chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Urine analysis
Clinical narrative: extreme knee pain; This is a spontaneous report from a contactable consumer. An unspecified gender of 63 years-old patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an intramuscular route of administration on 31Mar2021 at 12:45 as a DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history includes acid reflux, hot flashes from unspecified date in 2020 and ongoing condition. Breast reduction on unspecified date in 2000, hysterectomy on unspecified date in 1998 and Kidney stone laser removal on unspecified date in 2018. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6206) intramuscular administered in left arm on 10Mar2021 at 16:00 for covid-19 immunisation. On 01Apr2021 the patient experienced that Extreme knee pain. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included super urine with unknown results at the time of report on 17Feb2021. The reported reporting that events considered as non-serious. The outcome of the event resolved on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash, Rash vesicular
Clinical narrative: severe rash all over her back, down her side and down her leg; First dose: 16Mar2021 and  Second dose: 21Jul2021; she broke out in a rash; rash blisters all over her body; This is a spontaneous report from a contactable consumer. This consumer (patient husband) reported for a female patient that:   A 79-years-old female patient received bnt162b2 (COMIRNATY, Formulation; Solution for Injection), dose 2 via an unspecified route of administration, administered in Arm Right on 21Jul2021 13:00 (Age at vaccination was 79 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history not reported.concomitant medications: None. The patient previously received (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Formulation; Solution for Injection, Batch/Lot Number: EN6206 and Expiry date was not provided) via unspecified route of administration as Dose 1, on 16Mar2021 on Arm Right for (age at vaccination 79 years) COVID-19 immunisation. Vaccine was not Administered at Military Facility. There were no prior Vaccinations (within 4 weeks) list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced She broke out in a rash on 21Jul2021, Severe rash all over her back and down her side and down her leg on an unspecified date, Rash blisters all over her body on 21Jul2021.Patient visited physician office for reported events. The events were assessed as Non serious. The outcome of events was not recovered for events She broke out in a rash, for Severe rash all over her back, Down her side and down her leg It was recovered on 2021 and Rash blisters all over her body it was Unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash
Clinical narrative: sore arm; Headache; Rash around neck; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. After 2nd dose of vaccine (on an unspecified date), the patient experienced sore arm, headache, and 48 hours after, the shot developed a rash around neck. The patient received Benadryl as treatment for rash. Outcome of events was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Heart rate, Heart rate normal, Hyperhidrosis
Clinical narrative: She started feeling horrible like a bad flu; Just feeling unwell/lousy; Body pain/aches/pains; Terrible headache; Joint pain; Injection site pain; Sweating; My heartbeat is usually 50 or 52, but when I took it while I was waiting it was 80; My heartbeat is usually 50 or 52, but when I took it while I was waiting it was 80; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in Arm Left, at age 77 years, on 12Oct2021 13:00 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization/got the booster to build her immunity. Relevant medical history includes ongoing broken femur from 27Sep2021 and usual heartbeat of 50 or 52. There were no concomitant medications. The patient historically received the first dose of BNT162B2 (Lot number: EL or BL 8982) on the left arm at age 76 years, on 22Jan2021; and then second dose of BNT162B2 (lot number: EL9262) on the left arm at age 77 years, on 12Feb2021, for COVID-19 immunisation and experienced flu like symptoms and felt lousy that are small reactions, fell and broke femur after second vaccine. She fell and is recovering. Patient stated that she had heard the Pfizer vaccine did not have long term efficacy so she got the booster to build her immunity. She received the booster dose around 1:00 pm on 12Oct2021 and she was fine, heartbeat is usually 50 or 52, but when she took it while she was waiting it was 80 on 12Oct2021; then around 11:00 pm after booster, she stated she started feeling horrible like a bad flu symptoms, lousy, aches/pains, terrible headache, joint pain, injection site pain, body pain, sweating, just feeling unwell. She was real sweaty, and her hair was soaking wet. She was concerned how long she will feel like this.  With the second dose she only had symptoms for 6 hours or so and was gone. These symptoms have lasted about 13 hours from the time of report and this is lasting much longer. Patient had body aches, and she took two paracetamol (TYLENOL 8 hour arthritis pain relief 650mg) (Lot: 81830106M, expiration: Oct2023), and it really didn't help much. Patient has not talked to her doctor. The outcome of the event "heartbeat is usually 50 or 52, but when I took it while I was waiting it was 80" was unknown; while for the other events, it was recovering as patient was slightly better.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Pain, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: She started feeling horrible like a bad flu; Just feeling unwell/lousy; Body pain/aches/pains; Terrible headache; Joint pain; Injection site pain; Sweating; My heartbeat is usually 50 or 52, but when I took it while I was waiting it was 80; My heartbeat is usually 50 or 52, but when I took it while I was waiting it was 80; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in Arm Left, at age 77 years, on 12Oct2021 13:00 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization/got the booster to build her immunity. Relevant medical history includes ongoing broken femur from 27Sep2021 and usual heartbeat of 50 or 52. There were no concomitant medications. The patient historically received the first dose of BNT162B2 (Lot number: EL or BL 8982) on the left arm at age 76 years, on 22Jan2021; and then second dose of BNT162B2 (lot number: EL9262) on the left arm at age 77 years, on 12Feb2021, for COVID-19 immunisation and experienced flu like symptoms and felt lousy that are small reactions, fell and broke femur after second vaccine. She fell and is recovering. Patient stated that she had heard the Pfizer vaccine did not have long term efficacy so she got the booster to build her immunity. She received the booster dose around 1:00 pm on 12Oct2021 and she was fine, heartbeat is usually 50 or 52, but when she took it while she was waiting it was 80 on 12Oct2021; then around 11:00 pm after booster, she stated she started feeling horrible like a bad flu symptoms, lousy, aches/pains, terrible headache, joint pain, injection site pain, body pain, sweating, just feeling unwell. She was real sweaty, and her hair was soaking wet. She was concerned how long she will feel like this.  With the second dose she only had symptoms for 6 hours or so and was gone. These symptoms have lasted about 13 hours from the time of report and this is lasting much longer. Patient had body aches, and she took two paracetamol (TYLENOL 8 hour arthritis pain relief 650mg) (Lot: 81830106M, expiration: Oct2023), and it really didn't help much. Patient has not talked to her doctor. The outcome of the event "heartbeat is usually 50 or 52, but when I took it while I was waiting it was 80" was unknown; while for the other events, it was recovering as patient was slightly better.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Infection
Clinical narrative: body rash/The rash was across her groin, up the side of her body, and along her bust line and on her neck; kind of felt miserable; she got bad virus; feeling unwell; nausea; low fever; chills/chilled feeling; no appetite; fatigue/ tiredness (pretty much didn't get out of bed); sleeping through out the day/ Stayed in bed and was napping; injection site pain and swelling (little achy); injection site pain and swelling (little achy); This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: FF8841) via an unspecified route of administration, administered in Arm Right on 05Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization(at the age of 69-year-old). The patient's medical history included drug hypersensitivity from an unknown date and unknown if ongoing, she is allergic to a few antibiotics, gastroesophageal reflux disease from 2020 to an unknown date Had some problems over the last year or so and had some acid reflux attacks and received Fluzone shot on 2017 and experienced Fluzone shot kicked her in the rear and was not used to it. The patient received Flu vaccine 4 weeks prior vaccination on 04Sep2021. Concomitant medications included influenza vaccine (FLU VACCINE) taken for immunisation from 04Sep2021 to 04Sep2021, esomeprazole magnesium (NEXIUM) taken for gastroesophageal reflux disease from an unspecified start date and ongoing. Historical vaccination included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6206) via an unspecified route of administration, administered in Arm Right on 15Mar2021 as DOSE 1, SINGLE for covid-19 immunization and she felt fatigue and common symptoms and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on 05Apr2021 as DOSE 2, SINGLE for covid-19 immunization and she felt fatigue and common symptoms. On 06Oct2021, patient experienced she got bad virus, feeling unwell, nausea, low fever, chills/chilled feeling, no appetite, fatigue/ tiredness (pretty much didn't get out of bed), sleeping through out the day/ stayed in bed and was napping, injection site pain and swelling (little achy), kind of felt miserable. On 07Oct2021, patient experienced body rash/the rash was across her groin, up the side of her body, and along her bust line and on her neck. On 08Oct2021 the rash started to fade and the body rash was gone by 09Oct2021. She also added that she had some improvements from the other side effects from the first few days and the body rash developed. The events did not result in emergency room or physician office visit. The outcome of the event for rash was recovered on 09Oct2021. The outcome for other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, Rash, Somnolence
Clinical narrative: body rash/The rash was across her groin, up the side of her body, and along her bust line and on her neck; kind of felt miserable; she got bad virus; feeling unwell; nausea; low fever; chills/chilled feeling; no appetite; fatigue/ tiredness (pretty much didn't get out of bed); sleeping through out the day/ Stayed in bed and was napping; injection site pain and swelling (little achy); injection site pain and swelling (little achy); This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: FF8841) via an unspecified route of administration, administered in Arm Right on 05Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization(at the age of 69-year-old). The patient's medical history included drug hypersensitivity from an unknown date and unknown if ongoing, she is allergic to a few antibiotics, gastroesophageal reflux disease from 2020 to an unknown date Had some problems over the last year or so and had some acid reflux attacks and received Fluzone shot on 2017 and experienced Fluzone shot kicked her in the rear and was not used to it. The patient received Flu vaccine 4 weeks prior vaccination on 04Sep2021. Concomitant medications included influenza vaccine (FLU VACCINE) taken for immunisation from 04Sep2021 to 04Sep2021, esomeprazole magnesium (NEXIUM) taken for gastroesophageal reflux disease from an unspecified start date and ongoing. Historical vaccination included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6206) via an unspecified route of administration, administered in Arm Right on 15Mar2021 as DOSE 1, SINGLE for covid-19 immunization and she felt fatigue and common symptoms and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on 05Apr2021 as DOSE 2, SINGLE for covid-19 immunization and she felt fatigue and common symptoms. On 06Oct2021, patient experienced she got bad virus, feeling unwell, nausea, low fever, chills/chilled feeling, no appetite, fatigue/ tiredness (pretty much didn't get out of bed), sleeping through out the day/ stayed in bed and was napping, injection site pain and swelling (little achy), kind of felt miserable. On 07Oct2021, patient experienced body rash/the rash was across her groin, up the side of her body, and along her bust line and on her neck. On 08Oct2021 the rash started to fade and the body rash was gone by 09Oct2021. She also added that she had some improvements from the other side effects from the first few days and the body rash developed. The events did not result in emergency room or physician office visit. The outcome of the event for rash was recovered on 09Oct2021. The outcome for other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: body rash/The rash was across her groin, up the side of her body, and along her bust line and on her neck; kind of felt miserable; she got bad virus; feeling unwell; nausea; low fever; chills/chilled feeling; no appetite; fatigue/ tiredness (pretty much didn't get out of bed); sleeping through out the day/ Stayed in bed and was napping; injection site pain and swelling (little achy); injection site pain and swelling (little achy); This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: FF8841) via an unspecified route of administration, administered in Arm Right on 05Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization(at the age of 69-year-old). The patient's medical history included drug hypersensitivity from an unknown date and unknown if ongoing, she is allergic to a few antibiotics, gastroesophageal reflux disease from 2020 to an unknown date Had some problems over the last year or so and had some acid reflux attacks and received Fluzone shot on 2017 and experienced Fluzone shot kicked her in the rear and was not used to it. The patient received Flu vaccine 4 weeks prior vaccination on 04Sep2021. Concomitant medications included influenza vaccine (FLU VACCINE) taken for immunisation from 04Sep2021 to 04Sep2021, esomeprazole magnesium (NEXIUM) taken for gastroesophageal reflux disease from an unspecified start date and ongoing. Historical vaccination included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6206) via an unspecified route of administration, administered in Arm Right on 15Mar2021 as DOSE 1, SINGLE for covid-19 immunization and she felt fatigue and common symptoms and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on 05Apr2021 as DOSE 2, SINGLE for covid-19 immunization and she felt fatigue and common symptoms. On 06Oct2021, patient experienced she got bad virus, feeling unwell, nausea, low fever, chills/chilled feeling, no appetite, fatigue/ tiredness (pretty much didn't get out of bed), sleeping through out the day/ stayed in bed and was napping, injection site pain and swelling (little achy), kind of felt miserable. On 07Oct2021, patient experienced body rash/the rash was across her groin, up the side of her body, and along her bust line and on her neck. On 08Oct2021 the rash started to fade and the body rash was gone by 09Oct2021. She also added that she had some improvements from the other side effects from the first few days and the body rash developed. The events did not result in emergency room or physician office visit. The outcome of the event for rash was recovered on 09Oct2021. The outcome for other events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Dyspnoea, Feeling cold, Headache
Clinical narrative: fainted; very sore arm and under her arm pit; very sore arm and under her arm pit; Headache; severe chills; problems breathing; hyperventilating; felt like she was freezing to death; This is a spontaneous report from a non-contactable consumer or other non hcp. A 76-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Oct2021 (Batch/Lot Number: 30155BA; Expiration Date: 31Dec2021) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history was none (patient history: no). Concomitant medication included influenza vaccine (FLU VACCINE) taken for immunisation received by the patient on 05Oct2021. Historical vaccines included BNT162b2 received by the patient on 27Jan2021 as dose 1, single (Batch/Lot Number: EL3249) and BNT162b2 received by the patient on 17Feb2021 as dose 2, single (Batch/Lot Number: EL9262), both for COVID-19 immunisation and did not have a reaction to either one of those. The patient reported her side effects began Tuesday morning, 12Oct2021, and that she had a very sore arm and under her arm pit, which was not swelling in her armpit. She says she had a headache, severe chills, and problems breathing, like she thought she was hyperventilating and when she walked from the bathroom to the bedroom to tell her husband she ended up looking up at him because she fainted in his arms and he lowered her to the floor. She said she thought it was unusual to faint because of something like this, so she thought they should be aware in older people to know. She said the others were not unusual, she thought problems breathing and fainting they should be aware of. Her side effects got better, she rested with two quilts on her because she felt like she was freezing to death, and by midafternoon she was fine, and she was fine now. She said she was not overly concerned, but she thought she should report it since if other older people get the booster they might want to be aware to have some people around them after it. She got her yearly flu shot last Tuesday prior to this, she never had a problem with that before though. She says that she doesn't know which flu shot she got, it is the one for 65 and older which she guesses is stronger and covers more strains than the ones for younger people. For the rest of her symptoms, she was not concerned, it was just the fact that she fainted, so she thought older people might need to be aware of it. Outcome of the events was recovered on Oct2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Pain in extremity, Syncope
Clinical narrative: fainted; very sore arm and under her arm pit; very sore arm and under her arm pit; Headache; severe chills; problems breathing; hyperventilating; felt like she was freezing to death; This is a spontaneous report from a non-contactable consumer or other non hcp. A 76-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Oct2021 (Batch/Lot Number: 30155BA; Expiration Date: 31Dec2021) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history was none (patient history: no). Concomitant medication included influenza vaccine (FLU VACCINE) taken for immunisation received by the patient on 05Oct2021. Historical vaccines included BNT162b2 received by the patient on 27Jan2021 as dose 1, single (Batch/Lot Number: EL3249) and BNT162b2 received by the patient on 17Feb2021 as dose 2, single (Batch/Lot Number: EL9262), both for COVID-19 immunisation and did not have a reaction to either one of those. The patient reported her side effects began Tuesday morning, 12Oct2021, and that she had a very sore arm and under her arm pit, which was not swelling in her armpit. She says she had a headache, severe chills, and problems breathing, like she thought she was hyperventilating and when she walked from the bathroom to the bedroom to tell her husband she ended up looking up at him because she fainted in his arms and he lowered her to the floor. She said she thought it was unusual to faint because of something like this, so she thought they should be aware in older people to know. She said the others were not unusual, she thought problems breathing and fainting they should be aware of. Her side effects got better, she rested with two quilts on her because she felt like she was freezing to death, and by midafternoon she was fine, and she was fine now. She said she was not overly concerned, but she thought she should report it since if other older people get the booster they might want to be aware to have some people around them after it. She got her yearly flu shot last Tuesday prior to this, she never had a problem with that before though. She says that she doesn't know which flu shot she got, it is the one for 65 and older which she guesses is stronger and covers more strains than the ones for younger people. For the rest of her symptoms, she was not concerned, it was just the fact that she fainted, so she thought older people might need to be aware of it. Outcome of the events was recovered on Oct2021.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pneumonia, Pyrexia
Clinical narrative: Covid positive exactally 7 days later; Severe pneumonia 2 days later; fever; chills; fatigue; This is a spontaneous report from a contactable consumer.  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 16Aug2021 12:00 (Batch/Lot number was not reported) as dose 1, single (at the age of 62 years old) for COVID-19 immunisation.  Medical history included thyroid disorder, blood pressure abnormal and blood cholesterol abnormal.  The patient experienced Covid positive exactly 7 days later 25Aug2021. Severe pneumonia 2 days later fever, chills, fatigue within 48 hours of shot on 18Aug2021 02:00.  The patient required physician and emergency room visit. The patient received treatment. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow-up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature decreased, Cough, Diarrhoea
Clinical narrative: faint; feeling weak; feverish; nauseous; cough; sore throat; I took my temperature I was alarmed that it was 94 degrees (very low); diagnosed with an unknown virus; diarrhea; sneezing; runny nose; horrible body aches.; This is a spontaneous report from a contactable Healthcare Professional (patient). A non-pregnant 45-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 03Apr2021 14:00, at the age of 45 years, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included thalassaemia sickle cell from an unknown date, Gitelman's syndrome from an unknown date, sarcoidosis from an unknown date and allergy to hydromorphone hydrochloride (DILAUDID) and ketorolac tromethamine (TORADOL). The patient didn't receive any other vaccine in the previous 4 weeks. She was not diagnosed with COVID-19 prior vaccination and was not tested positive for COVID post vaccination. The patient reported that after she received the first shot, on 05Apr2021 at 08:00 PM, she had a severe reaction. It started with feeling weak and feeling feverish, nauseous and faint. She also had a cough and sore throat. When she took her temperature she was alarmed that it was 94 degrees (very low). She waited 30 minutes but the symptoms intensified. When she took her temperature again it was 95 degrees and she felt like she was going to lose consciousness. She immediately called # and an ambulance came and paramedics assessed her. She was taken to the ER and she was diagnosed with an unknown virus. It was reported that she was treated with unspecified IV drips. When she was released and returned home new symptoms started. On an unknown date she had severe nausea, diarrhea, extreme sneezing, runny nose, fever and horrible body aches. This all lasted for over a week. It was an incredibly difficult time for her and she felt compelled to share her experience in hopes of informing others who have the same bizarre series of symptoms. All the reported events resolved on an unknown date.  The lot number for BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: A contributory role of BNT162B2 to events eeling weak and feeling feverish, nauseous and faint, a cough and sore throat, temperature she was alarmed that it was 94 degrees (very low), diagnosed with an unknown virus cannot be excluded based on temporal association and available 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: faint; feeling weak; feverish; nauseous; cough; sore throat; I took my temperature I was alarmed that it was 94 degrees (very low); diagnosed with an unknown virus; diarrhea; sneezing; runny nose; horrible body aches.; This is a spontaneous report from a contactable Healthcare Professional (patient). A non-pregnant 45-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 03Apr2021 14:00, at the age of 45 years, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included thalassaemia sickle cell from an unknown date, Gitelman's syndrome from an unknown date, sarcoidosis from an unknown date and allergy to hydromorphone hydrochloride (DILAUDID) and ketorolac tromethamine (TORADOL). The patient didn't receive any other vaccine in the previous 4 weeks. She was not diagnosed with COVID-19 prior vaccination and was not tested positive for COVID post vaccination. The patient reported that after she received the first shot, on 05Apr2021 at 08:00 PM, she had a severe reaction. It started with feeling weak and feeling feverish, nauseous and faint. She also had a cough and sore throat. When she took her temperature she was alarmed that it was 94 degrees (very low). She waited 30 minutes but the symptoms intensified. When she took her temperature again it was 95 degrees and she felt like she was going to lose consciousness. She immediately called # and an ambulance came and paramedics assessed her. She was taken to the ER and she was diagnosed with an unknown virus. It was reported that she was treated with unspecified IV drips. When she was released and returned home new symptoms started. On an unknown date she had severe nausea, diarrhea, extreme sneezing, runny nose, fever and horrible body aches. This all lasted for over a week. It was an incredibly difficult time for her and she felt compelled to share her experience in hopes of informing others who have the same bizarre series of symptoms. All the reported events resolved on an unknown date.  The lot number for BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: A contributory role of BNT162B2 to events eeling weak and feeling feverish, nauseous and faint, a cough and sore throat, temperature she was alarmed that it was 94 degrees (very low), diagnosed with an unknown virus cannot be excluded based on temporal association and available 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Syncope, Viral infection
Clinical narrative: faint; feeling weak; feverish; nauseous; cough; sore throat; I took my temperature I was alarmed that it was 94 degrees (very low); diagnosed with an unknown virus; diarrhea; sneezing; runny nose; horrible body aches.; This is a spontaneous report from a contactable Healthcare Professional (patient). A non-pregnant 45-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 03Apr2021 14:00, at the age of 45 years, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included thalassaemia sickle cell from an unknown date, Gitelman's syndrome from an unknown date, sarcoidosis from an unknown date and allergy to hydromorphone hydrochloride (DILAUDID) and ketorolac tromethamine (TORADOL). The patient didn't receive any other vaccine in the previous 4 weeks. She was not diagnosed with COVID-19 prior vaccination and was not tested positive for COVID post vaccination. The patient reported that after she received the first shot, on 05Apr2021 at 08:00 PM, she had a severe reaction. It started with feeling weak and feeling feverish, nauseous and faint. She also had a cough and sore throat. When she took her temperature she was alarmed that it was 94 degrees (very low). She waited 30 minutes but the symptoms intensified. When she took her temperature again it was 95 degrees and she felt like she was going to lose consciousness. She immediately called # and an ambulance came and paramedics assessed her. She was taken to the ER and she was diagnosed with an unknown virus. It was reported that she was treated with unspecified IV drips. When she was released and returned home new symptoms started. On an unknown date she had severe nausea, diarrhea, extreme sneezing, runny nose, fever and horrible body aches. This all lasted for over a week. It was an incredibly difficult time for her and she felt compelled to share her experience in hopes of informing others who have the same bizarre series of symptoms. All the reported events resolved on an unknown date.  The lot number for BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: A contributory role of BNT162B2 to events eeling weak and feeling feverish, nauseous and faint, a cough and sore throat, temperature she was alarmed that it was 94 degrees (very low), diagnosed with an unknown virus cannot be excluded based on temporal association and available 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.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: Atrial Fibrillation with Rapid Ventricular Response; This is a spontaneous report from a contactable physician (patient himself). A 66-year-old male patient received third dose (booster) of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: 301308A), via an unspecified route of administration, administered in the right arm, on 29Sep2021 20:30 (at the age of 66 years) at a single dose for COVID-19 immunization. The patient received his vaccine at a pharmacy or drug store. Medical history included sepsis from Feb2019 due to LLE erysipelas on unspecified date, C-spine stenosis with decompression from Jun2015, and complicated by RUE C5 palsy on unspecified date. The patient has no known allergies. The patient has no Covid prior vaccination. The patient was not tested for Covid post vaccination. Concomitant medications included tadalafil and latanoprost eye drops. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EJ1685) administered in the left arm on 17Dec2020 at 06:00PM (at the age of 65 years) for COVID-19 immunisation, second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EL0142) administered in the left arm on 06Jan2021 at 11:00PM (at the age of 66 years) for COVID-19 immunisation, and Influenza Fluzone High Dose Quad Strength administered in the left arm on 22Sep2021 (at the age of 66 years) for immunisation. The patient experienced atrial fibrillation with rapid ventricular response, first episode, duration of 25 min on 13Oct2021 22:45 with outcome of recovered on 13Oct2021 23:10. The event was ECG confirmed on 13Oct2021. No treatment was received for the event. The event resulted in emergency room/department or urgent care.; Sender's Comments: Based on the available information in the case, the causal association between the event atrial fibrillation and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Caller reports he has noticed his hair falling out, more than normal for the past 2 to 3 months.; This is a spontaneous repot from a Pfizer sponsored Program. A contactable consumer (patient) reported that a 72-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 05Feb2021 (Lot number was unknown, reported as being either EK5318 or EN5318) as dose 2, single for COVID-19 immunization. Medical history included Large B-Cell Thyroid Lymphoma in Jan2010, Brain damage, cancer and has had chemotherapy he now has what is called Chemo brain, has lost a lot of his memory. His brother had a heart attack a couple of years ago; his mom had Alzheimer's; his dad passed away at 90 years old; his 2 brothers and sisters are still alive; his kids have no medical problems. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EK4176) administered in right arm on 06Jan2021 as single dose for COVID-19 immunization (at age 71 years old). The patient noticed his hair falling out, more than normal for the past 2 to 3 months and is persisting on unspecified date in 2021. He looked online and saw that Pfizer is working on a trial for people that are losing their hair.  He stated that he had a head full of hair and everyone commented about how nice it was at his age. He looked up online to see if the vaccine could have caused this. He can't think of any other reason that he would be losing hair. He mentions that he had cancer and has some brain damage. States he is a disabled veteran. He has had both doses of the Pfizer Covid 19 Vaccine and the booster dose in Oct2021. He clarifies that he has not received this dose yet.  After his first and second doses of the vaccine he had no pain and no other side effects. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 96-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 3 via an unspecified route of administration, administered in Arm Right, at age 96 years, on 28Sep2021 (Batch/Lot Number: 30135BA) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history was not reported. It was unknown if patient had COVID prior to vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. Patient historically received first dose of BNT162B2 (lot number: EL3248)  in the left arm, on 08Feb2021 at age 95 years; and then second dose of BNT162B2 (lot number: EL9262) in the right arm, on 08Feb2021 at age 95 years, both for COVID-19 immunisation. One week after receiving the booster shot on 07Oct2021, the patient experienced Congestive Heart Failure. Patient was admitted to hospital on 07Oct2021 to 15Oct2021 for 8 days. Patient was treated with a diuretic. Facility type Vaccine was Nursing Home/Senior Living Facility. AE resulted in Emergency room/department or urgent care, Hospitalization. COVID was not tested post vaccination. The outcome of the event was not recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Herpes virus infection, Skin disorder, Temporomandibular joint syndrome
Clinical narrative: TMD plus she is having some skin issue that the doctor thought be herpes; TMD plus she is having some skin issue that the doctor thought be herpes; TMD plus she is having some skin issue that the doctor thought be herpes; complaints of acid reflux; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Oct2021 09:30 (Batch/Lot Number: FF8839) at the age of 77 years old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history was none. (Patient's Medical History (including any illness at time of vaccination): none). There were no concomitant medications. There were no prior vaccinations within 4 weeks. On an unspecified date in 2021, the patient received flu vaccine few days prior (as reported). Other historical vaccines included BNT162B2 received by the patient on 21Jan2021 (Batch/Lot Number: EL9261) as dose 1, single, and BNT162B2 on 11Feb2021 (Batch/Lot Number: EM9809) as dose 2, single; both at the age of 76 years for COVID-19 immunisation. The patient received the Pfizer Covid-19 booster dose on 02Oct2021 and was prescribed acyclovir and prednisone on 08Oct2021. The patient stated that she started taking the prednisone three days after the booster dose of the Pfizer COVID-19 vaccine and only took two prednisone pills over two days and could not take anymore due to complaints of acid reflux. She asked if prednisone can interfere with the Pfizer COVID-19 vaccine. She was given some short-term medication. They were called acyclovir and prednisone. They were prescribed for TMD (Temporomandibular joint disorder) plus she had some skin issue that the doctor thought to be herpes. She just wanted to make sure they wouldn't compromise the vaccine. She went to the doctor and got the diagnosis of TMD and possible herpes on 08Oct2021, that is when the acyclovir was started. She didn't start the prednisone for 3 days and only took 2-3 pills and stopped, she couldn't handle it. She confirmed she was not taking the Prednisone but was taking the acyclovir. She thought it was probably okay, but she wanted to make sure, she didn't realize they were both immune suppressing. She remarks that she was probably worried about nothing especially since she hasn't taken very many; the most of the Prednisone used were 3 tablets, though this was not how the doctor wanted her to take it. She was supposed to take 4 the first day and so on. Therapeutic measures were taken as a result of events: "TMD plus she had some skin issue that the doctor thought be herpes" and these events resulted in Physician office visit. Outcome of all the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Feeling abnormal, Limb discomfort, Paraesthesia
Clinical narrative: heaviness in legs; tingling; droopiness in face,he doesn't know if it's drooping,; feels like her eye is heavy and not closing all the way; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported that a 46-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 14Oct2021 12:45 (Batch/Lot Number: FF2587; Expiration Date: 01Dec2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Oct2021, the patient experienced heaviness in legs, tingling, droopiness in face, feels like her eye is heavy and not closing all the way. The events were assessed as serious (medically significant). The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, The casual association between the reported events Heaviness in leg, Tingling, Feeling abnormal, Eyes heavy feeling of with suspected vaccine BNT162B2 cannot be completely 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Peripheral swelling, SARS-CoV-2 test, Skin fissures
Clinical narrative: Fingers began to swell and crack; Palms and plantar surface of his feet started drying out and cracking; Fingers began to swell and crack, Palms and plantar surface of his feet started drying out and cracking; This is a spontaneous report from a contactable other health professional (patient). A 48-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in arm right on 08Jan2021 at 08:00 AM at 48 years (Lot Number: ELO142) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history was none. Patient did not experience COVID-19 prior to vaccination. There were no concomitant medications. Patient did not receive other vaccines in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (Batch/Lot No: EK5730), in arm right, on 19Dec2020 at 08:00 AM at 48 years for COVID-19 immunisation. The patient experienced fingers began to swell and crack (medically significant) on 15Jan2021 at 06:00 AM with outcome of not recovered, palms and plantar surface of his feet started drying out and cracking (medically significant) on 15Jan2021 at 06:00 AM with outcome of not recovered. The events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the events and included treatment with steroids topical/injection. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Sep2021.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events Peripheral swelling, dry skin , skin fissures cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FF8841), via an unspecified route of administration, administered in left arm on 12Oct2021 11:45 (at the of 71 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included cancer. The patient has not had COVID prior to vaccination. The patient's concomitant medications were not reported. No other vaccine was given in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Mar2021 10:30 (Batch/Lot Number: En6203, at the of 70 years old) for COVID-19 immunization and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 26Mar2021 09:30 (Batch/Lot Number: Er8733, at the of 70 years old) for COVID-19 immunization. The patient experienced bell's palsy on 13Oct2021. No treatment was given in response to the event. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was tested for COVID post vaccination via nasal swab on an unspecified date with unknown results. The outcome of the event was not recovered.