chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: pain at the injection site; tired for part of the day; This is a spontaneous report from a contactable consumer. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 05Jun2021 (at the age of 12-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any 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 on an unknown date in May2021 (at the age of 12-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. The patient had no known allergies to medications, food or other products. On 06Jun2021, the patient experienced pain at the injection site and was tired for part of the day. 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 event pain at the injection site and tired for part of the day was recovered on 06Jun2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Lethargy, Migraine, Muscular weakness, Vomiting
Clinical narrative: Awoke 4 am next morning w/migraine- worst migraine I have ever had and it lasted 36 hours;; vomited once;; lethargic; weak in limbs;/Still have some weakness in limbs; lost five pounds; could not eat for 3-1/2 days.; This is a spontaneous report from a contactable consumer. This 60-year-old non-pregnant female consumer (Patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0153) via an unspecified route of administration on 02Jun2021 at 10:45 AM in right arm (at 60-year-old), as dose 2, single for COVID-19 immunization. Medical history of the patient included seasonal allergies, Known allergies: Seaweed (start date and ongoing status unknown), Malignant tumor removed in 2015 (mucoepidermoid carcinoma), mucoepidermoid carcinoma (2015). The patient did not have covid prior vaccination and was not tested for covid post vaccination. Concomitant medications included pravastatin, irbesartan, vitamin D3, biotin, niacin (taken for an unspecified indication, start and stop date were not reported). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0179) via an unspecified route of administration on 05May2021 at 04:45 PM in right arm (at 60-year-old), as dose 1, single for COVID-19 immunization. On 03Jun2021 at 04:00AM, the next morning the patient was awoke at 4 am w/migraineworst migraine she have ever had and it lasted 36 hours, she vomited once, was lethargic, was weak in limbs, lost five pounds-could not eat for 3-1/2 days. On her fourth day out of work no pay. She still have some weakness in limbs. No treatment was received for events. The patient was recovering.  Follow-Up (04Aug2021): Follow-up attempts were completed. No further information was expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Awoke 4 am next morning w/migraine- worst migraine I have ever had and it lasted 36 hours;; vomited once;; lethargic; weak in limbs;/Still have some weakness in limbs; lost five pounds; could not eat for 3-1/2 days.; This is a spontaneous report from a contactable consumer. This 60-year-old non-pregnant female consumer (Patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0153) via an unspecified route of administration on 02Jun2021 at 10:45 AM in right arm (at 60-year-old), as dose 2, single for COVID-19 immunization. Medical history of the patient included seasonal allergies, Known allergies: Seaweed (start date and ongoing status unknown), Malignant tumor removed in 2015 (mucoepidermoid carcinoma), mucoepidermoid carcinoma (2015). The patient did not have covid prior vaccination and was not tested for covid post vaccination. Concomitant medications included pravastatin, irbesartan, vitamin D3, biotin, niacin (taken for an unspecified indication, start and stop date were not reported). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0179) via an unspecified route of administration on 05May2021 at 04:45 PM in right arm (at 60-year-old), as dose 1, single for COVID-19 immunization. On 03Jun2021 at 04:00AM, the next morning the patient was awoke at 4 am w/migraineworst migraine she have ever had and it lasted 36 hours, she vomited once, was lethargic, was weak in limbs, lost five pounds-could not eat for 3-1/2 days. On her fourth day out of work no pay. She still have some weakness in limbs. No treatment was received for events. The patient was recovering.  Follow-Up (04Aug2021): Follow-up attempts were completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a non-contactable consumer. A 13-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Jun2021 as a single dose for COVID-19 immunisation. It was reported that medical history of the patient was not available. The patient has taken unspecified concomitant medications. The patient's history of known allergies was reported as none. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on May2021 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 05Jun2021, the day after the vaccine the patient experienced fever. It was unknown whether any therapeutic measures were taken as a result of this event. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event fever was recovered on an unknown date in Jun2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Drug withdrawal syndrome
Clinical narrative: After the second shot, I have zerodesire for coffee.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 26May2021 at 09:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, and some mild food allergies. Concomitant medications were not reported. Patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0173) in the left arm on 05May2021 at 09:00 (at the age of 46-years-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 28May2021, after the second shot of vaccination, patient experienced zero desire for coffee, clear head after the patient has a cup of coffee every morning. The patient felt like he was addicted to coffee (guess caffeine). The patient cannot remember, the last time he did not have coffee for the day. It has probably been 5+ years since have the patient not had coffee. Patient tried drinking a cup after one week, and it is not the same. Doesn't the coffee/caffeine create some reward pathway (addiction?) or what-not in the brain? How is it that the vaccine broke this response? The vaccine changed something (in brain)! It is very strange to have ZERO urge for coffee after needing it for so long. No therapeutic measures were taken as a result of reported events. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event zero desire for coffee was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Muscle cramping; Muscle twitching; This is a spontaneous report from a contactable consumer, the patient. A 30-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 01Jun2021 at 17:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient had no known allergies. Concomitant medications included cholecalciferol (VITAMIN D3) for an unknown indication and birth control medication; both from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jun2021, at 21:00 the patient experienced muscle cramping and muscle twitching following 1st dose of Pfizer COVID-19 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle cramping and muscle twitching was not recovered at the time of this report.   The lot number for BNT162b2, were not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Pruritus
Clinical narrative: Old scar on right knee (2017) inflamed, sore, itchy, raised.; Old scar on right knee (2017) inflamed, sore, itchy, raised.; Old scar on right knee (2017) inflamed, sore, itchy, raised.; This is a spontaneous report from a contactable consumer. This 14-year-old female patient received bNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EWO185, expiry date not reported) dose 2 via unspecified route of administration, administered in left arm on 04Jun21 16:15 (at age of 14-years-old) as dose 2, single for COVID-19 Immunisation. Patient medical history include penicillin allergy and concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The Patient previously received bNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EWO171, expiry date not reported) dose 1 via unspecified route of administration, administered in left arm on 14May21 16:00 (at age of 14-years-old) as single dose for COVID-19 Immunisation. On 05Jun21 (one day after vaccination) patient experienced Old scar on right knee (2017), inflamed, sore, itchy, raised. Patient did not receive treatment for adverse events. The Outcome of events was recovering.   Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: Exactly four days after the second dose of the Pfizer vaccine, I had SEVERE diarrhea for three days.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 08Feb2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and medication received within two weeks of vaccination was 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 12Feb2021, exactly four days after the second dose of the Pfizer vaccine, the patient had severe diarrhea for three days. The event 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 event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event exactly four days after the second dose of the Pfizer vaccine, had severe diarrhea for three days was resolved on 14Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Constant dizziness; This is a spontaneous report from a contactable consumer, the patient. A 36-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 right arm on 03Jun2021 at 15:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included diabetes and high blood pressure. The patient had no known allergies.  Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included lisinopril dihydrate (LISINOPRIL) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jun2021 at 00:30, the patient experienced constant dizziness since the days of shot. The patient did not receive any treatment for the 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constant dizziness was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Pain, Pruritus, Sleep disorder
Clinical narrative: Itching increased in intensity until it hurt/ pain; Could not sleep; Could not lean against anything; Itching on back/ itching went down both arms.; Red spots/redness went down on both arms; Raised lumps like hives/ lumps went downboth arms.; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient 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 19May2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included heart disease, type 2 diabetes, lymphedema, obesity and Meniere's disease. Concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26May2021, about a week after the shot, the patient developed itching on his back, this itching increased in intensity until it hurt, he could not lean against anything because it increased the itching and pain, he could not sleep, had red spots and then raised lumps like hives developed on his back. Then redness, lumps and itching went down both arms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with methylprednisolone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events itching on back/ itching went down both arms, itching increased in intensity until it hurt/pain, could not lean against anything, could not sleep, red spots/redness went down both arms and raised lumps like hives/ lumps went down both arms were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Itching increased in intensity until it hurt/ pain; Could not sleep; Could not lean against anything; Itching on back/ itching went down both arms.; Red spots/redness went down on both arms; Raised lumps like hives/ lumps went downboth arms.; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient 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 19May2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included heart disease, type 2 diabetes, lymphedema, obesity and Meniere's disease. Concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26May2021, about a week after the shot, the patient developed itching on his back, this itching increased in intensity until it hurt, he could not lean against anything because it increased the itching and pain, he could not sleep, had red spots and then raised lumps like hives developed on his back. Then redness, lumps and itching went down both arms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with methylprednisolone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events itching on back/ itching went down both arms, itching increased in intensity until it hurt/pain, could not lean against anything, could not sleep, red spots/redness went down both arms and raised lumps like hives/ lumps went down both arms were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Muscle tightness
Clinical narrative: After second shot I had substantial muscle tightness extending up my left arm and into my neck; It actually affected my swallowing a bit. (This was not a sore throat.); This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 05Mar2021 at 09:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (afib), aortic valve replacement (AVR), high cholesterol. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO), rosuvastatin calcium (CRESTOR), vitamin d nos (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN) for unknown indication. The patient had allergy to IV dye (contrast dye). 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 previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the arm left on 12Feb2021 at 08:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation.  On 05Mar2021 at 05:00, after second shot, the patient had substantial muscle tightness extending up his left arm and into neck. It actually affected his swallowing a bit. (This was not a sore throat.) It has subsided quite a bit but the tightness lingers on the left side of his neck. He had no fever or other effects. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event It actually affected swallowing a bit. (This was not a sore throat.) and substantial muscle tightness were recovered with sequelae on an unknown date in 2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Decreased appetite, Dysgeusia
Clinical narrative: Chills; 104 degree fever; Body aches even in feet; Loss of appetite; Loss of taste; Metal taste; Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 04Jun2021 at 10:30 (at the age of 44-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. The patient did not receive any concomitant medication. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 14May2021 at 10:00 as a single dose for COVID-19 immunisation. On 04Jun2021 at 21:00 the patient experienced chills, 104 degree fever, body aches even in feet, loss of appetite, loss of taste, metal taste and headache. On 04Jun2021, the patient underwent body temperature and the result was 104 degree fever. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events chills, 104 degree fever, body aches even in feet, loss of appetite, loss of taste, metal taste and headache were not recovered at the time of this report.   No follow-up attempts needed; No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Chills; 104 degree fever; Body aches even in feet; Loss of appetite; Loss of taste; Metal taste; Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 04Jun2021 at 10:30 (at the age of 44-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. The patient did not receive any concomitant medication. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 14May2021 at 10:00 as a single dose for COVID-19 immunisation. On 04Jun2021 at 21:00 the patient experienced chills, 104 degree fever, body aches even in feet, loss of appetite, loss of taste, metal taste and headache. On 04Jun2021, the patient underwent body temperature and the result was 104 degree fever. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events chills, 104 degree fever, body aches even in feet, loss of appetite, loss of taste, metal taste and headache were not recovered at the time of this report.   No follow-up attempts needed; No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Skin warm
Clinical narrative: Left hand and fingers: warm; Left hand and fingers: tingling; Left hand and fingers: numbness; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Jun2021 at 00:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included acetylsalicylic acid (aspirin) (MANUFACTURER UNKNOWN) and vitex agnus-castus (VITEX) for an unknown indication on an unknown date. 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 07Jun2021 at 14:00, the patient experienced left hand and fingers: warm, tingling and numbness. Therapeutic measures were not taken as a result of the events. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left hand and fingers: warm, tingling and numbness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 19-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 06Jun2021 at 13:15 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously took hydrocodone (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN) and escitalopram oxalate (ESCITALOPRAM), both from an unknown date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jun2021 at 14:15, the patient experienced arm soreness. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness was recovering 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.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia, Sinus disorder
Clinical narrative: nauseated; fever; diarrhea; achy; my sinuses is clear today than normal; This is a spontaneous report from a contactable consumer (Patient) based on the information received by Pfizer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nauseated, fever, diarrhea, achy and my sinuses is clear today than normal. Patient stated that my sinuses is clear today than normal. Patient reported that he received his second dose of the Pfizer Covid Vaccine on Saturday and on Sunday he started to feel nauseated (with no vomiting), fever, diarrhea, and achy. Patient reported he is fine now. The outcome of event my sinuses is clear today than normal was recovering and all other events were recovered on an unspecified date.   Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Chills, Diarrhoea, Dyspnoea
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; Shortness of breath; fever; chills; headache; body ache; soar throat; runny nose; fatigue; vomiting; diarrhea; loss of smell; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: Ew0158), at the age of 31 years old, in left arm on 15Apr2021 at 16:00 at single dose for COVID-19 immunisation. Medical history included allergies to penicillin and lactose intolerant. The patient had no COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced shortness of breath, fever, chills, headache, body ache, soar throat, runny nose, fatigue, vomiting, diarrhea and loss of smell on 18Apr2021 at 12:00. No treatment received for the events. The patient experienced COVID-19 confirmed by positive COVID-19 test on 19Apr2021. The patient had been tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included rapid COVID-19 test (Nasal Swab): positive on 19Apr2021 and rapid COVID-19 test: negative on 05May2021. The outcome of the event COVID-19 was recovered on 05May2021. The outcome of other events was recovered with sequel (recovered with lasting effects).  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; Shortness of breath; fever; chills; headache; body ache; soar throat; runny nose; fatigue; vomiting; diarrhea; loss of smell; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: Ew0158), at the age of 31 years old, in left arm on 15Apr2021 at 16:00 at single dose for COVID-19 immunisation. Medical history included allergies to penicillin and lactose intolerant. The patient had no COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced shortness of breath, fever, chills, headache, body ache, soar throat, runny nose, fatigue, vomiting, diarrhea and loss of smell on 18Apr2021 at 12:00. No treatment received for the events. The patient experienced COVID-19 confirmed by positive COVID-19 test on 19Apr2021. The patient had been tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included rapid COVID-19 test (Nasal Swab): positive on 19Apr2021 and rapid COVID-19 test: negative on 05May2021. The outcome of the event COVID-19 was recovered on 05May2021. The outcome of other events was recovered with sequel (recovered with lasting effects).  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; Shortness of breath; fever; chills; headache; body ache; soar throat; runny nose; fatigue; vomiting; diarrhea; loss of smell; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: Ew0158), at the age of 31 years old, in left arm on 15Apr2021 at 16:00 at single dose for COVID-19 immunisation. Medical history included allergies to penicillin and lactose intolerant. The patient had no COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced shortness of breath, fever, chills, headache, body ache, soar throat, runny nose, fatigue, vomiting, diarrhea and loss of smell on 18Apr2021 at 12:00. No treatment received for the events. The patient experienced COVID-19 confirmed by positive COVID-19 test on 19Apr2021. The patient had been tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included rapid COVID-19 test (Nasal Swab): positive on 19Apr2021 and rapid COVID-19 test: negative on 05May2021. The outcome of the event COVID-19 was recovered on 05May2021. The outcome of other events was recovered with sequel (recovered with lasting effects).  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal lesion, Vaginal ulceration
Clinical narrative: Vaginal lesions/ulcers within two days of receiving both the first dose and the second dose of the vaccine.; Vaginal lesions/ulcers within two days of receiving both the first dose and the second dose of the vaccine.; This is a spontaneous report from a contactable consumer. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0185) via an unspecified route of administration in the arm left on 14May2021(at the age of 13-year-old) and second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0217) via an unspecified route of administration in the arm left on 04Jun2021(at the age of 13-year-old) as a dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, 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 other vaccines within four weeks prior to the vaccination. On an unknown date in May2021,  the patient experienced vaginal lesions/ulcers within two days of receiving both the first dose and the second dose of the vaccine. It was reported that the patient previously had COVID-19 four weeks before her first vaccine dose. The patient was 13 years and is not sexually active. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events.  On an unknown date, the patient underwent HSV(Herpes simplex virus), HPV(Human papillomavirus), GBS(Group B streptococcus) and various STDs(Sexually transmitted diseases) test and all tested negative. The clinical outcome of the event vaginal lesions and vaginal ulcers was not recovered at the time of this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: feel extremely fatigued with 101 fever; feel extremely fatigued with 101 fever; no appetite; head/body aches; head/body aches; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0170) dose 1 via an unspecified route of administration in left arm on 28Apr2021 at 01:30 PM (at the age of 29-year-old) as single dose for COVID-19 immunisation in Hospital. Medical history included asthma, PCOS/ Polycystic ovarian syndrome, allergies to sulfa drugs, raw apples, covid-19 (prior vaccination). Concomitant medications were none. No other vaccine in four weeks. In 2021, 1st dose made her feel extremely fatigued with 101 fever, no appetite, & head/body aches. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feel extremely fatigued with 101 fever; feel extremely fatigued with 101 fever; no appetite; head/body aches; head/body aches; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0170) dose 1 via an unspecified route of administration in left arm on 28Apr2021 at 01:30 PM (at the age of 29-year-old) as single dose for COVID-19 immunisation in Hospital. Medical history included asthma, PCOS/ Polycystic ovarian syndrome, allergies to sulfa drugs, raw apples, covid-19 (prior vaccination). Concomitant medications were none. No other vaccine in four weeks. In 2021, 1st dose made her feel extremely fatigued with 101 fever, no appetite, & head/body aches. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness; Itching; Slightly warm at injection site; Swollen at injection site; This is a spontaneous report from a non-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: EW0175) via an unspecified route of administration in the left arm on 04Jun2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Hypertension (HTN), Gastroesophageal Reflux Disease (GERD), arthritis, asthma and COVID-19. The patient had no any known allergies. Concomitant medications included diltiazem (CARDIZEM), metoprolol (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and meloxicam (MELOXIC), all taken for unspecified indications from unknown dates. Prior to vaccination, 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 other vaccines within 4 weeks prior to the COVID vaccine.  On 04Jun2021 at 11:30, the patient experienced redness, itching, slightly warm and swollen at injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events redness, itching, slightly warm and swollen at injection site were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER. BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Jun2021 at 10:00 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 12:00 (at the age of 12-year-old) as a single dose for COVID-19 immunisation and received  a second dose of hpv vaccine (MANUFACTURER UNKNOWN) in the left arm on 03Jun2021 for immunisation within four weeks prior to the vaccination. 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 06Jun2021 at 16:00, 6 hours after vaccination, the patient experienced sore throat and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore throat and fever was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: fever; chils; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via intramuscular route of administration in the arm left on 06Jun2021 at 09:15(at the age of 12-year-old) as a single dose for COVID-19 immunisation. Medical history included lactose intolerance. Concomitant medications included tilactase (LACTAID) from unknown date for lactose intolerance. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via intramuscular route of administration in the left arm on 16May2021 at 10:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Prior to 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 07Jun2021 at 06:30 the patient experienced fever, chills and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment with Ibuprofen. The clinical outcome of the event fever, chills and nausea was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia
Clinical narrative: Insomnia; Extreme fatigue mixed with insomnia; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0202) via an unspecified route of administration in the right arm on 07Jun2021 at 12:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any other medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 17May2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Jun2021, the patient experienced extreme fatigue mixed with insomnia. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events extreme fatigue mixed with insomnia was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache; Fever; Fatigue; Joint pain; Muscle pain; Nausea; This is a spontaneous report from a non-contactable pharmacist, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 05Jun2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 08May2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Jun2021, the patient experienced headache, fever, fatigue, joint pain, muscle pain and nausea. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fever, fatigue, joint pain, muscle pain and nausea was recovering 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Fever; Fatigue; Joint pain; Muscle pain; Nausea; This is a spontaneous report from a non-contactable pharmacist, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 05Jun2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 08May2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Jun2021, the patient experienced headache, fever, fatigue, joint pain, muscle pain and nausea. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fever, fatigue, joint pain, muscle pain and nausea was recovering 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.