chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Tinnitus, Upper respiratory tract infection
Clinical narrative: upper respiratory infection; Fatigue; Headache; Ringing of the ears/Ringing in ears; Nausea; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiry date: unknown), via an unspecified route of administration on 04Jan2021 10:25 at single dose (left upper arm) for COVID-19 immunization. Medical history included asthma (diagnosed at 8 years old), covid from 2020 (she had Covid last year twice). There were no concomitant medications. The patient experienced nausea, headache, and ringing of the ears/ringing in ears on 04Jan2021; and fatigue on 05Jan2021. This went on for 2.5 days. By day 3 post vaccine (06Jan2021) got upper respiratory infection. Stated she is pre disposed because she is asthmatic. She states she took Zofran to treat the nausea, 8 mg, and that she took 1000mg Tylenol for the headache. States she received the vaccine at her employer, (healthcare center name). States the symptoms resolved after about 3 days, exact dates unknown. She wanted to know if the second vaccination is the exact same as the first. She wanted to know if Pfizer manufactures the Shingrix vaccine. Therapeutic measures were taken as a result of nausea, headache. The outcome of the event upper respiratory infection was unknown, while for other events was recovered on an unspecified date in Jan2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Body aches; Fever of 101.4; Headache; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL7249; Expiration date was not reported), intramuscularly on the left arm, on 12Jan2021 (17:30) at a single dose for COVID-19 immunization at the hospital. Medical history included migraine headache and arthritis of knees. Concomitant medication included topiramate (TOPAMAX). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported) on the left arm on 22Dec2020 for COVID-19 immunization (when the patient was 43 years old). The patient was not pregnant at the time of reporting. On 13Jan2021 (12:00 AM), the patient had chills; body aches; fever of 101.4 (unit was not reported); and headache. It was unknown if the patient had received treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'fever', and 'headache', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low grade fever; This is a spontaneous report from a Pfizer-sponsored program via a contactable nurse (patient wife). A male patient (husband) of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunization. It was reported that her husband had a low grade fever after 24 hours of receiving his second dose covid vaccine. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Somnolence
Clinical narrative: arm soreness; very achy; Drowsiness; bad headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 11Jan2021 at single dose (1.8 cc but unsure ((heard that but could be wrong) recommended dose)) as works with COVID positive patients. Medical history was none. No concomitant medications. Caller just wanted to know if she could take Tylenol for mild symptoms after having the COVID 19 vaccine. She received the vaccine yesterday. She was wondering if it would make the symptoms a little less. She didn't have a prescribing doctor. The side effects started last night. On 11Jan2021, she was expecting arm soreness, but this was worse. She developed it about 6 hours after the shot. This was the sorest her arm has ever been from any injection, and she had had a lot of them. Her arm was almost too sore to move. This morning, it was much better. It was really bad last night. She was also very achy, and experienced drowsiness, also has a very bad headache on 11Jan2021. The CDC website stated before the vaccine patients should not take Tylenol because it can tamper with the immune system response. It said it was alright to take after, but she just wanted to call to make sure. Investigation Assessment was no. The outcome of the event very achy was not recovered, of the events was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Tiredness/exhausted; injection site pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unspecified lot number, reported as EH9899 or TH9899), intramuscularly at site of right arm at 10:00 on 20Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN, lot number: 300045; Expiration date: May2022) from Jan2021. The patient previously took cetirizine hydrochloride (ZYRTEC) daily for allergies forever. Clinical course: Patient received the first dose of the BNT162B2 on 20Dec2020, and was tired afterwards, she didn't feel tired continually. She began to feel tired on 21Dec2020, she was just exhausted, she was so tired and she just slept, she couldn't get out of her own way. On 22Dec2020, she was fine, but on 23Dec2020, she began to feel tired and exhausted again. By 24Dec2020, her symptoms were over. She also experienced injection site pain in her right arm that started on 21Dec2020 and resolved by the evening of the same day. No treatment received for this event. Vaccination Facility Type was in hospital. No vaccine administered at Military Facility. No emergency room visit needed. It was unknown that physician office visit needed. No prior vaccinations within 4 weeks. Adverse event(s) following prior vaccinations was N/A. Family medical history relevant to adverse event(s) was not provided. Relevant tests were none. The outcome of event 'tiredness/exhausted' was recovered on 24Jan2021; of event 'injection site pain in her right arm' was recovered on 21Dec2020.  Information on the Lot/Batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysgeusia
Clinical narrative: Cough; has a metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient) reported that a 76-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number and Expiration Date unknown) via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications was not reported.  Patient was getting a cough and has a metallic taste in her mouth in Jan2021. Wanted to know if it was from the vaccine or Covid. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Welts and rashes; Welts and rashes; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the 2nd of the two reports.   A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 11Jan2021 at a 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 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The nurse reported that the patient received the second dose of the vaccine on Monday (11Jan2021) and broke out in welts and rashes in Jan2021. The patient was given steroids at home and did not report respiratory distress. The outcome of the events was unknown    Information on the batch/lot number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030825 Same reporter/drug/event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: low grade fever; he did not feel well; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a male patient of an unspecified age received second dose of bnt162b2, via an unspecified route of administration on an unspecified date at single dose for covid-19 vaccine. The patient's medical history and concomitant medications were not reported. The patient experienced low-grade fever, he did not feel well on an unspecified date. Caller was reporting on herself, her husband, and her doctor. This was the report for the caller's doctor. Her doctor told her that he had a low grade fever after his second dose and he did not feel well. The patient underwent lab tests and procedures which included body temperature: low grade on an unspecified date. The outcome of events unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable nurse (patient) and a contactable consumer (patient's son). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER5730, Expiry Date: Mar2021), via an unspecified route of administration on 22Dec2020 at a single dose on Left Deltoid for COVID-19 immunization. Medical history included asthma and sickle cell disease. There were no concomitant medications. She has had issues with vaccines in the past but not to this extent. Prior she experienced swelling in the arm from a pneumonia vaccination for immunization, back in 2012, she has no Lot or Expiry of this previous vaccine. She adds that she did feel dizzy after the first vaccine dose but that subsided. She has had no positive tests for COVID, and no antibody tests. The outcome of the event was recovered on an unspecified date.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort
Clinical narrative: Intense lower/middle back pain; Chest tightness; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 23-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EJ1686, expiry date: not reported), via an unspecified route of administration, on 12Jan2021 12:30 PM, at a single dose on left arm for COVID-19 immunization. The patient received the vaccine at a hospital. The patient was not pregnant. Medical history was not reported. The patient had no known allergies. Concomitant medications included sertraline (other medications in two weeks). The patient previously received another vaccine within 4 weeks, flu vaccine on 06Jan2021. On 12Jan2021 09:30 PM, the patient experienced intense lower/middle back pain and chest tightness. The patient was not diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient received no treatment. Outcome of the events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient (reporter's sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Medical history included virus 3-4 weeks ago in 2020 prior to getting the vaccine. The patient's concomitant medications were not reported. The patient had the virus 3-4 weeks ago and received the vaccine yesterday (11Jan2021). She experienced fever and chills for a short time after the vaccine. The reporter wanted to know "Is that more prominent after you have had the virus? Are we getting reports of patients who had Covid 19 prior to getting the vaccine having more side effects? If since his sister got those reactions, can she be more contagious." The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Feeling abnormal, Headache
Clinical narrative: Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; generalized body pain/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; swollen lymph nodes in her left arm pit/couldn't move her arm; This is a spontaneous report from a contactable nurse reporting for herself. A 43-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 on unspecified date for COVID-19 immunization and her arm was inflamed, and so swollen, she couldn't move it. Caller was instructed to call after getting the COVID vaccine. She had a reaction after the vaccine. Her doctor said to call Pfizer. It was after she received the 2nd dose of the vaccine, Saturday (09Jan2021). She had a reaction. She developed a headache and fatigue. She had had these side effects since Saturday. They have lasted Sunday, Monday, and today/Tuesday. She was very tired, and she has generalized body pain. The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back. Literally, her whole body was so painful. She had been taken Ibuprofen 800mg and Tylenol 1g. She had been taking those every 8 hours. She took them together. When she took them, her headache and body pain was maybe a 5-6/10. If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain. She also had swollen lymph nodes in her left arm pit. Which is the arm they injected the vaccine into. She just noticed it Saturday night. She couldn't move her arm. Now, after the second, she had a swollen lymph node the size of a quarter. It had been the same size since Saturday. She was wondering if it would go away? She was also becoming forgetful. Her brain was foggy-ongoing. Like she forgot her doctors appointment today. The outcome of event "brain was foggy" was not resolved while outcome of other events were unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Memory impairment, Mobility decreased, Pain, Pain assessment
Clinical narrative: Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; generalized body pain/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; swollen lymph nodes in her left arm pit/couldn't move her arm; This is a spontaneous report from a contactable nurse reporting for herself. A 43-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 on unspecified date for COVID-19 immunization and her arm was inflamed, and so swollen, she couldn't move it. Caller was instructed to call after getting the COVID vaccine. She had a reaction after the vaccine. Her doctor said to call Pfizer. It was after she received the 2nd dose of the vaccine, Saturday (09Jan2021). She had a reaction. She developed a headache and fatigue. She had had these side effects since Saturday. They have lasted Sunday, Monday, and today/Tuesday. She was very tired, and she has generalized body pain. The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back. Literally, her whole body was so painful. She had been taken Ibuprofen 800mg and Tylenol 1g. She had been taking those every 8 hours. She took them together. When she took them, her headache and body pain was maybe a 5-6/10. If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain. She also had swollen lymph nodes in her left arm pit. Which is the arm they injected the vaccine into. She just noticed it Saturday night. She couldn't move her arm. Now, after the second, she had a swollen lymph node the size of a quarter. It had been the same size since Saturday. She was wondering if it would go away? She was also becoming forgetful. Her brain was foggy-ongoing. Like she forgot her doctors appointment today. The outcome of event "brain was foggy" was not resolved while outcome of other events were unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Spinal pain
Clinical narrative: Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; generalized body pain/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; swollen lymph nodes in her left arm pit/couldn't move her arm; This is a spontaneous report from a contactable nurse reporting for herself. A 43-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 on unspecified date for COVID-19 immunization and her arm was inflamed, and so swollen, she couldn't move it. Caller was instructed to call after getting the COVID vaccine. She had a reaction after the vaccine. Her doctor said to call Pfizer. It was after she received the 2nd dose of the vaccine, Saturday (09Jan2021). She had a reaction. She developed a headache and fatigue. She had had these side effects since Saturday. They have lasted Sunday, Monday, and today/Tuesday. She was very tired, and she has generalized body pain. The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back. Literally, her whole body was so painful. She had been taken Ibuprofen 800mg and Tylenol 1g. She had been taking those every 8 hours. She took them together. When she took them, her headache and body pain was maybe a 5-6/10. If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain. She also had swollen lymph nodes in her left arm pit. Which is the arm they injected the vaccine into. She just noticed it Saturday night. She couldn't move her arm. Now, after the second, she had a swollen lymph node the size of a quarter. It had been the same size since Saturday. She was wondering if it would go away? She was also becoming forgetful. Her brain was foggy-ongoing. Like she forgot her doctors appointment today. The outcome of event "brain was foggy" was not resolved while outcome of other events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (patient 's mother). This consumer reported same event for 2 patients. This is the 1st of 2 reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced tested positive for COVID on 12Jan2021 with outcome of unknown. Event was assessed as non-serious by reporter.  Information on lot number/batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021035102 Same drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Neck pain
Clinical narrative: pain in head and neck; pain in head and neck; glands in neck swollen; 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 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain in head and neck, with glands in neck swollen. She received the shot on 23Dec2020 and is wondering if there have been any reports on a delayed reaction to the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: severe nausea; fevers; chills; This is a spontaneous report from a contactable physician. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medication included escitalopram oxalate (LEXAPRO). On 12Jan2021, the patient experienced severe nausea, fevers > 102 F and chills. The patient underwent lab tests and procedures which included body temperature: >102 f fahrenheit on an unspecified date. The outcome of the events was recovered.   Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Night sweats, Pain
Clinical narrative: intermittent dry cough; felt really tired and fatigued; night chills; night sweats; pain at the injection; mild body aches; This is spontaneous report from a contactable Other-HCP(patient).  A male patient of an unspecified age received second dose BNT162B2 , via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. He previously received first dose BNT162B2 for COVID-19 immunization. He experienced pain at the injection and mild body aches a after the shot in Jan2021. About 2 nights ago(12Jan2021), he experienced night chills and night sweats. Last night(13Jan2021) an intermittent dry cough started and he felt really tired and fatigued. Today he was feeling fairly similar to yesterday with the cough still lingering. Outcome of events was unknown.   Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: intermittent dry cough; felt really tired and fatigued; night chills; night sweats; pain at the injection; mild body aches; This is spontaneous report from a contactable Other-HCP(patient).  A male patient of an unspecified age received second dose BNT162B2 , via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. He previously received first dose BNT162B2 for COVID-19 immunization. He experienced pain at the injection and mild body aches a after the shot in Jan2021. About 2 nights ago(12Jan2021), he experienced night chills and night sweats. Last night(13Jan2021) an intermittent dry cough started and he felt really tired and fatigued. Today he was feeling fairly similar to yesterday with the cough still lingering. Outcome of events was unknown.   Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Fatigue, Pain
Clinical narrative: restless legs; itching on the palms, soles, and torso without developing rashes; not getting enough sleep due to the earlier symptoms; a slight ache on the lower back; fever; chills; bodyache; fatigue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported unusual symptoms related to the covid vaccine. Immediately after receiving the second dose of the vaccine she reported typical symptoms (fever, chills, bodyache, fatigue) which resolved in 48 hours. 6 days post-vaccination, she experienced what she described as horrible, restless legs, itching on the palms, soles, and torso without developing rashes. Currently she was 9 days post-vaccination and was feeling fatigued (she relates this to not getting enough sleep due to the earlier symptoms) and a slight ache on the lower back. She was looking if there were previous reports of these symptoms. The outcome of events fever, chills, bodyache was recovered in Jan2021. The outcome of event fatigue was not recovered. The outcome of events restless legs, itching, slight ache on the lower back was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Restless legs syndrome, Sleep disorder due to a general medical condition
Clinical narrative: restless legs; itching on the palms, soles, and torso without developing rashes; not getting enough sleep due to the earlier symptoms; a slight ache on the lower back; fever; chills; bodyache; fatigue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported unusual symptoms related to the covid vaccine. Immediately after receiving the second dose of the vaccine she reported typical symptoms (fever, chills, bodyache, fatigue) which resolved in 48 hours. 6 days post-vaccination, she experienced what she described as horrible, restless legs, itching on the palms, soles, and torso without developing rashes. Currently she was 9 days post-vaccination and was feeling fatigued (she relates this to not getting enough sleep due to the earlier symptoms) and a slight ache on the lower back. She was looking if there were previous reports of these symptoms. The outcome of events fever, chills, bodyache was recovered in Jan2021. The outcome of event fatigue was not recovered. The outcome of events restless legs, itching, slight ache on the lower back was unknown.  Information about lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness and itching at the injection site; redness and itching at the injection site; The vaccine administrator missed the main deltoid muscle. maybe it was a SQ injection; This is a spontaneous report from a contactable Nurse reporting for herself. A 72-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , subcutaneous in the right arm on 11Jan2021 09:00 at single dose for covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient stated that the vaccine administrator missed the main deltoid muscle. maybe it was a sq injection on 11Jan2021 09:00. The patient reported she experienced  redness and itching at the vaccination site  on 13Jan2021 with outcome of not recovered.  Further information has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in his right hand; This is a spontaneous report from a contactable pharmacist (patient himself). A 50-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EH9899, expiration date was unknown), intramuscularly on the right arm on 18Dec2020 at 12:00 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. He had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient had no Covid prior to vaccination. He was not tested for Covid post vaccination. On an unspecified date, following the first vaccine, the patient had numbness in his right hand for two (x2) days. The patient did not receive any treatment for the event. The patient recovered from the event "numbness in his right hand" on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: side effects of sore arm; mild itching; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 11Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. On an unspecified date, the patient reported side effects of sore arm and mild itching and she stated they were very mild and lasted about 72 hours. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pain
Clinical narrative: body ache/ all over achy feeling; muscle aches; feeling like coming down with the flu; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EJ1685), via an unspecified route of administration on left arm at 11:45 AM on 22Dec2020 at single dose for COVID-19 immunization. Medical history included Graves Disease and COVID-19 (Prior to vaccination, diagnosed with COVID-19). Concomitant medication included ibuprofen (MOTRIN), diclofenac sodium. The patient previously took percocet and experienced allergies, darvocet and experienced allergies. The patient experienced body ache and muscle aches the day after first shot also feeling like coming down with the flu all over achy feeling on unknown date that resolved in a days time. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: welts all over (her) body; Itching; Red welts all over body; This is a spontaneous report from a contactable consumer.   An 80-year-old female consumer BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 13Jan2021 at 12:00 p:m at single dose for COVID-19 immunization. Relevant medical history included penicillin and bee stings allergies. Concomitant medications were not reported. On 13Jan2021, about 3 hours after vaccine patient experienced red welts were all over her body, face, arms, and under breasts. She was itching all over. Patient took three allergy pills and the reaction subsided. Patient didn't provide product name of allergy pills. Patient informed she had a reaction before to Penicillin and clarified her reaction with Penicillin was red welts and itching, but her tongue didn't get sick on an unspecified date. Patient was supposed to go back and get second COVID-19 Vaccine, but she was not going to take it unless there is a COVID-19 Vaccine without Penicillin in it (as reported). Provided date on patient card of 03Feb2021. At the time of the reporting event outcome was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Dizziness, Nausea, Neck pain
Clinical narrative: weakness/feeling weak; Dizziness/head was dizzy; nausea; Neck was sore; discomfort; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, Expiry Date: Apr2021), via an unspecified route of administration at right arm on 08Jan2021 13:00 at single dose for covid-19 immunization. Vaccine was not administered at military facility. Vaccination facility type was health department. The patient got the flu shot every year and never had a problem. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021, the patient experienced severe dizziness/head was dizzy, feeling weak, nausea, neck was sore. The events did not require a visit to emergency room or physician office. She was very dizzy and laid back down. Today (14Jan2021) was better but she felt weak and wanted to figure out what was going on. She took it to make sure she felt better but the only thing she's had was discomfort. No treatment, not contacted the doctor. The outcome of events weakness/feeling weak, dizziness/head was dizzy was recovering. The outcome of events nausea, neck pain was not recovered. The outcome of event discomfort was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on stomach; itching all over body; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3302), intramuscular at right arm on 14Jan2021 11:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included granulomatous mastitis and allergy to Shrimp. The patient's concomitant medications was reported as none (no other medications in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on stomach and itching all over body on 14Jan2021 11:45. Treatment received included Allegra. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Myalgia
Clinical narrative: Severe muscle and joint pain.; Severe muscle and joint pain.; Stiffening is joints; This is a spontaneous report from a contactable other healthcare professional. A 47-year-old female patient received second dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) intramuscular in the right arm, on 13Jan2021 at 14:15 at a single dose, for COVID-19 immunization. Medical history included depression. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) on 22Dec2020, at 09:30 AM in the right arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 14Jan2021 at 05:15 A.M., the patient experienced severe muscle and joint pain, and stiffening of joints. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.  Information of lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in the right thigh anterior and lateral aspects; This is a spontaneous report from a contactable physician (patient). This 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 2nd dose (lot number:EJ1686) 06Jan2021 01:00 PM at left arm at single dose intramuscular for Covid-19 immunization. Facility type vaccine was hospital. Medical history was reported as "none". Patient had no known allergies. Concomitant drug in two weeks included finasteride (PROPECIA), acetylsalicylic acid (ASPRIN), atorvastatin, and multivitamin. Patient received 1st dose of BNT162B2 (lot number: EK5730) on 17Dec2020 01:30 PM at right arm for Covid-19 immunization. No other vaccine received in four weeks. It was unknown if covid prior vaccination. No covid tested post vaccination. Patient experienced numbness in the right thigh anterior and lateral aspects on 13Jan2021 starting on 09:00 PM. No treatment received. Outcome of the events was not resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever on evening of second vaccine - highest was 100 - Fever between 98-99.6; Body aches throughout body Headache; Body aches throughout body Headache; Chills; This is a spontaneous report from a contactable Other HCP. This 56-year-old female Other HCP (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: EL3246), via intramuscular at left arm on 12Jan2021 09:30AM at single dose for COVID-19 immunization. Medical history included known allergies: penicillin. Concomitant drugs included ascorbic acid (VITAMIN C). Historical vaccine included the first dose of BNT162B2 (Lot number: EH9899) on 22Dec2020 10:30AM via intramuscular at left arm for COVID-19 immunization. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. On 12Jan2021 08:00pm, patient had fever on evening of second vaccine -highest was 100 -Fever between 98-99.6 next day and evening, body aches throughout body, headache, chills, fever gone after 40 hours or so. No treatment for AE. Outcome of events was recovered in Jan2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort
Clinical narrative: Right arm numbness; Right arm numbness and discomfort when raising at shoulder level and above; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), intramuscularly on 07Jan2021 08:15 at right arm, at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included omeprazole, potassium gluconate; oenothera biennis oil (EVENING PRIMROSE); ascorbic acid (VIT C); glucosamine; ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient previously took clarithromycin (MACROBID) and known allergies was Macrobid. The patient was not pregnant at the time of vaccination. The patient experienced right arm numbness and discomfort when raising at shoulder level and above on 12Jan2021. No treatment was received. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Sore muscles; Slight headaches; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 13Jan2021 (13:30) at a single dose on the left arm, with route of administration unspecified for COVID-19 immunization at the workplace clinic. Medical history included high blood pressure (HBP); and high cholesterol. Concomitant medications included atorvastatin, citalopram, metoprolol and fenofibrate. The patient previously took dextromethorphan, and had drug allergy. On 13Jan2021 (15:00), the patient had sore muscles and slight headaches. The patient had not received any treatment for the reported events. The outcome of the events, sore muscles and slight headaches, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive after 7 days of taking the vaccine; Tested positive after 7 days of taking the vaccine; This is a spontaneous report from a contactable Pharmacist.  A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient tested positive after 7 days of taking the vaccine. Patient also received the "Bam antibodies", monoclonal antibody. Outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive) with BNT162b2 can not be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: feeling achy; headache; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not specified), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first shot of the COVID vaccine on 11Jan2021. She was still feeling achy, headache and chills on an unspecified date in Jan2021, and she was working on it, but she would like to know how long will this side effects last. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received bnt162b2, via an unspecified route of administration in left arm on 17Dec2020 16:00 (first dose, lot number: EJ1685, expire: unknown) at single dose, via an unspecified route of administration in left arm on 08Jan2021 09:00 (second dose, lot number: EL3246, expire: Apr2021) at single dose for COVID-19 immunization. Medical history included very frequent yeast infections that started about eight years ago, hypothyroidism from an unknown date and unknown if ongoing (she has been on medication her whole life). Concomitant medication included thyroid (ARMOUR THYROID) at 90 mg daily for hyperthyroidism (she has been on this particular medication about a year, but she has been on thyroid medication her whole life). The patient experienced ringing in ears on an unspecified date. She got two doses of Pfizer vaccine. It may be a coincidence. She started having intermittent ringing in ears and now it had been constant for 3 or 4 days in a row. She had continuous ringing in her ear and has never had problems with her ears before. It wasn't going away. She was at the point to go to the doctor. She honestly didn't know the date. She noticed it intermittently about the time she got the COVID vaccine. She didn't really pay much attention. She got the second shot about the time it started constantly. She couldn't say 100%, maybe it was coincidental. Caller clarified that she noticed intermittent ringing in the ears about the same time of the first dose. She noticed constant ringing about the same time as the second dose. She would rate seriousness criteria at a five, in the middle. It is not requiring hospitalization, but she would seek medical treatment if it didn't go away. The outcome of event was not resolved. Vaccination facility type was hospital. No additional vaccines administered on same date of the Pfizer suspect. The events were not required a visit to emergency room nor physician office at this time, but she was considering seeing her doctor or an ENT. No AE following prior vaccinations. No relevant tests.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous report from a contactable other hcp (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 4176), via an unspecified route of administration on the left arm on 12Jan2021 13:15 at a single dose for covid-19 immunisation. Medical history included PCN allergy from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications included multivitamins, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and fish oil (FISH OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685) on 22Dec2020 13:00 on the left arm for covid-19 immunization and stated that had no issues after first vaccination. On 12Jan2021 21:00, the patient had fever max 100.8 (no unit reported), chills, severe body aches, headaches, weakness, and fatigue. The patient underwent lab tests and procedures which included body temperature: max 100.8 (no unit reported) on 12Jan2021 21:00. As treatment, patient received OTC NSAIDS. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19.