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (solution for injection) via an unspecified route of administration, administered in right arm on 11Feb2021 (Batch/Lot Number: EL3302) at single dose for COVID-19 vaccination. The patient medical history was not reported. There were no concomitant medications. The patient previously took BNT162B2 on 20Jan2021 for covid-19 immunisation. Two days ago with her lymph nodes very swollen, mostly around arm pit, she couldn't tell pain in her arm and breast until pressed on side of arm. It was swollen, she has been doing massage and two days ago it started. She says yesterday it was a bit more, and last night it woke her up. She says this morning her arm when it touches side of breast has discomfort, not big pain, discomfort and was swollen around breast and armpit under arm on 11Feb2021. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis
Clinical narrative: tested positive for COVID-19; experiencing mild cold symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program  A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Feb2021, the patient experienced tested positive for COVID-19 and mild cold symptoms. The patient is asking how he can proceed with the second dose of the vaccine. The outcome of the events was unknown.  No follow up attempts are needed. Information on Lot/batch cannot be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: came out positive for covid-19 after first dose.; came out positive for covid-19 after first dose.; This is a spontaneous report received from a contactable female consumer (Wife) reported for a patient (Husband) via Pfizer-sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration at single dose on Feb2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid-19 2 weeks (on an unknown date in 2021) after first dose. It was also reported that patient went to emergency room and was back home with covid symptoms. Outcome of events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: She got positive to COVID-19 right after her first dose; This is a spontaneous report from a Pfizer Sponsored Program . A contactable female consumer (patient herself) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) on 27Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Feb2021, the patient tested positive for covid-19 right after her first dose and she mentioned that she had mild symptoms. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: My PCR test came back POSITIVE for COVID-19; POSITIVE for COVID-19; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 09Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Then patient had no adverse reactions or any sign that got an immune response from the Vaccine. The patient's husband had no vaccine as of yet, and he contracted COVID-19 being positive on 23Feb2021. On February 25, patient woke up extremely sick. On an unspecified date the patient experienced pcr test came back positive for covid-19 (vaccination failure),covid-19. On an unspecified date he patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information provided, the causality between the events and the suspect product BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported),  is possible.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Mobility decreased
Clinical narrative: My arm feels broken and I can't move it at all, I'm going on day 3 and still feels painful; My arm feels broken and I can't move it at all, I'm going on day 3 and still feels painful; fever; dizziness; tiredness; headaches; joint pain; This is a spontaneous report from a contactable consumer (patient). This 30-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 08Mar2021 at 09:30 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), hyperhidrosis, and hypothyroidism. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination on an unspecified date the patient was diagnosed with COVID-19. The patient had an allergy to pineapple. On 08Mar2021 at 11:00 the patient experienced arm felt broken and could not move it at all. She was going on "day 3" and still felt painful. She had fever, dizziness, tiredness, headaches, and joint pain. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of arm felt broken, could not move it at all, painful, fever, dizziness, tiredness, headaches, and joint pain were not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: My arm feels broken and I can't move it at all, I'm going on day 3 and still feels painful; My arm feels broken and I can't move it at all, I'm going on day 3 and still feels painful; fever; dizziness; tiredness; headaches; joint pain; This is a spontaneous report from a contactable consumer (patient). This 30-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 08Mar2021 at 09:30 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), hyperhidrosis, and hypothyroidism. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination on an unspecified date the patient was diagnosed with COVID-19. The patient had an allergy to pineapple. On 08Mar2021 at 11:00 the patient experienced arm felt broken and could not move it at all. She was going on "day 3" and still felt painful. She had fever, dizziness, tiredness, headaches, and joint pain. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of arm felt broken, could not move it at all, painful, fever, dizziness, tiredness, headaches, and joint pain were not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Insomnia
Clinical narrative: couldn't sleep one night; have had a tightening in the chest; This is a spontaneous report received from contactable consumer (patient). This 44-year-old-male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6206) via an unspecified route of administration on 04Mar2021 at 13:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19 diagnosis on an unspecified date prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included lisinopril and hydrochlorothiazide from unknown dates for unknown indications. On 07Mar2021 at 23:00, the patient could not sleep one night and since had a tightening in the chest. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of couldn't sleep one night and tightening in the chest were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sleepy; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration on 08Mar2021 at 15:45 (at the age of 71-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism and gastroesophageal reflux disease (GERD). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine, omeprazole, meloxicam, and calcium (CALCIUM 500) from unknown dates for unknown indications. The patient previously received acetaminophen, codeine (TYLENOL WITH CODEINE) and acetaminophen, hydrocodone (VICODIN) from unknown dates for unknown indications and experienced allergy. On 08Mar2021 at 19:00 the patient felt sleepy. The patient did not receive any treatment for the event. The outcome of sleepy was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Having intermittent hives on both hands, arms, face, leg & foot; This is a spontaneous report received from contactable consumer, the patient. A 55-year-old adult [non-pregnant] female received the first dose of BNT162B2 (solution for injection; Lot reported as unknown and expiry information not provided) as a single dose via an unspecified route in the left arm on 03Mar2021 at 15:15 (at 55-years-old), for COVID-19 immunization.  Relevant medical history included a leg amputation in Sep1975 due to bone cancer (osteosarcoma) and allergies to milk, wheat (gluten), bug bites, penicillin and prochlorperazine (COMPAZINE). Concomitant medications sans indication, posology and therapy dates included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), and bupropion hydrochloride (WELLBUTRIN). The patient was diagnosed with COVID prior to the vaccine and was not pregnant at the time of vaccination, Additionally, the patient denied receiving any other vaccines within four weeks prior to this vaccine. On 08Mar2021 at 12:00, eight days after receiving the vaccine (as reported) the patient experienced hives on both hands, arms, face, leg and foot.  The patient denied any visit to a doctor, other healthcare professional, clinic, emergency room or hospital as a result of the event. The patient has not been tested for COVID since receiving the vaccine. There was no treatment received for the events. The outcome of the events hives on both hands, arms, face, leg and foot was unknown.   The lot number for the vaccine, BNT162b2, was provided as unknown though will be requested during follow up.