chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Suspected COVID-19
Clinical narrative: thinks he has COVID 19 now; Fever; Headache; muscle aches; Chills; Sore throat; Runny nose; Upset stomach; This is a spontaneous report from a contactable consumer. A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 16Mar2021 (at the age of 26-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient had no medical history. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. The patient experienced thinks he has covid 19 now on an unspecified date. On 19Mar2021, he started to have a fever, headache, muscle aches, chills, sore throat, runny nose and an upset stomach that are still persisting today. The patient experienced thinks he has covid 19 now on an unspecified date, Adds the patient is really concerned, and thinks he has COVID 19 now. He even went so far as to get an appointment for the test. It was reported that he got the first dose of the Pfizer COVID 19 vaccine on Tuesday 16MAR2021 at unknown time in an unknown arm. Caller added they were wondered with all of these symptoms should he get a COVID 19 test as suggested to call Pfizer. Patient had not visited physician office. Time the vaccination was given was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The outcome of thinks he has covid was unknown and other events were not recovered.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Vaccination site pain
Clinical narrative: left arm injection site was very sore to the touch.; fever of 101 the first night; severe body aches; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6204) via an unspecified route of administration in the left arm on 17Mar2021 at 14.30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and non-alcoholic steatohepatitis (NASH). The concomitant medications included levothyroxine sodium (SYNTHROID), gabapentin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) for unknown indication. 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 left arm on 24Feb2021 at 15.30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient been not tested for COVID-19. On 17Mar2021 at 19.30, the patient experienced severe body aches, fever of 101 the first night and on 18Mar2021, experienced vaccination site sore. Patient took Advil but fever stayed over 99.  Second day patient had fever and body aches continued. On the second night fever went to 101.9 and patient had continued body aches. Advil was continued as directed and fever with Advil was 100. On the third day morning, the fever had subsided and on 20Mar2021 at 10:00 the patient was like normal and able to work. Treatment was taken for the events, severe body aches, fever, vaccination site sore with ADVIL. 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 severe body aches, fever and vaccination site sore was resolved on 20Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Moderate tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207) via unspecified route of administration in the left arm on 21Mar2021 at 10:00 AM (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6202) via unspecified route of administration in the right arm on 28Feb2021 at 10:00 AM (at the age of 41-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. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Mar2021, the patient experienced moderate tinnitus. The patient did not receive treatment for the reported event. The clinical outcome of moderate tinnitus was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy arm rash at injection site that appeared a week post injection; Itchy arm rash at injection site that appeared a week post injection; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6208) via an unspecified route of administration in left arm on 13Mar2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested positive for COVID-19. On 21Mar2021, the patient experienced itchy arm rash at injection site that appeared a week post injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported event. The clinical outcome of the event itchy arm rash at injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Severe rash over 80% of body; eczema-like in nature.; This is a spontaneous report from a contactable consumer, the patient. An 88-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the right arm on 24Feb2021 (at the age of 88-years-old), as a single dose for COVID-19 immunisation. Medical history included left bundle branch block in heart. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and rivaroxaban (XARELTO); both for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration on an unspecified date in Feb2021 at 09:00 (at the age of 88-years-old), as a single dose for COVID-19 immunisation. On 04Mar2021 at 08:00, the patient experienced severe rash over 80% of body and it was eczema -like in nature. This appeared 8 days after the second dose. The patient was treated with unspecified cream for eczema type symptoms. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of eczematous rash was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site mass
Clinical narrative: I have a black bump on my arm where COVID vaccine was administered; Bump on arm still present; This is a spontaneous report from a contactable consumer (patient herself). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9269, Expiry date: unknown, age at vaccination of 59-years), dose 1 intramuscular, administered in arm right on 09Mar2021 14:00 as single and dose 2 intramuscular, administered in arm left on 30Mar2021 14:00 (Batch/Lot Number: ER2613, Expiry date: unknown) as single for covid-19 immunisation. The vaccination facility type was others. Medical history included blood cholesterol and A Fib (atrial fibrillation). Concomitant medications included pravastatin for cholesterol, propafenone hydrochloride (RYTHMOL (PROPAFENONE HYDROCHLORIDE)) for A Fib, metoprolol (METOPROLOL) for A Fib and the medications were ongoing. The patient stated that bump on arm still present on 10Mar2021, I have a black bump on my arm where covid vaccine was administered on an unspecified date. No treatment medication was received for the event bump on arm still present. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache
Clinical narrative: Dizziness; Fogginess; Headache; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6208) via an unspecified route of administration in the left arm on 19Mar2021 at 10:00 (at the age of 48-years-old), as single dose for COVID-19 immunisation. The patient had no medical history. The patient was allergic to penicillin. The patient did not take any concomitant medications. 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 did not have allergies to medications, food, or other products. On 20Mar2021 at 00:00, the patient experienced dizziness, fogginess, headache. The patient did not receive any treatment for the reported 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 dizziness, foggy feeling in head and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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: UNKNOWN), via an unspecified route of administration in the right arm on 22Mar2021 at 10:45 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included essential tremor. The patient was allergic to sulfa drugs. Concomitant medication included birth control pill (unspecified). Prior to 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 vaccine within four weeks prior to vaccination. On 22Mar2021 at 22:00, the patient experienced sore arm. The patient did not receive any other treatment for the adverse event. The clinical outcome of sore arm was not recovered at the time of this report.  Information on lot number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; Headache; Fatigue; This is spontaneous report from non-contactable consumer, the patient. A 37-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8430) via an unspecified route of administration on left arm on 23Mar2021 at 08:15 as a single dose (at the age of 37-year-old) for COVID-19 immunisation. Medical history was not reported. The patient had allergy to penicillin and avocado. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 23Mar2021 at 20:30, the patient experienced sore arm, headache and fatigue. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events sore arm, headache and fatigue were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Intermittent soreness and pain at the left arm of injection site; This is a spontaneous report received from a contactable physician. A 31-year-old non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on an unspecified date in 2021 (at an age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Two months after the vaccination on an unknown date in 2021, the patient experienced intermittent soreness and pain at the left arm at the site of vaccination. The patient was not treated for the reported event. The clinical outcome of vaccination site pain was not resolved at the time of report.  Information on lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node above collarbone for about 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: BM6955), via an unspecified route of administration in the left arm on an unspecified date (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021, the patient experienced swollen lymph node above collarbone for about two weeks. It was unknown if the patient received treatment for the adverse event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of swollen lymph nodes was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Generalized pruritus in various places (abdomen, foot, legs); Hot swelling; This is a spontaneous report from a contactable other healthcare professional (the patient). A 36-years non-pregnant female patient received second dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: EP6955) via an unspecified route of administration in the arm left on 20Mar2021 at 10:00 (at the age of 36-years old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, borderline narcolepsy, pulmonary embolism, the patient is allergic to tetracycline and sulphonamide antibiotics, bee and wasp stings. Concomitant medications included spironolactone, sertraline (MANUFACTURER UNKNOWN), modafinil (MANUFACTURER UNKNOWN) and Vitamin d3(MANUFACTURER UNKNOWN) was taken for an unknown indication from an unknown 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 four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6203) via an unspecified route of administration in the arm left on 27Feb2021 at 09:45 as a single dose for COVID-19 immunisation. On 20Mar2021 at 20:00, patient experienced 1cm diameter round, raised, hot swelling and local pruritus at vaccine site after 10 hours of vaccination, the next day same as last day and diameter got raised to 2cm. After 36 hours of vaccination, the diameter changed to 4-5cm the patient experienced more swelling, very intense pruritus at the vaccine site also suffered from generalized pruritus in abdomen, foot and legs. After 48 hours, the diameter came down to 2cm and pruritic effect decreased. After 60 hours, the patient experienced swelling at the site again also suffered from itchy legs. The patient received oral diphenhydramine, topical corticosteroid and ice for the events. The events result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events pruritus and swelling were not recovered. No follow-up attempts are needed. No further information was expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: 24 hours after the injection- arm soreness; Fatigue; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the arm (unspecified) on 15Mar2021 (at the age of 62-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. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 16Mar2021, 24 hours after the injection, the patient experienced arm soreness. A week after the injection, on an unspecified date in Mar2021, the patient experienced fatigue and diarrhea. The patient believed that the diarrhea and fatigue occurred prior to the vaccine but it was unsure. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, diarrhea and fatigue was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Pain, Pain in extremity, Pruritus
Clinical narrative: Pain on the arm; Body ache; Itching by the hands and face (lips); Itching face(lips); This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Ep7534) via an unspecified route of administration in the left arm on 22Mar2021 at 13:15 pm (at the age of 44-years-old) as a single dose for COVID -19 immunisation. Medical history was not reported. The concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced Pain on the arm, Body ache, Itching by the hands and face (lips). The patient did not receive treatment for the reported 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. The clinical outcome of the Pain on the arm, body ache and itching by the hands and face (lips) was unknown 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: Joint swelling
Clinical narrative: Top of both wrists noticeably swollen/ A slight hump on each; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 11:45 (at the age of 44-year-old) as a single dose for COVID-19 Immunisation. Medical history included severe asthma. The concomitant medications included fluticasone furoate; vilanterol trifenatate (BREO ELLIPTA), mepolizumab (NUCALA) 100mg, bupropionXL (MANUFACTURER UNKNOWN) 300mg and ibuprofen (ADVIL) for unknown indications from unknown start date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 17:00 (day after the vaccine injection), the patient experienced swelling wrist from top of both wrists (where a wristwatch face would sit) were both noticeably swollen (swollen wrist). No redness, rash, itching or pain, but visibly swollen. A slight hump on each. The patient never experienced this before and it was strange. The patient did not receive any treatment for the reported 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. The clinical outcome of the event swollen wrists was not resolved (4 days after swelling was going down in one wrist but not the other) at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Insomnia
Clinical narrative: Diarrhea; Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 22Mar2021 at 21:15 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 09:15, the patient experienced diarrhoea and insomnia. The patient did not receive any treatment for the reported 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. The clinical outcome of diarrhoea and insomnia were recovering.   Information on lot number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: strong and uncomfortable heart palpitations whenever patient lay down, they get worse at night; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient was allergic to codeine. Concomitant medications included LEXAPRO and CLARITIN. Prior to vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021, the patient had strong and uncomfortable heart palpitations whenever she lay down and they get worse at night. No treatment was given to the patient for the adverse event palpitation. The event did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The clinical outcome of the event palpitation was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Pain in extremity, Paraesthesia
Clinical narrative: Pain in arm; Tightness in arm; Tingling to left arm; This is a spontaneous report received from a contactable pharmacist for patient. A 26-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via intramuscular route on left arm on 27Feb2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications were not reported. The patient did not receive other vaccine within four weeks prior to COVID-19 vaccine. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient was tested for COVID-19. On 27Feb2021 at 10:05, the patient experienced tingling of left arm with no complaints of dizziness or light headedness and the vital signs were normal. The patient drank water and orange juice with improvement to tingling noted at 10:17. At 10:22, the patient still complained of pain or tightness or tingling in arm. The event did not result in doctor or other healthcare professional office/clinic visit. It was reported that, the patient left at 10:34 and was stable and was advised to follow up with primary care physician (PCP) if symptoms persist. Therapeutic measure was taken as result of events and included the treatment with TYLENOL 325 mg. The clinical outcome of the events tingling to left arm, pain in arm and tightness in arm were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Myalgia, Vaccination site pain
Clinical narrative: pain at injection site; Muscle soreness on back and hips.; feeling too hot and too cold; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EL3247) via an unspecified route of administration in the right arm on 22Mar2021(at the age of 27 years) at 12:00 as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medication included birth control. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EL3247) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 27 years) at 14:15 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 23:00, patient experienced pain at injection site, muscle soreness on back and hips and alternating between feeling too hot and too cold. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment for the events were not reported. The clinical outcome of the event pain at injection site, muscle soreness on back and hips and alternating between feeling too hot and too cold were recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Nasal discomfort, Oral discomfort
Clinical narrative: Burning/ numbness feeling around the nose, jaws, lips and my mouth; Burning/ numbness feeling around the nose, jaws, lips and my mouth; Burning/ numbness feeling around the nose, jaws, lips and my mouth; This is a spontaneous report received from a contactable other healthcare professional, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration at left arm on 23Mar2021 at 10:45 (at the age of 56-year-old), as single dose for COVID-19 immunisation. The patient medical history included chronic back pain. The patient was allergic to erythromycin. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration and unspecified site on unspecified date, as single dose for COVID-19 immunisation. Prior to 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. The patient did not receive any other medications within two weeks of vaccination. On 23Mar2021 at 11:30, within 25 minutes after her second dose of vaccine, the patient experienced burning and numbness feeling around the nose, jaws, lips and her mouth. It was unknown if patient received any treatment for 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 burning and numbness feeling around the nose, jaws, lips and her mouth was unknown.   Information about lot number cannot be obtained. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Muscle ache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on 22Mar2021 at 12:30 in left arm (at the age of 53 years) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ADVIL for an unspecified indication. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to 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 first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in left arm on 01Mar2021 at 10:30 (at the age of 53 years) as a single dose for COVID-19 immunisation. On 22Mar2021 at 14:00, the patient experienced chills and muscle ache. No treatment was received as a result of adverse events. The clinical outcome of chills and muscle ache was resolving.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Bruising, itching, and small bumps at the injection site; Bruising, itching, and small bumps at the injection site; Bruising, itching, and small bumps at the injection site; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204), via an unspecified route of administration in the left arm on 18Mar2021 at 14:30 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced bruising, itching, and small bumps at the injection site. The patient did not receive any treatment for reported 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. The clinical outcome of the events vaccination site bruising, vaccination site pruritus, and vaccination site lump was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: unknown), via an unspecified route of administration in left arm on 09Mar2021 at 14:00 (at the age of 65-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. It was unknown if the patient had any allergies to medications, food, or other products. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), morphine (MANUFACTURER UNKNOWN), temazepam (MANUFACTURER UNKNOWN), atorvastatin calcium(LIPITOR) and acetaminophen-oxycodone hydrochloride(PERCOCET) all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 11Mar2021, the patient experienced sore arm. The patient had not received any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm was resolved on an unknown date in Mar2021.   Information on lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Dizziness
Clinical narrative: dizziness/light-headed; BP was 98/45, 104/48 and 96/45; This is a spontaneous report from a contactable pharmacist. A 45-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via intramuscular in the left arm on 22Feb2021 (at the age of 45-years-old), as a second dose for COVID-19 immunisation. Medical history included hypothyroidism from an unspecified date. Concomitant medication included levothyroxine 25mcg (MANUFACTURER UNKNOWN) was taken for hypothyroidism within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via intramuscular in the left arm on 01Feb2021 (at the age of 45-years-old), as a single dose for Covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 22Feb2021 at 19:45, after taking the vaccination shot, the patient complained of dizziness. The patient did not have breakfast and the blood pressure was 98/45 (units unspecified). After having snacks and water, blood pressure was checked and it was 104/48 (units unspecified). Still, she was feeling light-headed at 20:00, soon after at 20:23 blood pressure was 96/45 (units unspecified) and it was reported feeling better. The patient did not receive treatment for the reported events. Adverse 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 dizziness/light-headed and BP was 98/45, 104/48 and 96/45 was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus was noted several days after the vaccination and has been persistent; This is a spontaneous report from a contactable physician. A 49-year-old male patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) intramuscularly in the right arm on 11Mar2021 (at the age of 49-year-old) at 11:00 as a single dose for COVID-19 immunisation. The patient's medical history included hypertension. Concomitant medication included losartan (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. No allergies to medications, food, or other products had been reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 12Mar2021 at 08:00, patient experienced tinnitus, was noted several days after the vaccination and had been persistent. 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 event. The outcome of the event tinnitus was noted several days after the vaccination and had been persistent was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chills, Diarrhoea
Clinical narrative: Fever; Body aches; Shakes; Fatigue; Joint pain; Headache; Weakness; Chills; Sore arm; Nausea; Stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had only known allergy with z-pak. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR), estradiol (ESTRACE), simvastatin (ZOCOR) and multivitamins, all for unknown indication received within 2 weeks of vaccination and was unknown if ongoing. The patient experienced fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea on 20Mar2021 at 06:00. The patient did not receive any treatment for 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 fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea was resolving at the time of reporting. Information about lot/ batch number cannot be obtained. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Fever; Body aches; Shakes; Fatigue; Joint pain; Headache; Weakness; Chills; Sore arm; Nausea; Stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had only known allergy with z-pak. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR), estradiol (ESTRACE), simvastatin (ZOCOR) and multivitamins, all for unknown indication received within 2 weeks of vaccination and was unknown if ongoing. The patient experienced fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea on 20Mar2021 at 06:00. The patient did not receive any treatment for 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 fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea was resolving at the time of reporting. Information about lot/ batch number cannot be obtained. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever; Body aches; Shakes; Fatigue; Joint pain; Headache; Weakness; Chills; Sore arm; Nausea; Stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had only known allergy with z-pak. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR), estradiol (ESTRACE), simvastatin (ZOCOR) and multivitamins, all for unknown indication received within 2 weeks of vaccination and was unknown if ongoing. The patient experienced fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea on 20Mar2021 at 06:00. The patient did not receive any treatment for 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 fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea was resolving at the time of reporting. Information about lot/ batch number cannot be obtained. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: I have a bruise at the injection site; When I got the shot, I bled a bit, too.; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 21Mar2021 at 11:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, when the patient got the shot, she had bled a bit (vaccination site bleeding) and on 23Mar2021, reportedly two days after the vaccine, the patient had a bruise at the injection site (vaccination site bruising). The patient enquired whether it was normal to have bruise at injection site and was also concerned of vaccine shot bleeding that the vaccine  was not administered correctly in the muscle. The patient had not received any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vaccination site bleeding was recovered while that of vaccination site bruising was not recovered at the time of this report.   Information about lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: Loss of taste; Headache; Swollen lymph nodes in throat and ears; Feeling very tired and exhausted; Very sore arm; This is a spontaneous report received from a contactable consumer, the patient. An adult non-pregnant female patient of unspecified age 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 16Mar2021 at 10:45, as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, psoriasis, eczema, allergic rhinitis, high blood pressure and migraines. The patient was allergic to apremilast (OTEZLA), sulfasalazine (MANUFACTURER UNKNOWN), dairy, eggs and food preservatives. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) 10 mg, paracetamol (TYLENOL) 500 mg, loratadine (CLARITIN) 10 mg; all for unknown indications from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 00:00, the patient had very sore arm, headache, swollen lymph nodes in throat and ears, feeling very tired and exhausted. On 20Mar2021 (4 days later), the patient experienced loss of taste. The patient did not receive any treatment for the reported 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. The clinical outcome of the sore arm, loss of taste, headache, swollen lymph nodes in throat and ears, feeling very tired and exhausted were not recovered.  Information on lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Influenza like illness, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Flu like symptomss; congestion; runny nose; body aches; sore throat,; sinus pain; POPPING EAR; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) as unknown dose on 20Mar2021 at 10:15am for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 21Mar2021 at 08:00, the patient experienced flu like symptoms, congestion and runny nose, sore throat, body aches, headache, sinus pain and popping ears. 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 received any treatment for the reported events. The clinical outcome of the events flu like symptoms, congestion and runny nose, sore throat, body aches, headache, sinus pain and popping ears was not resolved. No follow-up attempts are possible. Information about lot number cannot be obtained.