chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Inflammation
Clinical narrative: Heavy bleeding and inflammation where IUD was; Heavy bleeding and inflammation where IUD was; Her period was very heavy, moreso than ever, and the next month and the month after was worse; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received bnt162b2 (BNT162B2), intramuscular administered in Arm Left on 14Apr2021 15:00, at the age of 48-years-old, (Lot Number: ER8729; Expiration Date: 31Jul2021) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation; intrauterine contraceptive device (PARAGARD), via an unspecified route of administration from Oct2019 (Batch/Lot number was not reported) for Birth control. Historical vaccine includes dose 1 of Comirnaty, lot number: EP6955, expiration date: 30Jun2021, 30mcg, injected in left arm in the muscle. The patient also previously received flu vaccine in which her arm hurt and felt tired. The patient's medical history includes none. Concomitant medication is none. On 30Apr2021 12:00, the patient stated she started having Heavy bleeding and inflammation where IUD was.  It kept getting worse. The patient stated her Paraguard causes heavy bleeding anyway, so she really did not put it together at that time.  Her period was very heavy, moreso than ever, and the next month and the month after was worse.  In Aug 2021, she was only without a cycle for 5 days and it was horrible.  Her IDU was removed a week after the hurricane.  She had it done in the doctor's office and had no effects.  She is fine now.  She doesn't know if it had some sort of reaction with the copper.  She is healthy and has no issues now.  The events involved physician office visit and emergency room visit. The action taken for the event INTRAUTERINE CONTRACEPTIVE DEVICE (PARAGUARD) was unknown. The outcome of the events was recovered. Treatment was received for the events.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Uterine haemorrhage, Uterine inflammation
Clinical narrative: Heavy bleeding and inflammation where IUD was; Heavy bleeding and inflammation where IUD was; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included intrauterine contraceptive device (PARAGARD) taken as contraceptive, start and stop date were not reported. The patient experienced heavy bleeding and inflammation where IUD was on an unspecified date .  She had her Paraguard IUD removed on an unknown date.Outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Inflammation
Clinical narrative: Heavy bleeding and inflammation where IUD was; Heavy bleeding and inflammation where IUD was; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included intrauterine contraceptive device (PARAGARD) taken as contraceptive, start and stop date were not reported. The patient experienced heavy bleeding and inflammation where IUD was on an unspecified date .  She had her Paraguard IUD removed on an unknown date.Outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Body temperature, Burning sensation, Cardiac flutter
Clinical narrative: intense pressure in chest with heart flutter; Rash; itching; shivers/chills; burning and tingling sensation; burning and tingling sensation; intense pressure in chest with heart flutter; rapid heartbeat; difficulty breathing; weird sound in ears; fever (101-102); fatigue; poor balance; confusion; pain in injected arm; very swollen arm; moderate to severe shooting joint pain; neurological pains; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FE5S92), via an unspecified route of administration in the right arm on 21Sep2021 at 14:15 (at the age of 32-year-old), dose 2, single for COVID-19 immunisation. Medical history included fibromyalgia, post-traumatic stress disorder (cPTSD), hypermobility, peanut allergy, scoliosis, allergic rhinitis, underweight, and chronic pain. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3183) administered via an unspecified route of administration in the left arm on 31Aug2021 (at the age of 31-year-old), dose 1, single for COVID-19 immunisation and the patient experienced skin peeling near injection site, chills, shivers, burning sensation entire body, itching, rash, difficulty breathing, swelling at injection site to the point the bandaid cut into the skin, fever, severe pain next day left arm, headache, fatigue. The patient previously took amoxicillin, codeine, and azithromycin (AZO) and the patient had allergy to these medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 21Sep2021 at 16:00, the patient experienced rash, itching, chills, shivers, burning and tingling sensation, intense pressure in chest with heart flutter, rapid heartbeat, difficulty breathing, weird sound in ears, fever (101-102), fatigue, poor balance, confusion, pain in injected arm, very swollen arm, moderate to severe shooting joint pain, neurological pains, and was bedridden the next day. The patient took Benadryl and Tylenol for the events. The patient called nurse and was under observation. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101147783 Same reporter/patient/product, different dose/similar events
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Confusional state, Dyspnoea, Fatigue
Clinical narrative: intense pressure in chest with heart flutter; Rash; itching; shivers/chills; burning and tingling sensation; burning and tingling sensation; intense pressure in chest with heart flutter; rapid heartbeat; difficulty breathing; weird sound in ears; fever (101-102); fatigue; poor balance; confusion; pain in injected arm; very swollen arm; moderate to severe shooting joint pain; neurological pains; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FE5S92), via an unspecified route of administration in the right arm on 21Sep2021 at 14:15 (at the age of 32-year-old), dose 2, single for COVID-19 immunisation. Medical history included fibromyalgia, post-traumatic stress disorder (cPTSD), hypermobility, peanut allergy, scoliosis, allergic rhinitis, underweight, and chronic pain. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3183) administered via an unspecified route of administration in the left arm on 31Aug2021 (at the age of 31-year-old), dose 1, single for COVID-19 immunisation and the patient experienced skin peeling near injection site, chills, shivers, burning sensation entire body, itching, rash, difficulty breathing, swelling at injection site to the point the bandaid cut into the skin, fever, severe pain next day left arm, headache, fatigue. The patient previously took amoxicillin, codeine, and azithromycin (AZO) and the patient had allergy to these medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 21Sep2021 at 16:00, the patient experienced rash, itching, chills, shivers, burning and tingling sensation, intense pressure in chest with heart flutter, rapid heartbeat, difficulty breathing, weird sound in ears, fever (101-102), fatigue, poor balance, confusion, pain in injected arm, very swollen arm, moderate to severe shooting joint pain, neurological pains, and was bedridden the next day. The patient took Benadryl and Tylenol for the events. The patient called nurse and was under observation. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101147783 Same reporter/patient/product, different dose/similar events
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Neuralgia, Paraesthesia, Peripheral swelling
Clinical narrative: intense pressure in chest with heart flutter; Rash; itching; shivers/chills; burning and tingling sensation; burning and tingling sensation; intense pressure in chest with heart flutter; rapid heartbeat; difficulty breathing; weird sound in ears; fever (101-102); fatigue; poor balance; confusion; pain in injected arm; very swollen arm; moderate to severe shooting joint pain; neurological pains; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FE5S92), via an unspecified route of administration in the right arm on 21Sep2021 at 14:15 (at the age of 32-year-old), dose 2, single for COVID-19 immunisation. Medical history included fibromyalgia, post-traumatic stress disorder (cPTSD), hypermobility, peanut allergy, scoliosis, allergic rhinitis, underweight, and chronic pain. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3183) administered via an unspecified route of administration in the left arm on 31Aug2021 (at the age of 31-year-old), dose 1, single for COVID-19 immunisation and the patient experienced skin peeling near injection site, chills, shivers, burning sensation entire body, itching, rash, difficulty breathing, swelling at injection site to the point the bandaid cut into the skin, fever, severe pain next day left arm, headache, fatigue. The patient previously took amoxicillin, codeine, and azithromycin (AZO) and the patient had allergy to these medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 21Sep2021 at 16:00, the patient experienced rash, itching, chills, shivers, burning and tingling sensation, intense pressure in chest with heart flutter, rapid heartbeat, difficulty breathing, weird sound in ears, fever (101-102), fatigue, poor balance, confusion, pain in injected arm, very swollen arm, moderate to severe shooting joint pain, neurological pains, and was bedridden the next day. The patient took Benadryl and Tylenol for the events. The patient called nurse and was under observation. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101147783 Same reporter/patient/product, different dose/similar events
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Tinnitus, Vaccination site pain
Clinical narrative: intense pressure in chest with heart flutter; Rash; itching; shivers/chills; burning and tingling sensation; burning and tingling sensation; intense pressure in chest with heart flutter; rapid heartbeat; difficulty breathing; weird sound in ears; fever (101-102); fatigue; poor balance; confusion; pain in injected arm; very swollen arm; moderate to severe shooting joint pain; neurological pains; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FE5S92), via an unspecified route of administration in the right arm on 21Sep2021 at 14:15 (at the age of 32-year-old), dose 2, single for COVID-19 immunisation. Medical history included fibromyalgia, post-traumatic stress disorder (cPTSD), hypermobility, peanut allergy, scoliosis, allergic rhinitis, underweight, and chronic pain. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3183) administered via an unspecified route of administration in the left arm on 31Aug2021 (at the age of 31-year-old), dose 1, single for COVID-19 immunisation and the patient experienced skin peeling near injection site, chills, shivers, burning sensation entire body, itching, rash, difficulty breathing, swelling at injection site to the point the bandaid cut into the skin, fever, severe pain next day left arm, headache, fatigue. The patient previously took amoxicillin, codeine, and azithromycin (AZO) and the patient had allergy to these medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 21Sep2021 at 16:00, the patient experienced rash, itching, chills, shivers, burning and tingling sensation, intense pressure in chest with heart flutter, rapid heartbeat, difficulty breathing, weird sound in ears, fever (101-102), fatigue, poor balance, confusion, pain in injected arm, very swollen arm, moderate to severe shooting joint pain, neurological pains, and was bedridden the next day. The patient took Benadryl and Tylenol for the events. The patient called nurse and was under observation. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101147783 Same reporter/patient/product, different dose/similar events
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, Confusional state, Dizziness, Dysstasia, Headache
Clinical narrative: got my first severe migraine; nauseous; headache; difficulty speaking; difficulty standing; severe aura; ringing in ears; dizziness; extreme confusion; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 03Sep2021 at 18:30 (Batch/Lot number was not reported) as dose 1, single (at the age of 28 years old) for COVID-19 immunization. Medical history included complex migraine in 2017. No known allergies. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. It was reported that the patient had no side effects first 48 hours after the shot. On 06Sep2021, she felt nauseous and got her first severe migraine that would go on daily for 15 days. That day of the report was the first day she only had a headache and no migraine. Migraines were debilitating 90% of the time difficulty speaking, difficulty standing, severe aura, ringing in ears, dizziness, extreme confusion. She had a history of less than 5 severe migraines, one in which she went to ER for in 2017 but had not experienced severe migraine since then. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown if patient had COVID prior vaccination and was tested post vaccination. The patient underwent lab tests and procedures which included covid test: negative on 09Sep2021 via nasal swab. Therapeutic measures were taken as result of the events, ae treatment Inhaler, migraine prescription. The outcome of the events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, SARS-CoV-2 test, Speech disorder, Tinnitus
Clinical narrative: got my first severe migraine; nauseous; headache; difficulty speaking; difficulty standing; severe aura; ringing in ears; dizziness; extreme confusion; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 03Sep2021 at 18:30 (Batch/Lot number was not reported) as dose 1, single (at the age of 28 years old) for COVID-19 immunization. Medical history included complex migraine in 2017. No known allergies. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. It was reported that the patient had no side effects first 48 hours after the shot. On 06Sep2021, she felt nauseous and got her first severe migraine that would go on daily for 15 days. That day of the report was the first day she only had a headache and no migraine. Migraines were debilitating 90% of the time difficulty speaking, difficulty standing, severe aura, ringing in ears, dizziness, extreme confusion. She had a history of less than 5 severe migraines, one in which she went to ER for in 2017 but had not experienced severe migraine since then. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown if patient had COVID prior vaccination and was tested post vaccination. The patient underwent lab tests and procedures which included covid test: negative on 09Sep2021 via nasal swab. Therapeutic measures were taken as result of the events, ae treatment Inhaler, migraine prescription. The outcome of the events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she now had COVID; she did took both the shots; she tested positive; she now had COVID; she did took both the shots; she tested positive; This is a spontaneous report from a Contactable consumer from a Pfizer sponsored program, Pfizer. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration in Mar2021 (Lot number was not reported) as single dose, and first dose via an unspecified route of administration in Feb2021 (Lot number was not reported) as single dose, both for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient was laying on her back at her home, she took both the shots and she went Monday and get tested and she tested positive and she took shots back in Feb2021 and Mar2021 of the Pfizer vaccine, she now had COVID, onset date 20Sep2021. The patient underwent laboratory tests and procedures which included sars-cov-2 test: positive on 20Sep2021. Outcome of the 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: Abdominal discomfort, Chest pain, Hunger, Influenza like illness, Pain in extremity
Clinical narrative: Sore arm; almost a feeling like you get a panic attack exact, that kind of feeling; she would eat; she still have that empty feeling in her stomach, felt like, almost if, she didn''t eat up felt that hunger even she ate; she said she felt almost like, somebody was pushing on her stomach, and then letting down like a weird feeling; flu like symptoms after the vaccine; she get chest pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional via  Support. A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 11Sep2021 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced sore arm , almost a feeling like you get a panic attack exact, that kind of feeling, she would eat; she still have that empty feeling in her stomach, felt like, almost if, she didn't eat up felt that hunger even she ate, she said she felt almost like, somebody was pushing on her stomach, and then letting down like a weird feeling, flu like symptoms after the vaccine, she get chest pain.The outcome of event was unknown.  The lot number for BNT162B2 was not provided and will be request during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction
Clinical narrative: Sore arm; almost a feeling like you get a panic attack exact, that kind of feeling; she would eat; she still have that empty feeling in her stomach, felt like, almost if, she didn''t eat up felt that hunger even she ate; she said she felt almost like, somebody was pushing on her stomach, and then letting down like a weird feeling; flu like symptoms after the vaccine; she get chest pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional via  Support. A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 11Sep2021 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced sore arm , almost a feeling like you get a panic attack exact, that kind of feeling, she would eat; she still have that empty feeling in her stomach, felt like, almost if, she didn't eat up felt that hunger even she ate, she said she felt almost like, somebody was pushing on her stomach, and then letting down like a weird feeling, flu like symptoms after the vaccine, she get chest pain.The outcome of event was unknown.  The lot number for BNT162B2 was not provided and will be request during follow-up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Ear pain, Facial pain, Gingival pain, Gingival recession
Clinical narrative: severe gum recession in mouth; severe gum and tooth pain; severe gum and tooth pain; difficulty opening mouth; severe pain in left ear; severe pain in left hear and left side of face; shingles-like events on left side of face; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown, Expiry date not reported), via an unspecified route of administration, administered in Arm Left on 07Apr2021 (age at vaccination was 28 years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included epilepsy, osteoporosis, and gluten sensitivity. The facility where the most recent COVID-19 vaccine was administered was a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted to doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Batch/Lot number: Unknown, Expiry date not reported), arm left, on 17Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced severe gum recession in mouth on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe gum and tooth pain on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe gum and tooth pain on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, difficulty opening mouth on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe pain in left ear on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe pain in left hear and left side of face on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, and shingles-like events on left side of face on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date. Therapeutic measures were taken as a result of the events included dental service, antibiotics, and antivirals. The events were reported as serious, disabling by the health authority.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Toothache
Clinical narrative: severe gum recession in mouth; severe gum and tooth pain; severe gum and tooth pain; difficulty opening mouth; severe pain in left ear; severe pain in left hear and left side of face; shingles-like events on left side of face; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown, Expiry date not reported), via an unspecified route of administration, administered in Arm Left on 07Apr2021 (age at vaccination was 28 years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included epilepsy, osteoporosis, and gluten sensitivity. The facility where the most recent COVID-19 vaccine was administered was a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted to doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Batch/Lot number: Unknown, Expiry date not reported), arm left, on 17Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced severe gum recession in mouth on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe gum and tooth pain on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe gum and tooth pain on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, difficulty opening mouth on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe pain in left ear on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe pain in left hear and left side of face on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, and shingles-like events on left side of face on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date. Therapeutic measures were taken as a result of the events included dental service, antibiotics, and antivirals. The events were reported as serious, disabling by the health authority.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bladder pain, Cystitis, Kidney infection, Renal pain
Clinical narrative: very achy as if I had a kidney infection; Alot of pain in bladder; if I had a bladder infection; Lower back pain above posterior; pain in the area of the kidneys; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 56 years old) via an unspecified route of administration, administered in Arm Right on Sep2021 09:30 AM (Batch/Lot Number: FC3183) as dose 1, single for covid-19 immunisation. Medical history included high blood pressure and 2 skin cancers (basal cells). The patient has no COVID-19 prior vaccination. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN HCT). The patient previously took avelox for vertigo and allergies. The patient has no other vaccine in four weeks. On 18Sep2021 at 05:00, the patient experienced a lot of pain in bladder as if she had a bladder infection, lower back pain above posterior and pain in the area of the kidneys which was very achy as if she had a kidney infection. No other symptoms than those. The patient was not tested for COVID-19 post vaccination. The events were not treated. The outcome of the events was recovered on an unspecified date.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Biopsy breast, Breast cancer, Investigation
Clinical narrative: Breast cancer; This is a solicited report from the non-Pfizer-sponsored program FACILITATED COLLECT, based on information received by Pfizer from a Facilitating Company, manufacturer control number: 21K-163-4081465-00.   Solicited report by a consumer of a 59 year old female with events of right breast cancer and non-serious lack of efficacy with adalimumab (HUMIRA). The patient had a relevant medical history of 'father had stomach cancer on an unknown date'. On an unknown date, the patient experienced lack of efficacy. In Sep2021, the patient experienced right breast cancer. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. The patient initially discontinued taking Humira because it stopped working. She was diagnosed stage zero lump/breast cancer in Sep2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Fe 2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer.  On 29Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient s past medications include: Orencia for rheumatoid arthritis  Enbrel for rheumatoid arthritis  Causality for adalimumab (HUMIRA) The reporter's causality for the event(s) of right breast cancer with adalimumab (HUMIRA) was no reasonable possibility. The reporter's causality for the event(s) of lack of efficacy was not provided. Facilitating Company's opinion is that the event of right breast cancer is not assessable. Facilitating Company's opinion is that there is no reasonable possibility that the event of lack of efficacy is related to adalimumab (HUMIRA).  Relevant Laboratory & Other Diagnostic Tests Sep2021 Genetic cancer testing: No markers.  Sep2021 Right breast biopsy: Confirmed Cancer on the right breast  Change History On 17Sep2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The event of "lack of efficacy" was added. The event of "female breast cancer" was amended to "right breast cancer".  According to the reporter, the event breast cancer was possibly related to BNT162b2.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As per available information in case, the causal association between the event breast cancer and the suspect drug BNT162B2 cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Hypoaesthesia, Insomnia, Pain in extremity, Paraesthesia
Clinical narrative: I felt tingling/pins and needles everywhere when I move my arm up and down; I feel like I am being electrocuted; my legs hurt all the time; causing me not to be able to sleep; big toe is asleep all the time; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 03Sep2021 15:15 (Batch/Lot Number: FC3183) as dose 1, single for COVID-19 immunisation. Medical history included known allergies: penicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 03Sep2021 21:30, hours after the vaccine, the patient felt tingling/pins and needles everywhere when she moved her arm up and down. She felt like she was being electrocuted. Her legs hurt all the time causing her not to be able to sleep. Big toe was asleep all the time. No treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: I have had complete hair loss of my entire body; Complete hair loss due to the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 24May2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that the patient took the second shot on 24May and patient have had complete hair loss of patient entire body, complete hair loss due to the vaccine. So now having conversation about getting a booster shot and patient not sure if patient should get a booster shot considering the side effects on the first 2. So patient guess just trying to see if there has been any studies, if anyone else has had complete hair loss due to the vaccine. 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: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a non-contactable consumer or other non hcp. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient experienced shingles on unspecified date. Additional information reported as he refers to AE's he knows about or has heard about. He saw a report that an infant received the Pfizer BioNTech Covid-19 and is paralysed. He also saw a news report about a doctor that pulled out parasite linked to vaccine. The same doctor showed blood samples of people that have had blood clots from the vaccine. He himself had a relationship with a woman who got the vaccine, and she got both Covid and shingles (shingles presented as a rash all over his body that lasted 2 months). He knows an adult female who gets migraines every other day. The clinical outcome of the event shingles was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 21Apr2021 (Batch/Lot Number: ER8731) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced persistent atrial fibrillation on Apr2021 (reported as within 3 days of receiving the second dose). The event resulted in Doctor office/clinic visit. Outcome of the event was not recovered. The patient received first dose of Comirnaty (lot number EP87533, administered to Left arm) on 31Mar2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dysphonia, Fatigue, Headache
Clinical narrative: elevated blood pressure; some pain and tenderness to the immunization site; very fatigued; bad headache; left eye sensitive to light; sensitivity to voices; sore throat; eye twitching; 0.5 ML; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Deltoid Left on 20Sep2021 17:30 (Batch/Lot Number: FF2587) as DOSE 1, 0.5 ML SINGLE for covid-19 immunisation. Medical history included ongoing hypertension diagnosed when she was 40. There were no concomitant medications. The patient had flu shot for immunization and experienced arm soreness. Caller stated she received her first dose of the vaccine on Monday 20Sep2021, On 21Sep2021, the patient experienced some pain and tenderness to the immunization site, very fatigued, bad headache, left eye sensitive to light and eye twitching, and sensitivity to voices. The patient stated she feels they are neurologic symptoms, and a sore throat, but this time on the right side, the other was on the left side. Confirms these symptoms are ongoing and persisting. Blood pressure is a little elevated: She has a history of high blood pressure, it has been controlled with medication, she checked it today and it was 147/83, confirms began today 23Sep2021, she has had it controlled in the past. Denies that it's ongoing. Seriousness: She confirms all symptoms reported, she would say is medically significant, like right now when she's speaking to her, she's not really sensitive to voices and now she is. The patient underwent lab tests and procedures which included blood pressure measurement: 147/83 on 23Sep2021 little elevated.  The outcome of the events some pain and tenderness to the immunization site, elevated blood pressure, and eye twitching was unknown while not recovered for the other events.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Oropharyngeal pain, Overdose, Photophobia, Vaccination site pain
Clinical narrative: elevated blood pressure; some pain and tenderness to the immunization site; very fatigued; bad headache; left eye sensitive to light; sensitivity to voices; sore throat; eye twitching; 0.5 ML; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Deltoid Left on 20Sep2021 17:30 (Batch/Lot Number: FF2587) as DOSE 1, 0.5 ML SINGLE for covid-19 immunisation. Medical history included ongoing hypertension diagnosed when she was 40. There were no concomitant medications. The patient had flu shot for immunization and experienced arm soreness. Caller stated she received her first dose of the vaccine on Monday 20Sep2021, On 21Sep2021, the patient experienced some pain and tenderness to the immunization site, very fatigued, bad headache, left eye sensitive to light and eye twitching, and sensitivity to voices. The patient stated she feels they are neurologic symptoms, and a sore throat, but this time on the right side, the other was on the left side. Confirms these symptoms are ongoing and persisting. Blood pressure is a little elevated: She has a history of high blood pressure, it has been controlled with medication, she checked it today and it was 147/83, confirms began today 23Sep2021, she has had it controlled in the past. Denies that it's ongoing. Seriousness: She confirms all symptoms reported, she would say is medically significant, like right now when she's speaking to her, she's not really sensitive to voices and now she is. The patient underwent lab tests and procedures which included blood pressure measurement: 147/83 on 23Sep2021 little elevated.  The outcome of the events some pain and tenderness to the immunization site, elevated blood pressure, and eye twitching was unknown while not recovered for the other events.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea
Clinical narrative: short of breath for years that got worst with Regen-Cov a few days after taking this; received the 1st dose of the Pfizer COVID 19 Vaccine on 03Aug2021 and tested positive for COVID-19 on 09Aug2021.; This is a spontaneous report from a contactable consumer (patient himself) via from a Pfizer sponsored program. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FC3183), via an unspecified route of administration, administered in left arm on 03Aug2021 (age at vaccination: 64 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included ongoing dyspnoea, pleurisy in early to middle 70s , pneumonia aspiration. The patient's concomitant medications were not reported. On 09Aug2021, the patient experienced received the 1st dose of the pfizer covid 19 vaccine on 03aug2021 and tested positive for covid-19 on 09aug2021, short of breath for years that got worst with regen-cov a few days after taking vaccine. On 09Aug2021, the patient underwent lab tests and procedures which included sars-cov-2 test which was positive and on 21Sep2021 sars-cov-2 test was negative. The patient received Regeneron for treatment of his COVID-19. He was suppose to receive his second dose of the vaccine on 24Sep2021 (tomorrow). The patient was prescribed two other medications of an antibiotic and steroid. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTBLE lot FC3183 was investigated. The investigation included reviewing, manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of covid-19 was recovered 21Sep2021 and dyspnoea was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Angiopathy, Blood pressure measurement, Cerebellar stroke, Dysstasia, Eye movement disorder
Clinical narrative: Cerebellar stroke; blockage of the blood vessel at the back of his neck; extreme vertigo; Headache; Sleepiness; unable to walk; he can't stand; he can't go to the bathroom on his own; rapid eye movements left to right; Numbness in face; Numbness of tongue; vomiting; This is a spontaneous report from a contactable consumer (patient's son-in-law) via medical information team. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 22Aug2021 (Batch/Lot Number: FC3182) as dose 1, single for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was a healthy person before the vaccination and always had good blood pressure. On 13Sep2021, the patient had a cerebellar stroke involving blockage of the blood vessel at the back of his neck. On 13Sep2021, patient had extreme vertigo, headache, and sleepiness. On an unspecified date in Sep2021, unable to walk, he can't stand, he can't go to the bathroom on his own, had rapid eye movements left to right, numbness in face, numbness of tongue, and vomiting. The patient went to the emergency room for the events. On 18Sep2021 the patient was hospitalized for cerebellar stroke involving blockage of the blood vessel at the back of his neck and was given an unspecified treatment. The reporter says his father in law probably had other symptoms but he is not sure what those are, his step mother in law is at the hospital visiting with him, he hasn't been able to see him due to only one person being allowed to be there due to COVID restrictions. The outcome of the events cerebellar stroke involving blockage of the blood vessel at the back of his neck was not recovered while for the rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.