chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over middle area of back and stomach, left front are, lower right thigh; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 10:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, rheumatoid arthritis, penicillin allergy, latex allergy and allergic reaction to bee stings. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received diazepam (VALIUM) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7534) via an unspecified route of administration in the left arm on 24Mar2021 at 10:15 (at the age of 52-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 10:30, the patient experienced hives all over middle area of back and stomach, left front area and lower right thigh. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with prednisone (MANUFACTURER UNKNOWN) and shot. The clinical outcome of the event hives all over middle area of back and stomach, left front area and lower right thigh was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus, Vertigo
Clinical narrative: Tinnitus; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE8732) via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was 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 05Apr2021, the patient experienced tinnitus and vertigo. 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. On 14Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events tinnitus and vertigo were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body aches; Fatigue; Sinus headache for about 24 hours; Very flu like; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: tw0151) via an unspecified route of administration in the right arm on 13Apr2021 at 11:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took Amoxicillin and experienced severe rash. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. 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 13Apr2021 at 21:00, the patient experienced fever, chills, body aches, fatigue, sinus headache for about 24 hours and very flu like. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, fatigue and very flu like was recovering; while that of sinus headache was recovered on 14Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: Fever; Chills; Body aches; Fatigue; Sinus headache for about 24 hours; Very flu like; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: tw0151) via an unspecified route of administration in the right arm on 13Apr2021 at 11:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took Amoxicillin and experienced severe rash. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. 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 13Apr2021 at 21:00, the patient experienced fever, chills, body aches, fatigue, sinus headache for about 24 hours and very flu like. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, fatigue and very flu like was recovering; while that of sinus headache was recovered on 14Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Lymph node pain, SARS-CoV-2 test
Clinical narrative: Pain/aching on the left side of  face; head/hair pain; lymph nodes pain; felt like  had sinus congestion or was bruised; This is a spontaneous report from a contactable consumer, the patient. A 39-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 08Apr2021 at 10:30 AM (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included none. The concomitant medications was not reported. The patient had no known food allergies (NKFA). The patient did not receive any other vaccines within four weeks prior to the vaccination Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 09Apr2021 at 21:00, next day of vaccination, the patient experienced pain/aching on the left side of the face, head/hair, lymph nodes,  hair follicles hurt, face felt like sinus congestion or was bruised, sharp feeling with  would swallow. 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. On 12Apr2021, the patient underwent Nasal Swab and the result was negative and also PCR test and the result was Negative. The clinical outcomes of the events pain/aching on the left side of face, head/hair pain, lymph nodes pain and felt like sinus congestion or was bruised were recovered 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, Feeling drunk, Vision blurred
Clinical narrative: Extreme exhaustion; blurred vision; feeling drunk; 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: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 17:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had known allergies to sulfa and carrots. The patient did not receive any other medications within 2 weeks of vaccination. 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 15Apr2021 at 05:00 the patient experienced extreme exhaustion, blurred vision and feeling drunk. Therapeutic measures were not taken as a result of the events. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme exhaustion, blurred vision and feeling drunk was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Complication of pregnancy
Clinical narrative: Having difficulty getting pregnant; This is a spontaneous report from a contactable consumer (patient's father). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, the reporter mentioned that her daughter was having difficulty getting pregnant and thus had an IVF (in-vitro fertilization). Reporter daughter had the first dose of the Pfizer-BioNTech COVID-19 Vaccine and was waiting for their second dose. The patient's father expressed concern for her daughter and asked if the vaccine could affect the DNA. The report was non serious. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: Intense fatigue; Sweats; Chills; Muscle aches; Joint aches; This is a spontaneous report from a contactable physician, the patient. A 56-year-old male 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 12Apr2021 at 12:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for 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: 2613) via an unspecified route of administration in the left arm on 23Mar2021 at 18:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 12:00, the patient experienced intense fatigue, sweats, chills, muscle aches, joint aches. He could not work for two days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event intense fatigue, sweats, chills, muscle aches and joint aches was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Vaccination site pain
Clinical narrative: Fatigue; Dizziness; Nausea; Soreness at injection site lasting over 24 hours so far; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 13:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included anxiety, depression, COVID-19 infection. The patient had no known allergies to medications, food or other products. Concomitant medications included EFFEXOR (MANUFACTURER UNKNOWN) extended release for unknown indication, on 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 COVID vaccine. On 14Apr2021 at 13:45, the patient experienced nausea, dizziness, fatigue and soreness at the injection site. 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 events. The clinical outcome of the events nausea, dizziness, fatigue and soreness at the injection site was 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: Blister, Chills, Erythema, Paraesthesia, Rash
Clinical narrative: 2 weeks from vaccine large blister on big toe, tiny blisters on right toes; pins and needles; red dots on both feet; rash & hives whole body, pins & needles; rash & hives whole body, pins & needles; chills; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) dose 1 via an unspecified route of administration, administered in the right arm on 25Mar2021 15:30 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia and allergy to sulfa. Concomitant medications included methotrexate, celecoxib (CELEBREX),  metoprolol and duloxetine. The patient did not receive any other vaccine within 4 weeks. The patient did not have COVID-19 prior to vaccination. The patient did not test positive for COVID-19 after vaccination. Exactly 1 week after the vaccine on 01Apr2021 at 19:00, the patient experienced red dots on both feet, rash and hives whole body, pins and needles, chills. Two weeks after the vaccine, the patient had a large blister on big toe, tiny blisters on right toes. This resulted in a Doctor or other healthcare professional office/clinic visit. The patient was treated with an injection of Solu Medrol. The outcome of red dots on both feet, rash and hives whole body, pins and needles, chills, blisters was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 2 weeks from vaccine large blister on big toe, tiny blisters on right toes; pins and needles; red dots on both feet; rash & hives whole body, pins & needles; rash & hives whole body, pins & needles; chills; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) dose 1 via an unspecified route of administration, administered in the right arm on 25Mar2021 15:30 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia and allergy to sulfa. Concomitant medications included methotrexate, celecoxib (CELEBREX),  metoprolol and duloxetine. The patient did not receive any other vaccine within 4 weeks. The patient did not have COVID-19 prior to vaccination. The patient did not test positive for COVID-19 after vaccination. Exactly 1 week after the vaccine on 01Apr2021 at 19:00, the patient experienced red dots on both feet, rash and hives whole body, pins and needles, chills. Two weeks after the vaccine, the patient had a large blister on big toe, tiny blisters on right toes. This resulted in a Doctor or other healthcare professional office/clinic visit. The patient was treated with an injection of Solu Medrol. The outcome of red dots on both feet, rash and hives whole body, pins and needles, chills, blisters was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vomiting
Clinical narrative: Burning in the throat; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Apr2021 at 11:15 (at the age of 56-year-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC), bupropion hydrochloride (WELLBUTRIN), (estradiol) ESTRACE and (apremilast) OTEZLA, all since unknown date and unknown indication. The patient previously took sulfur and experienced allergy to it. 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 at 14:00, the patient experienced burning in the throat, and throwing up. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events burning in the throat and throwing up was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: body aches; Low grade fever (100.1); head ache; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 11:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation.. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 at 10:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. 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, at 05:00 the patient experienced low grade fever (100.1), body aches and head ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events of low-grade fever (100.1), body aches and head ache were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Vaccination site joint movement impairment
Clinical narrative: Numbness/tingling sensation in left arm; Reduction of motor skills in left arm; Occasional mild pain; Numbness/tingling sensation in leftarm; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 05Apr2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history.  The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 15Mar2021 at 14:45 (at the age of 32-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 05Apr2021 at 17:00 the patient experienced numbness/tingling sensation in left arm, occasional mild pain and reduction of motor skills in left arm. 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 numbness/tingling sensation in left arm, occasional mild pain and reduction of motor skills in left arm was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, SARS-CoV-2 test
Clinical narrative: Shingles rash on left shoulder blade; Rash on left shoulder blade; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies and allergy to sulfa drugs. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown start date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On 26Mar2021, the patient underwent Sars-CoV-2 test and the result was negative. On 31Mar2021, the patient experienced shingles rash on left shoulder blade. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the events shingles rash on left shoulder blade was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Sluggishness
Clinical narrative: Very sore arm; Overall tiredness; Feeling sluggish; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 14Apr2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included multiple sclerosis. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), VICODIN and PERCOCET on an unknown date and experienced allergy. The patient's concomitant medications included interferon beta-1a (REBIF) and also birth control (unspecified) for unknown indications from an unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 24Mar2021 at 11:00 as a single dose for COVID-19 immunisation. On 15Apr2021 at 08:00, the patient had experienced very sore arm, overall tiredness and feeling sluggish. 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 adverse events. The clinical outcome of the events, very sore arm, overall tiredness and feeling sluggish was recovering at the time of this report.   No follow-up attempts are possible. Information about lot number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 3 days after the vaccine I got shingles; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 05Mar2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included heart issues from an unknown date. The patient did not receive any medications within two weeks of vaccination. The patient had no known allergies.  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 08Mar2021, three days after vaccination, the patient experienced shingles. The event 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 the event, shingles which included treatment with steroids and anti-viral medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was resolved with sequelae at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears; This is a spontaneous report from a non-contactable healthcare professional. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via intramuscular route of administration in the left arm on 02Jan2021 (at the age of 59-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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via intramuscular route of administration in the left arm on 17Dec2020 (at the age of 58-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 04Apr2021, the patient experienced tinnitus in both ears which started in the left then moved to the right, it was manageable but annoying. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with Zyrtec and Tylenol. The clinical outcome of the event tinnitus in both ears was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Fatigue; Headache; Chills; Fever; Redness, pain and swelling at injection site; Redness, pain and swelling at injection site; Redness, pain and swelling at injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 13Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) and loratadine (CLARITIN) from unknown date for unknown indication. 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 14Apr2021 at 09:00, the patient experienced redness, pain and swelling at injection site; fever; chills; headache; body aches; fatigue. 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 redness, pain and swelling at injection site; fever; chills; headache; body aches; fatigue was not resolved 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: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Body aches; Fatigue; Headache; Chills; Fever; Redness, pain and swelling at injection site; Redness, pain and swelling at injection site; Redness, pain and swelling at injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 13Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) and loratadine (CLARITIN) from unknown date for unknown indication. 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 14Apr2021 at 09:00, the patient experienced redness, pain and swelling at injection site; fever; chills; headache; body aches; fatigue. 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 redness, pain and swelling at injection site; fever; chills; headache; body aches; fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Oral pain, Stomatitis, Tongue ulceration
Clinical narrative: Painful sores (Psoriasis like) inside mouth; Painful sores (Psoriasis like) inside mouth; Painful sores (Psoriasis like) on tongue.; Painful sores (Psoriasis like) on tongue.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) in the right arm on 21Mar2021 at 18:00 (at the age of 61-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) in the left arm on 11Apr2021 at 18:00 (at the age of 61-years-old); both as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) , ezetimibe (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all for unspecified indication from 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 23Mar2021, the patient experienced painful sores (Psoriasis like) inside mouth and on tongue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event painful sores (Psoriasis like) inside mouth and on tongue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pain in extremity
Clinical narrative: red spots appeared on the the left inner elbowwith no pain; dark red bruise appeared on theside of right elbow; Pain started on the rightside arm with light red patch; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER 8730) via an unspecified route of administration in the arm left on 29Mar2021 at 14:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included betamethasone sodium phosphate (BETAMETHASONE) and beclometasone dipropionate (MANUFACTURER UNKNOWN) both on an 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 11th April, the patient experienced pain on the right side of arm with light red patch. On 12th April, dark red bruise appeared on the side of right elbow. The patient felt pain on the side arm and elbow while stretching the hand or pressing the red patch. On 15th April, red spots appeared on the the left inner elbow with no pain. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event pain started on the right side arm with light red patch, event dark red bruise appeared on the side of right elbow and red spots appeared on the the left inner elbow with no pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little tenderness at injection sight (1-2 days); The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (04Aug2021), this case now contains all required information to considered valid.  This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm at the age of 72 years old on 25Feb2021 08:00 (Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 Intramuscular administered in upper arm on 31Jan2021  at 09:15 am (Batch/Lot Number: EL9265; Expiration Date: 31Feb2021) at the age of 72 years old for COVID-19 immunisation. The patient experienced little tenderness at injection site (1-2 days) on an unspecified date. The patient stated that she is having open heart surgery and is concern about the Pfizer vaccine protection being compromised by the surgical procedure. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Total body aches; Injection site pain; Fatigue; Chills; Feverish; Headache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant 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 14Apr2021 at 10:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid and moderate eczema. Concomitant medications included norethisterone acetate, ethinylestradiol (AUROVELA 1/20), levothyroxine (MANUFACTURER UNKNOWN), betamethasone (BETAMETHA), mupirocin calcium (MUPIR) and macrogol, propylene glycol, simeticone, sorbic acid, sorbitol, white soft paraffin (VANICREAM); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 10.30, 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 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food or other products. On 14Apr2021 at 21:00, the patient experienced total body aches, injection site pain, fatigue, chills, feverish and headache. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of events total body aches, injection site pain, fatigue, chills, feverish and headache and included treatment with tylenol. The clinical outcome of the events total body aches, injection site pain, fatigue, chills, feverish and headache was recovering 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: Vaccination site pain
Clinical narrative: Total body aches; Injection site pain; Fatigue; Chills; Feverish; Headache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant 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 14Apr2021 at 10:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid and moderate eczema. Concomitant medications included norethisterone acetate, ethinylestradiol (AUROVELA 1/20), levothyroxine (MANUFACTURER UNKNOWN), betamethasone (BETAMETHA), mupirocin calcium (MUPIR) and macrogol, propylene glycol, simeticone, sorbic acid, sorbitol, white soft paraffin (VANICREAM); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 10.30, 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 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food or other products. On 14Apr2021 at 21:00, the patient experienced total body aches, injection site pain, fatigue, chills, feverish and headache. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of events total body aches, injection site pain, fatigue, chills, feverish and headache and included treatment with tylenol. The clinical outcome of the events total body aches, injection site pain, fatigue, chills, feverish and headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue
Clinical narrative: Chest pressure; Episodess of sob, chest pressure, and tiredness that started the day after 2nd injection and has continued every 2 or 3 day since last episode was 4/14 during the night.; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm right on 18Mar2021 at 13:15 hours (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and diabetes. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and metformin hydrochloride (METFORMIN) from unknown date and for unknown indications. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm right on 25feb2021 at 13:15 hours (at the age of 71-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 19Mar2021 at 09:00, the patient experienced episodes of shortness of breath, chest pressure, and tiredness that started the day after 2nd injection and has continued every 2 or 3 day since last episode was 14Apr2021 during the night. Therapeutic measures were not taken as a result of these 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 shortness of breath, chest pressure, and tiredness was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Disturbance in attention, Dyspepsia, Fatigue, Hunger
Clinical narrative: Blood pressure also went above normal; heart burn; sleeplessness; hungry; tiredness; could not concentrate; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 44-years-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 26Mar2021 18:30 (at the age of 44 years) as single for covid-19 immunization. Medical history included I am Diabetic from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 18:30 (at the age of 44 years) as single for covid-19 immunization. Patient did not have any known allergies. Patient did not have COVID prior vaccination and was not tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications in two weeks. On 28Mar2021 21:00 the patient experienced heart burn and sleeplessness from next 2 days of second dose. Patient started to feel hungry and heartburn and could not sleep for 10 days from there. Patient was also feeling so tiredness and could not concentrate and Blood pressure also went above normal. Adverse Events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement which went above normal on 28Mar2021. Adverse Event was treated by Doctor who suggested to use sleep aid like Benadryl. The outcome of the events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Insomnia
Clinical narrative: Blood pressure also went above normal; heart burn; sleeplessness; hungry; tiredness; could not concentrate; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 44-years-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 26Mar2021 18:30 (at the age of 44 years) as single for covid-19 immunization. Medical history included I am Diabetic from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 18:30 (at the age of 44 years) as single for covid-19 immunization. Patient did not have any known allergies. Patient did not have COVID prior vaccination and was not tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications in two weeks. On 28Mar2021 21:00 the patient experienced heart burn and sleeplessness from next 2 days of second dose. Patient started to feel hungry and heartburn and could not sleep for 10 days from there. Patient was also feeling so tiredness and could not concentrate and Blood pressure also went above normal. Adverse Events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement which went above normal on 28Mar2021. Adverse Event was treated by Doctor who suggested to use sleep aid like Benadryl. The outcome of the events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.