chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Myalgia, Pyrexia, Thirst
Clinical narrative: fatigue; malaise; I then noticed a set of flu-like symptoms; pain at injection site; muscle pain; joint pain; fever; chills; increased thirst; increased appetite; insomnia; This is a spontaneous report from a non-contactable consumer. This male consumer (patient) reported that: A 31-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 19Feb2021 at 11:45 as single dose for covid-19 immunisation. Medical history included known peanuts allergy. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included colecalciferol (D3) and cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrim and experienced drug allergy. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 29Jan2021 at 11:45 as single dose for covid-19 immunisation. Patient reported shortly after the injection was administered on 19Feb2021 at 13:00, I experienced fatigue and malaise. I then noticed a set of flu-like symptoms that persisted for around two days. These included pain at injection site, muscle pain, joint pain, fatigue, fever, chills, increased thirst, increased appetite, insomnia. All have resolved except the pain at the injection site. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The outcome of the event pain at the injection site was recovering and all other events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fatigue; malaise; I then noticed a set of flu-like symptoms; pain at injection site; muscle pain; joint pain; fever; chills; increased thirst; increased appetite; insomnia; This is a spontaneous report from a non-contactable consumer. This male consumer (patient) reported that: A 31-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 19Feb2021 at 11:45 as single dose for covid-19 immunisation. Medical history included known peanuts allergy. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included colecalciferol (D3) and cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrim and experienced drug allergy. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 29Jan2021 at 11:45 as single dose for covid-19 immunisation. Patient reported shortly after the injection was administered on 19Feb2021 at 13:00, I experienced fatigue and malaise. I then noticed a set of flu-like symptoms that persisted for around two days. These included pain at injection site, muscle pain, joint pain, fatigue, fever, chills, increased thirst, increased appetite, insomnia. All have resolved except the pain at the injection site. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The outcome of the event pain at the injection site was recovering and all other events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: her arm got red 5 days after the vaccine; This is a spontaneous report from a Pfizer-sponsored program via Medical Information team. A contactable reporter (patient) reported for herself that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration in arm on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, peanuts. The patient's concomitant medications were not reported. The patient's arm got red 5 days after the vaccine on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Nasopharyngitis, Sinus pain
Clinical narrative: pressure on her chest; headache/ bad headache; cold symptoms; sinus pain; This is a spontaneous report from a non-contactable consumer (patient) via a medical information team. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in the patient experienced pressure on her chest, bad headache, cold symptoms and sinus pain. All of it went away yesterday. However, she is still experiencing the headache. Patient was due to get the second dose. Her daughter got tested for COVID-19 since possibly exposed to the virus. Therefore, the patient may have been exposed too. The outcome of the event headache was not recovered, and rest events was recovered on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Vaccination site pain
Clinical narrative: her face feels a little warm and flush; headache; injection site pain in my left arm; This is a spontaneous report from a non-contactable consumer (parent). A 32-year-old female patient(daughter) received 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 left arm on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporter 32 y/o daughter had the Pfizer covid vaccine today, her face feels a little warm and flush, she doesn't look red, she's had reaction, no temperature, doesn't look flushed. reporter gave her Tylenol and advil, she took one of each. Daughter states that, she have a headache at this point, a little flush, injection site pain in my left arm. Her arm feels a little better. Her head is still in pain. Is it normal, can she take an antihistamine or what you would recommend. Can she take a Benadryl. Therapeutic measures were taken as a result of her face feels a little warm and flush, headache, injection site pain in my left arm. The outcome for event injection site pain in my left arm was recovering, outcome for event headache was not recovered and outcome for event her face feels a little warm and flush was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pruritus, Swelling
Clinical narrative: Swelling; hot to touch; itchy at injection site; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in right arm on 12Feb2021 at 10:00 (at the age of 79-year-old) as dose 1, single for COVID-19 immunisation at doctor's office/urgent care. Medical history included allergy to sulfa from an unknown date and unknown if ongoing. Concomitant medications included metoprolol, omeprazole, lovastatin, hydrochlorothiazide, triamterene (TRIAMTERENE/HYDROCHLOROTHIAZIDE) all from unknown dates to unknown dates for unknown indications. The patient previously took keflex [cefalexin], clindamycin, flonase [fluticasone propionate] and experienced drug hypersensitivity. Historical vaccine included dpt vaccine administrated in left arm on 01Feb2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced swelling, hot to touch, itchy at injection site, starting on 21Feb2021 at 10:00, and continuing. The patient did not receive any treatment for the events. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Injection site soreness; Rash all over upper body since injection; Very itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:15 (at the age of 58-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient had no known allergies. Patient reported that injection site soreness 1 week. Rash all over upper body since injection. 12 days now. Very itchy (11Feb2021 12:00 AM). Patient visited doctor or other healthcare professional office/clinic. There was no treatment for the events. The patient underwent lab tests and procedures which included COVID test/Nasal Swab: negative on 12Feb2021. The clinical outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rash erythematous
Clinical narrative: red rash on lower inner sides of feet, and toes; Psoriasis patch on eyeline; This is a spontaneous report from a contactable consumer (Patient). An elderly non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), Solution for injection, via an unspecified route of administration, administered in Arm Right on 18Feb2021 13:00 as single dose for covid-19 immunisation. Medical history included osteoarthritis, blepharitis, angle closure glaucoma, colitis, psoriasis and latex sensitivity allergy. There were no concomitant medications. Patient did not receive any other vaccine with four weeks of Pfizer vaccine. He did not receive any other medication in two weeks. Patient was not diagnosed with COVID-19 prior to receiving Pfizer vaccine. He was not tested for COVID-19 since vaccination. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302) via an unspecified route of administration, administered in Arm Right on 28Jan2021 at 10:15 AM for COVID-19 immunisation. On 20Feb2021 23:00, the patient experienced red rash on lower inner sides of feet, and toes and psoriasis patch on eyeline. It was reported that patient had red rash on lower inner sides of feet, and toes. 1-1/2" band from heel to mid foot, also bottom of feet Psoriasis (?) patch or ?? raised bumps centered on lower back starting 2" below waistline on 3" long , 1-/2" wide and psoriasis patch on eyeline. The outcome of event was not recovered.   Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pruritus, Vaccination site swelling
Clinical narrative: Mild headache; Mild itching; Swelling at injection site; This is a spontaneous report from a contactable consumer or non-health care professional (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Left arm on 20Feb2021 05:15 PM (at the age of 66-year-old) as dose 2, single for covid-19 immunization at Doctor's office/urgent care. Medical history included HBD (High blood pressure), pre-diabetes and high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included other medications taken within two weeks included Amlodipine besilate, Olmesartan medoxomil (AMLODIPINE AND OLMESARTAN MEDOXOMIL), Metformin taken as 500 mg and Famotidine all were taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Left arm on 30Jan2021 (at the age of 66-year-old) as single for COVID-19 immunization. Patient neither diagnosed with COVID-19 prior to vaccination nor tested since the vaccination. On 21Feb2021 09:00 AM, the patient experienced mild headache, mild itching and swelling at injection site. AE was not resulted in physician visit or ER. No treatment was received for the events. Outcome of the events were recovered on an unspecified date in 2021.  Information about Lot Number/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pruritus, Vaccination site swelling
Clinical narrative: pain; itching; swelling at injection site; headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 30Jan2021 17:45 as dose 1, single for COVID-19 immunization (at the age of 68-year-old, non-pregnant). Medical history included diabetes mellitus, high cholesterol and no known allergies. Concomitant medication(s) (in two weeks) included metformin. Patient did not receive any other vaccine in four weeks. Patient had no covid prior vaccination and was not covid tested post vaccination. The patient experienced pain, itching, swelling at injection site and headache on 31Jan2021. Patient did not receive treatment for the events. The outcome of the events was recovered.  Information on Lot/Batch number has been requested  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting; Aches; slight fever; tired; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in arm left on 21Feb2021 at 16:30 (04:30 PM) (at the age of 47-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included birth control, COVID-19 (COVID prior vaccination: Yes). The patient had no known allergies. The patient concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE) taken for birth control, start and stop date were not reported. The patient did not receive any other vaccine within four weeks. The patient was diagnosed with COVID-19 prior vaccination. Patient had not COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in arm left on 31Jan2021 at 16:00 (04:00 PM) (at the age of 47-year-old) as dose 1, single for COVID-19 immunization. On 22Feb2021 at 11:30 AM, the patient experienced vomiting, aches, slight fever, tired. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Lethargy, Pain
Clinical narrative: Abdominal pain; diarrhea; body aches; lethargic; chills; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL9263), dose 1 via an unspecified route of administration, administered in arm left on 20Jan2021 at 13:00 (at the age of 76-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient had known sulfa and penicillin allergies and other medical history hypertension (HTN) from an unknown date and unknown if ongoing. Patient was received other medications (unknown) in two weeks. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient experienced abdominal pain, diarrhea, body aches, lethargic and chills on 09Feb2021 at 19:00. It was reported that it was unknown if the patient received any treatment for the events. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dysgeusia, Headache, Pain in extremity
Clinical narrative: Headache; dizziness; taste of metal in mouth; heaviness in chest/tightness in chest; sore arm; This is a spontaneous report from a contactable consumer. This 67-Year-Old female consumer (patient) reported that: A 67-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 20Feb2021 (at the age of 67-year-old) as single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included stable tiny right apical nodule and allergy to sulfa drugs and Penicillin. Patient not diagnosed with covid-19 prior to vaccination. Patient was not received any other vaccine four weeks prior vaccination. Patient received unspecified medication two weeks prior vaccination. The patient experienced Headache, dizziness, taste of metal in mouth, sore arm, tightness in chest and heaviness in chest on 07Feb2021. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: a slight headache; fever; This is a spontaneous report from a Pfizer-sponsored program  Support from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller had her first shot of COVID-19 vaccine yesterday (20Feb2021). She reported that she experienced a slight headache and then fever as well. She was also asking whether she could take Advil. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Ear pain, Ear swelling, Nausea, Vertigo
Clinical narrative: Vertigo; Its swollen base of my left ear down to my jaw, mandible particular and when I open my mouth I can feel like pain; Its swollen base of my left ear down to my jaw, mandible particular and when I open my mouth I can feel like pain; Chills; Nauseated; This is a spontaneous report from a contactable physician (Patient).  A 74-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BOTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 31May2021), via an unspecified route of administration, administered in Arm Right on 10Feb2021 (Age at vaccination: 74-years-old) as dose 1 single for covid-19 immunization. Medical history included Chronic Otitis Media from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ), lisinopril (LISINOPRIL) both taken for an unspecified indication from an unspecified start date and ongoing. It was reported that patient had his first Pfizer vaccine dosage yesterday although he did not have any immediate allergic reactions within the first 15min, after 15 minutes he started getting chills, he had vertigo and he was nauseated so he laid down rest of the day. This morning his symptoms were pretty much same and its swollen base of his left ear down to his jaw, mandible particular and when he open his mouth he can feel like pain. he suffer from Chronic Otitis Media. It was reported maxilla, mandible, his ear to there, its swollen, if he open his mouth wide, it hurts little bit on that side. Stated hard to say all he know was approximately 30 min after the injection, it was terrible the jaw swelling does not bother me that much than he stand up he feel vertigo. Patient did no received treatment for the events. The outcome for the events was reported as not resolved at the time of this report.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced severe allergic reaction after the first dose on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021193923 same patient, different drug/AE
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Severe night time nose bleed 2 weeks after first Pfizer COVID vaccination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 08Feb2021 09:45 (at the age of 59-year-old) at dose 1, single for covid-19 immunisation. Medical history included diabetic, high blood pressure, obese (other medical history). Patient Known allergies were none. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Concomitant medications included lisinopril (LISINOPRIL) 5 mg; metformin (METFORMIN) 500; pantoprazole (PANTOPRAZOLE) 40 mg (Other medications in two weeks). On 23Feb2021 01:00 the patient experienced severe night time nose bleed 2 weeks after first pfizer covid vaccination. Adverse event led to Doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received treatment for the adverse event. Outcome of the event was unknown.   Information about Lot/batch number has been requested.  Follow-up (06Apr2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Hyperhidrosis, SARS-CoV-2 antibody test
Clinical narrative: mild headache for 3 days after Dose 2; Initial fatigue; diaphoresis; bilateral axillary pain; This is a spontaneous report from a contactable physician. A 37-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL1283, Expiry date: Unknown) via intramuscular route of administration on 08Jan2021 12:00 in left arm as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. There were no other vaccines within 4 weeks. No COVID prior vaccination. There were no known allergies. Covid tested post vaccination. On 18Dec2020 12:00 PM, the patient administered first dose of bnt162b2 intramuscularly in left arm (lot number: EK5730) for COVID-19 immunisation. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced initial fatigue, mild headache for 3 days after dose 2, as commonly described. Starting about 7-10 days after dose 2, diaphoresis, fatigue, bilateral axillary pain continued for 10 days, and recurring now in late Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient took antipyretics as treatment. The patient underwent lab tests and procedures on an unknown date in Feb2021 which included sars-cov-2 antibody test: negative, viral test: negative. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Viral test
Clinical narrative: mild headache for 3 days after Dose 2; Initial fatigue; diaphoresis; bilateral axillary pain; This is a spontaneous report from a contactable physician. A 37-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL1283, Expiry date: Unknown) via intramuscular route of administration on 08Jan2021 12:00 in left arm as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. There were no other vaccines within 4 weeks. No COVID prior vaccination. There were no known allergies. Covid tested post vaccination. On 18Dec2020 12:00 PM, the patient administered first dose of bnt162b2 intramuscularly in left arm (lot number: EK5730) for COVID-19 immunisation. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced initial fatigue, mild headache for 3 days after dose 2, as commonly described. Starting about 7-10 days after dose 2, diaphoresis, fatigue, bilateral axillary pain continued for 10 days, and recurring now in late Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient took antipyretics as treatment. The patient underwent lab tests and procedures on an unknown date in Feb2021 which included sars-cov-2 antibody test: negative, viral test: negative. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Mobility decreased, Muscle spasms
Clinical narrative: started experiencing headaches that got worse; nausea; chills; cramps in my legs; She felt so sick; She could not move both her legs; Both her legs were aching; I had a slight fever; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 73-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10Feb2021 (also reported as 13Feb2021 07:00) as dose 1, single (at the age of 73-years-old) for COVID-19 immunization. Patient medical history included COVID-19 from an unspecified date in 2020. She was infected with the Covid-19 virus last year (2020) and got better after a month and a half. The concomitant medications were not reported. Patient asked if she did not get the second dose, will the first one be any good. She received her first Pfizer Covid-19 vaccine on last Wednesday (10Feb2021). However, she stated it was 13Feb2021 around 07:00. She experienced some bad side effects. She went to work and about 2 or 3 in the afternoon started experiencing headaches that got worse, nausea, and chills, that Wednesday night she felt so sick and both her legs were aching, she could not move both her legs on 10Feb2021. The cramps in her legs subsided the next day (11Feb2021) after taking some Flexiril. She had a slight fever on an unspecified date in Feb2021. She asked should she take the second vaccination. The outcome of the event cramps in her legs was resolved on 11Feb2021, while that of the other events was unknown.   Information for lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: started experiencing headaches that got worse; nausea; chills; cramps in my legs; She felt so sick; She could not move both her legs; Both her legs were aching; I had a slight fever; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 73-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10Feb2021 (also reported as 13Feb2021 07:00) as dose 1, single (at the age of 73-years-old) for COVID-19 immunization. Patient medical history included COVID-19 from an unspecified date in 2020. She was infected with the Covid-19 virus last year (2020) and got better after a month and a half. The concomitant medications were not reported. Patient asked if she did not get the second dose, will the first one be any good. She received her first Pfizer Covid-19 vaccine on last Wednesday (10Feb2021). However, she stated it was 13Feb2021 around 07:00. She experienced some bad side effects. She went to work and about 2 or 3 in the afternoon started experiencing headaches that got worse, nausea, and chills, that Wednesday night she felt so sick and both her legs were aching, she could not move both her legs on 10Feb2021. The cramps in her legs subsided the next day (11Feb2021) after taking some Flexiril. She had a slight fever on an unspecified date in Feb2021. She asked should she take the second vaccination. The outcome of the event cramps in her legs was resolved on 11Feb2021, while that of the other events was unknown.   Information for lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body ache; Chills; fever; This is a spontaneous report from a contactable other hcp. A 40-year-old female non pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular route, administered in right arm on 22Feb2021 10:30 (age at vaccination 40-year-old, Batch/Lot Number: EN5318) as single dose for COVID-19 immunisation. The patient had no medical history. The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular route administered in right arm on 01Feb2021 09:00 AM (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. The patient experienced body ache, chills and, fever on 23Feb2021 12:00. Patient not received treatment. The No other vaccine in four weeks. Patient had no known drug allergies. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Respiratory disorder
Clinical narrative: have colds; respiratory issue; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable female consumer reported similar events for 2 patients (Herself and Husband). This is 1st of 2 reports. This female consumer reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she have colds and her 2nd dose due tomorrow. Patient was not sure if it was the right place but her husband and she have the COVID-19 Vaccine three weeks ago. We are due to have it again tomorrow but we have had enough of respiratory issue for the last week and her doctor said she thought it would be best if we postpone taking the second dose for at least two weeks and she was trying to let them know that we can't come tomorrow for the appointment to get our second injection and how will that affect us as far as being protected if we wait another 2 weeks. Patient need to cancel the appointment for our second injection that would be done in the (facility address). The outcome of the events was unknown.     Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021199395 Different patient, same drug and event
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Respiratory disorder
Clinical narrative: have colds; respiratory issue for the last week; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients (Herself and Husband). This is 2nd of 2 reports. This consumer reported for a male patient (husband) that:  A male patient of unspecified age had received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had colds and their 2nd dose is due tomorrow and have had enough of respiratory issue. Consumer stated, "I am not sure if it is the right place but my husband and I have the COVID-19 Vaccine three weeks ago. We are due to have it again tomorrow but we have had enough of respiratory issue for the last week and my doctor said she thought it would be best if we postpone taking the second dose for at least two weeks and I am trying to let them know that we can't come tomorrow for the appointment to get our second injection and how will that affect us as far as being protected if we wait another 2 weeks". "I am trying to cancel the appointment, how I can I cancel this appointment. At the time of reporting, the outcome of the events were unknown.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021199393 Different patient, same drug and event
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out into a light pink colored rash on upper torso of body; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6200) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 18Feb2021 at 03:15 PM as dose 1, single for COVID-19 immunization. Medical history included known allergies to Doxycycline, Aleve, Augmentin, Benadryl cream, Steristrips; break out into rash with above products. Concomitant medications included levothyroxine; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); Bone health supplement; all taken for an unspecified indication, start and stop date were not reported. The patient previously took Doxycycline, Aleve, Augmentin, Benadryl cream experienced allergy. Reported facility type vaccine was Public Health Clinic/Veterans Administration facility. No Covid prior vaccination was reported. The patient not tested Covid post vaccination. The patient received no other vaccine in four weeks. On 18Feb2021 at 09:00 PM the patient experienced broke out into a light pink colored rash on upper torso of body. The patient received no treatment for the adverse event. The clinical outcome of the event was recovered by morning of Saturday, on 20Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: fever; sore arm; This is a spontaneous report from a non-contactable other healthcare professional (nurse). A female patient of (Age: 74; Unit Unknown) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 19Feb2021, the patient experienced sore arm and on 21Feb2021, the patient had fever. Laboratory tests on 21Feb2021 included body temperature was 100.0 degree Fahrenheit (Fever). The patient took Tylenol. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal, Gait disturbance, Musculoskeletal discomfort
Clinical narrative: Ache at the site of application; joint pain; barely walk; hip pain; back pain; can't even get out of bed and can't even turn when she lay down; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Not reported) 21 days before the second dose for covid-19 immunisation. On an unspecified date, a few days after the second one, she had ache at the site of application but then she felt a little better. After that Friday she got very bad joint pain, she took a pain med, Aleve, and felt better. She still has joint pain and can barely walk. She also had back pain for which she applied Salonpas, and hip pain, stated she can't even get out of bed and can't even turn when she lay down. The patient inquired if was this because of the vaccine. She was wondering if she will have this pain her whole life. Therapeutic measures were taken as a result of joint pain (arthralgia) and back pain. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Ache at the site of application; joint pain; barely walk; hip pain; back pain; can't even get out of bed and can't even turn when she lay down; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Not reported) 21 days before the second dose for covid-19 immunisation. On an unspecified date, a few days after the second one, she had ache at the site of application but then she felt a little better. After that Friday she got very bad joint pain, she took a pain med, Aleve, and felt better. She still has joint pain and can barely walk. She also had back pain for which she applied Salonpas, and hip pain, stated she can't even get out of bed and can't even turn when she lay down. The patient inquired if was this because of the vaccine. She was wondering if she will have this pain her whole life. Therapeutic measures were taken as a result of joint pain (arthralgia) and back pain. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Haematuria, Headache, Urine analysis
Clinical narrative: light headache; but I still see my pee is real yellow; saw some blood in my urine; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) first dose via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as single dose and second dose via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included yeast infection and ongoing glaucoma (in my right eye so need to put on glasses to see the names of the prescriptions - preexisting condition). Concomitant medication included fluconazole (tablet, strength: 15 mg) taken for yeast infection and cefdinir (capsule, strength:300 mg). The patient stated, "I wanted to get the vaccine. People tell me not to take the vaccine but I did what I felt I needed to do for me and I am happy about it. I have not had no side effects beside a light headache and I feel good on an unspecified date. On 01Feb2021, I went for my annual check up and they saw some blood in my urine so that's when they gave me the first antibiotic (name not provided) and I took all of them but I still see my pee is real yellow. I decided to call my doctor the other day after my second Pfizer vaccine dose on last Wednesday, 17Feb2021, and they called in these antibiotics that I just picked up: fluconazole and cefdinir (note: When looking up antibiotic names, she stated "I have glaucoma in my right eye so need to put on glasses to see the names of the prescriptions - preexisting condition). They think it's a yeast infection. I have called my doctor to see if it was ok to start taking these but decided to call you as well. I will wait for them to call me back. The patient underwent lab tests and procedures which included urine analysis: some blood in my urine on 01Feb2021.Therapeutic measures were taken as a result of but I still see my pee is real yellow and saw some blood in my urine. The outcome of the event "but I still see my pee is real yellow" was not recovered and other events was unknown.   Follow-up attempts completed. No further information expected; Information about lot/Batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Sinusitis
Clinical narrative: About two hours later from injection, my right sinus became inflamed; skin became itchy and red. Started with my left arm and then spread to my chest and neck; skin became itchy and red. Started with my left arm and then spread to my chest and neck; This is a spontaneous report from a contactable consumer. This 32-year-old non pregnant female consumer(patient) reported for herself. A 32-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: E19266) via an unspecified route of administration in arm left on 21Feb2021 14:30 as dose 1, single (age at vaccination: 32 years) for COVID-19 immunisation. Medical history included known allergies: walnuts, cats, environmental, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination and did not tested covid post vaccination. On 21Feb2021 2:30PM, the patient experienced after first dose- skin became itchy and red. Started with my left arm and then spread to my chest and neck. About two hours later from injection, my right sinus became inflamed and stayed like that. Seems to be resolving slowly. Treatment received was benedryl. The clinical outcome of the events was resolving.   Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A female consumer (patient) reported for herself. A 73-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EN6200, expiration date not reported), age at the vaccination age of 73, via an unspecified route of administration, left arm, on Feb 18, 2021, 10:45, single dose, for COVID-19 immunisation. The patient has no known allergies. Concomitant medication not reported. The patient had a horrible rash all over body, privates and head on Feb 18, 2021. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The outcome of the event: not recovered. Follow-up (Jun 17, 2021): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: she had itching both ears and throat; she broke out in a rash, first on her left knee, then on her left leg, then on her right knee, now it's also on her back; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EL9267) via an unspecified route of administration in left arm on 21Feb2021 14:30 as single dose for COVID-19 immunisation. Medical history included crps (Complex regional pain syndrome), svt- super ventricular and allergies to wheat. Concomitant medications included naproxen sodium (ALEVE). Patient previously took codeine and experienced with Allergies. On 21Feb2021 patient stated that she broke out in a rash, first on her left knee, then on her left leg, then on her right knee, now it's also on her back and a little on chest and arms. This morning on 23Feb2021 she had itching both ears and throat. Therapeutic measures were taken as a result of events and the patient took the treatment. The outcome of events was not recovered.  Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: I then had a high fever; body aches; I got intense arm pain; a headache; This is a spontaneous report from a contactable consumer or other non health care professional. A 38-years-old non-pregnant female patient received bnt162b2 (solution for injection, Age at Vaccination: 38-years), dose 1 via an unspecified route of administration, administered in Arm Left on 21Feb2021 12:15 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization at Doctors office/urgent care. Medical history included covid-19 from an unknown date in January month and unknown if ongoing. The patients concomitant medications were not reported. There were no allergies. No other vaccine in four weeks. It was unknown that covid tested post vaccination. The patient experienced intense arm pain and headache on 22Feb2021 at 12:00. The headache continued the following day. The patient had a high fever and body aches on 23Feb2021. No treatment was required for adverse events (AE). The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.