chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: body aches; Fever; swollen lymph nodes in armpit; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO191) via an unspecified route of administration in the right arm on 09Jun2021 at 00:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as non that she was aware of. Concomitant medications was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO177) via an unspecified route of administration in the right arm on 19May2021 at 00:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Jun2021 at 02:45, the patient experienced fever, swollen lymph nodes in armpit and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, swollen lymph nodes in armpit and body aches were resolving at the time of this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Heart rate increased, Migraine, Muscle fatigue
Clinical narrative: increased heart rate (120 resting); fever; chills; muscle fatigue; joint pain; migraines; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced increased heart rate (120 resting), fever, chills, muscle, fatigue, joint pain and migraines. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab test for COVID-19 on an unknown date and the result was found to be negative. The clinical outcome of the events increased heart rate (120 resting), fever, chills, muscle, fatigue, joint pain and migraines were resolved with sequelae on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: increased heart rate (120 resting); fever; chills; muscle fatigue; joint pain; migraines; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced increased heart rate (120 resting), fever, chills, muscle, fatigue, joint pain and migraines. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab test for COVID-19 on an unknown date and the result was found to be negative. The clinical outcome of the events increased heart rate (120 resting), fever, chills, muscle, fatigue, joint pain and migraines were resolved with sequelae on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Breast tenderness
Clinical narrative: Both breasts were swollen; Both breasts were swollen, and very sensitive to the touch; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in left arm on an unknown date (at the age of 41-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in left arm on 25May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications were not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID 19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18May2021, the patient had experienced both breasts were swollen and very sensitive to the touch. The patient had also reported that she experienced the event 2 weeks after receiving both shots. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the events, both breasts were swollen and very sensitive to the touch was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Musculoskeletal discomfort, Off label use, PO2
Clinical narrative: I was supposed to get my second one on April the 18th but I was in the hospital so I couldn't get it; I was supposed to get my second one on April the 18th but I was in the hospital so I couldn't get it; I am on oxygen.; I have a bad rotator cuff in my right shoulder and it is been, it felt swollen; shoulder lets me know what's there, it feels like a 'bone' strap across my shoulder; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196, Expiration date was not reported), dose 2 via an unspecified route of administration on 07Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT: ER2613) on 26Mar2021 for covid-19 immunization. On an unspecified date the patient experienced she was supposed to get her second one on 18Apr2021 but she was in the hospital so she couldnt get it, she is on oxygen (po2), she has a bad rotator cuff in her right shoulder, and it is been, it felt swollen, shoulder lets her know what's there, it feels like a 'bone' strap across her shoulder (musculoskeletal discomfort). Patient stated, if she had to explain it and she didnt know if that would be a Covid side effect or just her rotator cuff acting that. The outcome of events was unknown.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Headache; Vomiting; Fever; Chills; This is a spontaneous report from a contactable 13-year-old male consumer (patient) reported for himself that received bnt162b2 (PFIZER COVID 19, Solution for injection, Lot Number: EWO180), via an unspecified route of administration, administered in arm left on 08Jun2021 11:45 (at the age of 13-year-old) as dose number unknown, single for covid-19 immunisation. Medical history was none. No known allergies. No other vaccine in four weeks. Also, no other medications in two weeks. Prior to vaccination, patient had not diagnosed with Covid. Post vaccination, the patient had not tested Covid. There were no concomitant medications. Facility type vaccine was pharmacy or drug store. The patient experienced headache, vomiting, fever and chills on 09Jun2021 00:15. No treatment received for adverse events. The outcome of events was resolved on Jun2021.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: A week or 2 after the 2nd shot  experienced sporadic heart palpitations.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 08Apr2021 at 16:00(at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, a week or two after the second shot the patient experienced sporadic heart palpitations. They have since diminished. The  primary care doctor ran tests on the patient. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the even sporadic heart palpitations was recovering.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: ear ringing; Fever; headache; arm soreness; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 07Jun2021 at 18:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 17May2021 at 12:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jun2021 the patient experienced fever, headache, arm soreness and fatigue. On 10Jun2021, on day 3, the patient experienced ear ringing. No therapeutic measures were taken as a result of the reported events. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, headache, arm soreness, fatigue and ear ringing were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Erythema, Feeling hot, Headache
Clinical narrative: Severe, debilitating, crushing, headache; debilitating; migraine-type; vision issues; sensivity to light; noise; arm swelling; hot; red; nausea; dizziness; muscle aches; This is a spontaneous report from a contactable consumer or other non-HCP. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267; Expiration Date: 31May2021), intramuscular, administered in Left Arm on 18Feb2021 as DOSE 2, SINGLE (at the age of: 65-year-old) for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number: EL3247) intramuscular, administered in Left Arm on 20Jan2021 (at the age of: 65-year-old) for covid-19 immunization. Medical history included psoriatic arthropathy from 1980 and ongoing, fibromyalgia, covid-19 from Feb2020 and she believes she had covid-19 in Feb2020. There were no concomitant medications. The patient previously took statins and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered is mentioned as Hospital. Vaccine was not administered at Military facility. Other vaccine in fourweeks as Pfizer COVID 19 on 04Feb2021. Prior to vaccination, Unknown about the patient was diagnosed with COVID-19 and since the vaccination, the patient has been not tested for COVID-19. On 20Feb2 021 the patient experienced severe, debilitating, crushing, headache, debilitating, migraine-type, vision issues, sensivity to light, noise, arm swelling, hot, red, nausea, dizziness, muscle aches. The patient underwent lab tests and procedures which included sars-cov-2 test: had covid-19 on Feb2020 I believe I had covid-19 in Feb2020.  Therapeutic measures were taken as Pain med, office visits, MRIs as a result of severe, debilitating, crushing, headache. The outcome of event severe, debilitating, crushing, headache was not recovered while outcome of rest all events unknown. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Nausea, Peripheral swelling, Photophobia
Clinical narrative: Severe, debilitating, crushing, headache; debilitating; migraine-type; vision issues; sensivity to light; noise; arm swelling; hot; red; nausea; dizziness; muscle aches; This is a spontaneous report from a contactable consumer or other non-HCP. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267; Expiration Date: 31May2021), intramuscular, administered in Left Arm on 18Feb2021 as DOSE 2, SINGLE (at the age of: 65-year-old) for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number: EL3247) intramuscular, administered in Left Arm on 20Jan2021 (at the age of: 65-year-old) for covid-19 immunization. Medical history included psoriatic arthropathy from 1980 and ongoing, fibromyalgia, covid-19 from Feb2020 and she believes she had covid-19 in Feb2020. There were no concomitant medications. The patient previously took statins and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered is mentioned as Hospital. Vaccine was not administered at Military facility. Other vaccine in fourweeks as Pfizer COVID 19 on 04Feb2021. Prior to vaccination, Unknown about the patient was diagnosed with COVID-19 and since the vaccination, the patient has been not tested for COVID-19. On 20Feb2 021 the patient experienced severe, debilitating, crushing, headache, debilitating, migraine-type, vision issues, sensivity to light, noise, arm swelling, hot, red, nausea, dizziness, muscle aches. The patient underwent lab tests and procedures which included sars-cov-2 test: had covid-19 on Feb2020 I believe I had covid-19 in Feb2020.  Therapeutic measures were taken as Pain med, office visits, MRIs as a result of severe, debilitating, crushing, headache. The outcome of event severe, debilitating, crushing, headache was not recovered while outcome of rest all events unknown. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus, Visual impairment
Clinical narrative: Severe, debilitating, crushing, headache; debilitating; migraine-type; vision issues; sensivity to light; noise; arm swelling; hot; red; nausea; dizziness; muscle aches; This is a spontaneous report from a contactable consumer or other non-HCP. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267; Expiration Date: 31May2021), intramuscular, administered in Left Arm on 18Feb2021 as DOSE 2, SINGLE (at the age of: 65-year-old) for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number: EL3247) intramuscular, administered in Left Arm on 20Jan2021 (at the age of: 65-year-old) for covid-19 immunization. Medical history included psoriatic arthropathy from 1980 and ongoing, fibromyalgia, covid-19 from Feb2020 and she believes she had covid-19 in Feb2020. There were no concomitant medications. The patient previously took statins and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered is mentioned as Hospital. Vaccine was not administered at Military facility. Other vaccine in fourweeks as Pfizer COVID 19 on 04Feb2021. Prior to vaccination, Unknown about the patient was diagnosed with COVID-19 and since the vaccination, the patient has been not tested for COVID-19. On 20Feb2 021 the patient experienced severe, debilitating, crushing, headache, debilitating, migraine-type, vision issues, sensivity to light, noise, arm swelling, hot, red, nausea, dizziness, muscle aches. The patient underwent lab tests and procedures which included sars-cov-2 test: had covid-19 on Feb2020 I believe I had covid-19 in Feb2020.  Therapeutic measures were taken as Pain med, office visits, MRIs as a result of severe, debilitating, crushing, headache. The outcome of event severe, debilitating, crushing, headache was not recovered while outcome of rest all events unknown. Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm, Pain, SARS-CoV-2 test, Skin disorder, Swelling
Clinical narrative: my neck swelled up; lumps and bumps became very hard and painful; lumps and bumps became very hard and painful; lumps and bumps became very hard and painful; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional. A 73-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265), via an unspecified route of administration, administered in Arm Left on 27Jan2021 (Age at vaccination: 73 years) as single dose for COVID-19 immunisation.  Medical history included chronic lymphocytic leukaemia from an unknown date and unknown if ongoing. The patient previously took benadryl and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2(lot number: EL9261), administered in left arm on 27Jan2021 09:00 AM for COVID-19 immunisation. Patient received 1st dose on 27Jan2021 at 9:00 in left arm with lot number EL9261. Patient did not receive any other vaccine in four weeks. Patient received 7 prescrip-tions and 4 OTC in two weeks. Patient did not have COVID prior vaccination. Patient tested COVID post vaccination. The patient experienced my neck swelled up, lumps and bumps became very hard and painful on 18Feb2021 at 08:00. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 08Feb2021. Primary care doctor and oncologist waited for a while, we then tried round of Rituxan. We were trying the chemotherapy, Treanda. Lump were quite painful, and she have not felt well since 17Feb. The outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling feeling on the whole left side of head, not face, above ear on left side only; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and heart issues. The patient had no known allergies. Concomitant medication include thyroid (ARMOUR THYROID) from an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced tingling feeling on the whole left side of her head, not face, above ear on left side only. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event tingling feeling on the whole left side of head, not face, above ear on left side only was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Epistaxis, Fatigue, Tinnitus, Vertigo
Clinical narrative: Nosebleed; Mysterious bruising on legs; fatigue; Vertigo; Ringing in ears; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0177) via an unspecified route of administration in the right arm on 25May2021 at 15:15 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (TRI LINYAH) from an unknown date taken for birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021 at12:00 since receiving the vaccine, the patient experienced fatigue, vertigo and ringing in the ears. On an unknown date in Jun2021, at the time of this report, the patient had a nosebleed for the first time in life seemed for no reason and also noticed mysterious bruising on legs.  The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events fatigue, vertigo, ringing in ears, nosebleed and mysterious bruising on legs were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache like head pulsing; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 10Jun2021 at 00:30 (at the age of 33-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown) via an unspecified route of administration in left arm on 13May2021 (at the age of 33-year-old) at single dose for COVID-19 immunisation. On 12Jun2021 at 08:30, the patient experienced headache like head was pulsing and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Arm was sore; Chills; vomited; Fever; headache; This is a spontaneous report from a contactable consumer. A 13-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 10Jun2021 at 16:15 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included headache, nausea, vomiting, COVID-9. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 19May2021 at (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 10Jun2021 at 16:30, the patient experienced arm was sore after receiving the vaccine. On 10Jun2021, the patient experienced about 12 hours after receipt of the vaccine, woke up with chills and vomited, about 2 hours later fever, headache, chills and vomited a second time. Patient reported that by 6pm on 11June, patient had no symptoms was feeling normal and eating regularly. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events arm was sore, chills and vomited, headache was recovered on 11Jun2021 at 18:00.  The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle ache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 12Jun2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient previously had penicillin for unknown indication and experienced penicillin allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 22May2021 at 12:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient previously took codeine (MANUFACTURER UNKNOWN), nitrofurantoin (MACRODANTIN) and pethidine hydrochloride (DEMEROL), all for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jun2021 at 08:00, the patient experienced fever, chills, muscle aches, fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills, muscle aches, fatigue was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: fever; fatigue; This is a spontaneous report from a contactable consumer. A elderly male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 11Jun2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19.  Since the vaccination, it was unknown whether the patient had been tested for COVID-19.It was unknown if the patient received any other medications within 2 weeks of vaccination.  It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccination. On 11Jun2021, the patient experienced fever for approximately 48 hours and fatigue. On the same day, the patient underwent body temperature test and the result was 103F. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the event fever and fatigue were resolving at the time of report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: she continued to not feel well; low grade fever to 99.0; the day after that she developed a sore throat; stuffy nose; mild cough; This is a spontaneous report from a contactable consumer (patient's parent). A 13 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW978) via an unspecified route, administered in Right arm on 08Jun2021 (13-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Facility type vaccine was reported as pharmacy or drug store. The patient was not diagnosed with Covid prior to vaccination. The patient was not tested for Covid post vaccination. The patient had not received any other vaccine in four weeks of Covid-19 vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8734) via an unspecified route, administered in Right arm on 17May2021 (12-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 09Jun2021 (the day after the vaccination), the reporter's daughter developed a low-grade fever to 99.0, which responded to ibuprofen, the day after that she developed a sore throat, stuffy nose and mild cough, with a very low-grade fever. On 10Jun2021, she continued to not feel well the next day with similar symptoms, and then started to become slightly better by the 4th day after the shot. By the 5th day, today she felt almost well. The patient underwent lab tests and procedures which included body temperature: 99.0 (units unspecified), low grade fever on 09Jun2021.No treatment medications were received for the events sore throat, stuffy nose, cough and not feel well. The outcome of the events was recovering.  Follow-up attempts are completed. No further information was expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she continued to not feel well; low grade fever to 99.0; the day after that she developed a sore throat; stuffy nose; mild cough; This is a spontaneous report from a contactable consumer (patient's parent). A 13 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW978) via an unspecified route, administered in Right arm on 08Jun2021 (13-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Facility type vaccine was reported as pharmacy or drug store. The patient was not diagnosed with Covid prior to vaccination. The patient was not tested for Covid post vaccination. The patient had not received any other vaccine in four weeks of Covid-19 vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8734) via an unspecified route, administered in Right arm on 17May2021 (12-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 09Jun2021 (the day after the vaccination), the reporter's daughter developed a low-grade fever to 99.0, which responded to ibuprofen, the day after that she developed a sore throat, stuffy nose and mild cough, with a very low-grade fever. On 10Jun2021, she continued to not feel well the next day with similar symptoms, and then started to become slightly better by the 4th day after the shot. By the 5th day, today she felt almost well. The patient underwent lab tests and procedures which included body temperature: 99.0 (units unspecified), low grade fever on 09Jun2021.No treatment medications were received for the events sore throat, stuffy nose, cough and not feel well. The outcome of the events was recovering.  Follow-up attempts are completed. No further information was expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Face has been brilliant red since shortly after receiving 2nd vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6203) via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies. Concomitant medications includes atorvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), timolol (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and  B all for unknown indications from an unknown date and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el3247) via an unspecified route of administration in the left arm on 17Feb2021 at 12:00 as a single dose for COVID-19 immunisation. On 19Mar2021, shortly after receiving 2nd vaccine, the patient face had been brilliant red. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event face has been brilliant red was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymph node pain, Myalgia
Clinical narrative: There is muscle pain going into my lymph nodes and breast tissue; There is muscle pain going into my lymph nodes and breast tissue; There is muscle pain going into my lymph nodes and breast tissue; This is a spontaneous report from a contactable consumer, the patient A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 11Jun2021 at 15:30(at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, penicillin allergy, and COVID-19. Concomitant medication was not reported. The patient previously received meningococcal vaccine (MANUFACTURER UNKNOWN) on 28May2021 for immunisation within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Jun2021 at 23:45 the patient experienced muscle pain going into her lymph nodes and breast tissue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event muscle pain going into lymph nodes and breast tissue was not recovered.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot
Clinical narrative: Tired; Hot; This is a spontaneous report from a contactable other healthcare professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Jun2021 at 15:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included graves' disease and hyperthyroidism. The patient had known allergies to food, gluten, sugar and diary. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and thiamazole (METHIMAZOLE); both from unknown dates for unspecified indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 11Jun2021 at 20:30, the patient reported that she felt tired and hot. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tired and hot was resolving at the time of this report.   The batch/lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; skin rash appeared on left hip / lower abdomen area; skin pain across left hip/ skin felt painful with pressure change (i.e., when touched, or when pressure from compression is lifted). Pain continuedthrough the week, spreading from hip across left lower back; Skin felt sensitive; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 09:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to shellfish, tree nuts, stone fruits and some alcohols. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 11Apr2021, the patient started to feel skin pain across left hip, skin felt sensitive and painful with pressure change (i.e., when touched, or when pressure from compression was lifted). Pain continued through the week, spreading from hip across left lower back. On 18Apr2021, a skin rash appeared on left hip/lower abdomen area. On 20April2021, patient saw physician, who diagnosed the rash and pain as shingles and immediately started valacyclovir. Therapeutic measures were taken as a result of the events which included treatment with valacyclovir (VALTREX). The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event skin felt sensitive and shingles was resolved on an unknown date in 2021 and outcome of the event skin rash appeared on left hip/lower abdomen area and skin pain/pain continued through the week, spreading from hip across left lower back was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: increased heart rate that continued to occur intermittently over the next 24 hours; Injection site redness; Injection site swelling; Injection site heat; This is a spontaneous report from a contactable nurse, the patient. A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0173), via an unspecified route of administration in the arm left on 11Jun2021 09:45 as dose 1, single (at the age of 50-years-old) for covid-19 immunization. Medical history was not reported. Concomitant medications included ergocalciferol (VITAMIN D), cetirizine hydrochloride (ZYRTEC), multivitamins and tocopherol (VITAMIN E). The patient previously took demerol and experienced hallucination. On 11Jun2021 15.30, the patient experienced increased heart rate that continued to occur intermittently over the next 24 hours, injection site redness, injection site swelling and injection site heat. The patient did not received the treatment for the events. The patient had tested positive for the covid prior to the vaccination but not tested for post vaccination. The patient did not received the any other vaccine in four weeks. The outcome of the events was unknown.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swollen; This spontaneous report received from a contactable consumer based on the information received by Pfizer (Reference ID: NVSC2021US106430).   A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history included swelling. The patient concomitant medications were not reported (unknown medication for swelling). On an unspecified date, the patient had swollen due to stopping medication after receiving her Covid-19 vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthma, Fatigue, Headache, Hyperhidrosis
Clinical narrative: upset stomach; nausea; mild asthma; excessive sweating in feet; dull headache; fatigue; pain in the arm where the injection was placed; low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the right arm on 09Jun2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma, which was still ongoing.  The patient had allergy to penicillin and eggs.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took gatifloxacin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Concomitant medication included multivitamin from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jun2021 at 10:45, the patient experienced mild asthma, excessive sweating in feet, dull headache, fatigue, pain in the arm where the injection was placed and low grade fever. On 10Jun2021, the patient experienced nausea. On 11Jun2021, the patient experienced upset stomach. The events resulted in emergency room/department visit  or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event(s). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of mild asthma, excessive sweating in feet, dull headache, fatigue, pain in the arm where the injection was placed, low grade fever, nausea and upset stomach was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: upset stomach; nausea; mild asthma; excessive sweating in feet; dull headache; fatigue; pain in the arm where the injection was placed; low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the right arm on 09Jun2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma, which was still ongoing.  The patient had allergy to penicillin and eggs.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took gatifloxacin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Concomitant medication included multivitamin from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jun2021 at 10:45, the patient experienced mild asthma, excessive sweating in feet, dull headache, fatigue, pain in the arm where the injection was placed and low grade fever. On 10Jun2021, the patient experienced nausea. On 11Jun2021, the patient experienced upset stomach. The events resulted in emergency room/department visit  or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event(s). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of mild asthma, excessive sweating in feet, dull headache, fatigue, pain in the arm where the injection was placed, low grade fever, nausea and upset stomach was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected