chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Muscular weakness, Pain in extremity, SARS-CoV-2 test
Clinical narrative: started have severe burning,; after 4 days my thighs became weakened; aching pain unrelenting and spread to my upper arms after that for weeks without relief.; This is a spontaneous report from a contactable consumer (patient herself). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6200; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 16Feb2021 13:30 (at the age of 75-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included coronary artery disease, type 2 diabetes mellitus, chronic kidney disease, glaucoma, rubber sensitivity; 21 on a list, including Latex from an unknown date and unknown if ongoing. Other medications (concomitant medications) in two weeks was reported as yes (drugs not specified). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that after 4 days on 20Feb2021 11:00 patient's thighs became weakened and started have severe burning, aching pain unrelenting and spread to her upper arms after that for weeks without relief. AEs resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of AEs as patient received treatment with Gabapentin 300 x 3x a day. The patient underwent lab tests and procedures which included SARS-COV-2 test (Nasal Swab) which was negative on 14Aug2021 post the vaccination. The outcome of all events was resolved with sequel on an unspecified date in 2021.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Limb injury
Clinical narrative: it was reaction that I got my left arm got a burning in it; my whole left leg from my left side of my body, my buttocks, all down the leg are twisting it is like shot one down to it; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced it was reaction that I got my left arm got a burning in it on an unspecified date with outcome of unknown, my whole left leg from my left side of my body, my buttocks, all down the leg are twisting it is like shot one down to it on an unspecified date. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; sore arm; This is a spontaneous report from a contactable consumer (patient) reporting oneself.  A patient of unspecified age and gender received (BNT162B2, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included tension headache from an unknown date and unknown if ongoing. And the patient concomitant medications were not reported. It was reported that patient experienced headache, sore arm after the first vaccine due to which the patient delayed second vaccine. Upon follow-up(21Sep2021); it was reported that, the patient reported that he/she get tension headaches and had a long day, so the headache could be attributed to that as well. The sore arm was for over a week. It was reported that, patient administered second dose on an unspecified date and did fine with the second shot. The clinical outcome of the events was unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity
Clinical narrative: delayed my second vaccine; did fine with the second shot (just a bit of a sore arm).; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, (Batch/Lot number was not reported)), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and experienced headache and sore arm. Due to the symptoms of dose 1 the patient delayed his/her second dose vaccine which was an off label scenario and post vaccination the patient experienced just a bit of a sore arm on an unspecified date. The outcome of all the events was unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Started period off-cycle on 5th day after receiving vaccine, 13 days early; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 15Sep2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified hormonal birth control pills (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. On 20Sep2021, the patient's period started off-cycle on the 5th day after receiving the vaccine which was 13 days early. It was reported that the period was normally on a regular schedule. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 20Sep2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the event started period off-cycle on 5th day after receiving vaccine, 13 days early was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout flare; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 08Sep2021 at 12:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included gout flare on an unspecified date in Aug2021 (reported as had 1 gout flare up the month prior). Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN-C); both for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Sep2021 at 17:00, (also reported as approximately 3 hours after 1st dose of the vaccine), the patient had a gout flare and noticed the left toe joint in his foot began to swell and turn red. He stated that he had 1 gout flare up the month prior and he was sure that it was another flare up happened. The next day he could hardly put pressure on the joint and it was very painful, which lasted about 4 days. Reportedly, it was during a low purine diet period, being active and usually that happens after alcohol or unhealthy food intake. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event gout flare was resolved on an unspecified date in 12Sep2021.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Thrombosis; This is a spontaneous report from a Pfizer Sponsored Program, received from a non-contactable consumer (patient). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller (patient) stated that he would like to make a claim against Pfizer for money because he took the CVOID vaccine and 3 months later he had to go to the emergency room with a thrombosis. Caller wondering if people have been calling with this issue after taking the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: double vaccinated and my symptoms from the described have almost by far 50 percent improved; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and received first dose of BNT162B2 (lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history included paranoid scysefrenik with hysterical tendencys (20 years ago I was diagnosed as paranoid scysefrenik), hysterical tendencys and extreme ptsd (20 years ago I was diagnosed as paranoid scysefrenik with hysterical tendencys and extreme ptsd). Concomitant medications were not reported. It was reported that, patient just wanted to let know patient read an article recently about other positive effects of the vaccine. Patient is 54-year-old retired deputy sheriff ilod 20 years ago patient was diagnosed as paranoid scysefrenik with hysterical tendencys and extreme ptsd patient was double vaccinated and patient symptoms from the described have almost by far 50 percent improved thanks. The outcome of the event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Retinal tear
Clinical narrative: Retinal tear; FACILITATED COLLECT  This is a Solicited report based on the information received by Pfizer (Manufacturer Control No: 21K-163-4076878-00) from a contactable female consumer reporting for herself.  A 58-year-old female subject received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 02May2021 (Batch/Lot number was not reported) (at the age of 58-year-old) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date (Batch/Lot number was not reported), at unspecified dose for rheumatoid arthritis.  Medical history included retinal tear repair surgery on an unspecified date. The subject's concomitant medications were not reported. The subject previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 01Apr2021 (Batch/Lot number was not reported) (at the age of 58-year-old) as single dose for COVID-19 immunisation. The subject had retinal tear five days after COVID-19 vaccine on 07May2021 with outcome of recovered. She had retinal tear repair surgery.  The action taken in response to the event for adalimumab was unknown. The reporter's causality for the event Retinal tear after Pfizer/BioNTech Covid Vaccine was not provided. Pfizer's opinion is that there is no reasonable possibility that the event of Retinal tear after Pfizer/BioNTech Covid Vaccine is related to HUMIRA (ADALIMUMAB).  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship the event of retinal tear is related to the suspect product BNT162B2. However medical history of retinal tear repair surgery indicates that the patient had retinal tear in the past which might have been related to underlying condition of rheumatoid arthritis and is a confounding factor for the present event.  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: shortness of breath; heart seemed to be beating fast/thumping; dizziness; extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 02Sep2021 20:00 (at the age of 42 years) (Batch/Lot Number: PC3182) as DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included venlafaxine hydrochloride (VENLAFAXINE ER); losartan taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. 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 did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Aug2021 08:00 PM (at the age of 42 years) (Batch/Lot Number: FD8448) for covid-19 immunisation. On 07Sep2021 09:00 the patient experienced, approximately 5 days after receiving the second dose of the vaccine began to have shortness of breath, heart seemed to be beating fast/thumping, dizziness, and extreme fatigue. This was still occurring as of 21Sep2021. The events resulted in visit to doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included heart rate increased: fast on an unspecified date. The patient received treatment was unknown. The clinical outcome of events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthma, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis aggravated; Asthma; FACILITATED COLLECT  This is a Solicited report based on the information received by Pfizer from (Manufacturer Control No: 21K-163-3819448-00) from a non-contactable female consumer reporting for herself. This is the first of two reports.  A 66-year-old female subject received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date (Batch/Lot number was not reported) at unspecified dose for an unspecified indication.  Medical history was none. No known allergies. There were no concomitant medications.  The subject experienced asthma and psoriatic arthritis aggravated, both on an unspecified date with outcome of unknown.  The action taken in response to the events for adalimumab was unknown. The reporter's causality for the event(s) of had COVID vaccine and had a really sore arm with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of COVID-19, psoriatic arthritis flare up and asthma was not provided.   The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Psoriatic arthropathy and Asthma cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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. ,Linked Report(s) : -PFIZER INC-202101241814 same patient, different event and dr
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: she stated she had a friend who also had the same issue with Bell's Palsy; This is a spontaneous report from a contactable other health care professional reported for her friend. This is a report 2 of 2, for the female friend: A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection Batch/Lot number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date, unknown dose number at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reason for the patient taking Pfizer COVID vaccine was not provided. Reporter, stated that she had a friend who also had the same issue with bell's palsy on an unspecified date. The drug result of suspect was reported as related. The clinical outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event bell's palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: After first shot severe fatigue for about 3 weeks; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 (Batch/Lot Number: EW0170) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing Asthma as a child but no adult issues or treatment. Patient did not have covid prior vaccination. covid tested post vaccination no. On an unspecified date the patient experienced after first shot severe fatigue for about 3 weeks. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Eczema, Herpes zoster, Lymphadenopathy, Neuralgia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non hcp. A 52-years-old female patient received bnt162b2 (COMIRNATY,Batch/Lot number was not reported)via an unspecified route of administration on an unspecified date,at the age of 52 years old,as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization.Medical history included ongoing eczema,Additional Information for Other Conditions: has dealt with this her whole life,mastectomy from an unknown date and unknown if ongoing.Additional Information for Other Conditions: surgery three years ago, not for staged cancer, just left side.There were no concomitant medications.The patient experienced shingles, lymph node in upper left chest very big and swollen bump on Aug2021,serious nerve pain,open sores and serious condition of eczema on 2021.Therapeutic measures were taken as a result of shingles,lymph node in upper left chest very big and swollen bump serious nerve pain,open sores and serious condition of eczema.The outcome of the event shingles was recovered with sequel while other events outcome was unknown.caller stated his wife may have been one of the first to get COVID-19 before it was even known since she works at the airport, states people got COVID back in Dec2019 Jan2020.Unknown exact dates for the shingles, the blisters scabbed and closed up about 10 days ago, the nerve pain has now started more than 10 days ago, started when she still had open sores. States it was treated with Lyrica.Caller was encouraged to reach out to his health care provider.Declined transfer.The patient had not received any treatment for the event.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Limb injury, Pain
Clinical narrative: fell; he was in pain; injured his shoulder; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported via medical information team.   A male 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 on Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date on 2021, the patient fell and got injured and was in the hospital. The patient Fell and injured shoulder. He said that he was in pain and had to go to surgery but he feels better now. He is asking if it is still okay for him to get the second shot. He is asking if it is okay for him to have the Johnson & Johnson COVID Vaccine since it would only be one dose. He said that he was in pain and had to go to surgery, but he felt better now. He was asking if it is okay for him to have the Johnson & Johnson COVID Vaccine since it would only be one dose. The events resulted in Hospitalisation. Therapeutic measures were taken as a result of fell, he was in pain, injured his shoulder. The outcome of the events were unknown.  No Follow-up attempts are needed, Information about Lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: took the whole Covid test and one came out negative and the other came out positive; getting sick; This is a spontaneous report from a contactable 19-year-old female consumer reported for herself. A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 17Sep2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 19-year-old) for covid-19 immunisation. Medical history included None. There were no concomitant medications. The patient experienced took the whole covid test and one came out negative and the other came out positive (covid-19) and getting sick on an unknown date in Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test one came out negative on an unknown date in Sep2021, sars-cov-2 test: the other came out positive on an unknown date in Sep2021 (took the whole Covid test and one came out negative and the other came out positive). The outcome for all events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Short of breath; little bit of chest pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 17-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 30135BA), via an unspecified route of administration on 21Sep2021 (Age at vaccination: 17-years-old) as single dose for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 on 20Aug2021 (Age at vaccination: 17-years-old) for covid-19 immunization. It was reported that patient stated he currently got the second dose of Pfizer vaccine. having some short of breath and a little bit of chest pain. Therapeutic measures were taken as a result of events with Tylenol. The outcome for the events was reported as not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Diarrhoea, Dizziness, Fatigue
Clinical narrative: She had allergy in her whole body like a rash and then she had hive she also got hiverash all over her whole body even her face from head to toe; She had allergy in her whole body like a rash and then she had hive she also got hive; Bad itch; She had allergy in her whole body like a rash and then she had hive she also got hive; Dizziness; Headache; Vomit; Diarrhea; Got a fever 104, 105; Tiredness; This is a spontaneous report from a contactable consumer (patient's husband) or other non hcp. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: 301308A via an unspecified route of administration on 15Sep2021 (at the age of 43-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FC3183 via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. On an unknown date in Sep2021, the patient had a bad reaction, the patient had allergy in her whole body like a rash and then she had hive she also got hive rash all over her whole body even her face from head to toe, bad itch, dizziness, headache, vomit, diarrhea, got a fever 104, 105, tiredness. So we took her to the hospital (further clarification unknown). They kept on trying to put different medication they put on steroids (unspecified medications) but it made it worse like she got hives all over again after they put, she got hives worse like it was itching her whole body she was in bad itch. She had rash all over her whole body even her face from head to toe. She was scared you know because every time they put a medication so they would also put Benadryl and this Benadryl seem like it helped with allergy with rash a little bit but then it would come back a little bit after it relived a little bit itching then the rash come out again. They put some other medication (unspecified medication) and she broke out again she got hives again and rash. She was there for 4 days like that. The reporter added that the patient was in hospital from 16Sep2021 to 19Sep2021. The patient underwent lab tests and procedures which included blood test: unknown results on Sep2021, body temperature: 104, 105 on Sep2021 Fever. Therapeutic measures were taken as a result of adverse events. The patient received treatment with Benadryl and an unspecified medication. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Pruritus, Pyrexia, Rash
Clinical narrative: She had allergy in her whole body like a rash and then she had hive she also got hiverash all over her whole body even her face from head to toe; She had allergy in her whole body like a rash and then she had hive she also got hive; Bad itch; She had allergy in her whole body like a rash and then she had hive she also got hive; Dizziness; Headache; Vomit; Diarrhea; Got a fever 104, 105; Tiredness; This is a spontaneous report from a contactable consumer (patient's husband) or other non hcp. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: 301308A via an unspecified route of administration on 15Sep2021 (at the age of 43-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FC3183 via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. On an unknown date in Sep2021, the patient had a bad reaction, the patient had allergy in her whole body like a rash and then she had hive she also got hive rash all over her whole body even her face from head to toe, bad itch, dizziness, headache, vomit, diarrhea, got a fever 104, 105, tiredness. So we took her to the hospital (further clarification unknown). They kept on trying to put different medication they put on steroids (unspecified medications) but it made it worse like she got hives all over again after they put, she got hives worse like it was itching her whole body she was in bad itch. She had rash all over her whole body even her face from head to toe. She was scared you know because every time they put a medication so they would also put Benadryl and this Benadryl seem like it helped with allergy with rash a little bit but then it would come back a little bit after it relived a little bit itching then the rash come out again. They put some other medication (unspecified medication) and she broke out again she got hives again and rash. She was there for 4 days like that. The reporter added that the patient was in hospital from 16Sep2021 to 19Sep2021. The patient underwent lab tests and procedures which included blood test: unknown results on Sep2021, body temperature: 104, 105 on Sep2021 Fever. Therapeutic measures were taken as a result of adverse events. The patient received treatment with Benadryl and an unspecified medication. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: She had allergy in her whole body like a rash and then she had hive she also got hiverash all over her whole body even her face from head to toe; She had allergy in her whole body like a rash and then she had hive she also got hive; Bad itch; She had allergy in her whole body like a rash and then she had hive she also got hive; Dizziness; Headache; Vomit; Diarrhea; Got a fever 104, 105; Tiredness; This is a spontaneous report from a contactable consumer (patient's husband) or other non hcp. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: 301308A via an unspecified route of administration on 15Sep2021 (at the age of 43-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FC3183 via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. On an unknown date in Sep2021, the patient had a bad reaction, the patient had allergy in her whole body like a rash and then she had hive she also got hive rash all over her whole body even her face from head to toe, bad itch, dizziness, headache, vomit, diarrhea, got a fever 104, 105, tiredness. So we took her to the hospital (further clarification unknown). They kept on trying to put different medication they put on steroids (unspecified medications) but it made it worse like she got hives all over again after they put, she got hives worse like it was itching her whole body she was in bad itch. She had rash all over her whole body even her face from head to toe. She was scared you know because every time they put a medication so they would also put Benadryl and this Benadryl seem like it helped with allergy with rash a little bit but then it would come back a little bit after it relived a little bit itching then the rash come out again. They put some other medication (unspecified medication) and she broke out again she got hives again and rash. She was there for 4 days like that. The reporter added that the patient was in hospital from 16Sep2021 to 19Sep2021. The patient underwent lab tests and procedures which included blood test: unknown results on Sep2021, body temperature: 104, 105 on Sep2021 Fever. Therapeutic measures were taken as a result of adverse events. The patient received treatment with Benadryl and an unspecified medication. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate irregular, Malaise
Clinical narrative: irregular heartbeat; he is not feeling too good; dizziness; eyes are blurry; high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 62-year-old male 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 an unspecified date 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 Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient's wife stated that he had high blood pressure and she said something was not right her husband was complaining and she gave him aspirin which calmed him down a little bit when he came back from therapy (not specified). Her wife mentioned that for his first dose he felt quite fine but during the second dose, his symptoms started showing after few days. His wife also clarified that he was being taken to hospital specifically for his irregular heartbeat and loud heart sounds. Her wife stated that her husband can feel and hear his heartbeat. Her wife mentioned that she was referring to dizziness when she mentioned incapacitated and also read all that has mentioned. After receiving the second dose of vaccine the patient experienced irregular heartbeat, he was not feeling too good for 5-6 days, dizziness, eyes are blurry, high blood pressure and felt dizzy on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: high, heart rate irregular: irregular. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: irregular heartbeat; he is not feeling too good; dizziness; eyes are blurry; high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 62-year-old male 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 an unspecified date 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 Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient's wife stated that he had high blood pressure and she said something was not right her husband was complaining and she gave him aspirin which calmed him down a little bit when he came back from therapy (not specified). Her wife mentioned that for his first dose he felt quite fine but during the second dose, his symptoms started showing after few days. His wife also clarified that he was being taken to hospital specifically for his irregular heartbeat and loud heart sounds. Her wife stated that her husband can feel and hear his heartbeat. Her wife mentioned that she was referring to dizziness when she mentioned incapacitated and also read all that has mentioned. After receiving the second dose of vaccine the patient experienced irregular heartbeat, he was not feeling too good for 5-6 days, dizziness, eyes are blurry, high blood pressure and felt dizzy on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: high, heart rate irregular: irregular. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I have had so much joint pain that remains despite therapy; This is a spontaneous report from a contactable consumer reported for a patient. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number & Expiry date not reported) via unspecified route of administration on unspecified date in Mar2021 as dose number unknown, single for COVID-19 Immunisation. Patient medical history and concomitant medications were not reported. It was reported that patient took covid shot in March 2021. I have had so much joint pain that remains despite therapy. Patient enquired are you having reports of this or ways to resolve this. The Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Wound, X-ray limb
Clinical narrative: I ended up losing consciousness & fell down a flight of concrete stairs; I ended up losing consciousness & fell down a flight of concrete stairs; Body aches; Fever; Chills; Eye pain; Diarrhea; Nausea; Extreme fatigue; Extreme shortness of breath; Dizziness/ Feeling lightheaded; I have multiple facial abrasions; a deep wound sustained from my face hitting the bolts that hold the rail down; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF2588), via an unspecified route of administration, administered in left arm on 20Sep2021 14:30 (at the age of 42 years) as dose 2, single for COVID-19 immunization. She also received Influenza Vaccine (INFLUENZA) via an unspecified route of administration, administered in left deltoid on 20Sep2021 (Batch/Lot number was not reported), at unspecified dose for an unspecified indication. Patient had no relevant medical history and concurrent conditions. Patient had no relevant past drug history including no known drug allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF2588), via an unspecified route of administration, administered in arm right on 30Aug2021 15:00 (at the age of 42 years) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID- 19. Concomitant medication included Hepatitis B Vaccine (HEPATITIS-B) taken for an unspecified indication on 14Sep2021. On 21Sep2021 13:30 (day after her shot) patient had all the common side effects all morning; body aches, fever, chills, eye pain, diarrhea, nausea, extreme fatigue. By the early afternoon she was experiencing extreme shortness of breath, dizziness and feeling lightheaded. She ended up losing consciousness and fell down a flight of concrete stairs. She had multiple facial abrasions and a deep wound sustained from her face hitting the bolts that hold the rail down. This resulted in visit to Emergency room/department or urgent care but didn't prolong hospitalization. On an unspecified date patient underwent lab tests and procedures which included Head CT scan, leg and chest X-ray, EKG. The result of which are unknown. Therapeutic measures were taken because of events. Outcome of all the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported loss of consciousness cannot be completely excluded based on information provided. 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.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was mentioned that in March, the patient had a reaction after the first dose. He asked, since it had been 6 and a half months after the first dose, if he needed to repeat the series again. He also wanted some contraindication for receiving second dose. He queried whether the second dose would be the same with the first dose and if the booster was the same as well. The patient noted that on the VAERS entry, there was a possibility about the vaccine and bell's palsy relationship, he asked for updated information on that. He mentioned that he had a cold and was asking if he needed to wait before receiving the vaccine (2nd dose). The outcome of the cold was unknown.   No follow-up attempts needed. No further information expected, batch/lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain University tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101237061 Same reporter/product/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain place tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101237061 Same reporter/product/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain educational facility tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101237061 Same reporter/product/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain location tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101237061 Same reporter/product/events, different patient