chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: My daughter doesn't feel good; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced my daughter does not feel good. Reporter stated, "I need to know I am trying to make sure I am calling to right place. I have some questions about side effects (Further clarification unknown hence captured as verbatim) from the Covid vaccine the second dose at about 20 days. I am trying to figure out if it would be the vaccine or if it is possible to be something else." Reporter stated, "I think I was on there; I mean the symptoms are so broad and big and most of the symptoms that listing on there that would match this, it looks like it happened with him like two to five days after the shot and it's been 20 then actually 21 days." Reporter stated, "No, I don't know I would have to go get my card to give. It is really bad time. My daughter does not feel good (Further clarification unknown hence not tab) I am trying to figure out if she needs to go to the hospital or not so I am going to hang up and see if I can get hold of somebody." The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: hair lose; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received first dose of bnt162b2 (COMIRNATY) via unspecified route of administration in the arm left, on 07Jun2021, at the age of 58-years-old, at single dose for COVID-19 immunization. Patient medical history included COVID-19 on unspecified date, prior vaccination. Concomitant medications were not reported.  The patient experienced hair loss (hair lose) on unspecified date in 2021. Event caused hospitalization on unspecified date in 2021 for 12 days.  Outcome of the event was recovered with lasting effects (recovered with sequel) on unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Head discomfort, Headache, Pain in extremity, Pyrexia
Clinical narrative: Little bit of Headache; Sore arm; Feel really horrible like my head got caught in it; Little bit of fever; Absolute no energy; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2) Pfizer COVID 19 Vaccine solution for injection, dose 1 (Lot Number: FC3181 expiry date was unknown) via an unspecified route of administration on 24Aug2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "patient got the Pfizer the first shot on 24Aug and patient did not have any serious side effects or anything little bit of Headache and Sore arm, but well today and half of yesterday patient just feel really horrible like patient head got caught in it or something and patient have got little bit of fever and then now patient have absolute no energy and patient wondering is that because of vaccine. Consumer informed about Pfizer Medical Information department and offered the number. Consumer was provided with the number of Pfizer Medical Information # and was requested to select option 3, timings as and 8 am to 8 pm Monday to Fridays. Consumer was also informed about the role of Pfizer Drug Safety department and requested to probe. Consumer stated, "Okay, thank you very much. Further probing could not be done as consumer was unwilling to answer any further information. Hence limited information available over the call.  QR Comment: Reporter type could not be probed as the consumer was unwilling to share any further information, hence captured by default as consumer or other non-health professional in tab.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Retinal vein occlusion, SARS-CoV-2 test
Clinical narrative: left retinal vein occlusion of unknown origin; large swollen lymph node in left armpit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (Batch/Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 29Jan2021 13:30 (at the age of 62 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included aspirin [acetylsalicylic acid] and methimazole, both taken for unspecified indications, start and stop dates were not reported. The patient previously took codeine and experienced codeine allergy. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EK9231), administered in left arm on 07Jan2021 13:30 (at the age of 62 years old) for COVID-19 immunisation. No other vaccine in four weeks. The day after 2nd vaccine, on 30Jan2021 (also reported as on 16May2021), the patient experienced large swollen lymph node in left armpit. Several months later, on 16May2021, the patient developed a left retinal vein occlusion of unknown origin. No COVID prior vaccination. Patient was COVID tested post vaccination. Covid test type post vaccination: Nasal Swab (on 07Jun2021): Negative. Events resulted in Doctor or other healthcare professional office/clinic visit, and Disability or permanent damage. It was unknown if treatment provided for adverse events. Outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Cough, Drug hypersensitivity, Drug ineffective
Clinical narrative: taken the first dose of the Pfizer COVID-19 vaccine on 02Aug/diagnosed with COVID-19; taken the first dose of the Pfizer COVID-19 vaccine on 02Aug/diagnosed with COVID-19; Has really bad allergies; Fever; Coughing; Sinuses out of whack; Problems trying to breathe; Sneezing; Congestion in his lungs; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother). A 28-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- FC3180) via an unspecified route of administration, administered in right arm on 02Aug2021 as dose 1, single for COVID-19 immunization. Patient medical history included adenoidal disorder from an unknown date and unknown if ongoing (reported as once a month his adenoids get triggered). Family history patient mother had chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. There were no concomitant medications. The reporter stated that patient taken the first dose of the pfizer covid-19 vaccine on 02Aug2021 diagnosed with covid-19 on 24Aug2021, congestion in his lungs, has really bad allergies, fever, coughing, sinuses out of whack, problems trying to breathe, sneezing on Aug2021. Reporter wanted to know the patient should take the second dose of the vaccine now. Patient did not receive any other vaccine in four weeks prior to the first administration date of the suspect vaccine. Vaccination facility type was reported as Pharmacy. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, sars-cov-2 antibody test positive: positive on 24Aug2021, x-ray: unknown on an unspecified date. The patient reached emergency room for the events Fever, Coughing, Problems trying to breathe, sneezing, congestion in his lungs, Covid 19. Therapeutic measures were taken as a result of taken the first dose of the pfizer covid-19 vaccine on 02Aug/diagnosed with covid-19, congestion in his lungs, has really bad allergies, fever, coughing, sinuses out of whack, problems trying to breathe, sneezing. The outcome of the events covid-19,fever, coughing, Sinuses out of whack, Problems trying to breathe, Sneezing were recovering and congestion in his lungs, has really bad allergies were unknown.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary congestion, Pyrexia, SARS-CoV-2 antibody test positive, Sinus disorder
Clinical narrative: taken the first dose of the Pfizer COVID-19 vaccine on 02Aug/diagnosed with COVID-19; taken the first dose of the Pfizer COVID-19 vaccine on 02Aug/diagnosed with COVID-19; Has really bad allergies; Fever; Coughing; Sinuses out of whack; Problems trying to breathe; Sneezing; Congestion in his lungs; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother). A 28-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- FC3180) via an unspecified route of administration, administered in right arm on 02Aug2021 as dose 1, single for COVID-19 immunization. Patient medical history included adenoidal disorder from an unknown date and unknown if ongoing (reported as once a month his adenoids get triggered). Family history patient mother had chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. There were no concomitant medications. The reporter stated that patient taken the first dose of the pfizer covid-19 vaccine on 02Aug2021 diagnosed with covid-19 on 24Aug2021, congestion in his lungs, has really bad allergies, fever, coughing, sinuses out of whack, problems trying to breathe, sneezing on Aug2021. Reporter wanted to know the patient should take the second dose of the vaccine now. Patient did not receive any other vaccine in four weeks prior to the first administration date of the suspect vaccine. Vaccination facility type was reported as Pharmacy. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, sars-cov-2 antibody test positive: positive on 24Aug2021, x-ray: unknown on an unspecified date. The patient reached emergency room for the events Fever, Coughing, Problems trying to breathe, sneezing, congestion in his lungs, Covid 19. Therapeutic measures were taken as a result of taken the first dose of the pfizer covid-19 vaccine on 02Aug/diagnosed with covid-19, congestion in his lungs, has really bad allergies, fever, coughing, sinuses out of whack, problems trying to breathe, sneezing. The outcome of the events covid-19,fever, coughing, Sinuses out of whack, Problems trying to breathe, Sneezing were recovering and congestion in his lungs, has really bad allergies were unknown.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing, X-ray
Clinical narrative: taken the first dose of the Pfizer COVID-19 vaccine on 02Aug/diagnosed with COVID-19; taken the first dose of the Pfizer COVID-19 vaccine on 02Aug/diagnosed with COVID-19; Has really bad allergies; Fever; Coughing; Sinuses out of whack; Problems trying to breathe; Sneezing; Congestion in his lungs; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother). A 28-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- FC3180) via an unspecified route of administration, administered in right arm on 02Aug2021 as dose 1, single for COVID-19 immunization. Patient medical history included adenoidal disorder from an unknown date and unknown if ongoing (reported as once a month his adenoids get triggered). Family history patient mother had chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. There were no concomitant medications. The reporter stated that patient taken the first dose of the pfizer covid-19 vaccine on 02Aug2021 diagnosed with covid-19 on 24Aug2021, congestion in his lungs, has really bad allergies, fever, coughing, sinuses out of whack, problems trying to breathe, sneezing on Aug2021. Reporter wanted to know the patient should take the second dose of the vaccine now. Patient did not receive any other vaccine in four weeks prior to the first administration date of the suspect vaccine. Vaccination facility type was reported as Pharmacy. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, sars-cov-2 antibody test positive: positive on 24Aug2021, x-ray: unknown on an unspecified date. The patient reached emergency room for the events Fever, Coughing, Problems trying to breathe, sneezing, congestion in his lungs, Covid 19. Therapeutic measures were taken as a result of taken the first dose of the pfizer covid-19 vaccine on 02Aug/diagnosed with covid-19, congestion in his lungs, has really bad allergies, fever, coughing, sinuses out of whack, problems trying to breathe, sneezing. The outcome of the events covid-19,fever, coughing, Sinuses out of whack, Problems trying to breathe, Sneezing were recovering and congestion in his lungs, has really bad allergies were unknown.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Dizziness, Headache, Malaise, Pain, Pyrexia
Clinical narrative: My body aches completely my whole body aches;  my body hurts; my head hurts; I get up when I am gonna get up after the bed or when I am sitting down I feel dizzy; I felt bad; I have been running a fever; This is a spontaneous report from a contactable consumer (patient).  A patient of an unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/batch number: unknown), via an unspecified route of administration on 20Aug2021, as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body aches completely whole body aches; body hurts, head hurts, I get up when I am gonna get up after the bed or when I am sitting down I feel dizzy, running a fever and I felt bad. The patient visited emergency room. The outcome of events was unknown.  Information on the lot/ batch number has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Received both doses of the Pfizer covid vaccine early on and they all got covid 19; Received both doses of the Pfizer covid vaccine early on and they all got covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is the second of five reports.   An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, 2nd dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received both doses of the Pfizer covid vaccine early on and the patient got COVID 19 on an unspecified date. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101133918 Same Reporter/Drug/AE, Different Patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received both doses of the Pfizer covid vaccine early on and they all got covid 19; received both doses of the Pfizer covid vaccine early on and they all got covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is the 3rd of five reports.   A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, 2nd dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received both doses of the Pfizer COVID vaccine early on and the patient got COVID 19 on an unspecified date. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101133918 Same Reporter/Drug/AE, Different Patient
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Who received both doses of the Pfizer covid vaccine early on and they all got covid 19; who received both doses of the Pfizer covid vaccine early on and they all got covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is the 4th of 5 reports.   A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on an unspecified date (at the age of 45-year-old) (Batch/Lot number was not reported) as a single dose, 2nd dose via an unspecified route of administration on an unspecified date (at the age of 45-year-old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received both doses of the Pfizer COVID vaccine early on and the patient got COVID 19 on an unspecified date. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101133918 Same Reporter/Drug/AE, Different Patient
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: who received both doses of the Pfizer covid vaccine early on and they all got covid 19; who received both doses of the Pfizer covid vaccine early on and they all got covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is the 5th of 5 reports.   A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on an unspecified date (at the age of 13-year-old) (Batch/Lot number was not reported) as a single dose, 2nd dose via an unspecified route of administration on an unspecified date (at the age of 13-year-old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received both doses of the Pfizer COVID vaccine early on and the patient got COVID 19 on an unspecified date. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101133918 Same Reporter/Drug/AE, Different Patient
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Tremor, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 31Aug2021 08:30 (Batch/Lot Number: EW0167) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea on 2021 with outcome of unknown, he is shaking like a baby with tremor, he is throwing up over everything with vomiting and chills on 2021 with outcome of unknown.  Follow-up (31Aug2021): This is a follow-up spontaneous report form a contactable consumer. This consumer reported for a patient (son) that: The adverse events were updated and wanted to know if he needs the emergency room.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, SARS-CoV-2 test
Clinical narrative: never had diabetes before believe diabetes is side effect of shot; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 27Aug2021 at 14:30 (at the age of 52-years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure and thyroid disorder. Concomitant medications included lisinopril, levothyroxine sodium (SYNTHROID) and cartilage, hyaluronic acid (MOVE FREE ULTRA), all taken for an unspecified indication, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 administered in right arm on 05Aug2021 at 02:30 PM for COVID-19 immunisation. Two days after the second shot, on 29Aug2021 at 00:00 (also reported as 12:00 AM), the patient experienced severe dry mouth and extremely high sugar, never had diabetes before and believes diabetes was side effect of the shot. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 03Aug2021. Therapeutic measures were taken as a result of all events (reported as 'Metforman'). The outcome of the event was not recovered.    The lot number for BNT162B2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a Pfizer sponsored program. A contactable other HCP (patient daughter) reported for a male patient (reporter father). A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bells palsy on an unspecified date. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the limited  information in the case report, a possible causal relationship between the event Bell's palsy 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood test, Dysphagia, Dyspnoea, Gait disturbance
Clinical narrative: her kidneys had shut down / kidneys were not functioning; She could barely walk, talk or breathe.; She could barely walk, talk or breathe.; She could barely walk, talk or breathe.; Nauseous; Throat was clogged up, she could not swallow; Her throat was clogged up, she could not swallow and so on but the dialysis helped her get her numbers good; This is a spontaneous report from a contactable consumer (patient's husband). A 76-year-old female patient received bnt162b2 (Pfizer COVID-19 Vaccine - Comirnaty), second single dose via an unspecified route of administration on 15Mar2021 (Batch/Lot Number: EN6208) for covid-19 immunisation at age of 75-year-old. The patient previous received first dose of bnt162b2 for COVID-19 immunization on 20Feb2021 (lot number: EN6200) at age of 75-year-old. Medical history included diabetic. Concomitant drug included taking diabetic medications for diabetic. The patient had no any other vaccination 4 weeks prior to the COVID 19 Vaccine. The patient had a serious event that may have been connected with the Pfizer COVID-19 Vaccine - Comirnaty. Patient received her second dose of the Pfizer COVID-19 Vaccine on 15Mar2021. He stated that to their knowledge she never had COVID-19. 2 weeks prior (Aug2021), her body shut down completely. She could barely walk, talk or breathe. Reporter took her to the emergency room and they ran all kinds of tests, MRI's and everything. They admitted her to ICU and determined from bloodwork that her kidneys had shut down. They put her own dialysis for 3 days and the infectious disease doctors and other doctors had no idea what caused this. They said they wanted to see if she could come off dialysis. So they took her off and her kidneys have been okay. She improved enough to be moved to a rehab facility and she is coming home tomorrow. Patient did not have COVID. Although it's possible that she had asymptomatic COVID (further clarification unknown). Now what happened was two weeks prior, all of a sudden her body shut down over a couple hours, reporter had to take her to the emergency room. She had trouble breathing, she was nauseous. They did not know what was wrong, they put her in critical condition into the ICU. They find out through the bloodwork that the kidneys were not functioning, they had shutdown. They put her on dialysis for three days each day her numbers got better. At the end of the three days, they stopped the dialysis just to see what would happen. They didn't have the clue as to what was wrong, if she could still at that point could really barely talk. Her throat was clogged up, she could not swallow and so on but the dialysis helped her get her numbers good and then over the next couple days everything cleared up and now two weeks later she's in rehab (further clarification unknown), she's coming home tomorrow. She did have some lab tests in Apr2021. Patient was improved after the events, after the treatment, they had improved with kidney dialysis.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a solicited report from a non-contactable consumer (patient) based on the information received by Pfizer from a company (Mfr. Control No.: 21K-163-4052598-00).   A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 intramuscular on 23Feb2021 (Batch/Lot number was not reported) as dose 2, single; and dose 1 intramuscular on 02Feb2021 (at the age of 74years) as dose 1, single for Covid-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Medical history included moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. On 31Jul2021, the patient experienced Covid-19 virus test positive. The outcome of events was unknown.  The reporter's assessment of the causal relationship of the events with BNT162B2 was reported as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I personally know 9 people who died from your vaccination; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 9 patients. This is one of 9 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated, "I personally know 9 people who died from your vaccination. You reported 16,000 people have died, even the people who work for the company speaking on this." It was unknown if autopsy was done. The outcome of the event was fatal.  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 from your vaccination
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Doesn't know if it was like a bells palsy reaction; mild numbness and tingling sensation in left side of face; mild numbness and tingling sensation in left side of face; Like there was novocaine on/in it; This is a spontaneous report from a contactable other health care professional, the patient. A 25-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8727), via an unspecified route of administration in the deltoid left on 22Mar2021 11:00 as dose 1, single (at the age of 25-years-old) for covid-19 immunization. Medical history included medication allergy. There were no concomitant medications. Vaccination Facility Type Hospital. The patient previously took flu vaccine for immunization. The patient received the first dose of this vaccine in Mar. Shortly after, clarified on her drive home from receiving the dose, the left side of face just face felt numb and tingly, like there was novocaine on/in it. The patient stated that her PCP assessed and did a neurological check. Again, stated that the numbness and tingly sensation was very mild, it was not a strong and it lasted 3-4 months after her first dose. She stated it was very weird and she was a healthy individual and not on any medications, she gets the flu vaccine every year, so this was scary and concerning. The patient discussed with her PCP and went by what the CDC said in regard to being 80 percent effective after one dose, versus 90 to whatever after the second dose. Both her and her doctor came to an agreement that they did not know what the reaction was. Patient did not know if it was like a bell's palsy reaction, so she delayed getting her second dose. The patient did not receive any other vaccine within four weeks prior to vaccination. The patient went to emergency room and physician office for the events. It was reported that doctor poked the patient face with a pen. The clinical outcome of the events mild numbness and tingling sensation in left side of face was recovered on an unknown date in 2021 while outcome of the other events was unknown.; Sender's Comments: Based on the information available the causal association between the events bell's palsy and the usage of the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sneezing
Clinical narrative: sneezing; stuffiness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's mother) reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Aug2021, as the first single dose, for COVID-19 immunisation. The patient woke up on 31Aug2021 sneezing and with stuffiness. The patient got exposed to a positive Covid-19 patient in school. She was due to have the second dose of the vaccine on 31Aug2021. The reporter wanted to know if her daughter could take the second dose on 31Aug2021 or if she needed to be tested first before taking the second dose.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I got a blood clot in my left leg; This is a spontaneous report from a contactable other health professional reporting for herself. A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Aug2021 09:00 (Lot number: EW0185) at the age of 41 years old at left arm as single dose for COVID-19 immunization. Medical history included Crohns. Concomitant medications were not reported. The patient got a blood clot in my left leg on 25Aug2021 17:00. The event resulted in Doctor or other health care professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Treatment received for the event included putting on Eliquis for 6 months. The outcome of the event was not resolved.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Thrombosis 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
Symptoms: Pericarditis
Clinical narrative: Her friend has had both Covid 19 vaccines and has developed pericarditis; This is a spontaneous report from a contactable consumer (patient's friend) via the Pfizer-sponsored Program. A female patient 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 (batch/lot number was not reported) as DOSE 1, SINGLE and received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that her friend has had both COVID-19 vaccines and has developed pericarditis on an unspecified date. Her friend will have some tests next week. The outcome of the event pericarditis was unknown.   The batch/lot numbers for BNT162B2 were not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Pneumonia, Rib fracture
Clinical narrative: Rib fracture; Coughing; Pneumonia; This is a Solicited report based on the information received by Pfizer from a company (MFR Control No: 21K-163-4052550-00). A contactable consumer for herself. A 60-year-old female patient received bnt162b2 (BNT162B2) intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history included COVID-19 in Oct2020. Concomitant medications were not reported. The patient experienced pneumonia in May2021, rib fracture on an unspecified date, coughing on an unspecified date. The action taken in response to the events for adalimumab was unknown. The outcome of events was not recovered.    The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information expected.; Sender's Comments: Based on available information, it appears unlikely that vaccine BNT162B2 contributed to the reported events Pneumonia, rib fracture and cough.However, current information is limited and does not allow a full medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This is a spontaneous report received via Optum speciality pharmacy. A contactable other healthcare professional and a non-contactable 39-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included palbociclib (IBRANCE, Tablet, Strength: 125 mg) for an unspecified indication from 18Aug2021 to an unspecified stop date. The patient experienced headache and Fatigue on Aug2021. Patient reports adverse event of headache and fatigue following COVID booster shot last week. Symptoms lasted for a few days then resolved. Outcome of events was recovered on Aug2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Extra dose administered, Immunodeficiency, Off label use, Pyrexia
Clinical narrative: Immunocompromised; Low grade fever; received the booster covid-19 vaccine; received the booster covid-19 vaccine; This is a spontaneous report from a contactable consumer (patient), based on information received by Pfizer (manufacturer control number: 21K-163-4051970-00). Spontaneous report received by by a consumer with events of non-serious. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 3 intramuscular in 2021 (Batch/Lot number was not reported) as single dose for COVID-19 Vaccination; and started to receive adalimumab (HUMIRA, strength 40 mg, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg for Psoriatic Arthritis. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. Historical vaccine included bnt162b2, dose 1 intramuscular and dose 2 via an unspecified route of administration, both in 2021 for COVID-19 Vaccination. In 2021, patient received the booster covid-19 vaccine manufactured by Pfizer. On an unknown date, the patient experienced immunocompromised. In 2021, the patient experienced low grade fever. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown. The reporter's causality for the events of adalimumab was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug effect incomplete; COVID VACCINE not as effective; This is a solicited report based on the information received by Pfizer from pharmaceutical company (MFR control no.: 21K-163-4051654-00) from a contactable consumer (patient) reported for himself.  A 16-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 09Aug2021 (Batch/Lot number was not reported, at age of 16 years old) as single dose for COVID-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at facility for moderate to severe pediatric crohns disease moderate to severe polyarticular. The patient medical history was not reported. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Aug2021, the patient experienced COVID VACCINE not as effective while on HUMIRA. The action taken in response to the events for adalimumab was not applicable. The outcome of events was not recovered. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID VACCINE not as effective while on HUMIRA was not provided. Causality for bnt162b2: The reporter's causality for the event COVID VACCINE not as effective while on HUMIRA was unrelated per reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a possible contributory role of the suspect BNT162B2 to the reported events of  LOE can be completely excluded/unrelated;The case will be reassessed once new information is available.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient reports she developed left chest Herpes Zoster 11 days after second shot and wanted it reported as adverse reaction.; This is a spontaneous report from a contactable physician. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810), intramuscular, administered in Arm Left on 11Feb2021 (at the age of 74-year-old) as dose 2, single for covid-19 immunisation. Medical history included hyperlipidaemia and peripheral neuropathy. Concomitant medication(s) included Gabapentin, Atorvastatin, prasterone (INTRAROSA), vitamin b12, ubidecarenone (CoQ10), calcium, multivitamin. Patient did not receive any other vaccine in four weeks. The patient previously took statins and experienced drug intolerance. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: 3249(Obscured by other product labelling)), intramuscular, administered in Arm Left on 21Jan2021 (at the age of 74-year-old) as dose 1, single for covid-19 immunisation. The patient reported she developed left chest herpes zoster 11 days after second shot and wanted it reported as adverse reaction on 22Feb2021. Patient received treatment for adverse event as Valacyclovir. Patient did not have covid prior vaccination and covid was not tested post vaccination. The outcome of event was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Hip pain; This is a solicited report based on the information received by Pfizer (Manufacturer control number: 21K-163-4052045-00).  A contactable consumer (patient) reported that a 66-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular on 05Mar2021 (Batch/Lot number was not reported) (at the age of 66-year-old) as single dose for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at 40 mg, Citrate Free for non-infectious intermediate, posterior and panuveitis moderate to severe rheumatoid arthritis. Medical history was not reported. The patient took the adalimumab (HUMIRA) subcutaneous from Jul2020 to an unknown date and in Oct2020, the patient experienced COVID-19 and brain fog. In Dec2020, the patient experienced right hip replacement. In Oct2020, the patient experienced exhaustion and nausea. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Feb2021 (at the age of 66-year-old) for Covid-19 Immunization. The patient's concomitant medications were not reported. On an unknown date, the patient experienced hip pain. BNT162b2 was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The case was reported as serious due to medically significant. The action taken in response to the event for adalimumab was dose not changed. The outcome of the event was unknown.  The reporter's causality for the events of right hip replacement, COVID-19, brain fog and hip pain was not provided. Company's opinion is that there is no reasonable possibility that the events of right hip replacement, COVID-19, brain fog and hip pain are related to HUMIRA.   The reporter's assessment of the causal relationship of the event with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event arthralgia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new infor-mation is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Lack of drug effect; Lack of drug effect; This is a solicited report based on the information received by Pfizer  (MFR Control No. # 21K-163-4050966-00). A non-contactable female consumer (patient) reported a 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 01Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 07Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) at CITRATE FREE for Moderate to severe chronic plaque psoriasis.  The patient's medical history and concomitant medications was not reported.The patient experienced lack of drug effect on an unspecified date with outcome of unknown.  The action taken in response to the event(s) for adalimumab was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relation the events of drug ineffective and COVID-19 are related to the suspect product of BNT162B2
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Musculoskeletal stiffness
Clinical narrative: Now she has permanent vocal cord hoarseness; she has this weird stiffness in her neck; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support via a contactable consumer (patient herself). An 8-decade female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date it was reported as now she has permanent vocal cord hoarseness. She got vaccinated, with Pfizer, and now she has this weird stiffness in her neck and is having to go to the chiropractor. Outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.