chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Throat tightness
Clinical narrative: rapid heartbeat; mild hypertension; Difficulty breathing; Swelling of your face and throat; Swelling of your face and throat; A bad rash all over your body; Dizziness and weakness; Dizziness and weakness; This is a spontaneous report from a contactable consumer (Patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Apr2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, she received the first dose of the Pfizer Covid vaccine on 29 Apr 2021. 4 days after taking the vaccine she began to experience a rapid heartbeat that continues until now. Caller states that she does have mild hypertension, and that she does have an appointment setup with her HCP. On an unspecified date, the patient experienced rapid heartbeat, mild hypertension, difficulty breathing, swelling of your face and throat, a bad rash all over your body, dizziness and weakness. Outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Appetite disorder, Asthenia, Decreased appetite, Depressed mood, Diarrhoea
Clinical narrative: Diarrhea; sick; had no energy; Feeling down; loss appetite; when he eats only eats very little; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207), via an unspecified route of administration in left arm on 14Apr2021 (at the age of 66 years old) as single for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (COPD) he was diagnosed several years ago; ongoing high blood pressure and he was diagnosed 10 years ago. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN69198), via an unspecified route of administration in left arm on 23Mar2021 (at the age of 66 years old) for covid-19 immunisation. Concomitant Medications included he takes breathing treatments. No further details provided. He stated that he had both shots in April. He had the first one the first week of April and one the last week of April. He further clarified that first shot 23Mar2021 and second shot 14Apr2021. He stated that since he got it he had no energy, sick, feeling down and out, loss of appetite, and when he eats that he eats very little on 26Apr2021. Wanted to know what was recommended. He stated that it feels like he has the stomach flu. He also experienced diarrhea on 12May2021. He clarified that it was for the Pfizer Covid shot. Wanted to if many people have called with side effects. Wanted to know if he should make an appointment with his doctor. The patient did not received treatment due to the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Diarrhea; sick; had no energy; Feeling down; loss appetite; when he eats only eats very little; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207), via an unspecified route of administration in left arm on 14Apr2021 (at the age of 66 years old) as single for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (COPD) he was diagnosed several years ago; ongoing high blood pressure and he was diagnosed 10 years ago. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN69198), via an unspecified route of administration in left arm on 23Mar2021 (at the age of 66 years old) for covid-19 immunisation. Concomitant Medications included he takes breathing treatments. No further details provided. He stated that he had both shots in April. He had the first one the first week of April and one the last week of April. He further clarified that first shot 23Mar2021 and second shot 14Apr2021. He stated that since he got it he had no energy, sick, feeling down and out, loss of appetite, and when he eats that he eats very little on 26Apr2021. Wanted to know what was recommended. He stated that it feels like he has the stomach flu. He also experienced diarrhea on 12May2021. He clarified that it was for the Pfizer Covid shot. Wanted to if many people have called with side effects. Wanted to know if he should make an appointment with his doctor. The patient did not received treatment due to the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: A high number of heartbeats/a fast heart beat; A very mild fever/ Mild temperature, fever; This is a spontaneous report from a contactable consumer. A 17-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12May2021 15:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing acne from an unknown date. Concomitant medications included doxycycline hyclate taken for acne, start and stop date were not reported.  Patient previously took first dose of BNT162B2 on 21Apr2021 03:15 PM in left shoulder for covid-19 Immunization. It was reported that patient experienced Fast heart beat, and Mild temperature after second vaccine on 13May2021. During the course of todays (reporting date) morning the patient has experienced a high number of heartbeats, she mentioned that the patient had a very mild fever. Additional Information for Concomitant Products Doxycycline Hyclate was he started the medication, maybe about 5 months ago, and stopped probably a week prior to the second vaccine. Regarding Fast heart beat time caller answers as it started last night and has been incrementing, according to his watch. Caller reports that the highest point, clarified as fastest heart rate, was at 9:40 am or 10 am. Caller states he thinks it happened in his sleep. caller answers as the heart rate has gone down, it has improved, but not very much. Caller states he wants to protect himself while he was out and about at work and at school. Patient took a Tylenol, 2 hours after he had the rapid heart beat. He took the Tylenol for his temperature, and the medication had a good effect. Outcome of the event A very mild fever/ Mild temperature, fever was recovered on 13May2021 and Outcome of the other event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: its been over 1 and half hr. and heartbeat is over 100/a rapid heart beat; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 69 year old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13May2021 (Batch/Lot number was not reported)(At the age of 69 years old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 13May2021 the patient stated that its been over 1 and half hr and heartbeat is over 100 rapid heart beat . Patient stated that she wanted to know what is considered a rapid heartbeat and how long before she should be concerned about it. its been over 1 and half hr. and heartbeat is over 100. She received her first dose of the Pfizer covid vaccine today .The patient underwent lab tests and procedures which included heart rate increased: 100 on 13May2021 .The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Restlessness, SARS-CoV-2 test, Sleep disorder
Clinical narrative: Not able to get a good night's sleep since receiving the vaccine. I am still currently experiencing poor sleep quality. I am sleeping the sameduration as before the vaccine but my sleep quality has plummeted; wake up feeling as unrested as I did before sleeping. I wakeup unrested.untested. I go to bed each night by 10pm and wake up at 5am as I always have but have terriblerecovery.; Severe fatigue after the 2nd dose; Achy joints for approximately 24hrs; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ewo0170), via an unspecified route of administration in the left arm on 26Apr2021 at 17:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not have any allergies to medications, food or other products. Concomitant medications included olmesartan and amlodipine (AMLODIPINE;OLMESARTAN)) 40mg/5mg, vitamin d nos (MANUFACTURER UNKNOWN) and magnesium sulfate (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ewo0151), via an unspecified route of administration in the left arm on 03Apr2021 at 11:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 17:00, after the second dose, the patient experienced sever fatigue and achy joints for approximately 24hrs. On 27Apr2021 at 22:00, the patient was not able to get a good night's sleep since receiving the vaccine. The patient was currently experiencing poor sleep quality. The patient was sleeping the same duration as before the vaccine but his sleep quality has plummeted and he woke up feeling as unrested as he did before sleeping. The patient woke up unrested. The patient go to bed each night by 22:00 and woke up at 05:00 as always but had terrible recovery. The patient had made no changes in his sleep environment. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as the result of poor sleep quality and wake up unrested which included OTC sleep aid but had not provided any favorable results. Therapeutic measures were not taken for the events severe fatigue and achy joints. On 11May2021, the patient underwent SARS-CoV-2 test and the result was negative. The clinical outcome of the events severe fatigue and achy joints were recovered on 27Apr2021 at 17:00. The clinical outcome of the events poor sleep quality and wake up unrested were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Nausea; Vomiting; Diarrhea; Chills; Sweating; Tired; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0168) via an unspecified route of administration in the right arm on 11May2021 at 12:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative proctitis and blood pressure. The patient had no known allergies to medications, food and other products. Concomitant medications included lisinopril 30mg (MANUFACTURER UNKNOWN) taken from unknown date, for blood pressure and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021 at 09:00, the patient experienced nausea, vomiting, diarrhea, chills, sweating and  tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events nausea, vomiting, diarrhea, chills, sweating and tired was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; Diarrhea; Chills; Sweating; Tired; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0168) via an unspecified route of administration in the right arm on 11May2021 at 12:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative proctitis and blood pressure. The patient had no known allergies to medications, food and other products. Concomitant medications included lisinopril 30mg (MANUFACTURER UNKNOWN) taken from unknown date, for blood pressure and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021 at 09:00, the patient experienced nausea, vomiting, diarrhea, chills, sweating and  tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events nausea, vomiting, diarrhea, chills, sweating and tired was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Several itch red dots on sole of right foot; Several itch red dots on sole of right foot; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew8736) via an unspecified route of administration in the right arm on 11May2021 at 16:30 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). Concomitant medications included melatonin (MANUFACTURER UNKNOWN) 5mg a night and unspecified postnatal vitamins; both for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 13May2021 at 12:00, the patient experienced several itch red dots on sole of right foot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event.  The clinical outcome of the event several itch red dots on sole of right foot was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: Loss of Taste; loss of smell; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Apr2021 at 10:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have any allergies to medications, food, or other products. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021 at 07:30, the patient experienced loss of taste and smell. The patient underwent lab tests and procedures, which included COVID-19 rapid antigen test on 01May2021 and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of loss of taste and smell were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 22Apr2021 at 15:45 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08May2021 at 21:00, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with valacyclovir.  The clinical outcome of the event shingles was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179), via an unspecified route of administration in the left arm on 13May2021 at 09:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), sunflower lecithin (MANUFACTURER UNKNOWN), birth control (MANUFACTURER UNKNOWN) and PRENATA; all from unknown dates for unspecified indications. The patient previously took amoxicillin on unknown date for an unspecified indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 22Apr2021 at 09:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021 at 20:00, the patient experienced fever 101+, chills, body aches and headache. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in May2021, the patient underwent lab test and procedure which included body temperature and result was shown as 101+. The clinical outcome of the events fever 101+, chills, body aches and headache were resolving at the time of reporting. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Menstrual cycle shortened by a week.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07May2021, the patient experienced menstrual cycle shortened by a week. The patient reported that her regular cycle was exactly 26 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event menstrual cycle shortened by a week was resolved on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Injection site muscle soreness; general fatigue; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 13May2021 at 17:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient medical history included COVID-19. The patient did not report any allergy to food, medications or other products. Patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021, the patient experienced injection site muscle soreness and general fatigue. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.  The clinical outcome of the events injection site muscle pain and fatigue were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Pyrexia, Tremor
Clinical narrative: Fever; Shaking chills; Shaking chills; Dizziness; Patient developed vomiting and diarrhea 3 hours after receiving 2nd vaccine dose.; Patient developed vomiting and diarrhea 3 hours after receiving 2nd vaccine dose.; This is a spontaneous report from a contactable healthcare professional. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 11May2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and penicillin allergy. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 11May2021, 3 hours after receiving 2nd vaccine dose, the patient developed vomiting and diarrhea. The following day on 12May2021, the patient still had vomiting, diarrhea and also reported fever, shaking chills and dizziness. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with ondansetron (ZOFRAN). The clinical outcome of the events vomiting, diarrhea, fever, shaking, chills and dizziness were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; Shaking chills; Shaking chills; Dizziness; Patient developed vomiting and diarrhea 3 hours after receiving 2nd vaccine dose.; Patient developed vomiting and diarrhea 3 hours after receiving 2nd vaccine dose.; This is a spontaneous report from a contactable healthcare professional. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 11May2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and penicillin allergy. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 11May2021, 3 hours after receiving 2nd vaccine dose, the patient developed vomiting and diarrhea. The following day on 12May2021, the patient still had vomiting, diarrhea and also reported fever, shaking chills and dizziness. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with ondansetron (ZOFRAN). The clinical outcome of the events vomiting, diarrhea, fever, shaking, chills and dizziness were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Extreme fatigue; Flu-like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male 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 13May2021 at 09:30 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food or other products. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 10:45, the patient experienced extreme fatigue and flu-like symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events extreme fatigue and flu-like symptoms were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report from a contactable consumer. A unspecified aged female patient, received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 13May2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in May2021 the patient experienced chills. It was unknown whether therapeutic measures were taken as a result of reported event. The clinical outcome of the event chills was unknown, at this time of this report.  No follow up attempts are needed; Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Mild fever; Fatigue; This is a spontaneous report from a contactable other healthcare professional. An unspecified aged non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 13May2021 at 14:30, as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had history of known allergies to petroleum-based dye. Concomitant medications included ibuprofen (ADVIL) for 2 to 3 times from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14May2021 at 08:00, the patient experienced sore arm, mild fever and fatigue. No therapeutic measures were taken as a result of the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of pain in arm, fever and fatigue were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain
Clinical narrative: Roughly 12-14 hours after receiving second vaccine, intense pain and pressure in and around the left ear.; Roughly 12-14 hours after receiving second vaccine, intense pain and pressure in and around the left ear.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO173) via an unspecified route of administration in the left arm on 13May2021, at 11:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other concomitant medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 21Apr2021 at 11:45 as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021 at 01:00, roughly 12-14 hours after receiving second vaccine, the patient experienced intense pain and pressure in and around the left ear in the middle of that night. Apart from these, the patient had felt no other side effects. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events roughly 12-14 hours after receiving second vaccine, intense pain and pressure in and around the left ear were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, SARS-CoV-2 test
Clinical narrative: Swollen underarm (left armpit); Swollen underarm (left armpit); discomfort in the area; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 07May2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal and cosmetic allergies. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) for allergies on an unknown date and ibuprofen (IBUPROFEN) for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021, the patient experienced swollen underarm (left armpit); discomfort in the area. On 20Mar2021, the patient underwent Oral Swab test for COVID-19 and the result was Negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event swollen underarm (left armpit); discomfort in the area  was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Nausea; Chills; Fevers beginning two days after second dose; This is a spontaneous report from a contactable healthcare professional. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05May2021 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient preciously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date in 2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medications included metformin (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07May2021, the patient experienced nausea, chills and fevers beginning two days after second dose. The patient still experiencing symptoms 7 days later (as reported). The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events nausea, chills and fevers beginning two days after second dose was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; severe body aches; chills; consistent headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 13May2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 21Apr2021 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 02:00, the patient experienced fever, severe body aches, chills and consistent headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, severe body aches, chills and consistent headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus, Rash, Sensitive skin
Clinical narrative: Generally felt like skin is on fire. Skin has also been hypersensitive to all stimulus.; The skin on the roof of my mouth all peeled off.; Hives all over body/ Hives can pop up anywhere on body and last for 20min to an hour then disappear only to pop up again somewhere else/ Most common areas are hands and feet; rash all over body/ This includes even genitals, inside my mouth, etc.; Extreme itch and agony; sore arm; headaches; sleepiness; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 06May2021 at 13:15 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 15Apr2021 at 13:00 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 07May2021,  the patient experienced hives and rash all over body and had extreme itch and agony. The patient felt like skin was on fire and skin had also been hypersensitive to all stimulus. Hives were popping up anywhere on body and lasted for 20min to an hour then disappeared only to pop up again somewhere else. Most common areas were hands and feet but there had been no area of body that patient did not have hives and rash. This included even genitals, inside mouth, etc. The skin on the roof of mouth had all peeled off. The hives and rashes had been going on for 9 days. Although day 8 and 9 had been slightly more tolerable and less frequent. The patient also experienced  the normal sore arm, sleepiness, headaches for the first two days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events hives and rash all over body and had extreme itch and agony, skin was on fire and skin had also been hypersensitive to all stimulus, skin on the roof of mouth had all peeled off were recovering at the time of this report. The clinical outcome of the events normal sore arm, sleepiness, headaches were recovered on 09May2021.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Skin exfoliation, Somnolence, Urticaria
Clinical narrative: Generally felt like skin is on fire. Skin has also been hypersensitive to all stimulus.; The skin on the roof of my mouth all peeled off.; Hives all over body/ Hives can pop up anywhere on body and last for 20min to an hour then disappear only to pop up again somewhere else/ Most common areas are hands and feet; rash all over body/ This includes even genitals, inside my mouth, etc.; Extreme itch and agony; sore arm; headaches; sleepiness; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 06May2021 at 13:15 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 15Apr2021 at 13:00 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 07May2021,  the patient experienced hives and rash all over body and had extreme itch and agony. The patient felt like skin was on fire and skin had also been hypersensitive to all stimulus. Hives were popping up anywhere on body and lasted for 20min to an hour then disappeared only to pop up again somewhere else. Most common areas were hands and feet but there had been no area of body that patient did not have hives and rash. This included even genitals, inside mouth, etc. The skin on the roof of mouth had all peeled off. The hives and rashes had been going on for 9 days. Although day 8 and 9 had been slightly more tolerable and less frequent. The patient also experienced  the normal sore arm, sleepiness, headaches for the first two days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events hives and rash all over body and had extreme itch and agony, skin was on fire and skin had also been hypersensitive to all stimulus, skin on the roof of mouth had all peeled off were recovering at the time of this report. The clinical outcome of the events normal sore arm, sleepiness, headaches were recovered on 09May2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever,; Body aches; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EWO179) via an unspecified route of administration in the left arm on 12May2021 at 10:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included vitiligo, eczema and IBS (irritable bowel syndrome). The patient did not have any allergies to medications, food, or other products. The patient received unspecified concomitant medications within 2 weeks of the vaccination. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EWO170) via an unspecified route of administration in the left arm on 21Apr2021 at 09:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12May2021 at 22:30, 12 hours after the shot was given, the patient experienced fever, body aches, headache and fatigue. No therapeutic measures were taken for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body aches, headache and fatigue were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis, SARS-CoV-2 test
Clinical narrative: I was diagnosed with mono on May 8. Unclear if there is a connection but unusual given social distancing and my age.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 28Mar2021 at 08:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to food, medicine or other products. The patient did not receive any medication within two weeks prior to vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6121 EN6199) via an unspecified route of administration in the left arm on 07Mar2021 at 08:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was diagnosed with mononucleosis on 08May2021. The patient was unclear if there was a connection but unusual given social distancing and her age. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. On 08May2021, the patient underwent COVID- 19 test and the result was negative. The clinical outcome of the event diagnosed with mononucleosis on 08May2021, unclear if there was a connection but unusual given social distancing and patients age was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.