chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eating disorder, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Headache/second day third day headache tired eating better tired fourth day night sweats headache tired.; Chills; body aches; Fever; sweating/second day third day headache tired eating better tired fourth day night sweats; not eating/second day third day headache tired eating better; shaking; tired all on first day and second day third day headache tired eating better tired fourth day night sweats headache tired.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/LOT: unknown), via unspecified route of administration on unspecified date in Feb2021 4:30 PM (at the age of 51-year-old) on left arm as a DOSE 1, SINGLE for COVID-19 immunization. Patient medical history and concomitant medication were not reported. Patient had not received any other vaccine in four weeks and patient had not received any other medications in two weeks. Patient had no known allergies. Patient does not have covid prior vaccination and was not tested to covid post vaccination. on unspecified date in Feb2021 4:30 PM patient experienced headache chilled body aches fever shaking not eating sweats tired all on first day and second day third day headache tired eating better tired fourth day night sweats headache tired. Patient had not received any treatment for the events. Outcome of the events was not recovered.  Information about lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Headache/second day third day headache tired eating better tired fourth day night sweats headache tired.; Chills; body aches; Fever; sweating/second day third day headache tired eating better tired fourth day night sweats; not eating/second day third day headache tired eating better; shaking; tired all on first day and second day third day headache tired eating better tired fourth day night sweats headache tired.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/LOT: unknown), via unspecified route of administration on unspecified date in Feb2021 4:30 PM (at the age of 51-year-old) on left arm as a DOSE 1, SINGLE for COVID-19 immunization. Patient medical history and concomitant medication were not reported. Patient had not received any other vaccine in four weeks and patient had not received any other medications in two weeks. Patient had no known allergies. Patient does not have covid prior vaccination and was not tested to covid post vaccination. on unspecified date in Feb2021 4:30 PM patient experienced headache chilled body aches fever shaking not eating sweats tired all on first day and second day third day headache tired eating better tired fourth day night sweats headache tired. Patient had not received any treatment for the events. Outcome of the events was not recovered.  Information about lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Somnolence
Clinical narrative: he can't eat; feeling very sleepy; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). An 87-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose unknown via an unspecified route of administration on 09Feb2021 (at the age of 87 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypoacusis. Concomitant medication included tafamidis (VYNDAMAX) taken for an unspecified indication. Patient stated on an unspecified date in Feb2021, he took the covid vaccine yesterday and he can't eat and was feeling very sleepy. The outcome of the events was unknown.  Information on batch/lot number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 29Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Feb2021, the patient had experienced dizziness. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Blood iron increased, Body height, Weight
Clinical narrative: she had an increase in her iron level; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself. An 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), intramuscular, administered in Arm Left on 05Feb2021 (at the age of 87-year-old) as dose 1, single for Covid-19 immunisation. Medical history included Open heart surgery in 2008, supplementation therapy to gain weight from an unknown date. Concomitant medication(s) included nutrients nos (ENSURE [NUTRIENTS NOS]) taken for supplementation therapy, start and stop date were not reported. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) and AE(s) following prior vaccinations was reported as none. On 09Feb2021, the patient had a blood test for a routine exam and found she had an increase in her iron level. She was wondering if the covid vaccine would increase her iron level. They told her that she had quite an increase in her iron and they were going to check. Her injection was the only thing that she has had. She has a follow up appointment with her physician. Caller said that her height and weight were unknown. She said that she does not weigh a lot and has been drinking Ensure to get her weight up. She had been taking ensure to gain weight and there was iron in it. She stated she weighs about 107lbs and was about 5ft 5in in her height. The patient underwent lab tests and procedures which included blood iron: increase in her iron level on 09Feb2021, body height: about 5ft 5in and weight: about 107 lbs on an unspecified date. The adverse event resulted in visit to Physician office. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: ; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable male consumer or other non-health care professional (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 30Jan2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced he has been having headaches off and on an unspecified date of 2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Paranasal sinus discomfort, Pyrexia
Clinical narrative: Severe headache; Sinus Pressure; Body aches; fever symptoms; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 30-year-old male patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in right arm as dose 2, single on 10Feb2021 14:00 (at the age of 30-year-old) for covid-19 immunisation at workplace clinic. The patient's medical history was not reported and no known allergies. Concomitant medication included ibuprofen(Advil) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in right arm as dose 1, single on 20Jan2021 13:00 (at the age of 30-year-old) for covid-19 immunisation. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medication within 2 weeks of vaccination: ibuprofen. On 11Feb2021 10:00, patient experienced severe headache, sinus pressure, body aches and fever. No therapeutic measures were taken as a result of the events. At the time of this report, outcome of the events was recovered on unspecified date in Feb2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Day after the injection I ended up in bed with low grade fever that would spike, break, and spike.; headache; chills; nausea; joint pain; This is a spontaneous report from a contactable consumer (reported for self).  A 62-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 14Feb2021 at 12:30 (at the age of 62-years-old), as single dose for covid-19 immunisation. Medical history included diabetic and high blood pressure. Patient was diagnosed with covid prior to vaccination. Concomitant medications included losartan potassium, atorvastatin, bupropion HCL, multi vitamin for women and melatonin. Patient was not tested for covid post vaccination. Patient did not receive any vaccine in four weeks. The patient previously took paxil (paroxetine hydrochloride) and experienced drug hypersensitivity. On 15Feb2021 at 09:00, day after the injection patient ended up in bed with low grade fever that would spike, break, and spike, headache, chills, joint pain and nausea. Therapeutic measures were not taken due to the events. The patient recovered from the events on an unspecified date.  Follow-up attempts were completed. No further information was expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: woke up feeling very fatigue/felt very tired and exhausted; swelling on injection site; feverish (low grade fever); bit dizzy; chills; muscle pain on injection site; This is a spontaneous report from a non-contactable consumer (patient). A 35-years-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 35-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 01:30 PM as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 35-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm right on 22Jan2021 at 11:30 AM as DOSE 1, SINGLE for covid-19 immunisation. Reported that within 24 hours of 2nd dose patient experienced events with injection site pain. Next morning at 8 AM, woke up feeling very fatigue. I also noticed swelling on injection site and but started to go down as the day passed by. Throughout the day, I felt very tired, exhausted, feverish (low grade fever), chills and bit dizzy. Next morning, I felt much better and recovered by Sunday afternoon to normal. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient was not tested for COVID-19. No allergies to medications, food, or other products reported. On an unspecified date in Feb2021, the patient experienced muscle pain on injection site, on 13Feb2021 at 08:00 AM the patient experienced woke up feeling very fatigue/felt very tired and exhausted, swelling on injection site, feverish (low grade fever), bit dizzy, chills. Patient received treatment for events with took short nap in afternoon, but it didn't help. The symptoms started to go down in the evening only after 2 hours of taking a Tylenol (500mg). No seriousness criteria reported. The outcomes of events were recovered on 14Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: woke up feeling very fatigue/felt very tired and exhausted; swelling on injection site; feverish (low grade fever); bit dizzy; chills; muscle pain on injection site; This is a spontaneous report from a non-contactable consumer (patient). A 35-years-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 35-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 01:30 PM as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 35-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm right on 22Jan2021 at 11:30 AM as DOSE 1, SINGLE for covid-19 immunisation. Reported that within 24 hours of 2nd dose patient experienced events with injection site pain. Next morning at 8 AM, woke up feeling very fatigue. I also noticed swelling on injection site and but started to go down as the day passed by. Throughout the day, I felt very tired, exhausted, feverish (low grade fever), chills and bit dizzy. Next morning, I felt much better and recovered by Sunday afternoon to normal. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient was not tested for COVID-19. No allergies to medications, food, or other products reported. On an unspecified date in Feb2021, the patient experienced muscle pain on injection site, on 13Feb2021 at 08:00 AM the patient experienced woke up feeling very fatigue/felt very tired and exhausted, swelling on injection site, feverish (low grade fever), bit dizzy, chills. Patient received treatment for events with took short nap in afternoon, but it didn't help. The symptoms started to go down in the evening only after 2 hours of taking a Tylenol (500mg). No seriousness criteria reported. The outcomes of events were recovered on 14Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: fever of 101 F; This is a spontaneous report received from a contactable consumer (Husband). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, the patient experienced fever of 101 f. Reporter called on behalf of wife who received the second dose of the Pfizer covid vaccine yesterday and currently had a fever of 101 F. Asked if ok to give advil. The patient underwent lab tests and procedures which included body temperature increased: 101 fahrenheit. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Headache, Vision blurred
Clinical narrative: I had a blurry vision and headache; sugar was off wack it was at 424; pounding headache; This is a spontaneous report from a contactable Consumer. This Female Consumer reported for herself.  A female patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 15Feb2021 09:15 am as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetic Mellitus and concomitant medications were not reported. On 15Feb2021 after the vaccination, around 14:00 the patient experienced pounding headache, her sugar was off whack it was at 424. she checked it again thinking it might be a mistake. It was still at 424.  In the morning she checked before getting the vaccine. It was stable at 106. she took her insulin and started drinking a lot of water. she couldn't't get sugar to come down by 3:00 clock it went up to 435. she never had her sugar this high. she had a blurry vision and headache. she called doctor and spoke to his R.N. She advised her to take humoral 4 units before dinner. she noticed around 7:00 pm, which is 5 hours later her sugar settled down to 205. she fairly believes the covid-19 vaccine brought her sugar skyrocketing. she took a fast-acting insulin 18 units and glyburide only then she was able to lower the sugar level. she was advised to not to eat carbs at night. Last night it got down to 169. In the morning was 197.  she still had headache. her arm felt like when she gets the flu vaccine. her concern was the high blood sugar, it took too long to come down. The patient lab data includes blood glucose levels on 15Feb2021 with a reading of 424 twice in back-to-back readings, and on same day patient glucose levels was 106 in the morning before vaccine. By 03:00pm it went up to 435. At around 07:00 pm sugar level showed a reading of 205. In the night it was 169 and in next morning it was 197. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (03Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up at-tempts have been completed and no further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Vaccination site pain
Clinical narrative: sore and red; sore and red; arm pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9266), via an unspecified route of administration, administrated in left arm, on 12Feb2021 about 2pm (age at the time of vaccination 73-years-old) as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 vaccine, on an unspecified date (age at the time of vaccination 73-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Feb2021, the patient experienced arm pain at injection site; and on an unspecified date sore and red. Caller would like to know if she should be worried about the side effects she experienced after the 2nd dose of the Pfizer vaccine. The outcome of the event arm pain at injection site was recovering and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Feeling abnormal
Clinical narrative: Shortness of breath; Cough; Feel moody; This is a spontaneous report from a contactable Other-HCP (patient). A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9267), via an unspecified route of administration, administered in left arm on 14Feb2021 05:00 (age at the time of vaccination 37-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. On 15Feb2021, the patient experienced shortness of breath, cough, and feel moody. No covid prior vaccination. Covid tested post vaccination was unknown. The outcome for all the events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Headache; Severe muscle and body aches; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported that.  A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 13Feb2021 11:15 as (At the age of 59-years) dose number unknown, single for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. It was reported that 16 hours post vaccine (3AM), patient woke with a fever, chills, headache and severe muscle and body aches. Temp was 100.6 and patient normally run 97.5. This lasted for over 12 hours. At 1:30 PM on 14Feb2021 patient took two extra strength tylenol (which was 26 hours post vaccine). The patient underwent lab tests and procedures which included body temperature: 100.6 on 14Feb2021, normally run 97.5. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Swelling
Clinical narrative: pain on the left hand, second finger; joint pain; swelling; This is a spontaneous report from a contactable consumer, the patient. A (age: 73, unit: unknown) male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 06Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced pain on the left hand, second finger, joint pain and swelling. Reporter stated that he saw his HCP and had been advised to take Tylenol. Reporter also stated that he was not sure if this was from something else or the vaccine. The outcome of the events was unknown.   Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Disorientation, Ear pain, Headache, Illness
Clinical narrative: Stomach hurts, is sick to her stomach; nausea; nose is running; ears are hurting; fever; Disoriented; sick; her head hurts; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient reports that she got her second vaccine and 2 days later her stomach hurts, is sick to her stomach leading to abdominal pain upper on an unspecified date with outcome of unknown , nausea, running nose, ears are hurting leading to ear pain, fever, disorientation, illness and her head hurts leading to headache on an unspecified date with outcome of unknown. She reports that her symptoms get worse when she takes her probiotic, anxiety pills or any medication.      Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Stomach hurts, is sick to her stomach; nausea; nose is running; ears are hurting; fever; Disoriented; sick; her head hurts; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient reports that she got her second vaccine and 2 days later her stomach hurts, is sick to her stomach leading to abdominal pain upper on an unspecified date with outcome of unknown , nausea, running nose, ears are hurting leading to ear pain, fever, disorientation, illness and her head hurts leading to headache on an unspecified date with outcome of unknown. She reports that her symptoms get worse when she takes her probiotic, anxiety pills or any medication.      Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer reported patient (father). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9264), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunisation. The patient experienced rash on an unspecified date. The reporter asked what to do about it use an antihistamine. The outcome of the event was reported as unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Myalgia
Clinical narrative: muscle pain; joint pain; just feeling all over unwell; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on 13Feb2021 as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included sciatica (she takes Tramadol for her sciatica and after experiencing the above symptoms) and heart failure from an unspecified date and unknown if ongoing. Past drug includes Tramadol taken for sciatica. Concomitant medications were unknown. Caller stated that patient received her second dose of the Pfizer BioNTech COVID-19 vaccine on 13Feb2021 and stated "I was ok at first" but then stated that later she experienced muscle pain, joint pain, "just feeling all over unwell" and that it "did seem to go over all my body." on an unspecified date in Feb2021. Caller stated that she had a history of sciatica and thought the joint pain and "just feeling all over unwell" were the same side effects she experienced with her sciatica. Caller stated that she took Tramadol for her sciatica and after experiencing the above symptoms after her second dose of the vaccine, took "three tramadol in 2 days" to help. Caller would like to know if taking the Tramadol has any effect on the vaccine. Caller stated that she did call an after hours doctor and asked about taking Tramadol with the vaccine and was told "it wouldn't matter." Caller also stated she recently received steroid injections on 01Feb2021 and "takes about 12 things" including medication for heart failure. Caller stated that she received both doses of the Pfizer BioNTech COVID-19 vaccine and would like to know how long she needs to "stay in to be perfectly safe" after receiving the vaccines. She has heard from different sources that the recommended time of quarantining is "6 days, 10 days, 2 weeks." Caller also stated that she herself has been quarantined since last March. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: Body Aches; Rash; This is a spontaneous report from a contactable other HCP (patient). A 70-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9264), via an unspecified route of administration, administrated in Right arm, on 11Feb2021 10:00 (age at the time of vaccination 70-years-old) as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EJ3302), via an unspecified route of administration, administrated in Right arm, on 18Jan2021 10:00 (age at the time of vaccination 70-years-old) as a single dose for COVID-19 immunization. The patient's medical history included hypertension and diabetic. The patient's concomitant medications included Diabetic Medicine. Patient had no known allergies. On 13Feb2021 08:00, the patient experienced Body Aches, and Rash. Treatment was received as a result of adverse events was unknown. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: cold; Deep cough; This is a spontaneous report from a contactable consumer or other non hcp.Pfizer Sponsored Program.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cold, deep cough on unknown date. The seriousness of the events was reported as non-serious. The outcome of all events on an unspecified date were unknown.  Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fall, Fatigue
Clinical narrative: temp. went to 106deg.; 12 hours after the shot I had a chill; I was weak all over; I could not walk; Tired all the time; walk holding on to wall; fell and could not get up; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Right on 04Feb2021 at 08:30 (Lot Number: EN9581) as dose1, single (at the age of 77-years-old) for COVID-19 immunisation. The patient's medical history included diabetic. No known allergies. The patient received other medications in two weeks included metformin, losartan, pantoprazole and glimepiride. On 04Feb2021 at 20:30 (reported as 12 hours after the shot), the patient experienced a chill and temperature went to 106 degree. The patient reported she was weak all over, could not walk, fell and could not get up, had to be lifted up and put in bed, next day was some better and able to walk holding on to wall. The patient was still having problems with legs and was tired all the time and was having to use a cane. The patient underwent lab test which included body temperature: went to 106 degree on 04Feb2021. The patient received no treatment for the events. Covid prior vaccination reported as yes. The patient did not get tested for COVID post vaccination. The patient had no other vaccine in four weeks. The patient was recovering from the events.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Gait inability, Pyrexia
Clinical narrative: temp. went to 106deg.; 12 hours after the shot I had a chill; I was weak all over; I could not walk; Tired all the time; walk holding on to wall; fell and could not get up; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Right on 04Feb2021 at 08:30 (Lot Number: EN9581) as dose1, single (at the age of 77-years-old) for COVID-19 immunisation. The patient's medical history included diabetic. No known allergies. The patient received other medications in two weeks included metformin, losartan, pantoprazole and glimepiride. On 04Feb2021 at 20:30 (reported as 12 hours after the shot), the patient experienced a chill and temperature went to 106 degree. The patient reported she was weak all over, could not walk, fell and could not get up, had to be lifted up and put in bed, next day was some better and able to walk holding on to wall. The patient was still having problems with legs and was tired all the time and was having to use a cane. The patient underwent lab test which included body temperature: went to 106 degree on 04Feb2021. The patient received no treatment for the events. Covid prior vaccination reported as yes. The patient did not get tested for COVID post vaccination. The patient had no other vaccine in four weeks. The patient was recovering from the events.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This is a spontaneous report from a contactable consumer (Patient). A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 02Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced joint pain on an unspecified date. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: facial swelling; This is a spontaneous report from a contactable consumer or other non-healthcare professional reported for patient (Father).  A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: UNKNOWN), via an unspecified route of administration as dose 1, single for on an unspecified date covid-19 immunisation. The patient medical history and concomitant medications were not reported. As per reporter, the patient received the first dose of the COVID-19 vaccine on Thursday and developed facial swelling. Reporter wanted to know if it was safe for him to get the second dose. At the time of this report, outcome of the event was unknown.  Information on Lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fear of falling, Feeling abnormal, Gait disturbance
Clinical narrative: He felt some uneasiness which was close to dizziness; Feels uneasiness when walking, like he is about to fall over; Feels uneasiness when walking, like he is about to fall over/dizziness is not like the world is spinning, but it feels like he is ready to tip over; He felt some uneasiness which was close to dizziness / light headedness; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 74-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 08Feb2021 at 11AM to 12PM (at the age of 74-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. Patient had the shot on Monday afternoon around 11 or 12 clock. Tuesday on unknown date he felt some uneasiness which was close to dizziness and lightheadedness on 09Feb2021. He would feel it when walking. It lasted for a while then went away. Then he woke up this morning and had this feeling again. It has now lasted for like 5 hours now. He stated he does not had a fever or sickness. He has this uneasy feeling when walking. It is like he is about to fall over and has to hold on to not top over, like a dizziness. Patient wanted to know if this was a symptom of the vaccine. Nothing occurs when he was sitting down, it was when he started moving around. He was wondering if that was one of the symptoms. Caller states the dizziness is not like the world is spinning, but it feels like he is ready to tip over. The outcome of the event dizziness was reported as not recovered and while other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoacusis, Paraesthesia
Clinical narrative: slight tingling of my face; muffled hearing; facial flushing; This is a spontaneous report from a non-contactable other health care professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), single dose via an unspecified route of administration on 16Feb2021 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient immediately after vaccination experienced slight tingling of my face, muffled hearing, and facial flushing. Patient questioned about who will decide if to get second dose or his doctor. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Haematoma, Myalgia, Vaccination site pain
Clinical narrative: injection site soreness; hematoma; muscle in my arm bothers me a little bit when I move my arm; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jan2021 (at the age of 75 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced injection site soreness, hematoma, muscle in my arm bothers me a little bit when i move my arm on an unspecified date on 2021. Reported as, "experienced a sore arm after the dose and the sore arm has continued for weeks/still present. muscle in my arm bothers me a little bit when I move my arm. asking if this was normal for the injection site soreness to last weeks. patient also asked if this pain could be related to taking a blood thinner. continues to ask questions about hematoma. she was having, the injection site was sore and she was calling because it was still sore and it has been quite a few weeks. She also mentioned that she is on a blood thinner (unspecified medication) and she asked if that was anything of concern". No treatment was given for the events. Outcome of the event injection site soreness was not recovered and unknown for rest of the events.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: developd a little bit of a rash on her chest which spread down to her arms, and shoulders; This is a spontaneous report from a non-contactable consumer reported that. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the administration of vaccine on Friday the patient experienced a little bit of a rash on her chest which spread down to her arms and shoulders on an unspecified date in Feb2021. She wants to know if this is a normal reaction to the vaccine. The patient should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of this vaccine and had a severe allergic reaction to any ingredient of this vaccine. She referred the consumer to her HCP for more guidance on whether it is still safe for her to receive the 2nd dose. The event outcome was Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Fatigue, Pain in extremity
Clinical narrative: no energy at all; He also experienced a sore arm; developed severe fatigue afterward, no energy, could not work or get out of bed or do anything; developed severe fatigue afterward, no energy, could not work or get out of bed or do anything; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982; Expiration Date: May2021) via an unspecified route of administration, administered in arm left on 11Feb2021 (at the age 57-year-old) at dose 1, single for covid-19 immunisation. He took the first Pfizer COVID shot this last Thursday. Medical history included ongoing high blood pressure (Diagnosed for 25-30 years). Concomitant medication included losartan potassium (LOSARTAN AGP) 100mg taken for high blood pressure from an unspecified start date and ongoing (he has been on it for 3 years). On an unspecified date in 2021 the patient experienced developed severe fatigue afterward, no energy, could not work or get out of bed or do anything, on 12Feb2021 no energy at all, he also experienced a sore arm. Reporter, male, aged 57 received first dose last Thursday and developed severe fatigue afterward, no energy, could not work or get out of bed or do anything. He also experienced a sore arm. Symptoms have resolved today. Then, he experienced a side effect from that following day up until today. He had no energy at all. He couldn't do anything or even work. He wants to know is this a normal side effect. Will he experience the same thing with the second dose. His left arm was sore that Friday. He didn't want to be where he was. He didn't feel good. Then, Saturday, Sunday, Monday and today he has been at home the whole time. He hasn't left at all. He is wondering when he goes back on the 04Mar2021 for the second one will it be worse or the same as the first one. He wasn't going to take the vaccine, but then decided to. Outcome of the events developed severe fatigue afterward, no energy, could not work or get out of bed or do anything was unknown, no energy at all was resolving and he also experienced a sore arm was resolved on 13Feb2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable consumer (the patient). A 74-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9264), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included diabetic from an unknown date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced arm soreness after second dose of vaccine. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Erythema, Fatigue, Paraesthesia, Pruritus
Clinical narrative: Rashes and itchiness on both shins; Rashes and itchiness on both shins; a few red dots/spots on my chest and face; a few red dots/spots on my chest and face; itching in my ears (around the antihelix and canal); redness around the helix; some respiratory symptoms; pins and needles in my left hand for half a day; debilitating fatigue; This is a spontaneous report from a contactable consumer (reported for herself). A 39-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3249/ Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 11Feb2021 at 14:45 (at the age of 39-years-old) as dose 2, single for covid-19 immunisation at other. Medical history included spinal osteoarthritis from an unknown date and unknown if ongoing (Only chronic cervical spine issues). Concomitant medication(s) included toradol (KETOROLAC TROMETHAMINE) taken for an unspecified indication, start and stop date were not reported and cyclobenzaprine (CYCLOBENZAPRINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3248/ Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 21Jan2021 at 10:00 (at the age of 39-years-old) as dose 1, single for covid-19 immunisation at other. On 12Feb2021, the consumer experienced rashes and itchiness on both shins, a few red dots/spots on my chest and face, itching in my ears (around the antihelix and canal) and redness around the helix, some respiratory symptoms, pins and needles in my left hand for half a day and debilitating fatigue. Therapeutic measures were taken as a result of events included treatment with Claritin and Benadryl. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.