chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: unresponsiveness for 2 minutes in seated position; bilateral arm tremor; pallor; eyes rolled back; drooling; nausea; vomiting; This is a spontaneous report from a non-contactable pharmacist. An 85-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on 27Jan2021 10:30 AM at single dose on Left arm for covid-19. Medical history included anaphylaxis history of unknown cause. The patient's concomitant medications were not reported. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position on 27Jan2021 11:00 AM. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting on 27Jan2021 11:00 AM. While seated, vital signs were taken- BP 148/76, HR 73, O2 98% on 27Jan2021. No falls or medication administered. (name withheld) arrived around 11:10 am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on (name withheld) assessment, recommendation was to go to the ER. No treatment received. Outcome of events was recovered on 27Jan2021.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness is possible. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hot flush, Hyperhidrosis, Lymphadenopathy
Clinical narrative: headache; Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine.; could be sinuses; Dizziness; Sweating; lymph nodes swollen; she tends to get hot flashes, she is currently going through menopause; This is a spontaneous report from a contactable consumer, the patient. A 48 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EL3248 ), intramuscular in the left arm on 15Jan2021 at 06:34 as a single dose, for COVID-19 immunization. The vaccination was administered at a Hospital Facility.  Patient contact her doctor who told her, she absolutely needed the COVID-19 vaccine. Medical history included ovarian cancer 2014 (stage 3B and 3C), lymphoedema 2015, (lymphedema after aggressive chemo/ told she would always have lymphedema), and menopause from an unknown date and ongoing (tends to get hot flashes). There were no concomitant medications. On 15Jan2021 (around noon), the patient experienced Lymph nodes swollen/her lymph nodes in her throat were swelling up, dizziness, and  sweating. Patient explains she tends to get hot flashes, she is currently going through menopause. However, she ran to the store and she was really sweating heavily and felt dizziness and  just ended up going home. She felt it was better to be at home if she was having a reaction.  By Saturday, 16Jan2021, she woke up and felt fine. The swelling of her lymph nodes in her throat went away. The dizziness and sweating went away. On 19Jan2021 (Tuesday Evening)  the patient experienced Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine. Also states it could be sinuses. She didn't know if this could be related to the COVID-19 vaccine and a reaction to it or her sinuses.  On Jan2021 patient experienced Hot flashes.  No other vaccines were given within 4 weeks.  The clinical outcome of Dizziness, Sweating was recovered on 16Jan2021, the outcome of Headache/migraine was not recovered, and the outcome of  lymph nodes swollen, hot flashes and sinuses were unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Sinus disorder
Clinical narrative: headache; Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine.; could be sinuses; Dizziness; Sweating; lymph nodes swollen; she tends to get hot flashes, she is currently going through menopause; This is a spontaneous report from a contactable consumer, the patient. A 48 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EL3248 ), intramuscular in the left arm on 15Jan2021 at 06:34 as a single dose, for COVID-19 immunization. The vaccination was administered at a Hospital Facility.  Patient contact her doctor who told her, she absolutely needed the COVID-19 vaccine. Medical history included ovarian cancer 2014 (stage 3B and 3C), lymphoedema 2015, (lymphedema after aggressive chemo/ told she would always have lymphedema), and menopause from an unknown date and ongoing (tends to get hot flashes). There were no concomitant medications. On 15Jan2021 (around noon), the patient experienced Lymph nodes swollen/her lymph nodes in her throat were swelling up, dizziness, and  sweating. Patient explains she tends to get hot flashes, she is currently going through menopause. However, she ran to the store and she was really sweating heavily and felt dizziness and  just ended up going home. She felt it was better to be at home if she was having a reaction.  By Saturday, 16Jan2021, she woke up and felt fine. The swelling of her lymph nodes in her throat went away. The dizziness and sweating went away. On 19Jan2021 (Tuesday Evening)  the patient experienced Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine. Also states it could be sinuses. She didn't know if this could be related to the COVID-19 vaccine and a reaction to it or her sinuses.  On Jan2021 patient experienced Hot flashes.  No other vaccines were given within 4 weeks.  The clinical outcome of Dizziness, Sweating was recovered on 16Jan2021, the outcome of Headache/migraine was not recovered, and the outcome of  lymph nodes swollen, hot flashes and sinuses were unknown.
Age: 43.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Chills, Dizziness, Headache, Musculoskeletal discomfort, Pyrexia
Clinical narrative: ?Moderna COVID?19 Vaccine EUA Fever, chills, extreme headache, every single joint throbbing Dizziness
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Diarrhoea, Dyspnoea, Facial pain
Clinical narrative: chest congestion; consisting of headache; sore throat; fever; shortness of breath; diarrhea; facial pain; burning sinuses; now she was weak; This is a spontaneous report based on the information received by Pfizer from Allergan (Manufacturer Report Number: AGN255108). A contactable consumer reported that a 6-decade-old female patient (not pregnant)received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took Botox for 8-10 years for Cervical Dystonia and in the beginning she had torticollis. The Botox straightened out her torticollis, which caused unspecified allergies for which she took Allegra-D. Her last Botox treatment was in Oct2020. She was past due for Botox due to having to take the Covid-19 vaccine. The patient got a Covid-19 vaccine on 20Jan2021. On 21Jan2021 she began having a "reaction" to the vaccine, consisting of headache, sore throat, fever, chest congestion, shortness of breath, diarrhea, facial pain, and burning sinuses. It took 24 hours after the vaccine to show symptoms, events began 21Jan2021. The symptoms were ongoing and now she was weak, and was unsure how long she will be at work today. There had been no treatment for the symptoms. The outcome of the events were not resolved.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pulmonary congestion, Pyrexia, Respiratory tract congestion
Clinical narrative: chest congestion; consisting of headache; sore throat; fever; shortness of breath; diarrhea; facial pain; burning sinuses; now she was weak; This is a spontaneous report based on the information received by Pfizer from Allergan (Manufacturer Report Number: AGN255108). A contactable consumer reported that a 6-decade-old female patient (not pregnant)received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took Botox for 8-10 years for Cervical Dystonia and in the beginning she had torticollis. The Botox straightened out her torticollis, which caused unspecified allergies for which she took Allegra-D. Her last Botox treatment was in Oct2020. She was past due for Botox due to having to take the Covid-19 vaccine. The patient got a Covid-19 vaccine on 20Jan2021. On 21Jan2021 she began having a "reaction" to the vaccine, consisting of headache, sore throat, fever, chest congestion, shortness of breath, diarrhea, facial pain, and burning sinuses. It took 24 hours after the vaccine to show symptoms, events began 21Jan2021. The symptoms were ongoing and now she was weak, and was unsure how long she will be at work today. There had been no treatment for the symptoms. The outcome of the events were not resolved.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: chest congestion; consisting of headache; sore throat; fever; shortness of breath; diarrhea; facial pain; burning sinuses; now she was weak; This is a spontaneous report based on the information received by Pfizer from Allergan (Manufacturer Report Number: AGN255108). A contactable consumer reported that a 6-decade-old female patient (not pregnant)received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took Botox for 8-10 years for Cervical Dystonia and in the beginning she had torticollis. The Botox straightened out her torticollis, which caused unspecified allergies for which she took Allegra-D. Her last Botox treatment was in Oct2020. She was past due for Botox due to having to take the Covid-19 vaccine. The patient got a Covid-19 vaccine on 20Jan2021. On 21Jan2021 she began having a "reaction" to the vaccine, consisting of headache, sore throat, fever, chest congestion, shortness of breath, diarrhea, facial pain, and burning sinuses. It took 24 hours after the vaccine to show symptoms, events began 21Jan2021. The symptoms were ongoing and now she was weak, and was unsure how long she will be at work today. There had been no treatment for the symptoms. The outcome of the events were not resolved.  Information on lot number/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: slight fever; headache; soreness in arm; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced slight fever, headache, soreness in arm. The outcome of the events was unkown. Information on the batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia
Clinical narrative: Patient stated she started feeling tingling on her forehead and seconds after it went away but she started to feel numbness on the top of her mouth.  No allergies reported.  No medications were administered, patient stated she is feeling better 15 minutes after.  Patient refused to go to the hospital, she said she is doing better and wants to go home.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: between the time she was covid positive; between the time she was covid positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number not known) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient said she got her first dose and between the time she was covid positive she said that she is scheduled to have the second dose this Thursday the 28Jan. Caller was asking if she could get the second dose even though she is a covid positive she said that she will be out of quarantine today (26Jan2021). The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Corneal graft rejection, Corneal opacity, Inflammation, Keratitis
Clinical narrative: evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; This is a spontaneous report from a contactable physician. A 62-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation. Medical history included diabetes and graft was 2.5 years old, partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. Concomitant medication included trazodone, rosuvastatin calcium (CRESTOR), zolpidem tartrate (AMBIEN), gabapentin, metformin. No COVID prior vaccination. Known allergies: Buspar. The patient previously received first dose of bnt162b2 on 28Dec2020 for COVID-19 immunization and experienced Cornea transplant rejection and inflammation/subepithelial infilatrates noted 1 week after the first vaccine. No other vaccine in four weeks. The patient experienced after 2nd vaccine, evidence of endothelial inflammation and anterior chamber cells and KP on endothelium. Clinical course reported as: Cornea transplant rejection. Graft was 2.5 years old. Partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. Signs of inflammation noted one week after each vaccine. Subepithelial infilatrates noted 1 week after the first vaccine. Resolved with Pred Forte. However, after 2nd vaccine, evidence of endothelial inflammation and anterior chamber cells and KP on endothelium noted on follow-up examination. Placed on stronger topical steroid with Durezol. Patient asymptomatic during entire process and this was found on routine follow-up exam and not because patient noted any symptoms. Vision not affected. Outcome of events was recovering. The doctor's office appointment was a routine appointment unrelated to receiving the vaccine. The temporal relationship with the COVID vaccine was reconstructed by the patient afterwards after thinking about it in retrospect. No COVID tested post vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Herpes virus infection, Pyrexia
Clinical narrative: Fever, chills, herpes outbreak
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported for a female patient (Wife) of unknown age that received first dose of bnt162b2 (Covid-19 Vaccine), via an unspecified route of administration at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Pharmacist said wife had 1st dose of covid vaccine 3 weeks ago, then tested positive for covid virus. Has fever and slight cough. Wondering if she can get 2nd dose of covid vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the COVID-19 infection is possible due to lack of efficacy of suspect vaccine BNT62B2.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Electrocardiogram
Clinical narrative: Within 24 hours of the injection my atrial fibrillation reoccurred; This is a spontaneous report from a contactable consumer.  A 72-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262), via an unknown route, on 23Jan2021 (at 13:15) at a single dose on the left arm for COVID-19 immunisation, administered at hospital. Relevant medical history included high cholesterol, high blood pressure and atrial fibrillation (she had been treated for Afib in the past but had been off of all medications for many months). Relevant concomitant medications included atorvastatin for high cholesterol and metoprolol for high blood pressure. No other vaccine was received in four weeks. Within 24 hours of the injection, on 24Jan2021 at 13:30, atrial fibrillation reoccurred. Physician office visit was done. Therapeutic measures taken as result of the event included apixaban (ELIQUIS) and dofetilide. An electrocardiogram (EKG) was done and results were unknown. Post-vaccination COVID test was not performed. The patient had recovered from the event in Jan2021.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. This consumer reported similar events for two patients. This is first of two reports. A patient of unspecified age and gender received first dose Covid-19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history includes patients were exposed to the virus. The patient's concomitant medications were not reported. The patient received first dose of the covid-19 vaccine and then contracted covid-19. Caller stated it is not an AE since her patients were exposed to the virus. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085847 Same reporter/ drug/ event for different patients.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is 2nd of two reports. A patient of unspecified age and gender received the first dose of Covid-19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunization. The patient medical history includes patients were exposed to the virus. The patient's concomitant medications were not reported. The patient received first dose of the covid-19 vaccine and then contracted covid-19. Caller stated it is not an AE since her patients were exposed to the virus. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085846 Same reporter/ drug/ event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Caller tested positive after the first shot/COVID; Caller tested positive after the first shot/COVID; He had a little bit of a cough but thought it was allergies; He had chills and sensitive skin; He had chills and sensitive skin; This is a Spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported a male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient said he was fortunate to have received the Pfizer COVID Vaccine. He was retired Navy. He received the dose at Hospital on 22Jan2021. Apparently at that time he had initial symptoms of COVID. He had a little bit of a cough but thought it was allergies. After the vaccine, the next few days his symptoms developed. His cough got worse. He had chills and sensitive skin. On 25Jan2021 he was tested for COVID. He got his results this morning and they were positive. He has been talking with online nurses and doctors. He has specific questions for Pfizer. Patient wanted to know about could the shot itself have contributed to a positive test from forming antibodies. Second dose was scheduled for 12Feb2021. Wanted to know if he should get that one. He pulled his back coughing too hard. He was headed to the Emergency Room (ER) to get treated because he cannot go anywhere else due to COVID. The outcome of the events was unknown with treatment received.  Information on the batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: Caller tested positive after the first shot/COVID; Caller tested positive after the first shot/COVID; He had a little bit of a cough but thought it was allergies; He had chills and sensitive skin; He had chills and sensitive skin; This is a Spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported a male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient said he was fortunate to have received the Pfizer COVID Vaccine. He was retired Navy. He received the dose at Hospital on 22Jan2021. Apparently at that time he had initial symptoms of COVID. He had a little bit of a cough but thought it was allergies. After the vaccine, the next few days his symptoms developed. His cough got worse. He had chills and sensitive skin. On 25Jan2021 he was tested for COVID. He got his results this morning and they were positive. He has been talking with online nurses and doctors. He has specific questions for Pfizer. Patient wanted to know about could the shot itself have contributed to a positive test from forming antibodies. Second dose was scheduled for 12Feb2021. Wanted to know if he should get that one. He pulled his back coughing too hard. He was headed to the Emergency Room (ER) to get treated because he cannot go anywhere else due to COVID. The outcome of the events was unknown with treatment received.  Information on the batch/Lot number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) reported that a 37 years old female patient received 2nd dose of BNT162B2 (Batch/lot number: EL1283/EH9899, Expiry Date: Mar2021) on 08Jan2021 at single dose on Left Deltoid, upper left arm for Covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient received both doses of Covid vaccine and tested positive for Covid day 18 post second dose. She received the second dose on 08Jan2021. However, she tested positive for COVID-19 on 24Jan2021. She wanted to know if she will be an asymptomatic carrier in the future. Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: infection; This is a spontaneous report from a contactable consumer.  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 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient resided in an assisted living facility. The patient experienced infection on an unspecified date with outcome of unknown.    Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure chronic, Diabetic wound, SARS-CoV-2 test positive
Clinical narrative: diabetic wounds; end stage heart failure; He tested positive for COVID; He tested positive for COVID; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received first dose of bnt162b2 (reported as COVID-19 vaccine), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose of the COVID-19 vaccine on 07Jan2021. He tested positive for COVID on 27Jan2021. Patient was in hospice care. He went to the hospital for treatment of diabetic wounds on 20Jan2021. In addition to diabetes he had end stage heart failure on an unspecified date. Event took place after use of product. The event outcome was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and fender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Jan2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received their Pfizer vaccine on 22Jan2021. The patient then tested positive for COVID on Monday, 25Jan2021. The patient was to receive a monoclonal antibody infusion, bamlanivimab. Patient had to wait 90 days to get the Pfizer vaccine. Pharmacist asked after that 90 days was up, should the patient get the second dose, or start the series over. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, SARS-CoV-2 antibody test negative
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored Program. A male patient of an unspecified age received first dose of BNT162B2 (Lot number: EK5730) on 21Dec2020, second dose of BNT162B2 (Lot number: EL1284) on 11Jan2021, and both via an unspecified route of administration at single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. The patient stating that he received his first dose of Covax on 21Dec2020 Lot#EK5730 and his second dose of Covax on 11Jan2021 Lot# EL1284, stating that after testing IGM and IGG he is negative for antibodies. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: ankle is kinda swollen; This is a spontaneous report from a Pfizer Sponsored Program, received by a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, in Jan2021 (a week ago, as reported) at a single dose for COVID-19 immunisation. Relevant medical history included arthritis (he took ibuprofen as needed when he had a flare up). No relevant concomitant medications were provided. After vaccination, patient's ankle is kinda swollen. He clarified that he was not taking ibuprofen since he has had vaccine and he wanted to know if he could retake it. The outcome of the event was unknown.   Information about Lot/Batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive after taking the first dose of the vaccine; tested positive after taking the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of unspecified age and gender received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient tested positive after taking the first dose of the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID 6 days post first dose/Sore throat/body aches; positive for COVID 6 days post first dose/sore throat/body aches; This is a spontaneous report from a contactable nurse. This report was received via a Pfizer Sales Representative. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date (reported as a Thursday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first shot on a Thursday. 5 days later patient was exposed to a COVID patient. Patient got tested for COVID-19 and tested positive for COVID 6 days post first dose. Day 7 post dose experienced sore throat and body aches. Events took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and drug ineffective due to temporal relationship.  This case will be reassessed once additional information is available.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Nasal congestion, Pain
Clinical narrative: Contracted Covid on 18Jan; Contracted Covid on 18Jan; Nasal congestion; Fever; Headache; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that a 63 years old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL0142 and Expiration Date 31Mar2021) via an unspecified route of administration on 14Jan2021 around 8:30am-8:45am (vaccine location: left upper arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history included compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergic to sulfa when she was a child, seasonal allergies, graves disease in 2014, which was been in remission for the last few years. Other medical history included high cholesterol. Family history included Her mother has Type II Diabetes; she has some unknown cancers in her family; no further information to provide. There was none other prior vaccinations (within 4 weeks). The concomitant medications were reported as ongoing atorvastatin at 40mg taken once daily for High cholesterol (Taken for a long time, at least 10 years).The day after she got the Pfizer COVID- 19 Vaccine she was around someone who had traveled who she did not realize had not quarantined and had seen relatives who were positive for COVID. Patient was contracted Covid on 18Jan2021 (possibly overnight while sleeping or early morning) and had Mild symptoms. First started with nasal congestion; then developed fever; headache; and body aches. Events has improved, she has gotten much better; just been having a fever on and off and nasal congestion but getting better every day; still just having a little bit of symptoms.  She was diagnosed with COVID after that administration. She is not saying the vaccine gave her COVID. She called to ask if she should still get the second dose of Pfizer COVID-19 Vaccine as scheduled for 04Feb2021 with this diagnosis. Rapid COVID test (nasal swab) on 21Jan2021 and Positive for COVID. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Contracted Covid on 18Jan; Contracted Covid on 18Jan; Nasal congestion; Fever; Headache; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that a 63 years old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL0142 and Expiration Date 31Mar2021) via an unspecified route of administration on 14Jan2021 around 8:30am-8:45am (vaccine location: left upper arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history included compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergic to sulfa when she was a child, seasonal allergies, graves disease in 2014, which was been in remission for the last few years. Other medical history included high cholesterol. Family history included Her mother has Type II Diabetes; she has some unknown cancers in her family; no further information to provide. There was none other prior vaccinations (within 4 weeks). The concomitant medications were reported as ongoing atorvastatin at 40mg taken once daily for High cholesterol (Taken for a long time, at least 10 years).The day after she got the Pfizer COVID- 19 Vaccine she was around someone who had traveled who she did not realize had not quarantined and had seen relatives who were positive for COVID. Patient was contracted Covid on 18Jan2021 (possibly overnight while sleeping or early morning) and had Mild symptoms. First started with nasal congestion; then developed fever; headache; and body aches. Events has improved, she has gotten much better; just been having a fever on and off and nasal congestion but getting better every day; still just having a little bit of symptoms.  She was diagnosed with COVID after that administration. She is not saying the vaccine gave her COVID. She called to ask if she should still get the second dose of Pfizer COVID-19 Vaccine as scheduled for 04Feb2021 with this diagnosis. Rapid COVID test (nasal swab) on 21Jan2021 and Positive for COVID. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Grandma was tested positive 11 days after the first dose; Grandma was tested positive 11 days after the first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient (reporter's grandmother) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was tested positive 11 days after the first dose. Grandmother had an appointment for 2nd dose on 30Jan2021 and tested positive after 1st dose. He said his grandmother had a test again on an unknown date but this time she's negative for Covid-19. The outcome of the events was recovered on an unknown date. Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EJ1685, via an unspecified route of administration on 22Dec2020 at 11:30, at 68 years of age, at single dose for COVID-19 immunization. Medical history included rheumatoid arthritis diagnosed 3 years before this report, coronary artery disease she has had for about 10 years and takes losartan for it, COVID-19 infection from Mar2020 to an unknown date; her family history is relevant for diabetes mellitus. In 2019 the patient got 2 flu vaccines at the same time, the regular flu and the one for seniors, and also the pneumonia shot. So she got 3 vaccines at once. Afterward she got sick and was in bed with chills and everything, she couldn't eat and was sick for the day. It was explained that she was at work but left for the day. This only lasted for the one day and she was fine and back to work the next day. There were no concomitant medications. On 23Dec2020 the patient experienced swollen lymph nodes on her left side; she got the shot on that side due to bad arthritis on the right side. It wasn't that bad and disappeared after 2 days. She did tell the doctor and was told by the doctor it was thought to just be inflammation from the shot. The patient recovered from the reported event on an 25Dec2020.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Illness, Nausea
Clinical narrative: got real sick; fever; Nauseous; chills and was freezing to death; chills and was freezing to death; her hands and feet were cold; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 25Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that while on the way home, the patient got real sick, she had a 102 fever, had chills and was freezing to death, and was nauseous. She is feeling a lot better than she did earlier. The husband put a heating pad on her feet, her hands were cold, she had chills, she was cold all over, when you touched her, her hands and feet were cold. The first time he checked, her temperature when she was first home was 101.7, then went up to 102, and stayed there for a while, but she feels like it came down. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: got real sick; fever; Nauseous; chills and was freezing to death; chills and was freezing to death; her hands and feet were cold; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 25Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that while on the way home, the patient got real sick, she had a 102 fever, had chills and was freezing to death, and was nauseous. She is feeling a lot better than she did earlier. The husband put a heating pad on her feet, her hands were cold, she had chills, she was cold all over, when you touched her, her hands and feet were cold. The first time he checked, her temperature when she was first home was 101.7, then went up to 102, and stayed there for a while, but she feels like it came down. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise, Myalgia, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: pain, redness, itching at site; pain, redness, itching at site; pain, redness, itching at site; Muscle ache; heaviness to arm; overall malaise; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number Ek9231), via an unspecified route of administration, on 13Jan2021 10:30 AM, in right arm as single dose for COVID-19 immunisation. The patient was vaccinated at workplace clinic. Patient age at vaccination was 56 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history includes seasonal allergies. Concomitant medications were not reported. On 13Jan2021 at 10:30 AM the patient experienced pain, redness, itching at site, muscle ache and heaviness to arm plus overall malaise as well lasting 2 weeks (clarification requested). No treatment was received for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has been tested for COVID-19 (Nasal Swabs, on 14Jan2021; 19Jan2021; 21Jan2021; 25Jan2021, all with negative result).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: pain, redness, itching at site; pain, redness, itching at site; pain, redness, itching at site; Muscle ache; heaviness to arm; overall malaise; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number Ek9231), via an unspecified route of administration, on 13Jan2021 10:30 AM, in right arm as single dose for COVID-19 immunisation. The patient was vaccinated at workplace clinic. Patient age at vaccination was 56 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history includes seasonal allergies. Concomitant medications were not reported. On 13Jan2021 at 10:30 AM the patient experienced pain, redness, itching at site, muscle ache and heaviness to arm plus overall malaise as well lasting 2 weeks (clarification requested). No treatment was received for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has been tested for COVID-19 (Nasal Swabs, on 14Jan2021; 19Jan2021; 21Jan2021; 25Jan2021, all with negative result).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient received 1st dose of covid vaccine Friday. Monday patient had tested positive Monday.; Patient received 1st dose of covid vaccine Friday. Monday patient had tested positive Monday.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received 1st dose of covid vaccine on Friday. Monday patient had tested positive. Called would like to know if and when patient can get 2 dose of covid vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Her sister was diagnosed with covid today 27Jan2021/Positive with covid after the first dose; Positive with covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable nurse (patient's sister). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on unknown date in Jan2021 at single dose on right arm for preventative.  Medical history and concomitant medications were not reported.  Reporter's sister had gotten COVID in between the two vaccine doses. She clarified that her sister only had the first dose of the vaccine. Her sister was diagnosed with COVID today 27Jan2021. Lab data included SARS-CoV-2 test positive on 27Jan2021. Her sister will be done with quarantine the day before she gets her second dose. She was calling to ask if her sister can get the second dose. She read all the information and she thought it should be ok for her sister to get the second dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.