chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose increased, Body temperature, Chills
Clinical narrative: my glucose levels were so incredibly high, I had NEVER had these high levels (320 mg/dL) before; woke up drained/ fatigue; product: COVID 19, brand: Pfizer, dose number: 3; 101.3oF fever; chills; body aches; shooting pains in my left arm  and wrist.; shooting pains in my left arm and wrist.; This is a spontaneous report from a contactable consumer (patient). An adult female patient (age unspecified) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 22Oct2021 09:00 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation.  Medical history included diabetes 1 from an unknown date and unknown if ongoing (Diabetes 1 as noted above).     The patient's concomitant medications were not reported. The most recent COVID-19 was administered in hospital. The patient was not pregnant at time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient had no known allergies. Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in the left arm on 20Mar2021 03:00 PM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE, and the second dose of BNT162B2 (start date and lot number: pending clarification) as DOSE 2, SINGLE for COVID-19 immunisation. On 22Oct2021, on the night of the injection, the patient  had 101.3oF fever, chills, body aches, shooting pains in her left arm and wrist. On 23Oct2021, 06:15, she woke up drained, fatigue lasted 2-3 days. The patient got the booster mostly due to her diabetes type 1. Over the last 3 days, when she woke up her glucose levels were so incredibly high (medically significant) from 23Oct2021 06:15. The patient had to take double dose of insulin just to bring it down before breakfast. She had never had these high levels (320 mg/dL) before, since her A1C was 6.4 at her last doctor's visit in Sep2021. As treatment received for the adverse event glucose levels were so incredibly high, she had to inject repeated doses of insulin.  The outcome of the event woke up drained, fatigue was recovered in Oct2021, while outcome of the rest of the events was recovering at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glycosylated haemoglobin, Immunisation, Pain, Pyrexia
Clinical narrative: my glucose levels were so incredibly high, I had NEVER had these high levels (320 mg/dL) before; woke up drained/ fatigue; product: COVID 19, brand: Pfizer, dose number: 3; 101.3oF fever; chills; body aches; shooting pains in my left arm  and wrist.; shooting pains in my left arm and wrist.; This is a spontaneous report from a contactable consumer (patient). An adult female patient (age unspecified) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 22Oct2021 09:00 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation.  Medical history included diabetes 1 from an unknown date and unknown if ongoing (Diabetes 1 as noted above).     The patient's concomitant medications were not reported. The most recent COVID-19 was administered in hospital. The patient was not pregnant at time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient had no known allergies. Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in the left arm on 20Mar2021 03:00 PM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE, and the second dose of BNT162B2 (start date and lot number: pending clarification) as DOSE 2, SINGLE for COVID-19 immunisation. On 22Oct2021, on the night of the injection, the patient  had 101.3oF fever, chills, body aches, shooting pains in her left arm and wrist. On 23Oct2021, 06:15, she woke up drained, fatigue lasted 2-3 days. The patient got the booster mostly due to her diabetes type 1. Over the last 3 days, when she woke up her glucose levels were so incredibly high (medically significant) from 23Oct2021 06:15. The patient had to take double dose of insulin just to bring it down before breakfast. She had never had these high levels (320 mg/dL) before, since her A1C was 6.4 at her last doctor's visit in Sep2021. As treatment received for the adverse event glucose levels were so incredibly high, she had to inject repeated doses of insulin.  The outcome of the event woke up drained, fatigue was recovered in Oct2021, while outcome of the rest of the events was recovering at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my glucose levels were so incredibly high, I had NEVER had these high levels (320 mg/dL) before; woke up drained/ fatigue; product: COVID 19, brand: Pfizer, dose number: 3; 101.3oF fever; chills; body aches; shooting pains in my left arm  and wrist.; shooting pains in my left arm and wrist.; This is a spontaneous report from a contactable consumer (patient). An adult female patient (age unspecified) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 22Oct2021 09:00 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation.  Medical history included diabetes 1 from an unknown date and unknown if ongoing (Diabetes 1 as noted above).     The patient's concomitant medications were not reported. The most recent COVID-19 was administered in hospital. The patient was not pregnant at time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient had no known allergies. Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in the left arm on 20Mar2021 03:00 PM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE, and the second dose of BNT162B2 (start date and lot number: pending clarification) as DOSE 2, SINGLE for COVID-19 immunisation. On 22Oct2021, on the night of the injection, the patient  had 101.3oF fever, chills, body aches, shooting pains in her left arm and wrist. On 23Oct2021, 06:15, she woke up drained, fatigue lasted 2-3 days. The patient got the booster mostly due to her diabetes type 1. Over the last 3 days, when she woke up her glucose levels were so incredibly high (medically significant) from 23Oct2021 06:15. The patient had to take double dose of insulin just to bring it down before breakfast. She had never had these high levels (320 mg/dL) before, since her A1C was 6.4 at her last doctor's visit in Sep2021. As treatment received for the adverse event glucose levels were so incredibly high, she had to inject repeated doses of insulin.  The outcome of the event woke up drained, fatigue was recovered in Oct2021, while outcome of the rest of the events was recovering at the time of the report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Fatigue, Headache
Clinical narrative: High fever over 104 for 48hrs.; Severe body ache; Chills; Fatigue; Blurry vision; Nausea; Headache; Stomach cramps; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 22Oct2021 12:30 at 37-year-old (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included Sinusitis, Known allergies: Sulfa and Antibiotics. The patient previously took first dose of BNT162B2 on 30Jan2021 at 37-year-old (Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM) for COVID-19 immunization; second dose of BNT162B2 on 20Feb2021 at 37-year-old (Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM) for COVID-19 immunization. Patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced high fever over 104 for 48hrs on 22Oct2021 21:00 with outcome of recovered in 2021, severe body ache on 22Oct2021 21:00 with outcome of recovering, chills on 22Oct2021 21:00 with outcome of recovering, fatigue on 22Oct2021 21:00 with outcome of recovering, blurry vision on 22Oct2021 21:00 with outcome of recovering, nausea on 22Oct2021 21:00 with outcome of recovering, headache on 22Oct2021 21:00 with outcome of recovering, stomach cramps on 22Oct2021 21:00 with outcome of recovering. No treatment given. Case was reported as non-serious.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vision blurred
Clinical narrative: High fever over 104 for 48hrs.; Severe body ache; Chills; Fatigue; Blurry vision; Nausea; Headache; Stomach cramps; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 22Oct2021 12:30 at 37-year-old (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included Sinusitis, Known allergies: Sulfa and Antibiotics. The patient previously took first dose of BNT162B2 on 30Jan2021 at 37-year-old (Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM) for COVID-19 immunization; second dose of BNT162B2 on 20Feb2021 at 37-year-old (Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM) for COVID-19 immunization. Patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced high fever over 104 for 48hrs on 22Oct2021 21:00 with outcome of recovered in 2021, severe body ache on 22Oct2021 21:00 with outcome of recovering, chills on 22Oct2021 21:00 with outcome of recovering, fatigue on 22Oct2021 21:00 with outcome of recovering, blurry vision on 22Oct2021 21:00 with outcome of recovering, nausea on 22Oct2021 21:00 with outcome of recovering, headache on 22Oct2021 21:00 with outcome of recovering, stomach cramps on 22Oct2021 21:00 with outcome of recovering. No treatment given. Case was reported as non-serious.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myocardial infarction, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: Major headache; Really bad headache; throat is hurting  really bad; Nausea; Sore arm; heart attack; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in arm right on 22Oct2021 (Batch/Lot Number: EW0173) at the age of 61 years old as dose 1, single for COVID-19 immunisation. Medical history included High blood pressure and Lupus from unknown dates and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took flu shot a year ago. On Oct2021, the patient experienced throat is hurting really bad, nausea and the sore arm. On 22Oct2021, the patient really had a major headache, was the worst of the side effects, it is ease up now (as reported) but, really bad headache. When asked for other medical conditions, patient stated have had a heart attack (Oct2021, as reported); patient on blood thinners, just overall falling apart, doesn't have diabetes or anything like that. Outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Ocular hyperaemia, SARS-CoV-2 test, Uveitis, Vision blurred
Clinical narrative: uveitis; a lot of itchy eyes; Had a lot of itchy eyes redness for last several months; Blurry vision; This is a spontaneous report from a Contactable HCP (patient). A 44-year-old female (not pregnant) patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 22Mar2021 at the age of 43-year-old as single dose for COVID-19 immunization. Medical history included auto immune. The patient didn't received other vaccine in four weeks. Known allergies included cupronickel, latex and shellfish. The patient performed COVID tested (Nasal Swab) post vaccination on 17Oct2021 and result was negative. The patient was not COVID prior vaccination. Concomitant medication was none. The patient previously received cupronickel and levaquin, both experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 15Oct2021, the patient had a lot of itchy eyes redness for last several months thought it was allergies but now have blurry vision and uveitis and going on 9 days. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received and not specified. The outcome of events was recovering.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event Uveitis. 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Significant edema of Lymph Nodes under left axillae; Significant edema of Lymph Nodes under left axillae, extreme tenderness.  Easily palpable.; This is a spontaneous report from a contactable other health care professional (patient).A 59-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported, expiry date: not reported) an unspecified route of administration, administered in Arm Left on 24Oct2021 13:45 ( at the age of 59-years-old) as DOSE 2, SINGLE for covid-19 immunisation in pharmacy or drug store. Medical history included none. No known allergies was reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number and expiry date: not reported) via an unspecified route of administration, administered in Arm Left in Sep2021 17:30 (at age of 59 years old) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication(s) included atenolol (ATENOLOL); famotidine (PEPCID AC); rosuvastatin calcium (CRESTOR); asa (ASA) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.On 26Oct2021 07:00 ,The patient experienced significant edema of lymph nodes under left axillae, extreme tenderness easily palpable. The reporter assesses the case as non serious. No treatment was received. No prolonged hospitalization was reported.The patient underwent lab tests and procedures which included BioMed: negative on 26Oct2021 Nasal Swab. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypertension, Illness, Lung disorder, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; sick; lung issues; high blood pressure; blood clots; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-years-old female patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: FC3180; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in Arm Left on 10Aug2021 11:00 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. Medical history included covid-19 pneumonia (About 2 months before her Covid shot she was diagnosed with Covid Pneumonia but did not test positive for Covid) and diabetes mellitus from an unknown date and unknown if ongoing (Family Medical History Relevant to AE(s): Diabetes). There were no concomitant medications. The patient prior vaccination was reported as none. It was reported that the patient had the vaccine on 10Aug2021. She was very sick from the shot itself. She ended up testing positive for Covid on 21Aug2021. On unspecified date in 2021 experienced patient still was going to the doctor for lung issues and was sent to a cardiologist for blood clots and for high blood pressure. When she saw the Cardiologist, they x-rayed her lungs, and they were not in good shape. She had an appointment on 06Dec2021 with the cardiologist and they are hoping she won't be sick by then. Patient was still sick. She wanted to know about the side effects. The cardiologist said that blood clots are known to happen. She said that she had something in her blood that makes her susceptible to getting blood clots. She had been out of work since she got the shot. She only had one shot and was advised not to get the second one. Patient wanted to know is there any type of financial assistance for people who got sick after taking the vaccine. The patient required emergency room visit and physician office visit as a result of all events. The patient underwent lab tests and procedures which included sars-cov-2 test with positive on 21Aug2021 and x-rayed her lungs with not in good shape on an unspecified date. Outcome of the events sick was not resolved and all other events was unknown.  Conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FC3180 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot FC3180, fill lot EY546, and bulk formulation lot EP8650. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, X-ray
Clinical narrative: positive COVID-19 test with symptoms; sick; lung issues; high blood pressure; blood clots; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-years-old female patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: FC3180; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in Arm Left on 10Aug2021 11:00 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. Medical history included covid-19 pneumonia (About 2 months before her Covid shot she was diagnosed with Covid Pneumonia but did not test positive for Covid) and diabetes mellitus from an unknown date and unknown if ongoing (Family Medical History Relevant to AE(s): Diabetes). There were no concomitant medications. The patient prior vaccination was reported as none. It was reported that the patient had the vaccine on 10Aug2021. She was very sick from the shot itself. She ended up testing positive for Covid on 21Aug2021. On unspecified date in 2021 experienced patient still was going to the doctor for lung issues and was sent to a cardiologist for blood clots and for high blood pressure. When she saw the Cardiologist, they x-rayed her lungs, and they were not in good shape. She had an appointment on 06Dec2021 with the cardiologist and they are hoping she won't be sick by then. Patient was still sick. She wanted to know about the side effects. The cardiologist said that blood clots are known to happen. She said that she had something in her blood that makes her susceptible to getting blood clots. She had been out of work since she got the shot. She only had one shot and was advised not to get the second one. Patient wanted to know is there any type of financial assistance for people who got sick after taking the vaccine. The patient required emergency room visit and physician office visit as a result of all events. The patient underwent lab tests and procedures which included sars-cov-2 test with positive on 21Aug2021 and x-rayed her lungs with not in good shape on an unspecified date. Outcome of the events sick was not resolved and all other events was unknown.  Conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FC3180 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot FC3180, fill lot EY546, and bulk formulation lot EP8650. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchiectasis, Dermatologic examination abnormal, Gastrointestinal disorder, Investigation, Nausea
Clinical narrative: lung disease/ lung disease is Bronchiectasis; a couple days of nausea; arm hardly a sore; GI issues; dermatological issue; This is a spontaneous report from a contactable consumer (patient) or other non hcp. This 78-year-old female patient reported for herself.  A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EN6203, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 24Feb2021 (77-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EM9809, Expiry date: not reported) via an unspecified route of administration, administered in left arm (upper) on 03Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date patient took flu vaccine (she only remembers getting flu vaccines in the last few years). On an unspecified date, the patient experienced lung disease/ lung disease is bronchiectasis, a couple days of nausea, arm hardly a sore, gi issues, dermatological. Patient reported that after the second shot she might have had a couple days of nausea and her arm hardly a sore but that was it. She has GI issues, lung disease, and dermatological issue so what she experienced could be related to that; at first, she thought it was that. Patient clarifies that her lung disease is Bronchiectasis. Patient remarks that everything that happened could have been related to her previous issues but was not her normal pattern. She experiences things similar, but each thing was not her normal, they were a little more than her normal On an unspecified date, the patient underwent lab tests and procedures which included test for covid-19: negative, test for flu: negative and test for rsv: negative. The outcome of the events was unknown.  Follow-Up (29Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: lung disease/ lung disease is Bronchiectasis; a couple days of nausea; arm hardly a sore; GI issues; dermatological issue; This is a spontaneous report from a contactable consumer (patient) or other non hcp. This 78-year-old female patient reported for herself.  A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EN6203, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 24Feb2021 (77-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EM9809, Expiry date: not reported) via an unspecified route of administration, administered in left arm (upper) on 03Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date patient took flu vaccine (she only remembers getting flu vaccines in the last few years). On an unspecified date, the patient experienced lung disease/ lung disease is bronchiectasis, a couple days of nausea, arm hardly a sore, gi issues, dermatological. Patient reported that after the second shot she might have had a couple days of nausea and her arm hardly a sore but that was it. She has GI issues, lung disease, and dermatological issue so what she experienced could be related to that; at first, she thought it was that. Patient clarifies that her lung disease is Bronchiectasis. Patient remarks that everything that happened could have been related to her previous issues but was not her normal pattern. She experiences things similar, but each thing was not her normal, they were a little more than her normal On an unspecified date, the patient underwent lab tests and procedures which included test for covid-19: negative, test for flu: negative and test for rsv: negative. The outcome of the events was unknown.  Follow-Up (29Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had anaphylaxis from the Covid 19 vaccine.  It was reported that I'm trying to figure out what caused it, so people in my family with similar allergies know whether or not it is safe for them. I have never had anaphylaxis from any other vaccine in my life. I believe very much in vaccines. Now I know that usually my worst anaphylaxis is from artificial sweeteners, such as sucralose, aspartame, and saccharine. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Lump; This is a spontaneous report from a contactable consumer, Pfizer colleague. An adult female patient of unknown age received the first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, someone told the reporter that they had had a lump, they went to check out but that it went away. The reporter did not think this was related to the vaccine, but they had received one of the vaccines and no further details. The clinical outcome of the event lump was resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: In concurrence with the reporter, the reported lump is unlikely related to the administration of COVID19 vaccine, BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Myalgia, Suspected COVID-19
Clinical narrative: he contracted Covid-19; he contracted Covid-19; strong muscle pain; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 25Jan2021 (age at vaccination: 82-year-old) as dose 1, single for COVID-19 immunization and experienced strong muscle pain. Patient was complaining of strong muscle pain after the 1st dose on 25Jan2021, of the Pfizer COVID vaccine, which then subsided for about a week, and then returned after receiving the 2nd dose on 17Feb2021. On unspecified date in 2021 which continued until he contracted COVID-19, at which point it stopped, and then resumed after COVID-19 infection passed, nobody can find out what is wrong with him. Patient was looking for treatment information. Verified above information, and added he have been seen, by his PCP, then an internist, then he went to a COVID-19 clinic, and then he went to a rheumatoid arthritis specialist, now they want him to go to a neurologist. Side effect that have been reported with COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer BioNTech COVID-19 Vaccine include Muscle pain. The patient visited physician office visit. The outcome for the event he contracted COVID-19 (Drug ineffective) was unknown and he contracted COVID-19 (COVID-19) was recovered on unspecified date in 2021 and event strong muscle pain was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hypoaesthesia, Movement disorder, Muscular weakness, SARS-CoV-2 test
Clinical narrative: woke up the next day with bilateral leg weakness; woke up the next day with bilateral leg weakness, numbness; inability to get up out of bed; inability to get up out of bed; This is a spontaneous report from a contactable physician. A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot Number: FF2587), via intramuscular, administered in Arm Left on 21Oct2021 (at the age of 52 years old) as dose 1, single for COVID-19 immunization. Medical history included complex regional pain syndrome right hand type 1, Hyperlipidaemia. Concomitant medication(s) included gabapentin (GABAPENTIN), nortriptyline (NORTRIPTYLINE), diclofenac sodium (VOLTARENE). The patient previously took codeine and epinephrine experienced drug hypersensitivity. The patient did not receive any other vaccination in last 4 weeks. The patient did not have COVID prior to vaccination. The patient is not pregnant at the time of vaccination. On 22Oct2021 the patient woke up the next day with bilateral leg weakness, numbness, and inability to get up out of bed. The patient was hospitalized for 7 days with the events woke up the next day with bilateral leg weakness, numbness, and inability to get up out of bed. The treatment received IV Solumedrol 1000 mg for 5 days. The patient underwent lab tests which included sars-cov-2 test negative on 26Oct2021 Nasal Swab. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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: U
Vaccine: COVID19
Symptoms: Death, Immunisation
Clinical narrative: died in 30 to 35 minutes after; booster; This is a spontaneous report from two contactable pharmacists. Three serious adverse events occurred after administration of Pfizer booster doses just in the past 5 days from one pharmacy location and all have been from the same Lot# FD0810 of Pfizer product. This is one of three cases. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, COVID 19 Vaccine, mRNA, purple cap), dose 3 via an unspecified route of administration on an unspecified date (Lot Number: FD0810; Expiration Date: 30Nov2021) as dose 3 (booster), single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historic vaccine was 1st and 2nd dose of bnt162b2 (lot unknown) received for COVID-19 immunization. The patient died in 30 to 35 minutes after on an unspecified date. It was not reported if an autopsy was performed. The outcome of event was fatal.; Sender's Comments: The information provided is limited and does not allow a meaningful medical assessment of the case. However, based on the available information in the case, a possible contributory role of the suspect product BNT162B2 to the development of reported fatal events of Unknown cause of death and Booster cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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.,Linked Report(s) : US-PFIZER INC-202101489288 same reporter/drug/AE, different patient.;US-PFIZER INC-202101489289 same reporter/drug/AE, different patient.; Reported Cause(s) of Death: died in 30 to 35 minutes after; booster
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Pyrexia, Rhinorrhoea
Clinical narrative: fever persists; dry cough; runny nose; diagnosed COVID-19 positive on Oct 30; diagnosed COVID-19 positive on Oct 30; This is a spontaneous report from a contactable consumer or other non-health care professional. An 87-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiration Date: was not reported), via an unspecified route of administration, administered in left arm, on 24Mar2021 at 15:00 (age at vaccination: 86-year-old), as dose 2, single for COVID-19 immunization in Pharmacy or Drug Store and the patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiration Date: was not reported), via an unspecified route of administration, administered in left arm, on 03Mar2021 at 15:00 (age at vaccination: 86-year-old), as dose 1, single for COVID-19 immunization. Medical history included blood cholesterol abnormal and hypertension from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines in four weeks. Prior to vaccination, the patient was not infected to COVID-19. The patient had no allergies. The patient was exposed on 25Oct2021 (with mask) and on 26Oct2021 (without mask) to a same person who was tested positive for COVID-19 but no symptoms and informed patient on 31Oct2021. On 28Oct2021, the patient experienced dry cough, runny nose. On 29Oct2021, the patient experienced fever of 101 degrees Fahrenheit. On 30Oct2021, the fever persists, the patient went to urgent care and tested positive. The adverse event resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 29Oct2021, SARS-CoV-2 test (Nasal Swab): positive on 30Oct2021. As a therapeutic measure, the patient received treatment with REGEN monoclonal antibody IV infusion, azithromycin, Vitamin D3, Zinc, Calcium, melatonin, green tea. The outcome of the events was resolving.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: fever persists; dry cough; runny nose; diagnosed COVID-19 positive on Oct 30; diagnosed COVID-19 positive on Oct 30; This is a spontaneous report from a contactable consumer or other non-health care professional. An 87-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiration Date: was not reported), via an unspecified route of administration, administered in left arm, on 24Mar2021 at 15:00 (age at vaccination: 86-year-old), as dose 2, single for COVID-19 immunization in Pharmacy or Drug Store and the patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiration Date: was not reported), via an unspecified route of administration, administered in left arm, on 03Mar2021 at 15:00 (age at vaccination: 86-year-old), as dose 1, single for COVID-19 immunization. Medical history included blood cholesterol abnormal and hypertension from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines in four weeks. Prior to vaccination, the patient was not infected to COVID-19. The patient had no allergies. The patient was exposed on 25Oct2021 (with mask) and on 26Oct2021 (without mask) to a same person who was tested positive for COVID-19 but no symptoms and informed patient on 31Oct2021. On 28Oct2021, the patient experienced dry cough, runny nose. On 29Oct2021, the patient experienced fever of 101 degrees Fahrenheit. On 30Oct2021, the fever persists, the patient went to urgent care and tested positive. The adverse event resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 29Oct2021, SARS-CoV-2 test (Nasal Swab): positive on 30Oct2021. As a therapeutic measure, the patient received treatment with REGEN monoclonal antibody IV infusion, azithromycin, Vitamin D3, Zinc, Calcium, melatonin, green tea. The outcome of the events was resolving.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash on abdomen and both legs and feet; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 12Oct2021 at 13:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had known allergies to shellfish. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 20Sep2021 at 11:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 13Oct2021, the patient had skin rash on abdomen and both legs and feet. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event skin rash on abdomen and both legs and feet was not resolved at the time of this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Breast tenderness, Inappropriate schedule of product administration, Mammogram
Clinical narrative: Dose 1: 23Aug2021, Dose 2: 22Oct2021; Breast swelling on OTHER side - not side with vaccine. Pain and swelling continued.; 36 hours after vaccine number 1 - breast swelling on OTHER side; Breast pain and tenderness.; Breast swelling on OTHER side/Hesitant to receive #2 - but did and exact same thing happened.; Still with breast pain and tenderness.; Still with breast pain and tenderness.; This is a spontaneous report from a contactable physician, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1086) via an unspecified route of administration in the left arm on 23Aug2021 at 10:00 (at the age of 54-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: F22593) via an unspecified route of administration in the left arm on 22Oct2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation.. Medical history included known allergy to penicillin (PCN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Aug2021 at 22:00, 36 hours after vaccine dose 1, the patient experienced breast swelling on other side - not side with vaccine. The pain and swelling had continued. The patient went for mammogram and everything was fine. The symptoms took about 3-4 weeks to resolve. The patient was hesitant to receive dose 2, but did and exact same thing happened. The patient still had breast pain and tenderness. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On an unknown date in 2021, the patient underwent lab test and procedure which included mammogram and the result was everything was fine (as reported). Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events breast swelling on other side - not side with vaccine with onset of 24Aug2021 at 22:00 was resolved on an unknown date in Sep2021; while that with onset of 2021 was unknown, pain and swelling continued with onset of 25Aug2021 was resolved on an unknown date in Sep2021; while that with onset of 2021 was not resolved, breast pain and tenderness with onset of 2021 (occurred after dose 1) was resolved on an unknown date in 2021; while that with onset of 2021(occurred after dose 2) was not resolved at the time of this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Spinal pain
Clinical narrative: Aches in spine and muscles; Aches in spine and muscles; Administration date: 29Oct2021, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 29Oct2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia (SVT). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications taken for an unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8733) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 57-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 29Oct2021, the patient had "administration date 29Oct2021, dose number=3". On 30Oct2021, the patient had aches in spine and muscles. The events aches in spine and muscles did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events aches in spine and muscles. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches in spine and muscles was resolved on an unknown date in 2021. The clinical outcome of the event "administration date 29Oct2021, dose number=3" was unknown at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: in the hospital and she has almost died three times since having the vaccine/ITP; This is a spontaneous report from a contactable consumer reported for her granddaughter from a Pfizer sponsored program. A 24-years-old female patient received bnt162b2 (PHIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at SINGLE dose for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  On the next day of vaccination, the patient came down with this condition they called immune thrombocytopenia (ITP), and the patient has been in the hospital and she has almost died three times since having the vaccine. The outcome of the event was unknown.   The lot number for BNT162b2, was not provided and will be requested during follow up.