chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Very sore dead  arm. Left tricep and left deltoid experience moderate to significant pain while in motion.; Very sore dead  arm. Left tricep and left deltoid experience moderate to significant pain while in motion.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EL3302, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 12Jan2021 at 14:00 (at the age of 48 years old) as first dose, single for COVID-19 immunisation. The facility it was administered was reported to be "other". Patient has no other medical history and has no known allergies. The patient did not receive any other vaccines in 4 weeks and no other medications in two weeks. Prior to vaccine the patient was not diagnosed with COVID-19. On13Jan2021 at 08:00 AM, the patient experienced very sore "dead" arm; Left tricep and left deltoid experience moderate to significant pain while in motion. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. The patient received second dose of BNT162B2 (lot number: EL9264) via an unspecified route of administration, administered in left arm on 02Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Fine motor skill dysfunction, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 25Feb2021 13:30 (at the age of 59-years-old) as first dose, single dose for COVID-19 immunization. Medical history included severe case of COVID-19 in which the patient spent 21 days on a ventilator from 2020 (spring) to an unknown date; hypertension from an unknown date and chronic health conditions (resulted from severe case of COVID-19) from 2020, both unknown if ongoing; and rash which was experienced with the disease (severe COVID-19) from 2020 to an unknown date. Concomitant medications included galcanezumab gnlm (EMGALITY), amlodipine, tamsulosin hydrochloride (FLOMAX), metoprolol and nystatin (STATIN); all were taken for an unspecified indication, start and stop dates were not reported. No other vaccine was given to the patient in four weeks. The patient was not tested for COVID post vaccination. The patient has no known allergies. On 25Feb2021 18:00, the patient experienced fever of up to 102.2 degrees for four days, a recurrence of a rash that the patient experienced with the disease, joint pain, fatigue, and issues with his dexterity reminiscent of when he had the virus (prior to being hospitalized). Therapeutic measure, paracetamol (TYLENOL), was taken as a result of the events. The patient underwent lab tests and procedures which included body temperature: 102.2 degrees (fever) on 25Feb2021 and COVID-19 test: Positive on 2020. The outcome of the events was recovering. The patient wanted to known if he should take the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 25Feb2021 13:30 (at the age of 59-years-old) as first dose, single dose for COVID-19 immunization. Medical history included severe case of COVID-19 in which the patient spent 21 days on a ventilator from 2020 (spring) to an unknown date; hypertension from an unknown date and chronic health conditions (resulted from severe case of COVID-19) from 2020, both unknown if ongoing; and rash which was experienced with the disease (severe COVID-19) from 2020 to an unknown date. Concomitant medications included galcanezumab gnlm (EMGALITY), amlodipine, tamsulosin hydrochloride (FLOMAX), metoprolol and nystatin (STATIN); all were taken for an unspecified indication, start and stop dates were not reported. No other vaccine was given to the patient in four weeks. The patient was not tested for COVID post vaccination. The patient has no known allergies. On 25Feb2021 18:00, the patient experienced fever of up to 102.2 degrees for four days, a recurrence of a rash that the patient experienced with the disease, joint pain, fatigue, and issues with his dexterity reminiscent of when he had the virus (prior to being hospitalized). Therapeutic measure, paracetamol (TYLENOL), was taken as a result of the events. The patient underwent lab tests and procedures which included body temperature: 102.2 degrees (fever) on 25Feb2021 and COVID-19 test: Positive on 2020. The outcome of the events was recovering. The patient wanted to known if he should take the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 02Mar2021 (at the age of 40-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient has no other medications in 2 weeks. The patient experienced sore arm at injection site on 02Mar2021. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: numbness/tingling or vibrating feeling in lips; numbness/tingling or vibrating feeling in lips; tiredness; light headedness; tingling sensation has spread to my entire body.; This is a spontaneous report from a contactable consumer (patient).   A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6202, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 02Mar2021 10:00 (at the age of 49-years-old) as unknown, single dose for COVID-19 immunisation. Medical history included diabetes mellitus, arthritis, morbid obesity, alopecia areata, psoriasis and sensitivity to glues used in band aids and other chemical sensitivities; all from an unknown date. Concomitant medications included glyburide, sitagliptin (JANUVIA), insulin aspart (NOVOLOG), insulin detemir (LEVEMIR) and telmisartan all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 02Mar2021 10:30, the patient experienced numbness/tingling or vibrating feeling in lips, tiredness and light headedness; tingling sensation has spread to my entire body on 02Mar2021. It was reported that numbness/tingling or vibrating feeling in lips occurred at just over half hour after dose. By end of the day the tingling sensation has spread to the entire body. The tingling was not over whelming but definitely there. The patient has also experienced tiredness and light headedness but to a minor degree. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy under left arm more 5 cm diameter; This is a spontaneous report from a contactable consumer. A 76-year-old male consumer (patient) reported for himself that he received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot  number unknown) via an unspecified route of administration in left arm on 26Feb2021 10:45 (at the age of 76-year-old) at single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medications were none. The patient was not administered with any other vaccine in four weeks. On 28Feb2021 the patient had lymphadenopathy under left arm more than 5cm diameter. The event was non-serious. Outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Fatigue, Pain
Clinical narrative: Extreme body and joint aches; joint aches; extreme fatigue/ very tired; cold sweats; This is a spontaneous report from a contactable consumer (patient).  A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 09:00 (Batch/Lot number was not reported), age at vaccination of 43-years-old, as single dose, for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing.  The patient previously took nitric oxide and experienced hypersensitivity, received BNT162B2 dose 1 administered in Arm Left on 03Feb2021 01:00 PM (Batch/Lot number was not reported) for covid-19 immunisation.  Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme body and joint aches, extreme fatigue, cold sweats and was very tired, all on 24Feb2021. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Developed a rash on front of both legs between ankles and knees; Constant itching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number FN 6200 RA), via an unspecified route of administration, in right arm on 25Feb2021 at 13:00 (at the age of 79-year-old) as first dose, single for COVID-19 immunization. Medical history included high blood pressure and occasional lower extremity edema. The patient had no known allergies. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) and nifedipine (NIFEDIPINE). The patient received no other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On 28Feb2021 the patient developed a rash on front of both legs between ankles and knees and constant itching. No treatment was received for the events. The events had not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fall
Clinical narrative: arthritis; fell; This is a spontaneous report from a program. A contactable female consumer reported for herself that  A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9269) via unspecified route, in left arm on 24Feb2021 at 10:30 as 2 nd dose, single dose for covid-19 immunization. The patient medical history included high blood pressure from an unspecified date in 2000 and was ongoing; anxiety, degenerative bone disease and depression from an unspecified date in 2014 and was ongoing; asthma, COPD (Chronic obstructive pulmonary disease) from an unspecified date in 1998 and was ongoing. The concomitant drugs were not reported. The past drug included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: EL3247), via unspecified rout, in left arm on 03Feb2021 at 09:30 for covid-19 immunization and also experienced Swollen gland, Slight headache on 03Feb2021 at 04:30. Prior to vaccination the patient had not taken any vaccine. The patient had arthritis and fell on 14Feb because of which she wanted to take medication in her back which the doctor had not given. The patient wanted to know if it is okay to take 800 mg of Tylenol since she received second dose of covid-19 today. The outcome of the events was unknown.  Follow-up (04May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP follow up letter sent which included: added the medical history high blood pressure, anxiety, degenerative bone disease and depression, asthma, COPD (Chronic obstructive pulmonary disease). Added the suspect drug details.   Follow-up attempts are completed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Pain in extremity
Clinical narrative: dizziness; Nausea; throwing up; bad vertigo; sore arm; chills; tiredness; This is a spontaneous report from a contactable consumer (patient's wife)  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as SINGLE dose for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced dizziness (non-serious) on 26Feb2021 with outcome of not recovered , nausea  (non-serious) on 26Feb2021 with outcome of not recovered , throwing up (vomiting) (non-serious) on 26Feb2021 with outcome of not recovered , bad vertigo (non-serious) on 26Feb2021 with outcome of unknown , sore arm (non-serious) on 26Feb2021 with outcome of unknown , chills (non-serious) on 26Feb2021 with outcome of unknown , tiredness  (non-serious) on 26Feb2021 with outcome of unknown.  The clinical course was reported as follows: my husband received the second dose of Pfizer's COVID vaccine on 24Feb2021 and was still experiencing dizziness, nausea, and bad vertigo. He just had a sore arm, chills, and tiredness for the first 2 days of receiving the second dose of the vaccine, but "the third day was when it hit him. He had bad vertigo, spinning, nausea, and throwing up which happened on 26Feb2021, which lasted for 2 and a half days. It went away for half a day or a day and it came back again. It's been 1 week already since he received the vaccine. He was eating very little and he's trying to drink. He was throwing up even water. He was taking Bonine at night and his doctor prescribed anti-nausea medication.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: dizziness; Nausea; throwing up; bad vertigo; sore arm; chills; tiredness; This is a spontaneous report from a contactable consumer (patient's wife)  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as SINGLE dose for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced dizziness (non-serious) on 26Feb2021 with outcome of not recovered , nausea  (non-serious) on 26Feb2021 with outcome of not recovered , throwing up (vomiting) (non-serious) on 26Feb2021 with outcome of not recovered , bad vertigo (non-serious) on 26Feb2021 with outcome of unknown , sore arm (non-serious) on 26Feb2021 with outcome of unknown , chills (non-serious) on 26Feb2021 with outcome of unknown , tiredness  (non-serious) on 26Feb2021 with outcome of unknown.  The clinical course was reported as follows: my husband received the second dose of Pfizer's COVID vaccine on 24Feb2021 and was still experiencing dizziness, nausea, and bad vertigo. He just had a sore arm, chills, and tiredness for the first 2 days of receiving the second dose of the vaccine, but "the third day was when it hit him. He had bad vertigo, spinning, nausea, and throwing up which happened on 26Feb2021, which lasted for 2 and a half days. It went away for half a day or a day and it came back again. It's been 1 week already since he received the vaccine. He was eating very little and he's trying to drink. He was throwing up even water. He was taking Bonine at night and his doctor prescribed anti-nausea medication.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Purpura
Clinical narrative: Purpura noted to right hand/wrist/forearm shortly after injection of Pfizer COVID vaccine #2 and during platelet infusion for TTP.; This is a spontaneous report from a contactable other healthcare professional. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular administered in left arm at doctor's office/urgent care on 02Mar2021 (at the age of 55-year-old) (Batch/Lot Number: EL9269) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no other vaccine in four weeks. It was unknown if patient had COVID prior to vaccination. The patient was not tested for COVID post vaccination. Medical history included thrombotic thrombocytopenic purpura (TTP), gastrooesophageal reflux disease (GERD), hypertension (HTN), cerebrovascular accident (CVA), chronic obstructive pulmonary disease (COPD), type 2 diabetes mellitus (DM), hyperlipidaemia (HLD), acute kidney infection(AKI), and known allergies to latex. The patient received unspecified other medications in two weeks. Historical vaccine includes first dose of bnt162b2 via intramuscular route on 05Feb2021 (at the age of 55-year-old) (Lot number: EL9262) for COVID-19 immunisation. On 02Mar2021, the patient experienced purpura noted to right hand/wrist/forearm shortly after injection of Pfizer covid vaccine #2 and during platelet infusion for TTP. No treatment was received for the event. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased
Clinical narrative: magnesium and potassium got down to 1; magnesium and potassium got down to 1; This is a spontaneous report from a contactable consumer (patient's sibling) via a Pfizer sponsored program. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 03Feb2021 (Lot number: EL9265; Expiry: 31May2021) at the age of 67 years old as 1st dose, single for COVID-19 immunisation. Medical history included ongoing type 2 diabetes mellitus. The patient's concomitant medications were not reported. The reporter stated that after the first dose, the patient had to go to the emergency room, and it was found that her magnesium and potassium were low (also reported as magnesium and potassium got down to 1) on 04Feb2021. The reporter didn't know what was going on with the patient and she was taken to the hospital. The emergency doctor stated that had the patient gone much longer without medical attention right away, she would've died. They were then advised by the emergency doctor to follow up with the family doctor. The patient went to the family doctor and was put on magnesium. The outcome of the events was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Persistent diarrhea; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265 and expiration date was not reported), via an unspecified route of administration in left arm, on 17Feb2021 at 13:00 (at the age of 22 year old) as first dose, single for COVID-19 immunization in doctor's office/urgent care. Medical history included X-linked hypophosphatemia and hypertension. Concomitant medications included amantadine; candesartan; burosumab (CRYSVITA) and vitamin D3. The patient had known allergies for codeine, oxybenzone, nickel and experienced drug allergy. The patient was not pregnant at the time of vaccination and did not receive any other vaccines within the 4 weeks of COVID-19 vaccine. Prior to the vaccination, the patient was not having COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient experienced persistent diarrhea on 18Feb2021 at 02:00. No treatment was received by the patient for this event. The outcome of the event was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, SARS-CoV-2 test
Clinical narrative: Alk phos raised; AST increased; ALT increased; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Dec2020 (Batch/Lot Number: EL9899) (at the age of 64 years old) as 1st dose, single for COVID-19 immunisation. Medical history included gastroesophageal reflux, fatty liver disease, obesity, ocular hypertension, coronary artery disease, osteoporosis, gallbladder removed, lumbar spinal stenosis grade II, sciatica, facet degenerative joint disease, disk degeneration, right ovary removal, radioiodine removal thyroid, Graves' disease, Han (as reported), hyperlipidemia, hypothyroidism, obstructive sleep apnea and osteopenia. The patient had allergies to penicillin, sulfa and lactose . Prior to vaccination, the patient was not diagnosed with COVID-19.  There  were no concomitant medications. The patient was not pregnant at the time of vaccination. The Vaccination Facility Type was Hospital and vaccine was not administered at Military Facility. No vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). On 04Jan2021, the patient experienced alkaline phosphatase (Alk Phos) raised, aspartate aminotransferase (AST) increased, alanine aminotransferase increased (ALT). The patient underwent lab tests and procedures in Oct2020 which included alanine aminotransferase: 29, aspartate aminotransferase: 23 and blood alkaline phosphatase: 130. On 04Jan2021, alanine aminotransferase: 123, aspartate aminotransferase: 75 and blood alkaline phosphatase: 163. On 19Jan2021, alanine aminotransferase: 198, aspartate aminotransferase: 124 and blood alkaline phosphatase: 171. Her liver specialist told her that her liver enzymes increased after each Pfizer COVID-19 Vaccine shot she received. She said her liver specialist told her she should report her liver enzymes increasing to Pfizer. Events did require a visit to Physician Office. She went to a liver specialist on 04Feb2021. No treatment received for the adverse events.  On 22Feb2021, Nasal Swab was negative. The outcome of the events was not recovered.
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Burning sensation, Headache, Movement disorder, Pain in extremity
Clinical narrative: her arm hurt/burning/arm still hurts and cannot move arm; couldn't move her arm; her arm hurt/burning; fever; headache; stomach ache; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), dose 2 via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient received 2nd dose of Trumenba Monday, almost instant her arm hurt/burning. Next day she had fever, headache, stomach ache and couldn't move her arm. Today arm still hurts and cannot move arm. The outcome of the events pain in arm and movement disorder was not recovered, other events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: her arm hurt/burning/arm still hurts and cannot move arm; couldn't move her arm; her arm hurt/burning; fever; headache; stomach ache; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), dose 2 via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient received 2nd dose of Trumenba Monday, almost instant her arm hurt/burning. Next day she had fever, headache, stomach ache and couldn't move her arm. Today arm still hurts and cannot move arm. The outcome of the events pain in arm and movement disorder was not recovered, other events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV, TTOX
Symptoms: Malaise, Pyrexia
Clinical narrative: 104 degree fever; sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vacccine (dipht crm197 protein) (trade name unspecified, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as unknown, single dose, for immunization; and tetanus vaccine (trade name unspecified), via unspecified route of route of administration, on an unspecified date, at an unspecified dose, for immunization. The patient medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she received a pneumonia vaccine shot and had a 104 degree fever for a week and was sick for a week and that went away. She reported that on an unspecified date, she had to get a tetanus vaccine shot and had the same reaction as she did with the pneumonia vaccine. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vacccine (dipht crm197 protein) in the country of incidence or the country where the product was purchased. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vacccine (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: fever; stomach ache; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Covax Us Support.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Previously on an unknown date received the first dose of the vaccine for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On an unknown date, after she got the 2nd dose of vaccine, the patient experienced fever and stomach ache.  The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Pain in extremity, SARS-CoV-2 test
Clinical narrative: my arm hurt; heaviness in the chest; Anxiety; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age (age reported as "Age: 50 Unit: Unknown") received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 09Mar2021 13:45 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient took a COVID test yesterday at 7:30 in the morning, and went on the 1st shot of the vaccine in the afternoon yesterday at 13:45, the test was positive. On unspecified date in 2021, the patient's arm hurt and heaviness in the chest. The patient didn't feel badly, arm hurt from the shot and had a little bit of heaviness in the chest but  patient guesses it could be anxiety overall. The side effects last for about 1 day or longer than that. The patient underwent lab tests and procedures which included COVID test with positive result on 09Mar2021 07:30. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Illness, Influenza like illness, Oropharyngeal discomfort
Clinical narrative: tested positive for COVID-19/tested positive for covid 19 virus after receiving covid 19 vaccine; flu like symptoms; achy body; high temperature; there was throat involvement; very, very ill/sick; This is a spontaneous report via Pfizer-sponsored program and medical information team from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in left arm on 25Feb2021 as 1st dose, single for COVID-19 immunization. Medical history included thyroid disorder, ongoing incontinence. Concomitant medications included mirabegron (MYRBETRIQ) for Incontinence. Patient previously years ago took flu vaccine and she had feel sick with flu, she did have flu symptoms. No Prior Vaccinations (within 4 weeks). On Sunday (28Feb2021), she became very, very ill with flu like symptoms, she had an achy body, she had high temperature, there was throat involvement. She had those symptoms until Monday (01Mar2021) and was feeling better on Tuesday (02Mar2021). On Wednesday (03Mar2021), she had a COVID-19 test and it tested positive for COVID-19/ tested positive for covid 19 virus. She thought she was having a reaction to the shot when she got sick. Yesterday was her last day of self-isolation. She has not had another test, she was senior. She was scheduled for her second dose of the vaccine a week from now from tomorrow (19Mar2021) and she wanted to know if she should have the second shot or she has to undergo an antibody test since she got COVID after the first dose. The outcome of tested positive for COVID-19/tested positive for covid 19 virus after receiving covid 19 vaccine was unknown; for illness recovered on 28Feb2021, flu like symptoms recovered on 02Mar2021, while for others was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19/tested positive for covid 19 virus after receiving covid 19 vaccine; flu like symptoms; achy body; high temperature; there was throat involvement; very, very ill/sick; This is a spontaneous report via Pfizer-sponsored program and medical information team from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in left arm on 25Feb2021 as 1st dose, single for COVID-19 immunization. Medical history included thyroid disorder, ongoing incontinence. Concomitant medications included mirabegron (MYRBETRIQ) for Incontinence. Patient previously years ago took flu vaccine and she had feel sick with flu, she did have flu symptoms. No Prior Vaccinations (within 4 weeks). On Sunday (28Feb2021), she became very, very ill with flu like symptoms, she had an achy body, she had high temperature, there was throat involvement. She had those symptoms until Monday (01Mar2021) and was feeling better on Tuesday (02Mar2021). On Wednesday (03Mar2021), she had a COVID-19 test and it tested positive for COVID-19/ tested positive for covid 19 virus. She thought she was having a reaction to the shot when she got sick. Yesterday was her last day of self-isolation. She has not had another test, she was senior. She was scheduled for her second dose of the vaccine a week from now from tomorrow (19Mar2021) and she wanted to know if she should have the second shot or she has to undergo an antibody test since she got COVID after the first dose. The outcome of tested positive for COVID-19/tested positive for covid 19 virus after receiving covid 19 vaccine was unknown; for illness recovered on 28Feb2021, flu like symptoms recovered on 02Mar2021, while for others was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test, Upper-airway cough syndrome
Clinical narrative: covid test result Positive; post nasal drip; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:15 (at age 60-year-old) (Batch/Lot Number: EL3247) as 1st dose, single for covid-19 immunisation. Medical history included stage 0 breast cancer survivor and surgical tape allergies. Patient was not pregnant and was not previously diagnosed with COVID-19. No other vaccines in four weeks was administered. Concomitant medication included ergocalciferol (VIT D), calcium (ALGAE CALCIUM), and strontium. On 11Mar2021 22:00, patient started with post nasal drip, cough and runny nose. She got progressively worse with headache, chills and fatigue on 12Mar2021. Overnight to 13Mar2021, the runny nose, post nasal drip and cough greatly was reduced but she was still fatigued, had headache, and very little chills. Patient called health network and was screened for a Covid 19 Test. Patient had the Covid Test (nasal swab) on 13Mar2021 with positive results. No treatment was received for the events. Events resulted in healthcare professional office/ clinic visit. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: his first dose on 17Feb2021. 10 days later he got covid; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wants to reschedule his Pfizer second covid vaccine shot as he has gotten his first dose on 17Feb2021. On 27Feb2021 then 10 days later, he got COVID and is still sick. The outcome of the event was not recovered.  Information on lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Muscle twitching in Right Arm; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN 6206), via an unspecified route of administration, administered in left arm on 09Mar2021 (at the age of 60-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Medical history included mitral valve prolapse, osteopenia, skin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included calcium citrate (CITRACAL); fish oil; sertraline; raloxifene; 'aspiri'. The patient's known allergies included erithomyicine, codeine, skin allergy, Propylene Glycol and other skin allergens. The patient experienced muscle twitching in right arm, not the arm vaccine was given in. Began on 13Mar2021. Since the vaccination, the patient was not tested for COVID-19. No treatment was received for events. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Lethargy
Clinical narrative: Lethary; Aches, body aches; soreness at injection site; Chills; Fever; Loose stools; Intense headache; heart raced; got very dizzy; This is a spontaneous report from a contactable consumer, the patient.   A 56-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 12Mar2021 at 09:15 (at 56- years-old) as a single dose for COVID-19 immunisation.  Medical history included unspecified autoimmune conditions. The patient was not aware of having any allergies.  Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole magnesium (PRILOSEC); cyanocobalamin (VITAMIN B-12); calcium (MANUFACTURER UNKNOWN); and colecalciferol (VITAMIN D); all taken for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021, the patient felt heart racing and felt dizzy and woozy.  On 13Mar2021, the patient experienced lethargy, aches/body aches, soreness at injection site, chills, fever, loose stools, and intense headache. The clinical course was as follows: immediately after injection, when standing, her heart raced and she got very dizzy, woozy. She sat for additional 40 minutes with water until this somewhat subsided. Then, she had intense headache and loose stools. She had normal fever, aches, chills, body aches and soreness at injection site lasting 48 hours (as reported). Also, lethargy and aches had lasted through Day 5 (as reported). The clinical outcomes of the heart racing, dizzy/woozy, lethargy, aches/body aches, soreness at injection site, chills, fever, loose stools, and intense headache, were recovering.   No follow-up attempts are possible; information about lot number cannot be obtained
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia, Vaccination site pain
Clinical narrative: Lethary; Aches, body aches; soreness at injection site; Chills; Fever; Loose stools; Intense headache; heart raced; got very dizzy; This is a spontaneous report from a contactable consumer, the patient.   A 56-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 12Mar2021 at 09:15 (at 56- years-old) as a single dose for COVID-19 immunisation.  Medical history included unspecified autoimmune conditions. The patient was not aware of having any allergies.  Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole magnesium (PRILOSEC); cyanocobalamin (VITAMIN B-12); calcium (MANUFACTURER UNKNOWN); and colecalciferol (VITAMIN D); all taken for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021, the patient felt heart racing and felt dizzy and woozy.  On 13Mar2021, the patient experienced lethargy, aches/body aches, soreness at injection site, chills, fever, loose stools, and intense headache. The clinical course was as follows: immediately after injection, when standing, her heart raced and she got very dizzy, woozy. She sat for additional 40 minutes with water until this somewhat subsided. Then, she had intense headache and loose stools. She had normal fever, aches, chills, body aches and soreness at injection site lasting 48 hours (as reported). Also, lethargy and aches had lasted through Day 5 (as reported). The clinical outcomes of the heart racing, dizzy/woozy, lethargy, aches/body aches, soreness at injection site, chills, fever, loose stools, and intense headache, were recovering.   No follow-up attempts are possible; information about lot number cannot be obtained
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Injection site pain; Tierdness; joint pain; Headache; Chills; Swollen lymph node; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6208), via an unspecified route of administration in the left arm on 12Mar2021 at 16:30 (at the age of 52-year-old), at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included chronic knee pain. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Meloxicam, Rosuvastatin, empagliflozin (JARDIANCE), Valsartan, Fenofibrate, Amlodipine, Paroxetine and Hydrocodone (reported as hydrocidine). On 13Mar2021, the patient experienced favor chills, headache, joint pain, tiredness, swollen lymph nodes, feeling unwell, injection site pain/soreness. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering. The report was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Injection site pain; Tierdness; joint pain; Headache; Chills; Swollen lymph node; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6208), via an unspecified route of administration in the left arm on 12Mar2021 at 16:30 (at the age of 52-year-old), at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included chronic knee pain. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Meloxicam, Rosuvastatin, empagliflozin (JARDIANCE), Valsartan, Fenofibrate, Amlodipine, Paroxetine and Hydrocodone (reported as hydrocidine). On 13Mar2021, the patient experienced favor chills, headache, joint pain, tiredness, swollen lymph nodes, feeling unwell, injection site pain/soreness. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering. The report was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: she had her period and non stop bleeding for 21 days with no end in sight; shaking; dizziness; nausea; sick; dry heaving; headache; Every muscle felt that I did a total body work out; Low grade fever of 96.8; weakness; loose stools; Slept 5-6 post inoculation/slept most of the day; tiredness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 12Mar2021 08:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, for covid-19 immunization.  Medical history included concussion from Sep2019. The patient received birth control within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient slept 5-6 post inoculation. On 12Mar2021 03:15, patient experienced loose stools. On Saturday morning 13Mar2021 at 3am, patient woke to shaking, dizziness, nausea, so much so that she did get sick twice, dry heaving followed for the next three hours. Extreme constant headache during the day and slept most of the day. She tried her best to stay hydrated. Every muscle felt that she did a total body work out, works than she had experienced with the flu. She had a low grade fever of 96.8. Continued weakness, tiredness, and headache Monday and Tuesday. It was also reported that on 13Mar2021 at 04:00 she had her period and non stop bleeding for 21 days with no end in sight. The outcome of event "she had her period and non stop bleeding for 21 days with no end in sight" was not recovered. The outcome of all other events was reported as Recovered/Resolved with Sequel. The patient did not receive treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.