chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report from a male nurse (patient) reported for himself. A 30-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3246) via an unspecified route of administration, administered in Arm Left on 12Jan2021 at the age of (30-years-old) as dose 2, single for covid-19 immunisation. Medical history included patient was diabetic diagnosed 31 years ago from an unknown date and unknown if ongoing diagnosed 31 years ago. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0140) via an unspecified route of administration, administered in Arm Left on 22Dec2020 as dose 1, single for covid-19 Immunisation. It was reported that on 14Jan2021 patient had developed pericarditis 2 days after getting the second dose. He does not had any pre-existing heart conditions. The patient was hospitalized for pericarditis from 14Jan2021 to 18Jan2021. On an unspecified date the patient underwent lab tests and procedures which included EKG which was showed that tombstone. The patient was recovered from the event on 15Jan2021.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of pericarditis 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive following full COVID-19 vaccination.; Patient tested positive following full COVID-19 vaccination.; This is a spontaneous report from a non-contactable other HCP. A 52-year-old female patient received bnt162b2 (BNT162B2, Formulation; Solution for Injection), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot Number: EL3248) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: EL3248) as DOSE 2, SINGLE (at the age of 52-year-old) for COVID-19 immunisation. It was unknown if patient was pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. It was unknown if patient had COVID prior vaccination. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient tested positive following full COVID-19 vaccination on 25Aug2021 (COVID test positive). It was unknown if patient received treatment or not.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Back pain, Body temperature, Chest pain
Clinical narrative: Mild Nausea; Moderate Upper Back/ Chest Pains; Moderate Upper Back/ Chest Pains; Partial memory loss after the dose injection; Feverish 'hot' feeling; Elevated Temperature; Severe to Moderate Chills/shaking; Severe to Moderate Chills/shaking; Moderate Muscle Soreness/Aches; Sharp but Mild Joint Pains; Mild Headache; Mild Sweating; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 20Aug2021 12:00 as dose 2, single for covid-19 immunization. The patient did not had any medical history and concomitant medications were not reported. On 20Aug2021, after receiving the vaccine on around 19: 00, the patient had feverish hot feeling which for 108 hours, elevated temperature for 36 hours, severe to moderate chills/shaking for 4.5-5 hours, moderate muscle soreness/aches for 60 hours, sharp but mild joint pains for 36 hours, mild headache for 2-4 hours, intermediate and rare, partial memory loss and mild sweating for 96-108 hour. On 22aug2021 in the afternoon, patient experienced moderate upper back/ chest pains for 6 hours and on 24Aug2021, patient had mild nausea for 4 hours, intermittently. The outcome of the events was recovered.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Mild Nausea; Moderate Upper Back/ Chest Pains; Moderate Upper Back/ Chest Pains; Partial memory loss after the dose injection; Feverish 'hot' feeling; Elevated Temperature; Severe to Moderate Chills/shaking; Severe to Moderate Chills/shaking; Moderate Muscle Soreness/Aches; Sharp but Mild Joint Pains; Mild Headache; Mild Sweating; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 20Aug2021 12:00 as dose 2, single for covid-19 immunization. The patient did not had any medical history and concomitant medications were not reported. On 20Aug2021, after receiving the vaccine on around 19: 00, the patient had feverish hot feeling which for 108 hours, elevated temperature for 36 hours, severe to moderate chills/shaking for 4.5-5 hours, moderate muscle soreness/aches for 60 hours, sharp but mild joint pains for 36 hours, mild headache for 2-4 hours, intermediate and rare, partial memory loss and mild sweating for 96-108 hour. On 22aug2021 in the afternoon, patient experienced moderate upper back/ chest pains for 6 hours and on 24Aug2021, patient had mild nausea for 4 hours, intermittently. The outcome of the events was recovered.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Mild Nausea; Moderate Upper Back/ Chest Pains; Moderate Upper Back/ Chest Pains; Partial memory loss after the dose injection; Feverish 'hot' feeling; Elevated Temperature; Severe to Moderate Chills/shaking; Severe to Moderate Chills/shaking; Moderate Muscle Soreness/Aches; Sharp but Mild Joint Pains; Mild Headache; Mild Sweating; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 20Aug2021 12:00 as dose 2, single for covid-19 immunization. The patient did not had any medical history and concomitant medications were not reported. On 20Aug2021, after receiving the vaccine on around 19: 00, the patient had feverish hot feeling which for 108 hours, elevated temperature for 36 hours, severe to moderate chills/shaking for 4.5-5 hours, moderate muscle soreness/aches for 60 hours, sharp but mild joint pains for 36 hours, mild headache for 2-4 hours, intermediate and rare, partial memory loss and mild sweating for 96-108 hour. On 22aug2021 in the afternoon, patient experienced moderate upper back/ chest pains for 6 hours and on 24Aug2021, patient had mild nausea for 4 hours, intermittently. The outcome of the events was recovered.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: He was not sleeping couple of days; Have some like Sucker punch on his arm at the injection site; This is a spontaneous report from a contactable consumer (parent) from a Pfizer-sponsored program regulatory authority Support. This consumer reported information for two different patients. This is the second of two reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number, expiration date was not reported) at dose 1 single and dose 2 single (lot number, expiry date unknown); both via an unspecified route of administration, on an unspecified date for covid-19 immunization. Family medical history included allergy. The patient's concomitant medications were not reported. The patient was not sleeping from a couple of days and had something like sucker punch on his arm at the injection site on an unspecified date. It was reported the second dose is worser than the first dose. The outcome of the event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116868 same reporter/drug and different patient.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Extra dose administered, HIV test positive, Malaise, Off label use
Clinical narrative: fever spike of 100.5F; general malaise.; sore arm; patient received booster dose on 08Aug2021.; patient received booster dose on 08Aug2021.; This is a spontaneous report received from a non-contactable consumer(patient)via company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number- FC3180, expiry date not reported) via an unspecified route of administration, on 08Aug2021, at dose 3, single for covid-19 immunisation. The patient's medical history include HIV positive.The patient concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number EL0142, expiry date not reported) via an unspecified route of administration, on 12Jan2021, dose 1, single for covid-19 immunisation and experienced arm pain the next day followed by fatigue and malaise  for 5 days. Patient also reported periodic severe headaches lasting several hours during this time then BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number EL3247, expiry date not reported) via an unspecified route of administration, on 02Feb2021, dose 2, single for covid-19 immunisation and experienced no reaction. The patient experienced a sore arm on next day followed by five days of general malaise on 09Aug2021. On day 2 10Aug2021 post vaccination patient experienced a fever spike of 100.5f which lasted about six hours per report.. The outcome of the events was unknown at the time of report  No follow-up attempts are possible. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever spike of 100.5F; general malaise.; sore arm; patient received booster dose on 08Aug2021.; patient received booster dose on 08Aug2021.; This is a spontaneous report received from a non-contactable consumer(patient)via company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number- FC3180, expiry date not reported) via an unspecified route of administration, on 08Aug2021, at dose 3, single for covid-19 immunisation. The patient's medical history include HIV positive.The patient concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number EL0142, expiry date not reported) via an unspecified route of administration, on 12Jan2021, dose 1, single for covid-19 immunisation and experienced arm pain the next day followed by fatigue and malaise  for 5 days. Patient also reported periodic severe headaches lasting several hours during this time then BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number EL3247, expiry date not reported) via an unspecified route of administration, on 02Feb2021, dose 2, single for covid-19 immunisation and experienced no reaction. The patient experienced a sore arm on next day followed by five days of general malaise on 09Aug2021. On day 2 10Aug2021 post vaccination patient experienced a fever spike of 100.5f which lasted about six hours per report.. The outcome of the events was unknown at the time of report  No follow-up attempts are possible. No further information is expected
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Extra dose administered, Off label use
Clinical narrative: blood sugar still high at 367; third dose was  yesterday 26Aug; third dose was  yesterday 26Aug; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: FD8448), via an unspecified route of administration, administered in left arm on 26Aug2021 (at the age of 64-year old) as dose 3, single for COVID-19 immunization. Medical history included breast cancer from 2000, she did not have a breast on the right, and was cancer free now; and ongoing blood pressure and diabetes diagnosed on an unspecified date. There were no concomitant medications. Historical vaccine included BNT162B2 (COMIRNATY), first dose on 27Jan2021 (lot number EFA765) and reported that the first time she took she could feel her head getting woozy and blood sugar was 400; then second dose on 23Feb2021 (lot number EN6200), both via an unspecified route of administration in left arm (at the age of 64-years-old) for COVID-19 immunization. The patient wanted to know if the COVID vaccine could elevate the blood glucose level because she had a history of diabetes and had been forgetting to take her medicine, but the first time she took it her blood sugar it was at 400 mg/dl. It dropped a bit low now on 27Aug2021, but it was still high at 367 mg/dl. She was going to check it again soon. She confirmed that it began at the time of report, ongoing and improving a little bit. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report received from a contactable consumer via company representative. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number and expiry date not reported) via unspecified route of administration, on unknown date, at dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced back pain. The outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Malaise, Nausea
Clinical narrative: fainted; dizziness; brain fog; nausea; general malaise; significant headaches; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. This consumer reported for a consumer (patient) that female of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : Not reported), via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unspecified date in Apr2021, the patient experienced fainted; On an unspecified date in 2021, significant headaches; dizziness; nausea; brain fog and general malaise. It was reported that patient to had a very bad reaction to the Pfizer COVID vaccine. She received the 2nd dose in April, fainted on the night of the 2nd dose and 6 days later had the sudden onset of significant headaches, dizziness, nausea, brain fog and general malaise that have not abated and if anything have gotten a bit worse 4 plus months later. She's been seeing a Neurologist in addition to her PCP, but no one seems to have any answers. Event took place after use of product. The clinical outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted; dizziness; brain fog; nausea; general malaise; significant headaches; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. This consumer reported for a consumer (patient) that female of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : Not reported), via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unspecified date in Apr2021, the patient experienced fainted; On an unspecified date in 2021, significant headaches; dizziness; nausea; brain fog and general malaise. It was reported that patient to had a very bad reaction to the Pfizer COVID vaccine. She received the 2nd dose in April, fainted on the night of the 2nd dose and 6 days later had the sudden onset of significant headaches, dizziness, nausea, brain fog and general malaise that have not abated and if anything have gotten a bit worse 4 plus months later. She's been seeing a Neurologist in addition to her PCP, but no one seems to have any answers. Event took place after use of product. The clinical outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Influenza like illness, Pain in extremity
Clinical narrative: She felt like she had the flu for 5-7 days; sore arm on the injection arm; arm felt feverish; This is a spontaneous report from a Pfizer sponsored program COVAX US Support via a contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number was not reported) via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced She felt like she had the flu for 5-7 days and a She had the sore arm and her arm felt feverish after both vaccines. The outcome of the event (She felt like she had the flu) was recovered on an unspecified date in 2021 and was unknown for other events.  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: Diarrhoea, Headache, Illness, Immune system disorder, Vomiting
Clinical narrative: Bad immune system; Sick; Headache; Diarrhea; throwing up; This is a spontaneous report from a contactable consumer (patient) from a Pfizer. A 68-year-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FC3180, expiration date: Oct2021) (age at the time of vaccination was 68 years) via an unspecified route of administration on 06Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included COVID 19. Concomitant medication was not reported. The patient had an immune (Clarification unknown) and a lot of health issue, her first dose of the vaccine was given on 06Aug2021. The patient stated that I had my first shot and I had COVID (later clarified as medical history) so when I got my shot I had the same symptoms headache, throwing up, everything that was in about a week. I have a very bad immune system and lot of things going on but I am 68, I will be 69 in October, no big deal but I take care of myself as best as I can. Consumer further stated, so my first Injection I got sick immediately, headache, throwing up, diarrhea and I felt like (incomplete sentence) and I had a headache every day, it's like a week and half, every day. The outcome of the events was unknown.  Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: mild nosebleed; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 26Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced mild nosebleed on Saturday 28Aug2021. Patient stated, and a bad nosebleed today on 30Aug2021. Patient wanted to know that do you have information on it causing nosebleeds. The outcome of event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive after getting the first dose; diagnosed with COVID; Tested positive after getting the first dose; diagnosed with COVID; This is a spontaneous report received from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single and a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, i got a caller was here on hold. He was in a hurry cause i was talking to earlier but she was no longer responding. The main concern here was that the caller just like to report a patient who tested positive after getting the first dose, diagnosed with COVID on unknown date. I would, I should be closing right now so I need answers for my questions please. While paraphrasing the concern, Reporter stated, I am not reporting. My question was what would be right time to pick the second dose. While paraphrasing, Reporter stated, She got the second dose and may be like and may like week or 10 days after she goes diagnosed with COVID. The events assessed as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, SARS-CoV-2 test
Clinical narrative: really low energy; This is a spontaneous report from a contactable female consumer. This female consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included covid-19 from an unknown date and unknown if ongoing tested positive for covid in July. The patient's concomitant medications were not reported. on an unspecified date the patient stated that she tested positive for covid in July she took the antibody test and had relaly high antibodies. After testing negative., she decided to get the first dose of the Pfizer covid vaccine had really low energy since getting the covid vaccine she was wondering if she can wait longer before getting the second dose of the vaccine the patient underwent lab tests and procedures which included antibody test: high antibodies, sars-cov-2 test: positive, sars-cov-2 test: negative. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her daughter tested positive for the COVID19; her daughter tested positive for the COVID19; This is a spontaneous report from a contactable consumer or other non-health care professional (parent) received via a Program.     A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she tested positive for the covid19 on an unspecified date. The caller stated that she is scheduled to receive the second dose of Pfizer Biontech COVID19 vaccine tomorrow. Caller said that she tested positive for the COVID19. Caller wanted to know if it was okay to receive the vaccine as scheduled tomorrow or if they need to re-schedule it. The patient underwent lab tests and procedures which included covid-19, positive on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Chills, Dizziness, Hyperhidrosis, Muscular weakness
Clinical narrative: Could not see; Sweating; Dizzy; Legs were weak.; Chills; This is a spontaneous report from a contactable consumer or other non hcp. A 13-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on 29Aug2021 12:45 (at the age of 13-Years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin (when she was 2-years-old) and clindamycin (when she was 12-years-old) and experienced urticaria. The patient experienced could not see, sweating, dizzy, legs were weak and chills on 30Aug2021 at 05:00. The adverse event could not see was considered as serious with seriousness criteria of medically significant and remaining events were non-serious. Patient mother reported her daughter is fine now and wanting to know is this normal and what will happen with a second dose and she is worried about the second dose and how she will react. The outcome of the events were reported as recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in his hands; This is a spontaneous report from a contactable consumer or other non-HCP (patient father) via Medical Information Team. A 29-year-old male patient BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient medical history included brain cancer and damage to his circulatory system. The concomitant medications included cisplatin, levetiracetam (KEPPRA) at a dose and frequency of 500 mg two times a day with a daily dosage of 1000 mg, lamotrigine (LAMICTAL) at a dose and frequency of 150 mg two times a day with a daily dosage of 300 mg. Father stated his 66-year-old brother received Comirnaty second dose and died in his sleep 6 weeks later. He reported his 29-year-old male son (history of brain cancer) received his first dose of the Comirnaty vaccine and after which he reported tingling in his hands. He reported his son had damage to his circulatory system from chemotherapy that resulted in ice cold hands and feet prior to the vaccine. However, he also reported he took a beet supplement as a treatment and now it was improved. He wanted to know if we have information on this as a side effect of the vaccine. He stated his son has taken or currently takes cisplatin, cyclafornite (father did not know spelling), Keppra 500 mg 2 times a day, and Lamictal 150 mg and 200 mg 2 times a day. The outcome of the event was resolving.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Hand, foot, and leg on my right side where I got the injection is numb.; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 28Aug2021 at 09:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cannabidiol (CBD OIL), famotidine (PEPCID) and paracetamol (TYLENOL); all from unknown dates, for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Aug2021 at 19:00, the patient experienced hand, foot, and leg on her right side, where she got the injection, was numb. This started 36 hours after her vaccine. It was the next day, on the day of the report, and it was still persisting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measure were taken as a result of the reported events. The clinical outcome of the event hand numb, foot numb and leg numb was not recovered at the time of report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Gait disturbance, Limb injury, Magnetic resonance imaging
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient).  A 83-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient experienced spinal stenosis, hard to walk, experience pain in my hip, my leg I felt a popping noise, the bursitis in my head, my left arm became really painful on an unspecified date. Several months after she got the second shot. She noticed that she had spinal stenosis, but it had not been bothering her at all. She noticed it started really bothering her and it became hard to walk so she went back to her pain management facility and she got an epidural that always worked in the past but it was she worked for a few days. Then the pain came back again so she got a second epidural it worked for a few days and the pain came back again and walking became difficult then she experienced pain in her hip on the left side from seemingly she meant that she was not sure if it was from the vaccine. But she was like just putting on her pants. She lived in her leg she felt a popping noise and a lot of pain in her hip. She went to the doctor and she was diagnosed so after that so now she had the bursitis in her head and her spinal stenosis was really bothering her the epidural gonna work. Then suddenly her left arm became really painful, and she could hardly lift it. He gave her a shot ceroid shot it did not help so she went to an MRI was still waiting for the results of the MRI. So now she had mmm pain in her left arm bursitis in her left hip and her spinal stenosis was really bothering her. She could hardly walk, and she never had this problem before and might be it was not related to the vaccine but when she was thinking about it. Everything happened about a month after she had the vaccine. She had been told that she been working for her. Therapeutic measures were taken as result of spinal stenosis, hard to walk, experience pain in my hip, my leg i felt a popping noise, the bursitis in my head, my left arm became really painful. The patient underwent lab tests and procedures which included magnetic resonance imaging: awaiting on (still waiting for the results). The outcome of all event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Spinal stenosis
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient).  A 83-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient experienced spinal stenosis, hard to walk, experience pain in my hip, my leg I felt a popping noise, the bursitis in my head, my left arm became really painful on an unspecified date. Several months after she got the second shot. She noticed that she had spinal stenosis, but it had not been bothering her at all. She noticed it started really bothering her and it became hard to walk so she went back to her pain management facility and she got an epidural that always worked in the past but it was she worked for a few days. Then the pain came back again so she got a second epidural it worked for a few days and the pain came back again and walking became difficult then she experienced pain in her hip on the left side from seemingly she meant that she was not sure if it was from the vaccine. But she was like just putting on her pants. She lived in her leg she felt a popping noise and a lot of pain in her hip. She went to the doctor and she was diagnosed so after that so now she had the bursitis in her head and her spinal stenosis was really bothering her the epidural gonna work. Then suddenly her left arm became really painful, and she could hardly lift it. He gave her a shot ceroid shot it did not help so she went to an MRI was still waiting for the results of the MRI. So now she had mmm pain in her left arm bursitis in her left hip and her spinal stenosis was really bothering her. She could hardly walk, and she never had this problem before and might be it was not related to the vaccine but when she was thinking about it. Everything happened about a month after she had the vaccine. She had been told that she been working for her. Therapeutic measures were taken as result of spinal stenosis, hard to walk, experience pain in my hip, my leg i felt a popping noise, the bursitis in my head, my left arm became really painful. The patient underwent lab tests and procedures which included magnetic resonance imaging: awaiting on (still waiting for the results). The outcome of all event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Aphasia, Asthenia, Balance disorder, Disturbance in attention
Clinical narrative: Severe brain fog; Difficulty concentrating; Impaired balance; Difficulty with word finding; Memory issues; Anxiety; Dizziness; Low energy; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0173) via an unspecified route of administration in the left arm on 14May2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisations. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 14May2021, the patient experienced severe fatigue within 5 hours and lasted approx. 24 hours. Severe brain fog started within 48 hours (16May2021) and lasted approximately 6 weeks. Including dizziness, difficulty concentrating, impaired balance, difficulty with word finding, memory issues, anxiety and low energy. The patient was still experiencing occasional symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of event severe fatigue was resolved on 15May2021 and severe brain fog was resolved on an unknown date in 2021. The clinical outcomes of dizziness, difficulty concentrating, impaired balance, difficulty with word finding, memory issues, anxiety and low energy were unknown at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Memory impairment
Clinical narrative: Severe brain fog; Difficulty concentrating; Impaired balance; Difficulty with word finding; Memory issues; Anxiety; Dizziness; Low energy; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0173) via an unspecified route of administration in the left arm on 14May2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisations. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 14May2021, the patient experienced severe fatigue within 5 hours and lasted approx. 24 hours. Severe brain fog started within 48 hours (16May2021) and lasted approximately 6 weeks. Including dizziness, difficulty concentrating, impaired balance, difficulty with word finding, memory issues, anxiety and low energy. The patient was still experiencing occasional symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of event severe fatigue was resolved on 15May2021 and severe brain fog was resolved on an unknown date in 2021. The clinical outcomes of dizziness, difficulty concentrating, impaired balance, difficulty with word finding, memory issues, anxiety and low energy were unknown at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Explosive diarrhea; This is a spontaneous report from a non-contactable other healthcare professional. A 31-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration on an unknown date (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced explosive diarrhea. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event explosive diarrhea was unknown at the time of report.  No follow-up attempts are possible. No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Pain in extremity
Clinical narrative: possibly been exposed to Covid; Sore arm; This is a spontaneous report from a contactable consumer (patient) received from Pfizer-sponsored program Support. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0179), via an unspecified route of administration in the upper left arm on 16Aug2021 (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. Medical history stroke, blood pressure abnormal from an unknown date and unknown if ongoing and thyroidectomy, thyroid removed from 29May2020 to an unknown date. Concomitant medication(s) included amlodipine taken for blood pressure abnormal, been on this medication since had a stroke at age 46, losartan taken for blood pressure abnormal, been taking since age 46, stated blood pressure had improved with thyroidectomy and is on so much less blood pressure medicine, lovastatin taken for blood pressure abnormal, stated began taking at age 46, pretty much started taking all blood pressure medicines at the same time, levothyroxine taken for thyroid from 29May2020 and ongoing, began taking the moment the caller had thyroid removed on 29May2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The reporter stated that, she had possibly been exposed to Covid. The exposure to Covid occurred on 23Aug2021. The patient was asking if she was to be tested for Covid and the test was positive will the patient be able to receive the second dose Pfizer Covid Vaccine. The patient also experienced a sore arm (16Aug2021) for one day after receiving the first dose Pfizer Covid Vaccine. The patient further stated that began the day she received the first dose Pfizer Covid Vaccine on 16Aug2021, the arm soreness went away on 18Aug2021, she did not take Tylenol. The caller states she recovered completely from the sore arm. The reporter also reported that she still wears a mask and takes precautions. The patient autoimmune panel was completely gone, plus last parathyroid. The patient was really nervous about that, patient would love for the Pfizer Covid Vaccine to work and be a real thing. The events did not resulted in physician room or emergency room visit. Patient did not receive any treatment for sore arm. The clinical outcome for possibly been exposed to Covid was unknown and sore arm was recovered on 18Aug2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual cycle is irregular and have missed two months at least; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 11Apr2021 at 15:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ED6955) via an unspecified route of administration in the left arm on 17Mar2021 at 16:45 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021, the patient experienced irregular menstrual cycle and the patient had missed two months at least. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. The clinical outcome of the event irregular menstrual cycle and missed two months at least was unknown at the time of this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19  on 29Aug21.; Tested positive for COVID-19 on 29Aug2021; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 23-year-old non-pregnant female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0170), via an unspecified route of administration on 09Apr2021 (23-year-old at the time of vaccination) as dose 1, single and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0158), via an unspecified route of administration on 30Apr2021 (23-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had not received any vaccine within four weeks. The patient was tested positive for covid post vaccination. On 29Aug2021, the patient was tested positive for COVID-19 and Loss of sense of taste/smell. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Nasal Swab, positive on 29Aug2021. The outcome of the events were recovering.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: a patient who just got the Covid-19 Vaccine and has tingling in her fingers.; This is a spontaneous report from a contactable pharmacist.   A patient of unspecified age and gender received an unknown dose BNT162B2 (FIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. he patient medical and concomitant medications were not reported.  The experienced tingling in her fingers after getting the COVID-19 vaccine. Reporter wanted to know whether it is normal, he does not think so. He told he will fax AE for side effects tingling in fingers. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.