chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: Anatomical site of vaccine administration: Left Arm, swelling on the arm like a hard notch/My arm is swelled up; Anatomical site of vaccine administration: Left Arm, There was really tender; Anatomical site of vaccine administration: Left Arm, swelling on the arm like a hard notch/My arm is swelled up; felt feverish; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL8982), via an unspecified route of administration on 13Jan2021 at SINGLE DOSE (first dose, left arm) for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date. The patient's concomitant medications were not reported.  The patient received the first dose of the vaccine on 13Jan2021. Anatomical site of vaccine administration was the left arm. The patient experienced a reaction afterwards which made her miss 2 days of work and work with her patients as she do home care (Jan2021). She experienced swelling on the arm like a hard notch/arm is swelled up and felt feverish and by the next day she could not move her arm at all/move her arms up the following day. She reported that there was really tender. She was supposed to get the 2nd dose of the vaccine on 03Feb2021 and was asking if she can take it on the 05Feb2021 so as she cannot miss work in the event, she experiences the reaction again. No Physician Office/ Emergency Room visit involved. Treatment included Tylenol to help with the pain and then put ice on it to break it keep swelling down. Outcome of the events was unknown. The case was reported as non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Testicular pain
Clinical narrative: Testicular ache; chills; headache; SI joint pain bilaterally; Fatigue; This is a spontaneous report from a contactable 51-year-old male Health care professional reported for himself. A 51-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration from 24Jan2021, 14:00 at SINGLE DOSE (second dose, left arm) for covid-19 immunisation, administered on a hospital. Medical history included history of chronic hives; no issues x 1 year from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on 03Jan2021 at 12:00 PM on the right arm for Covid-19 Immunization (Age of vaccination was 51 years old). The patient previously took Asa and experienced drug hypersensitivity and hives (known allergies: Asa - hives). Concomitant medication included celecoxib (CELEXA), and cetirizine hydrochloride (ZYRTEC), therapy dates and indication unspecified. The patient experienced testicular ache, chills, headache, si joint pain bilaterally, and fatigue on 25Jan2021 04:00. No treatment was given. Outcome of the events was recovered. Seriousness criteria was reported as non-serious.  Information on the lot/batch number has been requested
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Runny nose; Fever; Lots of aches; Threw up; Headache; Extremely tired; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported, expiration date: 31May2021), intramuscular (right arm) on 22Jan2021 at a single dose for COVID-19 vaccination. Medical history included hypertension, and cancer which was reported to have recovered from cancer twice. There were no concomitant medications. The patient was calling about BNT162B2 and reported that she had the vaccine on 22Jan2021. She reported that she was extremely tired Sunday, 24Jan2021, and Monday, 25Jan2021, and other than that, she started getting a runny nose on 25Jan2021. She reported that on 25Jan2021, she started running a fever of 100.2 to begin with and the morning of 26Jan2021 it was about that and it went up to 100.6. She reported that on evening of 25Jan2021 she had a lot of aches and went to bed early. Almost as soon as she got into bed before she took her temperature, she threw up. She also had a pretty bad headache. The patient was recovering from being extremely tired, and with unknown outcome from the rest of the events.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: Runny nose; Fever; Lots of aches; Threw up; Headache; Extremely tired; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported, expiration date: 31May2021), intramuscular (right arm) on 22Jan2021 at a single dose for COVID-19 vaccination. Medical history included hypertension, and cancer which was reported to have recovered from cancer twice. There were no concomitant medications. The patient was calling about BNT162B2 and reported that she had the vaccine on 22Jan2021. She reported that she was extremely tired Sunday, 24Jan2021, and Monday, 25Jan2021, and other than that, she started getting a runny nose on 25Jan2021. She reported that on 25Jan2021, she started running a fever of 100.2 to begin with and the morning of 26Jan2021 it was about that and it went up to 100.6. She reported that on evening of 25Jan2021 she had a lot of aches and went to bed early. Almost as soon as she got into bed before she took her temperature, she threw up. She also had a pretty bad headache. The patient was recovering from being extremely tired, and with unknown outcome from the rest of the events.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: axillary lymphadenopathy; This is spontaneous report from a non-contactable consumer reporting for himself. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL324), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has no known allergies. The patient experienced axillary lymphadenopathy on 24Jan2021. No treatment was received. Outcome of the event was recovering. The reporter assessed the event as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Chills, Fatigue, Insomnia
Clinical narrative: chills; fever of 101 f; went to bed with an uneasy feeling; had a hard time sleeping; intermittent body aches; fatigue; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek9231 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 11:00 at a single dose for COVID-19 immunization. The first dose was received on 04Jan2021 11:00 (lot number: Ek5730) on the left arm. Medical history included epilepsy. Patient was not pregnant at the time of vaccination. Concomitant medication included lamotrigine (LAMICTAL), and levetiracetam (KEPPRA) and unspecified multivitamin. There were no other vaccines received within 4 weeks prior to COVID vaccination. The patient previously took DILANTIN and experienced allergy. Patient went to bed with an uneasy feeling and had a hard time sleeping and had intermittent body aches on 25Jan2021 22:00. He woke up at 2am on 26Jan2021 with chills and a fever of 101 F. Patient took Acetaminophen and Iborprophin.  The medications did get rid of the fever and body aches. Patient woke up at 4 feeling a little better but the body aches and fatigue on Jan2021 was still there. Patient called in sick to work on 26Jan2021. Outcome of the events was recovering. Case was considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: chills; fever of 101 f; went to bed with an uneasy feeling; had a hard time sleeping; intermittent body aches; fatigue; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek9231 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 11:00 at a single dose for COVID-19 immunization. The first dose was received on 04Jan2021 11:00 (lot number: Ek5730) on the left arm. Medical history included epilepsy. Patient was not pregnant at the time of vaccination. Concomitant medication included lamotrigine (LAMICTAL), and levetiracetam (KEPPRA) and unspecified multivitamin. There were no other vaccines received within 4 weeks prior to COVID vaccination. The patient previously took DILANTIN and experienced allergy. Patient went to bed with an uneasy feeling and had a hard time sleeping and had intermittent body aches on 25Jan2021 22:00. He woke up at 2am on 26Jan2021 with chills and a fever of 101 F. Patient took Acetaminophen and Iborprophin.  The medications did get rid of the fever and body aches. Patient woke up at 4 feeling a little better but the body aches and fatigue on Jan2021 was still there. Patient called in sick to work on 26Jan2021. Outcome of the events was recovering. Case was considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash macular
Clinical narrative: tingly, itchy, prickly feeling hands; tingly, itchy, prickly feeling hands; red blotches on her hands; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), intramuscular on 21Jan2021 16:30 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 30 minutes after vaccination was administered, client stated she started tingly, itchy, prickly feeling hands. She did have red blotches on her hands. Public Health Nurse offered Benadryl which she accepted and was ok a half hour later. The outcome of the events was recovered on 21Jan2021 17:30.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pruritus, Rash papular, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Right arm was very sore; right hand felt numb; itchy on the right side of her back and her right arm; Itchy on the right side of my back; Rash with bumps; This is a spontaneous report from a contactable healthcare professional (patient). This 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 22Jan2021 15:00 at a single dose on the right arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included unspecified birth control pill. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On day 2, 23Jan2021 17:00, the patient's right arm was very sore, right hand felt numb, itchy on the right side of her back and her right arm. The patient started to develop rash with bumps. Rash went away as soon as she took Benadryl. On Day 3, she was back to normal, no soreness, no numbness and no itchiness. The events were reported as non-serious. Outcome of the events was recovered on 24Jan2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Dizziness, Headache, Pain
Clinical narrative: Chills; fever lasted two days, temp ranges 99.1-100.5; Intense headache; Severe body aches; Dizziness; Loss of taste to everything except salt and lemon taste of cough drops; This is a spontaneous report from a contactable physician (patient). A 69-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL9261, expiry date: not reported), via an unspecified route of administration, on 20Jan2021 12:00 AM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Medical history included hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Valsartan, Metoprolol, Atorvastatin, Vitamin, Meth (unspecified). The patient previously took morphine and experienced drug allergy. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EH9899, expiry date: not reported), via an unspecified route of administration, on 28Dec2020 12:15 AM at a single dose on the left arm for COVID-19 immunization (age at vaccination: 69-year-old). 16 hours later after vaccination, on 21Jan2021 04:00, the patient woke up with chills, fever, intense headache, severe body aches and dizziness. She noticed loss of taste to everything except salt and lemon taste of cough drops. Fever lasted two days, temp ranges 99.1-100.5. She cancelled clinic and stayed home. Due to loss of taste, she got tested for COVID infection on an unspecified date in Jan2021; result was negative. Body ache and loss of taste continued for 3 days. The reported adverse events resulted into doctor or other healthcare professional office/clinic visit. The patient underwent laboratory tests and procedures which included nasal swab on 07Jan2021 with result of negative. Therapeutic measures taken as a result of adverse events included Advil and Tylenol. Outcome of the events was recovered on unspecified dates in Jan2021. The reporter assessed the events as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Smear test
Clinical narrative: Chills; fever lasted two days, temp ranges 99.1-100.5; Intense headache; Severe body aches; Dizziness; Loss of taste to everything except salt and lemon taste of cough drops; This is a spontaneous report from a contactable physician (patient). A 69-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL9261, expiry date: not reported), via an unspecified route of administration, on 20Jan2021 12:00 AM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Medical history included hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Valsartan, Metoprolol, Atorvastatin, Vitamin, Meth (unspecified). The patient previously took morphine and experienced drug allergy. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EH9899, expiry date: not reported), via an unspecified route of administration, on 28Dec2020 12:15 AM at a single dose on the left arm for COVID-19 immunization (age at vaccination: 69-year-old). 16 hours later after vaccination, on 21Jan2021 04:00, the patient woke up with chills, fever, intense headache, severe body aches and dizziness. She noticed loss of taste to everything except salt and lemon taste of cough drops. Fever lasted two days, temp ranges 99.1-100.5. She cancelled clinic and stayed home. Due to loss of taste, she got tested for COVID infection on an unspecified date in Jan2021; result was negative. Body ache and loss of taste continued for 3 days. The reported adverse events resulted into doctor or other healthcare professional office/clinic visit. The patient underwent laboratory tests and procedures which included nasal swab on 07Jan2021 with result of negative. Therapeutic measures taken as a result of adverse events included Advil and Tylenol. Outcome of the events was recovered on unspecified dates in Jan2021. The reporter assessed the events as non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: injection site pain (current with itching); injection site pain (current with itching); tiredness/fatigue; tooth pain; joint pain; chills; low-grade fever (100.4); This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELo142), via an unspecified route of administration in right arm on 21Jan2021 09:15 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the workpalce clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included hypothyroidism and high blood pressure from an unknown date and unknown if ongoing.  Concomitant medication included losartan and levothyroxine sodium (LEVOTHROID). On 22Jan2021, the patient experienced injection site pain (current with itching), three days of tiredness/fatigue, tooth pain, joint pain, chills and low-grade fever (100.4). The patient recovered on unspecified date. No treatment was given to the patient for the events. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site pain (current with itching); injection site pain (current with itching); tiredness/fatigue; tooth pain; joint pain; chills; low-grade fever (100.4); This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELo142), via an unspecified route of administration in right arm on 21Jan2021 09:15 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the workpalce clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included hypothyroidism and high blood pressure from an unknown date and unknown if ongoing.  Concomitant medication included losartan and levothyroxine sodium (LEVOTHROID). On 22Jan2021, the patient experienced injection site pain (current with itching), three days of tiredness/fatigue, tooth pain, joint pain, chills and low-grade fever (100.4). The patient recovered on unspecified date. No treatment was given to the patient for the events. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Dizziness, Dyspnoea
Clinical narrative: Shortness of breath; chest tightness; dizziness; fatigue; joint and muscles pain; joint and muscles pain; headache; chills; injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 20Jan2021 09:15 at single dose for Covid-19 immunization. There was no medical history. The patient was not pregnant at time of vaccination. The patient's concomitant medication included losartan, citalopram hydrochloride (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]), clonazepam, hydrocodone bitartrate, paracetamol (NORCO), carisoprodol (SOMA [CARISOPRODOL]), and hydrochlorothiazide. On 20Jan2021 09:15, the patient experienced Shortness of breath, chest tightness, dizziness, fatigue, joint and muscles pain, headache, chills, injection site soreness. The patient did not received treatment for the events. The outcome of the events was recovering. No other vaccine was given in four weeks. The patient was not tested positive post vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Shortness of breath; chest tightness; dizziness; fatigue; joint and muscles pain; joint and muscles pain; headache; chills; injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 20Jan2021 09:15 at single dose for Covid-19 immunization. There was no medical history. The patient was not pregnant at time of vaccination. The patient's concomitant medication included losartan, citalopram hydrochloride (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]), clonazepam, hydrocodone bitartrate, paracetamol (NORCO), carisoprodol (SOMA [CARISOPRODOL]), and hydrochlorothiazide. On 20Jan2021 09:15, the patient experienced Shortness of breath, chest tightness, dizziness, fatigue, joint and muscles pain, headache, chills, injection site soreness. The patient did not received treatment for the events. The outcome of the events was recovering. No other vaccine was given in four weeks. The patient was not tested positive post vaccination.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling, Synovial cyst
Clinical narrative: bakers cyst behind my right Knee; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, lot number EH9899, via an unspecified route of administration in left arm on 06Jan2021 at 09:00 at single dose for COVID-19 immunization. The patient received vaccination in Doctor's office/urgent care. Medical history included bladder cancer from an unknown date, cancer treatment with tumor vaccine therapy BCG (Bacillus Calmette Guerin) on 23Dec2020, bone spur in right thumb from an unknown date, COVID-19 from an unknown date and drug allergy to amoxicillin/clavulanate potassium (AUGMENTIN). The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included doxycycline. On 08Jan2021 (also reported 3 days after the vaccine) at 05:45 the patient experienced pain and swelling in his right knee/calf and ankle. Pain and swelling in the right knee, calf and ankle continued until 14Jan2021 when the patient went to the urgent care. He was sent to the emergency room with a suspected blood clot and ultrasound proved no clot was in the leg. On 15Jan2021 the patient went to a hematologist and had an additional ultrasound which found a bakers cyst behind his right knee. He continued to have pain and swelling in the right leg and left hand which had already arthritis and he suspected it was an immune response to the vaccine. Rest, ice, compression and elevation were suggested as therapeutic measures to treat the events. The reported events had not resolved yet at the time of the report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: bakers cyst behind my right Knee; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, lot number EH9899, via an unspecified route of administration in left arm on 06Jan2021 at 09:00 at single dose for COVID-19 immunization. The patient received vaccination in Doctor's office/urgent care. Medical history included bladder cancer from an unknown date, cancer treatment with tumor vaccine therapy BCG (Bacillus Calmette Guerin) on 23Dec2020, bone spur in right thumb from an unknown date, COVID-19 from an unknown date and drug allergy to amoxicillin/clavulanate potassium (AUGMENTIN). The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included doxycycline. On 08Jan2021 (also reported 3 days after the vaccine) at 05:45 the patient experienced pain and swelling in his right knee/calf and ankle. Pain and swelling in the right knee, calf and ankle continued until 14Jan2021 when the patient went to the urgent care. He was sent to the emergency room with a suspected blood clot and ultrasound proved no clot was in the leg. On 15Jan2021 the patient went to a hematologist and had an additional ultrasound which found a bakers cyst behind his right knee. He continued to have pain and swelling in the right leg and left hand which had already arthritis and he suspected it was an immune response to the vaccine. Rest, ice, compression and elevation were suggested as therapeutic measures to treat the events. The reported events had not resolved yet at the time of the report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: menstrual cycle has been off and then it restarted with brown clotting old blood/her period was not due for another 10 days; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscularly on the left arm, on 07Jan2021 10:30, at single dose, for covid-19 immunization. Medical history included thyroid cancer. Concomitant medication included thyroid (ARMOUR THYROID). The patient previously took hydromorphone (DILAUDID) and metaxalone (SKELAXIN) and experienced allergies to both. The vaccine was given at the hospital. The patient stated that her menstrual cycle has been off and then it restarted with brown clotting old blood on 09Jan2021 (also reported as 24Jan2021); her period was not due for another 10 days. She added that her cycles have never been off, and she has never had issues with her menstrual cycles or any female problems. The adverse event resulted in doctor or other healthcare professional office/clinic visit on 27Jan2021. Unspecified treatment was received for the adverse event. The outcome of the adverse event was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Some very bad gout; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient had some very bad gout. The outcome of the event was unknown. The reporting nurse would want to give the patient indomethacin for the gout, and wanted to know if it will be safe.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: my left knee started hurting/knee started screaming at me; This is a spontaneous report from a contactable consumer (patient).  An 85-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included knee replacement (her right knee was replaced years ago). Concomitant medications were not reported. The patient reported that after getting the vaccine, her left knee started hurting on an unspecified date in Jan2021. She took some pills over the weekend that helped. But she stood up that morning and that knee started screaming at her. This was further clarified as the left knee began hurting badly when standing this morning. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: extreme fatigue; Headache; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1283), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE at arm left for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced extreme fatigue, and headache. The patient took Advil for the event headache. She says she has also had lots of rest and water. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: experienced rapid heartbeat; This is a spontaneous report from a non-contactable consumer reported for herself. This female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Not Provided), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. On 26Jan2021 13:30 she experienced rapid heartbeat for 4 hours. She said she feels better on 26Jan2021 and wanted advise on receiving 2nd dose.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysphagia, Illness, Oropharyngeal pain, Pain in extremity
Clinical narrative: She said that she rarely gets sick; A soreness in her throat and it was hard to swallow; A soreness in her throat and it was hard to swallow; The feeling of a tooth ache/ having a toothache currently; Felt like someone punched her arm; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in upper right arm on 21Jan2021 at a single dose  for COVID-19 immunization. Medical history included seasonal allergy. There were no concomitant medications. The patient experienced a soreness in her throat and it was hard to swallow, in which she had to get ice to help alleviate the pain in her throat. The pain in her throat resolved a couple of hours later (as reported). She wanted to know if these side effects were from the vaccine. She also reported the feeling of a tooth ache today (26Jan2021), in which she tried to medicate with Tylenol, but was not able to access any while at work. Patient asked what symptoms do people experience within 15 minutes if they have an allergic reaction to the vaccine. The patient got the vaccine 5-6 days ago, but today (26Jan2021) she was on the job in a group setting and was having difficulty swallowing and had a sore throat. She said that she treated it with ice and it is slowly subsiding. She noticed she almost had a like a headache type thing, but it was in the back of the throat. She has had tingling in the back of her throat from seasonal allergies, but nothing like this. Her temp was 97.9 and it was now 98.3. As she swallows, she is feeling pain. She said that the ice helped out. She is having a toothache currently too and stated that she needs to go to the dentist. She noticed her sore throat while she was talking and noticed the sore throat and it hurt and when swallowing. She said that after the injection, she felt like someone punched her in the arm the next day on 22Jan2021. This has resolved at this time. She said that she rarely gets sick. This is the second time she has had some type of symptoms within 2 years. She said that she has not been around anyone and is social distancing. Treatment received for "a soreness in her throat and it was hard to swallow" included ice. The outcome of the events "a soreness in her throat and it was hard to swallow" was recovering (as reported), for event "felt like someone punched her arm" was recovered on an unspecified date and the rest of the events was unknown.  Information on the Batch/Lot number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: She said that she rarely gets sick; A soreness in her throat and it was hard to swallow; A soreness in her throat and it was hard to swallow; The feeling of a tooth ache/ having a toothache currently; Felt like someone punched her arm; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in upper right arm on 21Jan2021 at a single dose  for COVID-19 immunization. Medical history included seasonal allergy. There were no concomitant medications. The patient experienced a soreness in her throat and it was hard to swallow, in which she had to get ice to help alleviate the pain in her throat. The pain in her throat resolved a couple of hours later (as reported). She wanted to know if these side effects were from the vaccine. She also reported the feeling of a tooth ache today (26Jan2021), in which she tried to medicate with Tylenol, but was not able to access any while at work. Patient asked what symptoms do people experience within 15 minutes if they have an allergic reaction to the vaccine. The patient got the vaccine 5-6 days ago, but today (26Jan2021) she was on the job in a group setting and was having difficulty swallowing and had a sore throat. She said that she treated it with ice and it is slowly subsiding. She noticed she almost had a like a headache type thing, but it was in the back of the throat. She has had tingling in the back of her throat from seasonal allergies, but nothing like this. Her temp was 97.9 and it was now 98.3. As she swallows, she is feeling pain. She said that the ice helped out. She is having a toothache currently too and stated that she needs to go to the dentist. She noticed her sore throat while she was talking and noticed the sore throat and it hurt and when swallowing. She said that after the injection, she felt like someone punched her in the arm the next day on 22Jan2021. This has resolved at this time. She said that she rarely gets sick. This is the second time she has had some type of symptoms within 2 years. She said that she has not been around anyone and is social distancing. Treatment received for "a soreness in her throat and it was hard to swallow" included ice. The outcome of the events "a soreness in her throat and it was hard to swallow" was recovering (as reported), for event "felt like someone punched her arm" was recovered on an unspecified date and the rest of the events was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oral herpes
Clinical narrative: chills; fever blisters; This is a spontaneous report from a contactable Consumer reporting for a patient. A female patient of an unspecified age (Age: 76, unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at SINGLE DOSE (second dose) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. The reporter stated that her friend has had the second dose of the PFIZER COVID-19 vaccine and had chills the first night and at the end of the second week (14 days) she broke out in fever blisters in her mouth and is on an antibiotic because of the fever blisters. Outcome of the events was unknown. Reporter wanted to know if this is a side effect of the vaccine. Reporter considered the event was non-serious.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urinary tract infection
Clinical narrative: UTI; fever; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age (age: 73, unit: unknown) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a reaction to the vaccine, a fever, the next day, 13Jan2021.  He stated that the  fever lasts 8 days and was "predictable" (started normal temperature in morning, then would increase as the day progressed). It was also reported that he was diagnosed with UTI on an unspecified date and was being treated for UTI and the fever subsided. The patient is scheduled to get the second dose on 02Feb2021 but was reluctant to have this dose if he had this reaction to the first one. He stated that he understands the reaction to booster is more significant to original. The outcome of the event fever was recovering while the outcome of the event UTI was unknown.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: HR at 11:30 and it was 104; This is a spontaneous report from a contactable consumer (reported for herself).  A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 26Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included Afib (atrial fibrillation) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination and reporting. Concomitant medications included apixaban (5 mg tab) at 5 mg, and atorvastatin calcium (10 mg tab) at 10 mg; both reported as other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient checked her HR (heart rate) at 11:30 and it was 104, and at 12:30 it had come down to 90. No treatments received in response to the event reported. The event was reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "HR at 11:30 and it was 104" was recovering.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Confusional state, Heart rate, Heart rate increased
Clinical narrative: Tightening of throat; Numbness in left thumb, arm, and jaw; Confused; Rapid heart rate; Nausea; Increased blood pressure; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 25Jan2021 at 11:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to bees, penicillin, and dairy. The patient's concomitant medications included loratadine (CLARITIN) and paracetamol (TYLENOL). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a school or student health clinic facility. Within 5 minutes of injection on 25Jan2021 (starting at 11:30), rapid heart rate, nausea, and increased blood pressure began, continued, and worsened. After an hour, these got worse and seen by medics. Then the patient was transported to emergency room (ER) by ambulance but could not be seen for 4 hours. About an hour and a half after the injection (13:00), the patient experienced tightening of throat and numbness in left thumb, arm, and jaw. The patient was also very confused at that point as well. After 2 hours in waiting room, the patient felt well enough to be taken home. The symptoms slowly improved on their own. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events in Jan2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Throat tightness
Clinical narrative: Tightening of throat; Numbness in left thumb, arm, and jaw; Confused; Rapid heart rate; Nausea; Increased blood pressure; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 25Jan2021 at 11:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to bees, penicillin, and dairy. The patient's concomitant medications included loratadine (CLARITIN) and paracetamol (TYLENOL). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a school or student health clinic facility. Within 5 minutes of injection on 25Jan2021 (starting at 11:30), rapid heart rate, nausea, and increased blood pressure began, continued, and worsened. After an hour, these got worse and seen by medics. Then the patient was transported to emergency room (ER) by ambulance but could not be seen for 4 hours. About an hour and a half after the injection (13:00), the patient experienced tightening of throat and numbness in left thumb, arm, and jaw. The patient was also very confused at that point as well. After 2 hours in waiting room, the patient felt well enough to be taken home. The symptoms slowly improved on their own. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events in Jan2021.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Confusional state, Dizziness
Clinical narrative: fast heartbeat; increased BP; weak; dizziness; nausea; headache; confused; a little soreness in her arm; felt like she could pass out; didn't know who she was, she just kept walking and walking; funny feelings; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiry date not reported), via an unspecified route of administration on the right upper arm on 21Jan2021 17:00 at single dose for covid-19 immunization.  Medical history included oral cancer from an unknown date and unknown if ongoing.  There were no concomitant medications. The patient previously received flu vaccine for immunization and reported that it made her sick for 10 days 4 or 5 years ago. The patient previously took Tylenol (takes 1 instead of 2, Everything she takes half the recommended dose). The patient experienced fast heartbeat, increased BP, weakness, dizziness, nausea and headache on an unspecified date in Jan2021. It was further reported that she had a fast heart beat, her blood pressure went real high, she was dizzy and weak. This was while she was there and being watched for the 15 minutes by a nurse. She is 84 years old and doesn't take any medication; she did have oral cancer but with no chemo as it had not spread and this was 2 years ago. It was explained that the patient didn't feel good about it but she drove home. When she got home she was confused and felt like she could pass out. She walked through the house didn't know who she was, she just kept walking and walking. It was a strange feeling that lasted 15-20 minutes. She called her son late in the afternoon and told him to check on her to make sure she made it through the night. She still had funny feelings over the next few days but at this point she only has the dizziness that happens occasionally. She notes also that her blood pressure was checked at home by her and was higher than normal the first few days after but is now normal. Over the next day she had a headache and a little nausea, but it was not severe. She also mentions having a little soreness in her arm but not bad. She did read about the side effects and states she had the elevated heart rate, increase in blood pressure and dizziness right after getting it. The patient wonders could she ask for smaller dose, she only weighs about 110lb. When she spoke with her doctor she was told that the COVID virus is worse than what she experienced after the vaccine. She has not been to the doctor since getting the vaccine, she just talked to them. The patient underwent lab tests and procedures which included blood pressure measurement: high and heart rate: fast on Jan2021. The patient was recovering from dizziness, the outcome of nausea was unknown and the patient recovered from the rest of the events on an unspecified date in Jan2021.