chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; fever; extreme body aches; headache; fatigue; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via unspecified route of administration in the left arm on 18Mar2021 at 17:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergies to amoxicillin, penicillin and wheat/gluten. Concomitant medications included mesalamine (MANUFACTURER UNKNOWN) and loratadine (CLARITIN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via unspecified route of administration in left arm on 25Feb2021 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021, at 03:00, the patient developed chills, fever, extreme body aches, headache, fatigue and nausea. 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 chills, fever, extreme body aches, headache, fatigue and nausea was resolved in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 50-years-old) at 14:30 as a single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. Concomitant medications included synthroid (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) for unknown indication on an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 50-years-old) at 14:30 as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, medications 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 had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 16:30, patient experienced headache, chills, fever, vomiting and body aches. The patient did not receive any treatment for the events. The outcome of the events headache, chills, fever, vomiting and body aches was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Hypoaesthesia
Clinical narrative: Numbness throughout left side of the body (injection was left arm),; difficulty swallowing; shortness of breath,; dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-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 the left arm on 22Mar2021 at 10.30am as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 22Mar2021 at 10.30 am, the patient experienced numbness through left side of the body (injection was left arm), difficulty swallowing, shortness of breath and dizzy. No therapeutic measures were taken for the treatment of reported events. The events had not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness through left side of the body (injection was left arm), difficulty swallowing, shortness of breath and dizzy was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness at injection site; Swollen at injection site; Itching at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration at right arm on 08Mar2021 at 09:15 (age of 55-year-old at vaccination), as single dose for COVID-19 immunisation. The patient medical history included common variable immune deficiency. Concomitant medications included LO LOESTRIN FE, magnesium (MANUFACTURER UNKNOWN), Vitamin C (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), Vitamin B12 (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN) for unspecified indication and from unknown start date. 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. On 16Mar2021 at 10:00, the patient experienced redness, swollen and itching at injection site. A little swelling but no pain. The patient did not receive any treatment for events. The clinical outcome of event redness at injection site, swollen at injection site and itching at injection site were recovered.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Fatigue, Vaccination site pain
Clinical narrative: Sore arm at injection sight; Joint pain in legs; Bone pain in legs; Chilled; Tired; This is a spontaneous report received from a non-contactable consumer, the patient. A 32-year-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 the right arm on 18Mar2021 at 11:00 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included methylphenidate (RITALIN), desogestrel, ethinyl estradiol (ISIBLOOM) and multivitamin (MANUFACTURER UNKNOWN), for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced sore arm at injection sight (vaccination site pain), joint pain in legs, bone pain in legs, chilled and tired on 18Mar2021. 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 event sore arm at injection sight, joint pain in legs, bone pain in legs, chilled and tired were not recovered.   No follow-up attempts are possible. No further information is expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6206), via an unspecified route of administration in the left arm on 13Mar2021 at 10:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included ductal carcinoma in situ (DCIS). The patient had allergies to unspecified medications, food, or other products.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included norethindrone (NORA BE), fish oil (MANUFACTURER UNKNOWN), and vitamins (unspecified) from unknown dates, for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6200) via an unspecified route of administration in the left arm on 20Feb2021 at 12:00 (at the age of 54-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-19 vaccination. On 16Mar2021 at 12:00, the patient experienced itchy rash on arms and legs, it began 3 days after second vaccination. The patient did not receive any treatment for the event itchy rash. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event itchy rash was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Sweat; High fever; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to sulfa, penicillin, clindamycin and tetracycline. The patient received PEPSID AC, multivitamin (MANUFACTURER UNKNOWN), calcium D, I (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Feb2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 20:00, the patient experienced high fever until 03:00 on 18Mar2021. In the night of 18Mar2021, the patients night gown was totally drenched with sweat as were her sheets. The patient did not feel normal until 22Mar2021. 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 event high fever was recovered on 18Mar2021 at 03:00. The clinical outcome of sweat was resolved on 22Mar2021.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 48 year-old non-pregnant female patient received second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG198) via an unspecified route of administration in left arm on 26Feb2021 at 12:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin.  The patient  did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via an unspecified route of administration in the left arm on 01Feb2021 at 16:00 (at the age of 48-years-old) as a 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. On 14Mar2021, the patient experienced shingles which was diagnosed on 19Mar2021. Therapeutic measure for shingles included treatment with valacyclovir and prednisone. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of shingles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia, Palpitations, Paraesthesia oral, Throat irritation
Clinical narrative: 25 minutes after shot. bright red hotflushed face; Tingly tongue; Itchy throat; Numb/tingly nose; 2 episodes of heart palpitations; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non pregnant old 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 21Mar2021 at 16:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient medical history included menopause and thyroid issues. The patient was allergic to penicillin and amoxicillin. The patient received unspecified other medications in two weeks. 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 21Mar2021 at 16:30 reportedly 25 minutes after shot the patient experienced bright red hot flushed face, tingly tongue, itchy throat, numb/tingly nose and two episodes of heart palpitations. The symptoms subsided within an hour or so. The patient was allergic to penicillin/amoxicillin and not sure if that was related. 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 treatment for the events. The clinical outcome of bright flushed face, palpitations, Itchy throat, Numb/tingly nose, tingly tongue was recovered on 21Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red discolouration; Swelling at vaccination site .; Black and blue discoloration; This is a spontaneous report from a contactable consumer, the patient. A 70-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 11Mar2021 at 00:00 (at the age of 70-year-old), for COVID-19 immunisation. The patient had unspecified medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received other unspecified medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested positive for COVID-19. The patient had unspecified allergies to medications, food, or other products. On 11Mar2021 at 00:00, the patient experienced swelling at vaccination site with red black and blue discoloration. Therapeutic measures were not taken for any of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling at vaccination site with red black and blue discoloration was not resolved (same after 12 days) at the time of the event.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), via an unspecified route of administration in the right arm on 21Mar2021 at 15:00 (at the age of 17-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient had a history of lactose intolerance. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW6203), via an unspecified route of administration in the right arm on 28Feb2021 at 14:00 (at the age of 17-years-old), as a first 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 tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 14:30, the patient had experienced fever, chills and body aches. The patient did not receive any treatment for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills and body aches were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Fever; chills; pain at injection site; headaches; muscle pains; joint pains; nausea; vomiting; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration on the right arm on 20Mar2021 at 15:00 (at the age of 63-year-old), as an unknown single dose for COVID-19 immunisation. Medical history included hypertension and colon cancer. Concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 1300, the patient experienced fever, chills, pain at injection site, headaches, muscle pains, joint pains, nausea, vomiting and feeling unwell. The patient received other medication within two weeks of vaccination. Tylenol and Motrin was taken as therapeutic measures as a result of adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, pain at injection site, headaches, muscle pains, joint pains, nausea, vomiting and feeling unwell was resolved on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Fever; chills; pain at injection site; headaches; muscle pains; joint pains; nausea; vomiting; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration on the right arm on 20Mar2021 at 15:00 (at the age of 63-year-old), as an unknown single dose for COVID-19 immunisation. Medical history included hypertension and colon cancer. Concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 1300, the patient experienced fever, chills, pain at injection site, headaches, muscle pains, joint pains, nausea, vomiting and feeling unwell. The patient received other medication within two weeks of vaccination. Tylenol and Motrin was taken as therapeutic measures as a result of adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, pain at injection site, headaches, muscle pains, joint pains, nausea, vomiting and feeling unwell was resolved on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Viral test
Clinical narrative: Memory problems with me and my husband. Can not remember words and places normally not a problem; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: unknown) via an unspecified route of administration in the left arm on 10Feb2021 at 12:00 (at the age of 72-years-old) and second dose of BNT162b2(PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: unknown) via an unspecified route of administration in the left arm on 13Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient has allergy to codeine. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient has received medication (unspecified) within 2 weeks of vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19. On 05Mar2021, patient underwent nasal swab test and result was negative. On an unknown date in Feb2021, patient experienced memory problems. Patient could not remember words and places normally not a problem. They were not really concerned but curious if this was in fact due to the vaccines. It appears to have started happening shortly after first vaccine and continued to be worse after the second vaccine. The patient did not receive any treatment for the event.  The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the event memory impairment was not recovered.   Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021318707 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: ear infections; This is a spontaneous report from a Pfizer sponsored program, from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 18Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ear infections on an unspecified date (wants to know will if affects the vaccine if she will take Amoxicillin). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Injection site pain; Aches / muscle soreness in ribs, neck, shoulders, opposite arm and abdomen.; Joint pain in one knee; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 at 08:45 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included auto immune hepatitis and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient previously received sulfa drugs (unspecified) and doxycycline (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergy. Concomitant medications included azathioprine (IMURAN) 50 mg, acetylsalicylic acid (ASPIRIN), levothyroxine (SYNTHROID) and venlafaxine hydrochloride (EFFEXOR); all for unknown indications received within two weeks of vaccination. 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 22March2021 at 14:00, the patient experienced injection site pain; aches or muscle soreness in ribs, neck, shoulders, opposite arm and abdomen; joint pain in one knee and fatigue. 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 injection site pain, muscle soreness, joint pain in one knee and fatigue were resolving.  No follow up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy
Clinical narrative: swollen lymph node under armpit on same side as vaccine 48 hours later; Discomfort on side of vaccine site by collarbone the first day; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received an unspecified dose number of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration to the left arm on 18Mar2021 at 0900 (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. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Concomitant medications included lexipro (MANUFACTURER UNKNOWN). On 19Mar2021, the patient experienced discomfort on side of vaccine site by collarbone the first day and swollen lymph node under armpit on the same side as vaccine, on 20MAr2021 reportedly 48 hours later. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any treatment for the adverse events. The clinical outcome of discomfort and axillary lymphadenopathy was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Dizzy spell; Right arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727/WCHD), via an unspecified route of administration in the right arm on 23Mar2021 at 09:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included selective antibody deficiency(immunodeficiency), hypogammaglobulinemia, thrombocytopenia and arthritis. Concomitant medications included immune globulin (CUVITRU) and naproxen (ALEVE) taken for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Mar2021 at 10:00, the patient had dizzy spell within 10 mins and right arm soreness. 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 events. The clinical outcome of the events dizzy spell and right arm soreness were resolved on an unknown date.    No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Insomnia
Clinical narrative: Sleeplessness at night; Tiredness during the day; This is a spontaneous report received from a non-contactable consumer, the patient. A patient of an unknown age and unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6026199) via an unspecified route of administration in the left arm on 05Mar2021 at 10:30, as a single dose for COVID-19 immunisation. The patients medical history was not reported. Concomitant medications included ozempic (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. 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 has not been tested for COVID-19. On 05Mar2021 at 22 hours, the patient experienced sleeplessness at night and the patient experienced tiredness during the day since the first dose. No treatment was received for the events. The clinical outcome of the events sleeplessness and tiredness was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash macular, Urticaria
Clinical narrative: Pain in both lower extremity; Swelling in both lower extremity; Red spots; Hives; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6205) via an unspecified route of administration in left arm on 18Mar20219 (at the age of 54 years old) at 14: 00, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 15:00, the patient experienced pain and swelling in both lower extremity, red spots and hives. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of pain and swelling in both lower extremity, red spots and hives was not recovered at the time of reporting. It was reported unknown whether the patient received any therapeutic measures.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Fatigue, Headache, Hypertension
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 05Mar2021 at 10:15 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received unspecified other medications within two weeks prior to the vaccination. The patient had COVID-19 nasal swab test on 15Mar2021 and resulted negative. On 12Mar2021 at 17:00, the patient experienced an ear ache, headache, tiredness, muscle pain, chills, not feeling well and had high blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the reported events. The clinical outcome of events ear ache, headache, tiredness, muscle pain, chills, feeling unwell and high blood pressure was resolving 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: Malaise, Myalgia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 05Mar2021 at 10:15 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received unspecified other medications within two weeks prior to the vaccination. The patient had COVID-19 nasal swab test on 15Mar2021 and resulted negative. On 12Mar2021 at 17:00, the patient experienced an ear ache, headache, tiredness, muscle pain, chills, not feeling well and had high blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the reported events. The clinical outcome of events ear ache, headache, tiredness, muscle pain, chills, feeling unwell and high blood pressure was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Needle separated from syringe during vaccination. It is unknown how much vaccine was lost and how much was successfully administered.; This is a spontaneous report from a contactable other health care professional. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE BIONTECH, Lot number: ER8730) intramuscularly in the left arm on 20Mar2021 at 12:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, unknown if patient was diagnosed with COVID-19. Since the vaccination, unknown if patient had been tested for COVID-19. On 20Mar2021, the patient experienced needle separated from syringe during vaccination and it was unknown how much vaccine was lost and how much was successfully administered. Event didn't result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken for the event. The outcome of the event needle separated from syringe during vaccination and is unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling, Vaccination site pain
Clinical narrative: The padded area on my hands between my thumb and pointer finger became swollen; Injection site pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unknown route of administration in right arm on 21Mar2021 at 14:30 (at an age of 63-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient was allergic to biaxin. 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 21Mar2021 at 15:30, the patient experienced swelling in the padded area on the hands between the thumb and pointer finger, injection site pain and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of swelling in the padded area on the hands between the thumb and pointer finger was resolved (for a couple hours) on 21Mar2021, while that of injection site pain was resolved (lasted for 24 hours) on 22Mar2021 and fatigue was resolved on an unknown date of Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Nausea, Pruritus
Clinical narrative: Injection site pain; Headache; Joint pain (primarily knees and ankles); Fever; Nausea; Unusual itchiness on head; Swollen lymph nodes in armpits; This is a spontaneous report from a non-contactable consumer, the patient. A 33-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 19Mar2021 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN) and LO LOESTRIN FE, all for unknown indication on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Mar2021, the patient experienced injection site pain, headache, joint pain (primarily knees and ankles), fever, nausea, unusual itchiness on head and swollen lymph nodes in armpits. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 23Mar2021, the patient underwent SARS-CoV-2 (nasal swab) and result was unknown. The outcome of vaccination site pain, headache, joint pain, fever, nausea, itchy and axillary lymphadenopathy was recovering at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Injection site pain; Headache; Joint pain (primarily knees and ankles); Fever; Nausea; Unusual itchiness on head; Swollen lymph nodes in armpits; This is a spontaneous report from a non-contactable consumer, the patient. A 33-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 19Mar2021 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN) and LO LOESTRIN FE, all for unknown indication on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Mar2021, the patient experienced injection site pain, headache, joint pain (primarily knees and ankles), fever, nausea, unusual itchiness on head and swollen lymph nodes in armpits. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 23Mar2021, the patient underwent SARS-CoV-2 (nasal swab) and result was unknown. The outcome of vaccination site pain, headache, joint pain, fever, nausea, itchy and axillary lymphadenopathy was recovering at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Hot flush
Clinical narrative: fever; chills; sore arm; fatigue; nausea; lightheadedness; vertigo; vomiting; diarrhea; hot flashes; This is a spontaneous report received from a contactable consumer, the patient. A 27 years-old patient of female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route on 12Mar2021 18:30, at an age of 27 years old and on right arm site as a single dose, for COVID-19 immunisation. Medical history included Spina Bifida, hydrocephalus, chiari malformation, fibromyalgia, lumbar radiculopathy and migraines from an unknown date. The patient was allergic to sulfur drugs, latex, penicillin and fentanyl. Prior to the vaccination, it was unknown whether the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received LAMICTAL, STRATERRA and NUEDEXTA from unknown date and unknown if its ongoing within two weeks of vaccination. On 13Mar2021, the patient experienced a fever, chills, fatigue, and sore arm for about 12 hours after vaccination, then felt fine for 3 days but at the time of reporting experienced all these events along with nausea, light headedness, vertigo, vomiting, diarrhoea, and hot flashes for six days. Patient had been waiting to hear from doctor for recommendation as patient was very concerned about receiving second dose. The patient did not receive treatment for events. The events had not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events fever, chills, fatigue, sore arm, nausea, light headedness, vertigo, vomiting, diarrhoea, and hot flashes were not recovered 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: Nausea, Pain in extremity, Pyrexia, Vertigo, Vomiting
Clinical narrative: fever; chills; sore arm; fatigue; nausea; lightheadedness; vertigo; vomiting; diarrhea; hot flashes; This is a spontaneous report received from a contactable consumer, the patient. A 27 years-old patient of female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route on 12Mar2021 18:30, at an age of 27 years old and on right arm site as a single dose, for COVID-19 immunisation. Medical history included Spina Bifida, hydrocephalus, chiari malformation, fibromyalgia, lumbar radiculopathy and migraines from an unknown date. The patient was allergic to sulfur drugs, latex, penicillin and fentanyl. Prior to the vaccination, it was unknown whether the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received LAMICTAL, STRATERRA and NUEDEXTA from unknown date and unknown if its ongoing within two weeks of vaccination. On 13Mar2021, the patient experienced a fever, chills, fatigue, and sore arm for about 12 hours after vaccination, then felt fine for 3 days but at the time of reporting experienced all these events along with nausea, light headedness, vertigo, vomiting, diarrhoea, and hot flashes for six days. Patient had been waiting to hear from doctor for recommendation as patient was very concerned about receiving second dose. The patient did not receive treatment for events. The events had not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events fever, chills, fatigue, sore arm, nausea, light headedness, vertigo, vomiting, diarrhoea, and hot flashes were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Thirst
Clinical narrative: Thirsty; Fever; Tired; Chills; This is a spontaneous report from a contactable healthcare professional, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccine 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 did not test for COVID-19. On 23Mar2021 at 07:00, the patient experienced fever, chills, tiredness and thirsty. There were not therapeutic measures taken 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 fever, chills, tiredness and thirsty was resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Oral mucosal blistering, Pyrexia
Clinical narrative: Mouth blisters; Fever; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 44-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 23Feb2021 at 11.30 (age at vaccination 44-years old), as single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unknown route of administration in the left arm on 16Mar2021 at 11.30 (age at vaccination 44-years old), as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included bupropion (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN), both for an unknown indication from an unspecified date. The patient did not had allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On an unknown date of 2021, the patient experienced fever, chills, fatigue and mouth blisters. The patient did not received treatment for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever, chills, fatigue and mouth blisters were unknown at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained.