chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore; This is a spontaneous report from a contactable consumer, the patient. A 55-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 14Apr2021 at 14:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, hypertension and hyperlipidemia. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and golimumab (SIMPONI); all medications for an unknown indication from an unknown date and unknown if ongoing. On 17Apr2021 at 09:00, the patient experienced cold sore. The event did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with ABREVA. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold sore was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: Allergic reaction to the sun; Red rash on exposed skin that was itchy; Red rash on exposed skin that was itchy; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male 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 13Apr2021 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, allergy to cats and overweight. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), topiramate (MANUFACTURER UNKNOWN) and montelukast sodium (SINGULAIR); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 09:30 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. On 13Apr2021 at 14:00, few hours after receiving the second dose, the patient had an allergic reaction to the sun within two minutes of exposure and also had red rash on exposed skin that was itchy. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 allergic reaction to the sun, red rash on exposed skin that was itchy was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting, Weight, Weight decreased
Clinical narrative: An 18 hour bout of fever; cyclical vomiting; Lost 7 pounds in 72 hours. This is a spontaneous report from a contactable consumer (patient) reported for herself. A 49-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ep7533, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 09Mar2021 at 14:00 pm (age at vaccination was 49 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered was  Health Clinic/ Administration facility. 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 16Mar2021 at 20:00 pm, the patient experienced an 18 hour bout of fever, cyclical vomiting and the patient lost 7 pounds in 72 hours. The patient received treatment with Phenegren. The patient recovered with lasting effects. The outcome of the events was resolved with sequel on an unspecified date in 2021.   No follow-up attempts are required. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dermatitis contact, Headache, Palpitations, Pruritus
Clinical narrative: Break out on the skin/ spread as a rash under the ribcage and back; Break out on the skin that looked like poison ivy; Itchy; In some spots oozing.; Bad headache; Chills; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 60-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 11Apr2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 00:00, the patient experienced break out on the skin that looked like poison ivy but spread as a rash under the ribcage and back, itchy and in some spots oozing, bad headache, chills and heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 breaks out on the skin that looked like poison ivy but spread as a rash under the ribcage and back, itchy and in some spots oozing, bad headache, chills and heart palpitations was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin weeping
Clinical narrative: Break out on the skin/ spread as a rash under the ribcage and back; Break out on the skin that looked like poison ivy; Itchy; In some spots oozing.; Bad headache; Chills; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 60-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 11Apr2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 00:00, the patient experienced break out on the skin that looked like poison ivy but spread as a rash under the ribcage and back, itchy and in some spots oozing, bad headache, chills and heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 breaks out on the skin that looked like poison ivy but spread as a rash under the ribcage and back, itchy and in some spots oozing, bad headache, chills and heart palpitations was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Hyperhidrosis, Neck mass, Neck pain
Clinical narrative: Pain started to radiate up my arm, from the injection site, up to my neck and collar bone; Pain in neck/ The lump was painful to the touch.; Firm lump the size of a marble on neck; Area is also red and swollen; Area is also red and swollen; Sweat profusely; Pain has begun to radiate up the left side of head; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0161) via an unspecified route of administration in the arm left on 19Apr2021 at 11:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Apr2021, the patient experienced pain started to radiate up her arm, from the injection site, up to her neck and collar bone, pain in neck, and upon inspection found a firm lump the size of a marble on neck. The area was also red and swollen. The lump was painful to the touch. She began to sweat profusely the at the time the pain started and the pain had begun to radiate up the left side of her head. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the reported events. The clinical outcome of the events pain started to radiate up her arm, from the injection site, up to her neck and collar bone, pain in neck, firm lump the size of a marble on neck, area was red and swollen, sweat profusely and pain begun to radiate up the left side of her head was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Pain started to radiate up my arm, from the injection site, up to my neck and collar bone; Pain in neck/ The lump was painful to the touch.; Firm lump the size of a marble on neck; Area is also red and swollen; Area is also red and swollen; Sweat profusely; Pain has begun to radiate up the left side of head; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0161) via an unspecified route of administration in the arm left on 19Apr2021 at 11:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Apr2021, the patient experienced pain started to radiate up her arm, from the injection site, up to her neck and collar bone, pain in neck, and upon inspection found a firm lump the size of a marble on neck. The area was also red and swollen. The lump was painful to the touch. She began to sweat profusely the at the time the pain started and the pain had begun to radiate up the left side of her head. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the reported events. The clinical outcome of the events pain started to radiate up her arm, from the injection site, up to her neck and collar bone, pain in neck, firm lump the size of a marble on neck, area was red and swollen, sweat profusely and pain begun to radiate up the left side of her head was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Sleep disorder, Tinnitus
Clinical narrative: Severe tinnitus, affecting hearing and sleep.; Affecting hearing and sleep.; Affecting hearing and sleep.; This is a spontaneous report from a contactable consumer, the patient. A 48-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 26Feb2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 05Feb2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021, the patient experienced severe tinnitus, affecting hearing and sleep. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event severe tinnitus, affecting hearing and sleep was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Urticaria, Varicella
Clinical narrative: Swollen hands; Chicken pox/hives like symptoms; Chicken pox; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right  arm on 31Mar2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included known allergy to shrimp on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 20:00, the patient experienced swollen hands and chicken pox/hives like symptoms. 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 swollen hands and chicken pox/hives like symptoms was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Dry mouth, Heart rate increased
Clinical narrative: About 70 minutes after injection, heart rate shot and bp shot up.; About 70 minutes after injection, heart rate shot and bp shot up.; Dry mouth; Light headed; This is a spontaneous report from a non-contactable other healthcare professional (the patient). A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 026-596) via an unspecified route of administration in the right arm on 20Apr2021 at 09:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), vitamins (MANUFACTURER UNKNOWN) for unknown indications and oral birth control (MANUFACTURER UNKNOWN); all from an unknown date and unknown if ongoing. On 20Apr2021 at 10:45, about 70 minutes after injection, the patient's heart rate and blood pressure shot up. The patient experienced dry mouth and light headed. Requested paramedic evaluation but did not go to hospital. Could resume normal activities about an hour and a half after onset. The event resulted in 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 heart rate and blood pressure shot up, dry mouth and light headed was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: 16 hours from onset, thought ''I'' was improving, ''I'' then lost sense of taste; Shaky; Dizziness; 13 hours following onset of 2nd vaccine, started experiencing fever; Muscle ache; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient medical history reported was not applicable (n/a). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 29Mar2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 20Apr2021 at 03:30, 13 hours following onset of 2nd vaccine, the patient experienced, fever, muscle ache, head ache, shaky, fatigue and dizziness. 16 hours from onset, (20Apr2021 at 03:30) thought she was improving, she then lost sense of taste, but not sense of smell. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events fever, muscle ache, head ache, shaky, fatigue, dizziness and lost sense of taste was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: 16 hours from onset, thought ''I'' was improving, ''I'' then lost sense of taste; Shaky; Dizziness; 13 hours following onset of 2nd vaccine, started experiencing fever; Muscle ache; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient medical history reported was not applicable (n/a). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 29Mar2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 20Apr2021 at 03:30, 13 hours following onset of 2nd vaccine, the patient experienced, fever, muscle ache, head ache, shaky, fatigue and dizziness. 16 hours from onset, (20Apr2021 at 03:30) thought she was improving, she then lost sense of taste, but not sense of smell. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events fever, muscle ache, head ache, shaky, fatigue, dizziness and lost sense of taste was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Headache, Muscle spasms
Clinical narrative: severe violent  projectile vomiting of foam & bile; stomach spasms; arm pain; nausea; general weakness; headache; urticaria on abdomen & thighs; general muscle spasms; severe abdominal pain; This is a spontaneous report from a non-contactable consumer (patient).   A 52-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 09:30 (at the age of 52-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation, administered at Hospital.  Medical history included: breast cancer stage III Stage 3C breast cancer survivor, renal impairment chemo induced lower kidney functioning, obesity, asthma, Hashimoto's hypothyroidism, Known allergies: multiple antibiotics with anaphylaxis reactions, multiple foods tree nuts, melons, tomatoes, pork, etc. many with anaphylaxis reactions, environmental allergies like pine, grasses, pets, etc. various reactions. Patient was not pregnant. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); bupropion hydrochloride (WELLBUTRIN); oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]); ropinirole hydrochloride (REQUIP); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced severe violent projectile vomiting of foam & bile (medically significant) on 15Apr2021 20:00 with outcome of not recovered, stomach spasms (medically significant) on 15Apr2021 20:00 with outcome of not recovered, arm pain (non-serious) on 15Apr2021 20:00 with outcome of not recovered, nausea (non-serious) on 15Apr2021 20:00 with outcome of not recovered, general weakness (non-serious) on 15Apr2021 20:00 with outcome of not recovered, headache (non-serious) on 15Apr2021 20:00 with outcome of not recovered, urticaria on abdomen & thighs (non-serious) on 15Apr2021 20:00 with outcome of not recovered, general muscle spasms (non-serious) on 15Apr2021 20:00 with outcome of not recovered, severe abdominal pain (non-serious) on 15Apr2021 20:00 with outcome of not recovered. The clinical course of events was as follows: Day 1-3 minor, arm pain, nausea, general weakness, headache. Day 3-4 severe, headache, urticaria on abdomen & thighs, general muscle spasms, severe abdominal pain followed by 6-7 hours severe violent projectile vomiting of foam & bile needed Emergency Room treatment to stop stomach spasms. Therapeutic measures were taken as a result of events: patient received treatment with I.V. Zofran, Ativan, Compazine. COVID was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Urticaria, Vomiting projectile
Clinical narrative: severe violent  projectile vomiting of foam & bile; stomach spasms; arm pain; nausea; general weakness; headache; urticaria on abdomen & thighs; general muscle spasms; severe abdominal pain; This is a spontaneous report from a non-contactable consumer (patient).   A 52-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 09:30 (at the age of 52-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation, administered at Hospital.  Medical history included: breast cancer stage III Stage 3C breast cancer survivor, renal impairment chemo induced lower kidney functioning, obesity, asthma, Hashimoto's hypothyroidism, Known allergies: multiple antibiotics with anaphylaxis reactions, multiple foods tree nuts, melons, tomatoes, pork, etc. many with anaphylaxis reactions, environmental allergies like pine, grasses, pets, etc. various reactions. Patient was not pregnant. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); bupropion hydrochloride (WELLBUTRIN); oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]); ropinirole hydrochloride (REQUIP); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced severe violent projectile vomiting of foam & bile (medically significant) on 15Apr2021 20:00 with outcome of not recovered, stomach spasms (medically significant) on 15Apr2021 20:00 with outcome of not recovered, arm pain (non-serious) on 15Apr2021 20:00 with outcome of not recovered, nausea (non-serious) on 15Apr2021 20:00 with outcome of not recovered, general weakness (non-serious) on 15Apr2021 20:00 with outcome of not recovered, headache (non-serious) on 15Apr2021 20:00 with outcome of not recovered, urticaria on abdomen & thighs (non-serious) on 15Apr2021 20:00 with outcome of not recovered, general muscle spasms (non-serious) on 15Apr2021 20:00 with outcome of not recovered, severe abdominal pain (non-serious) on 15Apr2021 20:00 with outcome of not recovered. The clinical course of events was as follows: Day 1-3 minor, arm pain, nausea, general weakness, headache. Day 3-4 severe, headache, urticaria on abdomen & thighs, general muscle spasms, severe abdominal pain followed by 6-7 hours severe violent projectile vomiting of foam & bile needed Emergency Room treatment to stop stomach spasms. Therapeutic measures were taken as a result of events: patient received treatment with I.V. Zofran, Ativan, Compazine. COVID was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting; Diarrhea; 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: EW 0171) via an unspecified route of administration in the left arm on 20Apr2021 at 10:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included subclinical hypothyroidism and known allergies to almonds. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ norethisterone acetate (JUNEL), bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (LEVOXYL) and liothyronine sodium (CYTOMEL); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received omeprazole (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 21Apr2021 at 04:00, the patient experienced vomiting and diarrhea. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events vomiting and diarrhea was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Fever; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 15Apr2021 at 07:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medication within two weeks of vaccination. 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 as a single dose for COVID-19 immunisation. On 20Apr2021 at 12:30, the patient experienced sore throat, fever and exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore throat, fever and exhaustion was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Dose 1: 20210401Dose 2: 20210419; Fever chills with a temperature of 102.4 deg Fahrenheit; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 at 14:30(at the age of 46-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in left arm on 01Apr2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 09:00, the patient experienced fever chills with a temperature of 102.4 degree Fahrenheit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever chills was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Nausea; Tiredness; Injection site pain; Feeling unwell; 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: ER8727) via an unspecified route of administration in the left arm on 19Apr2021 at 15:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included iodine contrast media allergy, adhesive tape allergy, allergic to codeine and sulfur. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included hydrochlorothiazide/triamterene (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and unspecified vitamin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 29Mar2021 at 15:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 04:30, the patient experienced fever, chills, nausea, tiredness, injection site pain and feeling unwell. 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 fever, chills, nausea, tiredness, injection site pain and feeling unwell were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; Chills; Nausea; Tiredness; Injection site pain; Feeling unwell; 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: ER8727) via an unspecified route of administration in the left arm on 19Apr2021 at 15:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included iodine contrast media allergy, adhesive tape allergy, allergic to codeine and sulfur. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included hydrochlorothiazide/triamterene (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and unspecified vitamin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 29Mar2021 at 15:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 04:30, the patient experienced fever, chills, nausea, tiredness, injection site pain and feeling unwell. 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 fever, chills, nausea, tiredness, injection site pain and feeling unwell were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Headache, Pain
Clinical narrative: Chills; Body aches; Headache; Fever (100.8); Temporary cough lasting a few hours; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 23:00, roughly 12 hours after administration, the patient experienced chills, body aches, headache, fever (100.8) and temporary cough lasting a few hours. On 20Apr2021 at 23:00, the patient underwent lab test which included body temperature test and the result was found to be 100.8 (units unspecified). 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 chills, body aches, headache, fever (100.8) and temporary cough lasting a few hours were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Body aches; Headache; Fever (100.8); Temporary cough lasting a few hours; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 23:00, roughly 12 hours after administration, the patient experienced chills, body aches, headache, fever (100.8) and temporary cough lasting a few hours. On 20Apr2021 at 23:00, the patient underwent lab test which included body temperature test and the result was found to be 100.8 (units unspecified). 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 chills, body aches, headache, fever (100.8) and temporary cough lasting a few hours were resolving 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: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: transient urticaria; This is a spontaneous report from a contactable consumer (parent). A 16-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) Dose 1 via an unspecified route of administration, administered in the right arm on 03Apr2021 at 15:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included vitiligo from an unknown date and unknown if ongoing (mild vitiligo since age 4), and COVID-19 from an unknown date and unknown if ongoing (diagnosed prior to vaccination). Concomitant medications included ibuprofen, and paracetamol (TYLENOL); both for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced transient urticaria (medically significant) on 12Apr2021 at 11:30. Therapeutic measures were taken as a result of transient urticaria, which included diphenhydramine (BENADRYL), oral steroids, steroid shot, cetirizine hydrochloride (ZYRTEC), and famotidine (PEPCID). Urticaria had been going on for over 7 days at the time of the report. The patient had not recovered from the event.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Lethargy, Nasal congestion, Pain
Clinical narrative: Fever; Chills; Lethargy; Body aches; Congestion; Coughing; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 19Apr2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), rheumatoid arthritis and allergy to metal except for surgical steel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive concomitant medications. The patient previously received tramadol hydrochloride (ULTRAM) for unspecified indication from unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. On 20Apr2021 at 07:00, the patient experienced fever, chills, lethargy, body aches, congestion and coughing. 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 fever, chills, lethargy, body aches, congestion and coughing was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Lethargy; Body aches; Congestion; Coughing; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 19Apr2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), rheumatoid arthritis and allergy to metal except for surgical steel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive concomitant medications. The patient previously received tramadol hydrochloride (ULTRAM) for unspecified indication from unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. On 20Apr2021 at 07:00, the patient experienced fever, chills, lethargy, body aches, congestion and coughing. 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 fever, chills, lethargy, body aches, congestion and coughing was 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: Body temperature, Chills, Decreased appetite, Headache, Insomnia
Clinical narrative: Chills; Low grade fever (never got above 99); ZERO appetite; Tingly body; Odd nausea "ie". I didn't feel it in my stomach but in the back of my throat, verge of being sick and and knew that if had anything solid, would not digest it.; Mild sleepiness; Lethargy; Swollen lymph nodes; Illusive headache; Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 20Apr2021 at 18:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergic to sulfa antibiotics and lactose intolerance. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin b complex (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D) and montelukast sodium (SINGULAIR); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation.  On 20Apr2021 at 18:30, the patient experienced chills, low grade fever (never got above 99) , zero appetite, tingly body, odd nausea where she didn't felt it in her stomach but in the back of her throat and it was like on the verge of being sick and knew that if it had anything solid which would not digest it, mild sleepiness and lethargy, swollen lymph nodes, illusive headache and insomnia. She also reported that most of that was immediately after the shot and only lasted a few hours. On the same day, the patient underwent body temperature test and the result was below 99 (unspecified units). 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 chills, low grade fever (never got above 99), zero appetite, tingly body, odd nausea, mild sleepiness and lethargy, swollen lymph nodes, illusive headache and insomnia was recovering at the time of this report.     No follow-up attempts are needed. No further information is expected.