chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Postural orthostatic tachycardia syndrome
Clinical narrative: Dysautonomia; POTS Syndrome; This is a spontaneous report from a contactable pharmacist (patient's sister-in-law). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbers and expiration dates were not provided), via an unspecified route of administration on an unspecified date at 1st dose, single dose and via an unspecified route of administration on an unspecified date at 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received both doses of Pfizer COVID-19 vaccine. She had mild but prolonged symptoms after the first dose, and she had similar symptoms after the second dose but was more severe and was not resolving. She has seen and consulted medical professionals and may be diagnosed with dysautonomia and POTS syndrome on an unspecified date which the pharmacist mentioned they have seen to be reported as a complication from the COVID-19 disease, but not with the vaccine per se. Dysautonomia was described as very rare and serious. She has been bedridden for six weeks. The patient was perfectly normal and healthy before she was vaccinated. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: The patient was 53-year-old female, and postural orthostatic tachycardia syndrome (POTS) syndrome was not uncommon in her age group. The events POTS syndrome and dysautonomia were unlikely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Choking sensation, Dysphagia, Hypertension
Clinical narrative: high blood pressures 170/63, 165/95; He is feeling like a choking type of feeling on the base of his chest; chest discomfort; Hard for him to swallow; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 20May2021 18:15 (Batch/Lot Number: EW0168) as 1st dose, single for COVID-19 immunisation. The patient had no relevant medical history and no concomitant medications. No additional vaccines was administered. The first day, the patient was fine but on day second (22May2021), he was feeling like a choking type of feeling on the base of his chest, like in the lower base of his throat. He said that it was hard for him to swallow. He was breathing normally. Patient's mother took his oxygen, he had enough oxygen but he says it felt weird and then he was having high blood pressure. Patient's mother wanted to know if it was normal. The patient experienced high blood pressures and chest discomfort on 22May2021. He has had blood pressures of 170/63. Today, it was 165/95. Events did not require visit to emergency room or physician office. The chest discomfort resolved on 23May2021 however the high blood pressures continue and have remained about the same. Patient's mother stated she does not want to give her son anything because she was not sure about the vaccine. Outcome of chest discomfort was recovered on 23May2021, of high blood pressure was not recovered, of remaining events was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Fatigue, Muscle spasms, Thrombosis
Clinical narrative: received the first dose of the Pfizer COVID-19 vaccine and also recently started taking Depo-Provera. After receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot; tired and frail; feels lost and light headed; cramping pain; This is a spontaneous report from a contactable consumer (Patient's mother). A 17-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 03May2021 15:00 (Batch/Lot number was not reported) as 1ST DOSE SINGLE for covid-19 immunization and medroxyprogesterone acetate (DEPO-PROVERA), route of administration, start and stop date, batch/lot number and dose were not reported for contraception. The patient's medical history and concomitant medications were not reported. The patient experienced received the first dose of the pfizer covid-19 vaccine and also recently started taking depo-provera. after receiving the first dose of the pfizer covid-19 vaccine her daughter developed a blood clot, tired and frail, feels lost and light headed and had cramping pain all on unspecified dates. It was reported that after receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot. Her daughter, who is currently on Depo Provera got her first dose of the Covid 19 vaccine. The daughter has been experiencing blood clotting and would like to further document this experience. Is also seeking medical advice to inform her daughter. Her daughter Has been on Depo Provera for 4 to 5 months. Since she had the Covid vaccine, she has been having bad blood clotting and has been having a continuous period.  When she got the shot, she has been getting blood clots straight for three weeks. Patient is Tired and frail: She is a waitress, so all of this has made it hard. It started right when she got the shot and has pretty much stayed the same. She will feel like she is lost when she wakes up and is light headed from the loss of blood. It occurs when she is doing activities, like working. Patient took some Midol one day for cramping pain but it barely did anything. The action taken for medroxyprogesterone acetate was unknown. Outcome of tired and frail was not recovered. Outcome of all the other events was unknown.   Information on Lot/Batch number was not available. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site haemorrhage, Vaccination site pruritus
Clinical narrative: Itchy reaction and very minor bleeding at the same location after the first dose; Itchy reaction and very minor bleeding at the same location after the first dose; Constant minor headache; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 06Apr2021 15:00 (Batch/Lot Number: ER8729) as 1ST DOSE, SINGLE for COVID-19 immunization at the public health clinic/veterans administration facility.  Medical history included high blood pressure. Concomitant medication included fluocinolone acetonide (FLUOCINOLONE ACETONIDE) taken for an unspecified indication and therapy date. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. It was reported that the patient had itchy reaction and very minor bleeding at the same location after the first dose on 09Apr2021 and stopped after a day (10Apr2021). The patient also had constant minor headache on 09Apr2021 which disappeared after the second dose (on 04May2021). The patient did not receive any treatment for the events.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Oral mucosal blistering
Clinical narrative: get more blisters in her mouth; progressed to two blisters, one on each arm; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported), at the age of 76-years-old as 1st dose, single; and dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included mucous membrane pemphigus. Historical vaccines included shingles vaccine and pneumonia vaccine on Nov2020 and flu shot on Dec2020; all taken at the age of 76-years-old. The patient's concomitant medications were not reported. The patient received her first shingles vaccine in November as well as pneumonia vaccine. She received Flu shot in December. She waited a month after second dose of product before receiving second dose of Shingrex. She knows vaccines can cause flare up of her historical condition of mucous membrane pemphigus and has been controlled with very low dose dapsone and under control for two years. She stated she started to get more blisters in her mouth and was prescribed dexamethasone wash. Then progressed to two blisters, one on each arm. Referred to her dermatologist who indicated she has seen the condition progress/ in those whose who are fully vaccinated. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Headache, Insomnia, Rash, Tinnitus
Clinical narrative: lost 50% hearing; ringing in ears; rash under eyes; insomnia; headaches; This is a spontaneous report from a non-contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had lost 50% hearing; experienced ringing in ears, rash under eyes, insomnia, and headaches. 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: M
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Arthralgia, Arthropathy, Decreased appetite, Fatigue
Clinical narrative: severe Rt knee pain & weakness/severe Lt knee pain & weakness; severe Rt knee pain & weakness/severe Lt knee pain & weakness; loss of appetite; unintentional weight loss; fatigue; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 11:00 (Batch/Lot Number: EL9266) at the age of 75 years old, as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included heart disease, diabetes and hypertension. Concomitant medications received by the patient within 2 weeks included lisinopril; metformin; rivaroxaban (XARELTO); carvedilol; furosemide (LASIX); all taken for an unspecified indication, start and stop date were not reported and "amio" (unspecified drug). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021, the patient experienced severe rt (right) knee pain and weakness/severe lt (left) knee pain and weakness, loss of appetite, unintentional weight loss, and fatigue. The events were reported as serious (hospitalization). The patient underwent sars-cov-2 test with result of negative on unspecified date post vaccination. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. No treatment was given for the adverse events. The patient has not recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: severe Rt knee pain & weakness/severe Lt knee pain & weakness; severe Rt knee pain & weakness/severe Lt knee pain & weakness; loss of appetite; unintentional weight loss; fatigue; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 11:00 (Batch/Lot Number: EL9266) at the age of 75 years old, as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included heart disease, diabetes and hypertension. Concomitant medications received by the patient within 2 weeks included lisinopril; metformin; rivaroxaban (XARELTO); carvedilol; furosemide (LASIX); all taken for an unspecified indication, start and stop date were not reported and "amio" (unspecified drug). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021, the patient experienced severe rt (right) knee pain and weakness/severe lt (left) knee pain and weakness, loss of appetite, unintentional weight loss, and fatigue. The events were reported as serious (hospitalization). The patient underwent sars-cov-2 test with result of negative on unspecified date post vaccination. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. No treatment was given for the adverse events. The patient has not recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity, Rash
Clinical narrative: Very inflamed under neck; Severe rash/rash started up around my neck and spreading/rash took over neck and chest; front and back; severe pain in left hand; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FSA RX 0884468; Expiration date was not reported) on the left arm on 19May2021 (16:30) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. The patient had no relevant medical history. Concomitant medication included ibuprofen (ADVIL 12 HOUR). The patient was not pregnant at the time of vaccination. On 20May2021, the patient had severe pain in the left hand. On 21May2021, the patient had severe rash; the rash started up around the neck and spreading. On 22May2021, the patient's rash took over the neck and chest, front and back; and the patient was very inflamed under the neck. The patient had received diphenhydramine (BENADRYL) and ibuprofen (ADVIL) as treatment for the events. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive again for covid; tested positive again for covid; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 intramuscular, administered in Arm Right on 19Dec2020 13:00 (Batch/Lot Number: EK5730) as 2nd dose, single and dose 1 intramuscular, administered in Arm Right on 07Jan2021 16:00 (Batch/Lot Number: EL3302) as 1st dose single for covid-19 immunisation. Medical history included covid-19 in Nov2020 to an unknown date. The patient is not pregnant. Concomitant medications included levothyroxine and propranolol both taken for an unspecified indication, start and stop date were not reported. The patient reported having tested positive again for covid on unspecified date in May2021. The patient underwent lab test and procedures which includes a nasal swab in Nov2020 and May2021 both resulted positive. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. The outcome of the events was unknown.  Follow up needed, further information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid 19. The case will be reassessed once new information is available.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cough, Diarrhoea, Electrocardiogram, Heart rate
Clinical narrative: Heart rate on 5/20 of 204 until now still higher than normal between 97-116, when usually is around 80; diarrhea; cough; cold symptoms; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 14-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 12:45 (Batch/Lot Number: EW0186) as 1ST DOSE, SINGLE for covid-19 immunization at the age at vaccination of 14 years old.  Patient was not pregnant. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. Past drug reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced heart rate on 5/20 of 204 until now still higher than normal between 97-116, when usually is around 80 (medically significant) on 20May2021 09:45 with outcome of not recovered; diarrhea, cough and cold symptoms (non-serious) on 20May2021 09:45 with outcome of not recovered. Reported as: Heart rate on 5/20 of 204 then we took her to the urgent care was given fluid and ekg and blood work, after that HR when down to 106, and until now still higher than normal between 97-116, when usually is around 80, also she had diarrhea on 5/20, and also cough from 5/20 until now like cold symptoms. The patient underwent lab tests which included blood test: unknown on 20May2021, electrocardiogram: unknown on 20May2021, heart rate: 204 on 20May2021, heart rate: 106 on 20May2021, heart rate: 97-116 on 20May2021 (still higher than normal, when usually is around 80), sars-cov-2 test: negative on 22May2021 (Nasal Swab; Test: Pcr). The events induced Emergency room/department or urgent care. The treatment received for the adverse event included: Fluids thru IV.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Heart rate on 5/20 of 204 until now still higher than normal between 97-116, when usually is around 80; diarrhea; cough; cold symptoms; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 14-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 12:45 (Batch/Lot Number: EW0186) as 1ST DOSE, SINGLE for covid-19 immunization at the age at vaccination of 14 years old.  Patient was not pregnant. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. Past drug reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced heart rate on 5/20 of 204 until now still higher than normal between 97-116, when usually is around 80 (medically significant) on 20May2021 09:45 with outcome of not recovered; diarrhea, cough and cold symptoms (non-serious) on 20May2021 09:45 with outcome of not recovered. Reported as: Heart rate on 5/20 of 204 then we took her to the urgent care was given fluid and ekg and blood work, after that HR when down to 106, and until now still higher than normal between 97-116, when usually is around 80, also she had diarrhea on 5/20, and also cough from 5/20 until now like cold symptoms. The patient underwent lab tests which included blood test: unknown on 20May2021, electrocardiogram: unknown on 20May2021, heart rate: 204 on 20May2021, heart rate: 106 on 20May2021, heart rate: 97-116 on 20May2021 (still higher than normal, when usually is around 80), sars-cov-2 test: negative on 22May2021 (Nasal Swab; Test: Pcr). The events induced Emergency room/department or urgent care. The treatment received for the adverse event included: Fluids thru IV.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got COVID too; Got COVID too; This is a spontaneous report from a contactable consumer (co-worker) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID on an unspecified date, after getting the Pfizer Covid vaccine, with unknown outcome. The reporting consumer tested positive for the Covid virus a week later. The reporter mentioned that the patient (who the reporter knew from the office) got covid too on an unspecified date.   Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Syncope, Vomiting
Clinical narrative: Fainted off the toilet/again fainted; Felt incredibly ill; Throw up; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Apr2021 13:00 (30 years old at vaccination) (Lot Number: EW0161) as single dose for covid-19 immunisation.  The patient was not pregnant at the time of vaccination. Medical history included Allergy: Bees. Concomitant medication(s) the patient received within 2 weeks of vaccination included drospirenone, ethinylestradiol betadex clathrate (YAZ).  Clinical course as reported: Sunday 18Apr around midnight I felt incredibly ill (roughly 30 hours after vaccine). I went to the bathroom and fainted off the toilet and then proceeded to throw up and have diarrhea at the same time while on the floor. After showering and cleaning up, roughly 30 minutes later I again fainted (this time in the safety and easy cleaning of the bath tub) and repeated the same throw up/diarrhea episode. I slept in the bathtub for the rest of the night. My doctor instructed me to go to the emergency room if I fainted again and to drink plenty of fluids. Events onset date reported as 18Apr2021 12:00 PM. No treatment received for events. Outcome for event was recovered on unspecified date in 2021. Serious reported as No. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Eye contusion, Lip erythema, Lip pain, Lip swelling
Clinical narrative: mild anaphylactic reaction; Both of her eyes looked like someone punched her because they were black, purple, blue under her eyes; The top lip swelled, was red, and very painful; The top lip swelled, was red, and very painful; lip swelled, was red; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included anaphylactic reaction, swollen tongue, typical can't breathe and disabled. The patient's concomitant medications were not reported. Caller stated she was calling about the Pfizer COVID 19 vaccine. Caller stated she went all over the internet to try to figure out what to do if one has a reaction and it is not helpful. Caller stated she called her physician office and her physician has not called back. Then she called VAERS and the representative at VAERS suggested to call a pharmacist. The caller then called the pharmacy and told the pharmacist everything that was going on and the pharmacist told the caller she had a mild anaphylactic reaction to the first shot and the pharmacist suggested to call Pfizer to find out Pfizer's input. Caller stated what happened is both of her eyes looked like someone punched her because they were black, purple, blue under her eyes and also the top lip swelled, was red, and very painful. Caller stated at first it was only the top of her half lip and she said she refers to it as kind of like duck lips and she still has it and she got the shot last Thursday but it has gone down some. Caller stated she has had an anaphylactic reaction before but never got these symptoms she would have a swollen tongue and typical can't breathe. Caller stated it has never been lips or her eyes. Caller stated her question is if she should get the second dose of the vaccine. Caller stated she was very high risk for COVID and she has only got one vaccine and no one was able to help her and this was utterly ridiculous. Caller stated she is disabled and has 50 health problems and can not go through another report. The event outcome for all events was unknown.  Information about lot/batch number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: 1st dose- He was tired a little bit; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported same event for two patients. This is the second of two reports.  An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. Medical history included diabetes from 2011 and ongoing (diagnosed about 10 years ago), cancer removed from his buttocks the beginning of the year (2021), within the last 5 to 6 months; had stent put in and surgery for a valve replacement at the beginning of the year (2021). The cancer on his buttocks was done by removal by the dermatologist, this was recent within the last 5 months when a spot was noticed. She thinks it was within the last 5 to 6 months. It was either a basal or a squamous and they didn't feel it was bad and they had removed it all. The patient is on a lot of medications because of his heart and he is post CA (clarified as meaning cancer), and he is diabetic but there is nothing that is out of the ordinary for him. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient was tired a little bit and the reporter thinks that it began that same day probably within an hour or two after they got the dose 1 of COVID vaccine in the afternoon. Her husband's tiredness didn't last as long as hers did. The reporter added that for patient's 1st dose, he didn't have any effects basically. The patient was reluctant to get the COVID vaccine at first but at their age they knew that they needed to be protected. They had the fear more out of the quickness on everything and how all at once they had the vaccine but not being a medical people, they listened to their doctors. The outcome of the event was recovered on 24Feb2021.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021595075 same drug/event, different patient
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: Sudden hearing loss in one ear; This is a spontaneous report from a contactable consumer (patient's wife). A 64-year-old male patient received bnt162b2 (Pfizer product), dose 1 via an unspecified route of administration, administered in arm on 18Apr2021 18:15 (Batch/Lot number was not reported) as single, dose 2 via an unspecified route of administration, administered in arm on 09May2021 18:15 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient experienced sudden hearing loss in one ear on 27Apr2021 16:30. Therapeutic measures were taken as a result of sudden hearing loss in one ear (sudden hearing loss) include prednisone on 27Apr2021 then again on 23May2021. He was treated by a doctor who sent him to another doctor that put him on steroids and he started getting better. He got his second dose and two weeks later the same thing happen, sudden hearing loss, he can't hear in his ear. Clarifies the sudden hearing loss is in one ear. The last outcome was unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Rash, Reaction to excipient, Skin exfoliation
Clinical narrative: Skin has been sort of erupting/ the rash is gone on and off some for about 25 years, I guess or more probably years/ I don't always have it this bad; thought if she was allergic to polyethylene glycerol or polysorbate; exfoliate; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8736), via an unspecified route of administration in upper left arm on 03May2021 (at the age of 63-years-old) at 1st dose, single dose for COVID-19 immunization. Medical history included dermatitis, asthma, and rash which has gone on and off for about 25 years or more. The patient's concomitant medications were not reported. The patient received the first Pfizer shot on 03May2021 at a pharmacy/ drug store. She has a long history of dermatitis issues and in January (unspecified), she had chemical testing done. She had quite a few chemicals that she reacted to and she have compared that with the list of chemicals that she received in print out when she received her first vaccination. She didn't see that there was a match, however she did speak with an allergist to ask her about any risk for her to get the vaccine due to chemical testing. The allergist stated to go ahead and recommended that the patient get the Johnson & Johnson if she could because there were just less chemicals or something. The allergist didn't explain that, but the patient did not find Johnson & Johnson vaccine available, so she went ahead and got the first Pfizer shot. The patient  waited until half an hour after her shot as suggested by the doctor and she did not have any reaction during that time, but ever since then, and it could be due to number of different things, her skin has been sort of erupting and exfoliating on May2021 and she really had a bad point today, she actually has an appointment with her dermatologist at 10:30 thinking they were going to have to put her on prednisone or something like that to stop it. This has just gotten really bad. The patient thought if she was allergic to polyethylene glycerol or polysorbate and she looked for those on the list of chemicals that she was tested for; she was not tested for either one of those chemicals, so she was actually unsure if she was linked to them or not. She was unsure if the first vaccine was the cause of this problem. The rash has gone on and off for about 25 years or more. She didn't always have it this bad, she does sometimes especially when summer season starts and ends. She was unsure if it was the vaccine that did this, if there was something in there which stayed in her body that reacted. When asked for the treatment, the patient stated that she took ZYRTEC and BENDARYL and added that she was seeing her doctor today at 10:30 so they might be treating her. The outcome of the events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Investigation, Pancreatitis acute
Clinical narrative: Acute pancreatitis; This is a spontaneous report from a contactable physician's assistant (retired) reporting on behalf of herself.  A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 06May2021 08:15 (Batch/Lot Number: EW0164) as 2ND DOSE, SINGLE for COVID-19 immunization at the hospital.  The patient does not drink alcohol.  Concomitant medications were not reported. She had no prior vaccinations (within 4 weeks). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Apr2021 (lot#: EW0151, expiration: 31Jul2021) on the right arm as COVID-19 immunization.  Then, the patient had her 2nd dose on 06May2021 08:15. On 09May2021 15:00 (also reported as 72 hours after the 2nd dose), the patient had acute pancreatitis out of the blue. The patient was brought to the emergency room and was hospitalized for 4 Days (09May2021 until 13May2021). She mentioned that she has no previous history of pancreatitis. She had labs drawn 2 weeks prior to the hospitalization (Apr2021) and there were no indications of any problems on the screening labs. Sje also had a CT scan in May2021, and there was no evidence of stones.  She stated that the event was pretty serious and debilitating.  She received support with IV fluids and pain medication until the pancreas settles down. The patient recovered from the event on 13May2021 16:00 and was scheduled for follow up on 18May2021.; Sender's Comments: Based on the temporal relationship, the association between the event acute pancreatitis with BNT162b2 can not be completely excluded.  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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rash
Clinical narrative: Arm hurt; Tired; Rash all over both of her legs; This is a spontaneous report from a contactable consumer (patient's grandparent). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 20May2021 16:30 (Batch/Lot number was not reported), at the age of 17-years-old as 2nd dose, single for COVID-19 immunization. Medical history included allergic reaction of Sulphur drugs. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient had her second Pfizer shot on Thursday 20May2021 at 4:30, the only side effect she seem to have, was her arm hurt and she was tired and the reporter don't know, her aunt was a pharmacist and said that circle that she developed at the site of the shot, and called it as a Covid bullseye. On Saturday 22May2021, the patient had rash about the size of a diameter of  a lemon on the inside of her leg, the reporter didn't think anything out she has been out in the sun so they just observed until Sunday, 23May2021 she got the rash all over both of her leg. Previously she was has an allergic reaction of Sulphur drugs so with this rash all over both of her legs what they did was they called her doctors office Sunday and they haven't answering. They have a service that you can call about medical things, person that answers, there was a woman and said she know nothing about a rash they thought it would may be side effect from Pfizer because the reporter looked on the website and in the website rash was listed, usually rare. The patient does not have anaphylactic shock any of that there was a rash they think it was 0.001 they tried to explain this to the woman and she insisted it was something called Petechiae rash, which is a serious rash. She insisted not take the patient to the urgent care, she said they should take her to the ER and not urgent care, they took her to the ER they said they didn't know, it was definitely not the Petechiae rash which was a released that's a serious problem. They said it was okay to just give her Benadryl which they could have decided to give at home, but they didn't know if Benadryl was okay to take if the patient took the COVID vaccine. They were advised to bring her back to the doctor in 2 days if it doesn't go away. ER said they had never seen anyone who had a rash, they don't know any rash. The reporter tried to tell  that it's on the website it's on a Pfizer website and thought she was thinking she should alert them about this because this was a lot of lot of gut ranching and anxiety that if this person calling from the doctor saying that the rash was a Petechiae rash which was a serious blood disease. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Dizziness, Dyspnoea, Fatigue
Clinical narrative: All over body rashes; Shortness of breath; Dizzy; Foggy head; Nausea; Tired/ Fatigue; horrible excruciating migratory arthritic pain; Have variety of symptoms very painful; Areas of my body have been in serious pain; I couldn't walk for days and it affected my right foot and right hip; Really been destroying my health; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 51-years, and administered in left arm on 02Apr2021 (Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was completely heathy before this vaccine. There were no concomitant medications. Historical Vaccine included the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient stated that she was having really horrible excruciating migratory arthritic pain and all over body rashes on 07Apr2021 since she took the Pfizer vaccine. it was reported that she had went emergency twice and she had been to the doctors going back to the doctors again and she was going to ask him can she see rheumatologist, they're taking blood test and urine test and she had variety of symptoms very painful. Areas of her body have been in serious pain like it felt like a migratory arthritis kind of pain that just moved area to area every three to four days and twice it got her unable to walk. The patient couldn't walk for days and it affected her right foot and right hip and she was unable to walk since in two instances she was left unable to walk for a few days and it was very painful but she also had like all over body rash, shortness of breath from time to time, dizzy, foggy head, nausea, tired, fatigue. The patient was completely heathy before this vaccine. It had really been destroying her health basically. The patient had been taking pain pills and Benadryl(Treatment) because of the rash and stuff, pain pills for pain but it had not really helping a lot it was just she had been taking like generic Tylenol(Further not clarified). And patient stated above symptoms still happening. The patient underwent lab tests and procedures which included blood test and urine test: normal on Apr2021 (They couldn't find anything wrong with patient).    No follow-up attempts needed. No further information expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait inability, General physical health deterioration, Investigation, Nausea
Clinical narrative: All over body rashes; Shortness of breath; Dizzy; Foggy head; Nausea; Tired/ Fatigue; horrible excruciating migratory arthritic pain; Have variety of symptoms very painful; Areas of my body have been in serious pain; I couldn't walk for days and it affected my right foot and right hip; Really been destroying my health; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 51-years, and administered in left arm on 02Apr2021 (Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was completely heathy before this vaccine. There were no concomitant medications. Historical Vaccine included the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient stated that she was having really horrible excruciating migratory arthritic pain and all over body rashes on 07Apr2021 since she took the Pfizer vaccine. it was reported that she had went emergency twice and she had been to the doctors going back to the doctors again and she was going to ask him can she see rheumatologist, they're taking blood test and urine test and she had variety of symptoms very painful. Areas of her body have been in serious pain like it felt like a migratory arthritis kind of pain that just moved area to area every three to four days and twice it got her unable to walk. The patient couldn't walk for days and it affected her right foot and right hip and she was unable to walk since in two instances she was left unable to walk for a few days and it was very painful but she also had like all over body rash, shortness of breath from time to time, dizzy, foggy head, nausea, tired, fatigue. The patient was completely heathy before this vaccine. It had really been destroying her health basically. The patient had been taking pain pills and Benadryl(Treatment) because of the rash and stuff, pain pills for pain but it had not really helping a lot it was just she had been taking like generic Tylenol(Further not clarified). And patient stated above symptoms still happening. The patient underwent lab tests and procedures which included blood test and urine test: normal on Apr2021 (They couldn't find anything wrong with patient).    No follow-up attempts needed. No further information expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: All over body rashes; Shortness of breath; Dizzy; Foggy head; Nausea; Tired/ Fatigue; horrible excruciating migratory arthritic pain; Have variety of symptoms very painful; Areas of my body have been in serious pain; I couldn't walk for days and it affected my right foot and right hip; Really been destroying my health; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 51-years, and administered in left arm on 02Apr2021 (Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was completely heathy before this vaccine. There were no concomitant medications. Historical Vaccine included the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient stated that she was having really horrible excruciating migratory arthritic pain and all over body rashes on 07Apr2021 since she took the Pfizer vaccine. it was reported that she had went emergency twice and she had been to the doctors going back to the doctors again and she was going to ask him can she see rheumatologist, they're taking blood test and urine test and she had variety of symptoms very painful. Areas of her body have been in serious pain like it felt like a migratory arthritis kind of pain that just moved area to area every three to four days and twice it got her unable to walk. The patient couldn't walk for days and it affected her right foot and right hip and she was unable to walk since in two instances she was left unable to walk for a few days and it was very painful but she also had like all over body rash, shortness of breath from time to time, dizzy, foggy head, nausea, tired, fatigue. The patient was completely heathy before this vaccine. It had really been destroying her health basically. The patient had been taking pain pills and Benadryl(Treatment) because of the rash and stuff, pain pills for pain but it had not really helping a lot it was just she had been taking like generic Tylenol(Further not clarified). And patient stated above symptoms still happening. The patient underwent lab tests and procedures which included blood test and urine test: normal on Apr2021 (They couldn't find anything wrong with patient).    No follow-up attempts needed. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: brain bleed; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sponsored program support. This is the first report of 2 reports, for the first dose.  A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 56-years, administered in left upper bicep on 26Mar2021 (Lot Number: EN6208) as single dose for COVID-19 immunisation.  Medical history included ongoing diabetes and the patient had it for 10 years or so and was diet controlled, his blood sugars was good. And ongoing supraventricular tachycardia (SVT) for about 4 years and was medication control. And patient was an amputee from an accident many years ago. Concomitant medications included ongoing carvedilol (COREG) taken for SVT.  It was reported that the patient had a brain bleed after the first dose that might be but probably wasn't related to the vaccine. Event outcomes was unknown.  No follow-up attempts needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021596614 same reporter/patient/drug, different event/dose.
Sex: U
Vaccine: COVID19
Symptoms: Near death experience, Nervous system disorder
Clinical narrative: near death; serious neurological problems; This is a spontaneous report from a contactable consumers. This consumer reported similar events for three patients. This is the second of three reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that people should know there are serious neurological problems associated with the Pfizer vaccine. She knows another 3 people, 2 of them are near death on an unspecified date. The outcome of the event was unknown.  The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021596593 same reporter/drug, similar events, different patient;-PFIZER INC-2021596788 same reporter/drug, similar events, different patient