chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; chills; body ache; nasal congestion; nausea; Headache; This is a spontaneous report from a contactable nurse. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 13:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and hypercholesterolemia. Concomitant medications were not reported. The patient had no known allergies. 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 unspecified date in 2021 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 03:30, the patient experienced fever, chills, body aches, nasal congestion, nausea and headache. The patient reported that it was more severe than expected and was only confined to bed. 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 fever, chills, body aches, nasal congestion, nausea and headache lasted for 12 hours before subsiding and was recovered on 16Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: body aches; chills; fever; sore arm; swollen lymph nodes; fatigue; headache; neck stiffness/pain; neck stiffness/pain; 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: ER8734) via an unspecified route of administration in the left arm on 14Apr2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (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. 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 14Apr2021 at 21:00, the patient experienced body aches, chills, fever, sore arm, swollen lymph nodes, fatigue, headache, neck stiffness/pain. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events body aches, chills, fever, sore arm, swollen lymph nodes, fatigue, headache, neck stiffness/pain was not resolved 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: Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; chills; fever; sore arm; swollen lymph nodes; fatigue; headache; neck stiffness/pain; neck stiffness/pain; 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: ER8734) via an unspecified route of administration in the left arm on 14Apr2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (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. 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 14Apr2021 at 21:00, the patient experienced body aches, chills, fever, sore arm, swollen lymph nodes, fatigue, headache, neck stiffness/pain. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events body aches, chills, fever, sore arm, swollen lymph nodes, fatigue, headache, neck stiffness/pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever the night after vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (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, the patient had not been tested for COVID-19. 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 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced fever the night after vaccine. The event 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 event. The clinical outcome of the event fever the night after vaccine was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: face turned bright red; face turned bright red and swollen the next day.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 14:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included charcot-marie-tooth disease. Patient had no known allergies. Concomitant medications included cyclobenzaprine (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified 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 at 08:00, the patient experienced face turned bright red and swollen the next day. 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 face turned bright red and swollen the next day was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Erythema, Rash papular, Skin warm
Clinical narrative: small red pimples; 10 small bumps located on mid sternum; red hot skin on upper chest from decolletage to sternal notch; red hot skin on upper chest from decolletage to sternal notch; This is a spontaneous report from a contactable physician. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via intramuscular route of administration in the left arm on 24Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to petroleum products. Concomitant medications included sertraline hydrochloride (ZOLOFT) and colecalciferol (VIT D3); taken for unknown indications from an unknown date 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 25Mar2021, the patient experienced red hot skin on her upper chest from decolletage to sternal notch. On 25Mar2021, the patient experienced 10 small bumps located on her mid sternum. On 08Apr2021, the patient experienced small red pimples. 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 event red hot skin on upper chest from decolletage to sternal notch was recovered on an unknown date in 2021 while the event small red pimples was recovered on an unknown date Apr2021. The clinical outcome of the event 10 small bumps located on mid sternum was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: Experienced balance problems within 24 hours of injection. Was significant for 7 days (more frequently wanting to fall to the right).; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; NDC number: NDC 59267-1000-1) via an unspecified route of administration in the right arm on 03Apr2021 at 11:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, bradycardia, hypermobility syndrome, history of deep vein thrombosis with pulmonary embolism (history of DVTs with PEs), cyst surgies and infection, squamous cell carcinoma, known slight allergy to latex allergy and milk products. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN), abatacept (ORENCIA), hydroxychloroquine sulfate (PLAQUENIL) and rivaroxaban (XARELTO) and etc (unspecified medications); all for unspecified indication from unknown date and unknown if ongoing. The patient previously took pioglitazone hydrochloride (ACTOS) and metformin (MANUFACTURER UNKNOWN) both for unknown indication from unknown date and experienced drug allergy to pioglitazone hydrochloride and metformin. 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 04Apr2021 at 07:00, the patient experienced balance problems within 24 hours of injection which was significant for 7 days (more frequently wanting to fall to the right). Critical point: The patient did not take methotrexate or orencia for 12 days after vaccination. Once back on methotrexate and orencia, balance had nearly returned to normal. The patient was not certain if this was a vaccine or unknown reaction to suddenly stopping medications. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event balance problems was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes, Migraine, Rash, Skin burning sensation
Clinical narrative: Large herpes outbreak in the genitalia area; Burning; Rash; Migraine; This is a spontaneous report from a contactable consumer, the patient. A 56-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 arm left on 05Apr2021 at 15:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune arthritis, connective tissue disorder and complex syndrome, chronic migraine, depression, anxiety and COVID-19. The patient has taken unspecified concomitant medications. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the arm left on 14Mar2021 at 15:30 (at the age of 56-year-old) 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 other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 19:00, the patient had a migraine every day since her second shot on March 5. She was taking medicine every day for the migraine. On 15Apr2021, which was 10 days after the second vaccine she developed a large herpes outbreak in the genitalia area. She also had burning and a rash in the crease of her legs near her genital area. Therapeutic measures were taken as a result of the events which included treatment with unknown migraine medication and valcyclovir. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events migraine, herpes, burning and rash was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Shoulder pain at injection site; Pain spread into upper shoulder and neckabout a week after injection; Pain spread down into arm about 2 weeksafter injection; Pain spread down into arm about 2 weeksafter injection with tingling in fingers; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 06Mar2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any past medical history. The patient had no allergy to medications, food, or other products. The patient did not receive any 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. On 09Mar2021, the patient experienced shoulder pain at injection site continues 3 weeks after shot. On an unknown date in Mar2021, about a week after vaccination, the patient experienced pain spread into upper shoulder and neck. On an unknown date in Mar2021, about 2 weeks after the vaccination, the patient experienced pain spread down into arm with tingling in fingers. The patient added that the nurse who administered the injection stuck the needle a lot higher than normal. She used one hand to locate the shoulder bone and stuck the needle in immediately below that bone. Most shots are usually lower in the muscle area. Doctor seemed to think this might have irritated a nerve.  The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events which included treatment with pain medicines, muscle relaxers and steroid pack. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shoulder pain at injection site, pain spread into upper shoulder and neck, pain spread down into arm with tingling in fingers was not resolved at the time of this report. The 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 27Mar2021 at 11:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Raised red bumps; Full body rash with intense itching; Full body rash with intense itching; This is a spontaneous report from a contactable consumer, the patient. A 63-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 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, gout, high cholesterol, high BP, glaucoma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications (11, not enough space to list all) within two weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 13Apr2021 at 14:00 on Tuesday, 8 days after vaccination, the patient experienced full body rash with intense itching and raised red bumps. Since the vaccination, the patient had not been tested for COVID-19. 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 reported events which included treatment with hydroxyzine (pill) (MANUFACTURER UNKNOWN)/Permethrin Cream. The clinical outcome of full body rash with intense itching and raised red bumps was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Furuncle
Clinical narrative: Had a pretty bad flare up on two places in the body (nose and groin) which resulted in an infected boil; Had a pretty bad flare up on two places in my body (nose and groin) which resulted in an infected boil; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD) and hidradenitis suppurativa from an unknown date. Concomitant medication included vitamin D supplement (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received minocycline (MANUFACTURER UNKNOWN) on an unknown date and experienced possible mild 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 4 weeks prior to the COVID vaccine. It was reported that the patient had a skin condition called hidradenitis suppurativa, which was thought to be auto-immune in nature and caused painful boils. The patient did not had a flare up in over a year before the vaccine. On 06Apr2021, in a week after the vaccine, the patient had a pretty bad flare up on two places in the body (nose and groin) which resulted in an infected boil which required oral antibiotics. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with steroid injection (unspecified), oral antibiotics (unspecified) and topical cream (unspecified). The clinical outcome of the event had a pretty bad flare up on two places in the body (nose and groin) which resulted in an infected boil was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in whole body; This is a spontaneous report from a contactable consumer, the patient. A 46-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 04Apr2021 at 18:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. 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 16Apr2021 at 09:00, the patient experienced rash on the whole body. Therapeutic measures were taken as a result of rash and included treatment with BRANDIL. The clinical outcome of the event rash on the whole body was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 37-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 37, via an unspecified route of administration, left arm, on Apr 8, 2021, at 16:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 37, via an unspecified route of administration, left arm, on Mar 18, 2021, at 16:00, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On Apr 12, 2021, patient experienced headache on and off, fever on and off, nausea,  body ache and sore throat. No therapeutic measures taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of headache on and off, fever on and off, nausea, body ache and sore throat: not recovered (at the time of this report). No follow-up attempts possible. Information about lot\batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Got metallic taste in mouth with 15 min of receiving both shots. After both shots it went away in 2 days but it reappeared 10 days after 2nd shot and it hasnt gone away yet and its been 5 days.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 05Mar2021 at 01:45 (at the age of 60-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 31Mar2021 at 01:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included calcium (MANUFACTURER UNKNOWN) and multivitamin. 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 05Mar2021 at 02:00 and 31Mar2021 at 02:00, the patient got metallic taste in mouth with 15 min of receiving both shots. After both shots it went away in two days but it reappeared ten days after second shot on 10Apr2021 and it hadn't gone away yet and it had been five days at the time of report. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event got metallic taste in mouth with 15 min of receiving both shots, after both shots it went away in two days but it reappeared ten days after second shot  and it hadn't gone away yet was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune thyroiditis, Vaccination site pain
Clinical narrative: Hashimotos Disorder; bodyaches in injection site BUT also in left hip; bodyaches in injection site BUT also in left hip; This is a spontaneous report from a contactable nurse, the patient. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EK5730, first dose) solution for injection intramuscular in the left arm on 19Dec2020 at 19:00 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal asthma, anxiety d/t (due to) COVID pandemic. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL). Past drug history included allergy to lidocaine. 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. On 20Dec2020 (5 hours after vaccination), the patient experienced body aches in injection site but also in left hip. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received unspecified treatment for the events bodyaches in injection, pain in hip. The patient now has been diagnosed with Hashimotos Disorder and on medication which has not taken away the pain. The outcome of the events bodyaches in injection, pain in hip was not recovered. The outcome of the event Hashimotos Disorder was unknown. The patient has not been tested for COVID post vaccination.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event Hashimotos Disorder due to temporal relationship. Additional information is needed to better assess the case, including complete medical history, family history, diagnostics, counteractive treatment measures.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymph node pain, Lymphadenopathy, Pain, Peripheral swelling
Clinical narrative: lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches; swollen arm and hand on injection arm,; lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches; lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches; Lymph nodes under arm painfully swollen; swollen arm and hand on injection arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0158) via an unspecified route of administration in the right arm on 13Apr2021 at 14:30(at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to bandage adhesive. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) both are started on unknown dates and for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in right arm on 23March2021 at 09:30(at the age of 49-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 14Apr2021 at 16:00, the patient experienced lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever and body aches. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 14Apr2021, the patient underwent body temperature and resulted with a temperature of 101(unspecified unit). The clinical outcome of the events lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches; swollen arm and hand on injection arm,; lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches; lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches; Lymph nodes under arm painfully swollen; swollen arm and hand on injection arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0158) via an unspecified route of administration in the right arm on 13Apr2021 at 14:30(at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to bandage adhesive. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) both are started on unknown dates and for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in right arm on 23March2021 at 09:30(at the age of 49-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 14Apr2021 at 16:00, the patient experienced lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever and body aches. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 14Apr2021, the patient underwent body temperature and resulted with a temperature of 101(unspecified unit). The clinical outcome of the events lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Arm pain; Slight headache; Muscles pain; Tiredness; Unexpected pain has been in ear.; Sharp shooting pains.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the arm left on 14Apr2021 at 10:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) 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 15Apr2021 at 17:30 the patient experienced some of the common effects but not bad, arm pain, slight headache, muscles pain, tiredness, unexpected pain has been in her ear and sharp shooting pains. 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 reported event. The clinical outcome of the events arm pain, slight headache, muscles pain, tiredness, unexpected pain has been in her ear and sharp shooting pains were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; Slight headache; Muscles pain; Tiredness; Unexpected pain has been in ear.; Sharp shooting pains.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the arm left on 14Apr2021 at 10:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) 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 15Apr2021 at 17:30 the patient experienced some of the common effects but not bad, arm pain, slight headache, muscles pain, tiredness, unexpected pain has been in her ear and sharp shooting pains. 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 reported event. The clinical outcome of the events arm pain, slight headache, muscles pain, tiredness, unexpected pain has been in her ear and sharp shooting pains were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN2604), at the age of 75, via an unspecified route of administration, right arm, on an unknown date Mar 2021, at 11:30, single dose, for COVID-19 immunisation. The patient had an unspecified medical history. The patient does not have any known allergies to medications, food or other products. The patient received unspecified/other medication within 2 weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not 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 2021; 4 weeks after the 1st shot, patient's right arm at the injection site turned into a hard multi-cell blister. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the 4 weeks after the 1st shot; patient's right arm at the injection site turned into a hard multi-cell blister: not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Leg and arm weakness; This is a spontaneous report from a contactable nurse, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 07Apr2021 at 10:45 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. 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 08Apr2021, the patient experienced leg and arm weakness. The patient experienced the sensation which continued even after 9 days post vaccine. The event 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 adverse events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event leg and arm weakness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dizziness, Dyspepsia, Muscle spasms, Pain in extremity
Clinical narrative: Arm sore/lower arm sore/ left hand pain; Heart feels burden; Left shoulder muscle cramps; Heat up from heart; Breathe faster; Fever; Dizziness; This is a spontaneous report from a 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 in the left arm on 15Apr2021 at 13:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, right after the shot, the patient experienced left shoulder muscle cramps, heat up from heart, breathe faster, fever and dizziness. On 16Apr2021, the second day, the patient experienced arm sore/lower arm sore/left hand pain and heart feels burden. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of left shoulder muscle  cramps, heat up from heart, breathe faster, fever, dizziness, arm sore/lower arm sore/left hand pain and heart feels burden was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachypnoea
Clinical narrative: Arm sore/lower arm sore/ left hand pain; Heart feels burden; Left shoulder muscle cramps; Heat up from heart; Breathe faster; Fever; Dizziness; This is a spontaneous report from a 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 in the left arm on 15Apr2021 at 13:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, right after the shot, the patient experienced left shoulder muscle cramps, heat up from heart, breathe faster, fever and dizziness. On 16Apr2021, the second day, the patient experienced arm sore/lower arm sore/left hand pain and heart feels burden. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of left shoulder muscle  cramps, heat up from heart, breathe faster, fever, dizziness, arm sore/lower arm sore/left hand pain and heart feels burden was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Upper left leg pain after vaccine; Shooting pain when standing up and walking around; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 13Apr2021 at 17:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medication was reported as birth control. 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 13Apr2021 at 21:00, the patient experienced upper left leg pain after vaccine and shooting pain when standing up and walking around. Therapeutic measures were not taken as a result of these 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 upper left leg pain after vaccine and shooting pain when standing up and walking around was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dehydration, Dizziness, Fatigue
Clinical narrative: Injection site swelling; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Fever; Joint pain; Vomiting; Dizziness; Overall fatigue; Ddehydration; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm right on 12Apr2021 at 12:15 hours (at the age of 68-year-old) as a single dose for COVID-19 immunisation. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm right on 24Mar2021 at 12:15 hours (at the age of 68-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 14:00 the patient experienced dehydration, injection site swelling, injection site pain, tiredness, headache, muscle pain, chills, fever, joint pain, vomiting, dizziness and overall fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dehydration, injection site swelling, injection site pain, tiredness, headache, muscle pain, chills, fever, joint pain, vomiting, dizziness and overall fatigue was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site swelling; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Fever; Joint pain; Vomiting; Dizziness; Overall fatigue; Ddehydration; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm right on 12Apr2021 at 12:15 hours (at the age of 68-year-old) as a single dose for COVID-19 immunisation. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm right on 24Mar2021 at 12:15 hours (at the age of 68-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 14:00 the patient experienced dehydration, injection site swelling, injection site pain, tiredness, headache, muscle pain, chills, fever, joint pain, vomiting, dizziness and overall fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dehydration, injection site swelling, injection site pain, tiredness, headache, muscle pain, chills, fever, joint pain, vomiting, dizziness and overall fatigue was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.