chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Middle insomnia, Mobility decreased, Pain
Clinical narrative: Went to bed around 9:00 to 9:30 PM and he woke up around 11:00 PM; Couldn't even move; Whole body is aching; Sweating; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0170), via an unspecified route of administration in left arm, on 29Apr2021 at 03:00 PM (15:00), as first dose, single, for COVID-19 immunization. The patient's medical history included blood pressure, atrial fibrillation, cholesterol, and heart problem. The patient's concomitant medications included metoprolol and acetylsalicylic acid (BABY ASPIRIN); both were ongoing. The patient takes acetylsalicylic acid because he can't take blood thinners because he works with sharp objects all day. The patient had no prior vaccinations within 4 weeks; and he didn't know adverse events following prior vaccinations as he received vaccines as a child. The patient received his first COVID-19 vaccine in his left arm (because he's right-handed) yesterday (29Apr2021) and his whole body is killing him, it's aching, and he's sweating. The patient was asking if his symptoms are normal. Last night (29Apr2021) when the patient was sleeping, he went to bed around 9:00 to 9:30 PM and he woke up around 11:00 PM and he couldn't even move. The patient got up this morning and took 2 paracetamol (TYLENOL) for the events. The patient was sweating like there's no tomorrow, but he thinks that paracetamol is working. The events did not require a visit to the emergency room and physician office. The patient's second COVID-19 vaccine is scheduled for 20May2021. The patient had not recovered from "Whole body is aching" and "Sweating". The outcome of the other events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a non-contactable nurse (patient). A 35-year-old female not pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on an unspecified date (Lot number was not reported) as single dose (at age of 35-year-old) for covid-19 immunisation. Medical history included Hereditary haemorrhagic telangiectasia (HHT) and allergies to sulfa. Concomitant medications were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on unknown date for Covid-19 immunisation. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On an unspecified date patient experienced shingles. Event resulted in Emergency room/department or urgent care, patient was treated with Antiviral,steroid, pain medication. Outcome of the event was unknown.  Follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hallucination
Clinical narrative: Dizziness; Hallucinations; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 11:45 as unknown, single for COVID-19 immunization. Medical history included other medical history: asthma, known allergie: shell fish, thyroid, COVID prior vaccination: Yes, known allergie: bee stings, and known allergie: codine. Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D), and fluticasone propionate (FLONASE). Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hallucinations on 30Apr2021, and dizziness on 30Apr2021 15:30. No treatment was received for the events. The outcome of the event hallucinations was recovered on 30Apr2021 and for dizziness was recovered on 01May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient (reporter's mother) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 04Mar2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient contracted COVID a few days before her second dose (event onset date 22Mar2021). She felt symptoms about 3 days before she was scheduled to receive her second dose. Covid test on 23Mar2021 was positive. She was officially diagnosed with COVID on 25Mar2021, the day of her scheduled second dose, which she did not get. She died several days later. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the event. The patient died on an unknown date with death cause of COVID.  It was unknown if autopsy performed.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Circumstance or information capable of leading to medication error, Drug ineffective, Fatigue, Illness
Clinical narrative: Missed appointment for second vaccine on 30Apr2021; Tested positive for Covid 19; Tested positive for Covid 19; Felt Sick; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153, Expire Date: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient states that she had her first vaccine a couple of weeks ago. She was supposed to have her second one on Friday. States her kids were sick. She went and got tested for Covid 19 and it was positive. She has conflicting information on when she can have the second dose of her vaccine. Was calling to see when she could get it. States that it is hard to say. On 23Apr2021, patient experienced felt sick, Tested positive for Covid 19 after first dose of Covid 19 vaccine, she was supposed to get her second dose on 30Apr2021 but missed The patient underwent lab tests and procedures which included COVID-19 (sars-cov-2) test: positive on 29Apr2021. Outcome of the events was unknown.  follow-up attempts are possible. further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Missed appointment for second vaccine on 30Apr2021; Tested positive for Covid 19; Tested positive for Covid 19; Felt Sick; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153, Expire Date: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient states that she had her first vaccine a couple of weeks ago. She was supposed to have her second one on Friday. States her kids were sick. She went and got tested for Covid 19 and it was positive. She has conflicting information on when she can have the second dose of her vaccine. Was calling to see when she could get it. States that it is hard to say. On 23Apr2021, patient experienced felt sick, Tested positive for Covid 19 after first dose of Covid 19 vaccine, she was supposed to get her second dose on 30Apr2021 but missed The patient underwent lab tests and procedures which included COVID-19 (sars-cov-2) test: positive on 29Apr2021. Outcome of the events was unknown.  follow-up attempts are possible. further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Post menopausal vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: Lot Number: ER8737), via an unspecified route of administration, administered in the left arm on 06Apr2021 at 10:30 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. 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. On 11Apr2021 at 08:00, the patient experienced post menopausal vaginal bleeding. The patient did not receive treatment for the event. The outcome of the event was not recovered.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: days later, on 21Mar2021, they both tested positive for Covid-19; days later, on 21Mar2021, they both tested positive for Covid-19; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6204), via an unspecified route of administration on 16Mar2021 (at an age of 83-years-old) as 2ND DOSE, SINGLE for covid-19 immunization. Caller stated wife takes medications for arthritis and high blood pressure, no other information provided. Stated they are pretty healthy for being in their 80s. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), via an unspecified route of administration on 23Feb2021 as 1ST DOSE, SINGLE for covid-19 immunization. Caller stated his wife and he both received the first dose of the Pfizer Covid 19 shot on 23Feb2021, stated they got second shot on 16Mar2021. Five days later, on 21Mar2021, they both tested positive for Covid-19. Caller clarified that they came down with symptoms on 21MAR2021, then tested positive on 22Mar2021. Caller stated his wife dealt with Covid symptoms for about 3 weeks and has pretty much recovered, her symptoms were somewhat more mild that callers. Product details : EN6204, Second dose, exact dosage was not recorded on the patient vaccine record card. On 22Mar2021, the patient underwent lab test which included covid-19 test: positive. The outcomes of events were unknown.  No follow-up attempts are needed; No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Expired product administered, Fatigue, Pain
Clinical narrative: body aches; Fatigue; laying around; vaccine expired two hours before he got it; This is a spontaneous report from a contactable physician. A 18-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration, administered in arm on 01May2021 (at the age of 18 years) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and meningococcal vaccine b (MENB) taken on Feb2021. The patient had no other vaccinations the dates he got his Pfizer COVID-19 vaccine or in the four weeks prior. On 01May2021, saturday patient received second dose of vaccine which was expired two hours before he got, which the patient should not had got and was called back in. On 02May2021 patient experienced side effects such as body aches, laying around, and fatigue. The reporter informed about seriousness that she felt it is significant, in that there was already hesitancy, so for them to mess up on this is significant. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Expired vaccine used, fatigue and the suspect drug BNT162B2. Also, there is limited information in the case provided, the causal association between the event pain, bedridden and the suspect drug BNT162B2 cannot be 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: He was positive for COVID 19; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old male consumer received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration in left arm on 27Apr2021 at 14.00 as first single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any antipyretic drug around the date of vaccination. Product complaint was reported. The patient reported that he got first shot 27Apr2021 and he took a test on 03May2021 and he was positive for COVID 19. He only got the first dose, he goes for the second dose 14May2021, he says they did not give him a vaccine card. He did not know any lot number or expiration for the dose he received. The case was classified as serious. The outcome of event was unknown.   Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death, Inappropriate schedule of product administration
Clinical narrative: first dose on 21Jan2021 and second dose on 01Feb2021; passed away; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Feb2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced a terrible reaction. The patient passed away (death) on 09Apr2021. It was unknown if an autopsy was performed.  The information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Product dose omission issue
Clinical narrative: Unknown event; 1st dose received in Jan2021, the patient missed her second dose appointment because she was in the hospital; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A pharmacist reported on behalf of the patient. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on Jan2021, as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient has been in and out of the hospital for an unknown event which was something unrelated to the COVID vaccine. The caller stated that the patient's hospitalization wasn't related. The patient missed her second dose appointment because she was in the hospital. The reporter wanted to know whether the patient could take their second dose or start all over again. The reporter was aware that the Pfizer shot has to be taken after 3 or 4 weeks at most apart but it had been 4 month or above for the patient. The case was assessed as serious (hospitalization). The outcome of the event was unknown.  Information about lot/batch number has been requested. ; Sender's Comments: Based on current information available, the events was considered unrelated to Bnt162b2.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient got the COVID, patient was tested positive; This is a spontaneous report from a contactable consumer(patient). A 67-year-old patient of an unspecified gender received first dose of BNT162B2 (Pfizer COVID-19 vaccine, solution for injection, lot# EL9262) via an unspecified route of administration on 29Jan2021 (at the time of 67-year-old) at single dose for COVID-19 immunization. The patient medical history included blood pressure, arthritis, depression and cholesterol. Concomitant medication included rosuvastatin at 10 mg for blood cholesterol, losartan potassium via oral at 25 mg once daily, venlafaxine at 75 mg twice daily, meloxicam via oral at 5 mg once daily, colecalciferol (D3) at 2000 daily, fish oil at 1000 mg, ascorbic acid (VITAMIN C), magnesium at 500 mg, ubidecarenone (COQ-10) once daily and hydrochlorothiazide at half of 25 mg. On an unspecified date it was reported that patient got the vaccination on 29Jan2021, 3 days later patient got the COVID, patient was tested positive. Patient went to the hospital last day at the vaccination centre and had diffusion that caused help with vial. Patient has to wait 9 days before got another shot. Didn't know whether it would be affective and patient might have to start all over again. Because it might not helped because it's been so long. Confirmed the date of getting positive as 29Jan2021, patient got the first shot on 29Jan2021 and then patient went next week and the COVID test and it tested positive. Patient tested positive probably around the 03Feb2021. Then patient went to have the diffusion on the 5Feb2021. Patient need to do diffusion because of high blood pressure at the hospital. So, patient had diffusion. Patient need to take another shot and patient might have to start back again with another first shot. Indications of the medications reported that for cholesterol, blood pressure, arthritis and depression. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer. This consumer reported same event for three patients. This is the first of three reports.  A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced Bell's palsy. The outcome of Bell's palsy was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.          Follow-up (06May2021): This is a follow-up report to notify that the case 2021345756 and case 2021507291 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 2021507291.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345757 same reporter, product, and event; different patient.;US-PFIZER INC-2021345758 same reporter, product, and event; different patient.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Chills, Lip dry, Pyrexia, Rash
Clinical narrative: Hashimoto's Thyroiditis; had a sore in my mouth after the 2nd outbreak; lips were really dry; rash; chills; low grade fever; This is a spontaneous report from a contactable consumer (reported on herself). The female patient of an unspecified age received second dose of BNT162B2 (solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a first dose, single for COVID-19 immunization. After the first dose on the third day, she had patchy redness on her cheek. Then she had a rash on her face from earlobe to the other earlobe. It started out as red spots that it was so bad that it welts together. It went down her neck and she had one spot that stayed on face and one spot on chest and a rash on face. After the first, she went to a dermatologist and he put her on a topical steroid cream and steroid tablet for 5 days. After she had the second vaccine, she did not have an outbreak until 2 weeks after because she still had that steroid in her system, as she believed. She had a sore in mouth after the second outbreak. It was also on her lips during my second one. Her lips were really dry, so it was possibly her body just being run down. About 5-6 days ago, she had a rash, but it had appeared only on lips. Each time she got this outbreak, she got chills (4 hours of chills) and a low grade fever. Now it was on lips and on the outer rim of lips. It was stated that she would be going to the dermatologist on the day of this report. On an unknown date, the patient had Hashimoto's Thyroiditis, which reduced her immune system. The patient had been to urgent care, to HCP, and was on third trip to the dermatologist. The outcome of the events of Hashimoto's Thyroiditis, had a sore in mouth after the second outbreak, lips were really dry, rash, chills, low grade fever was unknown.  information on about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: Hashimoto's Thyroiditis; had a sore in my mouth after the 2nd outbreak; lips were really dry; rash; chills; low grade fever; This is a spontaneous report from a contactable consumer (reported on herself). The female patient of an unspecified age received second dose of BNT162B2 (solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a first dose, single for COVID-19 immunization. After the first dose on the third day, she had patchy redness on her cheek. Then she had a rash on her face from earlobe to the other earlobe. It started out as red spots that it was so bad that it welts together. It went down her neck and she had one spot that stayed on face and one spot on chest and a rash on face. After the first, she went to a dermatologist and he put her on a topical steroid cream and steroid tablet for 5 days. After she had the second vaccine, she did not have an outbreak until 2 weeks after because she still had that steroid in her system, as she believed. She had a sore in mouth after the second outbreak. It was also on her lips during my second one. Her lips were really dry, so it was possibly her body just being run down. About 5-6 days ago, she had a rash, but it had appeared only on lips. Each time she got this outbreak, she got chills (4 hours of chills) and a low grade fever. Now it was on lips and on the outer rim of lips. It was stated that she would be going to the dermatologist on the day of this report. On an unknown date, the patient had Hashimoto's Thyroiditis, which reduced her immune system. The patient had been to urgent care, to HCP, and was on third trip to the dermatologist. The outcome of the events of Hashimoto's Thyroiditis, had a sore in mouth after the second outbreak, lips were really dry, rash, chills, low grade fever was unknown.  information on about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She tested positive with Covid-19 after taking the 1st dose; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified gender started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 16Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she got the first dose of the vaccine on 16Apr2021. She tested positive with Covid-19 after taking the first dose and it's already been 2 weeks. She's scheduled to get the second dose on 07May2021 and she wants to know if she should take the second dose on the scheduled date or if she needs to be tested as negative with Covid-19 first before taking the second dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on 4/24/2021 and hospitalized for 6 days; Tested positive for COVID on 4/24/2021 and hospitalized for 6 days; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration administered in left arm on 17Feb2021 (Lot Number: EN6201) (Lot number also reported as EL9262) (vaccination age was 63-year-old) as single dose for covid-19 immunisation. Medical history included ocular myasthenia gravis. There were no known allergies and no Covid prior vaccination. Concomitant medication in two weeks included prednisone. There was no other vaccine in four weeks. The patient had tested positive (Nasal swab) for COVID on 24Apr2021 and hospitalized for 6 days in 2021. The adverse event occurred on 22Apr2021. The event was considered as serious as results in emergency room/department or urgent care, hospitalization for 6 days. The patient had 5 days treatment of remdesivir for the event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Movement disorder, Neck pain
Clinical narrative: not able to move her shoulder/neck; experience pain in her neck and shoulder; experience pain in her neck and shoulder; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Apr2021 as 2ND DOSE, SINGLE, received 1ST DOSE on an unspecified date for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On Tuesday 27Apr2021, patient began to experience pain in her neck and shoulder. On Wednesday 28Apr2021, patient was not able to move her shoulder/neck. patient has been to the MD 3 times and also one time to the Emergency Department for treatment. patient states it is on-going extreme pain and patient has had to take time off of work and go to physical therapy to treat it. Patient was worried about taking time off of work and wants to know if there is anything that can be done to help (compensate) her. Outcome of the events was not recovered.  Information about batch/lot number has been requested. Further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Muscle spasms, Neck pain, Pain, Pain in extremity
Clinical narrative: not able to move her shoulder/neck; experience pain in her neck and shoulder; experience pain in her neck and shoulder; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Apr2021 as 2ND DOSE, SINGLE, received 1ST DOSE on an unspecified date for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On Tuesday 27Apr2021, patient began to experience pain in her neck and shoulder. On Wednesday 28Apr2021, patient was not able to move her shoulder/neck. patient has been to the MD 3 times and also one time to the Emergency Department for treatment. patient states it is on-going extreme pain and patient has had to take time off of work and go to physical therapy to treat it. Patient was worried about taking time off of work and wants to know if there is anything that can be done to help (compensate) her. Outcome of the events was not recovered.  Information about batch/lot number has been requested. Further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: not able to move her shoulder/neck; experience pain in her neck and shoulder; experience pain in her neck and shoulder; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Apr2021 as 2ND DOSE, SINGLE, received 1ST DOSE on an unspecified date for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On Tuesday 27Apr2021, patient began to experience pain in her neck and shoulder. On Wednesday 28Apr2021, patient was not able to move her shoulder/neck. patient has been to the MD 3 times and also one time to the Emergency Department for treatment. patient states it is on-going extreme pain and patient has had to take time off of work and go to physical therapy to treat it. Patient was worried about taking time off of work and wants to know if there is anything that can be done to help (compensate) her. Outcome of the events was not recovered.  Information about batch/lot number has been requested. Further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Feeling abnormal, Immunodeficiency, Multiple sclerosis relapse, Underweight
Clinical narrative: Immunocompromised; patient is skinny/underweight; having a multiple sclerosis relapse/Multiple Sclerosis flared up after she got the vaccine; double vision that is intermittent and unilateral; had a funny feeling around the lips, tongue, and on the left side of her face; This is a spontaneous combined report from a contactable consumer (patient) via Pfizer. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199) (51 year at the time of vaccination) via an unspecified route of administration in arm left on 15Apr2021 at 10:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included multiple sclerosis from 2000 and ongoing. The patient's concomitant medications were not reported. On 15Apr2021, after the first dose the patient started experiencing double vision and had funny feeling in her lip, tongue and left side of the face (started prior taking the vaccine). The patient said she might be relapsing from multiple sclerosis. The patient was confused whether she should take the second dose of the vaccine. The patient also received IV methylprednisolone (3gm) (to be administered over 2 hours for three days) and taking prednisone for her double vision which comes and goes. Patient stated she had been immunosuppressed due to being on prednisone for 7days. The patient went to the health care professional and the health care professional gave her a steroid and patient stated the steroid was not responding to the double vision. The patient reported that she does not remember having any issues with her eyes subsequent to taking the vaccine which could be coincidental or nothing to do with the vaccine, but she then developed double vision which was getting worse. The patient also reported that she was skinny and underweight. The patient took 3 grams of Solumedrol IV and it did not help her. Therapeutic measures were taken in response to the events and the patient also had to visit emergency room. The outcome of the event's multiple sclerosis relapse, double vision, immunocompromised and skinny/underweight was unknown while for the event funny feeling around the lips, tongue, and on the left side of her face it was reported as not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Hypokinesia, Lethargy
Clinical narrative: faint; Fever; chills; body ache; diahhrhea; nausea; light headed ness; unable to move cause in so much pain- arms felt like lead weights; unable to move cause in so much pain- arms felt like lead weights; ring in ears; lethargic; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 29Apr2021 13:00 (at the age of 17-year-old) (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Medical history included seasonal allergies and known allergies to non-steroidal inflammatory drugs (NSAIDs), tree nuts, and pitted fruit. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and mometasone furoate (ASMANEX). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number: EW0150), administered in left arm on 08Apr2021 at 01:00 PM for COVID-19 immunization and experienced foggy head and sore arm which was treated with Tylenol. On 29Apr2021 at 23:30, the patient experienced fever, chills, body ache, diarrhea, nausea, light headedness/faint, unable to move cause in so much pain- arms felt like lead weights, ring in ears, and lethargic. Therapeutic measures were taken as a result of all events. On an unspecified date, the patient recovered from all events.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea, Pain, Pyrexia, Syncope
Clinical narrative: faint; Fever; chills; body ache; diahhrhea; nausea; light headed ness; unable to move cause in so much pain- arms felt like lead weights; unable to move cause in so much pain- arms felt like lead weights; ring in ears; lethargic; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 29Apr2021 13:00 (at the age of 17-year-old) (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Medical history included seasonal allergies and known allergies to non-steroidal inflammatory drugs (NSAIDs), tree nuts, and pitted fruit. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and mometasone furoate (ASMANEX). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number: EW0150), administered in left arm on 08Apr2021 at 01:00 PM for COVID-19 immunization and experienced foggy head and sore arm which was treated with Tylenol. On 29Apr2021 at 23:30, the patient experienced fever, chills, body ache, diarrhea, nausea, light headedness/faint, unable to move cause in so much pain- arms felt like lead weights, ring in ears, and lethargic. Therapeutic measures were taken as a result of all events. On an unspecified date, the patient recovered from all events.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: faint; Fever; chills; body ache; diahhrhea; nausea; light headed ness; unable to move cause in so much pain- arms felt like lead weights; unable to move cause in so much pain- arms felt like lead weights; ring in ears; lethargic; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 29Apr2021 13:00 (at the age of 17-year-old) (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Medical history included seasonal allergies and known allergies to non-steroidal inflammatory drugs (NSAIDs), tree nuts, and pitted fruit. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and mometasone furoate (ASMANEX). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number: EW0150), administered in left arm on 08Apr2021 at 01:00 PM for COVID-19 immunization and experienced foggy head and sore arm which was treated with Tylenol. On 29Apr2021 at 23:30, the patient experienced fever, chills, body ache, diarrhea, nausea, light headedness/faint, unable to move cause in so much pain- arms felt like lead weights, ring in ears, and lethargic. Therapeutic measures were taken as a result of all events. On an unspecified date, the patient recovered from all events.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Brain stem infarction
Clinical narrative: STROKE IN PONS AREA OF BRAIN MEASURING 8.5MM; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er2613), via an unspecified route of administration, administered in the left arm, on 17Mar2021 12:00, as 1st dose, single, for COVID-19 immunisation, at a public health department. Medical history included bipolar 2, control hypertension, and control diabetes type 2. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since vaccination. Concomitant medications included lamotrigine; trazodone; verapamil, all taken for unspecified indications, start and stop dates were not reported. The patient previously took metformin and simvastatin and experienced allergies to both. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 19Mar2021 00:00, the patient experienced stroke in pons area of brain measuring 8.5 mm. This event resulted to emergency room visit and hospitalization for 2 days (from 19Mar2021 to 21Mar2021). Unspecified treatment was given by the neurologist, physical and occupational therapy. The event was assessed as serious (life-threatening, disability and hospitalization). The outcome of the event was not resolved.  Follow up needed, further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Suffered mini stoke approximately 20 days after vaccine and a stroke 21 days after vaccine.; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Mar2021 09:30 (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation. Medical history included Covid-19 from Jul2020 (prior Covid 19 in July of 2020 with longhaul issues) and allergy to compazine and meperghan. Concomitant medications included gabapentin, rosuvastatin, colecalciferol and ubidecarenone (CO-Q10+VITAMIN D3). On 10Apr2021, the patient suffered mini stoke approximately 20 days after vaccine and a stroke 21 days after vaccine. The patient was released from urgent care on 10Apr2021 and went back 11Apr2021 after apparently having the stroke during morning hours of 11Apr2021. Transported around midnight of the 11th to hospital. The patient was hospitalized for four days and received Plavix and aspirin. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure systolic, Blood pressure systolic increased, Cerebral haemorrhage, Hemiparesis, Platelet count
Clinical narrative: Left intracerebral brain hemorrhage; Right hemiparesis; His platelets were 46; Systolic blood pressure 220; only responsive to touch and pain; Unresponsive; This is a spontaneous report from a non-contactable healthcare professional. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunisation. Medical history included hypertension. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization. On 04May2021, the patient was found unresponsive by family, taken to Emergency department where left intracerebral brain hemorrhage was diagnosed.  His platelets were 46 and systolic blood pressure 220.  He has right hemiparesis and is only responsive to touch and pain. He is currently on hospice. The patient was hospitalized for 3 days and received platelet transfusion. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information and known drug profile it  is unlikely  that the reported events were causally related to bnt162b2 .  The patient's history of hypertension is a risk factor for the reported left intracerebral brain hemorrhage and. blood pressure systolic increased.  Case will be reassessed if additional information is received
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased, Sensory loss, Unresponsive to stimuli
Clinical narrative: Left intracerebral brain hemorrhage; Right hemiparesis; His platelets were 46; Systolic blood pressure 220; only responsive to touch and pain; Unresponsive; This is a spontaneous report from a non-contactable healthcare professional. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunisation. Medical history included hypertension. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization. On 04May2021, the patient was found unresponsive by family, taken to Emergency department where left intracerebral brain hemorrhage was diagnosed.  His platelets were 46 and systolic blood pressure 220.  He has right hemiparesis and is only responsive to touch and pain. He is currently on hospice. The patient was hospitalized for 3 days and received platelet transfusion. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information and known drug profile it  is unlikely  that the reported events were causally related to bnt162b2 .  The patient's history of hypertension is a risk factor for the reported left intracerebral brain hemorrhage and. blood pressure systolic increased.  Case will be reassessed if additional information is received
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: 13 minutes after dose patient passed out.; This is a spontaneous report from a contactable consumer. A male patient of an unknown age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, batch/lot number unknown) via an unspecified route of administration  on an unknown date at unknown dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received vaccine, 13 minutes after dose he passed out. The outcome of event was unknown.   Information on the Lot/Batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cytomegalovirus infection reactivation
Clinical narrative: 3rd time CMV has reactivated; This is a spontaneous report from a contactable consumer (patient) reported that a 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration, administered in arm left on 05Apr2021 14:45 (02:45 PM) (at the age of 36-years-old) as 1st dose, single for covid-19 immunization. The vaccine was administered at the hospital. The patient was not pregnant at the time of vaccination. The patient medical history included that she had preeclampsia, HELLP syndrome and CMV when she delivered her son 3 weeks early on 28Jan2021. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ferrous sulfate; and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) both taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021, for the 3rd time CMV has reactivated. It was unknown if the patient received treatment for the event. The outcome of the event was unknown. She also added that she also have a colicky 3-month-old at home that her husband dealt with.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509886 baby case