chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: my arm was sore; fever; chills; booster; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received third dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Nov2021 15:00 (at the age of 64-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included Diabetes, Blood pressure and High Sugar. The concomitant medications were not reported, the patient reported that she takes medicine for high sugar and blood pressure and Diabetes. The patient received first and second dose of COVID-19 (Primary Immunization series complete but unknown manufacturer) Vaccine on unknown dates for covid-19 immunisation. On 09Nov2021 at 15:00 the patient experienced booster. On 09Nov2021 at 21:00 the patient experienced fever and chills. On 10Nov2021 the patient experienced my arm was sore. The patient underwent lab tests and procedures which included body temperature: unknown result on an unknown date. Therapeutic measures were taken as a result of fever, chills and my arm was sore. She received a booster dose of the Comirnaty vaccine on 09Nov2021 at 3 PM. By 9 PM she stated she had a fever and chills, she stated she took Tylenol and it went away but she feels like the symptoms were returning. She wants to know if she would be contagious after receiving a booster dose. Treatment included Tylenol. She thinks it was 800. LOT number of Vaccine: she stated, was that on my card 32O3O8B. LOT# 32 either D or O3O8D. She stated she received her Comirnaty booster dose on Tuesday that was 09Nov2021 and she received that 09Nov2021 that was on Tuesday two days ago and that evening she received the shot 3 in afternoon and by 9 PM in the evening she had fever and chills and she called in to medical information to ask some medical question. She reported that her arm was sore on Wednesday but today it was not. She got the COVID Pfizer vaccine Booster. The outcome of the evets fever and chills was not resolved, for the event my arm was sore the outcome was resolved on an unknown date in 2021. The lot number for the vaccine, [Comirnaty], was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Condition aggravated, Fatigue, Headache
Clinical narrative: Fatigued; Bad headaches, 5/6; booster; Muscle aches; Joint pain; achy; Bad headaches/Fatigued/Muscle aches/ Joint pain, can't get out of bed/was reported as worsened; can't get out of bed; This is a spontaneous report from a contactable consumer (Patient) via a Pfizer sponsored program. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration in 2021 (Age at vaccination: 66 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation . Medical history was reported as None. Patients Medical History (including any illness at time of vaccination)? No. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 and dose 2, 2 months ago for covid-19 immunisation. The patient reported booster in 2021, bad headaches, 5/6 (headache) in Oct2021, fatigued on 03Oct2021, severe muscle aches, severe joint pain, achy, bad headaches/fatigued/muscle aches/ joint pain, can't get out of bed/was reported as worsened (condition aggravated), can't get out of bed (hard time getting out of bed) in 2021. The patient underwent lab tests and procedures which included magnetic resonance imaging: negative in 2021 Caller states he had an MRI done and it was negative, magnetic resonance imaging: normal on 25Oct2021. He wants some guidance, the doctors dont listen to him. Patient had Muscle aches, can't get out of bed, a week later after booster. He took Ibuprofen and Tylenol for the achiness, and it did help a little bit with his effects. He went to the doctor's office 2 or 3 times, his regular doctor and the doctor. The outcome of achy was unknown. The outcome of the rest of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Magnetic resonance imaging, Myalgia, Pain
Clinical narrative: Fatigued; Bad headaches, 5/6; booster; Muscle aches; Joint pain; achy; Bad headaches/Fatigued/Muscle aches/ Joint pain, can't get out of bed/was reported as worsened; can't get out of bed; This is a spontaneous report from a contactable consumer (Patient) via a Pfizer sponsored program. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration in 2021 (Age at vaccination: 66 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation . Medical history was reported as None. Patients Medical History (including any illness at time of vaccination)? No. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 and dose 2, 2 months ago for covid-19 immunisation. The patient reported booster in 2021, bad headaches, 5/6 (headache) in Oct2021, fatigued on 03Oct2021, severe muscle aches, severe joint pain, achy, bad headaches/fatigued/muscle aches/ joint pain, can't get out of bed/was reported as worsened (condition aggravated), can't get out of bed (hard time getting out of bed) in 2021. The patient underwent lab tests and procedures which included magnetic resonance imaging: negative in 2021 Caller states he had an MRI done and it was negative, magnetic resonance imaging: normal on 25Oct2021. He wants some guidance, the doctors dont listen to him. Patient had Muscle aches, can't get out of bed, a week later after booster. He took Ibuprofen and Tylenol for the achiness, and it did help a little bit with his effects. He went to the doctor's office 2 or 3 times, his regular doctor and the doctor. The outcome of achy was unknown. The outcome of the rest of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: rare Guillain Barre syndrome; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced rare Guillain barre syndrome on an unspecified date. The patient was on the mend but cant take any vaccine for 12 months. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fall, Immunisation, Limb injury, Muscle contusion, Rotator cuff syndrome
Clinical narrative: ripped my rotator cuff mechanism apart; muscle bruising; fell; severely injured my right should which is where I go the shot; booster; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Sep2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On the morning of the 21Sep2021 the patient fell and severely injured his/her right should which is where the patient went the shot. It was reported that his/her fall has nothing to do with the booster and everything to do with his/her clumsiness. In any event there was a lot of muscle bruising, and the ripped rotator cuff mechanism apart for which the patient will need surgery. The outcome was unknown.   The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of event fall is assessed to be unrelated and is more likely due to patient's condition of clumsiness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, SARS-CoV-1 test
Clinical narrative: Guillain-Barre Syndrome; This is a spontaneous report from a contactable consumer.  A 42 year-old female patient  received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) as single dose  for covid-19 immunisation(Age at vaccination 41 years)  .  The patient's medical history and concomitant medications were not reported.  The patient experienced Guillain-Barre syndrome  (medically significant) on 12Oct2021 with outcome of unknown.  The patient was hospitalized for Guillain-Barre syndrome  for 10 days.  The patient underwent lab tests and procedures which included sars-cov-1 test: unknown results   on 2021 after receiving the vaccine.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis that is spreading across my body with no family history of it.; This is a spontaneous report from a contactable consumer (Patient). A 54-years-old male patient re-ceived bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Age at vaccination: 54 years) as DOSE 2, SINGLE for covid-19 immunisation at hospital. Medical history included food allergy from an unknown date and unknown if ongoing known allergies: Strawberries. Concomitant medications included Gabapentin. Historical vaccine included bnt162b2 (COMIRNATY, solution for injection, lot number= EN6208) (Age at vaccination; 54 years) in left arm as dose 1 on 24March2021 for covid-19 immunisation. Patient did not receive other vaccines in 4 weeks. Patient did not have Covid prior vaccination. Patient did not test Covid post vaccination. The patient experienced psoriasis that is spreading across my body with no family history of it on 30Apr2021. AE resulted in doctor or other healthcare professional office/clinic visit. Betamethasone Dipropionate Aug 0.05 % Top Oint was given as a result of adverse event.  The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Depressed mood, Drainage, Drug ineffective, Head discomfort
Clinical narrative: feeling down; last night she was sweaty; drainage; coughing a little; feels like COVID/ it feels almost like she had COVID again; feels like COVID/ it feels almost like she had COVID again; flu-like symptoms/ felt like she had the flu; head feels crazy; not feeling good; Booster; This is a spontaneous report based on information received by Pfizer. A non-contactable consumer (patient) reported that an 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation, at the age of 84-years, , dose 3 via an unspecified route of administration on 12Oct2021 (batch/lot number: 301458A) as DOSE 3 (BOOSTER), SINGLE, first single dose and second single dose on unspecified date; influenza vaccine (FLU), via an unspecified route of administration on 15Oct2021 for immunization; ibandronate sodium (IBANDRONATE, tablet, strength: 150 mg), via an unspecified route of administration from 18Jun2021 to Jul2021, then (lot number: C2108087; expiration date: 31May2024) from Sep2021 and ongoing, at once a month for bone. Medical history included COVID since Jul2021. Concomitant medications included pelargonium sidoides (UMCKA COLD CARE) and multivitamins. On 08Nov2021, the patient experienced flu-like symptoms, not feeling good, head feels crazy, feels like COVID, drainage, coughing a little. The patient reported that she was not feeling good, felt like she had the flu. She also reported that took her Pfizer booster and then took flu shot, her head feels crazy, it feels almost like she had COVID again. She was still not feeling good, she was feeling down. She started the medication (ibandronate sodium) in Jun2021 and had COVID in Jul2021 so she didn't take it then (interruption of therapy), started again in Sep2021. She had had some drainage and coughing a little. Last night she was sweaty. Patient used cold and flu medicine to treat the adverse events. The action taken to the events for ibandronate sodium was dose not changed. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation, Influenza like illness, Malaise, Night sweats, Suspected COVID-19
Clinical narrative: feeling down; last night she was sweaty; drainage; coughing a little; feels like COVID/ it feels almost like she had COVID again; feels like COVID/ it feels almost like she had COVID again; flu-like symptoms/ felt like she had the flu; head feels crazy; not feeling good; Booster; This is a spontaneous report based on information received by Pfizer. A non-contactable consumer (patient) reported that an 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation, at the age of 84-years, , dose 3 via an unspecified route of administration on 12Oct2021 (batch/lot number: 301458A) as DOSE 3 (BOOSTER), SINGLE, first single dose and second single dose on unspecified date; influenza vaccine (FLU), via an unspecified route of administration on 15Oct2021 for immunization; ibandronate sodium (IBANDRONATE, tablet, strength: 150 mg), via an unspecified route of administration from 18Jun2021 to Jul2021, then (lot number: C2108087; expiration date: 31May2024) from Sep2021 and ongoing, at once a month for bone. Medical history included COVID since Jul2021. Concomitant medications included pelargonium sidoides (UMCKA COLD CARE) and multivitamins. On 08Nov2021, the patient experienced flu-like symptoms, not feeling good, head feels crazy, feels like COVID, drainage, coughing a little. The patient reported that she was not feeling good, felt like she had the flu. She also reported that took her Pfizer booster and then took flu shot, her head feels crazy, it feels almost like she had COVID again. She was still not feeling good, she was feeling down. She started the medication (ibandronate sodium) in Jun2021 and had COVID in Jul2021 so she didn't take it then (interruption of therapy), started again in Sep2021. She had had some drainage and coughing a little. Last night she was sweaty. Patient used cold and flu medicine to treat the adverse events. The action taken to the events for ibandronate sodium was dose not changed. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Fever of 103; This is a spontaneous report from a contactable consumer via the Medical Information Team. A patient of unspecified age and gender received BNT162B2 (COMIRNATY; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter denied having flu like symptoms following the vaccine like others she has heard about. She (reporter) speaks of someone (patient) who had a fever of 103 that resolved after 1-2 days. The outcome of the events was recovered on an unspecified date.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Bowel movement irregularity, Fatigue, Nausea
Clinical narrative: Bloating; Lack of bowel movement; Abdominal discomfort; Achy; Developed a sense of "itch" under right (vaccinated) armpit/axilla; Tired; Nauseous; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FF8841) via an unspecified route of administration in right arm on 25Oct2021 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant and not pregnant at the time of vaccination. Relevant medical history included BRCA1 gene mutation. The patient previously received the first dose of Moderna COVID vaccine (Lot number 039K20A) via an unspecified route of administration in left arm on 27Dec2020 10:00AM and second dose of Moderna COVID vaccine (Lot number 028L20A) via an unspecified route of administration in right arm on 25Jan2021 10:00AM, both taken for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medications included colecalciferol (VIT D), melatonin, cyanocobalamin (VIT B12) and magnesium. On 25Oct2021, after the booster dose, the patient had a few days when she felt horrible (tired, achy, nauseous). She also developed a sense of "itch" under right (vaccinated) armpit/axilla and abdominal discomfort. On day 3, she noticed bloating and lack of bowel movement since vaccination. Bloating, abdominal discomfort and lack of bowel function with bouts of nausea have continued. The patient went to urgent care, her PCP and a GI specialist. Events required Emergency Room visit and Physician office visit. Treatment was received: x-ray, prescription for Trulance, Zofran and Compazine. The events were not resolved at the time of report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, SARS-CoV-2 test
Clinical narrative: Bloating; Lack of bowel movement; Abdominal discomfort; Achy; Developed a sense of "itch" under right (vaccinated) armpit/axilla; Tired; Nauseous; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FF8841) via an unspecified route of administration in right arm on 25Oct2021 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant and not pregnant at the time of vaccination. Relevant medical history included BRCA1 gene mutation. The patient previously received the first dose of Moderna COVID vaccine (Lot number 039K20A) via an unspecified route of administration in left arm on 27Dec2020 10:00AM and second dose of Moderna COVID vaccine (Lot number 028L20A) via an unspecified route of administration in right arm on 25Jan2021 10:00AM, both taken for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medications included colecalciferol (VIT D), melatonin, cyanocobalamin (VIT B12) and magnesium. On 25Oct2021, after the booster dose, the patient had a few days when she felt horrible (tired, achy, nauseous). She also developed a sense of "itch" under right (vaccinated) armpit/axilla and abdominal discomfort. On day 3, she noticed bloating and lack of bowel movement since vaccination. Bloating, abdominal discomfort and lack of bowel function with bouts of nausea have continued. The patient went to urgent care, her PCP and a GI specialist. Events required Emergency Room visit and Physician office visit. Treatment was received: x-ray, prescription for Trulance, Zofran and Compazine. The events were not resolved at the time of report.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Sore arm; Booster; This is a spontaneous report from a non-contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included pirfenidone (ESBRIET). Historical Vaccine included BNT162B2 as dose 1 and dose 2 on an unspecified date for COVID-19 immunization (at the age of 75-years-old). The patient experienced sore on an unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: shortness of breath/ can't take full breath; Sore arm; tightness in chest; fatigue; This is a spontaneous report from a contactable consumer (Patient).  A 40 years-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: FH8027), via Intramuscular on arm left on 14Nov2021 10: 00 AM (at the age of 40 years-old) as dose 1, single for COVID-19 immunization at a Pharmacy or drug store. The patient's medical history was not reported. The patient did not take any other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 15Nov2021, the patient experienced shortness of breath/ can't take full breath, sore arm, tightness in chest and fatigue. On 15Nov2021 08: 00 AM, the patient underwent lab tests and procedures which included Nasal Swab: Pending. The patient did not receive any treatment for adverse event. The outcome of events was recovering.  Follow-Up (18Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Immunisation, Scan, Swelling
Clinical narrative: Swelling in armpit after covid19 booster injection; Swelling in armpit after covid19 booster injection; This is a spontaneous report from a contactable consumer. A 5-decade-old (also reported as in her 40s) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 11Nov2021 (at the age of 5-decade-old), as dose 3 (booster), single for COVID-19 immunization. The patient had no notable medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single and then as dose 2, single for covid-19 immunization and had no previous reaction to vaccine. The patient experienced swelling in armpit after covid19 booster injection, same side as injection site on 11Nov2021. The patient had seen by a doctor and given scan and x-ray and investigations showed nothing of concern. The outcome of the event was unknown at the time of this report.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Immunisation, Lethargy
Clinical narrative: extreme lethargy; Elevated temperature; chills; total body aches; booster dose; This is a spontaneous report from a contactable consumer or other non hcp. A 37-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: FF8841; Expiration date was not reported), dose 3 intramuscular, administered in Arm Right (age at vaccination 37-year-old) on 15Nov2021 01:15 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Patient had historical vaccine of first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247; Expiration date was not reported) via an unspecified route of administration on 11Mar2021 as DOSE 1, SINGLE and second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EP6955; Expiration date was not reported) via an unspecified route of administration in right arm on 30Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Facility type vaccine: Workplace clinic. There were no treatment for ae. There were no covid prior vaccination. There were no covid tested post vaccination. There were no known allergies. There were no other medical history. There were no concomitant medications. On 15Nov2021 01:15 the patient experienced booster dose, on 15Nov2021 18:00 experienced extreme lethargy, elevated temperature, chills, total body aches. The patient underwent lab tests and procedures which included body temperature: elevated temperature on 15Nov2021. The outcome of events were recovered on Nov2021.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: extreme lethargy; Elevated temperature; chills; total body aches; booster dose; This is a spontaneous report from a contactable consumer or other non hcp. A 37-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: FF8841; Expiration date was not reported), dose 3 intramuscular, administered in Arm Right (age at vaccination 37-year-old) on 15Nov2021 01:15 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Patient had historical vaccine of first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247; Expiration date was not reported) via an unspecified route of administration on 11Mar2021 as DOSE 1, SINGLE and second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EP6955; Expiration date was not reported) via an unspecified route of administration in right arm on 30Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Facility type vaccine: Workplace clinic. There were no treatment for ae. There were no covid prior vaccination. There were no covid tested post vaccination. There were no known allergies. There were no other medical history. There were no concomitant medications. On 15Nov2021 01:15 the patient experienced booster dose, on 15Nov2021 18:00 experienced extreme lethargy, elevated temperature, chills, total body aches. The patient underwent lab tests and procedures which included body temperature: elevated temperature on 15Nov2021. The outcome of events were recovered on Nov2021.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Blood test, Illness, Malaise, Pyrexia
Clinical narrative: fever; she was not feeling well; Graves disease; sick; lost weight; This is a spontaneous report from a contactable consumer(patient).   A 53 year old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EW0161 ) via an unspecified route of administration into arm left on 19Apr2021;17:30 as DOSE 2, SINGLE for covid-19 immunization(at the age of 53 years).The patient medical history and concomitant were not reported. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number:ER8727) via an unspecified route of administration on 29Mar2021into arm left  as DOSE 1, SINGLE for covid-19 immunization and experienced no adverse events. Patient had a query she  should be getting the flu shot and she had no issue ever for the flu shot and wondered about that as well regarding if she should get a flu vaccine or if the Pfizer covid vaccine triggered this and she should get the booster or should she get the Pfizer booster or another booster and noticed her doctor did not know if the Pfizer Covid vaccine had or had not been related to this and she wanted to know. On an unspecified date after administration of 2nd dose  the patient  became sick and lost weight  , she developed a fever the same night and had the shot at 5:30pm and the fever began about 11:00pm and states she had a high fever the following day but does not remember what it was but she was not feeling well. She was in and out of bed the first four days and was texting her friends overseas and said she lost all the weight and said she went to a weight facility and came to know that in kilos she lost 4 kilos over 4 days and the weight loss is not ongoing but she went overseas and used to be 63 kilos and is really down to 56 kilos and had lost 8 kilos. States her fever began around 11:00pm the same date she had the 2nd dose of the vaccine and it is not ongoing and all of that is gone and while she was overseas she saw doctors there and they found heart arrhythmia in her and thought it was an issue with her heart but turned out it was Graves disease and one symptom of Graves is heart arrhythmia and one symptom of Graves is weight loss. On Apr2021 the patient underwent lab test and procedures which included blood test and diagnosed with unknown results and also underwent  body weight test and diagnosed with really down to 56 kilos and had lost 8 kilos. The clinical outcome of the events were unknown.   No follow-up attempts are needed. No further information is expected.        .  .                   .
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: fever; she was not feeling well; Graves disease; sick; lost weight; This is a spontaneous report from a contactable consumer(patient).   A 53 year old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EW0161 ) via an unspecified route of administration into arm left on 19Apr2021;17:30 as DOSE 2, SINGLE for covid-19 immunization(at the age of 53 years).The patient medical history and concomitant were not reported. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number:ER8727) via an unspecified route of administration on 29Mar2021into arm left  as DOSE 1, SINGLE for covid-19 immunization and experienced no adverse events. Patient had a query she  should be getting the flu shot and she had no issue ever for the flu shot and wondered about that as well regarding if she should get a flu vaccine or if the Pfizer covid vaccine triggered this and she should get the booster or should she get the Pfizer booster or another booster and noticed her doctor did not know if the Pfizer Covid vaccine had or had not been related to this and she wanted to know. On an unspecified date after administration of 2nd dose  the patient  became sick and lost weight  , she developed a fever the same night and had the shot at 5:30pm and the fever began about 11:00pm and states she had a high fever the following day but does not remember what it was but she was not feeling well. She was in and out of bed the first four days and was texting her friends overseas and said she lost all the weight and said she went to a weight facility and came to know that in kilos she lost 4 kilos over 4 days and the weight loss is not ongoing but she went overseas and used to be 63 kilos and is really down to 56 kilos and had lost 8 kilos. States her fever began around 11:00pm the same date she had the 2nd dose of the vaccine and it is not ongoing and all of that is gone and while she was overseas she saw doctors there and they found heart arrhythmia in her and thought it was an issue with her heart but turned out it was Graves disease and one symptom of Graves is heart arrhythmia and one symptom of Graves is weight loss. On Apr2021 the patient underwent lab test and procedures which included blood test and diagnosed with unknown results and also underwent  body weight test and diagnosed with really down to 56 kilos and had lost 8 kilos. The clinical outcome of the events were unknown.   No follow-up attempts are needed. No further information is expected.        .  .                   .
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Pruritus, Scratch
Clinical narrative: When I took the second shot it took me about four almost five days to feel better; I had like extreme itching with the second and with all the shots; I had like within the first few hours and was just scratching like crazy; I had like extreme itching with the second and with all the shots; I had like within the first few hours and was just scratching like crazy; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sleep apnoea syndrome (Verbatim: Sleep apnea), sleep disorder (Why was the patient taking Concomitant Products Doxylamine succinate (Verbatim): Sleep), hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC) taken for Allergy, start and stop date were not reported; doxylamine succinate 25 mg (DOXYLAMINE SUCCINATE) taken for sleep disorder, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient stated that when she took the second shot it took her about four almost five days to feel better. She had like extreme itching with the second and with all the shots, she had like within the first few hours and was just scratching like crazy. The patient underwent lab tests and procedures which included laboratory test: unknown results in Aug2021 (Recently would be early in the summer around lab work was before my physical sometime in august pre august). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Impaired healing, Post procedural complication
Clinical narrative: Not healing properly; has had complications; This is a spontaneous report from a contactable consumer or other non HCP. A 54-years-old non-pregnant female patient received bnt162b2 (COMIRNATY,solution for injection), via an unspecified route of administration on unspecified date (Batch/Lot Number: UNKNOWN) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY, solution for injection) received on an unspecified date as Dose 1, single (batch/lot: unknown) for COVID-19 Immunisation. On unspecified date, the patient experienced Not healing properly and postoperative complication. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid test result Positive; This is a spontaneous report from a contactable other health care professional (Patient). A 39 year old male customer (patient) reported that he received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot : El1283), via an unspecified route of administration, administered in Arm Left on 20Jan2021 (at the age of 38-year-old)13:15 as dose 1, single for COVID-19 immunization . Patient medical history included Shrimp allergy and COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 25Jan2021the patient experienced covid test result positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Jan2021 nasal swab (sample) and on 17Aug2021 sars-cov-2 test: negative nasal swab (sample). Outcome of the event Covid-19 was unknown.  Follow-up attempts are completed. No further information is expected
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Immunisation, Influenza like illness
Clinical narrative: headaches; felt like had mild flu; fuzzy head type of feeling; hurt all over; arm was much more sore; booster; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp.  A 59-years-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on 12Nov2021 as dose 3 (booster), SINGLE for covid-19 immunisation. Medical history included hypertension ongoing diagnosed about 15 years ago, takes medication to treat this and it is not an issue, blood triglycerides increased from an unknown date diagnosed about 15 years ago. The patient's concomitant medications were not reported. No Prior Vaccinations within 4 weeks. Patient previously took first dose and second dose of bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 1 and 2 via an unspecified route of administration, administered in Arm Left on 2021 SINGLE for covid-19 immunisation. It was reported that, The patient experienced booster on 12Nov2021 with outcome of unknown, shortness of breath on 12Nov2021 with outcome of recovering, headaches, felt like had mild flu, on fuzzy head type of feeling, hurt all over, arm was much more sore, hurt all over on 13Nov2021 with outcome of recovering, arm was much more sore on 12Nov2021 with outcome of recovering.  Therapeutic measures were taken as a result of shortness of breath (dyspnoea), headaches (headache), felt like had mild flu (influenza like illness), fuzzy head type of feeling (feeling abnormal) , hurt all over (pain), arm was much more sore (pain in extremity). The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: headaches; felt like had mild flu; fuzzy head type of feeling; hurt all over; arm was much more sore; booster; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp.  A 59-years-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on 12Nov2021 as dose 3 (booster), SINGLE for covid-19 immunisation. Medical history included hypertension ongoing diagnosed about 15 years ago, takes medication to treat this and it is not an issue, blood triglycerides increased from an unknown date diagnosed about 15 years ago. The patient's concomitant medications were not reported. No Prior Vaccinations within 4 weeks. Patient previously took first dose and second dose of bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 1 and 2 via an unspecified route of administration, administered in Arm Left on 2021 SINGLE for covid-19 immunisation. It was reported that, The patient experienced booster on 12Nov2021 with outcome of unknown, shortness of breath on 12Nov2021 with outcome of recovering, headaches, felt like had mild flu, on fuzzy head type of feeling, hurt all over, arm was much more sore, hurt all over on 13Nov2021 with outcome of recovering, arm was much more sore on 12Nov2021 with outcome of recovering.  Therapeutic measures were taken as a result of shortness of breath (dyspnoea), headaches (headache), felt like had mild flu (influenza like illness), fuzzy head type of feeling (feeling abnormal) , hurt all over (pain), arm was much more sore (pain in extremity). The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: PNC13
Symptoms: Immunodeficiency
Clinical narrative: patient was immunocompromised/ unknown if the patient was immunocompromised before or after the Prevnar 13 shot was given; This is a spontaneous report from a Pfizer-sponsored Program. A contactable physician reported that a patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date in 2011 (batch/lot number was not provided) as DOSE NUMBER UNKNOWN, SINGLE for immunization. The patient's medical history and concomitant medications were not reported. The physician had a patient that was administered with Prevnar 13 product 10 years ago (2011). It was explained the patient was immunocompromised and the physician would like to know if the patient should be given the Prevnar 20 shot. Agent responded that caller needs to go to specified entity for this information since it could not be clarified if the patient was immunocompromised before or after the Prevnar 13 shot was given. The outcome of the event was unknown.   The batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not provided and will be requested during follow-up.; Sender's Comments: The association between the event immunocompromised with PREVENAR 13 can not be fully 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.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cough, Headache, Pain, Pyrexia
Clinical narrative: Fever; Cough; Runny nose; Headache; Body ache; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Nov2021 at 20:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 18Nov2021, the patient experienced fever, cough, runny nose, headache, body ache and upset stomach. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, cough, runny nose, headache, body ache and upset stomach was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Fever; Cough; Runny nose; Headache; Body ache; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Nov2021 at 20:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 18Nov2021, the patient experienced fever, cough, runny nose, headache, body ache and upset stomach. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, cough, runny nose, headache, body ache and upset stomach was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain, Pain in extremity
Clinical narrative: The patient received third/booster dose of BNT162b2; Sore arm; headache; body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an 17Nov2021 at 17:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Mar2021 at 11:00 (at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On an unknown date in Nov2021, the patient experienced sore arm, headache and body aches. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event sore arm, headache and body aches was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: got the shingles for 2 months; worse painful feeling; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and then 2 weeks later got the shingles for 2 months. The patient stated that he/she had the worse painful feeling.