chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: Measle like rash all over body; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-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 10Apr2021 at 09:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included sulfamethoxazole, trimethoprim (BACTRIM) and ibuprofen (MANUFACTURER UNKNOWN); from an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 00:00, about 4 days after the vaccine, the patient developed a measle like rash all over her body. The event resulted in emergency room/department visit or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event measle like rash all over body 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable nurse. A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration on 10Apr2021 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, the patient experienced fever. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event fever was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness, Pain
Clinical narrative: Body ache; Flu-like symptoms; Low energy; This is a spontaneous report from a non-contactable consumer. A 31-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 03Apr2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced body ache, flu-like symptoms and low energy on day received shot. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the events. The clinical outcome of the events body ache, flu-like symptoms and low energy were recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain at the injection site; Just a very mild ache deep in the arm; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the arm left on 18Jan2021 (at the age of 75-year-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included losartan 50mg (MANUFACTURER UNKNOWN) and simvastatin 20mg (MANUFACTURER UNKNOWN), both for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jan2021, the patient had pain at the injection site since the first shot date. No other reaction at all. Just a very mild ache deep in the arm. It worried the patient that she had an internal ache at the site since first dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain at the injection site and mild ache deep in the arm were unknown at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Em9810) via an unspecified route of administration in the arm right on 05Feb2021 (at the age of 75-year-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Symptom recurrence, Vaccination site pain
Clinical narrative: Injection site soreness but returned 7 days later. Even more sore this time.; Injection site soreness  but returned 7 days later. Even more sore this time.; Injection site soreness  but returned 7 days later. Even more sore this time.; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 hours (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient experienced injection site soreness which was normal at first and subsided quickly. On 12Apr2021, the patient experienced the same which returned 7 days later and was even more sore this time. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event injection site soreness was recovered on an unknown date in Apr2021. The clinical outcome of the events symptom recurrence and pain aggravated was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Pyrexia
Clinical narrative: Extreme fatigue; Joint pain; Low-grade fever  (101.1 F) which dropped to 100.3 F; 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: EW0151) via an unspecified route of administration in the left arm on 11Apr2021 at 07:45 (at the age of 36-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. The patient received unspecified medications within two weeks of vaccination. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Apr2021 at 07:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 01:30, the patient experienced extreme fatigue, joint pain, low-grade fever (101.1 F) which dropped to 100.3 F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event low grade fever which included treatment with acetaminophen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of extreme fatigue, joint pain, low-grade fever (101.1 F) which dropped to 100.3 F was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, SARS-CoV-2 test
Clinical narrative: sudden and severe double vision andmild dizziness; sudden and severe double vision andmild dizziness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 05Feb2021 at 15:00(at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to ciprofloxacin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021 at 10:00 the patient experienced sudden and severe double vision and mild dizziness. Closing either eye he had normal vision. Vision and dizziness self corrected within approximately 20 minutes. He never had these symptoms before or after this single event. Therapeutic measures were not taken as a result of the event(s). On 07Apr2021, the patient underwent lab test included nasal Swab and the result was Negative. The clinical outcome of the event sudden and severe double vision and mild dizziness were recovered on 15Feb2021 within 20 minutes.    No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Arm soreness; Nauseous; This is a spontaneous report from a non-contactable consumer. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 03Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient did receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced arm soreness and nauseous occurred right away after the shot, on the drive home. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events arm soreness and nauseous were recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Petechiae, Rash
Clinical narrative: Petechiae under breasts; Rash; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 20:15(at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, asthma, fibromyalgia, obesity and had allergy to sulfa antibiotics. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) , fluticasone propionate, salmeterol xinafoate (ADVAIR)  and azelastine (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and D3 (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since, 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 06Apr2021 at 07:30 the patient experienced rash - petechiae under breasts within 12 hours of injection, improved rapidly and gone by 4th day after injection, fatigue - lasted 4 days. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events petechiae under breasts, rash and fatigue was recovered on 10Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Tenderness
Clinical narrative: Tightness and soreness in left armpit; A tendon or something inmy armpit is very hard now and tenderto the touch.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 16Mar2021 at 17:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included genetically high cholesterol. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) 40 mg from an unknown date for genetically high cholesterol. 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 23Mar2021 at 08:00, the patient experienced tightness and soreness in left armpit the shot was administered in left arm. A tendon or something in armpit was very hard and tender to the touch. It was like a hard string inside armpit, and was noticeably different from right armpit. Patient reported that it had been 4 weeks since that shot and it was still present, had second dose in right arm, and the reaction didn't occur there. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tightness and soreness in left armpit, a tendon or something in armpit was very hard and tender to the touch. It was like a hard string inside armpit was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: SWOLLEN GLAND ON MY ARMPIT,; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 11:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced swollen gland on her armpit. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event swollen gland on armpit was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature fluctuation, Fatigue, Headache, Pain
Clinical narrative: Headache; temperature fluctuations; exhaustion; body aches; upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 66-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 12Mar2021 at 09:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis since an unknown date. The patient did not have allergy to any medications, food, or other products. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) taken once a week for rheumatoid arthritis and within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021, the patient experienced headache, temperature fluctuations, exhaustion, body aches, and upset stomach. 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 events. The clinical outcome of the events headache, temperature fluctuations, exhaustion, body aches, and upset stomach was recovered, in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid pain, Neck pain, Pain, Pain in extremity, Rash
Clinical narrative: Great deal of pain on right neck; Great deal of pain right side behind ear and small area by hairline; Great deal of pain on right eye lid; I have developed a rash; Great deal of pain on right upper arm; 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: EL3248) via an unspecified route of administration in the right arm on 19Jan2021 at 07:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history (The patient never had any issues). The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the right arm on 28Dec2020 at 15:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 06:00 the patient developed a rash and a great deal of pain on right upper arm, neck, behind ear, eye lid and small area by hairline. Everything was on the right side. The patient did see a doctor who said that was not shingles and could not explain what that was. That had been going on for one week. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with antibiotic and steroid (oral both) from an unknown date and unknown if ongoing. The clinical outcome of the events rash, great deal of pain on right upper arm, neck, behind ear, eye lid and small area by hairline were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: 1.25 diameter blue spot at injection site; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 13:15(at the age of 35-year-old) as a single dose for COVID-19 immunisation. The medical history included sulfa allergy, penicillin allergy, egg allergy and milk allergy. The concomitant medications included birth control (MANUFACTURER UNKNOWN), sumatriptan succinate (IMITREX) and meloxicam (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. The patient previously took Levaquin and experienced allergy to it. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Apr2021 at 00:00, after 5 days of vaccination, the patient experienced 1.25 (unspecified unit) diameter blue spot at injection site which was more noticeable when skin was cooler. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blue spot at injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: I had a rash below the injection site; It is red rash and warm to touch; It is red rash and warm to touch and below the injection site and not on the injection site..; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ep6955) via an unspecified route of administration in the left arm on 11Apr2021 at 00:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as no. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ew0151) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 12:00, the patient experienced a rash below the injection site a day or two after the 2nd dose. It was red rash and warm to touch and it was below the injection site and not on the injection site. It was  red at the time of report after noticing it after a day from the vaccine. Therapeutic measures were not taken as a result of the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events rash below the injection site, red rash and warm to touch 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: Fatigue, Pain in extremity, Vertigo
Clinical narrative: Severe vertigo- not able to walk or stand due to ongoing spinning. Injection date 4/9- first dose- regular symptoms of sore arm and fatigue for first 48 hours. Vertigo began 4/12 and is ongoing.; Injection date 4/9- first dose- regular symptoms of sore arm and fatigue for first 48 hours; Injection date 4/9- first dose- regular symptoms of sore arm and fatigue for first 48 hours; This is a spontaneous report from a non-contactable other healthcare professional. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the right arm on 09Apr2021 at 00:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy (reported as Shrimp allergy). Concomitant medications taken within two weeks of vaccination included collagen (MANUFACTURER UNKNOWN) (reported as collagen peptides) from unknown date for unknown indication. 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 09Apr2021, on the  injection date of first dose, patient experienced regular symptoms of sore arm and fatigue for first 48 hours. The patient experienced severe vertigo- not able to walk or stand due to ongoing spinning. Vertigo began on 12Apr2021, and was ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of vertigo and included treatment with over the counter (OTC) meclizine. The clinical outcome of the event regular symptoms of sore arm and fatigue for first 48 hours was resolved on 11Apr2021. The clinical outcome of the event severe vertigo- not able to walk or stand due to ongoing spinning was not resolved 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: Asthenia, Chest pain, Dysgeusia, Headache, Hypoaesthesia
Clinical narrative: numbness and tingling in my face, neck and ears; numbness and tingling in my face, neck and ears; Weakness in left side of body; Chest pain; Metallic taste in my mouth; Headache; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 11Apr2021 at 15:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune diseases, mixed connective tissue disease, lymphocytic colitis, B12 and folate deficiencies, fibromyalgia, depression and anxiety. The patient was allergic to penicillin. The patient received unspecified concomitant medications within two weeks of vaccination. The patient previously took codeine and vicodin and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 15:15, within about 5 minutes after the vaccine, the patient experienced weird metallic taste in her mouth. On 11Apr2021 at 15:20, about 5 minutes after that, the patient experienced numbness and tingling in her face, neck and ears and her whole left side of the body became weak and she had chest pains. Emergency Medical Technicians (EMTs) came over and checked her vitals a few times. On the same day, the patient slept for 5 hours and then had a horrible headache and her entire body ached. 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 metallic taste in mouth, numbness and tingling in face, neck and ears, whole left side of the body became weak, chest pains, headache and body ache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: numbness and tingling in my face, neck and ears; numbness and tingling in my face, neck and ears; Weakness in left side of body; Chest pain; Metallic taste in my mouth; Headache; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 11Apr2021 at 15:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune diseases, mixed connective tissue disease, lymphocytic colitis, B12 and folate deficiencies, fibromyalgia, depression and anxiety. The patient was allergic to penicillin. The patient received unspecified concomitant medications within two weeks of vaccination. The patient previously took codeine and vicodin and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 15:15, within about 5 minutes after the vaccine, the patient experienced weird metallic taste in her mouth. On 11Apr2021 at 15:20, about 5 minutes after that, the patient experienced numbness and tingling in her face, neck and ears and her whole left side of the body became weak and she had chest pains. Emergency Medical Technicians (EMTs) came over and checked her vitals a few times. On the same day, the patient slept for 5 hours and then had a horrible headache and her entire body ached. 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 metallic taste in mouth, numbness and tingling in face, neck and ears, whole left side of the body became weak, chest pains, headache and body ache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling/numbness in hands going on 23 days .; Numbness in hands going on 23 days .; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Gn6204), via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), prenatal vitamins (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Gn6206), via an unspecified route of administration in the left arm on 02Mar2021 at 11:15 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient previously took doxycycline (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 23Mar2021 at 12:30, the patient experienced tingling/numbness in hands going on for twenty-three days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingling/ numbness in hands were not resolved at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild pain on left arm; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 13Apr2021 at 16:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 17:00, the patient experienced mild pain on left arm. 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 reported event. The clinical outcome of mild pain on left arm was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Over half of severe fibromyalgia symptoms havebeen so greatly reduced in the last 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01SO), via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, spinal stenosis, spondylosis, osteoarthritis and asthma. The patient receives unspecified medications in two weeks of vaccination. The patient previously took codeine and IV administered prednisone; both on unknown dates for unspecified indications and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient did not experience any adverse effects. On the contrary, over half of severe fibromyalgia symptoms have been so greatly reduced in the last 2 weeks. So, the patient felt she should report it.  The patient considered this as a medical miracle for herself. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event over half of severe fibromyalgia symptoms have been so greatly reduced in the last 2 weeks was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Oropharyngeal pain, Urticaria, Vaccination site erythema
Clinical narrative: About ~40hrs after injection hives were observed covering torso, groin, and neck.; Headache; Sore throat; Sore joints; Injection site turned bright pink; 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: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy, source unknown. The patient did not receive any medication within two weeks of vaccination. The patient previously took the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient had not been not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021 at 06:00, about ~40hrs after injection, the patient experienced, hives covering torso, groin, and neck, headache, sore throat, sore joints, and injection site turned bright pink (coloring similar to the hives). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No therapeutic measures were taken for the reported events. The clinical outcome of the events hives covering torso, groin, and neck, headache, sore throat, sore joints, and injection site turned bright pink (coloring similar to the hives) was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysmenorrhoea, Menstruation irregular
Clinical narrative: Early period; Severe cramping,; Severe back pain; This is a spontaneous report from a non-contactable consumer. A 37-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 07Apr2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. 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 unknown date, the patient experienced early period, severe cramping, severe back pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events early period, severe cramping, severe back pain was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling of body temperature change, Headache, Menstrual disorder
Clinical narrative: headache; Later at 5:00PM, I noticed that I felt on my period which is not normal because It was not the time for it; period duration was 14 days instead of 7 days; first doze at 1:00PM and noticed small rash at 2:00PM; blood pressure 160/90 and later 180/90; felt hot and cool; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EM9809, first dose) solution for injection intramuscular in the left arm on 29Jan2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical and past drug history included sulpha antibiotic allergy and allergies to azithromycin (ZITHROMAX). Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I got the first dose on 29Jan2021 at 1:00PM and I noticed small rash at 2:00PM. Later at 5:00PM, I noticed that I felt on my period which was not normal because It was not the time for it. It was like 2 weeks in advance of the date I should felt. In addition, my period duration was 14 days instead of 7 days which was not normal. Also, the next day after the vaccine (30Jan2021) I felt a headache in the whole left side of my face including my head. I took acetaminophen (TYLENOL) and I still with the headache. Next day I was better but I started to feel light headaches for the next two weeks and felt hot and cool in 2021. I thought I was menopause. Two days before my vaccine I checked my blood pressure and I went to the urgent care because it was high after vaccination, my blood pressure 160/90 and later 180/90 in Jan2021. I am not a high blood pressure patient." The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for high blood pressure included unspecified medication for two days. The outcome of the events was recovered in 2021. The patient was not tested for COVID post vaccination.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea, Rash
Clinical narrative: headache; Later at 5:00PM, I noticed that I felt on my period which is not normal because It was not the time for it; period duration was 14 days instead of 7 days; first doze at 1:00PM and noticed small rash at 2:00PM; blood pressure 160/90 and later 180/90; felt hot and cool; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EM9809, first dose) solution for injection intramuscular in the left arm on 29Jan2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical and past drug history included sulpha antibiotic allergy and allergies to azithromycin (ZITHROMAX). Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I got the first dose on 29Jan2021 at 1:00PM and I noticed small rash at 2:00PM. Later at 5:00PM, I noticed that I felt on my period which was not normal because It was not the time for it. It was like 2 weeks in advance of the date I should felt. In addition, my period duration was 14 days instead of 7 days which was not normal. Also, the next day after the vaccine (30Jan2021) I felt a headache in the whole left side of my face including my head. I took acetaminophen (TYLENOL) and I still with the headache. Next day I was better but I started to feel light headaches for the next two weeks and felt hot and cool in 2021. I thought I was menopause. Two days before my vaccine I checked my blood pressure and I went to the urgent care because it was high after vaccination, my blood pressure 160/90 and later 180/90 in Jan2021. I am not a high blood pressure patient." The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for high blood pressure included unspecified medication for two days. The outcome of the events was recovered in 2021. The patient was not tested for COVID post vaccination.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Pain in extremity
Clinical narrative: Pain in right arm, under arm, elbow, upper back; Pain in right arm, under arm, elbow, upper back; Pain in right arm, under arm, elbow, upper back; Pain in right arm, under arm, elbow, upper back; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: 9266) via an unspecified route of administration in the left arm on 23Feb2021 at 10:30 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported.  The patient had known allergies to some blood pressure medicines. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified blood pressure medication from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: 1686) via an unspecified route of administration in the left arm on 02Feb2021 at 11:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021, the patient experienced pain in right arm, under arm, elbow and upper back. 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 chiropractor. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in right arm, under arm, elbow and upper back was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: High heart rate; Heavy and early onset of menstrual cycle; Heavy and early onset of menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to penicillin (MANUFACTURER UNKNOWN). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 20Mar2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 14:00, the patient experienced high heart rate for 24 hours, heavy and early onset of menstrual cycle. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of high heart rate was resolved on 08Apr2021 and the clinical outcome of heavy and early onset of menstrual cycle was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.