chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Lack of efficacy.  Fully vaccinated for COVID19 with symptoms and confirmed positive PCR test result on 9/27/21.; Lack of efficacy.  Fully vaccinated for COVID19 with symptoms and confirmed positive PCR test result on 9/27/21.; This is a spontaneous report from a contactable Pfizer colleague (Nurse) reported for a patient. A 46-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247), dose 2 via an intramuscular route of administration, administered in Arm Left on 04Mar2021 (at the age of 46-year-old) as DOSE 2, SINGLE and dose 1 via an intramuscular route of administration, administered in Arm Left on 11Feb2021 (Lot Number: EL3247), (at the age of 46-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. It was unknown prior to vaccination, the patient diagnosed with COVID-19. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Sep2021, the patient experienced COVID19. The reported stated that Lack of efficacy, fully vaccinated for COVID19 with symptoms and confirmed positive PCR test result on 27Sep2021. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures, which included PCR test: Positive on 27Sep2021, Nasal Swab. It was unknown if the patient received treatment for the events. The patient outcome of the event was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and the suspect drug BNT162B2.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Insomnia, Off label use
Clinical narrative: Headache; She received her booster dose; She received her booster dose; She tossed and turned all night last night; This is a spontaneous report from a contactable consumer(patient). An 80-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 80 years), dose 3 via an unspecified route of administration on 28Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) as dose 2, single and first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) as dose 1, single via an unspecified route of administration on an unspecified date for covid-19 immunisation. She had no issues with the first two doses. The patient reported she tossed and turned all night last night and received her booster dose on 28Sep2021 and experienced headache on 29Sep2021. Therapeutic measures were taken as a result of headache. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Immunisation, Insomnia, Pain
Clinical narrative: Her Pfizer booster shot was yesterday; Her Pfizer booster shot was yesterday; felt very tired; wasn't able to sleep good; body aches; woke up with sore arm; diarrhea; vomiting; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself. A 75-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 3 via an unspecified route of administration on 28Sep2021 10:30 (at the age of 75-year-old) (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first and second dose of BNT162B2 on an unspecified date for covid-19 immunisation and experienced sore arm in both doses. Patient previously took flu shot and she just got really sick, diarrhoea and vomiting but not same time, after some time got butter just colds sweat. She also added that it also happened years ago with her mom. The patient had her Pfizer booster shot 3 on 28Sep2021 at 10:30, which was an extra dose and was exposed to an off-label scenario, and experienced body aches, diarrhoea, vomiting, felt very tired, wasn't able to sleep good and woke up with sore arm. Also stated she was unsure if maybe the side effects were really because of the booster shot or maybe there is something in your system beforehand, she would just talk to her doctor. The outcome felt very tired, wasn't able to sleep good, body aches, woke up with sore arm, diarrhea and vomiting was not recovered. The outcome of all the other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Her Pfizer booster shot was yesterday; Her Pfizer booster shot was yesterday; felt very tired; wasn't able to sleep good; body aches; woke up with sore arm; diarrhea; vomiting; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself. A 75-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 3 via an unspecified route of administration on 28Sep2021 10:30 (at the age of 75-year-old) (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first and second dose of BNT162B2 on an unspecified date for covid-19 immunisation and experienced sore arm in both doses. Patient previously took flu shot and she just got really sick, diarrhoea and vomiting but not same time, after some time got butter just colds sweat. She also added that it also happened years ago with her mom. The patient had her Pfizer booster shot 3 on 28Sep2021 at 10:30, which was an extra dose and was exposed to an off-label scenario, and experienced body aches, diarrhoea, vomiting, felt very tired, wasn't able to sleep good and woke up with sore arm. Also stated she was unsure if maybe the side effects were really because of the booster shot or maybe there is something in your system beforehand, she would just talk to her doctor. The outcome felt very tired, wasn't able to sleep good, body aches, woke up with sore arm, diarrhea and vomiting was not recovered. The outcome of all the other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got their first dose of the Pfizer covid vaccine on 09sep2021 and tested positive on 12sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Sep2021. The outcome of the event covid-19 was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: he was down for the afternoon; This is a spontaneous report from a contactable consumer or other no-health care professional.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot: not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for covid-19 immunization. The patients medical history and concomitant medications was not reported. Patient reported that on unspecified date after the second Pfizer Covid 19 vaccine he was down for the afternoon but then he picked up. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Body height, Cardiac disorder, Cardiac failure, Cerebral disorder
Clinical narrative: heart fails; He had the lub dub in his heart and he had that after his 2nd shot; He can't remember what they call it because of his memory; his brain isn't working; in a lot of pain; This is a spontaneous report from a contactable HCP (patient himself). A 78-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose 2, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Caller said that he was laying in the hospital bed at the name withheld and after his 2nd shot he had something and he can't remember the name but it was when the heart fails or something. He couldnt remember what they call it because of his memory. He was in the hospital under their care and he also has had his third shot. He had the lub dub in his heart and he had that after his 2nd shot and he heard on the news as soon as he got home that this was a possible side effect of the shots. He couldnt think of the name of it right now but he got it and it had been with him but it started after the second shot. He didn't have a bad feeling but the nursing staff there said that it was two terms and he just can't think of it now. He was surprised because he had never had anything with his heart before. Caller stated that he was admitted inpatient at the hospital due to this. When probed for admission and discharge dates he said that was unknown to him, he was in bed and he couldnt give that information. He was in the hospital now. Clarified and confirmed that caller was currently still hospitalized. He said that he didn't know about it but he was in bed late at night and the nurse said the terms for it, it was with the chambers of the heart and it was very common but he can't think of it right now. He was in a lot of pain and laying here with all these problems. Attempted to clarify if caller was hospitalized prior to this side effect and he said that he was just laying there and they asked if he knew that he had that and he said that he had never had that happen before and it was right after his second shot. He heard on TV that some were having that with some shots. He can't remember the name of the thing with his heart. It was two of them, kind of like a lub dub but something in that area. It was common and he had heard of it many times in his life and his brain isn't working because it was full of drugs and he was just laying there. The patient underwent lab test which included body height, result: 5'11" (shrunk from 5'11", almost 6 feet tall, to now almost 5'9") and weight, result: 170 lbs on an unspecified date. The outcome of the events was unknown.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Weight
Clinical narrative: heart fails; He had the lub dub in his heart and he had that after his 2nd shot; He can't remember what they call it because of his memory; his brain isn't working; in a lot of pain; This is a spontaneous report from a contactable HCP (patient himself). A 78-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose 2, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Caller said that he was laying in the hospital bed at the name withheld and after his 2nd shot he had something and he can't remember the name but it was when the heart fails or something. He couldnt remember what they call it because of his memory. He was in the hospital under their care and he also has had his third shot. He had the lub dub in his heart and he had that after his 2nd shot and he heard on the news as soon as he got home that this was a possible side effect of the shots. He couldnt think of the name of it right now but he got it and it had been with him but it started after the second shot. He didn't have a bad feeling but the nursing staff there said that it was two terms and he just can't think of it now. He was surprised because he had never had anything with his heart before. Caller stated that he was admitted inpatient at the hospital due to this. When probed for admission and discharge dates he said that was unknown to him, he was in bed and he couldnt give that information. He was in the hospital now. Clarified and confirmed that caller was currently still hospitalized. He said that he didn't know about it but he was in bed late at night and the nurse said the terms for it, it was with the chambers of the heart and it was very common but he can't think of it right now. He was in a lot of pain and laying here with all these problems. Attempted to clarify if caller was hospitalized prior to this side effect and he said that he was just laying there and they asked if he knew that he had that and he said that he had never had that happen before and it was right after his second shot. He heard on TV that some were having that with some shots. He can't remember the name of the thing with his heart. It was two of them, kind of like a lub dub but something in that area. It was common and he had heard of it many times in his life and his brain isn't working because it was full of drugs and he was just laying there. The patient underwent lab test which included body height, result: 5'11" (shrunk from 5'11", almost 6 feet tall, to now almost 5'9") and weight, result: 170 lbs on an unspecified date. The outcome of the events was unknown.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Injection site joint movement impairment, Off label use
Clinical narrative: after getting her third dose; after getting her third dose; after getting her third dose she could not raise her injected arm as high as dining table; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose (BOOSTER) of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FD8448), via an unspecified route of administration, administrated in left arm on 03Sep2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/ Lot Number: EM9809), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization and experienced Sore arm and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 24Feb2021, as a single dose for COVID-19 immunization and experienced Sore arm. The patient took third dose was on 03Sep2021, rash that was about 3 inches across and in a circle at the injection site, pain at the injection site in her left arm, extreme fatigue, in her left arm where she received the injection, when she bends her arm a certain way, like a 90-degree angle at the elbow, her arm locks there, left arm is immobile for a time. Added that she knows a woman that after getting her third dose she could not raise her injected arm as high as dining table on Sep2021. Asking maybe if she should have tested her antibody first before getting her third dose. As maybe if her antibody result was high, the side effect that she would. The outcome for all the events was Unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she had the Delta variant; she had the Delta variant; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 26Feb2021 at around 7:30 in the morning or 8:00 in the morning (at the age of 68-year-old) as DOSE 2, SINGLE and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 68-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included cholesterol from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient's historical vaccine included flu shot in Sep2020. Prior to vaccinations (within 4 weeks), the patient had received no other vaccines. The patient had a breakthrough case in Sep2021. On 08Sep2021, the patient started to have COVID symptoms which further clarified as stuffy nose/stuffiness in nose, stuffy ears, slight fever, drainage, and sore throat. The patient also had tiredness, loose stools, and headache, stuffiness, stuffiness in nose and ears really bad. At first, the patient thought it was just sinus issue, went to the doctor and was tested for COVID. The test came back positive on 10Sep2021. The doctor informed the patient that they have been seeing breakthrough cases. The patient was assuming she had the delta variant. The patient was unsure what was happening, at first thinking it's a sinus infection. The adverse events resulted in physician office visit. The doctor was concerned that the patient was at the end of her shot period. The patient does not know how long the shot period was. The patient wanted to know if the booster shot will against the delta variant. The patient underwent lab tests and procedures which included body temperature: slight fever on 08Sep2021, covid/COVID swab: positive on 10Sep2021. The clinical outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Internal haemorrhage, Nephrolithiasis, Thrombosis
Clinical narrative: kidney stone/kidney stone infection; severe internal bleeding; blood clotting; bleeding; This is a spontaneous report from a contactable consumer (Consumer Husband) and also from a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 18Feb2021 as dose 2,single for COVID-19 immunization. Medical history included diabetes mellitus. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on as dose 1 ,single for COVID-19 immunization. Reporter stated her husband received his second dose of the Pfizer BioNTech Covid-19 Vaccine on 18Feb2021 and is now looking to get a booster dose of the vaccine. Reporter stated, however, that her husband had outpatient surgery for a kidney stone and ended up with severe internal bleeding (lost blood) and blood clotting. And also her husband resulted in two pints of blood on 10Aug2021. Caller asked, given the blood clots and blood transfusion, he was scheduled for the booster shot in 15 minutes and questioned if her husband can safely get a booster dose of the Pfizer BioNTech Covid-19 Vaccine and she works in the hospital and got Moderna so she is looking for information. Therapeutic measures were taken as a result of kidney stone/kidney stone infection, blood clotting, bleeding. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Pain
Clinical narrative: pain; bleeding; This is a spontaneous report received from a contactable consumer or other non hcp (patient herself) via medical information team. A 21-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 05Jul2021 as dose 2, single (at the age of 21-years-old) for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date for COVID-19 immunization. Medical history included endometriosis Treatment: BCP unspecified start date and ongoing. The patient's concomitant medications were not reported. On unspecified date of 2021 the patient experienced pain, bleeding. Patient wants to know anyone else reported these side effects and information is available regarding menstrual changes. The patient underwent lab tests and procedures which included pain: 10/10 on unspecified date. The outcome of events was unknown.    The lot number for the vaccine, [Pfizer COVID-19 Vaccine], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I tested positive for COVID; I tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3248) intramuscular, administered in Arm Right on 03Mar2021 12:45 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior to the vaccination. On 24Sep2021 18:30, the patient tested positive for COVID. The patient underwent lab tests and procedures which included SARS-CoV-2 test nasal swab on 24Sep2021 which was positive. No treatment was received for the adverse events. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Fatigue, Tendon disorder, Tendonitis
Clinical narrative: Spondylitis ankylosing aggravated; Tendonitis; Tendon thickening; Fatigue; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from Facilitating Company (manufacturer control number: 21K-163-4080256-00). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration on 01Apr2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization; and adalimumab (HUMIRA; solution for injection in pre-filled pen), subcutaneously from an unspecified date (lot number was not reported) and ongoing at unspecified dose and frequency for ankylosing spondylitis. Medical history included spinal nerve stimulator implantation from Feb2021 and ongoing ankylosing spondylitis. The patient's concomitant medications were not reported. On 02Apr2021 (1 day after vaccination), the patient experienced fatigue. On an unspecified date, the patient experienced spondylitis ankylosing aggravated, tendonitis, and tendon thickening. The action taken in response to the events for adalimumab was dose not changed. The outcome of event fatigue was unknown while the outcome of the remaining events was not recovered.  The reporter's causality for adalimumab with the events spondylitis ankylosing aggravated, tendonitis, and tendon thickening was reasonable possibility, while for fatigue it was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product, BNT162B2, was not provided at the time of the report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. 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
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Immunisation, Nausea
Clinical narrative: My wife just had the third booster shot; My wife just had the third booster shot; She has temperature of 103 may be a temperature of 105 under her armpit; Chills; Nausea; her growing hurt back pain; Leg pain; Injection site where they injected her it feels hot, she said the fire; This is a spontaneous report from a contactable consumer (patients husband). A 53-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration on 30Sep2021 11:00 (at the age of 53years) as dose 3 (BOOSTER), single for COVID-19 immunization. Medical history included Diabetes, High Blood pressure, she has high blood pressure and Diabetic and Cholesterol. Concomitant medications included Lisinopril taken for Blood pressure, Metformin taken for Diabetes, Atorvastatin taken for blood cholesterol. Previously patient received first dose and second dose bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection,), dose 1, dose 2 unspecified route of administration on unspecified date as single dose for COVID-19 immunization. On unspecified date 2021 the patient experienced she has temperature of 103 may be a temperature of 105 under her armpit, chills, nausea, her growing hurt back pain, leg pain, injection site where they injected her it feels hot, she said the fire. On 30Sep2021 my wife just had the third booster shot. Reporter stated, my wife just had the third booster shot and she is experiencing chills, nausea, she has temperature of 103 may be a temperature of 105 under her armpit, her growing hurt back pain, leg pain injection site where they injected her it feels hot, she said the fire. Patient received treatment of Tylenol Dosage: 6 tablet 500 mg once a day. The patient underwent lab tests and procedures which included body temperature: 103 body temperature: 105 in 2021. The outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site warmth
Clinical narrative: My wife just had the third booster shot; My wife just had the third booster shot; She has temperature of 103 may be a temperature of 105 under her armpit; Chills; Nausea; her growing hurt back pain; Leg pain; Injection site where they injected her it feels hot, she said the fire; This is a spontaneous report from a contactable consumer (patients husband). A 53-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration on 30Sep2021 11:00 (at the age of 53years) as dose 3 (BOOSTER), single for COVID-19 immunization. Medical history included Diabetes, High Blood pressure, she has high blood pressure and Diabetic and Cholesterol. Concomitant medications included Lisinopril taken for Blood pressure, Metformin taken for Diabetes, Atorvastatin taken for blood cholesterol. Previously patient received first dose and second dose bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection,), dose 1, dose 2 unspecified route of administration on unspecified date as single dose for COVID-19 immunization. On unspecified date 2021 the patient experienced she has temperature of 103 may be a temperature of 105 under her armpit, chills, nausea, her growing hurt back pain, leg pain, injection site where they injected her it feels hot, she said the fire. On 30Sep2021 my wife just had the third booster shot. Reporter stated, my wife just had the third booster shot and she is experiencing chills, nausea, she has temperature of 103 may be a temperature of 105 under her armpit, her growing hurt back pain, leg pain injection site where they injected her it feels hot, she said the fire. Patient received treatment of Tylenol Dosage: 6 tablet 500 mg once a day. The patient underwent lab tests and procedures which included body temperature: 103 body temperature: 105 in 2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Gait disturbance, Headache, Mental impairment, Pain
Clinical narrative: heavy chest pain; headache; inhabilities to barely walk; Very sore; Not able to function mentally; This is a spontaneous report received from a contactable consumer (patient). This is the second of two reports with events experienced under the second dose. A 60-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Left on 07Sep2021 16:00 (Lot Number: EW0191) as single dose for covid-19 immunisation. Medical history included blood clot in pelvis from 26Jan2015 and ongoing needing 5 stent surgery (Pertinent details: Taking warfarin blood thinners), covid-19 from Jan2021 to an unknown date (also had needed antibodies, 1 hour long infusion of Bamlavinivimad). Vaccination Facility Site: Pharmacy or Drug Store. Prior vaccinations were reported as no. Concomitant medications included warfarine (WARFARINE) taken for blood clots in pelvis, and blood thinners. First dose of bnt162b2 (BNT162B2) was administered on 18Aug2021 at 10:00 AM intramuscular in Upper left arm, Lot: EW0181, for COVID-19 immunisation and patient from 19Aug2021 to 20Aug2021 experienced walking difficulty, very sore, headache, not able to function mentally, muscle pain, pain in hip, severe leg pain and lower back pain. On 08Sep2021 patient experienced heavy chest pain, inhabilities to barely walk, very sore, headache, not able to function mentally. Events considered serious due to Persistent/significant disability/Incapacity. No treatment received for the events. Patient stated that both shots of vaccine resulted in total body inabilities to barely walk, very sore, headache, not able to function mentally, second shot has same but also included severe chest pain. Patient almost went to hospital, she had covid in Jan2021 and also has needed to antibodies 1 (hr) hour long infusion of Bamlavinivimad(?). On 09Sep2021 patient recovered from the events.  No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075436 Same reporter, patient and product / different events and dose
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid pneumonia; covid pneumonia; covid pneumonia; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration, on 05Aug2021 (age at vaccination of 54 years; Batch/Lot Number: FC3180) as single dose for COVID-19 immunization. Medical history included was diabetic and had obesity. The patient's concomitant medications were not reported. It was unknown if patient had received any other vaccine in four weeks. Patient had no COVID prior to vaccination. She developed COVID pneumonia on unspecified date in 2021. COVID was tested post vaccination on unspecified date with unspecified results. COVID pneumonia resulted in hospitalization and patient died. Patient was hospitalized for 5 days and passed away 04Sep2021. No autopsy was performed and cause of death was provided as COVID pneumonia.; Reported Cause(s) of Death: covid pneumonia; covid pneumonia; covid pneumonia
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder, Thrombosis
Clinical narrative: neurological issues and one a blood clot; neurological issues and one a blood clot; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated I know two patients of mine that reported neurological issues and one a blood clot on an unspecified date. Outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Vaccination site movement impairment
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 90-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration, Anatomical Site of injection: Left shoulder on 16Jan2021 09:00 (at the age of 90-year-old) at dose 1, single, and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, anatomical site of injection: right shoulder, on 06Feb2021 09:00 (at the age of 90-year-old) at dose 2, single, both the doses for covid-19 immunisation. Medical history was reported as none (Patient History: No). Concomitant medications were not reported. Patient did not have prior vaccinations within 4 weeks. On an unspecified date in on 2021 the patient experienced Pain in my elbow where I cannot really straighten my left arm where I got the shot. This case is made valid from invalid (Product confirm as BNT162B2, case is valid now). Additional Context: Consumer stated, I had my vaccination three days ago and I have pain in my elbow where I cannot really straighten my left arm where I got the shot and I wonder what you suggest doing about it. Will you be able to tell me what I should do to take care of it. Consumer stated, It says 06Feb.That is when my next one is scheduled. Weight: Consumer stated, I am 188. Route of administration: Consumer stated, Left arm. Other medication: Consumer stated, No, just normal things. Treatment: Consumer stated, Yes, I have taken Tylenol for pain and also a pain thing, a pain stuff that I have been rubbing in it. It is Anacort or something you need to know. Or I can go find out. Only side effect was pain and stiffness in left elbow after first vaccination. Outcome of the events was unknown.  Information on the batch number has been requested.  Follow-up(22Mar2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included the following: This case is made valid from invalid (Product confirm as BNT162B2, case is valid now). Vaccine name, vaccine 1st, 2nd doses information, vaccination dates of both doses of vaccine were added.  No follow-up attempts are needed. No further information is expected.  Follow-up (10May2021): Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ankylosing spondylitis, Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody, Antinuclear antibody negative, Arthralgia
Clinical narrative: At about midnight after the first dose of the covid vaccine that I received on 2/11/2021 at 8:00am, I experienced a migraine and pain in my spine, shoulders, hips and knees that kept me up trembling in excruciating pain. I was sore and fatigued 2 days after. At about 2:00pm after the second dose of the covid vaccine that I received on 3/4/2021 at 8:00am, I experienced fatigue, headaches, and the same excruciating pain in my spine, shoulders, hips, and knees. The fatigue and pain in my spine and joints after the two shots never went away. I also noticed a rapid regression in my muscle strength in my arms and legs at the gym. I went to my PCP on 3/5/2021 and he ordered labs that were completed on 3/11/2021. He noticed that my ANA screen was negative, my sed rate was negative, but my C-reactive protein was abnormal and wanted it repeated. On April 7,2021 my C-reactive protein level was even higher, to which he referred me to a Rheumotologist. After my referral finally went through, I was able to see the Rheumotologist on  July 6, 2021. He ordered labs that were completed on July 16, 2021. My ANA screen came back positive with a titer of 1:80 and the pattern was Nuclear, Speckled, and my HLA-B27 was positive. On my follow up appointment on 8/12/2021 at 10:45am he told me that my labs and symptoms are consistant with Ankylosing Spondylitis. He ordered X-rays on my spine and hips to determine the damage as well as my treatment plan. On 8/26/2021 at 2:30pm, I went to my follow up appointment and was prescribed Humira shots that I will now have to take for the rest of my life.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine normal, Blood uric acid normal, C-reactive protein increased, Double stranded DNA antibody, Fatigue
Clinical narrative: At about midnight after the first dose of the covid vaccine that I received on 2/11/2021 at 8:00am, I experienced a migraine and pain in my spine, shoulders, hips and knees that kept me up trembling in excruciating pain. I was sore and fatigued 2 days after. At about 2:00pm after the second dose of the covid vaccine that I received on 3/4/2021 at 8:00am, I experienced fatigue, headaches, and the same excruciating pain in my spine, shoulders, hips, and knees. The fatigue and pain in my spine and joints after the two shots never went away. I also noticed a rapid regression in my muscle strength in my arms and legs at the gym. I went to my PCP on 3/5/2021 and he ordered labs that were completed on 3/11/2021. He noticed that my ANA screen was negative, my sed rate was negative, but my C-reactive protein was abnormal and wanted it repeated. On April 7,2021 my C-reactive protein level was even higher, to which he referred me to a Rheumotologist. After my referral finally went through, I was able to see the Rheumotologist on  July 6, 2021. He ordered labs that were completed on July 16, 2021. My ANA screen came back positive with a titer of 1:80 and the pattern was Nuclear, Speckled, and my HLA-B27 was positive. On my follow up appointment on 8/12/2021 at 10:45am he told me that my labs and symptoms are consistant with Ankylosing Spondylitis. He ordered X-rays on my spine and hips to determine the damage as well as my treatment plan. On 8/26/2021 at 2:30pm, I went to my follow up appointment and was prescribed Humira shots that I will now have to take for the rest of my life.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Immunology test, Liver function test normal, Migraine, Muscle strength abnormal
Clinical narrative: At about midnight after the first dose of the covid vaccine that I received on 2/11/2021 at 8:00am, I experienced a migraine and pain in my spine, shoulders, hips and knees that kept me up trembling in excruciating pain. I was sore and fatigued 2 days after. At about 2:00pm after the second dose of the covid vaccine that I received on 3/4/2021 at 8:00am, I experienced fatigue, headaches, and the same excruciating pain in my spine, shoulders, hips, and knees. The fatigue and pain in my spine and joints after the two shots never went away. I also noticed a rapid regression in my muscle strength in my arms and legs at the gym. I went to my PCP on 3/5/2021 and he ordered labs that were completed on 3/11/2021. He noticed that my ANA screen was negative, my sed rate was negative, but my C-reactive protein was abnormal and wanted it repeated. On April 7,2021 my C-reactive protein level was even higher, to which he referred me to a Rheumotologist. After my referral finally went through, I was able to see the Rheumotologist on  July 6, 2021. He ordered labs that were completed on July 16, 2021. My ANA screen came back positive with a titer of 1:80 and the pattern was Nuclear, Speckled, and my HLA-B27 was positive. On my follow up appointment on 8/12/2021 at 10:45am he told me that my labs and symptoms are consistant with Ankylosing Spondylitis. He ordered X-rays on my spine and hips to determine the damage as well as my treatment plan. On 8/26/2021 at 2:30pm, I went to my follow up appointment and was prescribed Humira shots that I will now have to take for the rest of my life.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Spinal X-ray abnormal, Spinal pain, Tremor
Clinical narrative: At about midnight after the first dose of the covid vaccine that I received on 2/11/2021 at 8:00am, I experienced a migraine and pain in my spine, shoulders, hips and knees that kept me up trembling in excruciating pain. I was sore and fatigued 2 days after. At about 2:00pm after the second dose of the covid vaccine that I received on 3/4/2021 at 8:00am, I experienced fatigue, headaches, and the same excruciating pain in my spine, shoulders, hips, and knees. The fatigue and pain in my spine and joints after the two shots never went away. I also noticed a rapid regression in my muscle strength in my arms and legs at the gym. I went to my PCP on 3/5/2021 and he ordered labs that were completed on 3/11/2021. He noticed that my ANA screen was negative, my sed rate was negative, but my C-reactive protein was abnormal and wanted it repeated. On April 7,2021 my C-reactive protein level was even higher, to which he referred me to a Rheumotologist. After my referral finally went through, I was able to see the Rheumotologist on  July 6, 2021. He ordered labs that were completed on July 16, 2021. My ANA screen came back positive with a titer of 1:80 and the pattern was Nuclear, Speckled, and my HLA-B27 was positive. On my follow up appointment on 8/12/2021 at 10:45am he told me that my labs and symptoms are consistant with Ankylosing Spondylitis. He ordered X-rays on my spine and hips to determine the damage as well as my treatment plan. On 8/26/2021 at 2:30pm, I went to my follow up appointment and was prescribed Humira shots that I will now have to take for the rest of my life.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray of pelvis and hip abnormal
Clinical narrative: At about midnight after the first dose of the covid vaccine that I received on 2/11/2021 at 8:00am, I experienced a migraine and pain in my spine, shoulders, hips and knees that kept me up trembling in excruciating pain. I was sore and fatigued 2 days after. At about 2:00pm after the second dose of the covid vaccine that I received on 3/4/2021 at 8:00am, I experienced fatigue, headaches, and the same excruciating pain in my spine, shoulders, hips, and knees. The fatigue and pain in my spine and joints after the two shots never went away. I also noticed a rapid regression in my muscle strength in my arms and legs at the gym. I went to my PCP on 3/5/2021 and he ordered labs that were completed on 3/11/2021. He noticed that my ANA screen was negative, my sed rate was negative, but my C-reactive protein was abnormal and wanted it repeated. On April 7,2021 my C-reactive protein level was even higher, to which he referred me to a Rheumotologist. After my referral finally went through, I was able to see the Rheumotologist on  July 6, 2021. He ordered labs that were completed on July 16, 2021. My ANA screen came back positive with a titer of 1:80 and the pattern was Nuclear, Speckled, and my HLA-B27 was positive. On my follow up appointment on 8/12/2021 at 10:45am he told me that my labs and symptoms are consistant with Ankylosing Spondylitis. He ordered X-rays on my spine and hips to determine the damage as well as my treatment plan. On 8/26/2021 at 2:30pm, I went to my follow up appointment and was prescribed Humira shots that I will now have to take for the rest of my life.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Lymph node pain, Pain
Clinical narrative: 1) headache, bodyaches, weakness, chills, and low-grade temp that started 10/3/21 ~0300 that lasted about 12hrs.   2) experienced sore arm that started about 6 hrs after the shot and lasted about 48hrs after. 3) noticed tender lymph node under L armpit ~24hrs after the shot; disappeared today ~96hrs after the shot
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 1) headache, bodyaches, weakness, chills, and low-grade temp that started 10/3/21 ~0300 that lasted about 12hrs.   2) experienced sore arm that started about 6 hrs after the shot and lasted about 48hrs after. 3) noticed tender lymph node under L armpit ~24hrs after the shot; disappeared today ~96hrs after the shot
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal tenderness, Adenovirus test, Arteriosclerosis, Asthenia, Atelectasis
Clinical narrative: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting.  He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin.   Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia.  He reports severe nausea and vomiting to the point of dry heaving.  Has not been able to eat any food over the past 24 hours secondary to this.  He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses.   His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen.  Denies fevers, chills.  He does report slight cough, but no significant dyspnea.  No chest pain. No urinary symptoms.    The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1).  The patient denies chest pain.  UA was unremarkable.  EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes.  Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes.  The patient was given 1 L normal saline, 4 mg IV Zofran.  The patient was admitted to the hospitalist service for further workup and management.