chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Dizziness, Nausea, Rash, Urticaria
Clinical narrative: felt dizzy; Possible rash on face 2 days after dose but thought was acne due yo wearing mask at work; naseous around noon; hives; Rash/Rash on chest and torso, both arms and both legs/Possible rash on face 2 days after dose but thought was acne due yo wearing mask at work; This is a spontaneous report from a contactable consumer (patient) reported for himself.  A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 17Apr2021 at 10:00 am (Batch/Lot Number: ER8737) (age at vaccination 52-year-old) as dose 1, single for covid-19 immunisation at Hospital. Medical history included recent high cholesterol diagnosis about 3 weeks ago started meds, known allergies: triple anibiotic ointment, sulfa meds from an unknown date and unknown if ongoing. The patient had known allergies with past drugs included amoxicillin, doxycycline, augmentin bambini, zithromax. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications included rosuvastatin, cetirizine hydrochloride (Zyrtec) and paracetamol (Tylenol) within 2 weeks of vaccination for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After 3 days of dose 1, the patient experienced felt dizzy, naseous around, about 4 hours later hives, rash/rash on chest and torso, both arms and both legs/possible rash on face 2 days after dose but thought was acne due yo wearing mask at work and possible rash on face 2 days after dose but thought was acne due yo wearing mask at work on 20Apr2021 at 16:00. Took Zyrtec 10 mg about 4pm. Therapeutic measures included antihistamine was taken for all the events. The outcome of the events was not resolved.  No follow-up attempts are possible; No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Nausea, Pain, Pain in extremity
Clinical narrative: nausea; chills; arm pain; body aches/severe under arm pain; fever; injection site itchiness; discomfort; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Age at vaccination 40-years-old), as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took keflexin and experienced allergies. Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient did not have covid prior vaccination and not tested for covid post vaccination. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunization on 24Mar2021 at 12:15PM, in left arm and had nausea, injection site pain and itchiness and underarm pain. On an unspecified day in 2021, the patient experienced nausea, chills, arm pain/severe under arm pain, body ache, fever, injection site itchiness and discomfort. No treatment was received for the events. The clinical outcome of the events was recovered in 2021.   No follow-up attempts are possible. Information about Lot/Batch cannot be obtained
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pruritus
Clinical narrative: nausea; chills; arm pain; body aches/severe under arm pain; fever; injection site itchiness; discomfort; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Age at vaccination 40-years-old), as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took keflexin and experienced allergies. Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient did not have covid prior vaccination and not tested for covid post vaccination. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunization on 24Mar2021 at 12:15PM, in left arm and had nausea, injection site pain and itchiness and underarm pain. On an unspecified day in 2021, the patient experienced nausea, chills, arm pain/severe under arm pain, body ache, fever, injection site itchiness and discomfort. No treatment was received for the events. The clinical outcome of the events was recovered in 2021.   No follow-up attempts are possible. Information about Lot/Batch cannot be obtained
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: headache; body aches; pain in joints; chills; fatigue; This is a spontaneous report from a contactable consumer. A 37-years-old non-pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EN6204) via an unspecified route of administration, administered in arm left on 13Apr2021 16:45 (age at vaccination:37 years and non-pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient's medical history included none. There was no known allergies. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. There was no other medications in two weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EP6955) via an unspecified route of administration, administered in arm left on 23Mar2021 04:45 PM (age at vaccination:37 years and non-pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation and experienced headache after the first shot that lasted the entire day. On 13Apr2021 16:45 after second vaccination patient experienced headache, body aches, pain in joints, chills, fatigue. There was no treatment received for adverse events. The outcome of events was reported as resolved.  No follow-up attempts are possible. No further information was expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Vaccination site pain
Clinical narrative: After 1st dose, noticed soreness; arm pain at injection site along with minor breathing difficulties.; arm pain at injection site along with minor breathing difficulties.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Mar2021 11:30 (at the age of 50-years-old) as dose 1, single for covid-19 immunization at church. The patient medical history included MGUS, known allergies: penicillin (Known allergies: Penicillin and Macrobid). Concomitant medications included levothyroxine, liothyronine (NP THYROID), epinephrine (ADRENAL), estradiol, famotidine. Other medications patient received in two weeks included NP Thyroid, Adrenal, Estradiol, Famotidine. The patient previously took macrobid [clarithromycin] and experienced known allergies: penicillin. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that after 1st dose, on 16Mar2021 the patient noticed soreness and arm pain at injection site along with minor breathing difficulties. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: systemic pruritus; rash on neck, arms, thighs; This is a spontaneous report from a non-contactable pharmacist. A 51-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via intramuscularly on 30Mar2021 (age at vaccination: 51years-old) as dose 1, single for COVID-19 immunization. Medical history included asthma, hypertension, pre-diabetes, peptic ulcer disease from an unknown date and unknown if ongoing. Concomitant medications were not reported. Patient had known allergies with Aspirin, latex, strawberry. Patient was not pregnant at the time of vaccination. It was unknown if patient received any other vaccines within 4 weeks prior to covid-19 vaccine. It was unknown if the patient was tested positive for covid 19 prior to vaccination and tested post vaccination. On 30Mar2021, the patient experienced systemic pruritus and rash on neck, arms, thighs. Therapeutic measures were taken as a result of events. Diphenhydramine was not effective in reducing symptoms. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthenopia, Chills, Dizziness, Headache
Clinical narrative: Fever; Muscle pain; Chills; Dizziness; Weakness; Headache; Eyes are so heavy; Pain in arm; I feel like, I want to be sleepy all the time; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8731) via an unspecified route of administration, administered in arm left on 14Apr2021 (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. On an unspecified date, the patient experienced fever, muscle pain, chills, dizziness, weakness, headache, eyes were so heavy, developed pain in arm and felt like sleepy all the time. Patient stated that it's hard for me to get up I wanted to report because I did not know what to do, how long this going to be there these symptoms because I was allergic to ibuprofen, at the beginning I purchased it for allergy. Patient had been taking benadryl for fever, muscle pain and headache and reported that it helped a little bit, muscles are calm. I had been felling very bad and I did not know what to drink or what to take because I didn't call my doctor. Patient was scared because she cannot be able to work in job and was afraid of being fired. The outcome for fever, muscle pain and headache was recovering whereas outcome for other remaining events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Fever; Muscle pain; Chills; Dizziness; Weakness; Headache; Eyes are so heavy; Pain in arm; I feel like, I want to be sleepy all the time; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8731) via an unspecified route of administration, administered in arm left on 14Apr2021 (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. On an unspecified date, the patient experienced fever, muscle pain, chills, dizziness, weakness, headache, eyes were so heavy, developed pain in arm and felt like sleepy all the time. Patient stated that it's hard for me to get up I wanted to report because I did not know what to do, how long this going to be there these symptoms because I was allergic to ibuprofen, at the beginning I purchased it for allergy. Patient had been taking benadryl for fever, muscle pain and headache and reported that it helped a little bit, muscles are calm. I had been felling very bad and I did not know what to drink or what to take because I didn't call my doctor. Patient was scared because she cannot be able to work in job and was afraid of being fired. The outcome for fever, muscle pain and headache was recovering whereas outcome for other remaining events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache
Clinical narrative: headaches; chest pressure; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via intramuscular on 02Mar2021, 15:30 (at the age of 66-years) as dose 2, single for covid-19 immunization. Patient relevant medical history includes blood pressure, allergy and cholesterol and still ongoing. Concomitant medication amlodipine (5mg, BP, ongoing), cetirizine (10mg, allergies and ongoing) and atorvastatin (10mg, cholesterol, ongoing). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EL8982) via intramuscular route of administration on 10Feb2021 10.30 (at the age of 66-years) as dose 1, single for covid-19 immunization and experienced temperature dropped and 93.4 degree and remained sub normal for 10 days. Mild chills also a side effects along with no energy.  The patient was not diagnosed with COVID-19 prior to vaccination. After second dose on 03Mar2021 18:00 patient experienced debilating headache and chest pressure to some extent for 3 or more weeks. Patient did not had family medical history and relevant tests. Patient received treatment for chest pressure (consistent use of amlodipine for 3 weeks) and no treatment for headache. The outcome of the events recovered on 2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills and fever; chills and fever; This is a spontaneous report from a contactable consumer. 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 an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received first 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 an unspecified date, for COVID-19 immunisation. On an unspecified date, the patient experienced chills and fever (pyrexia, chills). The outcome of events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After my first shot, the next morning, no pain. And, it has NOT come back.; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Right on Mar2021 (at the age of 67-years-old) as dose 1, single for covid-19 immunisation. Medical history included mild osteoarthritis, high blood pressure and wake up with a little joint pain (in the morning, I usually wake up with a little joint pain which takes about 1/2 to 1 hour to go away). The concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 31Mar2021 at 05:00 the patient experienced after my first shot, the next morning, no pain. and, it has not come back. The patient reported that he had an unexpectedly good reaction to the first dose. He had a mild case of osteo-arthritis, so, in the morning, He usually wakes up with a little joint pain which takes about 1/2 to 1 hour to go away. After his first shot, the next morning, no pain. And, it has NOT come back, he had his second dose, and it still has not come back. The joints are still old and stiff, but the pain is gone. The patient wanted to know if he was the only one who has reported this result. The outcome of the event was not resolved. No follow-up attempts are possible; No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Two days after the shot, my right armpit is swollen and sore.; Two days after the shot, my right armpit is swollen and sore.; This is a spontaneous report from a contactable Consumer. This 65-year-old female consumer (patient) reported that: A 65-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0151) via an unspecified route of administration in arm right on 14Apr2021 08:45 (age at the time of the vaccination 65 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included controlled blood pressure. The patient was not pregnant at the time of the vaccination. No other vaccine in four weeks, and no other medication within two weeks. No COVID prior vaccination and no known allergies. Concomitant medications unspecified. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route of administration in arm left on 24Mar2021 10:00 (age at the time of the vaccination 65 years) as DOSE 1, SINGLE for COVID-19 immunization. On 16Apr2021 07:00, two days after the shot, the patient right armpit was swollen and sore. No treatment received. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash primarily on side of left torso underneath where lymph nodes had been removed 2 years ago due to breast cancer; Very itchy; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via unknown route of administration on an unknown date as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EP6955) via unknown route of administration in right arm on 04Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history included melanoma in situ and breast cancer. the patient concomitant medication included Tamoxifen for an unknown indication from an unknown date. patient did not have other vaccine in four weeks. It was reported that on 15Mar2021, a very small rash on wrists within 12hours of the first dose of the vaccine. Very itchy. Persisted for two weeks. After, second dose, same type of rash flared one week after the shot. Rash primarily on side of left torso underneath where lymph nodes had been removed 2 years ago due to breast cancer. Very itchy. Persists for 1 week so far. Patient did not receive treatment. Patient did not have COVID prior vaccination and not tested for COVID post vaccination. The outcome of the events were not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever; body ache; headache; stomachache; tiredness; This is a spontaneous report from a contactable consumer (patient himself).  A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number:  not reported; Expiry date: not reported), via an unspecified route, administered in Arm Left on 17Apr2021 at 13:00 (Age at vaccination 51-years-old) as dose number unknown, single for covid-19 immunization. Medical history included hepatitis C, when a child and toothache. The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for toothache. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Apr2021 at 21:00, the patient experienced low grade fever, body ache, headache, stomach ache and tiredness. Therapeutic measures were taken for events and patient received 400 mg advil on sunday night as treatment for the events. The clinical outcome of the events was recovering.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes simplex reactivation, Pain in extremity
Clinical narrative: HSV1 severe outbreak; Arm soreness; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route, administered in left arm on an unspecified date (at the age of 25 years and she was not pregnant at the time of vaccination) as dose 1, single for covid-19 immunization. Facility type vaccine was other. The patient's medical history included PCOS, hyperthyroidism, TMD, HSV1. There was no other vaccine in four weeks. There were other medications in two weeks included methimazole 10 mg, escitalopram oxalate (LEXAPRO) 10 mg. There were no covid prior vaccination. There were no known allergies. The patient experienced arm soreness, fatigue, hsv1 severe outbreak on 16Apr2021. She was not tested covid post vaccination. She did not receive treatment for adverse events. The outcome of events was recovering.  No follow-up attempts were possible. information about lot/batch number could not be obtained. No further information was expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Fatigue, Pain
Clinical narrative: less than 24 hours I'm here in bed with a fever of 102.5; body aches; fatigue again; The left elbow is now worsening to the point there is not much strength in that arm any more; left elbow pain as severe; This is a spontaneous report from a contactable consumer(patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EWO153, Expiry date: Unknown) via an unspecified route of administration, administered in the left arm on 18Apr2021 at 15:15 (age at the time of vaccination was 44-year-old) as dose 2, single for COVID-19 immunization. Right knee injury, several bulged disk in back, chronic pain. Patient had one surgery about 15 years for acid reflux. No other chronic issues. Patient had covid prior to vaccination. Concomitant medications included loperamide hydrochloride (IMODIUM) and marijuana taken for an unspecified indication, start and stop date were not reported. Historical vaccine include dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW10201, Expiry date: Unknown) via an unspecified route of administration, administered in the left arm on 31Mar2021 at 03:30 PM as dose 1, single for COVID-19 immunization and the patient reported event described as 48 hours after first vaccine my left elbow seemed to lock up, joint was difficult to move and painful. On an unspecified date, the patient experienced a moderate fever, body aches and fatigue. Patient did not receive any other vaccines within 4 weeks prior and received other medications 2 weeks prior to the COVID vaccine. Patient allergies were none. Patient was not tested for covid post vaccination. It was reported that patient elbow never healed, and he never had any issues with either elbow until the vaccine. After second vaccine less than 24 hours he was in bed with a fever of 102.5, body aches and fatigue again. The left elbow is now worsening to the point there is not much strength in that arm anymore and the left elbow pain as severe on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 102.5 on an unspecified date. No treatment was taken for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: less than 24 hours I'm here in bed with a fever of 102.5; body aches; fatigue again; The left elbow is now worsening to the point there is not much strength in that arm any more; left elbow pain as severe; This is a spontaneous report from a contactable consumer(patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EWO153, Expiry date: Unknown) via an unspecified route of administration, administered in the left arm on 18Apr2021 at 15:15 (age at the time of vaccination was 44-year-old) as dose 2, single for COVID-19 immunization. Right knee injury, several bulged disk in back, chronic pain. Patient had one surgery about 15 years for acid reflux. No other chronic issues. Patient had covid prior to vaccination. Concomitant medications included loperamide hydrochloride (IMODIUM) and marijuana taken for an unspecified indication, start and stop date were not reported. Historical vaccine include dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW10201, Expiry date: Unknown) via an unspecified route of administration, administered in the left arm on 31Mar2021 at 03:30 PM as dose 1, single for COVID-19 immunization and the patient reported event described as 48 hours after first vaccine my left elbow seemed to lock up, joint was difficult to move and painful. On an unspecified date, the patient experienced a moderate fever, body aches and fatigue. Patient did not receive any other vaccines within 4 weeks prior and received other medications 2 weeks prior to the COVID vaccine. Patient allergies were none. Patient was not tested for covid post vaccination. It was reported that patient elbow never healed, and he never had any issues with either elbow until the vaccine. After second vaccine less than 24 hours he was in bed with a fever of 102.5, body aches and fatigue again. The left elbow is now worsening to the point there is not much strength in that arm anymore and the left elbow pain as severe on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 102.5 on an unspecified date. No treatment was taken for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: severe chills, shivering; body aches/achy; headache; very tired; pain in my arm at the injection site; a high fever; This is a spontaneous report from a contactable consumer. A 42-years-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0158 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 18Apr2021 at 10:00 hours as dose 2, single (at the age of 42-years-old) for COVID-19 immunisation. The patient medical history included allergic to bananas and inappropriate sinus tachycardia (both from an unknown date and unknown if ongoing). The concomitant medication(s) within two weeks of vaccination included diazepam (Valium) taken for an unspecified indication from 09Apr2021 to an unspecified stop date; hydrocodone bitartrate, paracetamol (Norco) taken for an unspecified indication on 09Apr2021 and 10Apr2021 till an unspecified stop date. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EP6955 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 25Mar2021 at 15:30 hours as dose 1, single (at the age of 42-years-old) for COVID-19 immunisation and had COVID arm which started about eight days after the injection and lasted about four days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. On 18Apr2021, at 22:00 hours (12 hours after second dose), patient experienced severe chills, shivering, body aches, a headache, and then a high fever. These lasted for about six hours. It is now almost 24 hours since her shot, and patient was still very tired, achy, and had a headache. Patient also had pain in her arm at the injection site. Patient received no treatment for the events. The outcome of severe chills, shivering and high fever was recovered on 19Apr2021 and not recovered for rest of the events.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: severe chills, shivering; body aches/achy; headache; very tired; pain in my arm at the injection site; a high fever; This is a spontaneous report from a contactable consumer. A 42-years-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0158 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 18Apr2021 at 10:00 hours as dose 2, single (at the age of 42-years-old) for COVID-19 immunisation. The patient medical history included allergic to bananas and inappropriate sinus tachycardia (both from an unknown date and unknown if ongoing). The concomitant medication(s) within two weeks of vaccination included diazepam (Valium) taken for an unspecified indication from 09Apr2021 to an unspecified stop date; hydrocodone bitartrate, paracetamol (Norco) taken for an unspecified indication on 09Apr2021 and 10Apr2021 till an unspecified stop date. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EP6955 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 25Mar2021 at 15:30 hours as dose 1, single (at the age of 42-years-old) for COVID-19 immunisation and had COVID arm which started about eight days after the injection and lasted about four days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. On 18Apr2021, at 22:00 hours (12 hours after second dose), patient experienced severe chills, shivering, body aches, a headache, and then a high fever. These lasted for about six hours. It is now almost 24 hours since her shot, and patient was still very tired, achy, and had a headache. Patient also had pain in her arm at the injection site. Patient received no treatment for the events. The outcome of severe chills, shivering and high fever was recovered on 19Apr2021 and not recovered for rest of the events.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Musculoskeletal pain, Myalgia, SARS-CoV-2 test
Clinical narrative: sore at injection site, armpit and scapula; sore at injection site, armpit and scapula; sore at injection site, armpit and scapula; Fatigue; overall muscle soreness; This is a spontaneous report from a non-contactable other health care professional (patient). A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0170, expiry date: unknown) via an unspecified route of administration, administered in Left Arm on 19Apr2021 17:00 as dose 2, single (age at vaccination: 36-Years-old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ibuprofen (MOTRIN [IBUPROFEN]). The patient was allergic to Haldol. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Er8733, expiry date: unknown) via an unspecified route of administration, administered in Left Arm on 29Mar2021 05:45 PM as dose 1, single (age at vaccination:36-Years-old) for COVID-19 immunisation and experienced fatigue, muscle soreness, low grade fever, and chills. The patient was not diagnosed with covid-19 before, and was tested post vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Received Motrin medications in two weeks prior to the vaccination. On an unspecified date the patient experienced sore at injection site, armpit and scapula, fatigue, and overall muscle soreness. On an unspecific date the patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative. The patient had not received treatment for all the events. The outcome of the event was recovered on an unspecified date of 2021.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore at injection site, armpit and scapula; sore at injection site, armpit and scapula; sore at injection site, armpit and scapula; Fatigue; overall muscle soreness; This is a spontaneous report from a non-contactable other health care professional (patient). A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0170, expiry date: unknown) via an unspecified route of administration, administered in Left Arm on 19Apr2021 17:00 as dose 2, single (age at vaccination: 36-Years-old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ibuprofen (MOTRIN [IBUPROFEN]). The patient was allergic to Haldol. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Er8733, expiry date: unknown) via an unspecified route of administration, administered in Left Arm on 29Mar2021 05:45 PM as dose 1, single (age at vaccination:36-Years-old) for COVID-19 immunisation and experienced fatigue, muscle soreness, low grade fever, and chills. The patient was not diagnosed with covid-19 before, and was tested post vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Received Motrin medications in two weeks prior to the vaccination. On an unspecified date the patient experienced sore at injection site, armpit and scapula, fatigue, and overall muscle soreness. On an unspecific date the patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative. The patient had not received treatment for all the events. The outcome of the event was recovered on an unspecified date of 2021.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: I had an ablation of my uterus 2 -3 years ago and have not had periods; This is a spontaneous report from a contactable consumer (patient) reporting on herself. A 44-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 3248), via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:15 (At the age of 44-year-old) as single dose for COVID-19 immunization. Medical history included , endometrial ablation, amenorrhoea, inter menstrual bleeding (I had an ablation of my uterus 2 -3 years ago and have not had periods or have had very little spotting) from an unknown date. There were no concomitant medications. The patient had no known allergies. The patient had not tested covid prior to vaccination and post vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, (Batch/Lot Number was unknown) as single dose for COVID-19 immunization. The patient experienced had an ablation of my uterus 2 -3 years ago and have not had periods or have had very little spotting. following the second dose and on my cycle, my period is very, very heavy like before had an ablation on 18Apr2021 10:00. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021325918 Same patient, same drug, different event (split)
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Lethargy, Pyrexia, Tremor
Clinical narrative: mild fever; Lethargy; chills; shaking; reduced appetite; .This is a spontaneous report from a contactable consumer or other non hcp. A 24-years-old (non-pregnant) female patient received bnt162b2 (BNT162B2, PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number-not reported) via an unspecified route of administration, administered in Arm Left on 20Apr2021 12:00 as DOSE 2, SINGLE (at age 24-year-old) for covid-19 immunisation. Patient medical history included colitis ulcerative, anaemia, obesity, asthma exercise induced all were from an unknown date and unknown if ongoing. Patient had not diagnosed with covid prior vaccination and had not been tested covid post vaccination. Concomitant medications (medication within 2 weeks) included alprazolam (XANAX), omeprazole, alprazolam, fluoxetine all were taken for an unspecified indications, start and stop dates were not reported. Patient had not received any other vaccine in four weeks. Patient previously received dose 1 of BNT162B2, PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number-not reported) via an unspecified route of administration, administered in Arm right on 30Mar2021 12:00 PM as DOSE 1, SINGLE for covid-19 immunisation. On 21Apr2021 at 12:00 AM (12 hours after the dose) patient experienced mild fever, lethargy, chills, shaking, reduced appetite. Severity is similar with a very mild flu. Needed to rest more, but able to continue work as usual. The outcome of events were not recovered.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Vitamin B12 deficiency, Vitamin B6 deficiency
Clinical narrative: swollen lymph node under my armpit under the arm and it is just on the side where I got the shot.; The day of the shot that night I did feel a little tired and mild chills and same the next day Monday 19th, I did feel tired and mild chills; The day of the shot that night I did feel a little tired and mild chills and same the next day Monday 19th, I did feel tired and mild chills; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0161; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Left on 18Apr2021 (at the age of: 65-years-old) as dose 2, single for covid-19 immunisation. Medical history included pulmonary embolism from an unknown date and unknown if ongoing. Concomitant medication(s) included warfarin (WARFARIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that she just had her second Pfizer COVID-19 shot on this past Sunday on 18Apr2021 and she did wanted to call and report a slight side effect and that is the day of the shot that night she did feel a little tired and mild chills and same the next day Monday on 19th, she did feel tired and mild chills and it wasn't until like. Tuesday, on 20Apr2021, she noticed the swollen glands under her arm. swollen lymph node under her armpit under the arm and it is just on the side where she got the shot. She stated that you are a pharmacist, so she just wondered, should she also talk to her doctor about swollen glands under her arms, it is just under one arm or do you know or can you say will that just go away, resolve on its own and she should not worry about it. She had some lab test within a last year it was a blood work. It was found to have vitamin D deficiency, B6 and B12 deficiency for which she was taking the supplement now. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D deficiency
Clinical narrative: swollen lymph node under my armpit under the arm and it is just on the side where I got the shot.; The day of the shot that night I did feel a little tired and mild chills and same the next day Monday 19th, I did feel tired and mild chills; The day of the shot that night I did feel a little tired and mild chills and same the next day Monday 19th, I did feel tired and mild chills; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0161; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Left on 18Apr2021 (at the age of: 65-years-old) as dose 2, single for covid-19 immunisation. Medical history included pulmonary embolism from an unknown date and unknown if ongoing. Concomitant medication(s) included warfarin (WARFARIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that she just had her second Pfizer COVID-19 shot on this past Sunday on 18Apr2021 and she did wanted to call and report a slight side effect and that is the day of the shot that night she did feel a little tired and mild chills and same the next day Monday on 19th, she did feel tired and mild chills and it wasn't until like. Tuesday, on 20Apr2021, she noticed the swollen glands under her arm. swollen lymph node under her armpit under the arm and it is just on the side where she got the shot. She stated that you are a pharmacist, so she just wondered, should she also talk to her doctor about swollen glands under her arms, it is just under one arm or do you know or can you say will that just go away, resolve on its own and she should not worry about it. She had some lab test within a last year it was a blood work. It was found to have vitamin D deficiency, B6 and B12 deficiency for which she was taking the supplement now. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin disorder
Clinical narrative: Very itchy on her arm at the place she got the vaccine shot; Hard piece of skin, when she touches it, it was not the normal skin like on her other arm, it was itchy, it was like a hard skin; This is a spontaneous report received from a contactable consumer. A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 20Apr2021 between 8:30 to 9:00 (age at vaccination was 75 years) as dose 2, single for covid-19 immunisation. The relevant medical included high cholesterol (condition for about 20 years), blood pressure (condition for 25 years) and problem with the thyroid (for 4 to 5 years, some nodules in her thyroid, had a biopsy and treated with unspecified medication), all ongoing since an unspecified date. Family history included cancer for mother, father and sister. The concomitant medications included calcitriol (ZAVITROL) ongoing since 2020 for thyroid, atenolol ongoing since 2011 for blood pressure, amlodipine besilate (AMLOPRES) ongoing since an unspecified date for blood pressure, rosuvastatin for triglyceride and high cholesterol ongoing since 2016, COLECALCIFEROL (VITAMIN D3) for bone problems ongoing since 2020 and zinc sulfate (UNIZINCO) for thyroid problem ongoing since 2021. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in left arm, upper left arm on 30Mar2021 between 4:00 to 5:00 PM as dose 1, single for covid-19 immunisation with no adverse events. Prior vaccinations within 4 weeks were reported as none. On 20Apr2021, around 7 or 8 in the evening, the patient experienced very itchy on her arm at the place she got the vaccine shot and had a hard piece of skin, when she touches it, it was not the normal skin like on her other arm, it was itchy, it was like a hard skin. It was reported that, the conditions still itchy and hard, but not like yesterday. The reporter reported that, she said her mother shot was 20Apr2021 in the morning at 8:00. Around 7 or 8 in the evening she said her mother complained of being very itchy. The caller said do not touch was, but her mother scratched it a little then did not touch it. She said yesterday it was very itchy. The caller said she gave her mother 2 Tylenol in the day, 2 Tylenol at night, but her mother was still itchy and hard, but not like yesterday. The caller says she is concerned, her mother wants to know if she should ask if it was important, her mother was afraid of the side effects. The caller said the side effect was worse yesterday, today it was not very itchy, her mother complains about the skin she has, today it was a little bit better. The treatment medication included paracetamol (TYLENOL) in the day and at night. The outcome of the events was reported as not recovered.  No follow-up attempts are needed. No further information is expected.