chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Nasal oedema, Rash, Swelling of eyelid, Vaccination site rash
Clinical narrative: developed swelling of the eyelids, nose, and lips; developed swelling of the eyelids, nose, and lips; developed swelling of the eyelids, nose, and lips; a rash at the injection site; a rash on certain finger and toes on both the left and right side; lip swelling; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date: not reported), via an unspecified route of administration on 07Sep2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 08Sep2021, the patient experienced lip swelling. On 09Sep2021, the patient developed swelling of the eyelids, nose, and lips, a rash at the injection site, a rash on certain finger and toes on both the left and right side. Caller received her second dose of the bnt162b2 vaccine on 07Sep2021. Last night (day before reporting date) she noticed some lip swelling and then day of reporting date she developed swelling of the eyelids, nose, and lips as well as a rash at the injection site, and a rash on certain finger and toes on both the left and right side. The outcome of all the events was unknown.   No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101183653 mom/baby case
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Nerve compression, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Aug 30, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Aug 30, 2021, patient experienced some arm soreness, some joint pain only in her legs, weakness in her legs, a feeling like there was a pinch nerve but only one spot at a time. It was like it would be at her thigh and 15 to 20 minutes later it goes to her calf and then her feet. According to the caller, the pinch nerve feeling was all over her legs, but it was not happening constantly. This never happened to her before. She wants to know if these kinds of side effects have been reported previously. The outcome of the events: unknown. Follow-up activities closed. Batch/lot number not available for vaccine/BNT162B2.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vision blurred
Clinical narrative: Vision blurry/foggy all morning; Very nauseas; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 08Sep2021 at 13:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number : FC3184) via an unspecified route of administration on 17Aug2021 at 1200 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 09Sep2021 at 10:00, the patient reported vision was blurry/foggy all morning and got better in the afternoon and felt very nauseas but could not puke. The events did not result in a 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 reported events. The clinical outcome of the events vision blurry/foggy all morning and very nauseas were resolving at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report from a contactable nurse reported for her husband. A 71-years-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the reported stated her husband started Augmentin today for a sinus infection. Reported was asking about concomitant use/interactions. Patient treated event with Augmentin. The outcome of the event unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling, Vaccination site pain
Clinical narrative: lymphadenopathy (swollen lymph nodes); feeling pain on the injection site; feel some swelling on the right portion (same side with the injection site) above the clavicle "collar bone"; This is a spontaneous report from a contactable consumer reported for herself.  A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Aug2021, same evening, the patient started feeling pain on the injection site and just slept on it during the night. About 2 or 3 days, she started to feel some swelling on the right portion (same side with the injection site) above the clavicle collar bone. Up until now she still has the swelling. reporter also stated that others had it too" but she was just getting a bit concerned about the prolonged duration of the swelling. Caller wanted to know if lymphadenopathy (swollen lymph nodes) is a reported adverse event after getting the Pfizer BioNTech Covid-19 Vaccine. At the time of this report feel some swelling on the right portion was not recovered and other event outcome was not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Extra dose administered, Heart rate, Heart rate irregular, Off label use
Clinical narrative: shortness of breath; resting heartbeat went below 60 and below 90; received the third shot of the Pfizer Biontech COVID19 vaccine two and a half weeks ago; received the third shot of the Pfizer Biontech COVID19 vaccine two and a half weeks ago; This is a spontaneous report from a contactable consumer (other non-HCP) reported for himself. A 80-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date in Aug2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. second dose; during the first two inoculation, he has no adverse event and just a little unsettledness. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. first dose; during the first two inoculation, he has no adverse event and just a little unsettledness. On an unspecified date in 2021, the patient experienced shortness of breath, resting heartbeat went below 60 and below 90 and received the third shot of the Pfizer Biontech COVID19 vaccine two and a half weeks ago. Caller was a consumer who received the third shot of the Pfizer Biontech COVID19 vaccine two and a half weeks ago. Caller wants to know if it was safe for him to get a haircut. Caller stated that during the first shot, it took one month before he was safe. Caller said that during the first two inoculation, he had no adverse event and just a little unsettledness. In his third inoculation, his resting heartbeat went below 60 and below 90 and he also experienced shortness of breath for 1 week after the shot and it started after couple of days after the shot. Caller also wants to know what it means and if he should discontinue more shots in the future. The patient underwent lab and medical procedure of Heart rate twice on an unspecified date in 2021, with results of below 60 and below 90. The clinical outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate
Clinical narrative: During the first two inoculation, he has no adverse event and just a little unsettledness; This is a spontaneous report from a contactable consumer (patient). An 80-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, 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 immunization. The patient medical history and concomitant medications were not reported. It was reported that during the first two inoculation, he has no adverse event and just a little unsettledness. The patient underwent lab tests and procedures which included heart rate and showed results of 60 on third inoculation, resting heartbeat went below, heart rate was 90 on third inoculation, resting heartbeat went below. At the time of this report, the outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: just a little unsettledness; This is a spontaneous report from a contactable consumer (Patient).  A 80-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on unspecified date (Batch/Lot Number and Expiry date was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection), via an unspecified route of administration on unspecified date (Lot Number and Expiry date was not reported) as single dose for COVID-19 immunization. On unspecified date, the patient experienced just a little unsettledness. Caller stated it was a waste of time calling. Caller wanted to know if he should discontinue receiving more shots of the vaccine in the future. Response taken from attached and stated that as of now third dose for immunocompromised was only authorized. Referred caller to HCP then provided disclaimer on not providing recommendation. Request Name: REQ-493932 and Report Number: 8JOQ731D. Caller is a consumer who received the third shot of the Pfizer Biontech COVID19 vaccine two and a half weeks ago. Caller wants to know if it is safe for him to get a haircut. Caller stated that during the first shot, it took one month before he was safe. Caller said that during the first two inoculation, he has no adverse event and just a little unsettledness. In his third inoculation, his resting heartbeat went below 60 and below 90 and he also experienced shortness of breath for 1 week after the shot and it started after couple of days after the shot. Caller also wants to know what it means and if he should discontinue more shots in the future. Response taken from attached. Offered to give link for agency website but declined since he only has phone. The outcome for the event little unsettledness was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old female non pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 22Aug2021 13:00 (at the age of: 19-years-old) as dose 2, single for covid-19 immunisation. Patient medical history included covid-19 (Prior to vaccination). The patient's concomitant medications were not reported. Previously she had no allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccine with in 4 weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Sep2021 the patient developed shingles. The patient received treatment with anti virals and steroids as a result of developed shingles. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Electrocardiogram
Clinical narrative: chest discomfort; This is a spontaneous report from a contactable consumer or other non hcp. A 12-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number: unknown, Expiry Date: not reported), 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. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number: not reported, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date on tuesday night, the patient experienced chest discomfort, the reporter daughter took the patient to emergency room in the hospital (further not clarified) and they give blood test (further clarification unknown) and ECG (further clarification unknown) but the patient still has the discomfort in his chest. The patient inquired was that common. The patient underwent lab tests and procedures which included blood test (unknown result, further clarification unknown) and electrocardiogram (unknown result, further clarification unknown). Outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Condition aggravated, Dry skin, Fatigue, Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). A 80-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on Apr2021 as dose 2, single (at the age of 80-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunisation and two days later came down with a rash that went back and forth on his arm and back, once the rash got worse, he went to the emergency room (ER) and they said it was shingles, patient had a lot of pain and gets tired easily and never did before, he goes outside to work in the yard and gets very tired. On Apr2021, patient received his second dose 10 weeks after his first dose. On Apr2021, patient gets tired really easily and his balance was not what it used to be. Patient stated that when he works hard with his right arm with a wheelbarrow it seems to flare up and in the 90 degree heat it did the same thing and asks what he can do to get rid of this. Patient stated he had been to 12 or 14 doctors and none of them knew crap. On Apr2021, from the base of his neck down to his right arm and thumb and forefinger and his arm was like a piece of leather. Patient asked if Pfizer could give information to his physician, when patient got the covid shot and got shingles that was still there but was not contagious after a week and had all this pain and had shots and medicine. Patient wife asked how long will this last. The outcome of all the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). A 80-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on Apr2021 as dose 2, single (at the age of 80-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunisation and two days later came down with a rash that went back and forth on his arm and back, once the rash got worse, he went to the emergency room (ER) and they said it was shingles, patient had a lot of pain and gets tired easily and never did before, he goes outside to work in the yard and gets very tired. On Apr2021, patient received his second dose 10 weeks after his first dose. On Apr2021, patient gets tired really easily and his balance was not what it used to be. Patient stated that when he works hard with his right arm with a wheelbarrow it seems to flare up and in the 90 degree heat it did the same thing and asks what he can do to get rid of this. Patient stated he had been to 12 or 14 doctors and none of them knew crap. On Apr2021, from the base of his neck down to his right arm and thumb and forefinger and his arm was like a piece of leather. Patient asked if Pfizer could give information to his physician, when patient got the covid shot and got shingles that was still there but was not contagious after a week and had all this pain and had shots and medicine. Patient wife asked how long will this last. The outcome of all the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: pain in his right arm; shingles; This is a spontaneous report from a contactable consumer.    A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated they know one fella who on an unspecified date had pain in his right arm after the Covid shot, shingles was being affected from the shot. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Hot Flashes from getting the shot from the Pfizer shot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER2613, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had hot flashes from getting the shot from the pfizer shot. The consumer reported that have they heard of any side effect of older people of having hot flashes from getting the shot from the Pfizer shot. The outcome of the event was unknown.   No follow-up attempts possible. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Painful injection spot for about 5 days after; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Aug2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and cancer. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received sulfur (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 30Aug2021, the patient experienced painful injection spot for about 5 days after. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event painful injection spot for about 5 days after was recovered on an unknown date in Sep2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Menstruation irregular
Clinical narrative: Excessive fatigue; Malaise; Patient is post menopausal and restarted me stuck cycle; This is a spontaneous report from a contactable consumer or other non hcp. This report was received via a sales representative. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced excessive fatigue, malaise post vaccine and also patient had post-menopausal and restarted her stuck cycle. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: passed out; Dizzy; fell; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27May2021 at 18:30 (Batch/Lot Number: EW0180) (at the age of 41-years-old) as dose 2, single for COVID-19 immunisation. Medical history included minor asthma and known allergies to some fruits and vegetables. The patient did not have COVID prior to vaccination. Concomitant medications included levothyroxine, fish oil and unspecified multivitamins; all taken for an unspecified indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EW0167) via unspecified route of administration, administered in the left arm on 01May2021 (at the age of 41-years-old) for COVID-19 immunisation. On 28May2021 at 09:00, the patient felt dizzy, passed out then fell. The patient was not given any treatment for the events. The patient was not tested for COVID post vaccination. Outcome of events was recovered on an unspecified date.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Menstrual cycle was absent from Jan 2021 until July 2021.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 30Jan2021 (at the age of 34-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine and did not receive concomitant medication within two weeks of vaccination. The patient's menstrual cycle was absent from Jan2021 until July2021, since the patient received the vaccine and also missed a last month, always had a regular period. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included treatment with hormonal therapy progesterone (MANUFACTURER UNKNOWN). The clinical outcome of the event menstrual cycle was absent from Jan 2021 until July 2021, was resolved with sequelae on an unknown date in 2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Headache, Joint range of motion decreased
Clinical narrative: High fever; lethargic; nausea; upset stomach; severe headache; body aches; restless; very weak; dizziness; could not move arm that shot was received in; This is a spontaneous report received from a contactable consumer(patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  solution for injection; lot number and expiry were reported) via an unspecified route of administration, at the age of 61-year-old, on  08Sep2021 18:45, at the left arm, at dose number unknown, single for covid-19 immunisation in a Pharmacy/drug store. The patient had no known allergies. The patient's medical history was not reported. Concomitant medications in two weeks included hydrocodone bitartrate, paracetamol (NORCO), diazepam, bupropion hydrochloride (WELLBUTRIN), gabapentin and progesteron. The patient is not pregnant at the time of vaccination. The patient did not any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have prior COVID vaccination and was not tested post vaccination. On 08Sep2021 at 23:00, the patient experienced High fever, lethargic, nausea, upset stomach, severe headache, body aches, restless, very weak, dizziness, could not move arm that shot was received in. The patient did not receive treatment in response to the events. The outcome of the events was not recovered at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pain, Pyrexia, Restlessness
Clinical narrative: High fever; lethargic; nausea; upset stomach; severe headache; body aches; restless; very weak; dizziness; could not move arm that shot was received in; This is a spontaneous report received from a contactable consumer(patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  solution for injection; lot number and expiry were reported) via an unspecified route of administration, at the age of 61-year-old, on  08Sep2021 18:45, at the left arm, at dose number unknown, single for covid-19 immunisation in a Pharmacy/drug store. The patient had no known allergies. The patient's medical history was not reported. Concomitant medications in two weeks included hydrocodone bitartrate, paracetamol (NORCO), diazepam, bupropion hydrochloride (WELLBUTRIN), gabapentin and progesteron. The patient is not pregnant at the time of vaccination. The patient did not any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have prior COVID vaccination and was not tested post vaccination. On 08Sep2021 at 23:00, the patient experienced High fever, lethargic, nausea, upset stomach, severe headache, body aches, restless, very weak, dizziness, could not move arm that shot was received in. The patient did not receive treatment in response to the events. The outcome of the events was not recovered at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Laboratory test, Off label use, Pyrexia
Clinical narrative: fever; received the booster shot; received the booster shot; This is a spontaneous report from a contactable consumer (wife) reported for a 78-year-old male patient (husband). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), dose 3 via an unspecified route of administration on 02Sep2021 (at the age of 78 years old) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included ongoing spinocerebellar ataxia. When asking for medical conditions, medications, testing labs and treatment, the reporter referred to the facility where he lives. Confirms he has had Spinocerebellar ataxia for 20 years. She noted he had Covid in Apr2020 and after he had Covid he had a flare up of prostatitis which was something he never had before. This was prior to getting the vaccines. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on Dec2020 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on Jan2021 (at the age of 77 years old) for covid-19 immunisation and after the first 2 doses he was lethargic and weak, patient was diagnosed with colon cancer was diagnosed in May2021, after the first 2 vaccines. Reporter, a wife calling for her husband regarding the Pfizer Covid booster vaccine and who explained her husband received the booster shot last Thursday on 02Sep2021. The booster shot was given on 02Sep2021, the first shot was given in Dec2020 and the second was in Jan2021. He has a rare neurological condition Spinocerebellar ataxia. Currently he was getting chemotherapy for colon cancer. He has had 2 treatments of chemo and did wonderful after both. A week after the second dose of chemotherapy he had his booster shot and has tanked, he has not been the same and it has been hard for him to crawl back out of this. His labs and vitals are fine though he did have a little fever the day after vaccine on 03Sep2021, but he was not back to where he was the day before he got the vaccine. The reporter was looking for to evaluate his specific situation. She wonders if due to the neurological condition he should have gotten the booster shot. She was very concerned and though the doctors are telling her he has a lot of other things going on she felt she should take it a step further and question what was going on. She explained he got the first dose of the Covid vaccine in Dec2020 and the second dose in Jan2021. After the first 2 doses he was lethargic and weak but nothing like what he was experiencing now. She understands that now the booster shot has been compounded with the chemotherapy he was also taking but there was not an issues with the first and second dose of the Chemotherapy. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: his wife got covid in August after completing their two doses of covid vaccine with Pfizer; his wife got covid in August after completing their two doses of covid vaccine with Pfizer; This is a spontaneous report from a contactable consumer (husband) in response to consumer letter sent via follow-up letter. A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter mentioned that he and his wife (patient) got covid in an unspecified date in Aug2021 after completing their two doses of covid vaccine with Pfizer. The reporter got his vaccines in Jan2021 and his wife (patient) around Apr2021. Both were fully recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Aug2021. The outcome of the event covid-19 was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling
Clinical narrative: Both experienced swelling of the arm but her mother's was hotter, redder and hard; Tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's daughter) reported for a female patient (reporter's mother).  A 10-decade-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 02Sep2021 as dose 2, single and previously took dose 1 on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.. On an unspecified date in Sep2021 the patient experienced swelling of the arm but her mother's was hotter, redder and hard and tired. The outcome of the event were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Limb injury
Clinical narrative: weird accident that her husband had/ skin ripped/ Leg injury by cat; Very tired after first two doses of the Covid 19 Vaccines/ fatigued last time; This is a spontaneous report from a contactable consumer, the patient's wife via  sponsored program support. A 86-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, Expiration date was not reported) via an unspecified route of administration on 03Mar2021 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: reported but not clear, Expiration date was not reported) via an unspecified route of administration on 27Mar2021 (both at the age of 86 years) for covid-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease condition for 5-6 years/ around 6 or 7 years/ that was emphysema and had been on oxygen for a couple of years for unspecified indication. Patient did not take other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Concomitant medication included time-release prednisone (RAYOS) taken for an unspecified indication from an unspecified start date and ongoing. On an unknown date in 2021, the patient was very tired after first two doses of the of vaccine/ was fatigued. On an unknown date in Jun2021, patient had an weird accident in which his leg got injured from a cat. It was reported that, the cat did not actually scratch his skin because of the blanket; but patient's skin was thin from taking prednisone, so his skin ripped. Patient took dicloxacillin 500mg; states it is like penicillin, related to his wound care/ leg injury from cat. It was reported that, patient has gone through different types of wound care to heal his leg; states it was almost totally healed now. Patient did not visit to emergency room or physician office and denied of any labs, testing, or treatments relevant to events. The outcome of fatigue was unknown and leg injury from cat was recovering.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Bipolar disorder, Completed suicide, Hostility, Personality change
Clinical narrative: he was angry at everyone and committed suicide; whole personality changed.; He became so hositle; he was angry at everyone and committed suicide; bipolar, it exacerbated it.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included bipolar, it exacerbated it. The patient had covid prior vaccination. No known allergies. No other vaccine in four weeks. The patient received other medications in two weeks. Adverse event start date reported as 20Mar2021. From receiving second dose whole personality changed. All of a sudden he was picking fights with everyone. He went from being passive aggressive to arguing over politics religions and anything he could find. It did not matter. It got to the point his own family did not know him. He became so hostile that he by the end of the summer he was angry at everyone and committed suicide 29Aug2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.  The events were reported as life threatening illness (immediate risk of death from the event) and disability or permanent damage. The events received treatments. The patient did not test covid post vaccination. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: Started menstruating day after each vaccine with cramps; Started menstruating day after each vaccine with cramps; This is a spontaneous report from a contactable consumer, the patient. A 52-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 left arm on an unknown date in 2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 19Aug2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On an unknown date in 2021, day after first vaccine and on 20Aug2021 at 04:00, day after second vaccine, the patient started menstruating with cramps. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started menstruating day after each vaccine with cramps was resolved on an unknown date in 2021.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Fatigue, Pyrexia
Clinical narrative: I had pink eye maybe 3 days after the vaccine; Fever; Fatigue; This is a spontaneous report from a contactable consumer. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 18Aug2021 (age at vaccination 53 years) as dose number unknown, single for covid-19 immunisation. Medical history included High blood pressure. Concomitant medication(s) included amlodipine besilate (AMLODIPINE BESILATE); valsartan (VALSARTAN); hydrochloorthiazide (HYDROCHLOORTHIAZIDE). The patient had no known drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Aug2021 the patient experienced he had pink eye maybe 3 days after the vaccine, fever, fatigue. Patient visited doctor or other healthcare professional office/clinic visit. Patient reported, he was told that this is a common side effect and should end within 10 days. he still has fever and fatigue about twice that long. The patient received treatment of eye Rx. The outcome of event was recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Angular cheilitis, Aphthous ulcer, Lip swelling, Skin exfoliation
Clinical narrative: Angular cheilitis; Canker sore in mouth; Loss of sour taste for over 3 months; Peeling; Swollen lips; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8934) via an unspecified route of administration in the left arm on 28Mar2021 at 10:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The 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 received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 07Mar2021 at 10:15 as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 12Apr2021, the patient experienced angular cheilitis, canker sore in mouth, loss of sour taste for over 3 months, peeling and swollen lips. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures taken as a result of the events which included treatment with unspecified oral antibiotics, antifungal cream and acyclovir (MANUFACTURER UNKNOWN). The clinical outcome of the event loss of sour taste for over 3 months was recovered on an unknown date in 2021 while that of events angular cheilitis, canker sore in mouth, peeling and swollen lips were recovering at the time of report.
Sex: M
Vaccine: COVID19
Symptoms: Death, Pericardial effusion
Clinical narrative: He was hospitalized and then he died.; fluid around his heart; This is a spontaneous report from a non-contactable consumer via a Pfizer sponsored program COVAX support. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for Covid-19 Immunization. The patient was hospitalized and then he died. The doctor said the fluid around his heart was a direct symptom of the Pfizer Covid-19 vaccine. The outcome of event died was fatal and fluid around his heart was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: He was hospitalized and then he died
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Chills, Diarrhoea, Feeding disorder
Clinical narrative: chills; vomiting/ throwing up/ puking; fever; diarrhea; stomach cramping; bone are sore; after the second shot he is feeling really sick.; arm is the worse; Has not eaten or been drinking for 2-3 days; This is a spontaneous report from a contactable consumer.   A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Sep2021 (at the age of 28-year-old) as dose 2, single for covid-19 immunisation. Medical history included asthma diagnosed at least 5 years ago from an unknown date and unknown if ongoing. Concomitant medication included ongoing fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) taken for asthma. On an unspecified date patient received first dose of BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Reporter states her son just got second Pfizer Covid vaccine on Tuesday, 07Sep 2021, and has been deathly ill since then, states he has been throwing up, fever chills, puking, diarrhea, stomach cramps states he was just brought by ambulance to the hospital, states he is in the ER, cannot hold anything down, he is really sick, just happened after he got second Covid, states his bones are sore, arm is the worse. Has not eaten or been drinking for 2-3 days, staff at hospital said they will probably give him fluids and give him a Covid test. As a therapeutic measures staff at hospital said they will probably give him fluids as a result of chills, vomiting/ throwing up ,fever, diarrhea stomach cramping, bone are sore has not eaten or been drinking for 2-3 days. Outcome of the events chills, fever, diarrhoea, vomiting, bones are sore was not recovered and outcome of the rest all the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up