chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: had a positive Covid test after receiving the vaccine; had a positive Covid test after receiving the vaccine; This is a spontaneous report from a contactable nurse (patient) via a Pfizer Sponsored program, Pfizer First Connect. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EH9899, intramuscular in the left arm, on 18Dec2020 at 0.3 mL, single dose for COVID-19 immunization. Medical history included was none. There were no concomitant medications. The patient had a positive Covid test after receiving the vaccine with outcome of unknown. It was reported that the patient got the first dose of the vaccine on 18Dec2020, and tested positive on 28Dec2020 due to some exposure. She asked for any recommendations on the second dose whether or not she could get it. She is scheduled to get it this weekend. The reporter considered the event as non-serious and unrelated to the use of the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 antibody test
Clinical narrative: I just went and got my covid test done with a sore throat; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable nurse (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number and expiry date unknown), via an unspecified route of administration on 16Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her first dose of the COVID vaccine on 16Dec2020, stated that her boyfriend just tested positive. She stated, "I just went and got my covid test done with a sore throat".  She wanted to confirm if she can receive the second dose and also asked if there is a problem with delaying the second dose of the vaccine. The patient underwent lab tests and procedures which included Covid test: unknown results on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Malaise
Clinical narrative: Tired; Feeling unwell; Lethargy; Headache for 12 days post vaccine; This is a spontaneous report from a contactable Physician (patient himself). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection batch/lot no: EK5730 while expiration date: unknown), intramuscularly on the right arm on 21Dec2020 07:30 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  There were no concomitant medications reported. The patient previously took meropenem and experienced allergies. On 21Dec2020, at 03:30PM (15:00), patient experienced tired, feeling unwell, lethargy, and headache for 12 days post vaccine. No treatment for adverse events were received. Outcome of the events tired, feeling unwell, lethargy, and headache for 12 days post vaccine was not recovered. Patient has no COVID prior vaccination and has not received any other vaccine within 4 weeks prior to COVID vaccine. Since vaccination, patient was not tested for COVID-19. The COVID 19 vaccine was administered in the hospital. The events were assessed as non-serious. The events resulted to physician office visit.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site mass, Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: The injection site was itchy; injection site was itchy, then over time grew into a welt; It is now 10 days post injection, the welt is warm, hard and about 4.5mm and getting bigger each day; It is now 10 days post injection, the welt is warm, hard and about 4.5mm and getting bigger each day; This is a spontaneous report from a contactable other hcp (patient). A 49-year-old male patient received the first dose of BNT162B2 (Lot number: EK5730), intramuscular on 27Dec2020 12:00 at single dose in the left arm for COVID-19 immunization. Medical history included allergies: Sulfur and Acrylates from an unknown date. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), loratadine (CLARITINE), omeprazole, metoprolol, ibuprofen (ADVIL) and paracetamol (TYLENOL). The patient previously took cefalexin (KEFLEX) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the injection site was itchy, then over time grew into a welt. It is now 10 days post injection, the welt is warm, hard and about 4.5mm and getting bigger each day. He stated that he is seeing his physician tomorrow. Treatment for the events were unknown. The patient underwent lab tests and procedures which included Nasal Swab: negative on 31Dec2020. The outcome of the events was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: fever; chills; extreme muscle aches; constant nausea; Right deltoid was swollen and hot; Right deltoid was swollen and hot; This is a spontaneous report from a contactable healthcare professional (patient). A 59-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL1284), via an unspecified route of administration on the right deltoid on 04Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included high blood pressure (BP), gout, and shingles. The patient also had allergies with minocycline. Concomitant medications included allopurinol (ALLOPURINOL), amlodipine (AMLODIPINE), and valaciclovir hydrochloride (VALTREX).  The patient previously received the first dose of bnt162b2 (lot/batch number: EH9899) for COVID-19 immunization on 18Dec2020 10:00 AM on the left arm and no reaction. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. The patient received 2nd dose of vaccine 04Jan2021. When the patient woke up on 05Jan2021 05:00, she had fever, chills, extreme muscle aches and constant nausea which continued until the morning hours of 06Jan2021. It was also reported that the patient's right deltoid was swollen and hot noted on 05Jan2021. Outcome of the events of right deltoid was swollen and hot were unknown while the patient recovered from the remaining events on 06Jan2021.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: fever; chills; extreme muscle aches; constant nausea; Right deltoid was swollen and hot; Right deltoid was swollen and hot; This is a spontaneous report from a contactable healthcare professional (patient). A 59-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL1284), via an unspecified route of administration on the right deltoid on 04Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included high blood pressure (BP), gout, and shingles. The patient also had allergies with minocycline. Concomitant medications included allopurinol (ALLOPURINOL), amlodipine (AMLODIPINE), and valaciclovir hydrochloride (VALTREX).  The patient previously received the first dose of bnt162b2 (lot/batch number: EH9899) for COVID-19 immunization on 18Dec2020 10:00 AM on the left arm and no reaction. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. The patient received 2nd dose of vaccine 04Jan2021. When the patient woke up on 05Jan2021 05:00, she had fever, chills, extreme muscle aches and constant nausea which continued until the morning hours of 06Jan2021. It was also reported that the patient's right deltoid was swollen and hot noted on 05Jan2021. Outcome of the events of right deltoid was swollen and hot were unknown while the patient recovered from the remaining events on 06Jan2021.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Very minor light headedness the day after injection; typical sore arm; This is a spontaneous report from a contactable other HCP (patient). A 47-year-old male patient received the first dose of BNT162B2 (Lot number: EL1284), via an unspecified route of administration on Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. Medical history included high BP and Pre-diabetic, both from unknown dates. The patient's concomitant medications were not reported.  The patient previously took codeine and experienced allergies. The patient experienced very minor light headedness the day after injection on Jan2021. It lasted throughout the day. Also reported typical sore arm on Jan2021. Neither of which required any medical attention. The patient did not receive any treatment for the events. 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 outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Pain, Somnolence
Clinical narrative: generalized body aches; felt tired/exhaustion; sleepy; abdominal cramp; an episode of loose bowel movement; This is a spontaneous report from a contactable Physician (patient).  A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (vaccine location: arm left) on 15Dec2020 16:00 at single dose and the second dose via an unspecified route of administration (vaccine location: arm left) (lot number: EL1284; expiration date not provided) on 05Jan2021 15:45 at single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide. It was reported that in the evening of 05Jan2021 at 19:30, the patient felt tired and sleepy. Patient also had abdominal cramp followed by an episode of loose bowel movement. The tiredness and exhaustion continued until the following morning associated with generalized body aches. It was reported that patient was feeling better by 12:00 noon the following day. It was reported that no treatment was received for the adverse events. It was also reported that prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering/resolving.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache
Clinical narrative: mild brain fog-feeling "stupid" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place/ "stupid" with brain fog that I called in; mild fatigue; mild intermittent headache; mild intermittent headache/ only mild joint ache in knees; This is a spontaneous report from a contactable other health care professional. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 04Jan2021 11:30 at single dose at right arm for COVID-19 immunization.  Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included beclometasone dipropionate (QVAR), and metoprolol. On 04Jan2021 15:30, noted starting around 4 hours after vaccine, the patient experienced mild fatigue, mild intermittent headache, mild intermittent ache in knee joints. The patient was unsure if they were vaccine related but became a little more intense as the evening went on (next 5 hours) but still overall were mild, but enough for the patient to determine they seemed related to the vaccine. Also noted about 6 hours after vaccine, on 04Jan2021 17:30, mild brain fog-feeling "stupid" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place. The patient went to bed about 8-9 hours after vaccine (8pm). The patient usually gets up at 4:45-5am. She was so tired the next morning and "stupid" with brain fog that she called in. She wasn't uncomfortable per se, no headache the next day, only mild joint ache in knees, fatigue and brain fog. No serious reactions. The outcome of the events was recovered on an unspecified date in Jan2021. The patient did not receive treatment for the events.   Information about lot/ batch number is requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Chills, Fatigue, Headache, Hyperaesthesia
Clinical narrative: Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Paraesthesia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: Feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day, her entire body ached like that caused by the flu; Feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day, her entire body ached like that caused by the flu; This is a spontaneous report from contactable other healthcare professional (patient herself). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration at the left arm on 03Jan2021, 10:00AM at a single dose for COVID-19 immunization. The patient had no medical history and had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, 07:00 AM, the patient experienced feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day (no time reported), her entire body ached like that caused by the flu. No treatment was received for the events. Outcome of the events at the time of last observation in Jan2021 was reported as recovered. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.  Information on the batch/lot number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This is a spontaneous report from a non-contactable other healthcare professional. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH19899, expiry date not reported), intramuscular on 04Jan2021 11:00 at a single dose on right arm for COVID-19 immunization. Medical history included Prior type 2 diabetic, high cholesterol, and an OTC allergy. Concomitant medication included semaglutide (OZEMPIC), sertraline (SERTRALINE), fish oil (OMEGA 3 ELITE), biotin (BIOTIN), ergocalciferol (VIT D), l-lysine [lysine] (L-LYSINE [LYSINE]), chromium (CHROMIUM). The patient previously took l-lysine [lysine] and experienced allergies. The patient experienced extreme fatigue on 05Jan2021 07:30. No treatment received for the adverse event. The outcome of the event was recovering. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was Workplace 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. The event was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Frequent unifocal premature ventricular contractions; This is a spontaneous report from a contactable other healthcare professional. A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 21Dec2020 09:30 at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included fish oil (FISH OIL), zinc (ZINC). The patient previously took amoxicillin and experienced allergies. The patient experienced frequent unifocal premature ventricular contractions on 01Jan2021 12:00 AM. Patient reportedly lost his card. No treatment received for the adverse event. The outcome of the event was not recovered. The event was assessed as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: mild body aches; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EJ1685, intramuscular at left arm from 16Dec2020 11:30 to 16Dec2020 11:30 at a single dose then (lot number: EK9231) via an unspecified route of administration at left arm from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history included supraventricular tachycardia. Concomitant medication included propranolol. After first dose on Dec2020, the patient only had pain at the injection site. After the second dose of the vaccine on 06Jan2021, the patient had pain at the injection site as well as mild body aches, chills and a fever of 101.5. The patient dis not received any treatment for the adverse events. The outcome of th events was recovering.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: body ache; Headache; soreness in his arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reported for himself. A 52-year-old male patient intramuscularly received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), first dose on 15Dec2020 21:00 and second dose on 05Jan2021 09:00 at single dose at deltoid left for preventative. Medical history and concomitant medications were reported as none. The patient experienced body ache on 06Jan2021 with outcome of unknown, soreness in his arm on 05Jan2021 with outcome of recovering, headache on 06Jan2021 with outcome of not recovered.  He was asking if he can take paracetamol (TYLENOL) for body ache and soreness in his arm following administration.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Gait disturbance, Insomnia
Clinical narrative: intense chills; uncontrollable shaking; Could not get warm; Had trouble walking; Had trouble sleeping; Felt warm rest of night; Did not have a chance to take my temperature but probably had a fever; This is a spontaneous report from a contactable healthcare professional.  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration, at the left arm on Jan2021 09:15 at a single dose for COVID-19 immunization at a hospital.  Medical history included obesity.  Concomitant medications included ibuprofen (ADVIL), methylphenidate & unspecified multivitamins.  The patient previously took tetracycline and experienced allergies. On 06Jan2021 01:00, the patient woke up with intense chills and uncontrollable shaking, could not get warm or stop the shaking, had trouble walking or holding a glass of water shaking was so intense. Patient took ibuprofen helped and symptoms improved after 1-2 hours. The patient also had trouble sleeping and felt warm rest of night. Did not have a chance to take her temperature but probably had a fever. Overslept and missed first work meeting. Patient felt ok by 06Jan2021, 9:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient recovered from the events on 06Jan2021, 9:30.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: intense chills; uncontrollable shaking; Could not get warm; Had trouble walking; Had trouble sleeping; Felt warm rest of night; Did not have a chance to take my temperature but probably had a fever; This is a spontaneous report from a contactable healthcare professional.  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration, at the left arm on Jan2021 09:15 at a single dose for COVID-19 immunization at a hospital.  Medical history included obesity.  Concomitant medications included ibuprofen (ADVIL), methylphenidate & unspecified multivitamins.  The patient previously took tetracycline and experienced allergies. On 06Jan2021 01:00, the patient woke up with intense chills and uncontrollable shaking, could not get warm or stop the shaking, had trouble walking or holding a glass of water shaking was so intense. Patient took ibuprofen helped and symptoms improved after 1-2 hours. The patient also had trouble sleeping and felt warm rest of night. Did not have a chance to take her temperature but probably had a fever. Overslept and missed first work meeting. Patient felt ok by 06Jan2021, 9:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient recovered from the events on 06Jan2021, 9:30.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; aches; chills; headache; This is a spontaneous report from a contactable consumer (patient himself). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration at the left arm on 05Jan2021 13:30 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 from an unknown date. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021, 07:00 PM, the patient experienced fever, aches, chills, and headache. No treatment was received for the events. Outcome of the events at the time of last observation was reported as recovering. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: He tested positive last Tuesday for SARS-Cov-2; He tested positive last Tuesday for SARS-Cov-2; This is a spontaneous report from a Pfizer Sponsored Program, Pfizer First Connect via a contactable other health professional (HCP) (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient tested positive last Tuesday (05Jan2021) for SARS-Cov-2 and the patient wanted to know if he could receive his second dose of vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea
Clinical narrative: The 'left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away'; she felt 'a wave of nausea; This is a spontaneous report from a contactable consumer for herself. This 66-year-old female patient received the first dose of BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient stated 3 hours after having received the vaccine, she felt 'a wave of nausea that went away just as fast as it had hit' her. The left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away. This was on the same side that she got the vaccine. She had never experienced anything like that. The outcome of event face went numb was recovered. The outcome of other events was unknown.   Information about Batch/Lot number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eyelid pain, Fatigue, Headache, Myalgia
Clinical narrative: tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Swelling of eyelid
Clinical narrative: tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm; This is a spontaneous report from a contactable other HCP. An adult patient of an unspecified gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular in left arm on 05Jan2021 20:00 at a single dose for COVID-19 Immunization. Medical history included Traumatic brain injury, pacemaker, A-Fib and allergy to amoxicillin, and had covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2, lot number EH9899 on 15Dec2020 at 16:15, intramuscular in right arm for COVID-19 immunization The patient experienced sore left arm on 05Jan2021 20:00 with outcome of recovering. there was no treatment required for the said event. The event was assessed as non-serious. Since the vaccination, the patent has the patient not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Lip pruritus, Off label use, Paraesthesia oral, Product use issue
Clinical narrative: she was a lactating; she was a lactating; Have some side effects last night from Covid Vaccine, got hives right above my breast; she has really bad Asthma/because of that she has "shortness of breath"; Felt like itchy like tingling on my lip; Felt like itchy like tingling on my lip; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (lot#: EK5730, expiration date: 31Mar2021), via an unspecified route of administration at arm left, on 02Jan2021 04:00, at single dose, for COVID-19 immunization, and salbutamol (ALBUTEROL) via an unspecified route of administration, from an unspecified date, at unknown dose, for asthma. Medical history included ongoing asthma, and ongoing very unslept person, and she was a lactating for she has a baby about year like 13 months ago (2019) so she is still producing milk. Concomitant medication not provided. The patient thought she has some side effects last night from her Covid Vaccine, so she got it yesterday around 4 O'clock and around 10, 10:30 she got hives on her chest, right above her breast, and about an hour after she got the vaccine, she thought it was just her asthma, so she has really bad Asthma, her Asthma kept like, she kept Asthma and because of that she has "shortness of breath" (not clarified), so she was just taking her Inhaler (unspecified medication) but then like last night wherever after that her "bedtime" (not clarified) she got hives on her chest and it felt like itchy like tingling on her lip, she was very unslept person so she just took some Benadryl (treatment) today she woke up fine, she feel fine but she was just thinking it would be okay to take her second dosage (Covid vaccine). When probed if visited to any physician office/ emergency Room for the treatment, consumer stated she just at home, she just took Benadryl. The action taken in response to the events for salbutamol was unknown. The outcome of the events was recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: she was a lactating; she was a lactating; Have some side effects last night from Covid Vaccine, got hives right above my breast; she has really bad Asthma/because of that she has "shortness of breath"; Felt like itchy like tingling on my lip; Felt like itchy like tingling on my lip; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (lot#: EK5730, expiration date: 31Mar2021), via an unspecified route of administration at arm left, on 02Jan2021 04:00, at single dose, for COVID-19 immunization, and salbutamol (ALBUTEROL) via an unspecified route of administration, from an unspecified date, at unknown dose, for asthma. Medical history included ongoing asthma, and ongoing very unslept person, and she was a lactating for she has a baby about year like 13 months ago (2019) so she is still producing milk. Concomitant medication not provided. The patient thought she has some side effects last night from her Covid Vaccine, so she got it yesterday around 4 O'clock and around 10, 10:30 she got hives on her chest, right above her breast, and about an hour after she got the vaccine, she thought it was just her asthma, so she has really bad Asthma, her Asthma kept like, she kept Asthma and because of that she has "shortness of breath" (not clarified), so she was just taking her Inhaler (unspecified medication) but then like last night wherever after that her "bedtime" (not clarified) she got hives on her chest and it felt like itchy like tingling on her lip, she was very unslept person so she just took some Benadryl (treatment) today she woke up fine, she feel fine but she was just thinking it would be okay to take her second dosage (Covid vaccine). When probed if visited to any physician office/ emergency Room for the treatment, consumer stated she just at home, she just took Benadryl. The action taken in response to the events for salbutamol was unknown. The outcome of the events was recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; loose stools; This is a spontaneous report from a contactable other nurse. A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in left arm on 23Dec2020 14:45 at a single dose for covid-19 immunization. The vaccination was done in a hospital. Medical history included Acid reflux, depression, and B12 deficiency. The patient was not diagnosed COVID-19 prior to vaccination. Concomitant medication included drospirenone, ethinylestradiol (SYEDA), cyanocobalamin (B12-VITAMIIN), and venlafaxine hydrochloride (EFFEXOR). The patient experienced nausea and loose stools on 03Jan2021 04:00. The outcome of the events was not recovered. The event was assessed as non-serious. The patient was not tested for COVID-19 post vaccination. There was no treatment for the said events.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy supraclavicular nodes, left side; This is a spontaneous report from a contactable physician. A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140)  via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history included Known allergies with Penicillin. The patient was not pregnant. The patient was not diagnosed with COVID-19prior to vaccination. There were no concomitant medications. On 21Dec2020, the patient experienced Lymphadenopathy supraclavicular nodes, left side starting day 3 post vaccine and persistent to current with outcome of recovering. There was no treatment reported for the event. The event was assessed as non-serious. The patient was not tested for COVID-19 post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: she received the COVID-19 vaccine and the next day she tested positive for the viral infection; she received the COVID-19 vaccine and the next day she tested positive for the viral infection; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient was tested on 02Jan2021, and did not get the results till 06Jan2021 and tested positive. The patient wanted to know if she could have any side effects if she received the COVID-19 vaccine and the next day she tested positive for the viral infection. She is unsure of when she contracted the infection. The outcome was unknown.   Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Formication, Headache, Nausea
Clinical narrative: Severe fatigue; Headache; Body aches; Feel like my skin is crawling; Nauseous; Arm is very sore; I feel like I'm dying; This is a spontaneous report from a contactable healthcare professional. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine), via an unspecified route of administration left arm on an unspecified date (unknown lot number and expiration date) at a single dose; and via an unspecified route of administration left arm on 04Jan2021 18:00 [06:00 PM] (lot number: Eh9899; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had known allergies to amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine administered in a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Jan2021 17:00 [05:00 PM], the patient experienced severe fatigue, headache and body aches- feel like her skin is crawling and was hit by a freight train. The patient has never had a reaction like this before. The patient was also nauseous, and her arm is very sore, but she doesn't even notice since she feeling like she's dying. The patient has not been tested for COVID-19 since the vaccination. The treatment received by the patient for the adverse event included paracetamol (TYLENOL)/ibuprofen around the clock (OTC medication). The patient reported that the events was non-serious. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event was not resolved.  The following information on the batch/lot number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe fatigue; Headache; Body aches; Feel like my skin is crawling; Nauseous; Arm is very sore; I feel like I'm dying; This is a spontaneous report from a contactable healthcare professional. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine), via an unspecified route of administration left arm on an unspecified date (unknown lot number and expiration date) at a single dose; and via an unspecified route of administration left arm on 04Jan2021 18:00 [06:00 PM] (lot number: Eh9899; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had known allergies to amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine administered in a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Jan2021 17:00 [05:00 PM], the patient experienced severe fatigue, headache and body aches- feel like her skin is crawling and was hit by a freight train. The patient has never had a reaction like this before. The patient was also nauseous, and her arm is very sore, but she doesn't even notice since she feeling like she's dying. The patient has not been tested for COVID-19 since the vaccination. The treatment received by the patient for the adverse event included paracetamol (TYLENOL)/ibuprofen around the clock (OTC medication). The patient reported that the events was non-serious. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event was not resolved.  The following information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Upper respiratory tract congestion
Clinical narrative: Body aches; Head congestion; Fatigue; This is a spontaneous report from a non-contactable consumer. An adult female patient received 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. On an unspecified date, the patient had body aches; head congestion; and fatigue. The outcome of the events, body aches, head congestion and fatigue, was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.