chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Paraesthesia, Vaginal haemorrhage
Clinical narrative: Abnormal vaginal bleeding; Pain in hips, knees, ankles; Painful lymph nodes on left side especially neck area; Spleen pain; Painful armpit left side; Diarrhea; Numbness and tingling in hands and feet; Numbness and tingling in hands and feet; This is a spontaneous report from a non-contactable nurse, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), via an unspecified route of administration in the left arm on 15May2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date. The patient did not have any history of allergies to any food or medications or other products. Concomitant medication included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) for an unknown indication from an unknown date 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 15May2021, the patient experienced abnormal vaginal bleeding, pain in hips, knees, ankles, painful lymph nodes on left side especially neck area, spleen pain, painful armpit left side, diarrhea first 2 days, numbness and tingling in hands and feet and then only tingling in fingertips of both hands. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of the event diarrhea was resolved on an unknown date in May2021. The clinical outcome of the events abnormal vaginal bleeding, pain in hips, knees, ankles, painful lymph nodes on left side especially neck area, spleen pain, painful armpit left side, numbness and tingling in hands and feet were not resolved at the time of report.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Nausea, Pain
Clinical narrative: Became very nauseous about 18 hours after receiving the vaccine. Then got a headache shortly thereafter. Then came the extreme achy ness and lethargy.; Became very nauseous about 18 hours after receiving the vaccine. Then got a headache shortly thereafter. Then came the extreme achy ness and lethargy.; Became very nauseous about 18 hours after receiving the vaccine. Then got a headache shortly thereafter. Then came the extreme achy ness and lethargy.; Became very nauseous about 18 hours after receiving the vaccine. Then got a headache shortly thereafter. Then came the extreme achy ness and lethargy.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-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 an unknown date as a single dose for COVID-19 immunisation. Medical history included food allergy. Concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date about 18 hours after vaccination, the patient became very nauseous, then got a headache shortly thereafter, then came the extreme achyness and lethargy. 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 very nauseous, headache, extreme achy ness and lethargy was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Major diarrhea, multiple times a day; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on 22May2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. 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 medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021 at 14:00, the patient experienced major diarrhea, multiple times a day. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event major diarrhea, multiple times a day was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal discomfort, Rhinorrhoea
Clinical narrative: Running nose; Then stuffy nose; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer Ewo170) via an unspecified route of administration in the left arm on 20May2021 at 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergies. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21May2021, the patient experienced running nose and then stuffy nose. 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 reported events. The clinical outcome of the events running nose and stuffy nose was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Heart palpitations; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL96264) via an unspecified route of administration in the left arm on 11Feb2021 at 08:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included blood clot at age 29 and surgery to remove clot x2. Concomitant medication included ibuprofen (MOTRIN) from an unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN) taken for an 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 11Feb2021 at 16:00, about 7 hours after getting the shot, the patient had heart palpitations and shortness of breath. It lasted 13 mins and the patient ended up falling asleep for the night when the patient woke up the patient was fine. 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 heart palpitations and shortness of breath were recovered on 11Feb2021 at 16:13.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in rashes/hives on arms.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0176) via an unspecified route of administration in the  left arm on 28Apr2021 at 14:45 (at the age of 32-year-old) as a single dose for COVID-19immunisation. Medical history included blood pressure high. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC) and loratadine, pseudoephedrine sulfate (CLARITIN-D) both for an unknown indication started on an unknown date. The patient previously took vancomycin (MANUFACCTURER UNKNOWN) on an unknown date and experienced 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 03May2021 at 07:00, the patient experienced broke out in rashes/hives on arms. Therapeutic measures were not taken as a result of this event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event broke out in rashes/hives on arms was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Diarrhoea, Erythema, Eye pain, Fatigue
Clinical narrative: redness; swelling; pain in right eye; dilating pupil in that eye; Lymph node swelling; elevatedtemperature; fatigue; nausea; loose stool; headache; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167, expiration date: 31Aug2021) via an unspecified route of administration in the left arm on 05May2021 at 08:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, thyroid disorder and known allergies to penicillin (MANUFACTURER UNKNOWN). Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 100 mcg daily on an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735, expiration date: 31Jul2021) via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09May2021 at 10:00, the patient experienced re-occuring every 5 days (5/10, 5/15, 5/20) lymph node swelling, elevated temperature, fatigue, nausea, loose stool, headache lasting 24hrs then fading. Starting with loose stool (GI symptoms) and escalating into headache, elevated temperature. Intense symptoms for 9-12hrs during daytime requiring bed rest. In addition, 17d after 2nd dose redness, swelling, and pain in right eye along with differently dilating pupil in that eye (pupil remaining dilated even in bright light). The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcomes of the event lymph node swelling, elevated temperature, fatigue, nausea, loose stool, headache, redness, swelling, pain in right eye and dilating pupil in that eye were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Mydriasis, Nausea, Swelling
Clinical narrative: redness; swelling; pain in right eye; dilating pupil in that eye; Lymph node swelling; elevatedtemperature; fatigue; nausea; loose stool; headache; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167, expiration date: 31Aug2021) via an unspecified route of administration in the left arm on 05May2021 at 08:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, thyroid disorder and known allergies to penicillin (MANUFACTURER UNKNOWN). Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 100 mcg daily on an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735, expiration date: 31Jul2021) via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09May2021 at 10:00, the patient experienced re-occuring every 5 days (5/10, 5/15, 5/20) lymph node swelling, elevated temperature, fatigue, nausea, loose stool, headache lasting 24hrs then fading. Starting with loose stool (GI symptoms) and escalating into headache, elevated temperature. Intense symptoms for 9-12hrs during daytime requiring bed rest. In addition, 17d after 2nd dose redness, swelling, and pain in right eye along with differently dilating pupil in that eye (pupil remaining dilated even in bright light). The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcomes of the event lymph node swelling, elevated temperature, fatigue, nausea, loose stool, headache, redness, swelling, pain in right eye and dilating pupil in that eye were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Severe inflammation throughout my body; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Gu0182) via an unspecified route of administration in the left arm on 18May2021 at 13:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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 20May2021, the patient experienced severe inflammation throughout the body. The patient reported that she had the vaccine on Tuesday and by Thursday she had severe inflammation throughout her body. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe inflammation throughout my body was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Large bruise about 1 1/4 inch in diameter at the injection site of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 21May2021 at 17:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroid disease. Patient previously took azithromycin (ZYTHROMAX) and nitrofurantoin (MACROBID) and experienced drug allergy. Concomitant medications included torasemide (TORSEMIDE), levothyroxine sodium 88 mg (SYNTHROID), ascorbic acid, calcium carbonate (CAL C) and vitamins nos (MULTIPLE VITAMIN); all for an unknown indication and from an unknown start 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 COVID vaccine. On 22May2021 at 06:00, the patient experienced large bruise about 1 1/4 inch in diameter at the injection site of the vaccine. The patient did not receive any treatment for the event. The clinical outcome of the event large bruise about 1 1/4 inch in diameter at the injection site of the vaccine was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Muscle fatigue, Myalgia
Clinical narrative: Extreme muscle fatigue and soreness; Extreme muscle fatigue and soreness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable nurse, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 16May2021 at 16:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Concomitant medications taken within two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN) and fluticasone propionate (FLONASE) both from unknown date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 29Jan2021 at 12:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 at 04:00, the patient experienced extreme muscle fatigue and soreness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events extreme muscle fatigue and soreness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, SARS-CoV-2 test, Sleep disorder
Clinical narrative: heart rate increased to 104-108 beats; didn't sleep well; felt tired; This is a spontaneous report from a contactable other-health care professional (Patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm left on 27Mar2021 10:15 (at the age of 60 years) as single for COVID-19 immunization. Medical history included HTN, GERD followed by known allergies (as yes) from an unknown date and unknown if ongoing. Patient Concomitants were not reported. Patient did not receive any other vaccines within 2 or 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 06Mar2021 11:15 (at the age of 59 years) as single for covid-19 immunisation caused insomnia, patient couldn't fall asleep until 4am that night. On 27Mar2021 21:00 the patient experienced heart rate increased to 104-108 beats which started 9pm the day of vaccine 2 and lasted until the next day about 2pm, didn't sleep well, felt tired. The patient underwent lab tests and procedures which included heart rate found to be 104-108/returned to my normal resting rate on 27Mar2021 (increased beats per minute) and Nasal Swab test found to be negative on 05Apr2021. The outcome of the events was found be recovered on unspecified date of 2021.   No follow-up attempts are possible. No further information is expected
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Insomnia, Myalgia, Pyrexia
Clinical narrative: Fever; Joint pain; I couldnt sleep/I cant sleep; Joint muscle pain; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 47-years-old female patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 21May2021 17:00 (age at the vaccination 47-years-old) (Batch/Lot Number: EW0186) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included allergy to penicillin. The patient's concomitant medications were not reported. The patient had not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in leg Right (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation and patient could not sleep. On 21May2021, after few minutes of the vaccine she had some dizziness on the (Facility) Center. On 22May2021 at 01:00, patient experienced fever, joint pain, joint muscle pain and couldn't sleep. It was reported that patient took Tylenol. Adverse event result doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of fever, joint pain, joint muscle pain and dizziness. At the time of this report, the outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Throat is very itchy; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er8735) via an unspecified route of administration in the left arm on 20May2021 at 16:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD) and blood pressure high on an unknown date and unknown if ongoing. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN); atorvastatin (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC) all for an unknown indication from an unknown date and unknown if ongoing. The patient was not allergic to medications, food, or other products. The patient also received unspecified nasal drip as concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0161) via an unspecified route of administration in the left arm on 29Apr2021 at 09:00 (at the age of 40-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 18:00, the patient experienced very itchy throat. The patient reported that the event was perhaps from nasal drip or allergy reaction due to the shot. 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 reported events. The clinical outcome of the event very itchy throat was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Autoscopy, Balance disorder, Chills
Clinical narrative: Fever; swollen lymph nodes; euphoria; out of body experiences; joint pain; swollen joints; muscle pain; chills; headache; stomachache; diarrhea; disequilibrium; shingles; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 19Apr2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) since an unknown date. The patient previously received NSAIDs in the past used for unknown indication and on an unknown date and experienced an allergy to analgesics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021 at 14:45, the patient experienced fever, swollen lymph nodes, euphoria, out of body experiences, joint pain, swollen joints, muscle pain, chills, headache, stomach ache, diarrhea, disequilibrium and shingles. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events fever, swollen lymph nodes, euphoria, out of body experiences, joint pain, swollen joints, muscle pain, chills, headache, stomach ache, diarrhea, disequilibrium, shingles were not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 11May2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Euphoric mood, Headache, Herpes zoster, Joint swelling
Clinical narrative: Fever; swollen lymph nodes; euphoria; out of body experiences; joint pain; swollen joints; muscle pain; chills; headache; stomachache; diarrhea; disequilibrium; shingles; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 19Apr2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) since an unknown date. The patient previously received NSAIDs in the past used for unknown indication and on an unknown date and experienced an allergy to analgesics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021 at 14:45, the patient experienced fever, swollen lymph nodes, euphoria, out of body experiences, joint pain, swollen joints, muscle pain, chills, headache, stomach ache, diarrhea, disequilibrium and shingles. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events fever, swollen lymph nodes, euphoria, out of body experiences, joint pain, swollen joints, muscle pain, chills, headache, stomach ache, diarrhea, disequilibrium, shingles were not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 11May2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Fever; swollen lymph nodes; euphoria; out of body experiences; joint pain; swollen joints; muscle pain; chills; headache; stomachache; diarrhea; disequilibrium; shingles; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 19Apr2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) since an unknown date. The patient previously received NSAIDs in the past used for unknown indication and on an unknown date and experienced an allergy to analgesics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021 at 14:45, the patient experienced fever, swollen lymph nodes, euphoria, out of body experiences, joint pain, swollen joints, muscle pain, chills, headache, stomach ache, diarrhea, disequilibrium and shingles. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events fever, swollen lymph nodes, euphoria, out of body experiences, joint pain, swollen joints, muscle pain, chills, headache, stomach ache, diarrhea, disequilibrium, shingles were not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 11May2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: severe chills; joint pain; headache for 10 straight days; sweating; fatigue; muscle weakness; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included disorder thyroid (Thyroid disease). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 22:00, the patient experienced severe chills, joint pain, headache for 10 straight days, sweating, fatigue, muscle weakness. The patient did not receive any treatment for the events. The clinical outcome of events severe chills, joint pain, sweating, fatigue, muscle weakness recovered on an unspecified date in 2021. Headache recovered on 30Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: severe chills; joint pain; headache for 10 straight days; sweating; fatigue; muscle weakness; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included disorder thyroid (Thyroid disease). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 22:00, the patient experienced severe chills, joint pain, headache for 10 straight days, sweating, fatigue, muscle weakness. The patient did not receive any treatment for the events. The clinical outcome of events severe chills, joint pain, sweating, fatigue, muscle weakness recovered on an unspecified date in 2021. Headache recovered on 30Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 05Mar2021 at 10:15 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, obesity, thyroid nodules and seasonal allergies. Concomitant medications included acetylsalicylic acid (ASPIRIN) 325mg daily, insulin (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL) prn; all for unspecified indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 12Feb2021 at 09:45 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. The patient previously took cefixime (SUPRAX), clarithromycin (BIAXIN), lisinopril (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and fluticasone propionate;salmeterol xinafoate (ADVAIR DISCUS) for unspecified indication from unknown date and experienced drug allergy to cefixime (SUPRAX), clarithromycin (BIAXIN), lisinopril (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and fluticasone propionate;salmeterol xinafoate (ADVAIR DISCUS) on unknown dates. 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 09May2021, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with valacyclovir & gabapentin. The clinical outcome of the event shingles was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: My period started on May 11th and ended on May 15th (normal cycle).  I then had a second period start on May 20th. My cycle is regular and this is not something that commonly occurs.  I have not had a; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 08May2021 at 15:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia (SVT) and shellfish allergy. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 17Apr2021 at 15:00 (at the age of 39-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's period started on 11May2021 and ended on 15May2021 which was normal cycle.  The patient then had a second period on 20May2021. The patient cycle was regular and this was not something that commonly occurs. The patient not had any medicine changes or illnesses. 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 events. The clinical outcome of the event, period started on 11May2021 and ended on 15May2021 which was normal cycle, had a second period on 20May2021 and cycle was regular and this was not something that commonly occurs was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Nausea; Dizziness; tired; fever; unwell; tachycardia; bruised injection site; bruised injection site but it was only mildly tender; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TLC612Y) via an unspecified route of administration in the left arm on 18May2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Nov2020 and the patient did not have any other relevant medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19May2021 at 04:00, 16 hours after the first dose, the patient experienced nausea and dizziness which had gone by 3 hours. On the same day, the patient experienced tired, fever which was resolved with ibuprofen and the patient was unwell, had some feelings of tachycardia similar to when she had COVID. She was still active that day though, 48 hours later she felt fairly well and 72 hours later she felt mostly normal, though she still had occasional feelings of tachycardia and she also had a bruised injection site but it was only mildly tender. Therapeutic measures were taken as a result of fever and included treatment with ibuprofen. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea and dizziness were resolved on 19May2021 at 07:00, while the clinical outcome of the events tired, fever, unwell, bruised injection site mildly tender were resolved on an unknown date in May2021 and tachycardia was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site bruising, Vaccination site pain
Clinical narrative: Nausea; Dizziness; tired; fever; unwell; tachycardia; bruised injection site; bruised injection site but it was only mildly tender; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TLC612Y) via an unspecified route of administration in the left arm on 18May2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Nov2020 and the patient did not have any other relevant medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19May2021 at 04:00, 16 hours after the first dose, the patient experienced nausea and dizziness which had gone by 3 hours. On the same day, the patient experienced tired, fever which was resolved with ibuprofen and the patient was unwell, had some feelings of tachycardia similar to when she had COVID. She was still active that day though, 48 hours later she felt fairly well and 72 hours later she felt mostly normal, though she still had occasional feelings of tachycardia and she also had a bruised injection site but it was only mildly tender. Therapeutic measures were taken as a result of fever and included treatment with ibuprofen. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea and dizziness were resolved on 19May2021 at 07:00, while the clinical outcome of the events tired, fever, unwell, bruised injection site mildly tender were resolved on an unknown date in May2021 and tachycardia was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Soreness under the arm from armpit of injection site.; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0187) via an unspecified route of administration in the arm right on 19May2021 at 09:30(at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included atomoxetine hydrochloride (STRATTERA) from an unknown date for an unknown indication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 08:00, the patient experienced soreness under the arm from armpit of injection site. The patient received treatment for the reported events which included ice pack and was continued to monitor. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event soreness under the arm from armpit of injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Inappropriate schedule of product administration, Sinus tachycardia, Tachycardia
Clinical narrative: Dose 1 Apr2021 + Dose 2 Apr2021; Onset of acute Tachycardia after second dose of Pfizer vaccine; hypertensive; diagnosed with "Sinus Tachycardia".; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on Apr2021 (at the age of 62 years), (Batch/Lot number was not reported) as dose 2, single and dose 1 via an unspecified route of administration, administered in Arm Right on Apr2021 (at the age of 62 years), (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation in hospital. The patient was not pregnant at the time of vaccination. Medical history included hypertension, obesity, Mitral Valve Prolaspe from an unknown date and unknown if ongoing, Known allergies: Sulfa. Concomitant medication included atenolol, hctz and lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity. 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 08Apr2021 08:00 the patient experienced, Onset of acute Tachycardia after second dose of Pfizer vaccine. Heart rate sustaining at 100 and over. Also, hypertensive. Acute episode of Tachycardia not responding to new medications to help (Norvasc 5mg/day, Lisinopril 40mg/day, HCTZ 25mg/day, Metoprolol ER 25mg/day had been to the local Emergency Room and diagnosed with "Sinus Tachycardia". The events resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of onset of acute tachycardia after second dose of Pfizer vaccine, diagnosed with "sinus tachycardia" as Lopressor and Metoprolol. The clinical outcome of the event Onset of acute Tachycardia after second dose of Pfizer vaccine was unknown and remaining all other events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: fever; weakness; fatigue; dizziness; arm was sore for several days after the injection; This is a spontaneous report from a contactable consumer, the patient. A 38-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 11May2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to animal muscle like a steak but the patient could eat eggs and broths. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) and one a day woman's multivitamin; both from an unknown date and unknown if its ongoing. The patient previously received TYLENOL for unknown indication and experienced drug allergy. The patient previously received other vaccine in four weeks which included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on 20Apr2021 at 13:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11May2021 at 19:30, the patient got fever, weakness, fatigue, and dizziness about 5 hours after the vaccine until the following evening. The patient said that it probably lasted 18 to 26 hours. The patient's arm was sore for several days after the injection. 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, weakness, fatigue, dizziness and arm was sore for several days after the injection were recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.