chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Ear discomfort, Feeling hot, Influenza like illness, Nasal congestion
Clinical narrative: feels like he's a little warm; persisting flu like symptoms; congestion in nose; pressure build up in ears; throat not 100 percent; soreness in injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 26Feb2021 12:00 (Lot number: EN6200) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Feb2021, outcome "recovering", described as "soreness in injection site"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Mar2021, outcome "not recovered", described as "persisting flu like symptoms"; NASAL CONGESTION (non-serious) with onset 03Mar2021, outcome "not recovered", described as "congestion in nose"; EAR DISCOMFORT (non-serious) with onset 03Mar2021, outcome "not recovered", described as "pressure build up in ears"; PHARYNGEAL DISORDER (non-serious) with onset 03Mar2021, outcome "not recovered", described as "throat not 100 percent"; FEELING HOT (non-serious), outcome "not recovered", described as "feels like he's a little warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, influenza like illness, nasal congestion, ear discomfort, pharyngeal disorder, feeling hot.  Additional information: The patient had not received any other vaccines within 4 weeks prior COVID vaccine. Ibuprofen, DAYQUIL, and NYQUIL as needed were taken as treatment of the events.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal disorder, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: feels like he's a little warm; persisting flu like symptoms; congestion in nose; pressure build up in ears; throat not 100 percent; soreness in injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 26Feb2021 12:00 (Lot number: EN6200) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Feb2021, outcome "recovering", described as "soreness in injection site"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Mar2021, outcome "not recovered", described as "persisting flu like symptoms"; NASAL CONGESTION (non-serious) with onset 03Mar2021, outcome "not recovered", described as "congestion in nose"; EAR DISCOMFORT (non-serious) with onset 03Mar2021, outcome "not recovered", described as "pressure build up in ears"; PHARYNGEAL DISORDER (non-serious) with onset 03Mar2021, outcome "not recovered", described as "throat not 100 percent"; FEELING HOT (non-serious), outcome "not recovered", described as "feels like he's a little warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, influenza like illness, nasal congestion, ear discomfort, pharyngeal disorder, feeling hot.  Additional information: The patient had not received any other vaccines within 4 weeks prior COVID vaccine. Ibuprofen, DAYQUIL, and NYQUIL as needed were taken as treatment of the events.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea
Clinical narrative: I felt very nauseous 3 hours after the injection; I woke up feeling like I was in a zone or fog this morning. I feel very odd/weird today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 16:45 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; ZINC. The following information was reported: NAUSEA (non-serious) with onset 08Mar2021 19:00, outcome "recovering", described as "I felt very nauseous 3 hours after the injection"; FEELING ABNORMAL (non-serious) with onset 08Mar2021 19:00, outcome "recovering", described as " I woke up feeling like I was in a zone or fog this morning. I feel very odd/weird today". Therapeutic measures were not taken as a result of nausea, feeling abnormal.  Additional Information: The vaccine was administered at a hospital. The patient has taken multivitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no known allergies and prior to vaccination was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Vaccination site pain
Clinical narrative: Sore arm at injection site; felt jittery; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 08Mar2021 01:45 (Lot number: EL3247) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hay fever" (unspecified if ongoing). Concomitant medications included: FLONASE; ZYRTEC. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Mar2021 06:30, outcome "recovering", described as "Sore arm at injection site"; FEELING JITTERY (non-serious) with onset 09Mar2021 06:30, outcome "recovering", described as "felt jittery". Therapeutic measures were not taken as a result of vaccination site pain, feeling jittery. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: very tired; slept for 2 days after getting her vaccination; This is a spontaneous report received from a contactable consumer from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "very tired"; HYPERSOMNIA (non-serious), outcome "unknown", described as "slept for 2 days after getting her vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 12:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "headache".  Additional information: Patient was reported to be aged 62 and was asking if she can take 2 Tylenol post vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: pain on the left back part the body; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (reported as patient's age: 40; unit: unspecified) received BNT162B2 (COMIRNATY, Solution for injection), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "tumor on left kidney" (ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain on the left back part the body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: minor soreness at the injection site; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 11Feb2021 (Lot number: EM9810) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes Type 2" (ongoing), notes: doctor stated that patient really do not fit either profile. Concomitant medication(s) included: PIOGLITAZONE; METFORMIN; LISINOPRIL; AREDS 2. Past drug history included: Opioids, reaction(s): "allergies", "nauseous". Vaccination history included: Flu vaccine (4 hours after a Flu Vaccine that last almost exactly 24 hours), for influenza immunisation, reaction(s): "chills", "low grade fever (100-101)". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "minor soreness at the injection site". Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Poor quality sleep
Clinical narrative: terrible headache; body fatigue which kept me awake all night; kept me awake all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 14:30 (Lot number: EN6200) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: HEADACHE (non-serious) with onset 24Feb2021 21:00, outcome "not recovered", described as "terrible headache"; FATIGUE (non-serious) with onset 24Feb2021 21:00, outcome "not recovered", described as "body fatigue which kept me awake all night"; POOR QUALITY SLEEP (non-serious) with onset 24Feb2021 21:00, outcome "not recovered", described as "kept me awake all night". The events "terrible headache", "body fatigue which kept me awake all night" and "kept me awake all night" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache, fatigue, poor quality sleep. Additional information: However, it was also reported that the patient experienced the events five hours after the vaccination (probably discrepant). Treatment with Ibuprofen was taken as a result of the events. It was reported that the headaches were still there, and the patient was still feeling tired every day. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Parosmia
Clinical narrative: had a weird feeling in body; unpleasant medicinal taste that also was accompanied by a similar smell; unpleasant medicinal taste that also was accompanied by a similar smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 IMMUNISATION. The following information was reported: FEELING ABNORMAL (non-serious) with onset 20Feb2021, outcome "unknown", described as "had a weird feeling in body"; DYSGEUSIA (non-serious), PAROSMIA (non-serious) all with onset 20Feb2021, outcome "not recovered" and all described as "unpleasant medicinal taste that also was accompanied by a similar smell".  Additional information: On 20Feb2021, it was reported that patient received the 2nd COVID-19 vaccination and within 20 mins., had a weird feeling in body and the forward portion of tongue had a unpleasant medicinal taste that also was accompanied by a similar smell. Both these subsided in a few hours. Then, on 01Mar2021 it was back and has been with the patient (to varying degrees) up to this moment. The sensation was especially aggravated by toothpaste, cleaning product vapors and chewing tobacco, but was always lingering in the background.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: little headache or fuzziness in her head; little headache or fuzziness in her head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: E19262) at the age of 85 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset Feb2021, outcome "unknown" and all described as "little headache or fuzziness in her head".  Additional information: Other Products, Patient History and Investigation Assessment were Not Provided. The patient says that right after the first one, she just had a little headache or fuzziness in her head, not a headache, right after. The patient Weight was 97-98lbs.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  Additional information: The patient is worried about getting the second dose. The patient has read that side effects could be worse in second dose and she wanted to know if she should get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: slightly tender at the site of injection; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Lot number: EL3248) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "slightly tender at the site of injection"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: The patient reported that she had no side effects with the 1st dose other than slightly tender at the site of injection, but she'd say basically no side effects and that she was unsure of the time of the sore arm with the first shot, she thought it was the next day.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: full body aches; nausea; headache; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 09:00 (Lot number: EL3247) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EL 3247, administration time: 09:00, vaccine location: Left arm), administration date: 03Feb2021, when the patient was 28 years old, for COVID-19 immunisation, reaction(s): "enlarged lymph node located on top of my clavicle bone that moved independently". The following information was reported: PAIN (non-serious) with onset 25Feb2021 01:00, outcome "recovered", described as "full body aches"; NAUSEA (non-serious) with onset 25Feb2021 01:00, outcome "not recovered", described as "nausea"; HEADACHE (non-serious) with onset 25Feb2021 01:00, outcome "recovered", described as "headache".  Additional Information: The vaccine was administered in a workplace clinic. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's other medications in two weeks was birth control. Since vaccination, the patient has not been tested for COVID-19. It was reported that on an unspecified date, the body aches had seized but the nausea continued into the next day and the headache was persistent until "Saturday". The patient reported that the lymph node was still enlarged but feels much smaller and when she had visited her primary care she said it felt to be as big as 1 millimeter.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 15:00 (Lot number: EL9264) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not take any other medications received within 2 weeks of vaccination. The patient has no known allergies and prior to vaccination was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Photopsia, Tension headache, Visual impairment
Clinical narrative: head feeling like it is in a vice, then brain fog; head feeling like it is in a vice, then brain fog; being tired; seeing spots before her eyes; in the dark seeing flashes of light; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TENSION HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset 02Mar2021, outcome "unknown" and all described as "head feeling like it is in a vice, then brain fog"; FATIGUE (non-serious) with onset 02Mar2021, outcome "unknown", described as "being tired"; VISUAL IMPAIRMENT (non-serious) with onset 02Mar2021, outcome "unknown", described as "seeing spots before her eyes"; PHOTOPSIA (non-serious) with onset 02Mar2021, outcome "unknown", described as "in the dark seeing flashes of light".  Additional information: This report was received via Pfizer-sponsored program. The course of the events was as follows: Patient had her first COVID-19 vaccine last Monday, on Tuesday complaints of head feeling like it was in a vice, then brain fog, being tired, seeing spots before her eyes, and in the dark seeing flashes of light.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: chills; T max 100 F; headache; Aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician).  A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single , lot number: EL9262, intramuscular, administration time: 08:15), administration date: 25Jan2021, when the patient was 39 years old, for Covid-19 immunisation, reaction(s): "headache/ massive headache", "chills/ shivers", "Some fever 98.6/ temperature probably  went up to 98-99", "bodyaches", "sore arm". The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills"; BODY TEMPERATURE INCREASED (non-serious), outcome "recovered", described as "T max 100 F"; HEADACHE (non-serious), outcome "recovered", described as "headache"; PAIN (non-serious), outcome "recovered", described as "Aches"; FATIGUE (non-serious), outcome "recovered", described as "fatigue". The events "chills", "t max 100 f", "headache", "aches" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, body temperature increased, headache, pain, fatigue.  Additional Information: The vaccine was administered in a Public Health Department. It was reported that about 29 hours after vaccines symptoms/signs abated. The events did not result to emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: chills; T max 100 F; headache; Aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician).  A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single , lot number: EL9262, intramuscular, administration time: 08:15), administration date: 25Jan2021, when the patient was 39 years old, for Covid-19 immunisation, reaction(s): "headache/ massive headache", "chills/ shivers", "Some fever 98.6/ temperature probably  went up to 98-99", "bodyaches", "sore arm". The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills"; BODY TEMPERATURE INCREASED (non-serious), outcome "recovered", described as "T max 100 F"; HEADACHE (non-serious), outcome "recovered", described as "headache"; PAIN (non-serious), outcome "recovered", described as "Aches"; FATIGUE (non-serious), outcome "recovered", described as "fatigue". The events "chills", "t max 100 f", "headache", "aches" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, body temperature increased, headache, pain, fatigue.  Additional Information: The vaccine was administered in a Public Health Department. It was reported that about 29 hours after vaccines symptoms/signs abated. The events did not result to emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: whole body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "whole body ache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she had every symptom/ she was wondering what the chances are that she could have COVID-19 again; she had every symptom/ she was wondering what the chances are that she could have COVID-19 again; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 08Mar2021 (Lot number: EN6198) at the age of 39 years as dose 2, single; and administration date Feb2021 (reported as either 11Feb2021 or 12Feb2021) (Lot number: EN5318) as dose 1, single both for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: The patient had her second shot of the COVID-19 vaccine on 08Mar2021. She stated that she woke up at 03:00 in the morning (on 09Mar2021) and she had every symptom. She was wondering what the chances are that she could have COVID-19 again, or if these symptoms were all from the shot. She previously had COVID-19 in Jan2021. The events were reported as non-serious by the consumer.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain
Clinical narrative: Pain in deep in arm pit that radiates down to breast tissue; Pain in deep in arm pit that radiates down to breast tissue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY PAIN (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Pain in deep in arm pit that radiates down to breast tissue". The event "pain in deep in arm pit that radiates down to breast tissue" and "pain in deep in arm pit that radiates down to breast tissue" was evaluated at the physician office visit.  Additional information: The course of the event was as follows: Pain in deep in arm pit that radiates down to breast tissue. Patient experienced pain six days after first vaccine injection. Saw her physician on day two of pain. Her HCP explained that it could be an S/E of the vaccine. Vaccine injection site was on same side as patient reported pain. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Pain
Clinical narrative: headache; sore arm at injection site; Generalized body aches/soreness; hot flashes; chills (but no fever); feeling tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 13:45 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Celiac (gluten allergy)" (unspecified if ongoing); "Known allergies: Celiac (gluten allergy)" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION. Vaccination history included: Bnt162b2 (Dose 1, Administration time=10:00 AM, Vaccine location= Right arm.), administration date: 11Feb2021, when the patient was 35 years old, for COVID-19 immunisation, reaction(s): "sore arm", "headache overnight". The following information was reported: HEADACHE (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "sore arm at injection site"; PAIN (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "Generalized body aches/soreness"; HOT FLUSH (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "hot flashes"; CHILLS (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "chills (but no fever)"; FATIGUE (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "feeling tired". Therapeutic measures were not taken as a result of headache, vaccination site pain, pain, hot flush, chills, fatigue. Additional information: The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: headache; sore arm at injection site; Generalized body aches/soreness; hot flashes; chills (but no fever); feeling tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 13:45 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Celiac (gluten allergy)" (unspecified if ongoing); "Known allergies: Celiac (gluten allergy)" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION. Vaccination history included: Bnt162b2 (Dose 1, Administration time=10:00 AM, Vaccine location= Right arm.), administration date: 11Feb2021, when the patient was 35 years old, for COVID-19 immunisation, reaction(s): "sore arm", "headache overnight". The following information was reported: HEADACHE (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "sore arm at injection site"; PAIN (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "Generalized body aches/soreness"; HOT FLUSH (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "hot flashes"; CHILLS (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "chills (but no fever)"; FATIGUE (non-serious) with onset 07Mar2021 12:00, outcome "recovering", described as "feeling tired". Therapeutic measures were not taken as a result of headache, vaccination site pain, pain, hot flush, chills, fatigue. Additional information: The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Illness, Vomiting
Clinical narrative: felt sick; vomited; headache; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt sick"; VOMITING (non-serious), outcome "unknown", described as "vomited"; HEADACHE (non-serious), outcome "unknown", described as "headache"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional information: It was reported that the patient received the first dose of COVID-19 vaccine last Saturday (a week ago). The patient felt sick and vomited a week after, got a very bad headache and dizziness. The patient was asking if it was a possible reaction of the vaccine because she only experienced the side effects a week after receiving the first dose. The patient is scheduled for her 2nd dose on 20Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Confusional state, Feeling abnormal
Clinical narrative: feeling very confused; back was bothering her; brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 01Jan2021 13:00 (Lot number: EN5318) at the age of 80 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "blood thinner" (unspecified if ongoing); "hair and nails" (unspecified if ongoing); "stomach heart burn" (unspecified if ongoing); "heart" (unspecified if ongoing). Concomitant medication(s) included: MEDROXYPROGESTERONE, start date: 1989 (ongoing); CLOPIDOGREL taken for anticoagulant therapy (ongoing); ESTRADIOL, start date: 1989 (ongoing); BIOTIN taken for alopecia (ongoing); PANTOPRAZOLE taken for dyspepsia; IRBESARTAN taken for blood pressure measurement; BUSPIRONE, start date: 1989; CARVEDILOL taken for cardiac discomfort, start date: 2012.  The following information was reported: BACK PAIN (non-serious) with onset 03Feb2021, outcome "recovered" (04Feb2021), described as "back was bothering her"; FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "not recovered", described as "brain fog"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "feeling very confused".  Additional information: After the first dose, the patient noticed that her back was bothering. The patient went to an acupuncturist and the acupuncturist told her she noticed people who have chronic pain are having flare ups after the vaccine. The back pain was resolved after seeing the acupuncturist. After the second shot, she went to the acupuncturist again and mentioned that she was having brain fog and feeling very confused when she was driving.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273978 same patient/reporter/vaccine, similar events, and different dose
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: flare up of chronic pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "flare up of chronic pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: The nurse who gave her the shot said her father also had a flare up of chronic pain and so did her girlfriend; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "The nurse who gave her the shot said her father also had a flare up of chronic pain and so did her girlfriend".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: 3 inch long red itchy area at the injection site; 3 inch long red itchy area at the injection site; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 17Feb2021 11:30 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis", start date: 2018 (ongoing); "a ton of allergies to medicines" (ongoing). The patient took concomitant medications. Vaccination history included: Flu vaccine, administration date: Nov2020, for influenza immunisation, reaction(s): "No adverse effects". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 25Feb2021, outcome "recovering" and all described as "3 inch long red itchy area at the injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pruritus. Additional information: The patient received cortisone-10 cream as treatment for the events on 26Feb2021 (only once), but did not use it again as she said that it didn't help and it wasn't unbearable that she needed to continue using it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Paraesthesia
Clinical narrative: arm / thumb and finger next to it / very painful; very painful from about the shoulder down it gets to about the elbow; tingling of her thumb and finger next to it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (Lot number: EM9810) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL. Vaccination history included: Bnt162b2 (Lot number: EL3247 as dose 1, single), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Feb2021, outcome "unknown", described as "arm / thumb and finger next to it / very painful "; ARTHRALGIA (non-serious) with onset 19Feb2021, outcome "unknown", described as "very painful from about the shoulder down it gets to about the elbow"; PARAESTHESIA (non-serious) with onset 19Feb2021, outcome "unknown", described as "tingling of her thumb and finger next to it". Therapeutic measures were taken as a result of pain in extremity, arthralgia, paraesthesia.  Additional information: The patient was taking unspecified blood pressure medicine. It was further reported that the patient's arm, was very painful from about the shoulder down it gets to about her elbow. Her elbow becomes very sore and then it shoots down her arm. The patient experienced tingling not numb but tingling of her thumb and finger next to it. Only those two fingers, the rest of her hand and other fingers were not affected. This tingling was since 19Feb2021 and it doesn't hurt at all the time but when it does, it would wake her up from sleep and it would be very painful. It will shoot pain down the arm. The patient was using the arm as she normally have but did not see this side effects when reading and talking to other folks, so she just thought maybe it should be documented. Patient took some ibuprofen occasionally but not very often and seeing a chiropractor.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Headache; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 14:45 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Sore throat". Therapeutic measures were not taken as a result of headache, oropharyngeal pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: Rapid heart beat; My heart keeps beating kind of fast and it has been going on for like two hours; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACCINE), administration date 09Mar2021 10:50 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: on medication; "allergic to Lysol Spray" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LOSARTAN; ATENOLOL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "unknown", described as "Sore arm"; HEART RATE INCREASED (non-serious) with onset 09Mar2021 22:00, outcome "recovering", described as "Rapid heart beat; My heart keeps beating kind of fast and it has been going on for like two hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, heart rate increased.  Additional information: The patient's concomitant medications AMLODIPINE; LOSARTAN; ATENOLOL; all taken for an unspecified indication, start and stop dates were not reported. The course of the events was as follows: Patient had her first shot today and she did not know if she was experiencing a side effect or what was going on with her. Patient had the shot around, her appointment was at 10:50 am this morning and she felt okay around the day. Patient just had like a sore arm and around 10 o' clock this evening, she started getting like rapid heart beat and it went on until 11 to 11:30 and that is when she decided to call out. The only thing she did out of ordinary was she did not want them to spray, she was allergic to Lysol Spray. She was allergic to Lysol Spray the spray that you use to kill germs. Patient had a technician who came to fix the TV so when he left, due to COVID, she decided to use the spray. Patient left her home and was gone for three hours she waited and that was the only thing she did out of the ordinary because she did not want to use the spray. So, that was what confusing her and that was why she called because her heart keeps beating kind of fast and it has been going on for like two hours now and she decided she would call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sluggishness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 14Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore"; SLUGGISHNESS (non-serious), outcome "unknown", described as "Sluggish". Additional Information: The patient reported that other than the side effects, she was fine and also stated the COVID-19 shot was put a little higher. It was reported that the patient was a "CNA" for 19 years at the hospital and once COVID came out, she was pulled out of the hospital because of her lungs. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.