chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fall, SARS-CoV-2 test
Clinical narrative: That night she went to go to bed and fell to the floor.; 3 days later she caught covid in the hospital after taking the Pfizer shot.; 3 days later she caught covid in the hospital after taking the Pfizer shot.; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date in 2021 (at the age of 69 years old) as dose number unknown, single, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter said that the patient (girlfriend's mother) took the Pfizer Covid vaccine in 2021 and that night she went to go to bed and fell to the floor. They rushed her to the hospital and 3 days later she caught covid (2021) in the hospital after taking the Pfizer shot. She was covid positive. The patient was hospitalized from an unspecified date in 2021 due to the events reported. The outcome of the events was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Memory impairment
Clinical narrative: HA; brain fog; short term memory issues; This is a spontaneous report from a non-contactable nurse (patient). A 28-year-old male patient received BNT162B2, via an unspecified route of administration, administered in deltoid left on 18Sep2021 (Batch/Lot number was not reported) at the age of 28 years old, as dose 1, single for COVID-19 immunisation. There were no other medical history nor concomitant medications. No known allergies. No other vaccine in four weeks nor other medications in two weeks. No covid prior vaccination; not covid tested post vaccination. Got shot 2 weeks ago. The patient experienced headache (HA), brain fog and short term memory issues on 18Sep2021, every day since including the day of the injection. The reporter assessed adverse events as serious, resulted in disability or permanent damage. No treatment was provided. Outcome of events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Headache, Feeling abnormal, Memory impairment and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Erythema, General physical health deterioration, Malaise, Myocardial infarction
Clinical narrative: think it gave her/him a heart attack; real weak; right arm still swelled up; feel sick; face turned deep red; wrecked health; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced think it gave her/him a heart attack, real weak, right arm still swelled up, feel sick, face turned deep red, wrecked health on an unspecified date. Time she/he got back to the house she/he almost died. The patient mean it almost killed her/him. Her/his face turned deep red and think it gave her/him a heart attack (clarification unknown). She/he almost died right here at own home (further clarification was unknown) and she/he had a bad reaction, it literally gave 'bumps' in her/his body. The patient called about a month ago and was in 'normalization'. 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: Peripheral swelling
Clinical narrative: think it gave her/him a heart attack; real weak; right arm still swelled up; feel sick; face turned deep red; wrecked health; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced think it gave her/him a heart attack, real weak, right arm still swelled up, feel sick, face turned deep red, wrecked health on an unspecified date. Time she/he got back to the house she/he almost died. The patient mean it almost killed her/him. Her/his face turned deep red and think it gave her/him a heart attack (clarification unknown). She/he almost died right here at own home (further clarification was unknown) and she/he had a bad reaction, it literally gave 'bumps' in her/his body. The patient called about a month ago and was in 'normalization'. Outcome of the events was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Investigation, Pancreatitis relapsing
Clinical narrative: acute pancreatitis; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19, Lot Number: EK5730), via an unspecified route of administration, administered in arm right on 18Dec2020 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included acute pancreatitis from an unknown date. There were no concomitant medications. The patient previously took Reglan [metoclopramide hydrochloride], and experienced drug allergy. Within a week and a half from getting the 1st of 2 Pfizer vaccines, the patient had acute pancreatitis on 04Jan2021. The acute pancreatitis would resolve for a short time and then come back within days for several reoccurrences. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 5 days within the month of Jan/Feb of 2021. The patient received IV fluids, pain/nausea meds, CT scans, blood work as treatment. The outcome of the event was recovered.; Sender's Comments: Based on the currently available information the  causal association between the event acute pancreatitis and the suspect drug BNT162B2  is assessed unrelated and more likely due to underlying medical condition of acute pancreatitis.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood testosterone, Heavy menstrual bleeding, Menstruation irregular, Vitamin B12
Clinical narrative: started her period although like she had a week ago finished it; really very heavier than the normal period; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Oct2021 (Batch/Lot Number: 301458A) at the age of 46 years as single dose for covid-19 immunisation. Medical history included Blood pressure high. Concomitant medications included beta blockers for high blood pressure. Patient got the first dose of the Pfizer vaccine on Thursday 07Oct2021 and she started her period although like she had a week ago finished it, so it was really very heavier than the normal period, so patient was concerning. Event start date was 08Oct2021. Patient had blood work for hormones level, testosterone and Vitamin B12 and patient guessed on 27Sep2021. Events were worsening. No treatment was received for the event. Outcome of events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: rash on right arm from elbow to wrist that spread to left arm; Blotches; Severe itching; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (COVID 19), dose 1 via an unspecified route of administration, administered in right arm in May2021 07:00 (Batch/Lot number was not reported) as dose 1, single at the age of 52-year-old for COVID-19 immunization. The patient was not pregnant. Medical history included high bop, sleep apnea, obesity. No other vaccine in four weeks. Concomitant medications included lisinopril; linaclotide (LINZESS); levothyroxine; fluoxetine; vitamin d taken in two weeks. The patient previously took biaxin, claritin [loratadine] and experienced allergy. The patient experienced rash on right arm from elbow to wrist that spread to left arm. Blotches all over top of both legs. Severe itching to where she wanted to tear her skin off. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. The outcome of event was not recovered.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Illness, Loss of consciousness, Pleural effusion
Clinical narrative: kind of unconscious; his heart is barely working; water in the lungs; he got so sick; This is a spontaneous report from a contactable physician.   A male patient of (33 or 34 years old) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (Lot number: Not reported) on an unspecified date as dose 1, single and via intramuscular on an unspecified route of administration (Lot number: Not reported) on an unspecified date as dose 2, single for COVID-19 immunization. On an unspecified date in 2021 patient experienced kind of unconscious, his heart was barely working, water in the lungs and he got so sick. It was reported that after the patient received the third dose he got so sick he was hospitalized. The patient had been in the hospital for 6-7 days. What does Pfizer recommend. Had anything happened with the safety of the Pfizer covid booster vaccine. Had one had a severe reaction like this. was there an antidote. The caller understood the doctors in Australia were giving good care to the patient as the patient was in Australia. was there someone in Australia from Pfizer who could help the caller's sister. Caller was asking what Pfizer recommends for anaphylactic shock. Seriousness of the kind of unconscious, his heart was barely working was hospitalization and medically significant and events water in the lungs, he got so sick was medically significant. It was reported that as soon as the patient had the third dose he slept and then they took him to the emergency room. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information provided the causal association between the events loss of consciousness, heart failure, pleural effusion and illness with the usage of the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed once detailed information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Seizure
Clinical narrative: seizures; Had bad reaction; I had the wicked reaction; This is a spontaneous report from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on an unspecified date, at dose 2, single for covid-19 immunization. Medical history included asthma; did not use the inhaler every day, migraine and the patient  was immunocompromised (ongoing). Concomitant medications included cefaclor; fluticasone; oxcarbazepine; quetiapine fumarate (SEROQUEL) and amitriptyline hydrochloride (TRIPTA). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient experienced seizures and had a bad reaction/wicked reaction on an unspecified date. The patient had booster dose of bnt162b2 on an unspecified date. The 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: COVID-19
Clinical narrative: 10 day after the first shot contracted Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included gout from 2019. 10 day after the first shot the patient contracted covid. Concomitant medications included unspecified gout medication from 2019. The outcome of event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Facial pain, Headache
Clinical narrative: Severe body and head aches.; Severe body and head aches; Chills; Nausea; Diarrhea; Intense face pain in sinus zone and red splotches in these areas.; Intense face pain in sinus zone and red splotches in these areas.; Hives in armpit, under breasts, down sides, and in groin area; Fever of 102.5; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female consumer reported for herself that she received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number 30155BA) via an unspecified route of administration in left arm on 08Oct2021 at 09:00AM (at the age of 68-year-old) at single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in left arm on 16Jan2021 at 09:30AM and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in left arm on 06Feb2021 at 01:00PM, both for COVID-19 immunisation. Age at first and second vaccination was 67-year-old. Other relevant medical history was none. The patient did not receive any other vaccines withing 4 weeks prior to the COVID vaccine. The patient had allergy to Levaquin, Macrobid and Morphine. Concomitant medications included colesevelam, cetirizine hydrochloride (ZYRTEC), multivitamin and multimineral. On 08Oct2021 at 06:30PM the patient experienced fever of 102.5, severe body and head aches, chills, nausea, diarrhea, intense face pain in sinus zone and red splotches in these areas, hives in armpit, under breasts, down sides, and in groin area. The patient was told to go to ER if it got worse, but she did not go. The events required physician office visit and were treated with Benadryl, Tylenol and Ibuprofen. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. Nasal swab was negative on 11Mar2021, 27Jun2021 and 18Aug2021. The events were resolving at the time of report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Rash macular, SARS-CoV-2 test
Clinical narrative: Severe body and head aches.; Severe body and head aches; Chills; Nausea; Diarrhea; Intense face pain in sinus zone and red splotches in these areas.; Intense face pain in sinus zone and red splotches in these areas.; Hives in armpit, under breasts, down sides, and in groin area; Fever of 102.5; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female consumer reported for herself that she received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number 30155BA) via an unspecified route of administration in left arm on 08Oct2021 at 09:00AM (at the age of 68-year-old) at single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in left arm on 16Jan2021 at 09:30AM and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in left arm on 06Feb2021 at 01:00PM, both for COVID-19 immunisation. Age at first and second vaccination was 67-year-old. Other relevant medical history was none. The patient did not receive any other vaccines withing 4 weeks prior to the COVID vaccine. The patient had allergy to Levaquin, Macrobid and Morphine. Concomitant medications included colesevelam, cetirizine hydrochloride (ZYRTEC), multivitamin and multimineral. On 08Oct2021 at 06:30PM the patient experienced fever of 102.5, severe body and head aches, chills, nausea, diarrhea, intense face pain in sinus zone and red splotches in these areas, hives in armpit, under breasts, down sides, and in groin area. The patient was told to go to ER if it got worse, but she did not go. The events required physician office visit and were treated with Benadryl, Tylenol and Ibuprofen. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. Nasal swab was negative on 11Mar2021, 27Jun2021 and 18Aug2021. The events were resolving at the time of report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe body and head aches.; Severe body and head aches; Chills; Nausea; Diarrhea; Intense face pain in sinus zone and red splotches in these areas.; Intense face pain in sinus zone and red splotches in these areas.; Hives in armpit, under breasts, down sides, and in groin area; Fever of 102.5; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female consumer reported for herself that she received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number 30155BA) via an unspecified route of administration in left arm on 08Oct2021 at 09:00AM (at the age of 68-year-old) at single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in left arm on 16Jan2021 at 09:30AM and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in left arm on 06Feb2021 at 01:00PM, both for COVID-19 immunisation. Age at first and second vaccination was 67-year-old. Other relevant medical history was none. The patient did not receive any other vaccines withing 4 weeks prior to the COVID vaccine. The patient had allergy to Levaquin, Macrobid and Morphine. Concomitant medications included colesevelam, cetirizine hydrochloride (ZYRTEC), multivitamin and multimineral. On 08Oct2021 at 06:30PM the patient experienced fever of 102.5, severe body and head aches, chills, nausea, diarrhea, intense face pain in sinus zone and red splotches in these areas, hives in armpit, under breasts, down sides, and in groin area. The patient was told to go to ER if it got worse, but she did not go. The events required physician office visit and were treated with Benadryl, Tylenol and Ibuprofen. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. Nasal swab was negative on 11Mar2021, 27Jun2021 and 18Aug2021. The events were resolving at the time of report.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Experiencing headache; Feels like he is tired/ He is feeling tired; This is a spontaneous report from a contactable consumer or other non hcp (mother) reporting for a patient (son).  A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on 09Oct2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on unknown date as dose 1, single for covid-19 immunization. On an unspecified date in 2021, the patient reported experiencing headache, feels like he is tired/ he is feeling tired. Reporter stated her son had the second dose of vaccine yesterday but he was complaining he had a headache and he felt like he was tired. Reporter asked what kind of medicine that she needed to give. Her concern was could she give him a medicine just like over the counter medicine like Tylenol or Advil or Motrin or pain reliever. Reporter further stated she was going to ask somebody and she was not going to go to the doctor because that's only the side effect, it was not the fever, feeling right now. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myocardial infarction, Pain in extremity, Panic attack
Clinical narrative: Had severe panic attack, I thought I am having a heart attack; My shoulder within the right arm, it was sore for 3 weeks; Joints still hurt; had severe panic attack; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Aug2021 (Lot Number: EE2588) at the age of 54 years as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID). Patient wanted to report an adverse event that patient had from getting the vaccine. The first shot that she received, her shoulder within the right arm, it was sore for 3 weeks and the joints still hurt. Patient had had severe panic attack, she thought she was having a heart attack (Further clarification was unknown) and patient got passed that, so she got her second shot. Outcome of joints still hurt was not recovered and the other events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable consumer (patient). A 25-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8737) via an unspecified route of administration on 15Mar2021 (At the age of 25-year-old) as single dose and second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6208) via an unspecified route of administration on 05Apr2021 (At the age of 25-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19. On 04Oct2021 the patient experienced breakthrough covid case, covid. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 07Oct2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event breakthrough covid case was unknown, and other event covid was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; This is a spontaneous report from a contactable physician. A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Mar2021 at the age of 69 years as single dose for covid-19 immunisation. Medical history included hyperlipidemia, DDD (Degenerative disc disease), past drug history: allergy, covid-19. Concomitant medications included pravastatin. Historical vaccine included the first dose of bnt162b2, intramuscular in Mar2021 at the age of 69 years as single dose for covid-19 immunisation. Patient was not pregnant. Developed muscle pain in back of thighs and groins 2 weeks after covid vaccine, moved to neck and shoulders and then to radiating down arms Medrol dose pack helped - but pain recurred when she stopped. Date of start of reaction/event was Apr2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment Kenalog shot, Ibuprofen, Amitriptyline, Rheumatology referral, Prednisone were received. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events Myalgia, pain in extremity, groin pain, neck pain, arthralgia and the suspect drug BNT162B2.   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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling, Pruritus, Rash
Clinical narrative: rash/It's on my entire body's but mostly my arms and wrists; Severe itching; swelled on hands and feet; My finger tips on right hand are still numb; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (COMIRNATY),  via an unspecified route of administration, administered in Arm Left on 05Oct2021 12:00 (Lot Number: 30130BA), at the age of 47-year-old, as dose 2, single for COVID-19 immunisation. The patient's medical history included allergy to an unspecified drug. The patient received no concomitant medications. The patient was not pregnant at time of vaccination. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 14Sep2021 at 12:00 PM (Lot Number: EE3592), at the age of 47-year-old, as dose 1, single for COVID-19 immunisation. The patient reported she experienced rash that comes and goes. Seemed to be bad in the evening for some reason. It was on her entire body but mostly her arms and wrists. She had severe itching (she could't take it). First two days after second dose she swelled on hands and feet; that seemed to have stopped. Her fingertips on right hand were still numb. The events started on 05Oct2021 at 16:00. She never had a problem with breathing (Benadryl helped). As of 10Oct2021 she had been taking Benadryl for 5 days and she was going to go to doctor the next day because she couldn't take it anymore. The events were reported as non serious. The event 'swelled on hands and feet' was resolved on 08Oct2021, while other events had not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Tongue throat tingled; Tongue throat tingled; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 22Apr2021 15:45 (Batch/Lot Number: EW0175) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the dose 1 of bnt162b2 (Batch/Lot number: ER8733) intramuscular in left arm on 30Mar2021 01:15 (at age of 35 years old, as reported) for COVID-19 immunization. On an unspecified date, the patient experienced tongue throat tingled. The doctor talked to the patient, took Benadryl (as reported). The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Vaccination site pain
Clinical narrative: flutterings in my chest periodically; Right arm injection site pain; This is a spontaneous report from a contactable other HCP. A 29-year-old female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 08Oct2021 at 08:30 (Batch/Lot Number: FF2589) as DOSE 2, SINGLE for Covid-19 immunization. Medical history included obesity, known allergies: raw fruits and known allergies: vegetables. The patient received initial dose of BNT162B2 on 17Sep2021 (Dose number: 1, Lot number: FF2588, Administration time: 08:30 AM, location: Right arm) and reported Muscle/body aches from the bottom of my ribcage to the base of my neck and Chest pain- my heart was pounding hard against my chest like it was about to beat out of my chest. Concomitant medication included dextroamphetamine hydrochloride (DEXTROAMPHETAMINE HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took sodium benzoate and experienced drug hypersensitivity (Known allergies: sodium benzoate). The patient experienced fluttering in my chest periodically and right arm injection site pain on unspecified dates. The patient reported Right arm injection site pain was present to date of 2nd dose/ 3 weeks and I experience fluttering in my chest periodically which were not present prior to receiving this vaccine. No treatments was received for the events. Outcome of the events was recovered with sequelae.; Sender's Comments: Based on the available information,. the contributory role of the suspect product BNT162B2 (BNT162B2) to reported Cardiac flutter is possibly related. Case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202101346039 same patient/reporter/drug, different dose/Event
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Drug ineffective, Headache, Hyperhidrosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Lot Number: EJ1685) at the age of 29 years as single dose and the first dose of bnt162b2, via an unspecified route of administration on 01Mar2021 (Lot Number: EK5730) at the age of 29 years as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Household family member was positive for COVID. Pfizer colleague wellness labeled patient as presumed positive. Patient was experiencing the following symptoms: fever, chills, sweats, headache, and a cough. Adverse event start date was 09Oct2021. No treatment was received. Covid (Nasal Swab) tested post vaccination was negative. Outcome of events were recovering.   Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Lot Number: EJ1685) at the age of 29 years as single dose and the first dose of bnt162b2, via an unspecified route of administration on 01Mar2021 (Lot Number: EK5730) at the age of 29 years as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Household family member was positive for COVID. Pfizer colleague wellness labeled patient as presumed positive. Patient was experiencing the following symptoms: fever, chills, sweats, headache, and a cough. Adverse event start date was 09Oct2021. No treatment was received. Covid (Nasal Swab) tested post vaccination was negative. Outcome of events were recovering.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: specific patient that have gotten both doses of the Pfizer vaccine and have come down with covid; specific patient that have gotten both doses of the Pfizer vaccine and have come down with covid; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority support, received from a contactable other healthcare professional.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, and 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's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the reporter has patients that have gotten both doses of the Pfizer vaccine and have come down with COVID. The reporter wants to know if she gives the booster shot do the patients have to isolate for 2 weeks. She would also like to get the booster so she wants to get an answer if she would have to isolate as well. The reporter added that there is a specific patient that have gotten both doses of the Pfizer vaccine and have come down with COVID. The reporter has firsthand knowledge of the patient and was reporting on a specific patient. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to event have gotten both doses of the Pfizer vaccine and have come down with COVID cannot be excluded based on temporal association and available information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She was diagnosed with covid-19 on 11Sep2021; She was diagnosed with covid-19 on 11Sep2021; This is a solicited report from Regulatory Authority based on information received by Pfizer from the RA (manufacturer control number: 21K-163-4105766-00). A contactable consumer (patient) reported that a 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 45-years-old), dose 1 intramuscular on 20Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 intramuscular on 10Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation; and Risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous in Jun2020 (Batch/Lot number was not reported), at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient had received Pfizer covid-19 vaccination on 20Aug2021 and 10Sep2021. She was diagnosed with covid-19 on 11Sep2021. On 20Aug2021, she received first dose of COVID-19 vaccine manufactured by Pfizer Biontech. On 10Sep2021 she had received second dose of COVID-19 vaccine manufactured by Pfizer Biontech. The action taken in response to the events for Risankizumab was unknown. Causality for Skyrizi (Risankizumab): The reporter's causality for the event(s) of COVID-19 was not provided. Causality for COVID-19 vaccine per reporter was not reported.    The reporter's assessment of the causal relationship of the events with the BNT162B2  was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, The casual association between the reported event COVID-19 with suspected vaccine BNT162B2 cannot be completely excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Headache, Pain
Clinical narrative: severe pain; severe headache.; Skin crawling / painful; This is a spontaneous report from a contactable consumer via Pfizer colleague.   A 60-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unknown route, on 06Oct2021 (at the age of 60-year-old) at single dose for COVID-19 immunisation. The patient received the first and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunisation. On 06Oct2021, the patient developed severe pain, severe headache and skin crawling / painful. No seriousness criteria were provided. The patient was not treated for the events.  The patient had recovered from the events on unknown date in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Fatigue, Inflammation
Clinical narrative: Felt fatigued; High amounts of Inflammation; Crohn's disease flare up; This is a solicited report based on information by Pfizer from Regulatory Authority, manufacturer control number: 21K-163-4110252-00. A contactable female consumer (patient) reported a patient of an unspecified age received BNT162B2, intramuscular on 12Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at UNK (Citrate free) for moderate to severe adult Crohn's disease. Medical history included moderate to severe adult Crohn's disease. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient's concomitant medications were not reported. The patient previously took BNT162B2 via Intramuscular route on 12May2021 as DOSE 1, SINGLE for COVID-19 immunization. On unknown date in 2021, the patient experienced Crohn's disease flare up and high amounts of inflammation. In Jun2021, the patient experienced felt fatigued after second Covid vaccine. The action taken in response to the events for adalimumab was dose not changed. The outcome of Crohn's disease flare up was not recovered while the other events was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Crohn's disease flare up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of felt fatigued after second covid vaccine with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of high amounts of inflammation was not provided.  Causality for BNT162B2: Crohn's disease aggravated: Causality as per reporter (Drug/Vaccine): Not Related; Fatigue: Causality as per reporter (Drug/Vaccine): Possible; Inflammation: Causality as per reporter (Drug/Vaccine): Not Related.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. Case will be further reviewed on follow up information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Took deadly Vaccine then fell flat on his face.; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age (described as a little boy) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient "took deadly vaccine then fell flat on his face". The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Infertility female
Clinical narrative: two pregnant women lost their baby and can no longer have children.; two pregnant women lost their baby and can no longer have children.; This is a spontaneous report from a contactable consumer or other non HCP.  This consumer reported similar events for 2 patients. This is the first of 2 reports.  A female patient of an unspecified age received bnt162b2 (BNT162B2) unknown dose number, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history  and concomitant medications were not reported.  It was reported that two pregnant women lost their baby and can no longer have children. (medically significant) on an unspecified date with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : 202101366241 Same reporter, drug and events, different patient
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: received the Pfizer vaccine and still got Covid; received the Pfizer vaccine and still got Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I received the Pfizer vaccine and still got Covid". The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea
Clinical narrative: anaphylactic reaction; difficulty breathing; dizziness; This is a spontaneous report from a contactable physician.  A 69-year-old female patient (age at vaccination: 69-year-old) received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on 10Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient's medical history include scar. Concomitant medications were not reported. The patient previously took Flu vaccine for immunisation; hyaluronic acid and experienced allergic reaction; lidocaine (15Jan2021) for treatment of scar and experienced drained yellow fluid, infection in site, implant site swelling, had pain, felt hard as a rock/cyst like a rock in site, bruising, weight loss, area/site was black; took vaccine for shingles in 2020 for immunisation. On 10Feb2021, the patient received the Pfizer Covid vaccine and immediately had an anaphylactic reaction described as difficulty of breathing and dizziness. The patient was treated with an EpiPen EPINEPHRINE], Benadryl [DIPHENHYDRAMINE HYDROCHLORIDE, and IV steroids. While she was being observed in the ER, the patient requested and was given IV antibiotics for her implant site infection at her scar.  The outcome of events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Anaphylactic reaction, Difficulty breathing and Dizziness.  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