chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: My period was 45 days late; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 21Mar2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had allergies to bees and bay shrimp. The patient last menstrual period was on 07Feb2021. Concomitant medications included cholesterol meds. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 an unspecified date in 2021, the patient experienced (delayed periods) and felt that she was not sure if this was related to vaccine. However, her period was 45 days late. She did not go to her doctor thinking she was going through menopause due to her age. However, she was confused that her period just stopped them, her period started back up 45 days late. The period came again on 22Apr. The clinical outcome of delayed periods was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain in extremity
Clinical narrative: Dizzy immediately following injection; Tired; Nauseous; Sore arm; 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: ER8736) via an unspecified route of administration in the right arm on 29Apr2021 at 11:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included scoliosis. The patient did not receive any medication within two weeks of vaccination. The patient previously received unspecified 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 vaccination. On 29Apr2021, the patient experienced dizzy immediately following injection, tired, nauseous and sore arm. The clinical outcome of the events dizzy immediately following injection, tired, nauseous and sore arm was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Very warm sensation on inner right lower leg that comes and goes. It moves down the leg like a liquid was going down the leg. This happens several times a day, whether sitting, laying down or standing; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 09Apr2021 at 14:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin, sulfur drugs and seasonal pollen. Concomitant medications included probiotics (MANUFACTURER UNKNOWN). 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 19Apr2021, the patient experienced very warm sensation on inner right lower leg that comes and goes. It moved down the leg like a liquid was going down the leg. This happened several times a day, whether sitting, laying down or standing (sensation of warmth). The clinical outcome of the event sensation of warmth was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in face beginning 20 minutes after vaccine, subsiding 5 hours later. This happened after both shots but was worse after the second dose. No other symptoms.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration  on an unknown date and a second dose of BNT162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 02May2021(at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included budesonide (PULMICORT), allium sativum (KYOLIC), vitamin d nos (VIT D) and budesonide (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. 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-19 vaccination. On an unknown date in 2021, the patient experienced numbness in face. This happened after both shots but was worse after the second dose. The event began 20 minutes after second dose and subsided 5 hours later. The patient had no other symptoms. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event numbness in face was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menopause, Night sweats
Clinical narrative: Night sweats (2-3times daily) and 2-3 times during sleep; back in full blown menopause; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 03Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included menopause (at the age of fifty-five years old). Concomitant medications included sertraline hydrochloride (ZOLOFT) and lorazepam (MANUFACTURER UNKNOWN). The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 25Feb2021 at 11:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient experienced night sweats (two-three times daily) and two-three times during sleep since the patient received the last vaccine and the patient honestly felt back in full blown menopause. The clinical outcome of the event night sweats and back in full blown menopause was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: The lymph nodes under my right arm (injection arm) became swollen and achy.; The lymph nodes under my right arm (injection arm) became swollen and achy.; Lymph node pain had spread from just under my right arm pit up and over to part of my right breast towards the collar bone.; 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: EW0170) via an unspecified route of administration in the right arm on 27Apr2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and seasonal allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), ibuprofen (MANUFACTURER UNKNOWN) and birth control (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 14:15 (at the age of 44-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 28Apr2021 at 12:00, within 24 hours of the second injection, the patient experienced that the lymph nodes under her right arm (injection arm) became swollen and achy. The patient was unable to wear a bra due to the restrictive nature. Therapeutic measure were taken as a result of adverse events and included treatment with ibuprofen (ADVIL). When the ibuprofen wore off, the patient could feel the lymph node pain had spread from just under her right arm pit up and over to part of her right breast towards the collar bone. The lymph node pain began mid-Wednesday and lasted through Thursday. She did not have to take any ibuprofen for the pain on Friday. The clinical outcome of the events lymph nodes under right arm was swollen and achy and pain spread to right breast towards the collar bone were resolved on 29Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Herpes zoster, Nausea, Neuralgia
Clinical narrative: creating shingles/pityriasis type reaction; creating shingles/pityriasis type reaction; nerve ending pain, nerve pain,; nausea; itchy rashes on feet; body aches; chills.; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 56-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 an unknown date in Apr2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure and herpes. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Apr2021 at 07:00, the patient experienced shingles/pityriasis type reaction, nerve ending pain, nerve pain, nausea, itchy rashes on feet. It was reported that nine days of all symptoms. The patient also experienced body aches, chills and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken for the reported events and included treatment with steroid cream for feet, and now acyclovir from the patient. On 02May2021, the patient underwent rapid and full nasal swab COVID-19 test and the result was negative. The clinical outcome of the events creating shingles/pityriasis type reaction, nerve ending pain, nerve pain, nausea, itchy rashes on feet, body aches, chills and fatigue was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pityriasis, Rash pruritic, SARS-CoV-2 test
Clinical narrative: creating shingles/pityriasis type reaction; creating shingles/pityriasis type reaction; nerve ending pain, nerve pain,; nausea; itchy rashes on feet; body aches; chills.; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 56-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 an unknown date in Apr2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure and herpes. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Apr2021 at 07:00, the patient experienced shingles/pityriasis type reaction, nerve ending pain, nerve pain, nausea, itchy rashes on feet. It was reported that nine days of all symptoms. The patient also experienced body aches, chills and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken for the reported events and included treatment with steroid cream for feet, and now acyclovir from the patient. On 02May2021, the patient underwent rapid and full nasal swab COVID-19 test and the result was negative. The clinical outcome of the events creating shingles/pityriasis type reaction, nerve ending pain, nerve pain, nausea, itchy rashes on feet, body aches, chills and fatigue was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Headache; Joint pain/ache; Fatigue; Chills; This is a spontaneous report from a contactable consumer, the patient. A 21-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 arm left on 30Apr2021 at 15:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 09Apr2021 at 15:15 (at the age of 21-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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021, the patient experienced headache, joint pain/ache, chills, fatigue (but not debilitatingly so). 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. On 01May2021, patient underwent lab test which included nasal swab for SARS CoV-2 test and the result was negative. The clinical outcome of the event headache, joint pain/ache, chills, fatigue were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Oral fungal infection, Oral herpes
Clinical narrative: Multiple cold sores on lips; Fungal infection in mouth; This is a spontaneous report from a contactable consumer, the parent. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO0171) via an unspecified route of administration in the right arm on 23Apr2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included Angelman syndrome with severe disability and COVID-19. Concomitant medications included phenobarbital (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL2613) via unspecified route of administration in the left arm on 02Apr2021 (at the age of 45-year-old) as single dose of COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Apr2021, the patient experienced, multiple cold sores on lips and fungal infection in mouth. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received glucose azole (MANUFACTURER UNKNOWN) as a treatment for the events multiple cold sores on lips and fungal infection in mouth. The clinical outcome of the events cold sores on lips and fungal infection in mouth were resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Swollen lymph node; pain on left side of throat; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 15Apr2021 at 11:15 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included inositol (MYO INOSITOL) for unknown indication and unspecified birth control pill; both from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 03:00 the patient experienced swollen lymph node and pain on left side of throat. The clinical outcome of the events swollen lymph node and throat pain was recovered on an unknown date of 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: Vomiting; Body Chills; abdominal pains; body aches,; sharp pains in knees,; back spasms; and violent headaches,; warmth throughout the body,; severe exhaustion.; 100F; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male 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 30Apr2021 at 14:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included asthmatic and mushroom allergy (Food allergy). The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 06:00 the patient experienced vomiting, body chills, 100 degrees Fahrenheit, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion. The clinical outcome of the events vomiting, body chills, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion and 100 degrees Fahrenheit were recovering at the time of the report.   No follow-up attempts are needed; information about the lot number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Muscle spasms, Pain, Pyrexia
Clinical narrative: Vomiting; Body Chills; abdominal pains; body aches,; sharp pains in knees,; back spasms; and violent headaches,; warmth throughout the body,; severe exhaustion.; 100F; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male 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 30Apr2021 at 14:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included asthmatic and mushroom allergy (Food allergy). The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 06:00 the patient experienced vomiting, body chills, 100 degrees Fahrenheit, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion. The clinical outcome of the events vomiting, body chills, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion and 100 degrees Fahrenheit were recovering at the time of the report.   No follow-up attempts are needed; information about the lot number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Body Chills; abdominal pains; body aches,; sharp pains in knees,; back spasms; and violent headaches,; warmth throughout the body,; severe exhaustion.; 100F; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male 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 30Apr2021 at 14:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included asthmatic and mushroom allergy (Food allergy). The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 06:00 the patient experienced vomiting, body chills, 100 degrees Fahrenheit, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion. The clinical outcome of the events vomiting, body chills, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion and 100 degrees Fahrenheit were recovering at the time of the report.   No follow-up attempts are needed; information about the lot number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Chills; Severe Headache; Fever of 102 (Fahrenheit); This is a spontaneous report from a contactable consumer, the patient. A 22-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0162) via an unspecified route of administration, in the left arm on 30Apr2021 at 15:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic anaemia and low oxygenation. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration, in the left arm on 09Apr2021 at 15:30 (at the age of 22-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 tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01May2021, at 00:00 the patient experienced chills, severe headache, and fever of 102 (Fahrenheit). Therapeutic measures were not reported as the result of adverse events. The clinical outcome of the events chills, severe headache, and fever was recovered in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Armpit was very swollen and hurt; Armpit was very swollen and hurt; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 16:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included panic disorder, depression and blood pressure high. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), topiramate (TOPIMAX) and amlodipine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received latex, morphine (MANUFACTURER UNKNOWN), nickel and BUSPAR on an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 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 COVID-19 vaccine. On 29Apr2021 at 03:00, the patient armpit was very swollen and hurt on the same arm were shot was administered. The patient armpit was so swollen and was unable put the arm down all the way. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the reported events and included treatment with acetaminophen (TYLENOL) every 4-6 hours, ice and ultrasound examination. The clinical outcome of the event lymphadenopathy axillary and axillary pain was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Rash erythematous, Rash pruritic
Clinical narrative: Back of hands, elbows, thighs, knees have been itchy; Flushed; Regular rash. Knuckles, elbows, knees flushed in red and warm.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm left on 21Apr2021(at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and past drug history were reported as no. Concomitant medications were reported as not applicable. 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 COVID-19 vaccine. On an unknown date in Apr2021, a week after receiving the vaccine the patient experienced itchy and flushed on back of hands, elbows, thighs, knees for past 4 days. No visible, regular rash. Knuckles, elbows, knees flushed in red and warm. Therapeutic measures were taken for the reported events and included treatment with oral antihistamine(unspecified). Itching had minimally reduced with oral antihistamine. The event 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 Itchy rash, flushed and red rash was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: low grade fever 99.2; Headache.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: We 8731), via an unspecified route of administration on 16Apr2021 at 16:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep 6955), via an unspecified route of administration in the left arm on 22Mar2021 at 12:30 (at the age of 55- 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-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 17Apr2021 at 12:00, the patient experienced a low-grade fever of 99.2 (unspecified units) for more than two weeks since the second shot which was accompanied with an occasional headache. The patient reported that her normal temperature was 97.8 (unspecified units). On 17Apr2021, the patient underwent a body temperature measurement and result was found to be 99.2 (unspecified units). The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of all the events low grade fever and headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fatigue; sore arm; low grade fever; shortness of breath; This is a spontaneous report from a non-contactable consumer or other non hcp. A 32-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration, administered in arm left on 30Apr2021 at 10:00 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation. Patient medical history included drug hypersensitivity. The patient was allergic to Amoxicillin and ceclor. Concomitant medication included vitamin c [ascorbic acid], multivitamins [vitamins nos], biotin, quetiapine fumarate (SEROQUEL) and vilazodone hydrochloride (VIIBRYD). Patient historical vaccine included received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 09Apr2021 at 10:00 for covid-19 immunization. It was unknown if the patient was covid prior vaccination. On 30Apr2021 at 12:00, the patient experienced fatigue, sore arm, low grade fever and shortness of breath. Patient did not test for covid post vaccination. Facility where the most recent COVID-19 vaccine was administered was a pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was provided as 01May2021. Outcome of the events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Fatigue, Feeling abnormal, Muscular weakness
Clinical narrative: very tried; legs felt weak; foggy; could not breath; This is a spontaneous report from a contactable consumer or other non-HCP. A 67-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 13Apr2021 08:35 AM (age at the time of vaccination 67-years-old), as a single dose for COVID-9 immunization. The patient's medical history included PAD, has had an operation on each leg; bypass on each leg, had to have a bypass on each leg; and COPD, he may have COPD as well they are still doing tests to see. The patient's concomitant medication was not reported. On 13Apr2021, the patient experienced very tried, legs felt weak, foggy, and on an unspecified date 2021, the patient experienced could not breath. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 test: he didn't have it, he was having bad coughing spells. The outcome for all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: her chest feel tight also felt like her breathing is off.; her chest feel tight also felt like her breathing is off.; This is a spontaneous report from a Pfizer sponsored program COVAX US support from a non-contactable female consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (Pfizer COVID-19 Vaccine, Solution for Injection), via an unspecified route on 16Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced her chest feel tight also felt like her breathing is off. She wanted to know could she wait longer than the 21 days and how much longer could she wait. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular, Nausea, Vaginal haemorrhage, Vulvovaginal pain
Clinical narrative: cramping with a lot of pain; I was spot bleeding; By April 24th I was cramping with a lot of pain and bleeding.; I was supposed to start my period April 27/28; nauseous; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ew0161), dose 1 via an unspecified route of admin-istration, administered in Arm Left on 16Apr2021 at 15:15 (at the age of 35-years-old) as single dose for covid-19 immunisation. Medical history included none. Concomitant medication included semaglutide (OZEMPIC), ethinylestradiol, norethisterone acetate (AUROVELA 1.5/30) taken for unspecified indication from unknown date. The patient previously took amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 17:00 (in less than 24 hours after receiving the vaccine), the patient was started with the event of spot bleeding, by april 24th, was cramping with a lot of pain and bleeding, She reported that she does not usually have painful cramps and have been randomly nauseous since getting her vaccine shot. she was supposed to start her period april 27/28. Facility where the most recent COVID-19 vaccine was administered was a pharmacy or Drug Store. All the seriousness criteria was reported as no'.  It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was provided as 28Apr2021. Outcome of the events were unknown.  Information about Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Gingival bleeding, Incontinence
Clinical narrative: Hair on head is falling out/thinning; gums bled more than usual during dental cleaning; slight incontinence that seems to be worsening (not associated with toileting).; This is a spontaneous report from a contactable nurse (patient). A 53-years-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6208), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 (at the age of 53-years-old) as a dose 2, single for covid-19 immunization. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. The patient previously took keflex [cefalexin monohydrate] and and sulfa [sulfacetamide sodium] and experienced drug hypersensitivity. Concomitant medications taken within 2 weeks of vaccination included canagliflozin (INVOKANA [CANAGLIFLOZIN]) and metformin (METFORMIN) both were taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 01:00 PM as a dose 1, single for covid-19 immunization. After dose 1, Patient experienced there was pain in my joints (knees and hip) and hematoma-like bruising on my palm after using a hammer (it disappeared after a couple days and left no residual markings). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date, the patient experienced Hair on head is falling out/thinning, gums bled more than usual during dental cleaning, slight incontinence that seems to be worsening (not associated with toileting). Outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: bled really bad; This is a spontaneous report from a contactable consumer reported for a patient (consumers son) via a Pfizer sponsored program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 03May2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter mentioned his son got his 2nd dose that day and mentioned upon administering the vaccine he bleed really bad on an unspecified date. Reporter asked if it was injected in the vein or in his blood vessel. Reporter stated that his son did not take blood thinners. The outcome of the event was unknown.  No follow up attempts are needed. Information on lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Stasis dermatitis
Clinical narrative: Stasis dermatitis/dermatitis got worse after taking the Pfizer COVID-19 shots.; I experienced insomnia for about three nights after taking the COVID-19 Pfizer vaccine.  I continue to have insomnia from time to time.; This is a spontaneous report from a contactable consumer, reported for himself. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), dose 2 via an unspecified route of administration on right arm on 27Feb2021 13:00 as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on left arm on 06Feb2021 13:00 as a single dose for covid-19 immunization. Medical history included spinal stenosis, hypertension, stasis dermatitis. Concomitant medication(s) and received within 2 weeks of vaccination included hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ). The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination- allergy shot- on 19Feb2021, Pulmonary Associates. 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 had known allergies with ciprofloxacin, prednisone. On 28Feb2021 12:00, the patient experienced insomnia for about three nights after taking the covid-19 pfizer vaccine and continue to have insomnia from time to time. For this event he did not received any treatment. On 31Mar2021 12:00, he was being treated for stasis dermatitis at the Dermatology Center. It seems the dermatitis got worse after taking the Pfizer COVID-19 shots and a steroid shot was administered as treatment. Outcome of the event insomnia was resolving and other was not resolved. Follow-up attempts are possible. Further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dermatitis, Erythema, Pruritus, Stasis dermatitis
Clinical narrative: Stasis dermatitis/dermatitis got worse after taking the Pfizer COVID-19 shots.; I experienced insomnia for about three nights after taking the COVID-19 Pfizer vaccine.  I continue to have insomnia from time to time.; This is a spontaneous report from a contactable consumer, reported for himself. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), dose 2 via an unspecified route of administration on right arm on 27Feb2021 13:00 as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on left arm on 06Feb2021 13:00 as a single dose for covid-19 immunization. Medical history included spinal stenosis, hypertension, stasis dermatitis. Concomitant medication(s) and received within 2 weeks of vaccination included hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ). The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination- allergy shot- on 19Feb2021, Pulmonary Associates. 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 had known allergies with ciprofloxacin, prednisone. On 28Feb2021 12:00, the patient experienced insomnia for about three nights after taking the covid-19 pfizer vaccine and continue to have insomnia from time to time. For this event he did not received any treatment. On 31Mar2021 12:00, he was being treated for stasis dermatitis at the Dermatology Center. It seems the dermatitis got worse after taking the Pfizer COVID-19 shots and a steroid shot was administered as treatment. Outcome of the event insomnia was resolving and other was not resolved. Follow-up attempts are possible. Further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Stasis dermatitis/dermatitis got worse after taking the Pfizer COVID-19 shots.; I experienced insomnia for about three nights after taking the COVID-19 Pfizer vaccine.  I continue to have insomnia from time to time.; This is a spontaneous report from a contactable consumer, reported for himself. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), dose 2 via an unspecified route of administration on right arm on 27Feb2021 13:00 as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on left arm on 06Feb2021 13:00 as a single dose for covid-19 immunization. Medical history included spinal stenosis, hypertension, stasis dermatitis. Concomitant medication(s) and received within 2 weeks of vaccination included hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ). The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination- allergy shot- on 19Feb2021, Pulmonary Associates. 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 had known allergies with ciprofloxacin, prednisone. On 28Feb2021 12:00, the patient experienced insomnia for about three nights after taking the covid-19 pfizer vaccine and continue to have insomnia from time to time. For this event he did not received any treatment. On 31Mar2021 12:00, he was being treated for stasis dermatitis at the Dermatology Center. It seems the dermatitis got worse after taking the Pfizer COVID-19 shots and a steroid shot was administered as treatment. Outcome of the event insomnia was resolving and other was not resolved. Follow-up attempts are possible. Further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 16-years-old male patient received bnt162b2 (BNT162B2; Batch/Lot number was not reported), via an unspecified route of administration on 02May2021 11:00 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03May2021, the patient experienced high fever, chest pain and having trouble, like it hurts when he takes breath, ache. It was reported, reporter's son had the Pfizer vaccine, yesterday at 11AM, and he was fine and then this morning he had a high fever, the ache, all of that, but now, you know I have given him some Tylenol (treatment). He 16 and half, 17 in September and he was now complaining of some chest pain and having trouble, like it hurts when he takes breath, was this something that's normal, because have not heard about of this side effect. Therapeutic measures were taken as a result of events which includes TYLENOL. The clinical outcome for all events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.