chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Rash macular, Swelling face, Vaccination site pain
Clinical narrative: joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection site pain; Headache; Muscle pain; tired; This is a spontaneous report from a contactable consumer reporting for herself.    A 68-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the left arm, on 13Jan2021 14:30 at single dose for Covid-19 immunisation .  Medical history included cyclic neutropenia from 1998, thyroid disorder from 2001.  There were no concomitant medications.  The patient experienced feeling sick  on 13Jan2021 with outcome of recovering , injection site pain  on 13Jan2021 with outcome of recovering , headache  on 13Jan2021 with outcome of recovering , muscle pain on 13Jan2021 with outcome of recovering , tired  on 13Jan2021 with outcome of recovering , splotches on both cheeks on 14Jan2021 with outcome of recovering , dizzy on 16Jan2021 with outcome of recovering , face a little swollen  on 16Jan2021 with outcome of recovering , joint pain  on an unspecified date with outcome of recovering , burned  on 13Jan2021 with outcome of recovering.   The patient received ibuprofen 400 mg to treat  headache,  muscle pain,  joint pain.  The patient is not sure if LOT number is EL1283 or EC1283.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: a rash all over my body with yellowish raised skin/bumps; a rash all over my body with yellowish raised skin/bumps; Severe shivering and chills; 5 different fevers; Body aches; Headache; Loss of appetite; Fatigue; This is a spontaneous report from a contactable other HCP reporting for himself.  A 28-years-old male patient received the second dose of bnt162b2 (BNT162B2; Lot # EK9231) vaccine , via an unspecified route of administration in the left arm on 05Jan2021 at single dose for covid-19 immunisation .  Medical history included , type 2 diabetes mellitus , sinus arrhythmia, gout.  Concomitant medication included atenolol (ATENOLOL).  The patient previously took lisinopril and experienced drug hypersensitivity, on 15Dec2020 the patient received the first dose of bnt162b2 for covid-19 immunisation and complained from headache, and hyperhidrosis.  The patient experienced severe shivering and chills  on 05Jan2021 23:30 with outcome of recovering ,  fevers on 05Jan2021 23:30 with outcome of recovering , body aches  on 05Jan2021 23:30 with outcome of recovering , headache  on 05Jan2021 23:30 with outcome of recovering , loss of appetite on 05Jan2021 23:30 with outcome of recovering , fatigue  on 05Jan2021 23:30 with outcome of recovering , a rash all over my body with yellowish raised skin/bumps  on 21Jan2021 with outcome of recovering.   The patient received Prednisone and Benadryl as treatment.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash maculo-papular, Yellow skin
Clinical narrative: a rash all over my body with yellowish raised skin/bumps; a rash all over my body with yellowish raised skin/bumps; Severe shivering and chills; 5 different fevers; Body aches; Headache; Loss of appetite; Fatigue; This is a spontaneous report from a contactable other HCP reporting for himself.  A 28-years-old male patient received the second dose of bnt162b2 (BNT162B2; Lot # EK9231) vaccine , via an unspecified route of administration in the left arm on 05Jan2021 at single dose for covid-19 immunisation .  Medical history included , type 2 diabetes mellitus , sinus arrhythmia, gout.  Concomitant medication included atenolol (ATENOLOL).  The patient previously took lisinopril and experienced drug hypersensitivity, on 15Dec2020 the patient received the first dose of bnt162b2 for covid-19 immunisation and complained from headache, and hyperhidrosis.  The patient experienced severe shivering and chills  on 05Jan2021 23:30 with outcome of recovering ,  fevers on 05Jan2021 23:30 with outcome of recovering , body aches  on 05Jan2021 23:30 with outcome of recovering , headache  on 05Jan2021 23:30 with outcome of recovering , loss of appetite on 05Jan2021 23:30 with outcome of recovering , fatigue  on 05Jan2021 23:30 with outcome of recovering , a rash all over my body with yellowish raised skin/bumps  on 21Jan2021 with outcome of recovering.   The patient received Prednisone and Benadryl as treatment.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal oedema
Clinical narrative: my nose was significantly swollen; This is a spontaneous report from a contactable other health professional (patient). A 27-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EK4176), intramuscular in left arm on 21Jan2021 09:00 at single dose for covid-19 immunization. Medical history included eczema from an unknown date and unknown if ongoing, GERD (gastrooesophageal reflux disease) from an unknown date and unknown if ongoing, allergies: Penicillin from an unknown date and unknown if ongoing, septorhinoplasty on 06Jan2021. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), ibuprofen (MOTRIN), gummy multivitamin. The patient previously took azithromycin and experienced allergy. The patient previous received first dose of bnt162b2 (lot number: EK5730), intramuscular in left arm on 31Dec2020 09:15 AM at single dose for covid-19 immunization. The patient experienced her nose was significantly swollen on 22Jan2021 06:30. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received for adverse event. The patient was a healthcare professional reporting her side effects after vaccine. She had a septorhinoplasty on 06Jan2021. Two weeks after her procedure, her nasal swelling significantly decreased. She returned to work and received her second vaccine on 21Jan2021 at 09:00. When she woke up on 22Jan2021 at 06:30, her nose was significantly swollen, which she believed to have been a reaction to the vaccine. No other breathing problems resulted. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of event was resolving.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This is a spontaneous report from a non-contactable consumer reporting for herself. A 36-year-old female patient received the 1st  dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EL3247), via an unspecified route of administration in the right arm, on 21Jan2021 at 08:00, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced loss of taste on 21Jan2021 at 18:15 with outcome of recovered in Jan2021. No therapeutic measures were taken as a result of the event. Patient did not have COVID-19 prior to vaccination, and was not tested for COVID-19 after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash erythematous, Rash pruritic
Clinical narrative: Red rash that is about the size of her palm/Rash is red and warm to the touch; Rash itches a lot; Rash is red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. The patient had a regular routine appointment to the HCP on Monday. The patient medical history and concomitant medications were not reported. The patient noticed every day she had a red rash that was about the size of her palm. Rash itches a lot. Rash was red and warm to the touch. The patient wanted to know should she be concerned and what to do to get rid of it or should she ignore it. She did not think she was going to die, it just kept continuing. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia oral, Paraesthesia oral, Tachycardia
Clinical narrative: tachycardia HR into 140s; numbness and tingling around lips; numbness and tingling around lips; warm flushing; This is a spontaneous report from a contactable nurse (patient). This 35-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) intramuscular, in left arm, on 22Jan2021 at 08:00, for COVID-19 immunization. No other vaccine was given on the same day or in 4 weeks. The patient received the first dose of BNT162B2 vaccine on 04Jan2021 at 03:00 PM, lot number EK9231, intramuscular, in left arm. Medical history included Crohn's disease. The patient had no COVID before vaccination. Concomitant medication included azathioprine (IMURAN) at 150 mg, daily. On 22Jan2021 the patient experienced warm flushing within 5 minutes of vaccination and at 08:15 tachycardia (HR into 140s), numbness and tingling around lips. The events required Emergency room/department or urgent care and treatment with diphenhydramine (BENADRYL) 25 mg IV. COVID was not tested after vaccination. The events were resolving.; Sender's Comments: Based on a compatible temporal association, causality between events tachycardia (HR into 140s), numbness and tingling around lips and warm flushing and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: soreness at site; swelling at site; fatigue (slept for 12 hours next night); abdominal pain; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) intramuscular at single dose for COVID-19 immunisation on 20Jan2021, at 05:30 PM. The patient did not receive other vaccine same date. Relevant history included apnea, depression, high blood pressure, reflux, 2 strokes, restless legs and allergies with Clarithromycin, compazine, Hydrocodone; kiwi, peppers. The patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. The patient did not have COVID test post vaccination. Relevant concomitant medications in two weeks includes amlodipine, atorvastatin, duloxetine, plus more. The patient did not receive other vaccine in four weeks of vaccination. The patient experienced soreness at site, swelling at site, fatigue (slept for 12 hours next night); abdominal pain (may be unrelated) since 20Jan2021 at 08:00 PM. The events reported as non-serious. Treatment therapy included Acetaminophen. Outcome of events was resolved.   Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: fever; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient's friend). A 32-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on 21Jan2021 in the Left arm at single dose for COVID-19 immunization in hospital. Medical history included she had a negative pregnancy test before getting the first vaccine dose, but then had a positive pregnancy test a few days after the first dose. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS); Iron. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), on 31Dec2020 in the Left arm at single dose for COVID-19 immunization at the age of 32-year-old and had mild symptoms after first dose, but unfortunately she had a miscarriage about 5-6 days before her second dose. After second dose in Jan2021 she experienced worse symptoms such as fever, chills, nausea and fatigue. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, patient had not been tested for COVID-19. Events were resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid tested post vaccination, tested positive in PCR test, 7 days after receiving second dose; covid tested post vaccination, tested positive in PCR test, 7 days after receiving second dose; This is a spontaneous report from a non-contactable consumer.  A 31-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose, second dose via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient didn't get covid prior vaccination. Covid was tested post vaccination and tested positive in PCR test in Jan2021, 7 days after receiving second dose. There was no treatment received. The patient underwent lab tests and procedures which included PCR test: positive in Jan2021.  The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness of arm after first dose of covid vaccine; This is a spontaneous report from a contactable consumer (patient). This 82 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on 21Jan2021 via unknown route of administration at single dose on left arm for COVID-19 immunisation. Relevant medical history included back problems which was diagnosed prior to receiving the Covid vaccine and was treated with epidural injection with no side effects. Relevant concomitant medication were not provided. The patient reported that he received first dose of COVID-19 vaccine on 21Jan2021and experienced soreness of arm after first dose of COVID-19  vaccine. The outcome for other events was not recovered. The patient stated that she will receive her second epidural injection on 02Feb2021 but also reported that her second COVID-19 vaccine shot is scheduled for 11Feb2021. The patient inquired if there is any study, or danger in having the epidural shot and Covid shot close together or if she needs to space them apart.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, SARS-CoV-2 test positive
Clinical narrative: She had a positive covid test on 16Jan2021. Symptoms on 10Jan2021; She had a positive covid test on 16Jan2021. Symptoms on 10Jan2021; headache; Fatigue; This is a spontaneous report from a contactable Other HCP. A 48-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL0142 and Expiration Date unknown) via Intramuscular on 08Jan2021 12:00 PM (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EK5730 and Expiration Date unknown) via Intramuscular on 19Dec2020 11:15 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation and first dose of measles vaccine, mumps vaccine, rubella vaccine (MMR) booster for immunisation. The patient's medical history was included allergies to nubain and CT dye, chronic sinus issues. The concomitant vaccine included second dose of measles vaccine, mumps vaccine, rubella vaccine (MMR) booster on 23Nov2020 for immunisation. Patient had symptoms of increase headache and fatigue on 10Jan2021. Patient had a positive covid test on 16Jan2021. The outcome of events was not recovered and without treatment received.; Sender's Comments: Based on the available information, causality between events Drug ineffective / COVID-19 virus test positive and BNT162B2 vaccine cannot be completely excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hot flush, Lymphadenopathy, Menopausal symptoms
Clinical narrative: Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin.  There were no concomitant medications.  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Toothache, Vomiting
Clinical narrative: Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin.  There were no concomitant medications.  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chest discomfort, Heart rate increased, Pharyngeal swelling, Pruritus
Clinical narrative: allergic reaction to the product/ throat was swelling and started to close up/ hives and itching/ blood pressure dropped and heart rate increased/ chest tightness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old-female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL3248), via an unspecified route of administration into left deltoid on 21Jan2021 10:20 at a single dose for covid-19 immunization. The patient was allergies to sulfa medications and latex and she had the flu vaccine in Nov2020. The patient concomitant medications were none. The patient called to report on the COVID 19 vaccine and she had an allergic reaction to the product. The patient explained that she got the vaccine yesterday at around 10:20 am and was in the emergency room at 10:48 am. Her throat was swelling and started to close up and this has resolved after medication. She had hives and itching which are now ongoing and about the same, her blood pressure dropped and there was an increased in her heart rate which have both gotten better, and she had chest tightness which is about the same. She received IV Benadryl, Solumedrol, and Pepcid. The patient was treated and released from the emergency room. No investigation assessment. The outcome of the event was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: allergic reaction to the product/ throat was swelling and started to close up/ hives and itching/ blood pressure dropped and heart rate increased/ chest tightness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old-female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL3248), via an unspecified route of administration into left deltoid on 21Jan2021 10:20 at a single dose for covid-19 immunization. The patient was allergies to sulfa medications and latex and she had the flu vaccine in Nov2020. The patient concomitant medications were none. The patient called to report on the COVID 19 vaccine and she had an allergic reaction to the product. The patient explained that she got the vaccine yesterday at around 10:20 am and was in the emergency room at 10:48 am. Her throat was swelling and started to close up and this has resolved after medication. She had hives and itching which are now ongoing and about the same, her blood pressure dropped and there was an increased in her heart rate which have both gotten better, and she had chest tightness which is about the same. She received IV Benadryl, Solumedrol, and Pepcid. The patient was treated and released from the emergency room. No investigation assessment. The outcome of the event was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Throat irritation
Clinical narrative: Headache; scratchy throat; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 15Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included blood pressure high, thyroid disorder and mental health disorder. Concomitant medication included took one medication for high blood pressure and a thyroid medication, both of those have been diagnosed quite a while and she had been on those medications a while. Patient was also on a mental health medication as well.  Patient had a headache Tuesday (19Jan2021) or Wednesday (20Jan2021) this week. Patient also had a really scratchy throat. She didn't know if that was related to bnt162b2 or not. Treatment included ibuprofen (ADVIL 200mg, lot: R88356, expiration date: May2023). Patient took two 200mg, no more than every 4 hours or something, then clarified that patient took a couple at nighttime. Headache hadn't gotten worse. It was not as bad today (22Jan2021). It seemed to be subsiding. Outcome of headache was resolving. Outcome of scratchy throat was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Exposure to SARS-CoV-2, Malaise, Myalgia
Clinical narrative: there is a risk of being exposed for Covid; General malaise; muscle aches and pain; This is a spontaneous report from two contactable consumers A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), intramuscular in the right deltoid on 18Dec2020 07:15 at a single dose to prevent covid. Medical history included hypertension, stage 3 renal failure and his creatinine level was elevated ( and now it was under control since he was not taking nsaids and changed his medications around; he cannot take nsaids; and his creatinine was 1.6 and now it was 1.27 (dates unspecified)). Concomitant medication included unspecified medication for hypertension. Patient had no prior vaccinations (within 4 weeks) aside from first dose of covid vaccine. He got the local flu shot a few months ago as it was required by his employer. He received the mmr v vaccine about 4.5 years ago and he had a terrible reaction for a week: he had muscle aches, pain and joint pain and everything hurts and it eventually went away. He does not have the exact name, lot, ndc, or expiration date to provide. It is on record at his employer. On day 4, 22Dec2020, after the first dose of the vaccine he had generalized malaise, muscle aches and pain, it was painful to put a pair of socks on and it went away within 24 hours. He sees covid patients everyday at the hospital. He does echocardiography and he is close to the patients for 20 minutes and there is a risk of being exposed for Covid. He clarified he is a registered diagnostic licensed medical sonographer, not a hcp. The outcome of the events general malaise and muscle aches and pain was recovered on 23Dec2020.   Information on the Lot/Batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: fever; vomiting; This is a spontaneous report from a contactable consumer. This consumer reported for a (age group: adult) male patient received 2nd dose of BNT162B2 on 20Jan2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Historical Vaccine was 1st dose of BNT162B2 in Jan2021, had soreness in his arm. He had a fever and is vomiting from 21Jan2021 with outcome was not recovered. No covid prior vaccination. No covid tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021061327 Same reporter/patient, same vaccine in different dose, different events
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: temperature of 100.5, a little high; Headache; She took a nap and around 4pm, she woke up and didn't feel good; Nausea; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3248) on 21Jan2021 around 09:30 AM, in right upper arm, for COVID-19 immunization. No other vaccine was given on the same day or within 4 weeks prior. Medical history included gastric sleeve surgery on 05Jan2021. Concomitant medication included ondansetron hydrochloride (ZOFRAN) for nausea. The patient took a nap and around 16:00 on 22Jan2021 she woke up and didn't feel good and had nausea. On 22Jan2021 at 16:40 the patient experienced also temperature of 100.5, a little high and realized she had a headache. However, she also just had a gastric sleeve surgery on 05Jan2021 and she had been experiencing nauseas from some days, so she was not sure if what she was experiencing had anything to do with that or with the COVID-19 shot because she had not nausea every day. She did take a Zofran. The events did not require a physician office or ER visit. Relevant tests: none. Events outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 103.3 Fahrenheit; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age received 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's medical history and concomitant medications were not reported. The patient experienced a fever of 103.3 Fahrenheit on an unspecified date with outcome of unknown. Information about lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Gait disturbance, Pain in extremity
Clinical narrative: pain in her knees that went down to her feet; pain in her legs/ went down to her feet; maybe it was arthritis; can't hardly walk; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1284 and Expiration Date unknown) via an unspecified route of administration on 09Jan2021 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was reported as none.On Monday (11Jan2021) morning she had a lot of pain in her legs and knees that went down to her feet. She thought maybe it was arthritis, but it was still there and it still hurts. She can't hardly walk real good cause it hurts. She was wondering if it could be a side effect from that vaccine. She wanted to know if there been a reaction like this in other people. Supposed to get her second dose on 30Jan2021.  The outcome of events was not recovered without treatment involved.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Body aches; Tiredness; Slight headache; This is a spontaneous report from a Non-contactable Other-HCP reported for self. This 23-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 16:30 PM on Arm left at single dose for covid-19 immunisation. Medical history included GERD, Barrett's esophagus. No Known allergies. No covid prior vaccination. Concomitant medications included omeprazole for Birth control, hydroxyzine for Birth control, sertraline for birth control. She experienced Body aches, tiredness, slight headache on 22Jan2021. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient received both doses of COVID-19 vaccines and tested positive for COVID-19; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EH9899/expiration date: unknown), via unknown route of administration, on 22Dec2020 13:00 PM (at the age of 43 years old) as a single dose on right arm and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: unknown), via unknown route of administration, on 11Jan2021 09:30 AM (at the age of 43 years old) as a single dose on left arm, for COVID-19 immunisation at a hospital. Relevant medical history included exposure to COVID-19 on 15Jan2021 because her oldest son tested COVID positive on Tuesday with a rapid COVID test and she had dinner with her son on Friday (15Jan2021). Historical vaccine included flu shot in Oct2020. Relevant concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received both doses of COVID-19 vaccines and tested positive for COVID-19 via COVID PCR test on 20Jan2021. The patient reported that she was asymptomatic and was at home quarantining. The patient would like inquire for information on volunteering in any post-vaccination research trials as she would be a candidate for it. Laboratory test included COVID PCR (polymerase chain reaction) test on 20Jan2021 with positive result. The outcome of the events "patient received both doses of COVID-19 vaccines and tested positive for COVID-19 via COVID PCR test" was unknown. It was also reported that the sample of product was not available to be returned.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Therapeutic response unexpected
Clinical narrative: he noticed there was a total absence of discomfort of his normal pain that he was in, in his leg, and back, and with his joint issues; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK4176) intramuscularly in left arm on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient states that this would seem a little unusual, because he was not calling to tell Pfizer about an adverse reaction, but rather, a positive reaction to a product. Patient stated that this was extremely odd, and he had not heard this before, so Pfizer might be interested to know, that the patient received his COVID 19 Vaccine at his VA office on 19Jan2021, and within 24 hours, he noticed there was a total absence of discomfort of his normal pain that he was in, in his leg, and back, and with his joint issues (also reported as within 24 hours that his normal pain and discomfort were relieved). Patient stated that the product acted as an anti-inflammatory for him. Patient stated that this side effect was still ongoing at this time, but that it was starting to wane. Patient stated that he did not take any anti-inflammatories, no Advil, no Tylenol, so this was a totally raw experience. Patient received no other vaccines on the same day. Patient stated that he did not know if this was relevant, but he had blood type O Negative. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: She noticed on her chest and all around her neck is broken out in rash; she has welts on chest; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 11:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient noticed on her chest and all around her neck was broken out in rash and she had weltes on chest on 22Jan2021. Should she go to the emergency room? The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis from the shot in left arm; This is a spontaneous report from a contactable consumer reported for herself. This 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 in her left arm at single dose for covid-19 immunisation. Medical history and concomitant medications were none.  There were no additional vaccines administered on same date of BNT162B2. The patient previously received a pneumococcal vaccine (reported as pneumonia shot) on unspecified date for immunisation where kind of the same thing happened, she had red, bumped up and itchiness at the injection. she didn't remember if she was diagnosed with cellulitis as it was a long time ago and she has no NDC, Lot, or Expiry for the product.  The patient experienced cellulitis from the shot in left arm on 22Jan2021. The event did not require a visit to Emergency Room. She just called the doctor and was given a prescription, the name of the prescription was unknown. The outcome of event was not recovered.    Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This is a spontaneous report from a contactable pharmacist (patient). A 47-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration into left arm on 21Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were none. No known allergies. There is no other vaccine in four weeks and no other medications in two weeks.  No covid prior vaccination. The patient previously took the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration into left arm on 31Dec2020 14:30 at a single dose for covid-19 immunization. The patient experienced Loss of taste on 22Jan2021. There is no treatment received for event loss of taste and no covid test post vaccination. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Chest pressure sensation; also accompanied with slight burning sensation/chest sensation as internal; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EL1283; expiry date: 30Apr2021) via an unspecified route of administration on 22Jan2021 about 10:57 AM at left arm at a single dose for COVID-19 immunization. Patient History and other products were reported as no. The patient experienced chest pressure sensation on 22Jan2021 with outcome of resolving. The details was as follows: the patient got the vaccine today (on 22Jan2021) about 10:57AM. When getting the vaccine they made his go through stalls, it was multiple cars on each side, what stood out to him was, when his vehicle moved up, he was the driver in this case, and so the vaccination was on his left arm, when the gentlemen went to insert the needle, he expected it to be a green needle attached, but the color of the syringe was black with a black band. He noticed the car before had a green attachment for their needle and the syringe, it was Green and clear looking but his was black. He asks if the color of the needle is suppose to be a certain color. Caller was informed that he may need to contact the facility from where he received the vaccine for this clarification. He also adds that he was okay for the 15 minutes, but then he left feeling a little sensation in the chest that he did not have before, it was not superficial on the skin it was internal in his chest. He was naturally calling to see, what he could find out, are there multiple colors for the needles or were they standard, green or clear plastic. He also would like to know if Pfizer directs the administration of the product to be drawn up in front of the client. The chest sensation started about 1:30 or 2 o clock PM the same day, he described the chest sensation as internal, in the center of the chest, sort of like a pressure downward, also accompanied with slight burning sensation, something that was different that he had never usually felt. He also asks if there was a certain protocol or standard the folks administering the vaccine were suppose to follow. The outcome of event was reported as the chest sensation has dissipated a little in terms of intensity, but he felt as if it was trying to be dormant in that area.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: injection site red and hurting; injection site red and hurting; It is still swollen, red, with a big red circle/size of 2 half dollars; hot to touch; Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age receive the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at SINGLE DOSE for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Caller reports getting the first Covid vaccine on 13Jan2021 and is due for the second one on 03Feb2021. Having the first dose, after 8-9 days, in Jan2021 she is having some reaction to it. It's almost been 10 days. Had a reaction in beginning at the injection site, it was red and hurting and you can tell just by touching it. It is still swollen, red, with a big red circle, is hot to touch, and the size of 2 half dollars and this concerns her. Has had tiredness, headaches, and muscle pains. Thought the swelling would be gone by now, has been using cool compresses. She can deal with the other things, but wants to know why is the swelling and redness lasting so long. It's not hurting her, but it is worrisome. The area has gone down and it's not hot to touch. Has not had any fever. Has taken all safety precautions and does not feel like she has contracted Covid from anyone other than injection in 2021. The outcome of event Vaccination site erythema, Vaccination site swelling  was not recovered; outcome of event Vaccination site warmth was recovered on 22Jan2021; outcome of other events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site red and hurting; injection site red and hurting; It is still swollen, red, with a big red circle/size of 2 half dollars; hot to touch; Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age receive the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at SINGLE DOSE for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Caller reports getting the first Covid vaccine on 13Jan2021 and is due for the second one on 03Feb2021. Having the first dose, after 8-9 days, in Jan2021 she is having some reaction to it. It's almost been 10 days. Had a reaction in beginning at the injection site, it was red and hurting and you can tell just by touching it. It is still swollen, red, with a big red circle, is hot to touch, and the size of 2 half dollars and this concerns her. Has had tiredness, headaches, and muscle pains. Thought the swelling would be gone by now, has been using cool compresses. She can deal with the other things, but wants to know why is the swelling and redness lasting so long. It's not hurting her, but it is worrisome. The area has gone down and it's not hot to touch. Has not had any fever. Has taken all safety precautions and does not feel like she has contracted Covid from anyone other than injection in 2021. The outcome of event Vaccination site erythema, Vaccination site swelling  was not recovered; outcome of event Vaccination site warmth was recovered on 22Jan2021; outcome of other events was unknown.  Information on the batch/lot number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy on face and other parts of body; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3247, expiration date: 31May2021), via unspecified route of administration on right arm on 21Jan2021 at 13:30PM at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient mentioned she didn't have any of the side effects they mentioned on the paper. Stated about two hours later she started to feel itchy on her face and then it became itchy on other parts of her body including her back. Added she had no rash or welts. This continued to midnight. Added she woke up about a quarter to twelve and then fell back to sleep so she thought it was better. She still felt slightly itchy this morning, so she took Zyrtec this morning at 08:00AM and now she felt perfectly fine. Mentioned she would have taken the Zyrtec last night but she took Amitriptyline 10mg at night and didn't want to take them together. She was scheduled for the second dose of the vaccine on 11Feb2021. None of adverse events required a visit to physician or ER. None prior vaccinations within 4 weeks. The outcome of the event was recovered on 22Jan2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever 102.0; chills; vomiting; body aches; headache; This is a spontaneous report from a contactable nurse (patient). This 37-year-old female nurse (pregnant: No) received 2nd dose of BNT162B2 (lot number=El3249) intramuscular on 20Jan2021 01:45 AM at single dose on Left arm for covid-19 immunization. No other vaccine in four weeks. Concomitant drug was Amoxicillin. Historical Vaccine was first dose of BNT162B2 on 30Dec2020.  Patient experienced Fever 102.0, chills, vomiting, body aches, headache on 21Jan2021 06:00 AM with outcome was recovered. No treatment. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever 102.0; chills; vomiting; body aches; headache; This is a spontaneous report from a contactable nurse (patient). This 37-year-old female nurse (pregnant: No) received 2nd dose of BNT162B2 (lot number=El3249) intramuscular on 20Jan2021 01:45 AM at single dose on Left arm for covid-19 immunization. No other vaccine in four weeks. Concomitant drug was Amoxicillin. Historical Vaccine was first dose of BNT162B2 on 30Dec2020.  Patient experienced Fever 102.0, chills, vomiting, body aches, headache on 21Jan2021 06:00 AM with outcome was recovered. No treatment. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Nausea
Clinical narrative: Diarrhea; stomach cramping; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 12:00 PM at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at vaccination was 35 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included hypothyroid, known allergy to milk and latex, and COVID-19 on an unspecified date.  Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM), escitalopram oxalate (LEXAPRO), montelukast sodium (SINGULAIR). On 23Jan2021 at 12:00 pm, the patient experienced diarrhea, stomach cramping, nausea, fatigue. No treatment was given for the events. The events were resolving. The patient was not tested for COVID-19 post vaccination.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.