chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstrual disorder
Clinical narrative: in correlation with the first shot, she has not had her period since then; she had a very strange light period, it never became a real period, just spotting the whole time; This is a spontaneous report from a contactable consumer (patient). A clone report is created to document the friend experience. This is report one of two. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8736, Expiry date: unknown), via an unspecified route of administration, administered in arm right on 04Jun2021 16:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was none. Concomitant medications included cyclobenzaprine (MANUFACTURER UNKNOWN, Tablet) for sleep, norethisterone (MANUFACTURER UNKNOWN, Tablet) for birth control, norethisterone (DEBLITANE, Lot number: 20076009, Expiry date: Oct2022) for birth control. It was reported that patient took COVID vaccine to protect her children. Investigation assessment was no. She did not take any other vaccines within 4 weeks prior COVID vaccinations and no AEs following prior COVID vaccinations. On an unspecified date, it was reported that in correlation with the first shot, she has not had her period since then, she had a very strange light period, it never became a real period, just spotting the whole time. Now she has not had another period at all in Jul2021, Aug2021 and Sep2021. She has not had any tests or treatment yet and not visited emergency room or physician office. The seriousness of the event in correlation with the first shot, she has not had her period since then was serious and medically significant and the other was non-serious. The outcome of the event in correlation with the first shot, she has not had her period since then was not recovered and other event was unknown.  No follow-up attempts possible. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Premature menopause
Clinical narrative: not had another period/ No period; prospect of early menopause as her periods are very regular; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8736; Expiry Date: unknown) via an unspecified route of administration in Right arm on 25Jun2021 in the afternoon (at the age of 40-year-old) as dose 2, single for COVID- 19 Immunisation. Medical history included ongoing sleep. Family History were none. Concomitant medication included cyclobenzaprine for sleep, norethisterone (DEBLITANE, lot number: 20076009; expiration date: Oct2022 and discard by date: 12Aug2022) for birth control. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8736, Expiry Date: unknown) via an unspecified route of administration in Right arm on 4Jun2021 16:00 (at the age of 40-year-old) as dose 1, single for COVID- 19 Immunisation. It was stated that after getting the first dose of the vaccine, she had a very strange light period; it never became a real period, just spotting the whole time instead of no period. Patient did not take any other vaccine within 4 weeks Prior to COVID19 vaccination. The patient was received second dose of Pfizer vaccine on 25Jun2021 in the afternoon. She has not had another period/ No period at all in Jul2021; Aug2021; Sep2021. The patient was not visited to Emergency Room or Physician Office. The patient had a telehealth appointment with her PCP a couple of weeks ago in 2021, her doctor and the specialist were very concerned about the prospect of early menopause as her periods are very regular; they want to do a FSH test. She has not had any tests or treatment yet. Outcome of the event amenorrhea was not recovered and other event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Unknown),via an unspecified route of administration on 2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced just received vaccine and was kind of worried,the arm was sore a little bit on an unspecified date.When asked about the vaccine lot number,patient stated that they don't have vaccine card right now.The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: neurosurgeon who received the Pfizer COVID-19 vaccine died immediately after administration; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number unknown, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient neurosurgeon who received the Pfizer COVID-19 vaccine died immediately after administration on an unspecified date. The patient died on an unspecified date. The cause of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about the lot/batch number could not be obtained. No further information is expected.; Reported Cause(s) of Death: neurosurgeon who received the Pfizer COVID 19 vaccine and died immediately after administration
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Dry eye, SARS-CoV-2 test
Clinical narrative: Nasal Swab result positive; Nasal Swab result positive; I took the 2nd Covid vaccine a month after the first and the dry eyes started sooner about day 2 and was extremely severe; This is a spontaneous report from a contactable physician(patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. Medical history included hypertension and headache. The patient had no drug allergies. The patient had no COVID-19 prior to vaccination. Concomitant medications included doxazosin, metoprolol and amitriptyline for headaches, start and stop date unknown. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178) via intramuscular route in left arm on 22Jun2021 as dose 1, single for COVID-19 immunization. The patient developed severe dry eyes with the first COVID vaccine, started day 3 worsened and lasted 2 weeks. The patient had to use eye drops frequently. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient has been tested for COVID-19. The patient delayed the second dose because of it. The patient figured it was autoimmune related. The patient took the 2nd COVID vaccine a month after the first and the dry eyes started sooner about day 2 and was extremely severe. The patient explained it was as if he was rubbing his eyes against sandpaper not his eyelid. The patient visited the Ophthalmologist on 26Jul2021. She voiced her concerns and she noticed changes in eye gland. The patient was on cyclosporine eye drops, within 2-3 days of using cyclosporine her severe dry eyes started to resolve. The patient stopped the eye drop one day in mid-August and symptoms returned, and quickly resolved after resuming cyclosporine drops. The patient did not have any need for hydrating eye drops while on cyclosporine eye drops. On 20Aug2021, the patient noticed that her cyclosporine stopped working. The severe dry eyes returned despite being faithful with Cyclosporine eye drops. On 20Aug2021 the nasal swab result was positive for COVID 19. Seriousness criteria for dry eye-Disabling/Incapacitating: Yes. The event outcome for dry eyes was not recovered and that for covid-19 it was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events DI , Covid 19, dry eye and 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry eye, SARS-CoV-2 test
Clinical narrative: Nasal Swab result positive; Nasal Swab result positive; I took the 2nd Covid vaccine a month after the first and the dry eyes started sooner about day 2 and was extremely severe; This is a spontaneous report from a contactable physician(patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. Medical history included hypertension and headache. The patient had no drug allergies. The patient had no COVID-19 prior to vaccination. Concomitant medications included doxazosin, metoprolol and amitriptyline for headaches, start and stop date unknown. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178) via intramuscular route in left arm on 22Jun2021 as dose 1, single for COVID-19 immunization. The patient developed severe dry eyes with the first COVID vaccine, started day 3 worsened and lasted 2 weeks. The patient had to use eye drops frequently. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient has been tested for COVID-19. The patient delayed the second dose because of it. The patient figured it was autoimmune related. The patient took the 2nd COVID vaccine a month after the first and the dry eyes started sooner about day 2 and was extremely severe. The patient explained it was as if he was rubbing his eyes against sandpaper not his eyelid. The patient visited the Ophthalmologist on 26Jul2021. She voiced her concerns and she noticed changes in eye gland. The patient was on cyclosporine eye drops, within 2-3 days of using cyclosporine her severe dry eyes started to resolve. The patient stopped the eye drop one day in mid-August and symptoms returned, and quickly resolved after resuming cyclosporine drops. The patient did not have any need for hydrating eye drops while on cyclosporine eye drops. On 20Aug2021, the patient noticed that her cyclosporine stopped working. The severe dry eyes returned despite being faithful with Cyclosporine eye drops. On 20Aug2021 the nasal swab result was positive for COVID 19. Seriousness criteria for dry eye-Disabling/Incapacitating: Yes. The event outcome for dry eyes was not recovered and that for covid-19 it was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events DI , Covid 19, dry eye and 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, COVID-19, Drug ineffective, Illness
Clinical narrative: COVID-19; COVID-19; Illness; Toe injury; Stomach ache; This is a solicited report received from marketing program on the information received by Pfizer (MFR Control No. # 21K-163-4039839-00) via a consumer(patient) or hcp. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: Not reported), via intramuscular route on 20Jul2021 as DOSE 1 (at the age of 51-year-old), DOSE 2, SINGLE and intramuscular on 27Aug2021 (Batch/Lot number was not reported) SINGLE for COVID-19 immunization and the patient also received adalimumab (HUMIRA, Batch/Lot number was not reported), subcutaneous, at Citrate Free for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced COVID-19, illness, toe injury and stomach-ache. The patient underwent lab tests and procedures which included body temperature: unknown. The reporter's causality for the events of illness, injured small toe, had covid-19 after getting covid vaccine and stomach ache with HUMIRA(adalimumab) was no reasonable possibility. The reporter's causality for the events of illness, injured small toe, had covid-19 after getting covid vaccine and stomach ache with BNT162b2 was possible. Patient underwent lab test The event outcome for toe injury and illness was reported as recovered. The events outcome for COVID-19 and stomach-ache was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, covid-19, Illness, limb injury, and abdominal pain upper and BNT162B2.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: COVID-19; COVID-19; Illness; Toe injury; Stomach ache; This is a solicited report received from marketing program on the information received by Pfizer (MFR Control No. # 21K-163-4039839-00) via a consumer(patient) or hcp. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: Not reported), via intramuscular route on 20Jul2021 as DOSE 1 (at the age of 51-year-old), DOSE 2, SINGLE and intramuscular on 27Aug2021 (Batch/Lot number was not reported) SINGLE for COVID-19 immunization and the patient also received adalimumab (HUMIRA, Batch/Lot number was not reported), subcutaneous, at Citrate Free for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced COVID-19, illness, toe injury and stomach-ache. The patient underwent lab tests and procedures which included body temperature: unknown. The reporter's causality for the events of illness, injured small toe, had covid-19 after getting covid vaccine and stomach ache with HUMIRA(adalimumab) was no reasonable possibility. The reporter's causality for the events of illness, injured small toe, had covid-19 after getting covid vaccine and stomach ache with BNT162b2 was possible. Patient underwent lab test The event outcome for toe injury and illness was reported as recovered. The events outcome for COVID-19 and stomach-ache was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, covid-19, Illness, limb injury, and abdominal pain upper and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Eye pain, Hypersensitivity, Off label use
Clinical narrative: allergies; having stabbing pain the left eye; third dose 17Aug2021; third dose 17Aug2021; This is a spontaneous report from a contactable consumer. This 39-year-old female consumer (patient) reported for herself that:A 39-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 as single dose for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Apr2021 as single dose for covid-19 immunisation. Patient stated she received 3 doses of the Pfizer covid vaccine; first dose was on 19Mar2021, second dose 09Apr2021 and third dose 17Aug201. Patient stated since mid-Mar she has been having stabbing pain in the left eye, on and off, not consistent. she stated this time it was not with the headache/ migraine on an unspecified date (usually last 24 hours), no cluster headache which she usually gets. she has allergies on an unspecified date. Patient stated that its always the left eye not like other symptoms. The case assessed as non-serious by the reporter. The outcome of the event was reported as unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; This is a spontaneous report from a contactable consumer reporting the same event under the same suspect product for three patients. This is one of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died on an unspecified date. It was unknown if an autopsy was performed.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101172300 Same reporter/product/event; different patient.; PFIZER INC-202101172301 Same reporter/product/event; different patient.; Reported Cause(s) of Death: Died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a contactable consumer reporting the same event under the same suspect product for three patients. This is one of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died on an unspecified date. It was unknown if an autopsy was performed.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101172210 Same reporter/product/event; different patient.; PFIZER INC-202101172301 Same reporter/product/event; different patient; Reported Cause(s) of Death: died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for three patients. This is one of three reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101172300 Same reporter/product/event; different patient; PFIZER INC-202101172210 Same reporter/product/event; different patient; Reported Cause(s) of Death: died
Age: 77.0
Sex: M
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 contactable consumer (reporting on behalf of the father in-law). A 78 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Feb2021 at 12:00 AM, at the age of 77 years, at single dose, for COVID-19 immunization. The patient's medical history included high blood pressure. COVID prior vaccination: no. Concomitant medications were not reported. On 27Aug2021 the patient exhibited symptoms of fatigue and fever. Positive COVID-19 test (nasal swab) on 30Aug2021. AE resulted in: Doctor or other healthcare professional office/clinic visit. The events were treated with monoclonal antibody therapy. The patient was recovering.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: exhibited symptoms of fatigue, fever/underwent a positive COVID-19 test (nasal swab); exhibited symptoms of fatigue, fever/underwent a positive COVID-19 test (nasal swab); This is a spontaneous report from a contactable consumer. A 73-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 15Feb2021 12:00 (batch/lot number and expiry date unknown) at 73 years of age as dose number unknown, single for covid-19 immunization in facility. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior vaccination. The reporter informed that the patient exhibited symptoms of fatigue, fever on 27Aug2021, and underwent a positive COVID-19 test (nasal swab) on 30Aug2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent a monoclonal antibody therapy treatment on 31Aug2021 and was currently recovering.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died after getting one dose of the pfizer covid 19-vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 57) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1 , single for COVID-19 immunisation. Medical history included overweight and diabetes, from an unknown date. The patient's concomitant medications were not reported. On an unspecified date, the patient died after getting one dose of the Pfizer COVID 19-vaccine, was not specific if it was due to the vaccine. The patient died on an unspecified date. Outcome of the event was fatal. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died after getting one dose of the pfizer covid 19-vaccine
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored Program. A contactable 34-year-old female consumer (Patient) reported that: Who received dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 13Aug2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter, and her husband was a 38-year-old male consumer, both are on speaker phone, they received their first doses of the Pfizer COVID-19 Vaccine. Comirnaty on 13Aug2021 and about a week after their first doses they both tested positive for COVID-19. They were due for their second dose on 03Sep2021. The reporter would like to know if it was safe to receive their second dose since they tested positive for COVID-19 after receiving their first dose. Reporter husband, on speaker, asked if it is still recommended to receive the second dose or if the antibodies from having a COVID-19 infection after the first dose would provide enough protection. Outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram abdomen, Epstein-Barr virus test, Feeling abnormal
Clinical narrative: weakness; like she has weights on her legs and arms; Headache; tiny bit of a sore arm; This is a spontaneous report from a contactable consumer o(patient herself). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in left arm on 17Feb2021 13:40 as dose 2, single for COVID-19 immunisation (at the age of 73-year-old). Medical history included redundant colon, IBS C, a little elevated cholesterol, arthritis, right hip replacement, Epstein bar virus in 199, vitamin b12 deficiency (in college), low estrogen and progesterone (in the early 2000s) and mother had Alzheimer's and died at 81 and her father they think it was mesothelioma. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration and location on 27Jan2021 as dose 1, single for COVID-19 immunization (at the age of 73-year-old). On 17Feb2021 21:00, the patient experienced headache. On 07Aug2021, started having extreme weakness. The weakness is not fatigue, it feels like she has weights on her legs and arms. The patient had this weakness three other times in her life but every time they found the cause of it one time the caller had the Epstein bar virus in 199. The patient's B12 was fine, and it showed that she had Epstein Bar but they did a titer and checked to see if she had a current infection and it came back negative. Since the caller's weak she is not doing a lot and her Gynaecologist said the more she is not active the worse the weakness will be. On an unspecified date, the patient experienced tiny bit of a sore arm. The caller has been trying to push herself, but she was so weak she had to lean on a cart to get through the store. The caller had a physical and blood work, and it is perfect and there is no reason for this. On 13Aug2021, the patient underwent lab tests and procedures which included blood work: came back perfect. On 07Sep2021, CT abdomen: normal. On an unspecified date, Epstein-bar virus test: nothing has come back, Lyme's disease: nothing has come back, checked for vitamin deficiencies: nothing has come back and mammogram: normal. The outcome of the event tiny bit of a sore arm was recovered and all other events was unknown.   Follow-up (08Sep2021): This is a follow-up spontaneous report from a contactable consumer it included: event information updated, medical history and other clinical course has been updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Investigation, Mammogram, Pain in extremity
Clinical narrative: weakness; like she has weights on her legs and arms; Headache; tiny bit of a sore arm; This is a spontaneous report from a contactable consumer o(patient herself). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in left arm on 17Feb2021 13:40 as dose 2, single for COVID-19 immunisation (at the age of 73-year-old). Medical history included redundant colon, IBS C, a little elevated cholesterol, arthritis, right hip replacement, Epstein bar virus in 199, vitamin b12 deficiency (in college), low estrogen and progesterone (in the early 2000s) and mother had Alzheimer's and died at 81 and her father they think it was mesothelioma. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration and location on 27Jan2021 as dose 1, single for COVID-19 immunization (at the age of 73-year-old). On 17Feb2021 21:00, the patient experienced headache. On 07Aug2021, started having extreme weakness. The weakness is not fatigue, it feels like she has weights on her legs and arms. The patient had this weakness three other times in her life but every time they found the cause of it one time the caller had the Epstein bar virus in 199. The patient's B12 was fine, and it showed that she had Epstein Bar but they did a titer and checked to see if she had a current infection and it came back negative. Since the caller's weak she is not doing a lot and her Gynaecologist said the more she is not active the worse the weakness will be. On an unspecified date, the patient experienced tiny bit of a sore arm. The caller has been trying to push herself, but she was so weak she had to lean on a cart to get through the store. The caller had a physical and blood work, and it is perfect and there is no reason for this. On 13Aug2021, the patient underwent lab tests and procedures which included blood work: came back perfect. On 07Sep2021, CT abdomen: normal. On an unspecified date, Epstein-bar virus test: nothing has come back, Lyme's disease: nothing has come back, checked for vitamin deficiencies: nothing has come back and mammogram: normal. The outcome of the event tiny bit of a sore arm was recovered and all other events was unknown.   Follow-up (08Sep2021): This is a follow-up spontaneous report from a contactable consumer it included: event information updated, medical history and other clinical course has been updated.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash was "really itchy"; rash that started on her right arm that proceeded to her left arm and then to the rest of her body/ had a big rash everywhere; This is a spontaneous report from a contactable consumer, the patient. A 39-years-old female patient received first dose of bnt162b2 (formulation: solution for injection, lot Number: EW0198) via an unspecified route of administration, administered in right arm on 31Aug2021 10:00 as dose 1, single (age at the time of vaccination: 39 years) for covid-19 immunisation. The patient medical history was none. The patient did not have any family history relevant to adverse events. Concomitant medication(s) included ongoing lamotrigine taken for bi polar; ongoing pioglitazone taken for PCOS ; omega 3 taken for an unspecified indication; melatonin taken for sleeping. The patient states that after taking first dose of bnt162b2, 3 days later on 03Sep2021, she experienced a rash that started on her right arm that proceeded to her left arm and then to the rest of her body/ had a big rash everywhere. The patient states the rash was really itchy and went away the same afternoon. The patient stated that she consulted with her health care professional in which they referred her to contact Pfizer. The patient did not receive any treatment for the events and no tests were conducted. No prior vaccinations were administered to the patient (within 4 weeks). The outcome of both the events was recovered on 03Sep2021.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died after taking a Covid vaccine; This is a spontaneous report. A non-contactable consumer reported that a patient (reporter's cousin) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced died after taking a covid vaccine on an unspecified date. This report was reported as non-serous by reporter. The patient died on an unspecified date. It was not reported if an autopsy was performed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died after taking a Covid vaccine
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller states she has a patient who received their first dose of Comirnaty and then shortly afterward was diagnosed with Covid-19 infection; Caller states she has a patient who received their first dose of Comirnaty and then shortly afterward was diagnosed with Covid-19 infection; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in left arm on 28Apr2021 (at the age of 58-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated she has a patient who received their first dose of Comirnaty and then on an unspecified date in May2021 afterward was diagnosed with Covid-19 infection, the patients doctor instructed them to wait 3 months prior to receiving the second dose of the vaccine. Caller asked on behalf of the patient when the patient can safely and effectively receive their second dose of Comirnaty. Caller stated that she heard that the second dose can only be given between 21 and 42 days. Caller asking if this was true and informed that the Pfizer BioNTech COVID-19 Vaccine were administered as a 2-dose series, 3 weeks apart, into the muscle. If received one dose of the vaccine, should received a second dose of the vaccine 3 weeks later to complete the vaccination series. Per interim considerations: "The second dose of Pfizer-BioNTech vaccine should be administered as close to the recommended interval as possible, but not earlier than recommended (i.e., 3 weeks [Pfizer-BioNTech]). But if it was not possible to give the second dose at 3-weeks and a delay cannot be avoided, it may be given up to 6 weeks (42 days) after the first dose. If the second dose was given later than 6 weeks (42 days), the vaccination series does not need to be repeated. There were only limited information available on how well the vaccine protects against COVID-19 if given after this amount of time. The patient underwent lab tests and procedures which included Covid-19 test (sars-cov-2 test): positive on an unspecified date in May2021. Outcome of the events were unknown. Communication: PC filed. The caller stated that the patient was going to go back to the original clinic and declined to complete the remainder of the report. Full details unable to be obtained.  No follow-up attempts are possible. No further information is expected
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, COVID-19, Chills
Clinical narrative: they both tested positive for COVID-19.; they both tested positive for COVID-19.; losing weight; had a slight fever of 102; both lost their sense of smell and taste; both lost their sense of smell and taste; coughing; sneezing; chills; common cold; This is a spontaneous report from a  support program. This Consumer (patient's wife) reported for male patient.  A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EW0171), via unspecified route of administration, in left arm on 13Aug2021 (at the age of 38-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Reporter stated that her husband was tested positive for COVID on 07Sep2021. The test was between 4-5 days ago though. Patient was tested negative on 31Aug2021. Reporter knew that patient had it and at home test came back positive. The reporter also stated that about a week after their first doses they both tested positive for COVID-19. They were due for their second dose on 03Sep2021. The caller queried if it was safe to receive their second dose since they tested positive for COVID-19 after receiving their first dose. The reporter also mentioned that on unspecified date her husband's weight could be less, he has been losing weight like crazy and they felt like they just had a cold. They had coughing, sneezing, and chills; her husband had a slight fever of 102. Reporter stated that they both lost their sense of smell and taste. She said that it felt like they had the common cold. She stated that she can't get rid of the cough. The caller and her husband were seen by the physician over the phone and were both prescribed a Z-Pak. Patient had not attended any emergency Room and physician Office for the events reported. The outcome for all the reported events was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Nasopharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: they both tested positive for COVID-19.; they both tested positive for COVID-19.; losing weight; had a slight fever of 102; both lost their sense of smell and taste; both lost their sense of smell and taste; coughing; sneezing; chills; common cold; This is a spontaneous report from a  support program. This Consumer (patient's wife) reported for male patient.  A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EW0171), via unspecified route of administration, in left arm on 13Aug2021 (at the age of 38-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Reporter stated that her husband was tested positive for COVID on 07Sep2021. The test was between 4-5 days ago though. Patient was tested negative on 31Aug2021. Reporter knew that patient had it and at home test came back positive. The reporter also stated that about a week after their first doses they both tested positive for COVID-19. They were due for their second dose on 03Sep2021. The caller queried if it was safe to receive their second dose since they tested positive for COVID-19 after receiving their first dose. The reporter also mentioned that on unspecified date her husband's weight could be less, he has been losing weight like crazy and they felt like they just had a cold. They had coughing, sneezing, and chills; her husband had a slight fever of 102. Reporter stated that they both lost their sense of smell and taste. She said that it felt like they had the common cold. She stated that she can't get rid of the cough. The caller and her husband were seen by the physician over the phone and were both prescribed a Z-Pak. Patient had not attended any emergency Room and physician Office for the events reported. The outcome for all the reported events was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing, Weight decreased
Clinical narrative: they both tested positive for COVID-19.; they both tested positive for COVID-19.; losing weight; had a slight fever of 102; both lost their sense of smell and taste; both lost their sense of smell and taste; coughing; sneezing; chills; common cold; This is a spontaneous report from a  support program. This Consumer (patient's wife) reported for male patient.  A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EW0171), via unspecified route of administration, in left arm on 13Aug2021 (at the age of 38-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Reporter stated that her husband was tested positive for COVID on 07Sep2021. The test was between 4-5 days ago though. Patient was tested negative on 31Aug2021. Reporter knew that patient had it and at home test came back positive. The reporter also stated that about a week after their first doses they both tested positive for COVID-19. They were due for their second dose on 03Sep2021. The caller queried if it was safe to receive their second dose since they tested positive for COVID-19 after receiving their first dose. The reporter also mentioned that on unspecified date her husband's weight could be less, he has been losing weight like crazy and they felt like they just had a cold. They had coughing, sneezing, and chills; her husband had a slight fever of 102. Reporter stated that they both lost their sense of smell and taste. She said that it felt like they had the common cold. She stated that she can't get rid of the cough. The caller and her husband were seen by the physician over the phone and were both prescribed a Z-Pak. Patient had not attended any emergency Room and physician Office for the events reported. The outcome for all the reported events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The physician wanted to know request timing recommendations if a patient missed the 3 week dosing interval between the first and second dose of the Pfizer BioNtech Covid-19 Vaccine. The physician stated that there is an individual who missed the 2nd dose of the Pfizer BioNtech Covid-19 vaccine due to a delayed hives reaction after the first dose. The physician wanted to know if we have additional guidance in the administration of the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine if a patient experienced a delayed adverse reaction (hives). The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: she experienced what she thought was a rash and was diagnosed as having Shingles.; This is a spontaneous report from a contactable 46-year-old female consumer(reporter). A 46 year old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 13Aug2021 as DOSE 1, SINGLE for covid-19 immunization( at age of 46 years).The patient medical history and concomitant medications were not reported. On 13Aug2021 the patient had experienced what she thought was a rash and was diagnosed as having Shingles  The clinical outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Caller states that 3 days or 48-36 hours after the dose he broke out into whelps on his back; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that that 3 days or 48-36 hours after the dose the patient broke out into whelps on his back on an unspecified date in Jul2021. The patient was seeking information about if he should get the second dose or not? His family doctor advised him against it. The outcome of event was unknown.      The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Guillain-Barre syndrome, Polyneuropathy
Clinical narrative: Probably Guillain-Barre Syndrome (polyneuropathy similar to GBS that occurred in 1981); Probably Guillain-Barre Syndrome (polyneuropathy similar to GBS that occurred in 1981); Probably Guillain-Barre Syndrome (polyneuropathy similar to GBS that occurred in 1981); This is a spontaneous report from a contactable other hcp (patient). A 67-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in Arm Left on 20Aug2021 08:15 as dose 1, single for covid-19 immunisation.  Medical history included thyroid cancer from an unknown date and unknown if ongoing, allergy to arthropod sting from an unknown date and unknown if ongoing bee stings, polyneuropathy similar to GBS that occurred in 1981. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Aug2021, the patient experienced probably guillain-barre syndrome (polyneuropathy similar to gbs that occurred in 1981). The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was taken as a result of events. The outcome of the events was not recovered.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Guillain-Barre syndrome, Polyneuropathy and condition aggravated 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.