chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Inappropriate schedule of product administration, Myalgia, Nausea
Clinical narrative: Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Mild fever; Nausea; Headache; Pain in the muscles and joints; Pain in the muscles and joints; This is a spontaneous report from a contactable consumer reporting for her sister. A 40-years-old female patient  received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Jan2021 at single dose for COVID 19 immunization via an unspecified route of administration from 21Dec2020 to 21Dec2020 at SINGLE DOSE for an unspecified indication .  The patient medical history and concomitant medications were not reported.  The patient received the first dose of the vaccine on 21Dec2020. On 08Jan2021 about 12 hours after the administration of the vaccine, the patient experienced mild fever, nausea, headache, pain in the muscles and joints. The outcome of all the reported events was recovering. The patient received the second dose before the day 21.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Mild fever; Nausea; Headache; Pain in the muscles and joints; Pain in the muscles and joints; This is a spontaneous report from a contactable consumer reporting for her sister. A 40-years-old female patient  received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Jan2021 at single dose for COVID 19 immunization via an unspecified route of administration from 21Dec2020 to 21Dec2020 at SINGLE DOSE for an unspecified indication .  The patient medical history and concomitant medications were not reported.  The patient received the first dose of the vaccine on 21Dec2020. On 08Jan2021 about 12 hours after the administration of the vaccine, the patient experienced mild fever, nausea, headache, pain in the muscles and joints. The outcome of all the reported events was recovering. The patient received the second dose before the day 21.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Lymphadenopathy, Myalgia
Clinical narrative: Fever night sweats; Fever night sweats; severe anxiety from 12 am -5 am, anxiety subsiding; weakness; muscle pain; Dizziness; Now having swelling lymph nodes under left arm; pain down entirety of the arm; This is a spontaneous report from a contactable other health care rofessional (HCP) (Patient).  A 33-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular Left arm on 07Jan2021 02:00 PM at a single dose for COVID-19 immunization, Lot number: unknown. Medical history was reported as none. Patient had no known allergies. Concomitant medications were not provided. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 02:00 PM Intramuscular Left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient received any other vaccine within four weeks prior to the vaccination. Patient had not been tested for COVID-19 post vaccination. The patient received purified protein derivative (PPD) within two weeks prior to the vaccination on unknown date in Jan2021 (reported as last week), unknown results. On 08Jan2021 12:00 AM patient experienced fever night sweats, severe anxiety from 12 am -5 am, anxiety subsiding, residual fever, weakness, muscle pain and dizziness for the next 48 hours. Now having swelling lymph nodes under left arm and pain down entirety of the arm. No treatment received for the events. At the time of the report anxiety was recovering and patient had not recovered from the other mentioned events.  Information on the Lot/Batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain in extremity, Pyrexia, Tuberculin test
Clinical narrative: Fever night sweats; Fever night sweats; severe anxiety from 12 am -5 am, anxiety subsiding; weakness; muscle pain; Dizziness; Now having swelling lymph nodes under left arm; pain down entirety of the arm; This is a spontaneous report from a contactable other health care rofessional (HCP) (Patient).  A 33-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular Left arm on 07Jan2021 02:00 PM at a single dose for COVID-19 immunization, Lot number: unknown. Medical history was reported as none. Patient had no known allergies. Concomitant medications were not provided. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 02:00 PM Intramuscular Left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient received any other vaccine within four weeks prior to the vaccination. Patient had not been tested for COVID-19 post vaccination. The patient received purified protein derivative (PPD) within two weeks prior to the vaccination on unknown date in Jan2021 (reported as last week), unknown results. On 08Jan2021 12:00 AM patient experienced fever night sweats, severe anxiety from 12 am -5 am, anxiety subsiding, residual fever, weakness, muscle pain and dizziness for the next 48 hours. Now having swelling lymph nodes under left arm and pain down entirety of the arm. No treatment received for the events. At the time of the report anxiety was recovering and patient had not recovered from the other mentioned events.  Information on the Lot/Batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Fatigue; Headache; Dose number 1: 17Dec2020/dose number 2: 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 45-years-old female patient received second dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 04Jan2021 on Left arm at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient previously received COVID 19 (Pfizer), lot number=EK5730, administration date=17Dec2020, administration time=04:15 PM, administrator route=Intramuscular, vaccine location=Left arm, dose number=1. The patient received second dose of bnt162b2 on 04Jan2021, experienced fatigue and headache on 04Jan2021 23:00. The patient had no covid prior vaccination, no covid tested post vaccination. No known allergies. The patient did not receive treatment for events. The event outcome of Fatigue and headache was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: soreness at reaction site/ It was red/swollen; soreness at reaction site/ It was red/swollen; soreness at reaction site/ It was red/swollen; This is a spontaneous report from a contactable consumer.  A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as first single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced soreness at reaction site/ it was red/swollen on an unspecified date. Clinical details  were as follows:  After the 1st dose of the vaccine, the patient experienced soreness at reaction site only for 1-2 days then it went away; It was red and swollen. The patient kept rubbing it, and said that it was no big deal. The outcome of soreness at reaction site/ it was red/swollen was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Injection site erythema, Injection site swelling, Parosmia, Taste disorder
Clinical narrative: Injection site slight red and swollen for a day; Injection site slight red and swollen for a day; my taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat.  Even water tasted rotten.; everything smelled and tasted like spoiled or rotting meat.  Even water tasted rotten.; taste was bitter; This is a spontaneous report from a contactable Nurse (patient).  This 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), on 07Jan2021 at 10:00 AM in right arm at single dose for COVID-19 immunisation. Age at vaccination was 47-years-old. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 17Dec2020 at 02:00 PM in left arm (age of vaccination was 46-years-old). Medical history included hypothyroidism. Known allergies included metoclopramide (REGLAN) and tramadol hydrochloride (ULTRAM). Concomitant medications were unknown. The patient was vaccinated at hospital. No other vaccine was received in four weeks.  The second injection was given in the AM. By the afternoon on 07Jan2021 at 04:00 PM noted that her taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten. No fever or chills. Injection site slight red and swollen for a day, no joint pain, no body pain. Outcome was recovering. No treatment was received for the events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Neuralgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched; Swollen lymph node in left armpit with pain radiating down arm; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 08Jan2021 08:45 at single dose at left arm for COVID-19 immunization. Medical history included osteopenia, vitiligo, known allergies: Demerol and Vicodin. The patient's concomitant medication received in two weeks included Vitamins. The patient previously took the first dose of bnt162b2 intramuscularly on 18Dec2020 20:45 (lot number: EH9899) at single dose at right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine received in four weeks. The patient experienced swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched on 09Jan2021 07:00. No treatment received for the events. No COVID prior vaccination. COVID test post vaccination: Nasal Swab Negative on 05Jan2021. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: myalgias; severe headache; rigors; low-grade fever; nausea; fatigue; This is a spontaneous report from a contactable Physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscularly in right arm on 06Jan2021 11:30 at single dose for COVID-19 immunization. Facility type Vaccine: Hospital. Medical history included acne. Known allergies: No. Other medical history: none (on aldactone for acne). The patient was not pregnant. Concomitant medication in two weeks included spironolactone (ALDACTONE) for acne.  The patient previously received the first dose of BNT162B2 (lot number EH9899) intramuscularly in right arm on 16Dec2020 11:30 for COVID-19 immunization. If other vaccine in four weeks: No. The patient experienced myalgias, severe headache, rigors, low-grade fever, nausea, fatigue 06Jan2021 15:00.  The patient received treatment Ibuprofen and Acetominophen for the events. If Covid prior vaccination: No. If covid tested post vaccination: No. The outcome of all the events was recovered in Jan2021. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: myalgias; severe headache; rigors; low-grade fever; nausea; fatigue; This is a spontaneous report from a contactable Physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscularly in right arm on 06Jan2021 11:30 at single dose for COVID-19 immunization. Facility type Vaccine: Hospital. Medical history included acne. Known allergies: No. Other medical history: none (on aldactone for acne). The patient was not pregnant. Concomitant medication in two weeks included spironolactone (ALDACTONE) for acne.  The patient previously received the first dose of BNT162B2 (lot number EH9899) intramuscularly in right arm on 16Dec2020 11:30 for COVID-19 immunization. If other vaccine in four weeks: No. The patient experienced myalgias, severe headache, rigors, low-grade fever, nausea, fatigue 06Jan2021 15:00.  The patient received treatment Ibuprofen and Acetominophen for the events. If Covid prior vaccination: No. If covid tested post vaccination: No. The outcome of all the events was recovered in Jan2021. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; This is a spontaneous report from a contactable Nurse.   A  26-year-old female patient patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246) intramuscular, on 08Jan2021 at 16:00 on left arm at single dose for COVID-19 immunization. Relevant medical history included that patient had a Covid diagnosis on early October. Vaccination history included first dose of BNT162B2  (lot number: EK5730) on 18Dec2020 at 10:00 AM, Intramuscular on Left arm .Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). The patient was not pregnant. On 08Jan2021 at 16:00 the patient experienced Immediate arm pain - swelling, tender to touch. On the same day at 22:00 the patient experienced Fever up to 100.5, extreme fatigue, muscle aches, nausea and lack of appetite. Treatment received included Tylenol. The patient recovered from Immediate arm pain - swelling, tender to touch on an unspecified date, from other reported events, recovered on 10Jan2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; This is a spontaneous report from a contactable Nurse.   A  26-year-old female patient patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246) intramuscular, on 08Jan2021 at 16:00 on left arm at single dose for COVID-19 immunization. Relevant medical history included that patient had a Covid diagnosis on early October. Vaccination history included first dose of BNT162B2  (lot number: EK5730) on 18Dec2020 at 10:00 AM, Intramuscular on Left arm .Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). The patient was not pregnant. On 08Jan2021 at 16:00 the patient experienced Immediate arm pain - swelling, tender to touch. On the same day at 22:00 the patient experienced Fever up to 100.5, extreme fatigue, muscle aches, nausea and lack of appetite. Treatment received included Tylenol. The patient recovered from Immediate arm pain - swelling, tender to touch on an unspecified date, from other reported events, recovered on 10Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Crusty blood on her nose; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. Medical history included anticoagulant therapy. Concomitant medications were not reported. The patient experienced crusty blood on her nose on an unspecified date with outcome of unknown.   The information on the lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Pain at injection site; high persistent fever; Chills; Nausea; Severe headache; Diffuse aches; This is a spontaneous report from a contactable physician (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284), intramuscularly in the left arm, on 08Jan2021 at 16:45 (at the age of 28-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced pain at injection site, high persistent fever, chills, nausea, severe headache, and diffuse aches on 09Jan2021 at 06:00. The events were reported as non-serious. The events were reported to have started 12 hours after vaccination. The patient did not receive any treatment for the events. The clinical outcome of pain at injection site, high persistent fever, chills, nausea, severe headache, and diffuse aches was recovered in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; high persistent fever; Chills; Nausea; Severe headache; Diffuse aches; This is a spontaneous report from a contactable physician (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284), intramuscularly in the left arm, on 08Jan2021 at 16:45 (at the age of 28-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced pain at injection site, high persistent fever, chills, nausea, severe headache, and diffuse aches on 09Jan2021 at 06:00. The events were reported as non-serious. The events were reported to have started 12 hours after vaccination. The patient did not receive any treatment for the events. The clinical outcome of pain at injection site, high persistent fever, chills, nausea, severe headache, and diffuse aches was recovered in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Eye pain, Fatigue, Headache
Clinical narrative: Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chills; fever; muscle pain; This is a spontaneous report from a contactable other HCP.  A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  lot number=EL1284 via an unspecified route of administration on 06Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation dose number=2 vaccine location=Left arm facility type vaccine: Military Base. Medical history included diabetes mellitus, asthma, dry eye, blood cholesterol increased, rubber sensitivity Known allergies: Latex, food allergy: Nuts. Concomitant medication included lactobacillus reuteri (BIOGAIA), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), metformin hydrochloride (GLUCOPHAGE XR) , benazepril hydrochloride (LOTENSIN [BENAZEPRIL HYDROCHLORIDE]), magnesium oxide (MAG-OX), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ciclosporin (RESTASIS), montelukast sodium (SINGULAIR) , liraglutide (VICTOZA), ascorbic acid, bioflavonoids nos (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC). The patient previously took remeron and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity. The first dose of BNT162B2 vaccine for covid-19 immunisation was done on 16Dec2020 08:30  Intramuscular at single dose, Vaccine location Left arm Dose number 1 Lot number=EK5730. On 06Jan2021 13:00 the patient experienced headache outcome of recovered, fatigue outcome of recovered, aches/soreness of the shot outcome of recovered, shortness of breath on 06Jan2021 13:00 with outcome of recovered, eyes hurting on 06Jan2021 13:00 with outcome of recovered, swollen site outcome of recovered, chills outcome of recovered, fever outcome of recovered, muscle pain outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06Aug2020.  The action taken was not applicable.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chills; fever; muscle pain; This is a spontaneous report from a contactable other HCP.  A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  lot number=EL1284 via an unspecified route of administration on 06Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation dose number=2 vaccine location=Left arm facility type vaccine: Military Base. Medical history included diabetes mellitus, asthma, dry eye, blood cholesterol increased, rubber sensitivity Known allergies: Latex, food allergy: Nuts. Concomitant medication included lactobacillus reuteri (BIOGAIA), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), metformin hydrochloride (GLUCOPHAGE XR) , benazepril hydrochloride (LOTENSIN [BENAZEPRIL HYDROCHLORIDE]), magnesium oxide (MAG-OX), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ciclosporin (RESTASIS), montelukast sodium (SINGULAIR) , liraglutide (VICTOZA), ascorbic acid, bioflavonoids nos (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC). The patient previously took remeron and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity. The first dose of BNT162B2 vaccine for covid-19 immunisation was done on 16Dec2020 08:30  Intramuscular at single dose, Vaccine location Left arm Dose number 1 Lot number=EK5730. On 06Jan2021 13:00 the patient experienced headache outcome of recovered, fatigue outcome of recovered, aches/soreness of the shot outcome of recovered, shortness of breath on 06Jan2021 13:00 with outcome of recovered, eyes hurting on 06Jan2021 13:00 with outcome of recovered, swollen site outcome of recovered, chills outcome of recovered, fever outcome of recovered, muscle pain outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06Aug2020.  The action taken was not applicable.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: nausea; body aches; fatigue; severe headache; This is a spontaneous report from a contactable nurse (patient). This 35-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730) on 18Dec2020 at 07:30 AM, in left arm, for COVID-19 immunisation. Medical history included seasonal allergies. The patient had no COVID prior vaccination. No other vaccine was given in 4 weeks. Concomitant medications were not reported. About 4 hours after vaccination, on 18Dec2020 at 11:30 AM, the patient experienced nausea, body aches, fatigue and severe headache, all lasting 3-4 days. The events resolved on an unspecified date in Dec2020 without any treatment. COVID was not tested post vaccination. The second dose of BNT162B2 vaccine dose was given on 08Jan2021 at 14:30.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Muscles aches; Fever up to 101.2 F; This is a spontaneous report from a contactable nurse reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), intramuscular, on 08Jan2021 at 06:45 AM, at single dose, for COVID-19 immunisation. Medical history included mild hypertension, Hashimoto's disease, gastrooesophageal reflux disease (GERD), insomnia. Patient did not have COVID-19 prior to vaccination. Concomitant medications included hydrochlorothiazide (unknown manufacturer), gabapentin (unknown manufacturer), acetylsalicylic acid (BABY ASPIRIN), omeprazole (PRILOSEC), trazodone (unknown manufacturer), cefixime (FLEXERIL), levothyroxine (unknown manufacturer), elderberry [sambucus nigra] (unknown manufacturer), vitamin c [ascorbic acid] (unknown manufacturer), colecalciferol (VITAMIN D). Previously the patient received the 1st dose of bnt162b2 (lot# EK5730), for immunisation, on 19Dec2020 at 03:30 PM, intramuscular in right arm. The patient experienced muscles aches on 09Jan2021 at 15:30 with outcome of recovered, fever up to 101.2 F on 09Jan2021 at 15:30 with outcome of recovered. The patient underwent lab tests and procedures which included body temperature: up to 101.2 F on 09Jan2021. Therapeutic measures were taken as a result of the events and included treatment with Tylenol. Patient was not tested for COVID-19 post vaccination.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting; high fever; achey; This is a spontaneous report from a contactable consumer (patient).   A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at 14:00 at single dose in Left arm for COVID-19 immunization. Medical history included cystic fibrosis. No known allergy. The patient's concomitant medications were not reported.  Patient previously, on an unknown date, received the first dose of the vaccine in Left arm for COVID-19 immunization.On 08Jan2021 at 22:00 the patient experienced vomiting, high fever and achey. No treatment given. The outcome of the events was unknown. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive after 1st dose; tested positive after 1st dose; This is a spontaneous report from a contactable nurse reporting for herself. This nurse reported similar events for 2 patients: this is the first of two reports. This 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient tested positive after first dose. Outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021021888 same reporter/drug/AE, different patient.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Loss of personal independence in daily activities, Myalgia
Clinical narrative: fever; extreme body/ muscle aches; extreme body/ muscle aches; headache; sore throat; I can't get out of bed; extremely tired; This is a spontaneous report from a contactable consumer (patient).  A 49-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EL3248), via an unspecified route of administration in the right arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history was none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EK5730) on 19Dec2020 at 11:30 AM in the left arm. The patient's concomitant medications were not reported. On 09Jan2021 10:00 the patient experienced fever, extreme body/ muscle aches, headache, sore throat, can't get out of bed, extremely tired all with outcome of not recovered. The patient received no treatment due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: fever; extreme body/ muscle aches; extreme body/ muscle aches; headache; sore throat; I can't get out of bed; extremely tired; This is a spontaneous report from a contactable consumer (patient).  A 49-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EL3248), via an unspecified route of administration in the right arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history was none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EK5730) on 19Dec2020 at 11:30 AM in the left arm. The patient's concomitant medications were not reported. On 09Jan2021 10:00 the patient experienced fever, extreme body/ muscle aches, headache, sore throat, can't get out of bed, extremely tired all with outcome of not recovered. The patient received no treatment due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: Swollen lymph nodes on left collar bone area on neck; Neck muscle pain, left arm muscle pain near armpit; This is a spontaneous report from a non-contactable nurse(patient). A 26-year-old female patient received first dose BNT162B2( lot number EL1284) , via an unspecified route of administration at Arm Left on 29Dec2020 15:30 at the 26 years old at single dose for COVID-19 immunization.  The medical history was none. There were not known allergies. The concomitant medication included fluoxetine hydrochloride(PROZAC). On 06Jan2021 the patient experienced Swollen lymph nodes on left collar bone area on neck, neck muscle pain, left arm muscle pain near armpit. There was no treatment received for the events. There was no other vaccine in four weeks. There was not covid prior vaccination. There was not covid tested post vaccination. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Between then and now I tested positive; Between then and now I tested positive; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I have taken the vaccine (1st dose) on 28Dec2020 at the hospital. Between then and now I tested positive on the 04Jan2021, the hospital sent me home for 2 weeks. The 2nd part of the vaccine is coming up, it isn't until the 18Jan2021." The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Myalgias; cephalgia; nausea; diarrhea; abdominal pain; Fatigue; first dose on 15Dec2020 15:30, second dose on 04Jan2021 16:00; first dose on 15Dec2020 15:30, second dose on 04Jan2021 16:00; This is a spontaneous report from a contactable physician (patient). A 31-year-old non-pregnant female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1284), via an unspecified route of administration on 04Jan2021 16:00 at single dose (Vaccine location: Left arm) for COVID-19 immunization. Medical history included Anxiety and Allergic Rhinitis. There were no known drug allergies. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) via an unspecified route of administration (Vaccine location: Left arm) on 15Dec2020 15:30 at single dose for COVID-19 immunization. There were no other vaccines received in four weeks. Concomitant medication included fexofenadine, sertraline. The patient did not have Covid-19 prior vaccination and did not have Covid-19 tested post vaccination. The patient experienced Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue on 05Jan2021 08:00. No treatment received for the reported events Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue. The outcome of the events Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue was recovered in Jan2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Product use issue
Clinical narrative: Myalgias; cephalgia; nausea; diarrhea; abdominal pain; Fatigue; first dose on 15Dec2020 15:30, second dose on 04Jan2021 16:00; first dose on 15Dec2020 15:30, second dose on 04Jan2021 16:00; This is a spontaneous report from a contactable physician (patient). A 31-year-old non-pregnant female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1284), via an unspecified route of administration on 04Jan2021 16:00 at single dose (Vaccine location: Left arm) for COVID-19 immunization. Medical history included Anxiety and Allergic Rhinitis. There were no known drug allergies. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) via an unspecified route of administration (Vaccine location: Left arm) on 15Dec2020 15:30 at single dose for COVID-19 immunization. There were no other vaccines received in four weeks. Concomitant medication included fexofenadine, sertraline. The patient did not have Covid-19 prior vaccination and did not have Covid-19 tested post vaccination. The patient experienced Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue on 05Jan2021 08:00. No treatment received for the reported events Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue. The outcome of the events Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue was recovered in Jan2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Ear pain, Headache, Myalgia
Clinical narrative: Tmax (max temperature) 102; chills; muscle aches; headache; sharp shooting jaw pain; shooting into ears; This is a spontaneous report from a contactable nurse who reported for herself. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK 9231) second dose, via an unspecified route of administration on 07Jan2021 10:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have prior vaccination. Patient did not test COVID post vaccination. Patient had no known allergies. Historical vaccine included first dose of bnt162b2 (lot number EC 0140) on 21Dec2020 11:45 AM at single dose on right arm for COVID-19 immunisation. Patient experienced side effects included Tmax (max temperature) 102, chills, muscle aches, headache, sharp shooting jaw pain, shooting into ears, all on 07Jan2021 20:00 with outcome not resolved. It was unknown if patient received treatment for the events or not.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pyrexia
Clinical narrative: Tmax (max temperature) 102; chills; muscle aches; headache; sharp shooting jaw pain; shooting into ears; This is a spontaneous report from a contactable nurse who reported for herself. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK 9231) second dose, via an unspecified route of administration on 07Jan2021 10:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have prior vaccination. Patient did not test COVID post vaccination. Patient had no known allergies. Historical vaccine included first dose of bnt162b2 (lot number EC 0140) on 21Dec2020 11:45 AM at single dose on right arm for COVID-19 immunisation. Patient experienced side effects included Tmax (max temperature) 102, chills, muscle aches, headache, sharp shooting jaw pain, shooting into ears, all on 07Jan2021 20:00 with outcome not resolved. It was unknown if patient received treatment for the events or not.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: I experienced chills; mild headache; fever ranging from 100.8 - 101.8; Mild body aches; This is Spontaneous report from a contactable consumer.  A 64-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 08Jan2021 at 01:00 PM at single dose for COVID-19 immunization. The patient had a medical history of Rheumatoid Arthritis, Sjogren's Syndrome, Osteoarthritis and known allergies to penicillin, Valium, ketamine. Concomitant drug included Synthroid and Humira - Abbvie on 31Dec2020 (lot number 1136949). On 09Jan2021 approximately 24 hours after BNT162B2 administration, the patient experienced chills, mild headache and fever ranging from 100.8 - 101.8 and mild body aches. 48 hours later she still had fever ranging 100-101. No treatment was received. The patient did not have Covid prior vaccination and was not covid tested post vaccination. At the time of reporting the patient was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site mass
Clinical narrative: it was given subcutaneously instead of intramuscularly; She reports that has a lump in her subcutaneous tissue where the vaccine was given; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was unknown), subcutaneously on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient reported that she her second dose of the COVID-19 vaccine on Friday 08Jan2021 and she believes that it was given subcutaneously instead of intramuscularly. She reported that she has a lump in her subcutaneous tissue where the vaccine was given and this did not occur after the first dose was received. She was asking if she should be revaccinated. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Tremor
Clinical narrative: fever as high as 101 F (now down to 97 F); body aches; chills; shaking; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included tested COVID positive from 27Dec2020. The patient's concomitant medications were not reported. Historical vaccine included first dose of vaccine on 17Dec2020. The patient started having symptoms on 23Dec2020 and tested COVID positive on 27Dec2020. Received the second dose of vaccine on 07Jan2021 and then was "having reaction to vaccine", experiencing the following: fever as high as 101 F (now down to 97 F), body aches, chills, shaking, "as I did when I had COVID". The patient said her coworkers are "experiencing the same things". Fever had resolved while the outcome of the remaining events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : -2021021949 Same patient/reporter/drug
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; headache; fatigue; nausea; muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 09Jan2021 15:30 at single dose (vaccine location=left arm) for COVID-19 immunization.  Medical history included allergies: Iodine, shellfish. The patient had COVID prior vaccination. Patient was not pregnant, and did not receive other vaccine in four weeks. The patient's concomitant medications were not reported. On 10Jan2021 07:00 AM, the patient experienced fever, headache, fatigue, nausea, muscle aches. No treatment received for events. Patient had not tested COVID post vaccination. The outcome of events was not recovered.    Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: interrupt sleep throughout the night; mild body aches; lightheadedness; fatigue; slight headache; injection site soreness; Chills; fever; This is a spontaneous report from a contactable pharmacist (patient) and a contactable other health professional.  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), on 17Dec2020 at 14:30 and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 08Jan2021 at 12:30, each via an unspecified route of administration at right arm at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included bupropion XL at 150 mg. On an unspecified date, the patient experienced 12 hrs. after vaccine administration, chills and subjective fever began and lasted approximately 24 hrs. (until 36 hrs. post-vaccine) severe enough to interrupt sleep throughout the night. Mild body aches during this time, along with lightheadedness, fatigue, slight headache and injection site soreness. The patient didn't receive any treatment. The patient outcome of the events was recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pyrexia, Vaccination site pain
Clinical narrative: interrupt sleep throughout the night; mild body aches; lightheadedness; fatigue; slight headache; injection site soreness; Chills; fever; This is a spontaneous report from a contactable pharmacist (patient) and a contactable other health professional.  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), on 17Dec2020 at 14:30 and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 08Jan2021 at 12:30, each via an unspecified route of administration at right arm at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included bupropion XL at 150 mg. On an unspecified date, the patient experienced 12 hrs. after vaccine administration, chills and subjective fever began and lasted approximately 24 hrs. (until 36 hrs. post-vaccine) severe enough to interrupt sleep throughout the night. Mild body aches during this time, along with lightheadedness, fatigue, slight headache and injection site soreness. The patient didn't receive any treatment. The patient outcome of the events was recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue; pretty severe muscle aches; This is a spontaneous report from Non-contactable consumer (patient) via.    A 32-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) intramuscular at single dose on 06Jan2021 for Covid-19 immunisation.  Medical history included drug hypersensitivity. The patient has not suffered from Covid prior vaccination. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported.  The patient experienced fatigue and pretty severe muscle aches on 07Jan2021. No treatment received. The outcome of recovered in Jan2021. Post-vaccination COVID tests were not performed.  No follow up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy near left side of clavicle, near injection site; This is a Spontaneous report from a contactable Consumer (patient). A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on left arm on 09Jan2021 at 13:00 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient experienced lymphadenopathy near left side of clavicle, near injection site on 10Jan2021 at 13:00. The patient did not receive treatment for the event. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was not recovered.  Information about Lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Off label use, Product use issue
Clinical narrative: Heartburn; Dose Number:1, Date of start of drug: 18Dec2020; Dose Number:2, Date of start of drug: 07Jan2021; Dose Number:1, Date of start of drug: 18Dec2020; Dose Number:2, Date of start of drug: 07Jan2021; This is a spontaneous report from a contactable physician (patient himself). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 07Jan2021 08:30 in right arm at single dose for covid-19 immunisation. Other medical history included hypertension. The patient was known allergies: latex. Other medications in two weeks included nebivolol hydrochloride (BYSTOLIC). The patient previously took the first dose of BNT162B2 (lot# EJ1685) on 18Dec2020 03:00 PM in left arm for COVID-19 immunization. Facility type vaccine was in hospital. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient experienced heartburn on 08Jan2021 with outcome of not recovered. No treatment was received for heartburn.