chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeding disorder, Headache, Pyrexia
Clinical narrative: 1st dose- 06Jan2021/ her 2nd dose received on 20Jan2021; wiped out/ tired; headache; had no energy; Rigors; fever of 102.6; This is a spontaneous report from a contactable nurse (patient). This 55-year-old female patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 at 8:45AM via an unknown route at right arm for Covid-19 immunization. No vaccines administered on same date with the Pfizer vaccine considered as suspect. Medica history and concomitant drug were reported as "none". Patient previously had 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 in right arm (Lot/NDC/Expiry unknown). No other vaccinations within four weeks prior to the first administration date of the suspect vaccine; no adverse events following prior vaccinations. No family medical history relevant to adverse event. The patient reported some side effects from her 2nd dose received on 20Jan2021 at 8:45AM. She had a fever of 102.6 which started at 8pm on 20Jan2021 and broke this morning at 6am. The patient stated that the fever was gone, but she wouldn't say she has recovered completely because she still feels wiped out; had headache and was tired; also stated that she was not able to eat, and had no energy while she had the fever. The rigors started at 9pm on Wednesday, 20Jan2021. She stated that she couldn't do anything for the few hours it lasted. No other relevant diagnostic and confirmatory test results for events. No investigation assessment performed. The event did not require a visit to Emergency room or Physician office. The reported considered seriousness for fever was medically significant, for rigors was disabling.  Outcome of fever was resolving. Outcome of rigors was resolved on 21Jan2021. Outcome of the other events was unknown.    Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia and chills cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Rash
Clinical narrative: feeling icky all day; Rash on front and back of nect; chest, and little bit down both arms; Muscle aches; This is a spontaneous report from a contactable consumer(patient).A 74-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3246), via an unspecified route of administration on 12Jan2021 16:45 at single dose, left upper arm for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient had a little bit of muscle aches on 12Jan2021 after the vaccine kind of all day. Other days it came and went. On 19Jan2021 the patient felt icky all day. She got a rash on the front and back of her neck. Rash was also on her chest and a little bit down both arms. She went to a walk-in clinic. Wasn't sure if it would be related to the COVID-19 Vaccine, but was advised to report it.  Events required a visit to walk-in clinic. The outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: Low grade temp 99.1; diarrhea; body aches; chills; migraine; sweats; severe fatigue; Dose Number 1, Date of start of drug 21Dec2020/ Dose Number 2, Date of start of drug 20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 20Jan2021 07:30 at left arm, at single dose for covid-19 immunization. The patient medical history was not reported.  Concomitant medication included isotretinoin (ACCUTANE), cetirizine. The patient previously took pediazole and experienced Known allergies: pediazole. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 21Dec2020 09:15, at Left arm, at single dose for covid-19 immunization. The patient experienced low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue at 20Jan2021 12:00. No treatment was received for events low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue. The outcome of the events low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue was recovering. 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Migraine, Pain, Pyrexia
Clinical narrative: Low grade temp 99.1; diarrhea; body aches; chills; migraine; sweats; severe fatigue; Dose Number 1, Date of start of drug 21Dec2020/ Dose Number 2, Date of start of drug 20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 20Jan2021 07:30 at left arm, at single dose for covid-19 immunization. The patient medical history was not reported.  Concomitant medication included isotretinoin (ACCUTANE), cetirizine. The patient previously took pediazole and experienced Known allergies: pediazole. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 21Dec2020 09:15, at Left arm, at single dose for covid-19 immunization. The patient experienced low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue at 20Jan2021 12:00. No treatment was received for events low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue. The outcome of the events low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue was recovering. 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: soreness in right arm; numbness in right hand; tingling in right foot; This is a spontaneous report from a contactable consumer (patient).  A 77-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/lot number: EL9262), via an unspecified route of administration in the right upper arm on 20Jan2021 at single dose for covid-19 immunisation. The patient medical history included ongoing diabetes. Concomitant medications were not reported. The patient experienced soreness in right arm, numbness in right hand and tingling in right foot on 22Jan2021 with outcome of not recovered. She was schedule for the second dose on 10Feb2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer reported for herself.  A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route at the left arm on 01Jan2021 at single dose and the second dose via unspecified route at the right arm on 21Jan2021 around 10am at single dose, for COVID-19 immunization. Medical history included depression. The patient is not pregnant. The patient had no covid prior vaccination and no known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and birth control for awhile. On 01Jan2021 the patient experienced sore arm.  The event was assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the event was unknown  Information on the lot/batch number has been requested
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling hot, Insomnia, Nausea
Clinical narrative: sore arm; cannot sleep at all; chills; body aches; a bit of a hard time breathing; restless; feeling warm/heat; nauseous; This is a spontaneous report from a contactable consumer. A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm, via an unspecified route of administration on 21Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included depression. The patient had no covid prior vaccination and no known allergies. Historical Vaccine included first dose of bnt162b2 taken on 01Jan2021 (Vaccine location: Left arm) for covid-19 immunisation and the patient experienced sore arm. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), and birth control for awhile. The first dose the patient just had a sore arm, the second dose which she took yesterday 21Jan2021 around 10:00 caused a much more sore arm than the first dose she felt this after 2-3 hours of 2nd dose of vaccine, tonight she cannot sleep at all Jan. From 21Jan2021 to 22Jan2021 she keep waking up every 2 hours with chills body aches very sore arm a bit of a hard time breathing feeling very restless and not able to sleep, feeling warm/heat as well and a bit nauseous. The adverse events started on 21Jan2021 13:00. The patient received no treatment for the adverse events. The patient had no covid tested post vaccination. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Restlessness
Clinical narrative: sore arm; cannot sleep at all; chills; body aches; a bit of a hard time breathing; restless; feeling warm/heat; nauseous; This is a spontaneous report from a contactable consumer. A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm, via an unspecified route of administration on 21Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included depression. The patient had no covid prior vaccination and no known allergies. Historical Vaccine included first dose of bnt162b2 taken on 01Jan2021 (Vaccine location: Left arm) for covid-19 immunisation and the patient experienced sore arm. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), and birth control for awhile. The first dose the patient just had a sore arm, the second dose which she took yesterday 21Jan2021 around 10:00 caused a much more sore arm than the first dose she felt this after 2-3 hours of 2nd dose of vaccine, tonight she cannot sleep at all Jan. From 21Jan2021 to 22Jan2021 she keep waking up every 2 hours with chills body aches very sore arm a bit of a hard time breathing feeling very restless and not able to sleep, feeling warm/heat as well and a bit nauseous. The adverse events started on 21Jan2021 13:00. The patient received no treatment for the adverse events. The patient had no covid tested post vaccination. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Chills, Dizziness, Dysarthria
Clinical narrative: dizziness; increased heart rate; increased blood pressure; flushed; weakness; shakiness; lethargy; chilled; in particular hands were very cold; pale color; slurred speech; mental fog; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3249), via an unspecified route of administration at site of right arm on 20Jan2021 09:30 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included vitamin D3 and iron (SLOW RELEASE IRON) and daily multivitamin. Within minutes of receiving the dose on 20Jan2021 at 09:45 AM, dizziness, increased heart rate, increased blood pressure, flushed, weakness, and shakiness. About an hour after receiving the dose on 20Jan2021, lethargy, chilled, in particular hands were very cold, pale color, mental fog, and slurred speech. The patient did not receive any treatment from events. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported temporary mental fog/mental impairment was likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Heart rate increased, Lethargy, Pallor
Clinical narrative: dizziness; increased heart rate; increased blood pressure; flushed; weakness; shakiness; lethargy; chilled; in particular hands were very cold; pale color; slurred speech; mental fog; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3249), via an unspecified route of administration at site of right arm on 20Jan2021 09:30 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included vitamin D3 and iron (SLOW RELEASE IRON) and daily multivitamin. Within minutes of receiving the dose on 20Jan2021 at 09:45 AM, dizziness, increased heart rate, increased blood pressure, flushed, weakness, and shakiness. About an hour after receiving the dose on 20Jan2021, lethargy, chilled, in particular hands were very cold, pale color, mental fog, and slurred speech. The patient did not receive any treatment from events. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported temporary mental fog/mental impairment was likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Tremor
Clinical narrative: dizziness; increased heart rate; increased blood pressure; flushed; weakness; shakiness; lethargy; chilled; in particular hands were very cold; pale color; slurred speech; mental fog; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3249), via an unspecified route of administration at site of right arm on 20Jan2021 09:30 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included vitamin D3 and iron (SLOW RELEASE IRON) and daily multivitamin. Within minutes of receiving the dose on 20Jan2021 at 09:45 AM, dizziness, increased heart rate, increased blood pressure, flushed, weakness, and shakiness. About an hour after receiving the dose on 20Jan2021, lethargy, chilled, in particular hands were very cold, pale color, mental fog, and slurred speech. The patient did not receive any treatment from events. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported temporary mental fog/mental impairment was likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Myalgia, Nausea
Clinical narrative: Vertigo; 101 F oral temperature; nausea; generalized weakness; rigors/ chills; generalized muscle aches; This is a spontaneous report from a non-contactable Nurse (patient). A 27 years old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 27 years old on 21Jan2021 09:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Vertigo, 101 F oral temperature, nausea, generalized weakness, chills, rigors, generalized muscle aches. Patient did not have covid prior vaccination and did not have covid tested post vaccination. The outcomes of events were unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Vertigo; 101 F oral temperature; nausea; generalized weakness; rigors/ chills; generalized muscle aches; This is a spontaneous report from a non-contactable Nurse (patient). A 27 years old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 27 years old on 21Jan2021 09:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Vertigo, 101 F oral temperature, nausea, generalized weakness, chills, rigors, generalized muscle aches. Patient did not have covid prior vaccination and did not have covid tested post vaccination. The outcomes of events were unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: COPD is a whole lot better; COPD is a whole lot better; This is a spontaneous report from a contactable consumer reporting for himself and from another consumer. An 80-year-old male patient  received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration in left arm, on 19Jan2021 at 11:30, at single dose, for COVID-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (from 10 to 15 years), ongoing diabetes mellitus (from 10 to 15 years), ongoing cardiac disorder, ongoing bone disorder, ongoing body height decreased (due to natural aging). Concomitant medications included lisinopril (unknown manufacturer, 20 mg) from 10/15 years and ongoing for cardiac disorder, calcium, colecalciferol (CALCIUM + VITAMIN D3, 400IU/600mg) from 2020 (from 1 year) and ongoing for bone disorder and to help immunisation. The patient reported that COPD was a whole lot better on 21Jan2021 at 10:30. He had no popping in the lungs and his lungs were clear.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: severe pain in her right ear cartilage; This is a spontaneous report from a contactable consumer(the patient).  A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246, expiration date Apr2021), via an unknown route of administration, on 19Jan2021 at 13:45 (at the age of 68-years-old)  as a single dose in the right arm for COVID-19 vaccination.  Medical history was reported as "none." The patient was administered the vaccine in a clinic. The patient's concomitant medications were not reported. The patient had not received any other vaccines within four weeks prior to the vaccination. On 21Jan2021 at 16:30 the patient experienced severe pain in her right ear cartilage which she stated hurt unbelievably.  The patient took an aspirin and Benadryl and went to bed, but the pain woke her up about every fifteen minutes throughout the night. She stated that as of the reporting date it was eighty percent better.  The clinical outcomes of pain in ear was reported as recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Mouth swelling, Pain, Urticaria
Clinical narrative: Mouth swelling; hives in mouth and lips; Body aches; joint pain; chills; This is a spontaneous report from a  (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK4176), via an unspecified route of administration in left arm on 14Jan2021 11:45 at first single dose for COVID-19 immunization. Medical history included covid-19 (covid prior vaccination), known allergies: Penicillin, sulfa drugs. There were no concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced body aches, joint pain and chills began about 16 hours after receiving vaccine (15Jan2021). Mouth swelling and hives in mouth and lips began 4 days after (18Jan2021 10:00 AM). AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment included: prescribed steroids. Covid was not tested post vaccination. Outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Feeling hot, Headache
Clinical narrative: nauseous/sick to my stomach; Weird headache; slight ache in my hip; Slight dizziness; fogginess/didn't feel right; I got hot/got very over heated; This is a spontaneous report from a contactable other hcp (patient). A 55-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL3246), intramuscular at left arm, on 20Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included possibly ibs occasionally from an unknown date. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No Known allergies. Approximately 20 hours after, on 21Jan2021 14:15, slight dizziness/ fogginess, she got hot, just didn't feel right lasted about 5 minutes. Around 1030 am on 22Jan. She got very nauseous, sick to her stomach, dizziness/ fogginess again, got very over heated. Weird headache. No fever, slight ache in her hip. After about 10 minutes it passed and she feels fine. No treatment AE. No COVID tested post vaccination. The outcome of the events slight dizziness/ fogginess, she got hot, just didn't feel right on 21Jan2021 14:15 were recovered on 21Jan2021 14:20 (reported as lasted about 5 minutes), of events nauseous, sick to her stomach, dizziness/ fogginess again, got very over heated, Weird headache, slight ache in her hip on 22Jan2021 10:30 were recovered on 22Jan2021 10:40 (reported as passes after about 10 minutes).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous/sick to my stomach; Weird headache; slight ache in my hip; Slight dizziness; fogginess/didn't feel right; I got hot/got very over heated; This is a spontaneous report from a contactable other hcp (patient). A 55-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL3246), intramuscular at left arm, on 20Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included possibly ibs occasionally from an unknown date. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No Known allergies. Approximately 20 hours after, on 21Jan2021 14:15, slight dizziness/ fogginess, she got hot, just didn't feel right lasted about 5 minutes. Around 1030 am on 22Jan. She got very nauseous, sick to her stomach, dizziness/ fogginess again, got very over heated. Weird headache. No fever, slight ache in her hip. After about 10 minutes it passed and she feels fine. No treatment AE. No COVID tested post vaccination. The outcome of the events slight dizziness/ fogginess, she got hot, just didn't feel right on 21Jan2021 14:15 were recovered on 21Jan2021 14:20 (reported as lasted about 5 minutes), of events nauseous, sick to her stomach, dizziness/ fogginess again, got very over heated, Weird headache, slight ache in her hip on 22Jan2021 10:30 were recovered on 22Jan2021 10:40 (reported as passes after about 10 minutes).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Headache, Pain
Clinical narrative: Cough; joints were really sore; Headache; feeling really tired; body aches; sore at injections site; This is a spontaneous report from a contactable consumer reported for himself.  A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot FL3302 via unspecified route at the left upper arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications were not reported. The patient had received a flu shot vaccine and he also got a shingles shot in Oct2020. The patient reported that he worked on the military base. On the day of vaccination, he had a slight headache after getting the shot. Toward the evening he began to feel really tired and had bad headache. The next day he was still really tired and developed a slight cough. It was clarified that the slight headache started the day of the shot, 20Jan2021 followed by it getting worse that evening and feeling really tired. On 21Jan2021 he was still really tired and developed a slight cough. On 22Jan2020, he was still really tired, had the headache and cough. He was taking Ibuprofen. The patient stated he also had body aches that started on night 20Jan2020 at the vaccination site, it was not really bad, but it felt like his joints were really sore. The outcome of  the events was reported as not recovered. He was supposed to go back for the second shot on 10Feb2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Cough; joints were really sore; Headache; feeling really tired; body aches; sore at injections site; This is a spontaneous report from a contactable consumer reported for himself.  A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot FL3302 via unspecified route at the left upper arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications were not reported. The patient had received a flu shot vaccine and he also got a shingles shot in Oct2020. The patient reported that he worked on the military base. On the day of vaccination, he had a slight headache after getting the shot. Toward the evening he began to feel really tired and had bad headache. The next day he was still really tired and developed a slight cough. It was clarified that the slight headache started the day of the shot, 20Jan2021 followed by it getting worse that evening and feeling really tired. On 21Jan2021 he was still really tired and developed a slight cough. On 22Jan2020, he was still really tired, had the headache and cough. He was taking Ibuprofen. The patient stated he also had body aches that started on night 20Jan2020 at the vaccination site, it was not really bad, but it felt like his joints were really sore. The outcome of  the events was reported as not recovered. He was supposed to go back for the second shot on 10Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Nausea
Clinical narrative: chills; nausea; felt like he had the flu; This is a spontaneous report from a contactable consumer. An adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 11:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. Patient received first dose of BNT162B2 on an unspecified date. On 21Jan2021 03:00 AM, the patient had chills, nausea and felt like he had the flu after getting the 2nd shot of the vaccine. No treatment received. Events outcome was unknown.   Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Nausea; Fever; Chills; Body aches; Lethargy; Injection site inflammation and swelling; Injection site inflammation and swelling; This is a spontaneous report from a non-contactable healthcare professional reporting for self. This 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9261) on 20Jan2021 10:00 AM at single dose (vaccine location=left arm) for COVID-19 immunisation.  Medical history was none. No known allergies.  Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=EL0140) on 30Dec2020 07:15 PM at single dose (vaccine location=left arm) for COVID-19 immunisation. The were no other vaccine in four weeks, patient did not have COVID prior vaccination. Patient was not pregnant. The patient experienced nausea, fever, chills, body aches, lethargy, injection site inflammation and swelling on 21Jan2021. No treatment received. Patient did not test COVID post vaccination. The outcome of events was recovered in Jan2021.    No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site swelling
Clinical narrative: Nausea; Fever; Chills; Body aches; Lethargy; Injection site inflammation and swelling; Injection site inflammation and swelling; This is a spontaneous report from a non-contactable healthcare professional reporting for self. This 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9261) on 20Jan2021 10:00 AM at single dose (vaccine location=left arm) for COVID-19 immunisation.  Medical history was none. No known allergies.  Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=EL0140) on 30Dec2020 07:15 PM at single dose (vaccine location=left arm) for COVID-19 immunisation. The were no other vaccine in four weeks, patient did not have COVID prior vaccination. Patient was not pregnant. The patient experienced nausea, fever, chills, body aches, lethargy, injection site inflammation and swelling on 21Jan2021. No treatment received. Patient did not test COVID post vaccination. The outcome of events was recovered in Jan2021.    No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Pain, Pyrexia, Vaccination site pain
Clinical narrative: arm injection site pain(soreness); ran a fever of 101; Body aches; stuff nose; This is a spontaneous report from a contactable consumer.   A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route on 21Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient is not pregnant. The patient had received the first dose of the same vaccine on unknown date. On 21Jan2021 the patient experienced arm injection site pain, ran a fever of 101, body aches and stuff nose. The outcome of the events was reported as recovering. The patient did not receive any treatment for the events. The patient had not been tested for COVID post vaccination. No COVID prior vaccination. The events were assessed as non-serious.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Dizziness, Joint swelling, Nausea
Clinical narrative: inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test negative, Tremor
Clinical narrative: inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: Chills; Joint pain; This is a spontaneous report from a contactable other health professional. A 55-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in left arm, in Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient experienced chills and joint pain both in Jan2021, 6 days after vaccination, with outcome of recovered after several hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: extremely swollen lymph node in right arm pit. required a doctor visit, with medical tests ordered; This is a spontaneous report from a contactable Other-HCP. This Other-HCP reported for self that the 25-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Pfizer), via Intramuscular on Jan2021 03:45 PM on Right arm at single dose for covid-19 immunisation. Medical history included known allergies: shellfish, some nuts and cats. Concomitant medications included Birth control. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, Pfizer), via Intramuscular in Dec2020 08:30 PM on Right arm at single dose for covid-19 immunisation. Facility type vaccine was hospital. No other vaccine in four weeks. The patient experienced extremely swollen lymph node in right arm pit on 20Jan2021. Required a doctor visit, with medical tests ordered from 20Jan2021. AE resulted in: [Doctor or other healthcare professional office/clinic visit]. The outcome of the event was not recovered. Treatment received included medical tests ordered. No covid prior vaccination. No covid tested post vaccination.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: very intense headache; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced very intense headache on an unspecified date. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild soreness at Injection site; This is a spontaneous report from a non-contactable consumer for himself.   A 24-years-old male patient received bnt162b2 (BNT162B2; Lot # EL 3247) vaccine , via an unspecified route of administration in the left arm on  21Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced mild soreness at injection site  on 22Jan2021 with outcome of recovering.  Follow up not possible. Lot number already received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscle soreness at injection site for ~24 hrs after injection; This is a spontaneous report from a non-contactable consumer reported for self. This 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3248) at single dose in right arm on 12Jan2021for COVID-19 immunization. Medical history was not reported. Concomitant medications included amlodipine besilate (NORVASC), lisinopril, potassium/calcium supplements. There was no other vaccine in four weeks. There was no covid prior vaccination; no covid tested post vaccination. Patient experienced muscle soreness at injection site for 24 hrs after injection (in Jan2021). The outcome of event was recovered (in Jan2021).   No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: She woke up the next morning with a wet sweat.  Every morning she gets wetter and wetter; This is a spontaneous report from a contactable consumer (patient). An 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 12Jan2021 at first single dose for covid-19 immunisation. Medical history included: gained weight and is now 190 pounds. The food in her complex had a lot of calories and she can not get out. The patient stated she had a whole list of medications, but none that are relevant. She had no issues with wet sweats until after getting the vaccine. There were no concomitant medications. Caller said she received the COVID vaccination on 12Jan2021. She woke up the next morning with a wet sweat. Every morning she got wetter and wetter. Wet sweat was reported as worsened. It had been a week and four days and she wanted to report this, as it is terrible. She also wanted to ask if the second shot will give her a worse reaction than she had already from the first shot. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Lots of pain in her arm, it is also swollen; Lots of pain in her arm, it is also swollen; Fever of 101; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller was calling on behalf of her mother who got the COVID vaccine yesterday on 21Jan2021 in the afternoon around 2 o'clock. She woke up this morning on 22Jan2021 with lots of pain in her arm. It was also swollen. She also has a fever of 101. The outcome of the events was unknown.   Information about lot and batch number was requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Moderate pain at the site of injection that appeared 8hrs after the injection and lasted for 48hrs; This is a spontaneous report from a non-contactable Consumer. This 37-year-old male consumer (patient) reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at single dose for COVID-19 immunication on 20Jan2021.  Relevant history was none. No known allergies. Relevant concomitant drug was none. The patient experienced moderate pain at the site of injection that appeared 8hrs after the injection and lasted for 48hrs. No treatment was received. Outcome of the events was resolved. The patient did not received other vaccine in four weeks. The was not been diagnosed with COVID prior vaccination. The patient did not have COVID test post vaccination.    No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Lip erythema, Nausea, Ocular hyperaemia
Clinical narrative: blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still having some type of reaction; She did have nausea this morning; This is a spontaneous report from a contactable consumer reporting for herself.  A 68-years-old female patient received bnt162b2 (BNT162B2; Lot # EL1283) , via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation .  Medical history included cataract operation on 10Nov2020, oedema , swelling  , brain operation on 2016 , aneurysm (aneurysm that did not rupture and there are 8 coils protecting that) , implantable cardiac monitor insertion , hypertension.  Concomitant medication included lisinopril dihydrate (LISINOPRI)Lacetylsalicylic acid (ASPIRIN BAYER), amlodipine besilate (AMLODIPIN)  pravastatin sodium (PRAVASTATIN) The patient experienced chills  on 21Jan2021 with outcome of not recovered , her lips are a pinkish color as if she is still having some type of reaction  on 21Jan2021 with outcome of not recovered , she did have nausea this morning on Jan2021 with outcome of unknown , blood shot right eye  on 22Jan2021 with outcome of not recovered , she thinks she had an allergic reaction  on 21Jan2021 with outcome of not recovered.   The patient received Benadryl, Prednisolone and Ketorolac as treatment.  Follow up information has ben requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still having some type of reaction; She did have nausea this morning; This is a spontaneous report from a contactable consumer reporting for herself.  A 68-years-old female patient received bnt162b2 (BNT162B2; Lot # EL1283) , via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation .  Medical history included cataract operation on 10Nov2020, oedema , swelling  , brain operation on 2016 , aneurysm (aneurysm that did not rupture and there are 8 coils protecting that) , implantable cardiac monitor insertion , hypertension.  Concomitant medication included lisinopril dihydrate (LISINOPRI)Lacetylsalicylic acid (ASPIRIN BAYER), amlodipine besilate (AMLODIPIN)  pravastatin sodium (PRAVASTATIN) The patient experienced chills  on 21Jan2021 with outcome of not recovered , her lips are a pinkish color as if she is still having some type of reaction  on 21Jan2021 with outcome of not recovered , she did have nausea this morning on Jan2021 with outcome of unknown , blood shot right eye  on 22Jan2021 with outcome of not recovered , she thinks she had an allergic reaction  on 21Jan2021 with outcome of not recovered.   The patient received Benadryl, Prednisolone and Ketorolac as treatment.  Follow up information has ben requested.