chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Parotid gland enlargement, Sciatica
Clinical narrative: severe shooting pains up both arms, her hands hurt really bad; ANA positive; enlarged parotid glad on the left side and inflamed parotid glands; enlarged parotid glad on the left side and inflamed parotid glands; sciatica pain of the right side; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8735) via an unspecified route of administration at left arm on 19Apr2021 16:30 (46-year old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history depression, thrombocytopenia, severe IBS, carpal tunnel right extremity, and allergies to Penicillin, Sulfa drugs. Concomitant medications that the patient received within 2 weeks of vaccination included ONDANSETRON. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 29Mar2021 (46-year old at time of vaccination), at single dose, for COVID-19 immunization and experienced "there was a hole inside her left ear/ ear abscess", "thick yellow, clear puss and blood was oozing out of her left ear", "sciatica pain", and "nerve pain". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor Visit 24Apr2021 for sudden onset sciatica pain of the right side this time and got a cortisone injection that helped. CT Scan 25Apr2021 to figure out what is happening in patient's ear and showed enlarged parotid glad on the left side and inflamed parotid glands. Patient has severe shooting pains up both arms, her hands hurt really bad. Doctor visit 27Apr2021 followed up with ENT and he indicated patient needed to see rheumatologist for ANA positive test. Doctor visit 03May2021 Rheumatologist. 09May2021 labwork. Urgent care Doctor visit 14May2021 for severe sciatica pain that continues. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event sciatica and included cortisone injections, deep muscle massage/exercise. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Blister, Chest pain, Computerised tomogram, Condition aggravated
Clinical narrative: severe shooting pains up both arms, her hands hurt really bad; ANA positive; enlarged parotid glad on the left side and inflamed parotid glands; enlarged parotid glad on the left side and inflamed parotid glands; sciatica pain of the right side; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8735) via an unspecified route of administration at left arm on 19Apr2021 16:30 (46-year old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history depression, thrombocytopenia, severe IBS, carpal tunnel right extremity, and allergies to Penicillin, Sulfa drugs. Concomitant medications that the patient received within 2 weeks of vaccination included ONDANSETRON. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 29Mar2021 (46-year old at time of vaccination), at single dose, for COVID-19 immunization and experienced "there was a hole inside her left ear/ ear abscess", "thick yellow, clear puss and blood was oozing out of her left ear", "sciatica pain", and "nerve pain". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor Visit 24Apr2021 for sudden onset sciatica pain of the right side this time and got a cortisone injection that helped. CT Scan 25Apr2021 to figure out what is happening in patient's ear and showed enlarged parotid glad on the left side and inflamed parotid glands. Patient has severe shooting pains up both arms, her hands hurt really bad. Doctor visit 27Apr2021 followed up with ENT and he indicated patient needed to see rheumatologist for ANA positive test. Doctor visit 03May2021 Rheumatologist. 09May2021 labwork. Urgent care Doctor visit 14May2021 for severe sciatica pain that continues. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event sciatica and included cortisone injections, deep muscle massage/exercise. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dry mouth, Ear pain, Furuncle, Inflammation
Clinical narrative: severe shooting pains up both arms, her hands hurt really bad; ANA positive; enlarged parotid glad on the left side and inflamed parotid glands; enlarged parotid glad on the left side and inflamed parotid glands; sciatica pain of the right side; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8735) via an unspecified route of administration at left arm on 19Apr2021 16:30 (46-year old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history depression, thrombocytopenia, severe IBS, carpal tunnel right extremity, and allergies to Penicillin, Sulfa drugs. Concomitant medications that the patient received within 2 weeks of vaccination included ONDANSETRON. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 29Mar2021 (46-year old at time of vaccination), at single dose, for COVID-19 immunization and experienced "there was a hole inside her left ear/ ear abscess", "thick yellow, clear puss and blood was oozing out of her left ear", "sciatica pain", and "nerve pain". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor Visit 24Apr2021 for sudden onset sciatica pain of the right side this time and got a cortisone injection that helped. CT Scan 25Apr2021 to figure out what is happening in patient's ear and showed enlarged parotid glad on the left side and inflamed parotid glands. Patient has severe shooting pains up both arms, her hands hurt really bad. Doctor visit 27Apr2021 followed up with ENT and he indicated patient needed to see rheumatologist for ANA positive test. Doctor visit 03May2021 Rheumatologist. 09May2021 labwork. Urgent care Doctor visit 14May2021 for severe sciatica pain that continues. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event sciatica and included cortisone injections, deep muscle massage/exercise. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritable bowel syndrome, Musculoskeletal pain, Neuralgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: severe shooting pains up both arms, her hands hurt really bad; ANA positive; enlarged parotid glad on the left side and inflamed parotid glands; enlarged parotid glad on the left side and inflamed parotid glands; sciatica pain of the right side; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8735) via an unspecified route of administration at left arm on 19Apr2021 16:30 (46-year old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history depression, thrombocytopenia, severe IBS, carpal tunnel right extremity, and allergies to Penicillin, Sulfa drugs. Concomitant medications that the patient received within 2 weeks of vaccination included ONDANSETRON. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 29Mar2021 (46-year old at time of vaccination), at single dose, for COVID-19 immunization and experienced "there was a hole inside her left ear/ ear abscess", "thick yellow, clear puss and blood was oozing out of her left ear", "sciatica pain", and "nerve pain". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor Visit 24Apr2021 for sudden onset sciatica pain of the right side this time and got a cortisone injection that helped. CT Scan 25Apr2021 to figure out what is happening in patient's ear and showed enlarged parotid glad on the left side and inflamed parotid glands. Patient has severe shooting pains up both arms, her hands hurt really bad. Doctor visit 27Apr2021 followed up with ENT and he indicated patient needed to see rheumatologist for ANA positive test. Doctor visit 03May2021 Rheumatologist. 09May2021 labwork. Urgent care Doctor visit 14May2021 for severe sciatica pain that continues. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event sciatica and included cortisone injections, deep muscle massage/exercise. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Paraesthesia, Sciatica
Clinical narrative: severe shooting pains up both arms, her hands hurt really bad; ANA positive; enlarged parotid glad on the left side and inflamed parotid glands; enlarged parotid glad on the left side and inflamed parotid glands; sciatica pain of the right side; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8735) via an unspecified route of administration at left arm on 19Apr2021 16:30 (46-year old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history depression, thrombocytopenia, severe IBS, carpal tunnel right extremity, and allergies to Penicillin, Sulfa drugs. Concomitant medications that the patient received within 2 weeks of vaccination included ONDANSETRON. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 29Mar2021 (46-year old at time of vaccination), at single dose, for COVID-19 immunization and experienced "there was a hole inside her left ear/ ear abscess", "thick yellow, clear puss and blood was oozing out of her left ear", "sciatica pain", and "nerve pain". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor Visit 24Apr2021 for sudden onset sciatica pain of the right side this time and got a cortisone injection that helped. CT Scan 25Apr2021 to figure out what is happening in patient's ear and showed enlarged parotid glad on the left side and inflamed parotid glands. Patient has severe shooting pains up both arms, her hands hurt really bad. Doctor visit 27Apr2021 followed up with ENT and he indicated patient needed to see rheumatologist for ANA positive test. Doctor visit 03May2021 Rheumatologist. 09May2021 labwork. Urgent care Doctor visit 14May2021 for severe sciatica pain that continues. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event sciatica and included cortisone injections, deep muscle massage/exercise. The outcome of the events was not recovered.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 16:45 (Batch/Lot Number: EWO172) as 1st dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included myocardial ischaemia/Ischemic heart disease. Concomitant medication included acetylsalicylic acid (ASPIRINE) received within 2 weeks of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Past drug event. The patient experienced bell's palsy on 13May2021 13:00. Hospitalization Prolonged was No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 included RT PCR SARS COV 2 on 09May2021: negative with Nasal Swab. treatment received for the adverse event included Corticosteroids, naproxen. Outcome of the event was recovering.   Follow up needed, further information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product leakage, Sneezing, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Sneezing a lot, after the first and second vaccine; Right arm with rising and swelling: described as red in a crescent moon shape at injection area, after first vaccine; red in a crescent moon shape at injection area, after first vaccine; Vaccine poured and trickled out of arm, after first vaccine; Vaccine poured and trickled out of arm, after first vaccine; This is a spontaneous report from a contactable consumer.  A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 21Apr2021 (caller states it was the evening) (Batch/Lot Number: EW0161) as 1st dose, single for covid-19 immunisation (Reported as because she is her daughter's mother, and told her daughter to get the vaccine. her daughter's school is making all the seniors get the shot to go back to school). Medical history included Birth control. Family Medical History relevant to AE was No. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE) from Mar2021 (two months ago) taken for birth control. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AEs following prior vaccinations was None. Caller states she is calling for her daughter. Caller confirms she is calling about the Pfizer vaccine, confirmed as the Covid 19 vaccine. Caller states that when her daughter went and got the injection, some of the vaccine poured out of her arm, vaccine poured and trickled out of arm, after first vaccine was on 21Apr2021 3:20 pm. Caller states that 3 days later (in the morning), her daughter's arm started to get a rising, later clarified as swelling. Caller states that it was red, in a crescent moon shape, and raised up off her arm at the injection site. Caller states it was really huge. Caller states that she called the pharmacy and she was told to give her daughter Benadryl and Cortisone cream. Caller reports that this treatment was effective. caller then reports that her daughter had lasting effects, clarified as sneezing a lot, after the first injection and then it got more intense after the second injection. The event was not required a visit to Emergency Room and Physician Office. Relevant Tests was None. No Investigation Assessment. Treatment received for the events. Outcome of red in a crescent moon shape at injection area, after first vaccine was recovered on 26Apr2021 (also reported the area is still a little brown spot but not raised up off her arm). Outcome of Sneezing a lot was not recovered. Outcome of the events was unknown. Seriousness criteria is Medically Significant.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: COVID-19, Chills, Decreased appetite, Drug ineffective, Dysgeusia
Clinical narrative: i took your Pfizer vaccine both of them and you know that I got COVID; i took your Pfizer vaccine both of them and you know that I got COVID; chills; the features of my face and skin changed; tongue felt, tasted bitter; lost a lot of weight; lost your appetite; This is a spontaneous report from Pfizer. A contactable consumer (patient) reported that a 74-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single and as 2nd dose, single for COVID-19 immunisation; estrogens conjugated, medroxyprogesterone acetate (PREMPRO), via an unspecified route of administration from an unspecified date, at 2.5 mg for an unspecified indication; estrogens conjugated (PREMARIN), via an unspecified route of administration from an unspecified date at an unspecified dose and frequency for an unspecified indication; and celecoxib (CELEBREX), via an unspecified route of administration from an unspecified date at an unspecified dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient took the Pfizer vaccine both of them and the patient got COVID and was better. "I only got it for two days, this is three months ago and I got it from my husband but the side effects after the aftermath lingers on and it effects other things in my body. I got the chills for two days and the features of my face and skin changed with COVID and I got the chills for two days and then your tongue felt, tasted bitter. I lost a lot of weight because you lost your appetite." The action taken in response to the events for estrogens conjugated, medroxyprogesterone acetate, estrogens conjugated and celecoxib was unknown. Outcome of the event i took your Pfizer vaccine both of them and you know that I got COVID was recovered on an unspecified date while unknown for the other events.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Skin disorder, Weight, Weight decreased
Clinical narrative: i took your Pfizer vaccine both of them and you know that I got COVID; i took your Pfizer vaccine both of them and you know that I got COVID; chills; the features of my face and skin changed; tongue felt, tasted bitter; lost a lot of weight; lost your appetite; This is a spontaneous report from Pfizer. A contactable consumer (patient) reported that a 74-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single and as 2nd dose, single for COVID-19 immunisation; estrogens conjugated, medroxyprogesterone acetate (PREMPRO), via an unspecified route of administration from an unspecified date, at 2.5 mg for an unspecified indication; estrogens conjugated (PREMARIN), via an unspecified route of administration from an unspecified date at an unspecified dose and frequency for an unspecified indication; and celecoxib (CELEBREX), via an unspecified route of administration from an unspecified date at an unspecified dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient took the Pfizer vaccine both of them and the patient got COVID and was better. "I only got it for two days, this is three months ago and I got it from my husband but the side effects after the aftermath lingers on and it effects other things in my body. I got the chills for two days and the features of my face and skin changed with COVID and I got the chills for two days and then your tongue felt, tasted bitter. I lost a lot of weight because you lost your appetite." The action taken in response to the events for estrogens conjugated, medroxyprogesterone acetate, estrogens conjugated and celecoxib was unknown. Outcome of the event i took your Pfizer vaccine both of them and you know that I got COVID was recovered on an unspecified date while unknown for the other events.   Information on the lot/batch number has been requested.
Age: 63.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: Breathing was still not back up where it should be so the patient was on oxygen all the time instead of being on at night; arm's still a little bit sore; This is a spontaneous report from a Pfizer. A contactable consumer (patient) reported that a 63-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via unspecified route of administration on 12May2021 as single dose for COVID-19 immunization; misoprostol, diclofenac sodium (ARTHROTEC), via unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The relevant medical history and concomitant medications were not reported. The patient just had Pfizer Vaccine, the first Pfizer vaccine on Wednesday because that's what the patient wanted. That's what the patient was trying to get before got COVID and ended up in the hospital, it was last month. On 14May2021, breathing was still not back up where it should be so the patient was on oxygen all the time instead of being on at night. It was just temporary. Patient later stated that arm's still a little bit sore but other then that the patient hadn't had any side effects with the vaccine. The patient was just happy and had a mild case. Action taken for misoprostol, diclofenac sodium was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a contactable physician. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced seizure in May2021 with outcome of recovered.    Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHIRTIS; This is a spontaneous report received from a Pfizer program. A contactable other healthcare professional reported that a 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) (at the age of 62 years old) as 2nd dose, single for COVID-19 immunisation; and tofacitinib citrate (XELJANZ XR), oral from Aug2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. The patient's medical history included sinus infection. Concomitant medications were not reported. Tofacitinib citrate was placed on hold per MD order, 1 week prior and 1 week after both COVID-19 vaccines were administered. The patient previously received the first dose of BNT162B2 on unknown date for COVID-19 immunisation. After receiving the second dose of COVID-19 vaccine on 04Feb2021, the patient experienced pain and swelling in lower back, knees, and soles of feet on an unspecified date in 2021. The patient experienced rheumatoid arthritis (aggravated) on unspecified date in 2021. The patient was prescribed prednisone to help with inflammation. The pain now is "not as severe and tolerable". MD was aware. Patient was able to manage symptoms at home with rest and heating pad. MD was aware. The action taken in response to the tofacitinib citrate was dose not changed. The outcome of the event rheumatoid arthritis aggravated was recovered on unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: A contributory role of the reported aggravation of rheumatoid arthritis, for which it is detailed that 'the patient experienced pain and swelling in lower back, knees, and soles of feet', as signs and symptoms, cannot be completely excluded for Covid-19 immunization. The event is assessed as unrelated to tofacitinib. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, White blood cell count, White blood cell count decreased
Clinical narrative: Immunocompromised; My WBC go down to upper ones; This is a spontaneous report received from a contactable physician and a contactable consumer. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reported Event Term: Immunocompromised, her white blood cell (WBC) go down to upper ones. Outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on an implied temporal association, a causal relationship between events Immunocompromised and white blood cell (WBC) go down, and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: heart attack; COVID; COVID; This is a spontaneous report from Pfizer. A non-contactable consumer (patient wife) reported a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had COVID. The patient had recently had a heart attack and was hospitalized for two weeks. Lab data included positive COVID 19 test. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Pain, Pyrexia
Clinical narrative: he's experiencing fever; terrible fatigue; body aches; severe sight pain; This is a spontaneous report from a Pfizer. A contactable consumer reporting for her husband. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Apr2021 for Covid-19 immunization. In May2021, after 2nd dose, the patient had been experiencing fever, terrible fatigue, body aches, severe sight pain and he even took TYLENOL but he was experiencing worse. The patient's wife was worried about his situation now. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vaccination site pain
Clinical narrative: he felt headache; dizziness; pain on the injection site; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 28Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  After the first dose the patient felt headache, dizziness and pain on the injection site. Outcome for the events was unknown. Patient also asked if it is okay for him to take NyQuil for his allergies prior to the second dose on May 19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Culture, Flushing, Urinary tract infection
Clinical narrative: 4 days after the vaccine I developed UTI symptoms that became increasingly painful.; Flushing of face and chest 30 minutes after receiving the vaccine.; This is a spontaneous report from a contactable consumer (patient).   A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:30 (Batch/Lot Number: EW0161) at the age of 28-year-old as SINGLE DOSE for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history included allergies to Sulfa, amoxicillin sodium;clavulanate potassium (AUGMENTIN). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient's concomitant medication included Birth Control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. The patient experienced Flushing of face and chest 30 minutes after receiving the vaccine on 23Apr2021 15:00. 4 days after the vaccine on 28Apr2021, the patient developed Urinary tract infection (UTI) symptoms that became increasingly painful. After teledoc visit patient started an antibiotic (macrobid) and the symptoms continued to worsen. Patient saw her Obstetrics and gynaecology (OBGYN) office and was given Ciprofoxacin and a culture test. The culture came back negative for infection. The pain became severe 7 days after the initial pain and were severe until 11 days after the initial symptoms. After about 13 days it was tolerable, but still uncomfortable. There were burning, pulling, pinching and pressure sensations during this time and it was incredibly painful to urinate, adverse event resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle aches; This is a spontaneous report from Pfizer-sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15May2021 (lot number and expiry date: unknown) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle aches on 15May2021. The patient wanted to know if she can take ibuprofen. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information has been expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: having pain in arm; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at around 4:00 PM (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported having pain in arm. The patient had 1st dose around 4:00 PM. Several hours after shot, patient's pain was much worse. Patient had been icing and heating the injured arm but not helping. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Feeling hot, Headache, Rash erythematous
Clinical narrative: felt like a little fuzzy; Lot of discomfort; warm spots on her skin; Headache; Blood clots; itchy red rash; This is a spontaneous report from a contactable consumer (parent of the patient). A 13-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration on 14May2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced blood clots, really warm spots on her skin in one of her legs, front of her thigh and her knees, her arms the tip part between her elbow and wrist on both of them, like where you can feel it's warm to the touch, lot of discomfort, headache and she kind of feel like a little fuzzy like in her thinking, she said she felt like she was  forgetting things like what you guys were saying. On 16May2021, she developed an itchy red rash on her legs and over her knees and on the tops of her arms from her wrist to her elbows. She has taken Benadryl to treat but it did not help. She is calling to see if this has been reported before. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: felt like a little fuzzy; Lot of discomfort; warm spots on her skin; Headache; Blood clots; itchy red rash; This is a spontaneous report from a contactable consumer (parent of the patient). A 13-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration on 14May2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced blood clots, really warm spots on her skin in one of her legs, front of her thigh and her knees, her arms the tip part between her elbow and wrist on both of them, like where you can feel it's warm to the touch, lot of discomfort, headache and she kind of feel like a little fuzzy like in her thinking, she said she felt like she was  forgetting things like what you guys were saying. On 16May2021, she developed an itchy red rash on her legs and over her knees and on the tops of her arms from her wrist to her elbows. She has taken Benadryl to treat but it did not help. She is calling to see if this has been reported before. The outcome of events was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID test, nasal swab/ developing a cough/fatigue, sore throat, lost sense of taste/smell; positive COVID test, nasal swab/ developing a cough/fatigue, sore throat, lost sense of taste/smell; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247) intramuscular in left arm single dose for COVID-19 immunization; second dose on 09Feb2021, first dose on 19Jan2021, at 25-year-old. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received a positive COVID test on 17May2021. COVID test post vaccination via nasal swab tested positive on 17May2021. On 12May2021, the patient started developing a cough/fatigue. On 15May2021, the patient developed a sore throat. On 15May2021, the patient lost sense of taste/smell. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 12 year old child has a 102 fever; This is a spontaneous report from a contactable consumer (patient's mom). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as 1st dose, single, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. This 12-year-old child had a 102 fever on unspecified date, 1 day after receiving her first shot. Patient had no symptoms on the day of vaccination. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: like little temperature; achy joints; bad headache that usually she has, but it gets a little more achy; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 13May2021 (lot number and expiry date: unknown) as 2nd dose, single, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunisation. On 14May2021, the patient experienced a reaction like little temperature, achy joints, and bad headache that usually she has, but it gets a little more achy. She took Excedrin, a type of Aspirin as treatment for the events. She was asking if those reactions can spread to others. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Nasopharyngitis
Clinical narrative: colds; Flu; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable male consumer reporting for himself that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced colds and flu in 2021. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pain, Pyrexia, Rash
Clinical narrative: throwing up; feels nauseous; fever; rash, growing on the arm she got the covid vaccine; severe cramping; pain; This is a spontaneous report from a contactable consumer (patient). This 20-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EW01S5), dose 2, via an unspecified route of administration in the left arm on 17May2021 08:35 (at the age of 20-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EW0167), dose #1, via an unspecified route of administration in the left arm on 26Apr2021 at 08:35 as 1st DOSE, SINGLE for COVID-19 immunization and experienced no adverse effects. After the first dose of the vaccine, the patient reported being fine. After the second dose, on 17May2021, the patient reported experienced severe cramps at 10:00. The patient developed a rash on the same day at 12:00 that is reportedly growing on the arm she got the covid vaccine. At about 23:00, she could not handle the pain and was going to go to the emergency room, but her mother talked out of it and told her to sleep it off. On 17May2021 at 23:30, the patient experienced a fever. And at 00:00 on 18May2021, the patient reported throwing up. At around 02:00 on 18May2021, the patient awoke screaming in pain. It was not a period cramp. She stated she could not tolerate it. She stated the fever comes and goes. The patient mentioned every time she smells food, she wants to vomit. She feels nauseous. The adverse events experienced did not require a visit to the emergency room or to a physician's office. Clinical outcome of the event severe muscle spasms was not resolved. Clinical outcome of the remaining events was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throwing up; feels nauseous; fever; rash, growing on the arm she got the covid vaccine; severe cramping; pain; This is a spontaneous report from a contactable consumer (patient). This 20-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EW01S5), dose 2, via an unspecified route of administration in the left arm on 17May2021 08:35 (at the age of 20-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EW0167), dose #1, via an unspecified route of administration in the left arm on 26Apr2021 at 08:35 as 1st DOSE, SINGLE for COVID-19 immunization and experienced no adverse effects. After the first dose of the vaccine, the patient reported being fine. After the second dose, on 17May2021, the patient reported experienced severe cramps at 10:00. The patient developed a rash on the same day at 12:00 that is reportedly growing on the arm she got the covid vaccine. At about 23:00, she could not handle the pain and was going to go to the emergency room, but her mother talked out of it and told her to sleep it off. On 17May2021 at 23:30, the patient experienced a fever. And at 00:00 on 18May2021, the patient reported throwing up. At around 02:00 on 18May2021, the patient awoke screaming in pain. It was not a period cramp. She stated she could not tolerate it. She stated the fever comes and goes. The patient mentioned every time she smells food, she wants to vomit. She feels nauseous. The adverse events experienced did not require a visit to the emergency room or to a physician's office. Clinical outcome of the event severe muscle spasms was not resolved. Clinical outcome of the remaining events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient's husband) reported a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization in Jan2021. The patient medical history was not reported. The patient's concomitant medications were not reported. After the first shot in Jan2021, the patient contracted COVID. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Severe Rash; Swollen Lymph node under left Armpit; This is a spontaneous report from a contactable consumer (patient wife).  A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included tooth extraction from 10May2021 to 10May2021.  The patient's concomitant medications were not reported.  The patient experienced severe rash and swollen lymph node under left armpit on 16May2021 at 07:42. Outcome of the events was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: blood on the bandaid/Bleeding; feel a little sore/Soreness; This is a spontaneous report from contactable consumers (included patient) via medical information team. A 20-year-old female patient received bnt162b2 (Solution for injection), via an unspecified route of administration, administered in Arm Left on 18May2021 (at the age of 20-year-old) (Lot Number: EW0177; Expiration Date: 21Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no history and concomitant medication. The patient had a quick concern and stated got vaccinated on 18May2021 (today) with first dose and she just looked up at her injection site little there was bit of blood, it was not bleeding but there was blood. On an unknown date in May2021, she had a little bit of blood on her bandage after she got the vaccine, but it was no longer bleeding. The patient did mention a little soreness on same date. Outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.