chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ophthalmological examination, Palpitations, Tinnitus, Vertigo, Vertigo positional
Clinical narrative: Numbness; tingling; dizziness; vertigo; diarrhea; heartburn; head pain; ear pain; tinnitus; joint pain; flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0153) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (dose 1, lot number: ER2613, administration time: 01:30PM , vaccine location: Left arm), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 immunization. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: HYPOAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tingling"; DIZZINESS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "dizziness"; VERTIGO (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "vertigo"; DIARRHOEA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "diarrhea"; DYSPEPSIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "heartburn"; HEADACHE (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "head pain"; EAR PAIN (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "ear pain"; TINNITUS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tinnitus"; ARTHRALGIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "joint pain"; FLUSHING (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "flushing". The events "numbness", "tingling", "dizziness", "vertigo", "diarrhea", "heartburn", "head pain", "ear pain", "tinnitus", "joint pain" and "flushing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness, vertigo, diarrhoea, dyspepsia, headache, ear pain, tinnitus, arthralgia, flushing on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, Visual acuity tests, Visual impairment, Vitamin B12, Vitamin D
Clinical narrative: Numbness; tingling; dizziness; vertigo; diarrhea; heartburn; head pain; ear pain; tinnitus; joint pain; flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0153) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (dose 1, lot number: ER2613, administration time: 01:30PM , vaccine location: Left arm), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 immunization. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: HYPOAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tingling"; DIZZINESS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "dizziness"; VERTIGO (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "vertigo"; DIARRHOEA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "diarrhea"; DYSPEPSIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "heartburn"; HEADACHE (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "head pain"; EAR PAIN (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "ear pain"; TINNITUS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tinnitus"; ARTHRALGIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "joint pain"; FLUSHING (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "flushing". The events "numbness", "tingling", "dizziness", "vertigo", "diarrhea", "heartburn", "head pain", "ear pain", "tinnitus", "joint pain" and "flushing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness, vertigo, diarrhoea, dyspepsia, headache, ear pain, tinnitus, arthralgia, flushing on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitreous floaters, Weight decreased
Clinical narrative: Numbness; tingling; dizziness; vertigo; diarrhea; heartburn; head pain; ear pain; tinnitus; joint pain; flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0153) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (dose 1, lot number: ER2613, administration time: 01:30PM , vaccine location: Left arm), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 immunization. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: HYPOAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tingling"; DIZZINESS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "dizziness"; VERTIGO (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "vertigo"; DIARRHOEA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "diarrhea"; DYSPEPSIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "heartburn"; HEADACHE (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "head pain"; EAR PAIN (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "ear pain"; TINNITUS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tinnitus"; ARTHRALGIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "joint pain"; FLUSHING (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "flushing". The events "numbness", "tingling", "dizziness", "vertigo", "diarrhea", "heartburn", "head pain", "ear pain", "tinnitus", "joint pain" and "flushing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness, vertigo, diarrhoea, dyspepsia, headache, ear pain, tinnitus, arthralgia, flushing on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: myocarditis; pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; ILL-DEFINED DISORDER (non-serious), outcome "unknown", described as "his young man is dying". It was reported that patient had to quit his job and was in a very dire situation. Reporter also mentioned that doctors are giving him (the patient) requests for treatments that he can't afford. Reporter wanted to know if Pfizer has the liability for those who experienced side effects from the vaccine. It was further reported that patient was lost and sort of dismayed pertaining to the adverse effect he experienced after receiving the COVID-19 Vaccine. Reporter can't imagine that Pfizer doesn't have some sort of liability to this kind of side effect. Reporter stated that patient have already applied to the site/program and they only looked at 40 patients so far. It was very unfair as this young man (patient) was dying and on a wheelchair now.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: had the original shot and still got pneumonia.; had the original shot and still got pneumonia.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "pneumonia" (unspecified if ongoing), notes: I've had pneumonia twice. The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "had the original shot and still got pneumonia.".  Additional information: Open-ended question: Thinking of the [Prevnar 20] advertising you just saw, please enter anything you felt, thought, or were reminded of while viewing it. Everything is acceptable. There are no right or wrong answers, no silly or dumb feelings. Don't worry about spelling, punctuation, or grammar. I've had pneumonia twice. I had the original shot and still got pneumonia. When the latest shot became available, I got that shot. I feel hopeful that I'm better protected this time.  The lot number for pneumococcal 20-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Palpitations, Vomiting
Clinical narrative: elevated heart rate which was 130 (it has been 127 to 132 which was higher than normal); felt like his heart was racing; vomiting; Dizziness; This is a spontaneous report received from contactable nurse.  A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm right, administration date 28Feb2022 (Batch/Lot number: unknown) at the age of 14 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history and family medical history. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: On 01Mar2022, around 15:00, the patient began having vomiting, dizziness, elevated heart rate which was 130 (it has been 127 to 132 which was higher than normal) and felt like his heart was racing. The nurse stated he seemed fine and ok. The events did not require a visit to emergency room and physician office. The reporter stated that the elevated heart rate was medically significant, but the vomiting and dizziness were not serious. The patient underwent the following laboratory tests and procedures: heart rate: (02Mar2022) 127-132, notes: higher than normal; (02Mar2022) 130, notes: elevated. The patient recovered from vomiting on 01Mar2022. The outcome of dizziness was unknown. The patient has not recovered from the rest of the events. The events "vomiting", "felt like his heart was racing", and "elevated heart rate" were assessed as related to BNT162B2.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed symptoms and tested positive for COVID 19; developed symptoms and tested positive for COVID 19; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "developed symptoms and tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Reporter stated that he had been vaccinated and boosted with "the Pfizer Vaccine" for COVID 19 and about eight weeks ago developed symptoms and tested positive for COVID 19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Rash/ Rash, all over, arms, legs, chest, back; Urticaria/Hives; Legs were itchy and red was reported as worsened; Legs were itchy and red was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 16:14 (Lot number: FC3181) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had gall stones" (unspecified if ongoing), notes: She had her gall bladder removed/ had the surgery, 04Feb2022; "Obesity" (unspecified if ongoing), notes: Obesity, she is  overweight, that's what the doctors say. Family history included: "Eczema" (unspecified if ongoing): Dad's side has eczema. There were no concomitant medications. The following information was reported: RASH (medically significant) with onset 20Aug2021, outcome "not recovered", described as "Rash/ Rash, all over, arms, legs, chest, back"; URTICARIA (medically significant) with onset 20Aug2021, outcome "not recovered", described as "Urticaria/Hives"; PRURITUS (medically significant), ERYTHEMA (medically significant) all with onset 20Aug2021, outcome "not recovered" and all described as "Legs were itchy and red was reported as worsened". The event "rash/ rash, all over, arms, legs, chest, back" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, urticaria, pruritus, erythema. Clinical course: it was reported that since the first dose, patient has been getting rashes, which she has not had before and wonders if she was allergic to something. She went to a dermatologist and they called it urticaria/hives, they told her to have allergy testing done, but it started after the vaccine. Patient was asking what was in the vaccine that she could be allergic to?. The event rash started the same day she got her vaccine, she went swimming and when she got out of the pool her legs were itchy and red. The rash gives her like a raised look, lately it is getting worse, itching is worse. Urticaria/Hives: rash, all over, arms, legs, chest, back, She was told to go to the ER if the rash was on her face, she has not gone to the hospital. They didn't prescribe anything they just told her to take Benadryl. She tried to use an ointment and Benadryl. The ointment was an anti-itch cream from the pharmacy. Ointment and Benadryl didn't work it didn't decrease the hives or stop the itching. She went to the dermatologist for the rash. No medical testing done, they just looked at it. It was also reported that the event took place around 4 or 5 PM. The patient has no prior vaccinations (within 4 weeks) from the administration of Covid-19 vaccine. The patient was given the second dose of vaccine on 10Sep2021 (lot: FD8448) at the age of 19 years in the right arm.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Cholelithiasis, Dyspnoea, Erythema, Pharyngeal oedema
Clinical narrative: Rash/ Rash, all over, arms, legs, chest, back; Urticaria/Hives; Legs were itchy and red was reported as worsened; Legs were itchy and red was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 16:14 (Lot number: FC3181) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had gall stones" (unspecified if ongoing), notes: She had her gall bladder removed/ had the surgery, 04Feb2022; "Obesity" (unspecified if ongoing), notes: Obesity, she is  overweight, that's what the doctors say. Family history included: "Eczema" (unspecified if ongoing): Dad's side has eczema. There were no concomitant medications. The following information was reported: RASH (medically significant) with onset 20Aug2021, outcome "not recovered", described as "Rash/ Rash, all over, arms, legs, chest, back"; URTICARIA (medically significant) with onset 20Aug2021, outcome "not recovered", described as "Urticaria/Hives"; PRURITUS (medically significant), ERYTHEMA (medically significant) all with onset 20Aug2021, outcome "not recovered" and all described as "Legs were itchy and red was reported as worsened". The event "rash/ rash, all over, arms, legs, chest, back" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, urticaria, pruritus, erythema. Clinical course: it was reported that since the first dose, patient has been getting rashes, which she has not had before and wonders if she was allergic to something. She went to a dermatologist and they called it urticaria/hives, they told her to have allergy testing done, but it started after the vaccine. Patient was asking what was in the vaccine that she could be allergic to?. The event rash started the same day she got her vaccine, she went swimming and when she got out of the pool her legs were itchy and red. The rash gives her like a raised look, lately it is getting worse, itching is worse. Urticaria/Hives: rash, all over, arms, legs, chest, back, She was told to go to the ER if the rash was on her face, she has not gone to the hospital. They didn't prescribe anything they just told her to take Benadryl. She tried to use an ointment and Benadryl. The ointment was an anti-itch cream from the pharmacy. Ointment and Benadryl didn't work it didn't decrease the hives or stop the itching. She went to the dermatologist for the rash. No medical testing done, they just looked at it. It was also reported that the event took place around 4 or 5 PM. The patient has no prior vaccinations (within 4 weeks) from the administration of Covid-19 vaccine. The patient was given the second dose of vaccine on 10Sep2021 (lot: FD8448) at the age of 19 years in the right arm.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Urinary cystectomy, Urticaria
Clinical narrative: Rash/ Rash, all over, arms, legs, chest, back; Urticaria/Hives; Legs were itchy and red was reported as worsened; Legs were itchy and red was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 16:14 (Lot number: FC3181) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had gall stones" (unspecified if ongoing), notes: She had her gall bladder removed/ had the surgery, 04Feb2022; "Obesity" (unspecified if ongoing), notes: Obesity, she is  overweight, that's what the doctors say. Family history included: "Eczema" (unspecified if ongoing): Dad's side has eczema. There were no concomitant medications. The following information was reported: RASH (medically significant) with onset 20Aug2021, outcome "not recovered", described as "Rash/ Rash, all over, arms, legs, chest, back"; URTICARIA (medically significant) with onset 20Aug2021, outcome "not recovered", described as "Urticaria/Hives"; PRURITUS (medically significant), ERYTHEMA (medically significant) all with onset 20Aug2021, outcome "not recovered" and all described as "Legs were itchy and red was reported as worsened". The event "rash/ rash, all over, arms, legs, chest, back" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, urticaria, pruritus, erythema. Clinical course: it was reported that since the first dose, patient has been getting rashes, which she has not had before and wonders if she was allergic to something. She went to a dermatologist and they called it urticaria/hives, they told her to have allergy testing done, but it started after the vaccine. Patient was asking what was in the vaccine that she could be allergic to?. The event rash started the same day she got her vaccine, she went swimming and when she got out of the pool her legs were itchy and red. The rash gives her like a raised look, lately it is getting worse, itching is worse. Urticaria/Hives: rash, all over, arms, legs, chest, back, She was told to go to the ER if the rash was on her face, she has not gone to the hospital. They didn't prescribe anything they just told her to take Benadryl. She tried to use an ointment and Benadryl. The ointment was an anti-itch cream from the pharmacy. Ointment and Benadryl didn't work it didn't decrease the hives or stop the itching. She went to the dermatologist for the rash. No medical testing done, they just looked at it. It was also reported that the event took place around 4 or 5 PM. The patient has no prior vaccinations (within 4 weeks) from the administration of Covid-19 vaccine. The patient was given the second dose of vaccine on 10Sep2021 (lot: FD8448) at the age of 19 years in the right arm.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eczema, Pruritus, Rash, Urticaria
Clinical narrative: Rash/ Rash, all over, arms, legs, chest, back; Urticaria/Hives; Legs were itchy and red was reported as worsened; Legs were itchy and red was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 16:14 (Lot number: FC3181) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had gall stones" (unspecified if ongoing), notes: She had her gall bladder removed/ had the surgery, 04Feb2022; "Obesity" (unspecified if ongoing), notes: Obesity, she is  overweight, that's what the doctors say. Family history included: "Eczema" (unspecified if ongoing): Dad's side has eczema. There were no concomitant medications. The following information was reported: RASH (medically significant) with onset 20Aug2021, outcome "not recovered", described as "Rash/ Rash, all over, arms, legs, chest, back"; URTICARIA (medically significant) with onset 20Aug2021, outcome "not recovered", described as "Urticaria/Hives"; PRURITUS (medically significant), ERYTHEMA (medically significant) all with onset 20Aug2021, outcome "not recovered" and all described as "Legs were itchy and red was reported as worsened". The event "rash/ rash, all over, arms, legs, chest, back" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, urticaria, pruritus, erythema. Clinical course: it was reported that since the first dose, patient has been getting rashes, which she has not had before and wonders if she was allergic to something. She went to a dermatologist and they called it urticaria/hives, they told her to have allergy testing done, but it started after the vaccine. Patient was asking what was in the vaccine that she could be allergic to?. The event rash started the same day she got her vaccine, she went swimming and when she got out of the pool her legs were itchy and red. The rash gives her like a raised look, lately it is getting worse, itching is worse. Urticaria/Hives: rash, all over, arms, legs, chest, back, She was told to go to the ER if the rash was on her face, she has not gone to the hospital. They didn't prescribe anything they just told her to take Benadryl. She tried to use an ointment and Benadryl. The ointment was an anti-itch cream from the pharmacy. Ointment and Benadryl didn't work it didn't decrease the hives or stop the itching. She went to the dermatologist for the rash. No medical testing done, they just looked at it. It was also reported that the event took place around 4 or 5 PM. The patient has no prior vaccinations (within 4 weeks) from the administration of Covid-19 vaccine. The patient was given the second dose of vaccine on 10Sep2021 (lot: FD8448) at the age of 19 years in the right arm.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022.; rashes; Urticaria/Hives: rash, all over, arms, legs, chest, back,; Urticaria/Hives: rash, all over, arms, legs, chest, back,; she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022.; legs were itchy and red; legs were itchy and red; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FC3181) at the age of 19 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY CYSTECTOMY (medically significant), CHOLELITHIASIS (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022."; RASH (medically significant) with onset 20Aug2021, outcome "not recovered", described as "rashes"; URTICARIA (medically significant), URTICARIA (medically significant) all with onset 20Aug2021, outcome "not recovered" and all described as "Urticaria/Hives: rash, all over, arms, legs, chest, back,"; ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 20Aug2021, outcome "not recovered" and all described as "legs were itchy and red"; PHARYNGEAL OEDEMA (non-serious), DYSPNOEA (non-serious), CHEST PAIN (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,".  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Cholelithiasis, Dyspnoea, Erythema, Pharyngeal oedema
Clinical narrative: she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022.; rashes; Urticaria/Hives: rash, all over, arms, legs, chest, back,; Urticaria/Hives: rash, all over, arms, legs, chest, back,; she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022.; legs were itchy and red; legs were itchy and red; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FC3181) at the age of 19 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY CYSTECTOMY (medically significant), CHOLELITHIASIS (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022."; RASH (medically significant) with onset 20Aug2021, outcome "not recovered", described as "rashes"; URTICARIA (medically significant), URTICARIA (medically significant) all with onset 20Aug2021, outcome "not recovered" and all described as "Urticaria/Hives: rash, all over, arms, legs, chest, back,"; ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 20Aug2021, outcome "not recovered" and all described as "legs were itchy and red"; PHARYNGEAL OEDEMA (non-serious), DYSPNOEA (non-serious), CHEST PAIN (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,".  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Urinary cystectomy, Urticaria
Clinical narrative: she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022.; rashes; Urticaria/Hives: rash, all over, arms, legs, chest, back,; Urticaria/Hives: rash, all over, arms, legs, chest, back,; she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022.; legs were itchy and red; legs were itchy and red; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FC3181) at the age of 19 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY CYSTECTOMY (medically significant), CHOLELITHIASIS (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022."; RASH (medically significant) with onset 20Aug2021, outcome "not recovered", described as "rashes"; URTICARIA (medically significant), URTICARIA (medically significant) all with onset 20Aug2021, outcome "not recovered" and all described as "Urticaria/Hives: rash, all over, arms, legs, chest, back,"; ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 20Aug2021, outcome "not recovered" and all described as "legs were itchy and red"; PHARYNGEAL OEDEMA (non-serious), DYSPNOEA (non-serious), CHEST PAIN (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,".  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eczema, Pruritus, Rash, Urticaria
Clinical narrative: she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022.; rashes; Urticaria/Hives: rash, all over, arms, legs, chest, back,; Urticaria/Hives: rash, all over, arms, legs, chest, back,; she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022.; legs were itchy and red; legs were itchy and red; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FC3181) at the age of 19 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY CYSTECTOMY (medically significant), CHOLELITHIASIS (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "she had her gall bladder removed, she had gall stones. Had them before and after receiving the COVID-19 vaccine, had the surgery, 04 FEB 2022."; RASH (medically significant) with onset 20Aug2021, outcome "not recovered", described as "rashes"; URTICARIA (medically significant), URTICARIA (medically significant) all with onset 20Aug2021, outcome "not recovered" and all described as "Urticaria/Hives: rash, all over, arms, legs, chest, back,"; ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 20Aug2021, outcome "not recovered" and all described as "legs were itchy and red"; PHARYNGEAL OEDEMA (non-serious), DYSPNOEA (non-serious), CHEST PAIN (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "she had trouble breathing and went to the ER in December 2021, she had bad chest pain, felt like her throat was closing,".  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood creatine, Blood creatine increased, Hepatic enzyme abnormal, Hepatic enzyme increased
Clinical narrative: diagnosed with Polymyositis; high liver enzymes; high muscle creatine levels very high; extreme weakness; muscle pains; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 (Lot number: EN6204) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Brand: Pfizer, Lot number: EN6205, Dose number: 1, Vaccine location: left arm), administration date: 19May2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: POLYMYOSITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "diagnosed with Polymyositis"; HEPATIC ENZYME INCREASED (non-serious) with onset Sep2021, outcome "not recovered", described as "high liver enzymes"; BLOOD CREATINE INCREASED (non-serious) with onset Sep2021, outcome "not recovered", described as "high muscle creatine levels very high"; ASTHENIA (non-serious) with onset Sep2021, outcome "not recovered", described as "extreme weakness"; MYALGIA (non-serious) with onset Sep2021, outcome "not recovered", described as "muscle pains". It was reported that during routine blood work 6 weeks after the 2nd dose, the patient had high liver enzymes. After further testing, they found high muscle creatine levels very high. Now, the patient was diagnosed with Polymyositis after extreme weakness and muscle pains. The patient underwent the following laboratory tests and procedures: blood creatine: (Sep2021) high, notes: very high; hepatic enzyme abnormal: (Sep2021) high; sars-cov-2 test: (12Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of polymyositis, hepatic enzyme increased, blood creatine increased, asthenia, myalgia which includes taking steroids (unspecified, as reported).; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Polymyositis, SARS-CoV-2 test
Clinical narrative: diagnosed with Polymyositis; high liver enzymes; high muscle creatine levels very high; extreme weakness; muscle pains; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 (Lot number: EN6204) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Brand: Pfizer, Lot number: EN6205, Dose number: 1, Vaccine location: left arm), administration date: 19May2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: POLYMYOSITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "diagnosed with Polymyositis"; HEPATIC ENZYME INCREASED (non-serious) with onset Sep2021, outcome "not recovered", described as "high liver enzymes"; BLOOD CREATINE INCREASED (non-serious) with onset Sep2021, outcome "not recovered", described as "high muscle creatine levels very high"; ASTHENIA (non-serious) with onset Sep2021, outcome "not recovered", described as "extreme weakness"; MYALGIA (non-serious) with onset Sep2021, outcome "not recovered", described as "muscle pains". It was reported that during routine blood work 6 weeks after the 2nd dose, the patient had high liver enzymes. After further testing, they found high muscle creatine levels very high. Now, the patient was diagnosed with Polymyositis after extreme weakness and muscle pains. The patient underwent the following laboratory tests and procedures: blood creatine: (Sep2021) high, notes: very high; hepatic enzyme abnormal: (Sep2021) high; sars-cov-2 test: (12Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of polymyositis, hepatic enzyme increased, blood creatine increased, asthenia, myalgia which includes taking steroids (unspecified, as reported).; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Dyspnoea, Muscle swelling, Nausea
Clinical narrative: feeling very nauseous; weak; unable to breathe; muscles around my vital organs had swollen up so much; airways were blocked; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  An 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 15:00 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: NAUSEA (hospitalization) with onset 02Sep2021 06:00, outcome "recovered", described as "feeling very nauseous"; ASTHENIA (hospitalization) with onset 02Sep2021 06:00, outcome "recovered", described as "weak"; DYSPNOEA (hospitalization) with onset 02Sep2021, outcome "recovered", described as "unable to breathe"; MUSCLE SWELLING (hospitalization) with onset 02Sep2021, outcome "recovered", described as "muscles around my vital organs had swollen up so much"; OBSTRUCTIVE AIRWAYS DISORDER (hospitalization) with onset 02Sep2021, outcome "recovered", described as "airways were blocked". The patient was hospitalized for nausea, asthenia, dyspnoea, muscle swelling, obstructive airways disorder (hospitalization duration: 1 day(s)). The events "feeling very nauseous", "weak", "unable to breathe", "muscles around my vital organs had swollen up so much" and "airways were blocked" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (unspecified date) unknown results; sars-cov-2 test: (06Jan2022) negative, notes: Covid test type post vaccination: Nasal swab. Therapeutic measures were taken as a result of nausea, asthenia, dyspnoea, muscle swelling, obstructive airways disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Reported Event: I woke up about 15 hours after receiving the first dose of the vaccine, feeling very nauseous and weak. I went back to sleep, unable to attend school and then woke up about 2 hours later unable to breathe. I was taken to the ER where they determined that the muscles around my vital organs had swollen up so much that my airways were blocked and that it was a bad reaction to the vaccine. I was given oxygen and medication to relax my muscles and then instructed not to receive any further COVID vaccinations by various medical professionals. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included: Oxygen, Medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.