chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: Day1-2 could not raise my arm above my right shoulder; My right arm from shoulder to elbow was quite sore for 4 days post injection; woke me at Day 1; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the right arm on 18Oct2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety and seasonal allergies. The patient had no other 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 included vitamin d nos (MANUFACTURER UNKNOWN), unspecified inhaler, unspecified over the counter (OTC) allergy and unspecified multivitamin; all taken for unknown indications from an unknown date and unknown if ongoing. On 18Oct2021 at 17:00, her right arm from shoulder to elbow was quite sore for 4 days post-injection and woke her at day 1 and day1-2 could not raise her arm above her right shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events day1-2 could not raise her arm above her right shoulder was resolved on 19Oct2021 while her right arm from shoulder to elbow was quite sore for 4 days post injection and woke her at day 1 was resolved on 21Oct2021.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Lymphadenopathy, Swelling face
Clinical narrative: On the 1st dose, my left eye drooped for 1 week; On the 1st dose, my left eye drooped for 1 week; then my face swelled up; After those symptoms went away I developed a swollen right lymph node; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The medical history included osteoarthritis right fingers, allergy to hazelnuts, mango and wine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included cetirizine hydrochloride (ZYRTEC), calcium (MANUFACTURER UNKNOWN), ascorbic acid/pyridoxal phosphate/tocopherol/retinol palmitate/docosahexaenoic acid/magnesium sulfate/cod-liver oil/eicosapentaenoic acid/mucin/ribes nigrum seed oil (HYDROEYE), ciclosporin (RESTASIS), glucose/potassium chloride/ sodium citrate acid (OASIS) and unspecified vitamins, all for unknown indications from unknown dates and unknown if ongoing. The patient previously took sulfamethoxazole (MANUFACTURER UNKNOWN) and cefalexin (CEPHALEXIN) and experienced allergy. On 17Apr2021, after the 1st dose, the patient's left eye drooped for 1 week; then her face swelled up; after those symptoms went away, on an unknown date in 2021, she developed a swollen right lymph node. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left eye drooped was resolved on 23Apr2021, while the clinical outcome of the event face swelled up was resolved on an unknown date in  2021. The clinical outcome of the event swollen right lymph node was not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 27Apr2021 at 08:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Immunisation, Off label use, Pyrexia
Clinical narrative: Booster; Off label use; Fever; Headache; Shingles; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FV3181) via an unspecified route of administration in the left arm on 30Aug2021 at 00:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney transplant in 1998. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included prednisone (MANUFACTURER UNKNOWN), ciclosporin (NEORAL), atorvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN), all for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK8734) via an unspecified route of administration in the left arm on 05Apr2021 at 00:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on 30Apr2021 at 00:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021 (also reported as 21Oct2021 at 16:00), the patient experienced fever, headache and shingles that appeared 2 months after third dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with valacyclovir (MANUFACTURER UNKNOWN). The clinical outcome of the events fever, headache and shingles that appeared 2 months after third dose were not resolved at the time of this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstruation irregular
Clinical narrative: The patient received the third/booster dose of BNT162b2; Begin menstrual cycle two weeks early each covid vaccine.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Jan2021 (at the age of 38-years-old), received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Feb2021 (at the age of 38-years-old) and also received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Oct2021 at 16:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA), citalopram (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took iodine(MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in 2021, the patient's menstrual cycle began two weeks early after each covid vaccine. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event began menstrual cycle two weeks early each covid vaccine was resolved with sequalae on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chest pain, Dyspnoea, Electric shock sensation
Clinical narrative: Palpitaions; Tachycardia/ Episodes of tachycardia during sleep; Chest pain; Body weakness; Left eye twitch; Feet burning; Cold sensation; SOB; Heat and exercise intolerance; Heat and exercise intolerance; Electric feeling throughout body; Numbness in left ring finger and pinky; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the arm left on 16Sep2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. 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. The concomitant medications included citalopram hydrobromide (CELEXA) and multivitamins (unspecified); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 26Aug2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 16:00, the patient experienced palpitations, tachycardia, chest pain, body weakness, left eye twitch, feet burning and cold sensation, shortness of breath (SOB),episodes of tachycardia during sleep, heat and exercise intolerance, electric feeling through out body, numbness in left ring finger and pinky. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events palpitations, tachycardia, chest pain, body weakness, left eye twitch, feet burning and cold sensation, shortness of breath (SOB), episodes of tachycardia during sleep, heat and exercise intolerance, electric feeling throughout body, numbness in left ring finger and pinky were not resolved at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Feeling cold, Hypoaesthesia, Muscle twitching, Palpitations
Clinical narrative: Palpitaions; Tachycardia/ Episodes of tachycardia during sleep; Chest pain; Body weakness; Left eye twitch; Feet burning; Cold sensation; SOB; Heat and exercise intolerance; Heat and exercise intolerance; Electric feeling throughout body; Numbness in left ring finger and pinky; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the arm left on 16Sep2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. 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. The concomitant medications included citalopram hydrobromide (CELEXA) and multivitamins (unspecified); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 26Aug2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 16:00, the patient experienced palpitations, tachycardia, chest pain, body weakness, left eye twitch, feet burning and cold sensation, shortness of breath (SOB),episodes of tachycardia during sleep, heat and exercise intolerance, electric feeling through out body, numbness in left ring finger and pinky. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events palpitations, tachycardia, chest pain, body weakness, left eye twitch, feet burning and cold sensation, shortness of breath (SOB), episodes of tachycardia during sleep, heat and exercise intolerance, electric feeling throughout body, numbness in left ring finger and pinky were not resolved at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Temperature intolerance
Clinical narrative: Palpitaions; Tachycardia/ Episodes of tachycardia during sleep; Chest pain; Body weakness; Left eye twitch; Feet burning; Cold sensation; SOB; Heat and exercise intolerance; Heat and exercise intolerance; Electric feeling throughout body; Numbness in left ring finger and pinky; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the arm left on 16Sep2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. 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. The concomitant medications included citalopram hydrobromide (CELEXA) and multivitamins (unspecified); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 26Aug2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 16:00, the patient experienced palpitations, tachycardia, chest pain, body weakness, left eye twitch, feet burning and cold sensation, shortness of breath (SOB),episodes of tachycardia during sleep, heat and exercise intolerance, electric feeling through out body, numbness in left ring finger and pinky. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events palpitations, tachycardia, chest pain, body weakness, left eye twitch, feet burning and cold sensation, shortness of breath (SOB), episodes of tachycardia during sleep, heat and exercise intolerance, electric feeling throughout body, numbness in left ring finger and pinky were not resolved at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Ultrasound Doppler
Clinical narrative: 24 hours after injection right leg was not moveable/ Mobility is still limited; Right leg was in pain and sore; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135BA) via an unspecified route of administration in the left arm on 15Oct2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included losartan (MANUFACTURER UNKNOWN) 50 mg for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. On 16Oct2021, 24 hours after injection, the patient's right leg was not moveable and right leg was in pain and sore. Doppler was performed 10 days later and there was no blood clot however the mobility was still limited. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with an unspecified steroid shot. On 26Oct2021, the patient underwent doppler scan and result was no blood clot. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 24 hours after injection right leg was not moveable, mobility is still limited and right leg was in pain and sore was resolved with sequelae on an unknown date in 2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Nasopharyngitis, Tremor
Clinical narrative: High blood pressure if 206; Dizziness; Uncontrollably Shaking; Cold; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FH8020) at single dose via an unknown route in right arm on 29Oct2021 11:30 at 50-year-old for Covid-19 immunization.  Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included diabetes. Patient received other medications the patient received within 2 weeks of vaccination; did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included Ace inhibitors and celecoxib (CELEBREX) and experienced allergy. Patient experienced dizziness, uncontrollably shaking, cold, high blood pressure "if 206" (as reported) on 29Oct202111:30. The adverse event result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No hospitalization involved. No treatment was received. Outcome of the events was unknown.  The report was assessed as serious with seriousness criteria of life threatening.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Broke out with shingles two days after injection; Severe headache; Joints aching; Chills; Nausea; Arm pain; Injection site pain; Redness at injection site; Fever; Diarrhea; Feeling unwell; Tiredness; Muscle pain; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 14Oct2021 at 10:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included apixaban (ELIQUIS), omeprazole (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8922) via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 65-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9276) via an unspecified route of administration in the left arm on 19Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 15Oct2021 at 18:00, the patient experienced severe headache, joints aching, chills, nausea, arm pain, injection site pain, redness at injection site, fever, diarrhea, feeling unwell, tiredness, muscle pain and on 16Oct2021, two days after injection, the patient broke out with shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event broke out with shingles two days after injection and included treatment with valacyclovir (VALTREX). Since the vaccination, the patient had been tested for COVID-19. On 29Oct2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events severe headache, joints aching, chills, nausea, arm pain, injection site pain, redness at injection site, fever, diarrhea, feeling unwell, tiredness, muscle pain and broke out with shingles two days after injection was resolving at the time of this report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Malaise, Myalgia, Nausea
Clinical narrative: Broke out with shingles two days after injection; Severe headache; Joints aching; Chills; Nausea; Arm pain; Injection site pain; Redness at injection site; Fever; Diarrhea; Feeling unwell; Tiredness; Muscle pain; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 14Oct2021 at 10:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included apixaban (ELIQUIS), omeprazole (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8922) via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 65-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9276) via an unspecified route of administration in the left arm on 19Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 15Oct2021 at 18:00, the patient experienced severe headache, joints aching, chills, nausea, arm pain, injection site pain, redness at injection site, fever, diarrhea, feeling unwell, tiredness, muscle pain and on 16Oct2021, two days after injection, the patient broke out with shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event broke out with shingles two days after injection and included treatment with valacyclovir (VALTREX). Since the vaccination, the patient had been tested for COVID-19. On 29Oct2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events severe headache, joints aching, chills, nausea, arm pain, injection site pain, redness at injection site, fever, diarrhea, feeling unwell, tiredness, muscle pain and broke out with shingles two days after injection was resolving at the time of this report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain
Clinical narrative: Broke out with shingles two days after injection; Severe headache; Joints aching; Chills; Nausea; Arm pain; Injection site pain; Redness at injection site; Fever; Diarrhea; Feeling unwell; Tiredness; Muscle pain; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 14Oct2021 at 10:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included apixaban (ELIQUIS), omeprazole (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8922) via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 65-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9276) via an unspecified route of administration in the left arm on 19Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 15Oct2021 at 18:00, the patient experienced severe headache, joints aching, chills, nausea, arm pain, injection site pain, redness at injection site, fever, diarrhea, feeling unwell, tiredness, muscle pain and on 16Oct2021, two days after injection, the patient broke out with shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event broke out with shingles two days after injection and included treatment with valacyclovir (VALTREX). Since the vaccination, the patient had been tested for COVID-19. On 29Oct2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events severe headache, joints aching, chills, nausea, arm pain, injection site pain, redness at injection site, fever, diarrhea, feeling unwell, tiredness, muscle pain and broke out with shingles two days after injection was resolving at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Body temperature, COVID-19, COVID-19 pneumonia, Chest X-ray
Clinical narrative: to be COVID positive (patient was fully vaccinated but not yet received booster); COVID-related pneumonia (Grade 3 lung infection); fever of 102F; hemoglobin was at 5.3 mg/dL (Grade 3 anemia).; to be COVID positive (patient was fully vaccinated but not yet received booster); This is a spontaneous report from a contactable physician.   A 42-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (at the age of 42-year-old) (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (at the age of 42-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced drug ineffective (medically significant) on 21Oct2021 with outcome of unknown, to be covid positive (patient was fully vaccinated but not yet received booster) (hospitalization, medically significant) on 21Oct2021 with outcome of unknown, fever of 102 F (hospitalization) on 21Oct2021 with outcome of unknown, COVID-related pneumonia (grade 3 lung infection) (hospitalization, medically significant) on 21Oct2021 with outcome of unknown, hemoglobin was at 5.3 mg/dl (grade 3 anemia) (hospitalization, medically significant) on 21Oct2021 with outcome of unknown. The patient was hospitalized events from 21Oct2021 to an unknown date.  The patient underwent lab tests and procedures which included:  body temperature: 102 F on 21Oct2021 (Grade 1 fever), chest x-ray: pneumonia (COVID induced) on 21Oct2021, haemoglobin: 5.3 mg/dl on 21Oct2021 (Grade 3  anemia) , sars-cov-2 test: positive on 21Oct2021.  The clinical course of events was as follows: Patient presented to local ED on 10/21/2021 due to having a fever of 102F (Grade 1 fever)at home. Patient evaluated in ED, found to be COVID positive (patient was fully vaccinated but not yet received booster). Chest x-ray showed COVID-related pneumonia (Grade 3 lung infection) and hemoglobin was at 5.3 mg/dL (Grade 3 anemia). Patient was admitted, received blood transfusion and IV antibiotics. Patient was still in the hospital.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "COVID positive", "COVID-related pneumonia" and fever.  The event anemia is considered not related to BNT162B2, but rather intercurrent medical condition. 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Haemoglobin, Pyrexia, SARS-CoV-2 test
Clinical narrative: to be COVID positive (patient was fully vaccinated but not yet received booster); COVID-related pneumonia (Grade 3 lung infection); fever of 102F; hemoglobin was at 5.3 mg/dL (Grade 3 anemia).; to be COVID positive (patient was fully vaccinated but not yet received booster); This is a spontaneous report from a contactable physician.   A 42-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (at the age of 42-year-old) (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (at the age of 42-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced drug ineffective (medically significant) on 21Oct2021 with outcome of unknown, to be covid positive (patient was fully vaccinated but not yet received booster) (hospitalization, medically significant) on 21Oct2021 with outcome of unknown, fever of 102 F (hospitalization) on 21Oct2021 with outcome of unknown, COVID-related pneumonia (grade 3 lung infection) (hospitalization, medically significant) on 21Oct2021 with outcome of unknown, hemoglobin was at 5.3 mg/dl (grade 3 anemia) (hospitalization, medically significant) on 21Oct2021 with outcome of unknown. The patient was hospitalized events from 21Oct2021 to an unknown date.  The patient underwent lab tests and procedures which included:  body temperature: 102 F on 21Oct2021 (Grade 1 fever), chest x-ray: pneumonia (COVID induced) on 21Oct2021, haemoglobin: 5.3 mg/dl on 21Oct2021 (Grade 3  anemia) , sars-cov-2 test: positive on 21Oct2021.  The clinical course of events was as follows: Patient presented to local ED on 10/21/2021 due to having a fever of 102F (Grade 1 fever)at home. Patient evaluated in ED, found to be COVID positive (patient was fully vaccinated but not yet received booster). Chest x-ray showed COVID-related pneumonia (Grade 3 lung infection) and hemoglobin was at 5.3 mg/dL (Grade 3 anemia). Patient was admitted, received blood transfusion and IV antibiotics. Patient was still in the hospital.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "COVID positive", "COVID-related pneumonia" and fever.  The event anemia is considered not related to BNT162B2, but rather intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Starting bleeding a few hours after the vaccine and severe bleeding for 10 days; Started to have severe cramps; Starting bleeding a few hours after the vaccine and started to have severe cramps and bleeding for 10 days. It wasnt even my menstrual time; This is a spontaneous report from a contactable other healthcare professional, the patient. An adult non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient started bleeding a few hours after the vaccine and started to have severe cramps and bleeding for 10 days. Reportedly, it was not even her menstrual time and her periods were absolutely horrible like never before. 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 started bleeding a few hours after the vaccine, started to have severe cramps and bleeding for 10 days and it was not even her menstrual time were not resolved 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid infection positive; Covid infection positive; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6207) as dose 1, single and via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: EKC734) as dose 2, single for covid-19 immunisation. Age at vaccination was 39 years old. The patient's medical history and concomitant medications were not reported. No other vaccines received within 4 weeks prior to COVID vaccine. On 21Oct2021, the patient experienced covid infection positive. The events were reported as non-serious. The patient underwent lab tests and procedures which included RT-PCR (nasal swab): positive   on 21Oct2021. No treatment was given. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was recovering from the event.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid positive- symptomatic; Covid positive- symptomatic; This is a spontaneous report from a contactable consumer. A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscularly on 22Jun2021 (at the age of 12 years old; lot number: EW0185) as dose 2, single and intramuscularly on 28May2021 (at the age of 12 years old; lot number: EW0179) as dose 1, single for COVID-19 immunization. Medical history included known allergies: peanuts from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced Covid positive- symptomatic on 20Oct2021. It was reported that the patient experienced Covid positive- symptomatic: fever, headache, chills, cough, cold on 20Oct2021 that lasted 10 days. The events required emergency room visit. No treatment was received. There was no other vaccine in four weeks. The patient underwent lab tests and procedures which included COVID Test: RT-PCR: positive (post vaccination: nasal swab) on 20Oct2021. The outcome of all events was recovered with sequel on an unspecified date in Oct2021.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Spinal cord disorder, Tachycardia
Clinical narrative: Enlargement of the spinal cord suspected; Tachycardia; Paresthesia; Burning feeling in the head/face; This is a spontaneous report from a non-contactable consumer (patient) based on information received by Pfizer from Moderna (MDCH21-00500). This consumer reported similar events for two patients. This is the second of two reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. On an unknown date (after the vaccination), this patient experienced tachycardia, paresthesia and burning feeling in the head/face. This patient attended a medical examination where he met another patient who experienced the same events after the vaccination and these symptoms were caused by an enlargement of the spinal cord. It was reported that they probably were both affected by the same condition (enlargement of the spinal cord). The outcome of the events suspected enlargement of the spinal cord, tachycardia, paresthesia and burning feeling in the head/face was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101440896 same reporter/AE/SD, different patient
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Arm is so sore; Can barely move the arm; This is a spontaneous report from a contactable healthcare professional. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 320380) via intramuscular route of administration in the left arm on 01Nov2021 at 16:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history and 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 01Nov2021 at 18:00, the patient's arm was so sore and on 03Nov2021, the patient had to stay home from work. The patient could barely move the arm. The patient was using a heating pad for soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with heating pad. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm is so sore and can barely move the arm was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Hernia
Clinical narrative: Hernia.; This is a spontaneous report received from a contactable consumer.   A male patient of unspecified age received of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), unspecified route of administration on an unspecified date as a dose1, single for COVID-19 immunization. The patient medical history and concomitant were not reported. The patient experienced hernia (medically significant) on an unspecified date. The Patient husband had the first dose of the Pfizer COVID-19 vaccine and is scheduled for the second dose on 04Mar2021. He recently had a hernia repair after the first dose. Yesterday (25Feb2021), he went to his doctor and was prescribed with doxycycline. Patient wanted to know if that would affect the vaccine that he is taking on 04Mar2021. Therapeutic measures were taken as a result of hernia includes doxycycline. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy, Muscle disorder
Clinical narrative: having a bad muscle and joint reaction; having a bad muscle and joint reaction; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACINE, solution for injection), via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 04Feb2021, the patient experienced having a bad muscle and joint reaction. The events resulted in emergency room visit and physician office visit. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Feeling abnormal, Sensory disturbance
Clinical narrative: feels like something inside; he was not normal; feel a little bit dizzy; he was just uncomfortable; This is a spontaneous report from a contactable consumer (patient). This case is for dose 1 of 2. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9464, Expiry date: unknown), intramuscularly, administered in left arm on 28Jan2021 (at the age of 72 years) as dose 1, single for COVID-19 immunization. Patient took second dose of bnt162b2 (Lot number: EM6198, expiry date: 30Jun2021) intramuscularly, administered in left arm on 23Feb2021 as dose 2, single for COVID-19 immunization. Patient had no medical history (including any illness at time of vaccination). More or less, he was in good health and may be his condition was too good. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Patient previously received flu vaccine in Oct2020, which he takes every year, the last one he had was sometime in late Oct2020. On an unknown date, the patient felt like it was something inside. He clarified for about a day or day and a half, he was not normal, and it felt the same way as any flu shot. He thought it was normal to feel a little bit dizzy or feel a little "this". Patient explained that he was just uncomfortable. He felt like there was something inside him for about a day or day and a half. Patient wanted to know if he had to do a test in 3 or 4 weeks to be sure of the COVID-19 vaccine. He wanted to know what degree he has immunization. He knows the vaccine was supposed to be around 94 or 95% effective, but maybe he was in the 5% that is not. The outcome of all the events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Heart rate increased, Illness
Clinical narrative: Nauseous; upset stomach; little tired; little lightheaded; Runny nose; little hyper; my heart rate was raising; Not my arm even hurt that much; I feel like cold; got sick; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 73-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6203), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at age of 73-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure, blood cholesterol and thyroid disorder. Concomitant medication(s) included nadolol (NADOLOL) taken for blood pressure, pitavastatin calcium (LIVALO) taken for blood cholesterol, levothyroxine (LEVOTHYROXINE) taken for thyroid disorder and amlodipine (AMLODIPINE) taken for blood pressure. The patient experienced nauseous, upset stomach, little tired, little lightheaded, runny nose, got sick and little hyper on an unspecified date. The patient reported that "When I got the vaccine I just felt a little tired, a little lightheaded, that was all I experienced". After vaccination: The arm did not bother her much, she felt just a little tired and had a runny nose "could be allergies". "On Saturday I felt the same way". On Sunday night: "I felt a little nauseous and felt a little hyper and my heart rate was raising but all went away and my stomach has been bothering me it felt like a virus (infection) but I feel better today". The patient stated, "I got my Covid shot on Wednesday and I don't, I don't "tired" (not clarified) whatever but I did not feel a bit, not my arm even hurt that much but yesterday I have a runny nose, I feel like cold and I felt the cold coming on and then last night it was very nauseous and I had both so it was very nauseous last night this was I had it Wednesday, so that was last night was Sunday night I felt a little nauseous I was wondering if that's the effect of the vaccine or maybe I got the cold.". The patient also stated "I am not experiencing the problem anymore. I just wanted to call up to see if that was a side effect, I had it last night and it went away, I just was curious if that was a side effects that was the reason of phone call." The patient didn't receive any treatment medication for the events. The events outcome was reported as recovered on an unspecified date of 2021.  No follow up attempts are possible. No further information is expected.