chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke into a skin rash over entire body; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Aug2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, heart murmur and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Jul2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Aug2021, within 18 hours of second vaccination, the patient broke into a skin rash over entire body. The adverse event did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with Ibuprofen (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the event broke into a skin rash over entire body was resolved on an unknown date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Nausea, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: palpitations; nausea; sore arm; fever; throwing up; eyes were hurting; This is a spontaneous report from a contactable consumer via medical information team. A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number was not reported, expiry date was not reported) via an unspecified route of administration on 30Aug2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Sep2021, the patient the patient experienced some side effects such as palpitations, nausea, sore arm, and a little fever. She said she was throwing up, and her eyes were hurting. The reporter wants to know if that was normal, and how long they last. She also mentioned that her granddaughter was already starting to get better. The outcome for the events was recovering.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: palpitations; nausea; sore arm; fever; throwing up; eyes were hurting; This is a spontaneous report from a contactable consumer via medical information team. A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number was not reported, expiry date was not reported) via an unspecified route of administration on 30Aug2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Sep2021, the patient the patient experienced some side effects such as palpitations, nausea, sore arm, and a little fever. She said she was throwing up, and her eyes were hurting. The reporter wants to know if that was normal, and how long they last. She also mentioned that her granddaughter was already starting to get better. The outcome for the events was recovering.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: cold or flu; being achy; little bit of fever; cold or flu; This is a spontaneous report from a contactable other hcp. This consumer (patient's wife) reported for a male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and first dose was fine. The patient experienced cold or flu, being achy, little bit of fever on an unspecified date. The patient's wife reported that she was calling to find out if this is a normal reaction or something that she needs to be concerned with. She says she wanted to know if it was a common side effect, which she kind of looked online but can't find this side effect listed. she was wondering if her son should have the second dose or not. Caller says that the rest of us did not experience anything like this, the first dose was fine, then for the second they had the regular symptoms of like cold or flu, being achy, a little bit of fever; but he of course has to be different. She says that her son is supposed to go back on the 15th to get his second one. 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: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Fatigue, Pruritus, Rash erythematous, Rash papular
Clinical narrative: Extreme fatigue.; Was sleeping about 16 hours a day; 4 days after vaccine, rash began on both inside of both forearms. The rash was raised red bumps, they spread to wrist over a period of 4 or 5 days; 4 days after vaccine, rash began on both inside of both forearms. The rash was raised red bumps, they spread to wrist over a period of 4 or 5 days; Severe itching and burning; Severe itching and burning; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 13May2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included genital herpes, migraines, mild arthritis and allergy to penicillin and Wheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamins unspecified from unknown date for an unknown indication and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) and topiramate (TOPAMAX); both on unknown date for unspecified indication and experienced drug allergy. On 16May2021, 4 days after vaccine, the patient experienced rash on (both) inside of both forearms, the rash was raised red bumps, they spread to wrist over a period of 4 or 5 days and severe itching and burning and no blisters. It was cleared up in week 4. On 07Jun2021, the patient experienced extreme fatigue, was sleeping about 16 hours a day. Lasted about 3 weeks. Since the vaccination, the patient had been tested for COVID-19.  On an unknown date in 2021, the patient underwent COVID-19 test via Nasal Swab and the result was Negative.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash on both inside of both forearms, the rash was raised red bumps, they spread to wrist and severe itching and burning and extreme fatigue, was sleeping about 16 hours a day was recovered on unknown date in Jun2021.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Somnolence
Clinical narrative: Extreme fatigue.; Was sleeping about 16 hours a day; 4 days after vaccine, rash began on both inside of both forearms. The rash was raised red bumps, they spread to wrist over a period of 4 or 5 days; 4 days after vaccine, rash began on both inside of both forearms. The rash was raised red bumps, they spread to wrist over a period of 4 or 5 days; Severe itching and burning; Severe itching and burning; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 13May2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included genital herpes, migraines, mild arthritis and allergy to penicillin and Wheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamins unspecified from unknown date for an unknown indication and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) and topiramate (TOPAMAX); both on unknown date for unspecified indication and experienced drug allergy. On 16May2021, 4 days after vaccine, the patient experienced rash on (both) inside of both forearms, the rash was raised red bumps, they spread to wrist over a period of 4 or 5 days and severe itching and burning and no blisters. It was cleared up in week 4. On 07Jun2021, the patient experienced extreme fatigue, was sleeping about 16 hours a day. Lasted about 3 weeks. Since the vaccination, the patient had been tested for COVID-19.  On an unknown date in 2021, the patient underwent COVID-19 test via Nasal Swab and the result was Negative.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash on both inside of both forearms, the rash was raised red bumps, they spread to wrist and severe itching and burning and extreme fatigue, was sleeping about 16 hours a day was recovered on unknown date in Jun2021.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Depression, Fatigue, Hypersomnia, Hypoaesthesia
Clinical narrative: Extreme fatigue.; Was sleeping about 16 hours a day; 4 days after vaccine, rash began on both inside of both forearms. The rash was raised red bumps, they spread to wrist over a period of 4 or 5 days; 4 days after vaccine, rash began on both inside of both forearms. The rash was raised red bumps, they spread to wrist over a period of 4 or 5 days; Severe itching and burning; Severe itching and burning; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 13May2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included genital herpes, migraines, mild arthritis and allergy to penicillin and Wheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamins unspecified from unknown date for an unknown indication and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) and topiramate (TOPAMAX); both on unknown date for unspecified indication and experienced drug allergy. On 16May2021, 4 days after vaccine, the patient experienced rash on (both) inside of both forearms, the rash was raised red bumps, they spread to wrist over a period of 4 or 5 days and severe itching and burning and no blisters. It was cleared up in week 4. On 07Jun2021, the patient experienced extreme fatigue, was sleeping about 16 hours a day. Lasted about 3 weeks. Since the vaccination, the patient had been tested for COVID-19.  On an unknown date in 2021, the patient underwent COVID-19 test via Nasal Swab and the result was Negative.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash on both inside of both forearms, the rash was raised red bumps, they spread to wrist and severe itching and burning and extreme fatigue, was sleeping about 16 hours a day was recovered on unknown date in Jun2021.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pruritus, Rash, Rash erythematous
Clinical narrative: Extreme fatigue.; Was sleeping about 16 hours a day; 4 days after vaccine, rash began on both inside of both forearms. The rash was raised red bumps, they spread to wrist over a period of 4 or 5 days; 4 days after vaccine, rash began on both inside of both forearms. The rash was raised red bumps, they spread to wrist over a period of 4 or 5 days; Severe itching and burning; Severe itching and burning; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 13May2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included genital herpes, migraines, mild arthritis and allergy to penicillin and Wheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamins unspecified from unknown date for an unknown indication and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) and topiramate (TOPAMAX); both on unknown date for unspecified indication and experienced drug allergy. On 16May2021, 4 days after vaccine, the patient experienced rash on (both) inside of both forearms, the rash was raised red bumps, they spread to wrist over a period of 4 or 5 days and severe itching and burning and no blisters. It was cleared up in week 4. On 07Jun2021, the patient experienced extreme fatigue, was sleeping about 16 hours a day. Lasted about 3 weeks. Since the vaccination, the patient had been tested for COVID-19.  On an unknown date in 2021, the patient underwent COVID-19 test via Nasal Swab and the result was Negative.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash on both inside of both forearms, the rash was raised red bumps, they spread to wrist and severe itching and burning and extreme fatigue, was sleeping about 16 hours a day was recovered on unknown date in Jun2021.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Started seeming like hearing was a bit muffled to ringing in the ear; Started seeming like hearing was a bit muffled from what it should be.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the left arm on 26Apr2021 at 02:00 (at the age of 51-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 17May2021 at 14:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and pre-diabetic. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks, but it was unspecified. On an unknown date in May2021, the patient started seeming like hearing was a bit muffled from what it should be, then lead to about two weeks later to ringing in the ear that had not gone away. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started seeming like hearing was a bit muffled from what it should be, then lead to about two weeks later to ringing in the ear was not recovered at the time of this report.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Dizziness, Eye pain, Fatigue, Feeling abnormal
Clinical narrative: Became confused; Had transient global amnesia which lasted about 10 hours; Severe headaches; Eye pain; Feeling very tired; Dizziness; Right hand weakness; Facial numbness; Difficulty speak; Brain fog; Body aches; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via intramuscular route of administration in the right arm on 04Aug2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19 on an unknown date (prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included losartan (MANUFACTURER UNKNOWN) and Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 04Aug2021 at 10:00, half hour after receiving the first dose of vaccine, the patient became confused, then had transient global amnesia which had lasted about 10 hours, severe headaches with eyes pain, felt very tired, dizziness, right hand weakness, some facial numbness and difficulty to speak, brain fog and body ache. On 17Aug2021, the patient underwent COVID-19 antibody test and the result was positive. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of brain and inflammatory markers were checked and the results were unknown. Therapeutic measures were taken as a result of the events and included treatment with aspirin 81 mg daily for 1 week. The clinical outcome of the events confused and transient global amnesia were resolved on 04Aug2021, while the clinical outcome of the events, severe headaches, eye pain, felt very tired, dizziness, right hand weakness, facial numbness, difficulty to speak, brain fog and body ache were resolving at the time of this report.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Inflammatory marker test, Magnetic resonance imaging head, Muscular weakness
Clinical narrative: Became confused; Had transient global amnesia which lasted about 10 hours; Severe headaches; Eye pain; Feeling very tired; Dizziness; Right hand weakness; Facial numbness; Difficulty speak; Brain fog; Body aches; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via intramuscular route of administration in the right arm on 04Aug2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19 on an unknown date (prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included losartan (MANUFACTURER UNKNOWN) and Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 04Aug2021 at 10:00, half hour after receiving the first dose of vaccine, the patient became confused, then had transient global amnesia which had lasted about 10 hours, severe headaches with eyes pain, felt very tired, dizziness, right hand weakness, some facial numbness and difficulty to speak, brain fog and body ache. On 17Aug2021, the patient underwent COVID-19 antibody test and the result was positive. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of brain and inflammatory markers were checked and the results were unknown. Therapeutic measures were taken as a result of the events and included treatment with aspirin 81 mg daily for 1 week. The clinical outcome of the events confused and transient global amnesia were resolved on 04Aug2021, while the clinical outcome of the events, severe headaches, eye pain, felt very tired, dizziness, right hand weakness, facial numbness, difficulty to speak, brain fog and body ache were resolving at the time of this report.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 antibody test, Speech disorder, Transient global amnesia
Clinical narrative: Became confused; Had transient global amnesia which lasted about 10 hours; Severe headaches; Eye pain; Feeling very tired; Dizziness; Right hand weakness; Facial numbness; Difficulty speak; Brain fog; Body aches; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via intramuscular route of administration in the right arm on 04Aug2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19 on an unknown date (prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included losartan (MANUFACTURER UNKNOWN) and Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 04Aug2021 at 10:00, half hour after receiving the first dose of vaccine, the patient became confused, then had transient global amnesia which had lasted about 10 hours, severe headaches with eyes pain, felt very tired, dizziness, right hand weakness, some facial numbness and difficulty to speak, brain fog and body ache. On 17Aug2021, the patient underwent COVID-19 antibody test and the result was positive. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of brain and inflammatory markers were checked and the results were unknown. Therapeutic measures were taken as a result of the events and included treatment with aspirin 81 mg daily for 1 week. The clinical outcome of the events confused and transient global amnesia were resolved on 04Aug2021, while the clinical outcome of the events, severe headaches, eye pain, felt very tired, dizziness, right hand weakness, facial numbness, difficulty to speak, brain fog and body ache were resolving at the time of this report.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Brain fog, Confusional state, Disturbance in attention, Dizziness
Clinical narrative: Became confused; Had transient global amnesia which lasted about 10 hours; Severe headaches; Eye pain; Feeling very tired; Dizziness; Right hand weakness; Facial numbness; Difficulty speak; Brain fog; Body aches; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via intramuscular route of administration in the right arm on 04Aug2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19 on an unknown date (prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included losartan (MANUFACTURER UNKNOWN) and Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 04Aug2021 at 10:00, half hour after receiving the first dose of vaccine, the patient became confused, then had transient global amnesia which had lasted about 10 hours, severe headaches with eyes pain, felt very tired, dizziness, right hand weakness, some facial numbness and difficulty to speak, brain fog and body ache. On 17Aug2021, the patient underwent COVID-19 antibody test and the result was positive. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of brain and inflammatory markers were checked and the results were unknown. Therapeutic measures were taken as a result of the events and included treatment with aspirin 81 mg daily for 1 week. The clinical outcome of the events confused and transient global amnesia were resolved on 04Aug2021, while the clinical outcome of the events, severe headaches, eye pain, felt very tired, dizziness, right hand weakness, facial numbness, difficulty to speak, brain fog and body ache were resolving at the time of this report.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Inflammatory marker test, Magnetic resonance imaging head normal
Clinical narrative: Became confused; Had transient global amnesia which lasted about 10 hours; Severe headaches; Eye pain; Feeling very tired; Dizziness; Right hand weakness; Facial numbness; Difficulty speak; Brain fog; Body aches; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via intramuscular route of administration in the right arm on 04Aug2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19 on an unknown date (prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included losartan (MANUFACTURER UNKNOWN) and Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 04Aug2021 at 10:00, half hour after receiving the first dose of vaccine, the patient became confused, then had transient global amnesia which had lasted about 10 hours, severe headaches with eyes pain, felt very tired, dizziness, right hand weakness, some facial numbness and difficulty to speak, brain fog and body ache. On 17Aug2021, the patient underwent COVID-19 antibody test and the result was positive. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of brain and inflammatory markers were checked and the results were unknown. Therapeutic measures were taken as a result of the events and included treatment with aspirin 81 mg daily for 1 week. The clinical outcome of the events confused and transient global amnesia were resolved on 04Aug2021, while the clinical outcome of the events, severe headaches, eye pain, felt very tired, dizziness, right hand weakness, facial numbness, difficulty to speak, brain fog and body ache were resolving at the time of this report.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Myalgia, Nervous system disorder, SARS-CoV-2 antibody test positive, Transient global amnesia
Clinical narrative: Became confused; Had transient global amnesia which lasted about 10 hours; Severe headaches; Eye pain; Feeling very tired; Dizziness; Right hand weakness; Facial numbness; Difficulty speak; Brain fog; Body aches; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via intramuscular route of administration in the right arm on 04Aug2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19 on an unknown date (prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included losartan (MANUFACTURER UNKNOWN) and Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 04Aug2021 at 10:00, half hour after receiving the first dose of vaccine, the patient became confused, then had transient global amnesia which had lasted about 10 hours, severe headaches with eyes pain, felt very tired, dizziness, right hand weakness, some facial numbness and difficulty to speak, brain fog and body ache. On 17Aug2021, the patient underwent COVID-19 antibody test and the result was positive. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of brain and inflammatory markers were checked and the results were unknown. Therapeutic measures were taken as a result of the events and included treatment with aspirin 81 mg daily for 1 week. The clinical outcome of the events confused and transient global amnesia were resolved on 04Aug2021, while the clinical outcome of the events, severe headaches, eye pain, felt very tired, dizziness, right hand weakness, facial numbness, difficulty to speak, brain fog and body ache were resolving at the time of this report.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Reddish raised bump on wrist/ Reddish bumps appearing on stomach/ break out on elbow area with many bumps on both arms at this point/ bumps all over arms, legs, back, stomach, chest, all over body with many areas complete raised red area.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 12May2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was not aware of the known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 21Apr2021 at 15:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 14May2021 (Friday night), the patient noticed a reddish raised bump on wrist. On 15May2021 (Saturday morning), the patient had multiple reddish bumps on the wrist area and that evening noticed the reddish bumps appearing on stomach. On Saturday night, the patient had break out on elbow area with many bumps on both arms at that point. On 16May2021 (Sunday morning), the patient had bumps all over arms, legs, back, stomach, chest and all over body with many areas complete raised red area (bumps combined together). On Sunday evening, the patient started taking prednisone. On 17May2021 (Monday evening), the bumps started reducing and by Wednesday into Thursday were pretty much gone. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported event which included treatment with prednisone (MANUFACTURER UNKNOWN) 20 mg, one every 10-12 hours. The clinical outcome of the event reddish raised bump on wrist/ reddish bumps appearing on stomach/ break out on elbow area with many bumps on both arms at this point/ bumps all over arms, legs, back, stomach, chest, all over body with many areas complete raised red area was resolved on an unknown date in May2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Off label use, SARS-CoV-2 test
Clinical narrative: consistent headache since 3rd vaccination; consistent headache since 3rd vaccination; consistent headache since 3rd vaccination; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19. On 17Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. From 21Aug2021 at 12:00, the patient experienced consistent headache since third vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event consistent headache since third vaccination was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, Nausea
Clinical narrative: fatigue; nausea; no taste; headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (Comirnaty, Formulation: solution for injection, Lot/Batch not provided, expiry date not provided), via an unknown route of administration, administered on 24Aug2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose on 24Aug2021, Since then consumer confirms that since vaccination he has experienced fatigue, nausea, no taste and a headache. He was still experiencing these symptoms to date and he confirms he would like to know if this is normal. The patient also enquired whether should he got tested for the actual virus. The outcome of events was not recovered.   That information on the Lot/batch number has been requested
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Soreness, Aching; Headache; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on 01Sep2021 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL) and unspecified birth control medication; taken for unknown indication from unknown dates and unknown if ongoing. On 01Sep2021, the patient experienced soreness, aching and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events soreness, aching and headache was not resolved at the time of report.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease
Clinical narrative: Crohn's disease aggravated; This is a solicited report from non-Pfizer sponsored program, received from a contactable consumer, the patient, based on information received by Pfizer (21K-163-4051022-00). A 62-year-old adult female received the first dose of intramuscular BNT162b2 (TOZINAMERAN, solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 06Apr2021 (at 62-years-old) for COVID-19 immunisation. The patient also started to receive subcutaneous adalimumab (HUMIRA, solution for injection in pre-filled pen, citrate free; batch/lot and expiry information not provided) unspecified dose at an unspecified frequency from an unspecified date for moderate to severe adult Crohn's disease. There was no medical history or concomitant medications reported. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (TOZINAMERAN, solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 16Mar2021 (at 62-years-old). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 15Apr2021, the patient experienced Crohn's disease aggravated. The action taken with adalimumab was unknown. The outcome of the event Crohn's disease aggravated was recovered on an unspecified date in 2021.   The reporter's assessment of the causal relationship of the event with the suspect product 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 reporter's causality for the event(s) of CROHN'S DISEASE FLARE UP AFTER COVID 19 VACCINE with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information, the event chron's disease aggrevated is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Muscle spasms
Clinical narrative: chest ache (not feeling well in chest area)/ chest was aching; Dull cramp in the chest; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number not reported) via an unspecified route of administration on an unknown date as dose 1, single for COVID- 19 Immunisation. Relevant medical history and concomitant medications was not reported. On an unknown date, the patient had her "first dose of the Pfizer COVID-19 vaccine and experienced chest ache (not feeling well in chest area) which felt like a dull cramp in the chest which was constant and did not go away". Further, the patient mentioned that she was feeling fine but her chest was aching." The patient wanted to know if this had been reported as a side effect with the Pfizer COVID-19 vaccine. The report was considered as non serious. The outcome of the event of dull cramp in the chest was recovered on an unknown date and other event of chest pain was unknown.  Lot number of the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea; Vomiting; Headache; Clavicle tenderness; Arm pain; Fatigue; This is a spontaneous report from a contactable nurse, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 07:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 28Aug2021 at 16:45, the patient experienced nausea, vomiting, headache, clavicle tenderness, arm pain and fatigue. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, vomiting, headache, clavicle tenderness, arm pain and fatigue were resolving at the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Sense of taste has been affected/  taste buds were markedly dulled at breakfast Sunday morning/Sense of taste still has not returned. The difference between her sense of taste before and after 2nd shot is substantial; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3182) via an unspecified route of administration in the left arm on 28Aug2021 at 17:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, nickel sensitivity, serious side effects from some medications; internal bleeding and hyponatremia. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any new medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3180) via an unspecified route of administration in the left arm on 07Aug2021 at 17:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. On 29Aug2021 at 09:00, the patient experienced sense of taste has been affected. The patient received 2nd shot at approximately 18:00 on Saturday, and was shocked to find that the taste buds were markedly dulled at breakfast Sunday morning. It was reported that the patient was writing this at 06:00 Tuesday morning and the sense of taste still has not returned. The difference between her sense of taste before and after the 2nd shot is substantial, which alarms the patient. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sense of taste has been affected/ taste buds were markedly dulled at breakfast Sunday morning/Sense of taste still has not returned. The difference between her sense of taste before and after 2nd shot is substantial were not resolved at the time of this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Woke up with tingling in right foot; This is a spontaneous report from a contactable nurse, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 12:30 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. On 04Aug2021, the next day of vaccination, the patient woke up with tingling in right foot and every day since then, the patient woken up with tingling. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event woke up with tingling in right foot was not recovered at the time of this report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse abnormal, SARS-CoV-2 test
Clinical narrative: A pulsing in the vein or muscle in point under the front of my right knee; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 27Aug2021 at 13:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 29Jul2021 at 13:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Aug2021, the patient underwent COVID-19 test (Polymerase Chain Reaction (PCR)) and the result was negative. On 30Aug2021 at 12:00, the patient experienced a pulsing in the vein or muscle in point under the front of the right knee. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event pulsing in the vein or muscle in point under the front of the right knee was not resolved at the time of this report.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Swollen left chest and  swollen left shoulder; Severe swollen lymph node under left arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 30Aug2021 at 12:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic fatigue, low testosterone and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included testosterone (FORTESTA) and daily supplements (unspecified); from an unknown date for an unknown indication and unknown if ongoing. On 31Aug2021 at 17:00, the patient experienced severe swollen lymph node under left arm, swollen left chest and swollen left shoulder. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe swollen lymph node under left arm, swollen left chest and swollen left shoulder were resolved with sequelae (also reported as resolved with lasting effects) on an unknown date in 2021.