chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection site soreness; redness; skin sensitivity; brain fog; hot flashes; fatigue; swollen lymph nodes (left armpit); This is a spontaneous report from a contactable other hcp. A 44-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9268), via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included migraines. Patient had no known allergies. Patient had not covid prior and post vaccination. Concomitant medication(s) included ibuprofen (ADVIL LIQUI GELS); acetaminophen (ACETAMINOPHEN). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 (at the age of 44-year-old) as 1st dose, single for COVID-19 immunization. The patient stated that on 13Feb2021 02:00, he had a 102.5 degree fever off and on for two days, severe body aches, chills, headaches, injection site soreness, redness, skin sensitivity, brain fog, hot flashes, fatigue, and swollen lymph nodes (left armpit). Patient did not received any treatment for the events. The outcome of the events was reported as recovering.  Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Lymphadenopathy, Pain, Pyrexia, Skin sensitisation
Clinical narrative: I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection site soreness; redness; skin sensitivity; brain fog; hot flashes; fatigue; swollen lymph nodes (left armpit); This is a spontaneous report from a contactable other hcp. A 44-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9268), via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included migraines. Patient had no known allergies. Patient had not covid prior and post vaccination. Concomitant medication(s) included ibuprofen (ADVIL LIQUI GELS); acetaminophen (ACETAMINOPHEN). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 (at the age of 44-year-old) as 1st dose, single for COVID-19 immunization. The patient stated that on 13Feb2021 02:00, he had a 102.5 degree fever off and on for two days, severe body aches, chills, headaches, injection site soreness, redness, skin sensitivity, brain fog, hot flashes, fatigue, and swollen lymph nodes (left armpit). Patient did not received any treatment for the events. The outcome of the events was reported as recovering.  Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection site soreness; redness; skin sensitivity; brain fog; hot flashes; fatigue; swollen lymph nodes (left armpit); This is a spontaneous report from a contactable other hcp. A 44-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9268), via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included migraines. Patient had no known allergies. Patient had not covid prior and post vaccination. Concomitant medication(s) included ibuprofen (ADVIL LIQUI GELS); acetaminophen (ACETAMINOPHEN). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 (at the age of 44-year-old) as 1st dose, single for COVID-19 immunization. The patient stated that on 13Feb2021 02:00, he had a 102.5 degree fever off and on for two days, severe body aches, chills, headaches, injection site soreness, redness, skin sensitivity, brain fog, hot flashes, fatigue, and swollen lymph nodes (left armpit). Patient did not received any treatment for the events. The outcome of the events was reported as recovering.  Follow-up attempts have been completed and no further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Flushing, Headache
Clinical narrative: lightheadedness; headache; flushed; left deltoid where vaccination given hot to touch; nausea; Blood pressure elevated; This is spontaneous report from a non-contactable Other HCP. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9809) via an unspecified route of administration in left deltoid as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that during her 15-minute waiting period after the injection, the patient began to experience lightheadedness and headache, flushed, left deltoid where vaccination given hot to touch, nausea. She denied rash, difficulty breathing, lip swelling and tongue swelling. Patient with flushing, headache, left arm warm to touch, and nausea after first vaccine administration of Pfizer in the 15-minute waiting period. Blood pressure elevated, SpO2 was 98-99% on room air, pulse 68. Patient notes that she has reactions with medications and vaccines. Water provided. After sitting for a few minutes, patient reports that she was no longer lightheaded, headache was almost gone, nausea has resolved. Patient feeling back to normal. BP 152/76 at 12:03. All symptoms have resolved. Left deltoid without swelling, redness, rash. Patient ambulating without difficulty. She was cleared to drive home. The patient underwent lab tests and procedures which included blood pressure elevated, and 152/76, SpO2 was 98-99% on room air, pulse 68. The outcome of the events was recovered on unspecified date.  No follow up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Nausea, Oxygen saturation, Vaccination site warmth
Clinical narrative: lightheadedness; headache; flushed; left deltoid where vaccination given hot to touch; nausea; Blood pressure elevated; This is spontaneous report from a non-contactable Other HCP. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9809) via an unspecified route of administration in left deltoid as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that during her 15-minute waiting period after the injection, the patient began to experience lightheadedness and headache, flushed, left deltoid where vaccination given hot to touch, nausea. She denied rash, difficulty breathing, lip swelling and tongue swelling. Patient with flushing, headache, left arm warm to touch, and nausea after first vaccine administration of Pfizer in the 15-minute waiting period. Blood pressure elevated, SpO2 was 98-99% on room air, pulse 68. Patient notes that she has reactions with medications and vaccines. Water provided. After sitting for a few minutes, patient reports that she was no longer lightheaded, headache was almost gone, nausea has resolved. Patient feeling back to normal. BP 152/76 at 12:03. All symptoms have resolved. Left deltoid without swelling, redness, rash. Patient ambulating without difficulty. She was cleared to drive home. The patient underwent lab tests and procedures which included blood pressure elevated, and 152/76, SpO2 was 98-99% on room air, pulse 68. The outcome of the events was recovered on unspecified date.  No follow up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Depressed mood, Malaise, Pain, Pyrexia
Clinical narrative: fever; Body aches; Not feeling well; She had been feeling ok all week, has not felt bad, just felt a little rundown; Sore left arm where injection site was; This is a spontaneous report from a contactable consumer (daughter). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9269; Expiration Date: 03May2021), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 at 10:30 (at the age of 20-year-old) as 1st dose, single for COVID-19 immunization. The Patient's Medical History was not reported. Family medical history of the patient was not reported. Concomitant medications were reported as none. The Patient has received prior vaccinations (within 4 weeks), prior to the COVID vaccine reported as none. Additionally, vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as None. Consumer stated that her daughter received the first dose of the pfizer covid 19 vaccine while at school on 07Feb2021. The patient woke up around at 08:00, 15Feb2021 with fever, body aches and not feeling well. She had been feeling ok all week, had not felt bad, just felt a little rundown since around 08Feb2021; but she was a college student so that was not shocking. She had sore left arm where injection site was with onset around 08Feb2021. Consumer wanted to know if those were common to get side effects from the Pfizer COVID-19 Vaccine this long after vaccine or could she (patient) had COVID-19, should they had her tested for COVID-19. Consumer stated, they kind of anticipated side effects immediately following the vaccine; but unsure about side effects that was long after she was administered the Pfizer COVID-19 Vaccine. On 15Feb2021 at 08:00, the patient experienced fever, body aches, not feeling well; on 08Feb2021, felt a little rundown and sore left arm where injection site was. The patient did not require any visit in emergency room or physician office for events. The reporter classified the patient was not hospitalized. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 15Feb2021 and Saliva tested for COVID-19: negative on Feb2021, Negative for COVID-19 at school every other day. The outcome of the event 'Sore left arm where injection site was' resolved on unspecified date of Feb2021, event 'Felt a little rundown' was with unknown outcome and all other events was not recovered.  Follow-up (15Feb2021): This is a follow-up spontaneous report from a contactable consumer. event information and patient information was added.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: fever; Body aches; Not feeling well; She had been feeling ok all week, has not felt bad, just felt a little rundown; Sore left arm where injection site was; This is a spontaneous report from a contactable consumer (daughter). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9269; Expiration Date: 03May2021), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 at 10:30 (at the age of 20-year-old) as 1st dose, single for COVID-19 immunization. The Patient's Medical History was not reported. Family medical history of the patient was not reported. Concomitant medications were reported as none. The Patient has received prior vaccinations (within 4 weeks), prior to the COVID vaccine reported as none. Additionally, vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as None. Consumer stated that her daughter received the first dose of the pfizer covid 19 vaccine while at school on 07Feb2021. The patient woke up around at 08:00, 15Feb2021 with fever, body aches and not feeling well. She had been feeling ok all week, had not felt bad, just felt a little rundown since around 08Feb2021; but she was a college student so that was not shocking. She had sore left arm where injection site was with onset around 08Feb2021. Consumer wanted to know if those were common to get side effects from the Pfizer COVID-19 Vaccine this long after vaccine or could she (patient) had COVID-19, should they had her tested for COVID-19. Consumer stated, they kind of anticipated side effects immediately following the vaccine; but unsure about side effects that was long after she was administered the Pfizer COVID-19 Vaccine. On 15Feb2021 at 08:00, the patient experienced fever, body aches, not feeling well; on 08Feb2021, felt a little rundown and sore left arm where injection site was. The patient did not require any visit in emergency room or physician office for events. The reporter classified the patient was not hospitalized. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 15Feb2021 and Saliva tested for COVID-19: negative on Feb2021, Negative for COVID-19 at school every other day. The outcome of the event 'Sore left arm where injection site was' resolved on unspecified date of Feb2021, event 'Felt a little rundown' was with unknown outcome and all other events was not recovered.  Follow-up (15Feb2021): This is a follow-up spontaneous report from a contactable consumer. event information and patient information was added.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure systolic, Hypertension, Throat tightness
Clinical narrative: throat tightness; bp is up; This is a spontaneous report from a non-contactable other HCP. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EM9809) via unspecified route of administration, on an unspecified date as 1st dose single for COVID-19 immunisation. The patient's medical history included hypertension, a-fib, allergies and asthma. The patient's concomitant medications included allergy medications and hypertension medication. On an unspecified date during her 15-minute waiting period after the vaccination, the patient had experienced throat tightness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. She had taken her allergy medications along with her hypertension medication. The patient reported that she usually checks her home blood pressure and runs around 140s systolic. She stated that her blood pressure was up as she was anxious. She stated that she got like this prior to doctor appointments or visits. She had felt well and wished to go home. She was informed to monitor blood pressure at home and follow up in ED if throat symptoms worsen or do not improve. The patient received antihistamines as treatment. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes in left armpit swollen to grapefruit size; This is a spontaneous report from a contactable consumer. A 43-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on 13Feb2021 at 08:45 (at the age of 43-year-old) as 2ND DOSE, SINGLE in left arm for COVID-19 immunization. The patient's medical history included a known allergies of Peas, apples, pork. Patient was not pregnant at the time of vaccination. Concomitant medications included Zoloft. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 23Jan2021 at 10:30 AM (at the age of 43-year-old) as single dose in left arm for COVID-19 immunization. On 14Feb2021, the patient's lymph nodes in left armpit swollen to grapefruit size, making it difficult to use that arm/shoulder. The patient did not receive any treatment for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blood test, Breast pain, Cluster headache, Eye pain
Clinical narrative: Lymph nodes in left armpit swollen to grapefruit size; This is a spontaneous report from a contactable consumer. A 43-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on 13Feb2021 at 08:45 (at the age of 43-year-old) as 2ND DOSE, SINGLE in left arm for COVID-19 immunization. The patient's medical history included a known allergies of Peas, apples, pork. Patient was not pregnant at the time of vaccination. Concomitant medications included Zoloft. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 23Jan2021 at 10:30 AM (at the age of 43-year-old) as single dose in left arm for COVID-19 immunization. On 14Feb2021, the patient's lymph nodes in left armpit swollen to grapefruit size, making it difficult to use that arm/shoulder. The patient did not receive any treatment for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Laboratory test, Lymphadenopathy, Migraine, Neck pain
Clinical narrative: Lymph nodes in left armpit swollen to grapefruit size; This is a spontaneous report from a contactable consumer. A 43-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on 13Feb2021 at 08:45 (at the age of 43-year-old) as 2ND DOSE, SINGLE in left arm for COVID-19 immunization. The patient's medical history included a known allergies of Peas, apples, pork. Patient was not pregnant at the time of vaccination. Concomitant medications included Zoloft. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 23Jan2021 at 10:30 AM (at the age of 43-year-old) as single dose in left arm for COVID-19 immunization. On 14Feb2021, the patient's lymph nodes in left armpit swollen to grapefruit size, making it difficult to use that arm/shoulder. The patient did not receive any treatment for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, X-ray
Clinical narrative: Lymph nodes in left armpit swollen to grapefruit size; This is a spontaneous report from a contactable consumer. A 43-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on 13Feb2021 at 08:45 (at the age of 43-year-old) as 2ND DOSE, SINGLE in left arm for COVID-19 immunization. The patient's medical history included a known allergies of Peas, apples, pork. Patient was not pregnant at the time of vaccination. Concomitant medications included Zoloft. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 23Jan2021 at 10:30 AM (at the age of 43-year-old) as single dose in left arm for COVID-19 immunization. On 14Feb2021, the patient's lymph nodes in left armpit swollen to grapefruit size, making it difficult to use that arm/shoulder. The patient did not receive any treatment for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose for 3 days; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer reported that:  A 56-year-old non pregnant female patient received BNT162B2, (CONMIRATY, Solution for injection, Lot number- EM9809, Expiration date- Unknown), via an unspecified route of administration in arm left on 11Feb2021, as 2nd DOSE SINGLE for covid-19 immunization. Previously on 21Jan2021, 16:45 the patient received 1st dose of BNT162B2(, Solution for injection, Lot number- EL3247, Expiration date- Unknown), via an unspecified route of administration in arm left for covid-19 immunization. Medical history was not reported. No other medication and vaccine was reported in two and four weeks. Patient was not reported with covid prior to vaccination. Concomitant medications was not reported. On 12Feb2021, the patient experienced runny nose for 3 days. Patient was not tested for covid post vaccination.Therapeutic measures was not reported. The outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm swelled up; This is a spontaneous report from a contactable consumer. A female patient of unknown age received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unknown route of administration on an unknown date, as SINGLE DOSE for COVID-19 immunisation. Patient was pregnant reported unknown. The patient took any other vaccine in four weeks, other medications received in two weeks was unknown. The patient test covid prior vaccination and post vaccination was unknown. The patient medical history and concomitant medications were not reported. She recently got her hair cut and the stylist mentioned in casual conversation that her grandma had an adverse reaction to the Covid vaccine. Her arm swelled up and she received appropriate medical attention. The patient received treatment for the event. The patient had visited Emergency room/department or urgent care. The outcome of the event was recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Pain in extremity
Clinical narrative: she is having diarrhea.; some stomach issues; sore arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated she received the first dose of the vaccine on 19Jan2021 and the second dose 3 weeks later on 09Feb2021. She stated she did not have any side effects after either dose other than a sore arm on an unspecified date Feb2021. However today she is having diarrhea. She asked if this could still be related to the vaccine and how long she might experience this. The patient was vaccinated both doses of the Pfizer Covid19 vaccine. The first one on 19Jan and the second one on 09Feb. So, that is 3 weeks apart and I have zero side effects from both. The first time my arm hurt a little bit more than the second time. So, it has been 6 days since the patient had the second dose and today she was having some diarrhea and some stomach issues on 15Feb2021, the patient treatment received 2 Imodium. Would it be possible that it stated from the vaccine 6 days ago or not. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Gastric disorder, Pain in extremity
Clinical narrative: she is having diarrhea.; some stomach issues; sore arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated she received the first dose of the vaccine on 19Jan2021 and the second dose 3 weeks later on 09Feb2021. She stated she did not have any side effects after either dose other than a sore arm on an unspecified date Feb2021. However today she is having diarrhea. She asked if this could still be related to the vaccine and how long she might experience this. The patient was vaccinated both doses of the Pfizer Covid19 vaccine. The first one on 19Jan and the second one on 09Feb. So, that is 3 weeks apart and I have zero side effects from both. The first time my arm hurt a little bit more than the second time. So, it has been 6 days since the patient had the second dose and today she was having some diarrhea and some stomach issues on 15Feb2021, the patient treatment received 2 Imodium. Would it be possible that it stated from the vaccine 6 days ago or not. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling cold, Rhinorrhoea, SARS-CoV-2 test, Throat irritation
Clinical narrative: she feels like she has a cold; scratchy throat; runny nose; Coughing; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). Follow-up (15Feb2021) received from a consumer via Pfizer-sponsored program  was processed together with initial information.   A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration on 26Jan2021 around 02:00 Pm, (Batch/Lot Number: EL8982) as 1st dose in left arm shoulder, single for COVID-19 immunization. Medical history included colonoscopy 10 days ahead of her COVID-19 vaccine. She was given some type of drug then. She explains she had a Covid test right before the colonoscopy. She clarifies she had the COVID-19 test on 12Jan2021, and then on 14Jan2021, she had the actual colonoscopy, and she was given drugs at the time. She believes it was Fentanyl and a couple of others. No further details were provided. The patient's concomitant medications were not reported. On an unspecified date the patient had felt like she has cold, scratchy throat, she sneezed a couple times and had a little bit of a runny nose (It's not like she is sick. It's not a real cold or an advancing cold) and a little cough but that went away. She said she has a residual feeling that something was there, so she thinks it is on it'd way out. It was reported that scratchiness was not totally gone. Outcome of cough was recovered, scratchiness in her throat was resolving while for other events is unknown.  No further details were provided or obtained. Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: swelling; pain at the injection site; it feels warm and it is "a little red"; it feels warm and it is "a little red"; This is a spontaneous report received from a contactable Other HCP. This 26-year-old female Other HCP reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Feb2021 (at the age of 26-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer COVID-19 vaccine on Saturday, 13Feb2021. The patient reported that, on an unspecified date she experienced pain at the injection site, swelling, and it feels warm and it was "a little red." The patient wanted to know that these side effects were common after receiving the Pfizer COVID-19 vaccine. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash/rash and itching around the surgical wound that extended to other parts of her body, including her forearm (same arm where she received the vaccine), ribcage, and gluteal area; This is a spontaneous report from a contactable consumer(patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN9581) via unspecified route, administration on right arm on 29Jan2021 as a 1st dose single dose for COVID-19 immunization. Medical history included hip, knee, and thigh surgery all on that one side of her body over the past 3 years. The patient underwent 5 surgical procedures. The patient's concomitant medications were not reported. The patient was not on any other products. No investigation assessment was performed. 02Feb2021, the patient underwent surgery (last surgery after vaccination) on her IT (Iliotibial) band, releasing a tendon on the outside of her thigh. She knew that she would go for surgery as it was scheduled prior to the vaccination. On 05Feb2021(a week after vaccination) the patient experienced rash/an itchy rash, itching around the surgical wound that extended to other parts of her body, including her forearm (same arm where she received the vaccine), ribcage, and gluteal area. Rash apparently improved today (date of reporting) she did not find any new spots and it was not as itchy. The patient was treating rash with an over-the-counter salve per her doctor's recommendation, and it was now subsiding, but that it was jumping from body part to body part. She wanted to know if she should still get the second dose considering she had the rash as the dose was due on Friday or Saturday next week. The outcome of the event itchy rash was recovering and unknown for another event.  Follow-up attempts are completed. No further information was expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Palpitations
Clinical narrative: It's been almost three weeks and I'm still having patches that won't go away. It's 98% gone with just annoying lingering itchiness; Hives across entire body within ten minutes. Hives lasted eight days; Also had slight throat swelling; heart pounding; dizziness; headache; fever; chill; general ugh; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318), via an unspecified route of administration on 27Jan2021 at 09:00 (at the age of 47-year-old) as UNKNOWN, SINGLE in the left arm for covid-19 immunisation. The patient medical history included diabetes, thyroid. The patient had Known allergic to seabass and grouper (seafood), sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications in two weeks included Levothyroxine Sodium, Glyburide, Ergocalciferol (Vitamin D), Atorvastatin all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021 at 09:15, the patient experienced hives across entire body within ten minutes. Hives lasted eight days. Also had slight throat swelling, heart pounding, dizziness, headache, fever, chills, and general ugh. It's been almost three weeks and patient still having patches that would not go away. It was 98% gone with just annoying lingering itchiness. The patient did not receive any treatment for the events. The outcome of the events was recovering.  On 13May2021 Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Pyrexia, Urticaria
Clinical narrative: It's been almost three weeks and I'm still having patches that won't go away. It's 98% gone with just annoying lingering itchiness; Hives across entire body within ten minutes. Hives lasted eight days; Also had slight throat swelling; heart pounding; dizziness; headache; fever; chill; general ugh; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318), via an unspecified route of administration on 27Jan2021 at 09:00 (at the age of 47-year-old) as UNKNOWN, SINGLE in the left arm for covid-19 immunisation. The patient medical history included diabetes, thyroid. The patient had Known allergic to seabass and grouper (seafood), sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications in two weeks included Levothyroxine Sodium, Glyburide, Ergocalciferol (Vitamin D), Atorvastatin all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021 at 09:15, the patient experienced hives across entire body within ten minutes. Hives lasted eight days. Also had slight throat swelling, heart pounding, dizziness, headache, fever, chills, and general ugh. It's been almost three weeks and patient still having patches that would not go away. It was 98% gone with just annoying lingering itchiness. The patient did not receive any treatment for the events. The outcome of the events was recovering.  On 13May2021 Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Muscle/joint pain in his upper legs/hips; Muscle/joint pain in his upper legs/hips; Started hurting right on my legs like coming out of my body; This is a spontaneous report from a contactable consumer (Patient) via Medical information team. Follow-up (15Feb2021) was received from same reporter and processed together with initial information.  A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 08Feb2021 as 2nd dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 via an unspecified route of administration on 21Jan2021 as 1st dose, single for COVID-19 immunization and had no problems. The second one the patient took on 08Feb2021. On an unspecified date in FEB-2021, the patient started hurting right on legs like coming out of body. On 08Feb2021, the patient experienced muscle/joint pain in his upper legs/hips. The patient was calling to find out, he hasn't had any kind of problems up until now and wanted to know could this be the part of symptoms. The outcome of the events was unknown.  Further probing could not be initiated as consumer was unwilling to further answer the questions.   Information on batch/lot number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Vaccination site pain
Clinical narrative: Sore Arm at injection site; slight clamminess on forehead; This is a spontaneous report from a contactable consumer. A 62-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration in arm left on 15Feb2021 at 08:45 AM (at the age of 61-year-old) as a 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included methotrexate. It was reported that, patient did not receive any other vaccine in fourweeks. No covid prior vaccination and no covid tested post vaccination. The patient experienced, sore arm at injection site and slight clamminess on forehead. The outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm where vaccine was given hurt for 2 days; This is a spontaneous report from a non-contactable consumer (Patient herself). A 66-year-old non pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration administered in left arm on 12Feb2021 15:00 (at the age of 66-year-old) as single dose for COVID-19 immunization. No Medical history provided. Concomitant medications were not reported. Patient did not other vaccine in four weeks. Patient did not receive any treatment for AE. The patient did not have covid prior vaccination and did not test covid post vaccination. On 12Feb2021 15:00 patient experienced Left arm where vaccine was given hurt for 2 days; resolved thereafter. No other issues. The outcome of the event was recovered on unspecified date.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A rash that spread from my stomach to back, shoulders, neck, arms and legs; This is a spontaneous report from a contactable Other HCP (patient). A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL8982, Expiration Date: unknown) via an unspecified route of administration in left arm on 01Feb2021 (at the age 26 years) as 1st dose, single for COVID-19 immunization. Medical history included COVID prior vaccination and allergy to animal (cats). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. On 03Feb2021, the patient experienced a rash that spread from stomach to back, shoulders, neck, arms and legs. AE resulted in doctor or other healthcare professional office/clinic visit. Patient visited Dermatology, topical steroid and allergy med were given a treatment for the event. The patient was not tested for COVID-19 post vaccination. The outcome of the event was recovering.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Fatigue, Hyperglycaemia, Hypoglycaemia, Pain in extremity
Clinical narrative: Hypo and hyperglycemia; Hypo and hyperglycemia; scalp and armpit acne; fatigue; sore arm; This is a spontaneous report from a contactable physician (Patient). A 69-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, in left arm on 01Feb2021 11:30, as 2nd single dose for covid-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1284 and Expiration date was not reported), via an unspecified route of administration, in left arm on 04Jan2021 01:00 PM, as 1st single dose for covid-19 immunisation. Medical history included diabetes 2, hypertension I, hyperlipidaemia and hypogonadism. Patient was allergies to Penicillin, Cipro and Bactrim. Concomitant medication(s) that patient received in two weeks included insulin (INSULIN); metformin (METFORMIN); terazosin (TERAZOSIN); finasteride (FINASTERIDE); hctz (HCTZ). Facility where COVID-19 vaccine was administered was at Public Health Clinic/Veterans Administration facility. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient not tested for COVID-19 prior vaccination. On 04Feb2021 10:30 AM, the patient experienced hypo and hyperglycaemia, scalp and armpit acne, fatigue, sore arm which continued at two-week mark after second dose. No treatment received for reported adverse events. Patient not tested for COVID-19 after the vaccination. The outcome of the events was reported as not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: After second dose--slightly sore arm for one day; chills; slight body aches; slight headache; This is a spontaneous report from a non-contactable non-healthcare professional.   A 48-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left on 19Jan2021 at 11:45 as first single dose for covid-19 immunisation. after first dose patient had slightly sore arm for 3 days and second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left on 09Feb2021 at 12:30 as second single dose for covid-19 immunisation.  Medical history included food allergy (allergies: freshwater prawns) and concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, not had the patient been tested for COVID-19. On 10Feb2021 at 08:00, the patient experienced after second dose slightly sore arm for one day, chills, slight body aches and slight headache. Patient was not treatment received for the adverse event. The outcome of the events was recovered o an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site oedema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: vaccination site red; vaccination site swollen; vaccination site hot; vaccination site itchy; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that:  A 76-year-old female patient received dose bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number: E19264 but it could be EL9264, and expiration date were not reported) via a unspecified route of administration in left arm, on 05Feb2021 at 14:30PM (at the age of 76-year-old) as single dose for COVID-19 immunization. The patient was not administered an additional vaccine on same date of the Pfizer vaccine. The concomitant medications included a Proto-nix used for Barrett's oesophagus, Celexa used for Anxiety, Rosuvastatin used for Blood cholesterol increased, and baby Aspirin for a while.  On 14Feb2021 at 9PM the patient had a huge reaction at the injection site where it was red, swollen, hot, and itchy. The reaction is in the left arm and that is where she received the injection. It is still hot and swollen and red. She has no fever. On 16Feb2021 for the first time she took a little Tylenol. She is due in 10 days for the next dose. The outcome of event is not recovered.  Follow-up (16Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 76-year-old consumer reported a significant information regarding suspect drug and events.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever; body aches; headache; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 24-years-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247; Expiration Date: unknown), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Feb2021, the patient experienced fever, body aches, headache. The clinical outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: felt like I got hit by an eletric shock in my heart going to my neck and left arm lasted 2 seconds; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration in left arm on 13Feb2021 at 11:00 (at age of 77-year-old) as 2ND DOSE SINGLE for COVID-19 immunization. The patient medical history includes AAA Aneurysm, Osteoarthritis, Costochondritis from unspecified date. The patient concomitant medications include losartan, carvedilol, ezetimibe, ascorbic acid vitamin D, Curcuma longa (TURMERIC) from unspecified date and unknown if still ongoing. Patient had allergic to penicillin and ciprofloxacin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), Lot number & Expiry date not reported) via unspecified route of administration in left arm on 23Jan2021 at 11:00 as single dose for COVID-19 immunization. On 14Feb2021 at 13:00 (one day after vaccination) Patient experienced she felt like got hit by an electric shock in my heart going to my neck and left arm lasted 2 seconds. No treatment was received by patient. The outcome of event was recovered.  Information on the lot/batch number has been requested. No further information expected.