chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: had a severe pain in upper left hip; hurt to lift my left leg up (while taking a step forward); This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular in the left arm on 24Dec2020 08:15AM at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included lyme disease from 2014. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive other vaccines in last four weeks. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 25Dec2020 07:30AM, the patient had a severe pain in upper left hip. It felt like an IT band issue she had before but this time it didn't radiate to her knee like it usually does. She did not have exercise since the morning of the 22nd when she did an upper body weight-lifting session. She took ibuprofen that took the edge off, and she was able to finish her day as a nurse in the Covid ICU. The following morning, she felt fine and went to her other job. She was fine in the morning during her usual drills practicing getting out of the helicopter while on the ground. She sat in one of the seats for about 15 minutes while having a discussion when she started to feel the pain again. She got out of the helicopter and tried to walk around, but it hurt to lift her left leg up (while taking a step forward) in Dec2020. She has never experienced this before. She limped back to the hanger, took ibuprofen 600mg and rested/stretched for an hour. The pain was reduced to a minor and tolerable ache. The outcome of the events was recovering. The report was considered non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypogeusia, Hyposmia, Mental disorder
Clinical narrative: Weird mental fog where she was lightheaded and dizzy; Weird mental fog where she was lightheaded and dizzy; Taste was diminished as well as her smell; Taste was diminished as well as her smell; Arm soreness; fatigue; This is a spontaneous report from a contactable physician (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2, via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The physician said she had the first dose of the COVID vaccine on 23Dec2020 (last Wednesday). She had arm soreness and fatigue the next day on 24Dec2020, but it was fine. Over the weekend she had less common symptoms. She had read on blogs that this could be vaccine related. She felt overall very well, but was wondering how long these symptoms should last? Three days after getting the vaccine she had a weird mental fog where she was lightheaded and dizzy on 26Dec2020. It was a weird sensation. She stayed in bed most of the day and did not do much. Saturday and Sunday she felt like her taste was diminished as well as her smell on 26Dec2020. It was still occurring this morning too. It was very noticeable that her taste and smell are diminished. She was wondering how long these things will last? The outcome of the events arm soreness and fatigue was recovered in Dec2020. The outcome of the events taste was diminished as well as her smell was not recovered. The outcome of the other events was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Weird mental fog where she was lightheaded and dizzy; Weird mental fog where she was lightheaded and dizzy; Taste was diminished as well as her smell; Taste was diminished as well as her smell; Arm soreness; fatigue; This is a spontaneous report from a contactable physician (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2, via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The physician said she had the first dose of the COVID vaccine on 23Dec2020 (last Wednesday). She had arm soreness and fatigue the next day on 24Dec2020, but it was fine. Over the weekend she had less common symptoms. She had read on blogs that this could be vaccine related. She felt overall very well, but was wondering how long these symptoms should last? Three days after getting the vaccine she had a weird mental fog where she was lightheaded and dizzy on 26Dec2020. It was a weird sensation. She stayed in bed most of the day and did not do much. Saturday and Sunday she felt like her taste was diminished as well as her smell on 26Dec2020. It was still occurring this morning too. It was very noticeable that her taste and smell are diminished. She was wondering how long these things will last? The outcome of the events arm soreness and fatigue was recovered in Dec2020. The outcome of the events taste was diminished as well as her smell was not recovered. The outcome of the other events was unknown.  Information on the Batch/Lot number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: Severe headache; Nausea; Sweats; Fatigue; This is a spontaneous report from a non-contactable physician. A 38-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular in arm left on 18Dec2020 08:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included eczema. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cetirizine hydrochloride (ZYRTEC).  The patient experienced 'Severe headache with nausea Sweats Fatigue' on 19Dec2020 09:00.  Case was non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of events (Tylenol, Naproxen). The outcome of the events was recovered in Dec2020.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Got first vaccine dose on the 18th and came out Covid test positive; Got first vaccine dose on the 18th and came out Covid test positive; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown) via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose on the 18th, and she came out Covid test positive yesterday (unspecified date in Dec2020). She wanted to know if she should get the second vaccine or what is the protocol into that. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with COVID after receiving first dose of COVID-19 Vaccine; Diagnosed with COVID after receiving first dose of COVID-19 Vaccine; This is a spontaneous report from a contactable nurse (patient).  A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number PAA156051, expiration date unknown), via an unspecified route of administration on 15Dec2020 16:00 at a single dose at the right arm for COVID-19 immunization. The patient has no medical history, no family medical history and no concomitant medications.  The patient is a nurse in the Emergency Room. She had a first dose of COVID-19 vaccine on 15Dec2020. She was diagnosed with COVID after receiving first dose of COVID-19 vaccine on 23Dec2020. Due for second dose of COVID-19 vaccine on 04Jan2021. She wanted to know if she should go through with second dose if her symptoms subside. The COVID swab was done in the Emergency Room and was not admitted to hospital.  The outcome of the event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported similar events for 2 patients. This is a 2nd of two reports. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on 14Dec2020 at single dose for covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The reporter was a pharmacist asking if there was a contraindication for administering antibody therapy to a person after they had received the first dose of the covid vaccine. He reported that there was a patient that received the covid vaccine the week of 14Dec and subsequently tested positive for covid on the 23rd and 24th of December. The reporter was trying to determine the safety of administering antibody therapy for the patient even though the patient already got the first vaccine dose.  The reporter reported this question had some urgency and needed the information within 48 hours. The patient underwent lab tests and procedures which included covid test: positive on 23Dec2020, positive on 24Dec2020. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the COVID test positive and vaccination with BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2020516319 same reporter/ drug/ AE, different patient
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730), intramuscular in left arm on 16Dec2020 10:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included none. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included influenza vaccine (FLU) on 01Dec2020 at single dose for immunization. The patient experienced rash (non-serious) on 16Dec2020 16:00. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of rash (Benadryl). The outcome of event was recovered in Dec2020.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fatigue; muscle soreness at site; muscle ache; mild joint pain; fever 100.1; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 12:00 at single dose at left arm for COVID-19 immunization. Medical history included known allergies: Penicillin, erythromycin. Concomitant medication received in two weeks included melatonin. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 15:00 (03:00 PM), the patient experienced fatigue, muscle soreness at site, muscle ache, mild joint pain, fever 100.1. Treatment received for the adverse events included Acetaminophen. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fatigue; muscle soreness at site; muscle ache; mild joint pain; fever 100.1; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 12:00 at single dose at left arm for COVID-19 immunization. Medical history included known allergies: Penicillin, erythromycin. Concomitant medication received in two weeks included melatonin. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 15:00 (03:00 PM), the patient experienced fatigue, muscle soreness at site, muscle ache, mild joint pain, fever 100.1. Treatment received for the adverse events included Acetaminophen. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: severe sore arm in limb it was given; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), intramuscular in the right arm on 23Dec2020 10:15 at a single dose for COVID-19 immunization. The patient has no other medical history. The patient has no known allergies. The patient has no COVID prior vaccination, and COVID was not tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), escitalopram oxalate (LEXAPRO), and vitamin c (ascorbic acid). The patient has no other vaccine in the past four weeks. On 23Dec2020 01:00 PM, the patient experienced severe sore arm in limb it was given (by nighttime she was almost unable to use her right arm, improved by next morning), nausea, and fatigue. The outcome of the events was recovered in Dec2020. No treatment was received for the adverse events. The report was considered non-serious.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: mild nausea (on a scale of 1 to 5 ---like 2 to 3); little light headed (2 on a scale of 1 to 5); This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 28Dec2020 10:00 at a single dose for COVID-19 immunization. Medical history included Epstein Barr, shingles in Oct2020 (2 months previous), detached retina in 2016 (4.5 years ago), and covid prior vaccination. There is no covid test done post vaccination. The patient's concomitant medications were not reported. The patiently previously had allergies to gentamycin. On 28Dec2020 12:00, the patient just had some mild nausea (like 2 to 3 on a scale of 1 to 5) and a little lightheaded (2 on a scale of 1 to 5). There is no treatment received for the adverse events. The outcome of the events was recovering. The report is considered non-serious.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in the last four weeks. Concomitant medications included omeprazole (PRILOSEC), metoprolol, levothyroxine sodium (SYNTHROID), aciclovir sodium (ACYCLOVIR VIAL), and meloxicam (MOBIC). The patient previously had allergies with morphine. On 28Dec2020, the patient experienced dizziness 12 hours after injection with outcome of recovering. The patient did not receive treatment for the reported adverse event. The report was considered non-serious.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Sedation, Speech disorder
Clinical narrative: headaches; kinda unwell; difficulty in finishing sentences; feeling drugged; This is a spontaneous report from a contact physician (patient) from a Pfizer-sponsored program Pfizer First Connect. A female patient of unspecified age received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. After taking the Covid-19 vaccine, she's experiencing headaches, kinda unwell, difficulty in finishing sentences, and feeling drugged. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; This is a spontaneous report from a contactable other HCP (patient herself).  This 28-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route of administration, on 19Dec2020 at 15:00 at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant.  Relevant medical history included sinus tachycardia and obstructive sleep apnea.  Patient's Body mass index (BMI) is more than 35. No known allergies. Relevant concomitant medications included ibuprofen. The patient was vaccinated at Clinic, age at vaccination was 28-year-old. No other vaccine was received in four weeks.  Pre-vaccination and post-vaccination COVID tests were not performed. On 28Dec2020, at 12:30, the patient developed tenderness, redness, and swollen at injection site, approximately 2 inches by 1 inch in size. The patient was not treated for the events.  The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Night sweats, Pain, Pain in extremity
Clinical narrative: Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EJ1685), via an unspecified route of administration, on 18Dec2020 at 02:45 PM at single dose for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 42-years-old. No other vaccine was received in four weeks. Medical history included prior to vaccination the patient diagnosed with COVID-19 and known allergies were Penicillin (PCN), ephedrine, calamine, calendula, pollen. Concomitant medications included escitalopram 10mh. On 19Dec2020 at 07:00 AM, the patient experienced sore arm, nocturnal diaphoresis, generalized mild pain, fatigue. The events were reported as non-serious. The patient recovered in Dec2020 form the events. No treatment was received.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over belly; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: rash all over belly (non-serious).  The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Cold sweat, Decreased appetite
Clinical narrative: weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath; nausea; vomiting when exercised; headache; Sore arm; chills; no appetite; clammy hands/clammy hands and feet; very sore at injection site; This is a spontaneous report from a contactable other HCP (patient) reported for himself. A 48-years-old male patient received first dose of BNT162B2, via intramuscular in left arm on 21Dec2020 10:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included known allergies: Shellfish, Corn, Whitefish. The patient's concomitant medications were none. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. The patient experienced no appetite, clammy hands, very sore at injection site on 21Dec2020 (reported as day 1), sore arm, no appetite, clammy hands and feet, chills on 22Dec2020 (reported as day 2), no appetite, nausea, vomiting when exercised, headache, clammy, chills on 23Dec2020 (reported as day 3), no appetite, nausea, stomach cramps, headache, felt out of breath, clammy, chills on 24Dec2020 (reported as day 4), tired, clammy, headache on 25Dec2020 (reported as day 5) and symptoms resolved but weak from lack of nutrition on 26Dec2020 (reported as day 6). No treatment was received for all the events. The outcome of the events was recovered in Dec2020.  The information on the Lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Malnutrition, Nausea
Clinical narrative: weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath; nausea; vomiting when exercised; headache; Sore arm; chills; no appetite; clammy hands/clammy hands and feet; very sore at injection site; This is a spontaneous report from a contactable other HCP (patient) reported for himself. A 48-years-old male patient received first dose of BNT162B2, via intramuscular in left arm on 21Dec2020 10:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included known allergies: Shellfish, Corn, Whitefish. The patient's concomitant medications were none. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. The patient experienced no appetite, clammy hands, very sore at injection site on 21Dec2020 (reported as day 1), sore arm, no appetite, clammy hands and feet, chills on 22Dec2020 (reported as day 2), no appetite, nausea, vomiting when exercised, headache, clammy, chills on 23Dec2020 (reported as day 3), no appetite, nausea, stomach cramps, headache, felt out of breath, clammy, chills on 24Dec2020 (reported as day 4), tired, clammy, headache on 25Dec2020 (reported as day 5) and symptoms resolved but weak from lack of nutrition on 26Dec2020 (reported as day 6). No treatment was received for all the events. The outcome of the events was recovered in Dec2020.  The information on the Lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain, Vomiting
Clinical narrative: weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath; nausea; vomiting when exercised; headache; Sore arm; chills; no appetite; clammy hands/clammy hands and feet; very sore at injection site; This is a spontaneous report from a contactable other HCP (patient) reported for himself. A 48-years-old male patient received first dose of BNT162B2, via intramuscular in left arm on 21Dec2020 10:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included known allergies: Shellfish, Corn, Whitefish. The patient's concomitant medications were none. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. The patient experienced no appetite, clammy hands, very sore at injection site on 21Dec2020 (reported as day 1), sore arm, no appetite, clammy hands and feet, chills on 22Dec2020 (reported as day 2), no appetite, nausea, vomiting when exercised, headache, clammy, chills on 23Dec2020 (reported as day 3), no appetite, nausea, stomach cramps, headache, felt out of breath, clammy, chills on 24Dec2020 (reported as day 4), tired, clammy, headache on 25Dec2020 (reported as day 5) and symptoms resolved but weak from lack of nutrition on 26Dec2020 (reported as day 6). No treatment was received for all the events. The outcome of the events was recovered in Dec2020.  The information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Strawberry tongue
Clinical narrative: strawberry tongue /taste buds popped up and inflamed like I'd eaten something sour.  It was all inflamed; rash the next day and a few days after I got a rash on my chest; This is a spontaneous report from a contactable healthcare professional, the patient.  A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have a history of rash or food allergies.  In Dec2020, the patient experienced strawberry tongue and rash. The clinical course was as follows: the patient stated that she believed she had a delayed reaction to the vaccine as it didn't happen within 15 minutes.  It happened later on (not further specified).  She started to get a strawberry tongue and described it as "taste buds popped up and inflamed like she had eaten something sour."  It was all inflamed.  She also noticed a rash the next day and a few days after she got a rash on her chest. The clinical outcomes of the strawberry tongue and rash were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Illness, Oropharyngeal pain
Clinical narrative: felt a little sick; I got my temperature about 100.2/Fever that I have is 7 days after the vaccine; Had mild body ache; Chills; Usual soreness at the site of injection; Cough; mild sore throat; This is a spontaneous report from a contactable Physician (patient). A 62-year-old male patient received NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL01-40), via an unspecified route of administration on 20Dec2020 09:30 at single dose for COVID-19 immunization. Anatomical Location provided as Left deltoid. Medical history provided as none. Concomitant medication included hydrochlorothiazide, levothyroxine sodium (SYNTHROID). Physician stated, he got his Pfizer vaccine on last Sunday on 20Dec2020 around 9:30 there was usual soreness at the site of injection on 20Dec2020, which was there but no problem. But Monday (21Dec2020) after his vaccine that was Sunday he had and Monday night on 21Dec2020 he had chills he thought these were all just the reaction to the vaccine. Next day on 22Dec2020 he went into work he had mild body ache at work, at about 3:30 he felt a little sick and he got his temperature about 100.2, get home rested, next day on 23Dec2020 he worked from home, did not go so for next four days (from 24Dec2020 to 27Dec2020) he rested at home but his chills and body ache are not going away. They were there, they come and go, he took Tylenol, it went he have mild sore throat, cough on Dec2020. Today on 27Dec2020, the patient just took the temperature 100.7. For Causality assessment: Physician stated, "he didn't know, he was just trying to find out to get to bottom of it. Is it really COVID infection or is it due to side effects as from what he read the reaction shouldn't really last long. It may last probably 3-4 days but this has gone beyond that so he was little concerned and the fever that he had was 7 days after the vaccine." The patient still had chills and body ache which he means they were not going away and now mild fever. When probed for the outcome of, Physician stated, "They are persistent you know some day he had one day which was good but after that in the afternoon in the evening he felt the same thing. Fortunately, he was off for four days it didn't really have much problem, physically it was persistent has not gone away." Therapeutic measures were taken as a result of chills, had mild body ache, felt a little sick, cough, fever, mild sore throat. The outcome of events chills, mild body ache was not recovered. The outcome of the other events was unknown.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: felt a little sick; I got my temperature about 100.2/Fever that I have is 7 days after the vaccine; Had mild body ache; Chills; Usual soreness at the site of injection; Cough; mild sore throat; This is a spontaneous report from a contactable Physician (patient). A 62-year-old male patient received NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL01-40), via an unspecified route of administration on 20Dec2020 09:30 at single dose for COVID-19 immunization. Anatomical Location provided as Left deltoid. Medical history provided as none. Concomitant medication included hydrochlorothiazide, levothyroxine sodium (SYNTHROID). Physician stated, he got his Pfizer vaccine on last Sunday on 20Dec2020 around 9:30 there was usual soreness at the site of injection on 20Dec2020, which was there but no problem. But Monday (21Dec2020) after his vaccine that was Sunday he had and Monday night on 21Dec2020 he had chills he thought these were all just the reaction to the vaccine. Next day on 22Dec2020 he went into work he had mild body ache at work, at about 3:30 he felt a little sick and he got his temperature about 100.2, get home rested, next day on 23Dec2020 he worked from home, did not go so for next four days (from 24Dec2020 to 27Dec2020) he rested at home but his chills and body ache are not going away. They were there, they come and go, he took Tylenol, it went he have mild sore throat, cough on Dec2020. Today on 27Dec2020, the patient just took the temperature 100.7. For Causality assessment: Physician stated, "he didn't know, he was just trying to find out to get to bottom of it. Is it really COVID infection or is it due to side effects as from what he read the reaction shouldn't really last long. It may last probably 3-4 days but this has gone beyond that so he was little concerned and the fever that he had was 7 days after the vaccine." The patient still had chills and body ache which he means they were not going away and now mild fever. When probed for the outcome of, Physician stated, "They are persistent you know some day he had one day which was good but after that in the afternoon in the evening he felt the same thing. Fortunately, he was off for four days it didn't really have much problem, physically it was persistent has not gone away." Therapeutic measures were taken as a result of chills, had mild body ache, felt a little sick, cough, fever, mild sore throat. The outcome of events chills, mild body ache was not recovered. The outcome of the other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a contactable nurse reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine on 22Dec2020 and tested positive (COVID) on 27Dec2020, she didn't expect to be immune. The outcome of the event tested positive was unknown.  Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.  Further information like specific SARS-CoV-2 test and any symptom associated with SARS-CoV-2 test positive needed for full medical assessment
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizzy; a little weak; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number EH9899/Expiration date: not provided), via an unspecified route of administration, on 27Dec2020 at 8:07am (at the age of 20-years-old), as a single dose for COVID-19 vaccination. Relevant medical history was not provided. Concomitant medication included medroxyprogesterone acetate (DEPO-PROVERA) shot every 3 months for birth control. On 27Dec2020 at 9:41am, the patient reported that while she was at the grocery store, after she received the vaccine, she got kind of dizzy and a little weak. The consumer believed the effects were due to the vaccine, as she had not experienced this before. The outcome of the events dizzy and weak were unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder
Clinical narrative: Taste alteration; Funny taste; This is a spontaneous report from a contactable Pharmacist.  A 51-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 28Dec2020 at 03:15 PM at single dose for COVID-19 immunisation. Vaccine location was right arm.  The patient was vaccinated at workplace clinic, age at vaccination was 51-years-old (reported also as 49-years-old, to be clarified). No other vaccine was received in four weeks. Medical history included thryoid disease, and current tx for pulmonary embolism (PE, 3months). Concomitant medications included levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS). On 28Dec2020 at 03:15 PM, the patient experienced taste alteration - funny taste upon injection. Transient. Lasted 10 seconds or so. The event was reported as non-serious. Outcome of the event was recovered on 28Dec2020. No treatment was received for the event. Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Photosensitivity reaction, Vaccination site pain
Clinical narrative: severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injection site; nausea; This is a spontaneous report from a contactable physician. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 23Dec2020 01:00AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included folic acid, ascorbic acid (VIT C), tocopherol (VITAMIN E), Multivitamins. The patient previously took metronidazole and experienced drug allergy, NTG and experienced drug allergy. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe intractable headache, photo sensitivity, generalised body malaise, pain & tenderness in injection site, nausea on 23Dec2020 12:00 PM. Patient received Tylenol, neurofen and rest as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The events were reported as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; myalgia; body ache; fatigue; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number ek5730) intramuscular in the left arm on 20Dec2020 at single dose for COVID-19 immunisation.  Relevant medical history and concomitant medications were not reported. On 24Dec2020, the patient experienced fever, myalgia, body ache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. After the vaccination, on 26Dec2020, the patient was tested for COVID-19 with a nasal swab which resulted negative. At the time of the report, the outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: Joint pain and Chills; Joint pain and Chills; This is a spontaneous report from a contactable physician received via a sales representative. A female patient of an unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain and chills on an unspecified date. The outcome of the events was unknown. Events took place after use of product.   Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Pain
Clinical narrative: tired; stomach pain; swelling at site; itching; body aches; headache; lightheaded; This is a Spontanoeus report from a contactable other HCP (patient)  A 20 years old female patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 11:00 AM, at single dose on left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 28Dec2020 at 11:45 PM the patient experienced stomach pain, swelling at site, itching, body aches, headache, lightheaded, tired. At the time of the reporting the patient was recovering from reported events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained, No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site swelling
Clinical narrative: tired; stomach pain; swelling at site; itching; body aches; headache; lightheaded; This is a Spontanoeus report from a contactable other HCP (patient)  A 20 years old female patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 11:00 AM, at single dose on left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 28Dec2020 at 11:45 PM the patient experienced stomach pain, swelling at site, itching, body aches, headache, lightheaded, tired. At the time of the reporting the patient was recovering from reported events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained, No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Rash erythematous, Sensation of foreign body, Throat tightness
Clinical narrative: Red rash on her chest and arms; Had a tightness and lump in her throat; Had a tightness and lump in her throat; Cheeks were flushed; This is a spontaneous report from a contactable nurse and contactable physician. This nurse reported similar events for 3 patients. This is the 2nd of 3 reports.   A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced red rash on chest and arms, tightness and lump in throat and cheeks were flushed. The patient outcome of the  events was unknown.    The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516277 different patient, same drug and same event.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Rash erythematous, Sensation of foreign body, Throat tightness
Clinical narrative: red rash on her chest and arms; had a tightness and lump in her throat; had a tightness and lump in her throat; cheeks were flushed; This is a spontaneous report from a contactable nurse and contactable physician. This nurse reported similar events for 3 patients. This is the 3rd of 3 reports.   A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced red rash on chest and arms, tightness and lump in throat and cheeks were flushed. The patient outcome of the  events was unknown.    The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516277 different patient, same drug and same event;US-PFIZER INC-2020517133 different patient, same drug and same event.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain assessment
Clinical narrative: knee pain; This is a spontaneous report from a contactable physician (patient).  This 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK5730), via an unspecified route of administration, on 20Dec2020 at 07:15 AM at single dose for COVID-19 immunisation. Vaccine location was right arm.  The patient was vaccinated at hospital, age at vaccination was 62-years-old. No other vaccine was received in four or two weeks. Medical history was unknown. Concomitant medications were none. Th patient developed left (L) knee pain (7/10) on 23Dec2020 which has not yet resolved as of 28Dec2020. No treatment was administered for the event.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle strain, Myalgia, Vaccination site movement impairment
Clinical narrative: Pain in my arm where I received the vaccine; Cannot raise my arm ; like my shoulder; Fatigue; I thought maybe I dislocated the shoulder; Starting to feel like pretty bad joint pain like I sub-located the joint; Feels like strain; Muscle pain; This is a spontaneous report from a contactable nurse, the patient.  A 50-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/lot number: EK9231; Expiry Date: 30Apr2021), via an unspecified route of administration in an unspecified site on 26Dec2020 around 12:40 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. The patient has no relevant medical history. The patient's concomitant medications were not reported. I received the Covid vaccine today and I am a Nurse and I am having pretty significant pain in my arm where I received the vaccine. Consumer (Nurse) stated, "I had the vaccine at around 12:40. I came back to my unit and around 3:00PM, I moved a patient. I was holding a patient and so I thought maybe some of that was just fatigue from holding a patient in the procedure but and then I started to move it and I thought maybe I dislocated the shoulder. I was starting to feel like pretty bad joint pain like I sub-located the joint and then it started to be in you know, then I was like really trying to concern like what the sensation was that I was feeling .Knowing all while I got the vaccine and I am feeling the muscle sort of feels like strain. I was told that I cannot say for sure if it just the vaccine. It could also be the handling the patient. But it is both types of pain like looking at the side effects it says joint pain, muscle pain. Injection site pain I do not have. Tiredness and headache no. So it is Muscle pain and joint pain I have. I took a Tylenol (not further clarified) as the pain really started to bother me at around 4. I took Tylenol at about 5 and I started putting an ice pack at around 5:30. It is still pretty significant I would say with those interventions this calmed down to about at 6 and I cannot raise my arm like to my shoulder. I am scheduled to get the second shot on the 17th." It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.  The patient took Tylenol for pain. The clinical outcome of vaccination site pain, vaccination site movement impairment, fatigue, joint pain, myalgia, was unknown.