chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Pyrexia
Clinical narrative: 103 fever; Migraine; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 27Aug2021 at 18:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took cephalosporin nos (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy and previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 06Aug2021 at 06:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Aug2021 at 13:00, the patient experienced 103 fever and migraine. On 28Aug2021 at 13:00, the patient underwent lab tests and investigations that included body temperature and the result was 103 (unspecified units). The 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 103 fever and migraine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 103 fever and migraine was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Feeling cold, Vision blurred
Clinical narrative: began to feel a cold run all over my body; felt pressure dropped; felt very weak; dizziness / felt that I was going to faint; Vision blurred; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3185) via an unspecified route of administration in the left arm on 27Aug2021 at 08:45 (at the age of 55-years-old) as a single dose for COVID-19immunisation. The patient did not have any relevant medical history. It was unknown if the patient had any allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Aug2021 at 09:15, after 30 minutes of taking the first dose, the patient experienced cold run all over body, felt that her pressure dropped, felt very weak with dizziness, vision blurred and felt that she was going to faint, all these feelings stayed for at least 4 hours. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events felt cold run all over body, pressure dropped, very weak with dizziness, vision blurred and felt faint were resolving at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain, Poor quality sleep, Pyrexia
Clinical narrative: Severe vomiting; severe fever; severe pain all over body; Sever neck pain; Severe head pain; Cannot sleep; This is a spontaneous report from a contactable consumer, the patient. A 30-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 31Aug2021 at 14:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any 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 on an unknown date as a single dose for 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 vaccination within two weeks prior to the COVID-19 vaccine. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 31Aug2021 at 22:00, the patient experienced severe vomiting, severe fever, severe pain all over body, severe neck, head pain and cannot sleep. The 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 result of these events. The clinical outcome of the events severe vomiting, severe fever, severe pain all over body, severe neck, head pain and cannot sleep were not recovered at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe vomiting; severe fever; severe pain all over body; Sever neck pain; Severe head pain; Cannot sleep; This is a spontaneous report from a contactable consumer, the patient. A 30-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 31Aug2021 at 14:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any 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 on an unknown date as a single dose for 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 vaccination within two weeks prior to the COVID-19 vaccine. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 31Aug2021 at 22:00, the patient experienced severe vomiting, severe fever, severe pain all over body, severe neck, head pain and cannot sleep. The 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 result of these events. The clinical outcome of the events severe vomiting, severe fever, severe pain all over body, severe neck, head pain and cannot sleep were not recovered at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for the COVID; tested positive for the COVID; This is a spontaneous report from a contactable consumer. An unknown age female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number were not reported) dose 2 via unknown route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. the patient past drug therapy included bnt162b2 (dose 1, single) for COVID-19 Immunisation on an unspecified date. The patient would like to submit a complaint about there isn't a site that the patient can report that she have severe symptoms and tested positive for the COVID-19, 5 months after the second dose. She would like to be part of the trial to show why some people we get sick with the COVID-19 even already fully vaccinated with pfizer. The patient underwent lab tests and procedures which included COVID-19 test was positive on an unknown date. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Fatigue; Headache; Body aches; Fever; Chills; Soar arm; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Aug2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 27Aug2021, the patient experienced fatigue, headaches, body aches, fever, chills, sore arm and diarrhea. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were 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 fatigue, headache, body aches, fever, chills, sore arm and diarrhea were not resolved at the time of this report.  The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fatigue; Headache; Body aches; Fever; Chills; Soar arm; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Aug2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 27Aug2021, the patient experienced fatigue, headaches, body aches, fever, chills, sore arm and diarrhea. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were 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 fatigue, headache, body aches, fever, chills, sore arm and diarrhea were not resolved at the time of this report.  The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Biopsy, Body temperature, Breast mass
Clinical narrative: Fever of 102.7 for 2 days; Hives on trunk; Extremely sore breasts/armpits; Extremely sore breasts/armpits; Painful lumps; Painful lumps; 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: EW0161) via an unspecified route of administration in the right arm on 28Apr2021 at 10:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included diverticulitis, traumatic brain injury (TBI) and allergies which were unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received unspecified medication within two weeks of the vaccination. 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 right arm on 07Apr2021 at 10:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 13:00 the patient experienced a fever of 102.7 (Unspecified units) for two days, hives on trunk which required prednisone prescription, extremely sore breasts/armpits with painful lumps which had continued daily since the second vaccine. On 06Aug2021, the patient underwent nasal swab (COVID-19 virus test) and the result was negative. On an unknown date in 2021, the patient underwent mammogram, ultrasound, and biopsy and the result was unknown. The events resulted in several doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives on trunk and included treatment with prednisone (MANUFACTURER UNKNOWN) and as a result of fever, and extremely sore breasts/armpits with painful lumps included treatment with RX (unspecified prescription). The clinical outcome of the events fever of 102.7 was recovered on 30Apr2021, hives on trunk and extremely sore breasts/armpits with painful lumps were not recovered at the time of this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Mammogram, Pyrexia, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Fever of 102.7 for 2 days; Hives on trunk; Extremely sore breasts/armpits; Extremely sore breasts/armpits; Painful lumps; Painful lumps; 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: EW0161) via an unspecified route of administration in the right arm on 28Apr2021 at 10:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included diverticulitis, traumatic brain injury (TBI) and allergies which were unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received unspecified medication within two weeks of the vaccination. 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 right arm on 07Apr2021 at 10:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 13:00 the patient experienced a fever of 102.7 (Unspecified units) for two days, hives on trunk which required prednisone prescription, extremely sore breasts/armpits with painful lumps which had continued daily since the second vaccine. On 06Aug2021, the patient underwent nasal swab (COVID-19 virus test) and the result was negative. On an unknown date in 2021, the patient underwent mammogram, ultrasound, and biopsy and the result was unknown. The events resulted in several doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives on trunk and included treatment with prednisone (MANUFACTURER UNKNOWN) and as a result of fever, and extremely sore breasts/armpits with painful lumps included treatment with RX (unspecified prescription). The clinical outcome of the events fever of 102.7 was recovered on 30Apr2021, hives on trunk and extremely sore breasts/armpits with painful lumps were not recovered at the time of this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Fever of 102.7 for 2 days; Hives on trunk; Extremely sore breasts/armpits; Extremely sore breasts/armpits; Painful lumps; Painful lumps; 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: EW0161) via an unspecified route of administration in the right arm on 28Apr2021 at 10:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included diverticulitis, traumatic brain injury (TBI) and allergies which were unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received unspecified medication within two weeks of the vaccination. 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 right arm on 07Apr2021 at 10:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 13:00 the patient experienced a fever of 102.7 (Unspecified units) for two days, hives on trunk which required prednisone prescription, extremely sore breasts/armpits with painful lumps which had continued daily since the second vaccine. On 06Aug2021, the patient underwent nasal swab (COVID-19 virus test) and the result was negative. On an unknown date in 2021, the patient underwent mammogram, ultrasound, and biopsy and the result was unknown. The events resulted in several doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives on trunk and included treatment with prednisone (MANUFACTURER UNKNOWN) and as a result of fever, and extremely sore breasts/armpits with painful lumps included treatment with RX (unspecified prescription). The clinical outcome of the events fever of 102.7 was recovered on 30Apr2021, hives on trunk and extremely sore breasts/armpits with painful lumps were not recovered at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Vaccination site pain
Clinical narrative: Bruning sensation while administering vaccine.; Joint pain; Aching in bones; This is a spontaneous report from a non-contactable consumer, the patient. A 41-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 on 30Aug2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to Penicillin. Concomitant medication received within two weeks of vaccination was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. On 30Aug2021, the patient experienced bruning sensation while administering vaccine. On an unknown date in Aug2021, the patient experienced joint pain, aching in bones. The clinical outcome of the events bruning sensation while administering vaccine, joint pain, aching in bones was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe Itching; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 25Aug2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 31Aug2021 at 19:00, the patient experienced severe itching. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event severe itching was not recovered at the time of report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Face has been numb; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10May2021 at 08:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 respiratory infection. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient had no known allergies. On 10May2021 at 10:00, the patient experienced that her face had been numb ever since and the doctors could not find any other reason why her face went numb right after getting the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event face had been numb was not resolved at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, SARS-CoV-2 test
Clinical narrative: Lips blew up allergic reaction; This is a spontaneous report from a contactable other healthcare professional, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 27Aug2021 at 18:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included alprazolam (XANAX), ascorbic acid (VIT C), colecalciferol (VIT D3), zinc (MANUFACTURER UNKNOWN), curcuma longa rhizome (TURMERIC), acetylsalicylic acid (BABY ASPIRIN) and multi (as reported); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Aug2021 at 15:00, 2 days later, the patient's lips blew up allergic reaction. Since the vaccination, the patient had been tested for COVID-19. On an unknown date of Aug2021, the patient underwent lab tests and procedures which included polymerase chain reaction (PCR-nasal swab) and tested negative. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with benadryl. The clinical outcome of the event lips blew up allergic reaction was recovering at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: Got a blood clot that went to his brain and died; This is a spontaneous report from a contactable consumer (patient's friend) based on information received by Pfizer, on behalf of Moderna (Case: MOD21-136450). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. Medical history included Hashimoto's disease. The patient's concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient got a blood clot that went to his brain and had died on an unspecified date after 16-18 days of being fully vaccinated. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Got a blood clot that went to his brain and died
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Breast pain
Clinical narrative: Had an egg size knot come up under vaccinated arm about 3 hours after vaccine; Was painful also painful into breast area; Was painful also painful into breast area; This is a spontaneous report from a contactable pharmacist. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via intramuscular route of administration in the right arm on 20Aug2021 at 19:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as unknown. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any medications within two weeks of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 20Aug2021 at 22:45, about 3 hours after her vaccine, the patient experienced an egg size knot came up under her vaccinated arm and it was painful also painful into her breast area. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Tylenol or pain medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events egg size knot came up under her vaccinated arm and it was painful also painful into her breast area was recovering at the time of this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Myalgia
Clinical narrative: Back pain; Neck pain; Jaw pain; Day 5 and 6 bicep/shoulder/back/hip/neck/jaw pain on the side of the injection; Shoulder, hip pain; Headache; Muscle aches; Feverish; Fatigue; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old, non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FC3183) via an unspecified route of administration on 27Aug2021 at 16:30 in the left arm (at an age of 55-year-old) as single dose for COVID-19 immunisation. The medical history of the patient included breast cancer twice. The patient was in chemotherapy during vaccine dose 1 and was out of chemotherapy at the time of vaccine dose 2. This was her booster, all Pfizer. The patient was allergic to hydrocodone (MANUFACTURER UNKNOWN) and experienced itching with the medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included letrozole (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and acyclovir (MANUFACTURER UNKNOWN) started on unknown date for an unknown indication. On 28Apr2021 at 05:00, the patient experienced two days of fatigue, muscle aches, feverish and headache. Days 3-4 better, still fatigued. On day 5 and 6, the patient experienced bicep, shoulder, back, hip, neck and jaw pain on the side of the injection, headache and fatigue on an unknown date in Sep2021. Pain was the worst part. The 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feverish was recovered on 30Aug2021 while that of the events fatigue, muscle aches, headache, bicep, shoulder, back, hip, neck and jaw pain was not recovered at the time of this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in jaw, Pyrexia
Clinical narrative: Back pain; Neck pain; Jaw pain; Day 5 and 6 bicep/shoulder/back/hip/neck/jaw pain on the side of the injection; Shoulder, hip pain; Headache; Muscle aches; Feverish; Fatigue; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old, non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FC3183) via an unspecified route of administration on 27Aug2021 at 16:30 in the left arm (at an age of 55-year-old) as single dose for COVID-19 immunisation. The medical history of the patient included breast cancer twice. The patient was in chemotherapy during vaccine dose 1 and was out of chemotherapy at the time of vaccine dose 2. This was her booster, all Pfizer. The patient was allergic to hydrocodone (MANUFACTURER UNKNOWN) and experienced itching with the medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included letrozole (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and acyclovir (MANUFACTURER UNKNOWN) started on unknown date for an unknown indication. On 28Apr2021 at 05:00, the patient experienced two days of fatigue, muscle aches, feverish and headache. Days 3-4 better, still fatigued. On day 5 and 6, the patient experienced bicep, shoulder, back, hip, neck and jaw pain on the side of the injection, headache and fatigue on an unknown date in Sep2021. Pain was the worst part. The 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feverish was recovered on 30Aug2021 while that of the events fatigue, muscle aches, headache, bicep, shoulder, back, hip, neck and jaw pain was not recovered at the time of this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 08:45 (Batch/Lot number was not reported) as dose 2, single (Age at vaccination 38-year-old) for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received other medications within 2 weeks of vaccination includes antacid. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162B2, solution for injection, unspecified route of administration, administered in Arm Left on 22Jan2021 at 08:45 as single dose for covid-19 immunization. The patient experienced body aches on 12Feb2021 17:30. The patient did not receive treatment for the event. The outcome for the event was not recovered.   Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: hypertension; This is a spontaneous report from a contactable physician. A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 08Jan2021 (at the age of 71-year-old) as dose 2, single for COVID-19 immunisation at workplace clinic. Medical history included labile hypertension from an unknown date and unknown if ongoing, hyperlipid from an unknown date and unknown if ongoing, mild arthritis surgery from an unknown date and unknown if ongoing (Exacerbation of mild arthritis sx). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EH9899), via an unspecified route of administration in left arm on 18Dec2020 at 8:30 (at the age of 71-year-old) as dose 1, single for COVID-19 immunisation. Concomitant medications included lisinopril taken for an unspecified indication, start and stop date were not reported; simvastatin taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jan2021 at 21:00, the patient had "hypertension to 180/90. Milder elevations starting 1/4. Lasted till 2/2. Can provide BID (Two times a day) measures in spreadsheet. Increased Lisinopril to 40/day on 1/9. Discussed with my MD 1/11. Now am fine. So sx from the Ht. Can provide more details. Exacerbation of mild arthritis sx". The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included hypertension was 180/90 (units not provided) on 09Jan2021 (Milder elevations starting 1/4. Lasted till 2/2). The patient did not receive any treatment for the events. The outcome of the event was resolved on an unknown date.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Extreme Fatigue; Sleeping longer at nights more than usual; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 07Feb2021 at 09:00 AM as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies and no chronic health conditions. The patient concomitant medications included lisinopril, levothyroxine, fenofibrate, all drugs taken 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. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 post vaccination. On 09Feb2021 at 14:00 (02:00 PM), the patient experienced extreme fatigue, sleeping longer at nights more than usual. Adverse event: Extreme Fatigue ongoing since Tuesday, 2 days after shot. Able to function in morning, but by afternoon, fatigue sets in and have to go to bed. Sleeping longer at nights more than usual with naps in afternoon. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.  Follow-Up (PRD/SRD 31Mar2021): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer. This 72-year-old female consumer reported that.  A 72-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 12Feb2021 (at the age of 72-year-old) as dose 2, single for COVID-19 immunization. patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 22Jan2021 11:30 AM (at the age of 72-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes penicillin allergy from an unspecified date and concomitant medications were not reported. On 13Feb2021 01:00 AM, 13 hours 30 minutes after the vaccination, the patient experienced Chills, Headache and nausea. The outcome of the events are recovering.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (10Jun2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: "Woozy" feeling; Headache; Some diarrhea; Chills; Some nausea but not throwing up; Extreme fatigue; This is a spontaneous report received from a contactable consumer or other non hcp. A 68-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9269) via an unspecified route of administration in Arm Left on 10Feb2021 14:15 (age at vaccination 68years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL8982) via an unspecified route of administration in Arm Left on 20Jan2021 14:15 (age at vaccination 68years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 11Feb2021 13:00 the patient experienced "woozy" feeling, headache, some diarrhoea, chills, some nausea but not throwing up, extreme fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: "Woozy" feeling; Headache; Some diarrhea; Chills; Some nausea but not throwing up; Extreme fatigue; This is a spontaneous report received from a contactable consumer or other non hcp. A 68-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9269) via an unspecified route of administration in Arm Left on 10Feb2021 14:15 (age at vaccination 68years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL8982) via an unspecified route of administration in Arm Left on 20Jan2021 14:15 (age at vaccination 68years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 11Feb2021 13:00 the patient experienced "woozy" feeling, headache, some diarrhoea, chills, some nausea but not throwing up, extreme fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Nausea
Clinical narrative: Temperature of 100.2 with chills; nausea; tiredness; general malaise; temperature of 100.2; This is a spontaneous report from a contactable Nurse (patient). A 73-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL3302), via an intramuscular route in the left arm on 11Feb2021 at 15:15 (age at vaccination: 73-year-old), as a single dose for covid-19 immunization. Medical history included covid. Concomitant medication included raloxifene hydrochloride (EVISTA) 60 md qd. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. On 12Feb2021 at 08:00, patient experienced temperature of 100.2 with chills, nausea, tiredness and general malaise. Patient did not receive any treatment for the events. The patient underwent lab test and procedure which included temperature of 100.2 with chills on 12Feb2021. The clinical outcome of the events was recovered.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temperature of 100.2 with chills; nausea; tiredness; general malaise; temperature of 100.2; This is a spontaneous report from a contactable Nurse (patient). A 73-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL3302), via an intramuscular route in the left arm on 11Feb2021 at 15:15 (age at vaccination: 73-year-old), as a single dose for covid-19 immunization. Medical history included covid. Concomitant medication included raloxifene hydrochloride (EVISTA) 60 md qd. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. On 12Feb2021 at 08:00, patient experienced temperature of 100.2 with chills, nausea, tiredness and general malaise. Patient did not receive any treatment for the events. The patient underwent lab test and procedure which included temperature of 100.2 with chills on 12Feb2021. The clinical outcome of the events was recovered.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine type headache; This is a spontaneous report from a contactable consumer(patient). A 50-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9269), via an Intramuscular route of administration on 13Feb2021 at 10:00(at the age of 50-years-old) administered in Arm Right as a single dose for COVID-19 immunisation. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9261), via an Intramuscular route of administration on 26Jan2021 at 20:00(at the age of 50-years-old) administered in Upper right arm as a single dose for COVID-19 immunisation. Medical history included epstein barr virus positive mucocutaneous ulcer from 2010 and ongoing, Penicillin allergies from an unknown date and unknown if ongoing , Low thryoid function from 2015 and ongoing , thyroid from an unknown date and unknown if ongoing, Chronic pain from an unknown date and unknown if ongoing. Concomitant medication(s) included tramadol taken for pain from an unspecified start date and ongoing; cyanocobalamin (B12) taken for epstein barr virus positive mucocutaneous ulcer from an unspecified start date and ongoing; levothyroxine sodium (LEVOTHYROXINE) taken for thyroid disorder from an unspecified start date and ongoing; liothyronine sodium (LIOTHYRONINE) taken for thyroid disorder from an unspecified start date and ongoing. On 13Feb2021 at 22:00, the patient experienced Migraine type headache. The patient had received advil as a treatment medication. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: Arm turned red; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 (Wednesday) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.)) (Patient has no bleeding disorder but took a low dose aspirin before having the vaccine) taken for an unspecified indication, start and stop date were not reported. It was mentioned that, when vaccinating persons with increased bleeding risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection. The patient experienced arm turned red then black then now it was green. Patient asked is it normal. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: red sore in his arm; This is a spontaneous report from a contactable consumer (patient himself). A 88-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm on 13Feb2021 (at age of 88-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced red sore in his arm on an unspecified date. It was reported that, caller had his first COVID-19 vaccine on Saturday. Caller was asking once the vaccine was injected in the arm, when could he remove the band-aid and did he need to have any treatment for it. He said that it was already 2 days since he has been vaccinated and he had not removed the band aid once. He was asking what to use for treatment for the red sore in his arm. Caller denied the presence of any other side effects. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain on the arm where he got the vaccine. Pain lasted for two days.; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old (current age/ age unit: 37 years, as reported) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN5318, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 03Feb2021 at 11:45 (at the age of 38 years old) as dose 1, single for COVID-19 immunisation. No medical history was reported. The patient has no known allergies and prior to vaccination the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not have other vaccine in four weeks and no other medications in two weeks. On 03Feb2021 at 11:45, the patient experienced pain on the arm where he got the vaccine. The pain lasted for two days. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on an unspecified date.  No follow-up attempts are needed. No further information is expected.