chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Four hours after receiving second shot in left arm, arm started itching. It later moved to right arm; This is a spontaneous report from a contactable consumer, the patient. A 61-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 12Apr2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. 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 right arm on 09Mar2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient previously took ampicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 12Apr2021 at 18:30, four hours after receiving second shot in left arm, the patient arm started itching. It later moved to right arm. The patient reported that, she was still dealing with uncontrolled itching and had been to dermatologist 2 times. The patient had next appointment in one week and doctor was not sure what was going on. The patient stated, nothing had worked to cure it. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported event which included treatment with hydroxyzine (MANUFACTURER UNKNOWN), cream and ointment. The clinical outcome of event arm started itching. It later moved to right arm was not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash and hives on neck/around chin and middle of back; Rash and hives on neck/around chin and middle of back; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 27Jul2021 at 11:15 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history included eczema. The patient did not have any allergies to food, medications, or other products. 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. Concomitant medication included unspecified birth control medication from an unknown date for an unknown indication. On 27Jul2021 at 19:00, the patient experienced rash and hives on neck/around chin and middle of back. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event rash and hives on neck/around chin and middle of back was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Right arm was numb and tingling.; Right arm was numb and tingling; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6955) via an unspecified route of administration in the left arm on 03Apr2021 at 12:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obesity and allergies to apples, bananas and avocados. 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. Concomitant medication included doxylamine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 at 12:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 04Apr2021, at 08:00 in the morning the patient's right arm was numb and was tingling which lasted for the whole day. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events right arm was numb and tingling were recovered on 04Apr2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Angular cheilitis, Dysgeusia
Clinical narrative: Metallic taste; loss of sense is taste to salt; Angular cheilitis; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Mar2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia. The patient had no known allergies to medications, food, or other products. 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 did not receive any medication within two weeks of vaccination. On 11Mar2021, the patient experienced metallic taste, loss of sense was taste to salt and angular cheilitis. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metallic taste, loss of sense was taste to salt and angular cheilitis was not recovered at the time of this report.  The lot number for, BNT162b2, was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash
Clinical narrative: Rash; pruritus of left forearm; headache; This is a spontaneous report from a contactable consumer, the patient. A 28-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 09Aug2021 at 15:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included postpartum disorder NOS (3 weeks postpartum) and polycystic ovarian syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS), pyridoxine hydrochloride (VITAMIN B6), vitamin d nos (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), macrogol 3350 (MIRALAX) and ibuprofen (ADVIL); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Aug2021 at 15:30, the patient experienced rash, pruritus of left forearm and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash, pruritus of left forearm and headache was unknown at the time of the report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 07Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache on 07Aug2021. Patient wanted to know if patient could use Tylenol because patient had a headache. The outcome of event headache was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone swelling, Dysgeusia, Mass, Pain
Clinical narrative: 48 hours after multiple lumps; Lumps on collarbone, armpit 7pm; Lumps on collarbone, armpit 7pm; Weird chemical taste in mouth; Fever chills; So thirsty; Radiating pain left side; Heart palps; Back pain; Swelling; Left upper side of body stilltender/sore; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 02Aug2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve regurgitation and blood pressure high (reported healthy otherwise). The patient was allergic to PHENERGAN. Prior to the vaccination ,it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021 at 01:30, 14 hours after shot the patient had fever chills, thirsty, radiating pain left side, heart palpitations and back pain. On 03Aug2021 at 19:00, approximately 30 hours after shot the patient had lumps on collarbone, armpit and had weird chemical taste in mouth. On 4Aug2021, 48 hours after  multiple lumps felt swelling. On an unknown date in Aug2021, one week after shot the patient had collarbone swelling and left upper side of body was tender/sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever chills, so thirsty, radiating pain left side, heart palpitations, back pain, lumps on collarbone, armpit, weird chemical taste in mouth, multiple lumps felt, swelling and left upper side of body still tender/sore were not recovered at the time of this report
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Swelling, Thirst
Clinical narrative: 48 hours after multiple lumps; Lumps on collarbone, armpit 7pm; Lumps on collarbone, armpit 7pm; Weird chemical taste in mouth; Fever chills; So thirsty; Radiating pain left side; Heart palps; Back pain; Swelling; Left upper side of body stilltender/sore; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 02Aug2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve regurgitation and blood pressure high (reported healthy otherwise). The patient was allergic to PHENERGAN. Prior to the vaccination ,it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021 at 01:30, 14 hours after shot the patient had fever chills, thirsty, radiating pain left side, heart palpitations and back pain. On 03Aug2021 at 19:00, approximately 30 hours after shot the patient had lumps on collarbone, armpit and had weird chemical taste in mouth. On 4Aug2021, 48 hours after  multiple lumps felt swelling. On an unknown date in Aug2021, one week after shot the patient had collarbone swelling and left upper side of body was tender/sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever chills, so thirsty, radiating pain left side, heart palpitations, back pain, lumps on collarbone, armpit, weird chemical taste in mouth, multiple lumps felt, swelling and left upper side of body still tender/sore were not recovered at the time of this report
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity
Clinical narrative: Minor joint pain, mainly in knees; Minor headache; Feeling blah (washed out); Soreness in arm; This is a spontaneous report from a non-contactable consumer, the patient.  A 62-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on an unknown date in 2021, as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and penicillin allergy. 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. Concomitant medications were not reported. On an unknown date in Aug2021, on day one, the patient experienced minor joint pain, mainly in knees that lasted one day, minor headache that lasted one day, feeling blah (washed out) lasted one day and soreness in the arm that lasted three days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events minor joint pain, mainly in knees, minor headache, feeling blah (washed out) were resolved on an unknown date in Aug2021, after a duration of one day; while that of the soreness in arm was resolved on unknown date in Aug2021, after a duration of three days.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Influenza
Clinical narrative: Flu Symptoms; Dull headache; Low 99 fever; Joint pain; Muscle pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on 07Aug2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), nicotinic acid (NIACIN) and fish oil (MANUFACTURER UNKNOWN); all were taken for unspecified indications from unknown dates and unknown if ongoing. On 08Aug2021 at 07:00, the patient experienced flu symptoms which included dull headache, low fever of 99 (unit unspecified), joint pain, muscle pain and tiredness. The events 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. Therapeutic measures were taken as a result of the events and included treatment with Advil 400 mg after 24 hours and night before bed. The clinical outcome of the events flu symptoms, dull headache, low 99 fever, joint pain, muscle pain and tiredness was resolved on an unknown date in Aug2021.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Flu Symptoms; Dull headache; Low 99 fever; Joint pain; Muscle pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on 07Aug2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), nicotinic acid (NIACIN) and fish oil (MANUFACTURER UNKNOWN); all were taken for unspecified indications from unknown dates and unknown if ongoing. On 08Aug2021 at 07:00, the patient experienced flu symptoms which included dull headache, low fever of 99 (unit unspecified), joint pain, muscle pain and tiredness. The events 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. Therapeutic measures were taken as a result of the events and included treatment with Advil 400 mg after 24 hours and night before bed. The clinical outcome of the events flu symptoms, dull headache, low 99 fever, joint pain, muscle pain and tiredness was resolved on an unknown date in Aug2021.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: He started experiencing a cough the next day with no other symptoms; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reported for a 12-year-old male patient (reporter's son). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer reported, ''my son just turned 12 years old on 28Jul2009. He received his 1st dose of the Pfizer covid-19 vaccine on 03Aug2021. He started experiencing a cough the next day with no other symptoms. His cough still lingers daily. It was just one cough every so often. He had not been sick nor in contact with anyone with the covid virus. He was not sick nor running a fever. You should know this symptom was caused by the vaccine''. The clinical outcome of the event was not recovered at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Quarter size rash under the armpit of the same arm of vaccination; Swollen lymph nodes at collar bone on opposite side of vaccinated arm; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, about 5 days after the first shot, the patient experienced quarter size rash under the armpit of the same arm of vaccination and lasted approximately 40 days. The patient also experienced swollen lymph nodes at collar bone on opposite side of vaccinated arm. The events resulted in doctor or other healthcare professional office/clinic visit.  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 quarter size rash under the armpit of the same arm of vaccination and swollen lymph nodes at collar bone on opposite side of vaccinated arm was resolved on an unknown date in 2021.   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: Electrocardiogram, Palpitations
Clinical narrative: palpitations 3 hours after receiving vaccine; This is a spontaneous report from a non-contactable other healthcare professional. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Jul2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history, and concomitant medications of the patient were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 31Jul2021, the patient experienced palpitations 3 hours after receiving vaccine. Still had intermittent palpitations 10 days post vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event palpitations and included treatment with EKG. On an unknown date in Jul2021 the patient underwent EKG (Electrocardiogram) and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event palpitations was 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Shakes; Chills; Fever; Body aches; Back aches; Sweating; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0178) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced shakes, chills, fever, body aches, back aches and sweating. The clinical outcome of the events of shakes, chills, fever, body aches, back aches and sweating were unknown at the time of this report.   No follow-up attempts are possible; No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shakes; Chills; Fever; Body aches; Back aches; Sweating; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0178) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced shakes, chills, fever, body aches, back aches and sweating. The clinical outcome of the events of shakes, chills, fever, body aches, back aches and sweating were unknown at the time of this report.   No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement
Clinical narrative: Increased breast size.; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received 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. Medical history and concomitant medication 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 COVID vaccine. On an unknown date, the patient experienced increased breast size. The events did not result in doctor or other healthcare professional office/clinic visit, 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 event. The clinical outcome of the event increased breast size was 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Diarrhoea, Fatigue
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Fever; Nausea; Diarrhea; lost my sense of taste and smell; lost my sense of taste and smell; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left at age of 27 years on 31Jul2021 13:00 (Lot Number: EW0151) as dose 1, single for covid-19 immunisation. Medical history included Known allergies with penicillin (causes rash). No covid prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Per CDC website, the side effects of the Pfizer vaccine include: tiredness, headache, muscle pain, chills, fever, nausea. The patient experienced all of these things as described, however he additionally had diarrhea and lost his sense of taste and smell. The CDC said that no vaccine can cause loss of taste and smell, yet one week after the vaccination patient did. Patient had a fever for 3 straight days starting 6 days after the vaccination, during which he lost sense of taste and smell. Patient took a Covid-19 nasal swab test from CVS 7 days after vaccination (during the middle of 3 days straight of fever) and had it sent to a lab, and tested negative. Which means all the side effects he was experiencing were not from a live virus but the vaccine itself, including sense of smell and taste, which he deem an adverse side effect not described. As this event has just taken place, he has yet to recover from loss of taste and smell. Adverse event start date was 06Aug2021 13:00. Covid test (SARS-COV-2 RNA, QL NAAT, RTPCR/TMA (COVID-19)) on 07Aug2021 was negative. No treatment was received. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Fever; Nausea; Diarrhea; lost my sense of taste and smell; lost my sense of taste and smell; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left at age of 27 years on 31Jul2021 13:00 (Lot Number: EW0151) as dose 1, single for covid-19 immunisation. Medical history included Known allergies with penicillin (causes rash). No covid prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Per CDC website, the side effects of the Pfizer vaccine include: tiredness, headache, muscle pain, chills, fever, nausea. The patient experienced all of these things as described, however he additionally had diarrhea and lost his sense of taste and smell. The CDC said that no vaccine can cause loss of taste and smell, yet one week after the vaccination patient did. Patient had a fever for 3 straight days starting 6 days after the vaccination, during which he lost sense of taste and smell. Patient took a Covid-19 nasal swab test from CVS 7 days after vaccination (during the middle of 3 days straight of fever) and had it sent to a lab, and tested negative. Which means all the side effects he was experiencing were not from a live virus but the vaccine itself, including sense of smell and taste, which he deem an adverse side effect not described. As this event has just taken place, he has yet to recover from loss of taste and smell. Adverse event start date was 06Aug2021 13:00. Covid test (SARS-COV-2 RNA, QL NAAT, RTPCR/TMA (COVID-19)) on 07Aug2021 was negative. No treatment was received. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable pharmacist. A 42-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 20Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives on an unspecified date. Reporter had a female patient who received the 1st dose of the Pfizer Biontech Covid vaccine last 20Jul2021. Patient broke out in hives, took Benadryl then felt fine. Patient asked if she can get the 2nd dose today. Outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mass
Clinical narrative: Pain in shoulder; Knot around collarbone; This is a spontaneous report from a contactable healthcare professional, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3180) via an unspecified route of administration in the left arm on 09Aug2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications taken within two weeks of vaccination included phentermine (ADIPEX) from unknown date for unknown indication. The patient previously took first of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa6780) via an unspecified route of administration in the left arm on 19Jul2021 at 15:30 (at the age of 29-years-old) as a dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021 at 13:00, the patient experienced pain in shoulder, knot around collarbone. The events resulted in emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events pain in shoulder, knot around collarbone was unknown at the time of this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Growing red spot at injection site; This is a spontaneous report from a contactable consumer, the patient. A 49-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 01Aug2021 at 16:30 (at the age of 48-years-old), as single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Concomitant medications were not reported. The patient previously took erythromycin (MANUFACTURER UNKNOWN), clindamycin (MANUFACTURER UNKNOWN) and ketorolac tromethamine (TORADOL); all on unknown dates for unspecified indications and experienced drug allergy. On 09Aug2021, the patient experienced growing red spot at injection site started a week after receiving vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event growing red spot at injection site was not resolved at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Nausea
Clinical narrative: Sweats; Chills; Body aches; Nausea; Vomiting; Diarrhea; Headache; Sore throat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration on 05Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced sweats, chills, body aches, nausea, vomiting, diarrhea, headache, sore throat. Patient reported as got everything except for the taste and the fever from it. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Vomiting
Clinical narrative: Sweats; Chills; Body aches; Nausea; Vomiting; Diarrhea; Headache; Sore throat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration on 05Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced sweats, chills, body aches, nausea, vomiting, diarrhea, headache, sore throat. Patient reported as got everything except for the taste and the fever from it. The outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Menard spotting for two days outside of normal period; 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: Em9809) via an unspecified route of administration in the left arm on 23Feb2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy and allergy to sulfa drugs (sulfonamide allergy). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En5318) via an unspecified route of administration in the left arm on 02Feb2021 (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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021, the patient experienced menard spotting (spotting menstrual) for two days outside of normal period. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menard spotting (spotting menstrual) was recovered on 05Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Intermenstrual bleeding
Clinical narrative: Menard spotting for two days outside of normal period; 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: Em9809) via an unspecified route of administration in the left arm on 23Feb2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy and allergy to sulfa drugs (sulfonamide allergy). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En5318) via an unspecified route of administration in the left arm on 02Feb2021 (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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021, the patient experienced menard spotting (spotting menstrual) for two days outside of normal period. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menard spotting (spotting menstrual) was recovered on 05Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: On March 4th I had menstrual spotting for two days,which I have never experienced before. One week later I had a normal period.  In the months of July, August and September,I've had no period and i suspect that I've entered  menopause  quite suddenly.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Intermenstrual bleeding
Clinical narrative: On March 4th I had menstrual spotting for two days,which I have never experienced before. One week later I had a normal period.  In the months of July, August and September,I've had no period and i suspect that I've entered  menopause  quite suddenly.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: muscle soreness at the site of injection which lasted approximately 48 hours.; muscle soreness at the site of injection; This is a spontaneous report from a non-contactable pharmacist, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 06Aug2021 at 15:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included fluocinonide cream (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Aug2021 at 20:00, the patient experienced muscle soreness at the site of injection which lasted approximately 48 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event muscle soreness at the site of injection was recovered on 08Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 62-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 10Aug2021 at 17:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease. The patient had no known allergies to medications, food, or other products. The patient had received concomitant medication (unspecified) within two weeks of vaccination on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021 at 17:45, the patient experienced insomnia. 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, emergency room/department or urgent care. The clinical outcome of the event insomnia was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a sore arm; This is a spontaneous report from a contactable consumer or other non hcp.   An 87-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Feb2021 as dose 1, single for covid-19 immunisation.  Medical history included urinary tract infection. Concomitant medication(s) included ciprofloxacin (CIPROFLOXACIN) taken for urinary tract infection. It was Reported that, Caller (female, age 87 years old -she just turned this age) received her first dose of the Pfizer covid vaccine in Feb2021 and her 2nd dose on 19Mar2021. Caller stated, "Saturday night, she went out with her son, who just had 1 shot of his vaccine and his wife and their 2 children. My daughter-in-law came down this covid 19 yesterday,. After the first shot she had a sore arm. After the 2nd shot maybe for 3 days had aches and pain. A day an half of muscle pain and very bad dizziness the patient experienced had a sore arm on 2021 with outcome of unknown.   Discussed symptoms of covid from fact sheet.  Response: Fact Sheet for Recipients and Caregivers (LAB-#) under section  Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Genital burning sensation, Genital swelling
Clinical narrative: burning and swelling in the genitalia; burning and swelling in the genitalia; This is a spontaneous report from a contactable consumer. This consumer reported for female (patient) that includes:  A 5-decade-old (a woman in her 40's) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was 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 and concomitant medications were not reported. The patient experienced burning and swelling in the genitalia on 2021. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101029567 Same reporter/ drug, different patient/ AE
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness at the injection site/her arm was red around the injection site and then today it's like spreading out further on the injection site; This is a spontaneous report from a contactable consumer (patient mother) or other non-healthcare professional. A 13-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 08Aug2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included anxiety. Concomitant medications included fluoxetine hydrochloride (FLUOXETINE) taken for anxiety, start and stop date were not reported. On an unspecified date in Aug2021, the patient experienced redness at the injection site/her arm was red around the injection site and then today it's like spreading out further on the injection site. Reported that her daughter received the first dose of the vaccine on 08Aug2021. She observed redness at the injection site but the redness has spread, from 09Aug2021 to 10Aug2021. She was wondering if this is normal and if her daughter should receive the second dose. It was reported that she got the vaccine on Sunday afternoon and on Monday, noticed that her arm was red around the injection site and then today it is like spreading out further on the injection site so, she was not quite sure. As per reporter, there is something redness that is associated with it but she was not quite sure how much and how long it would be it will be irritated. She is suffering from redness from COVID vaccine but she does takes medications. She had the Covid vaccine Sunday. She had redness on her arm since Sunday. The reporter stated that she has read that is just for last 24 hours. This is supposed to last for little bit longer seems like it may be possibly spreading. So that is a common side effect. Do we need to worry about it.  She wanted to know what needs to be done. Do she get the second dose. Reporter was not willing for further probing, further probing could not be done. Hence, limited information available over the call. The clinical outcome of the event was unknown.  Information about batch/lot number was requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 14Feb2021 at 12:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included atorvastatin calcium (LIPITOR) from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL5248) via an unspecified route of administration in the left arm on 24Jan2021 at 12:00 (age at vaccination unknown) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021 at 00:00, the patient experienced shingles. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles and included treatment with Acyclovir. The clinical outcome of the event shingles was resolved on an unknown date in 2021.