chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Apr2021 at 13:15 (at the age of 44-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had a history of allergy to sulfa. Concomitant medications included montelukast sodium (SINGULAIR) 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. On 08Apr2021 at 13:30, the patient experienced metallic taste after the first dose, the patient reported that it had been almost a month and a half and could taste metal like the first day of the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the event metallic taste was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Vaccination site pain
Clinical narrative: Injection site is sore; Slight nasal pressure; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 14May2021 at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and elevated cholesterol. The patient had no known allergies to medications, food or other products. Concomitant medication included verapamil (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 14May2021 at 15:00, the patient noticed slight nasal pressure not necessarily related to the vaccine. On 14May2021 at 16:15, (7 hours later) the patient reported that the injection site was sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events injection site sore and slight nasal pressure was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus developed in both ears (stronger in left ear); This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 18Mar2021 at 08:00(at the age of 64-year-old) as a single dose for COVID-19 immunisation.  Medical history included mild hypertension. Concomitant medications included olmesartan medoxomil(MANUFACTURER UNKNOWN) and multivitamins (unspecified), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203) via an unspecified route of administration in the arm left on 25Feb2021 at 08:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient developed tinnitus in both ears (stronger in left ear). The patient did not receive any treatment for the reported event. The adverse event 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 tinnitus in both ears was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated, Paraesthesia
Clinical narrative: Significant increase in arthritis pain in knee and hip; Significant increase in arthritis pain in knee and hip; Tingling in toes; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the left arm on 20Mar2021 at 13:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and high blood pressure. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), oxybutynin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN), all taken from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6205) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 13:00, the patient experienced significant increase in arthritis pain in knee and hip and tingling in toes. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events significant increase in arthritis pain in knee and hip and tingling in toes were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Hypoaesthesia, Pain
Clinical narrative: right sided numbness involving whole body; .She also complains of 'poofiness' of right side of body without any swelling noticed; pain in whole right side of body that was more than generalized body aches.; This is a spontaneous report from a contactable physician. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E020176) via intramuscular route of administration in the right arm on 30Apr2021 at 15:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included etonogestrel (NEXPLANON) insert in left arm for unspecified indication from an unknown date. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unspecified indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 00:00, the patient experienced right sided numbness involving whole body and also complained of  'poofiness' of right side of body (without any swelling noticed). The patient also felt pain in the whole right side of body that was more than the generalized body aches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events right sided numbness involving whole body, 'poofiness' of right side of body without any swelling and pain in the whole right side of body that was more than the generalized body aches was recovered on unknown date of May2021.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: menstruation restarted after menopause for 8 months; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 12:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient was known to be allergic to sulfa. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 16Feb2021 at 10:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 09:00 exactly two weeks after receiving the second dose of vaccination, the patient's menstruation restarted after being menopause for 8 months. 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 as a result of the event. The clinical outcome of the event menstruation restarted after being menopause for 8 months was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Insomnia, Malaise
Clinical narrative: pain in the site of vaccine; sever chills; couldn't sleep for five hours straight; Every move was painful from the chills; I feel unwell; nausea; joint pain; whole body is exhausted; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 13May2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included ibuprofen (ADVIL), and omeprazole (PRILOSEC) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 22Apr2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 04:30, the patient experienced pain in the site of vaccine after a couple of hours. The night after taking the vaccine, felt sever chills to the point where she couldn't sleep for five hours straight. Felt captivated because she couldn't move much. Every move was painful from the chills. Never felt like this before, finally slept after five hours. Slept for four hours that night and then felt unwell. felt nausea and joint pain and just whole body was exhausted. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in the site of vaccine after a couple of hours. The night after taking the vaccine, felt sever chills to the point where she couldn't sleep for five hours straight. Felt captivated because she couldn't move much. Every move was painful from the chills. Never felt like this before, finally slept after five hours. Slept for four hours that night and then felt unwell. felt nausea and joint pain and just whole body was exhausted was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site pain
Clinical narrative: pain in the site of vaccine; sever chills; couldn't sleep for five hours straight; Every move was painful from the chills; I feel unwell; nausea; joint pain; whole body is exhausted; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 13May2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included ibuprofen (ADVIL), and omeprazole (PRILOSEC) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 22Apr2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 04:30, the patient experienced pain in the site of vaccine after a couple of hours. The night after taking the vaccine, felt sever chills to the point where she couldn't sleep for five hours straight. Felt captivated because she couldn't move much. Every move was painful from the chills. Never felt like this before, finally slept after five hours. Slept for four hours that night and then felt unwell. felt nausea and joint pain and just whole body was exhausted. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in the site of vaccine after a couple of hours. The night after taking the vaccine, felt sever chills to the point where she couldn't sleep for five hours straight. Felt captivated because she couldn't move much. Every move was painful from the chills. Never felt like this before, finally slept after five hours. Slept for four hours that night and then felt unwell. felt nausea and joint pain and just whole body was exhausted was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Nausea, Swelling face
Clinical narrative: Achey joints; nausea; vomiting; diarrhea; headache; Face swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6199) via an unspecified route of administration in the left arm on 13May2021 at 17:00(at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included iron deficiency anemia, blood pressure high, sulfonamide allergy and allergy to walnuts, almonds, horse products. Concomitant medications included chlortalidone (CHLORTHALIDONE) and cetirizine hydrochloride (ZYRTEC); both for an unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number:ER8737) via an unspecified route of administration in the arm left on 23Apr2021 at 09:45(at the age of 41-year-old) as a single dose for COVID-19 immunisation and took Percocet and Darvocet on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 21:00, within 4 hours of Shot, the patient experienced Face swelling. On 13May2021 at 23:00, 6 hours, the patient experienced nausea, vomiting, diarrhea, headache. On 14May2021, within 10-12 hours. the patient experienced Achey joints. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the face swelling, nausea, vomiting, diarrhea, headache and ache joints were ongoing.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Achey joints; nausea; vomiting; diarrhea; headache; Face swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6199) via an unspecified route of administration in the left arm on 13May2021 at 17:00(at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included iron deficiency anemia, blood pressure high, sulfonamide allergy and allergy to walnuts, almonds, horse products. Concomitant medications included chlortalidone (CHLORTHALIDONE) and cetirizine hydrochloride (ZYRTEC); both for an unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number:ER8737) via an unspecified route of administration in the arm left on 23Apr2021 at 09:45(at the age of 41-year-old) as a single dose for COVID-19 immunisation and took Percocet and Darvocet on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 21:00, within 4 hours of Shot, the patient experienced Face swelling. On 13May2021 at 23:00, 6 hours, the patient experienced nausea, vomiting, diarrhea, headache. On 14May2021, within 10-12 hours. the patient experienced Achey joints. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the face swelling, nausea, vomiting, diarrhea, headache and ache joints were ongoing.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Couple of days later after having the vaccine I started to feel severe lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 06May2021 at 14:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient did not have any allergies to medications, food, or other products. Concomitant medications included women ultra mega vitamins and levothyroxine sodium (EUTHYROX). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was unknown whether any therapeutic measures were taken as a result of the reported event. On 09May2021 at 20:00, the patient experienced severe lower back pain couple of days later after having the vaccine. 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 event lower back pain was not recovered 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: Chills, Headache, Nasal congestion, Pyrexia
Clinical narrative: Chills; Low grade fever; Headache; Slight congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 26Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 05Apr2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient experienced chills, low-grade fever, headache and slight congestion. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure was taken as a result of the event headache which included treatment with EXCEDRIN. The clinical outcome of the events chills, low grade fever, headache and slight congestion were recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Large rash/ hives at injection site started 48 hours post injection. Itches and burns; Large rash/ hives at injection site started 48 hours post injection. Itches and burns; Large rash/ hives at injection site started 48 hours post injection. Itches and burns; This is a spontaneous report from a contactable consumer, the patient. A 43-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 in the left arm on 12May2021 at 15:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no known medical history. The patient did not receive any other medications within two weeks of the vaccination. The patient did not have any allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 15:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021 at 12:00, the patient experienced large rash/hives at injection site started 48 hours post injection, itches and burns. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events large rash/hives at injection site started 48 hours post injection, itches and burns were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Discharge, Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstruation irregular
Clinical narrative: Tenderness; discharge; bloating; 2 weeks early period; Great deal of bleeding; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the arm left on 11May2021 at 15:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included IUD embedded which was ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the arm left on 27Apr2021 at 10:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks of vaccination. On 14May2021 at 21:00, 3 days after the Pfizer covid shot dose 2 , she had a great deal of bleeding, discharge, tenderness and bloating. Her period is also 2 weeks early. The patient had not experienced any of that in 9 years since the patient had started using IUDs. The patient had 2nd IUD and had been using for 9 years. Previously, the patient periods with an IUD had no bleeding and just spotting. The patient received the second dose of vaccination outside the scheduled window period (inappropriate schedule of vaccine administered). The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events tenderness, discharge, bloating, irregular periods and menstruation increased were resolving. The clinical outcome of the event Inappropriate schedule of vaccine administered was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness; discharge; bloating; 2 weeks early period; Great deal of bleeding; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the arm left on 11May2021 at 15:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included IUD embedded which was ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the arm left on 27Apr2021 at 10:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks of vaccination. On 14May2021 at 21:00, 3 days after the Pfizer covid shot dose 2 , she had a great deal of bleeding, discharge, tenderness and bloating. Her period is also 2 weeks early. The patient had not experienced any of that in 9 years since the patient had started using IUDs. The patient had 2nd IUD and had been using for 9 years. Previously, the patient periods with an IUD had no bleeding and just spotting. The patient received the second dose of vaccination outside the scheduled window period (inappropriate schedule of vaccine administered). The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events tenderness, discharge, bloating, irregular periods and menstruation increased were resolving. The clinical outcome of the event Inappropriate schedule of vaccine administered was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 13May2021 at 10:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to food, medicine or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 22Apr2021 at 10:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 11:00, the patient experienced fever up to 102 degrees (units unspecified), chills, body aches, arm soreness near injection site, nausea when moving around. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events.  The clinical outcome of the events fever up to 102 degrees (units unspecified), chills, body aches, arm soreness near injection site, nausea when moving around was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 13May2021 at 10:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to food, medicine or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 22Apr2021 at 10:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 11:00, the patient experienced fever up to 102 degrees (units unspecified), chills, body aches, arm soreness near injection site, nausea when moving around. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events.  The clinical outcome of the events fever up to 102 degrees (units unspecified), chills, body aches, arm soreness near injection site, nausea when moving around was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On an unknown date, after receiving the vaccine, the patient experienced ringing in ears that would not go away. The adverse event result in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event ringing in ears was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Little bit of pain on my shoulder; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 14May2021 at 03:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 04:45 the patient experienced little bit of pain on shoulder. 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 clinical outcome of the event little bit of pain on shoulder was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: Fever; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 12May2021 at 15:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8713 via an unspecified route of administration in the left arm on 21Apr2021 at 15:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 13May2021 at 05:00, the patient experienced fever, joint pain and fatigue for two days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events fever, joint pain and fatigue and included treatment with unspecified non-steroidal anti-inflammatory drug (NSAID). The clinical outcome of the events fever, joint pain and fatigue were recovered on 14May2021.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: Prominent orbicularis oris (upper lip)  muscle tightness; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), hypothyroidism, lumbar spinal stenosis and season allergies to grass. The patient had no known drug allergies (NKDA). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 30Apr2021 at 15:00, three weeks after she received the first dose of the COVID-19 vaccine, the patient experienced prominent orbicularis oris (upper lip) muscle tightness that was yet to resolve. The patient reported that there was no change of muscle tightness described with second dose of vaccine and the bottom lip was not affected by this. There was no inflammation or irregularities to upper lip. The patient reported that the adverse drug event (Ade) was yet to resolve. The patient reported that no treatments like otc (Over-the-counter), medications or home remedies were implemented. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event prominent orbicularis oris (upper lip) muscle tightness was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: My skin color got lighter in a perfect circle about 2 inches in diameter at vaccine site. Hasn't gone away. No redness or itching not a rash. Almost as if it was bleached; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 16:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 12:00 the patient experienced "My skin color got lighter in a perfect circle about 2 inches in diameter at vaccine site. Hasn't gone away. No redness or itching not a rash. Almost as if it was bleached". The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event "My skin color got lighter in a perfect circle about 2 inches in diameter at vaccine site. Hasn't gone away. No redness or itching not a rash. Almost as if it was bleached "was not recovered at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: Very swollen glands; Red rash on face; Red rash on face; Arm sore from injection site to collarbone; Nausea; Headache; Tiredness; Stinging feeling while injection took place; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 18:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mushrooms. The patient received unspecified concomitant medications within two weeks of vaccination. The patient previously took ampicillin and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 18:30, the patient experienced stinging feeling while injection was given. On 28Apr2021 at 19:30, the patient experienced very swollen glands, red rash on face and arm sore from injection site to collarbone for a week, nausea, headache and tiredness. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events very swollen glands, red rash on face and arm sore from injection site to collarbone were resolved on an unknown date in May2021 and the clinical outcome of the events stinging feeling while injection, nausea, headache and tiredness were resolved on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Vaccination site pain
Clinical narrative: Very swollen glands; Red rash on face; Red rash on face; Arm sore from injection site to collarbone; Nausea; Headache; Tiredness; Stinging feeling while injection took place; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 18:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mushrooms. The patient received unspecified concomitant medications within two weeks of vaccination. The patient previously took ampicillin and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 18:30, the patient experienced stinging feeling while injection was given. On 28Apr2021 at 19:30, the patient experienced very swollen glands, red rash on face and arm sore from injection site to collarbone for a week, nausea, headache and tiredness. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events very swollen glands, red rash on face and arm sore from injection site to collarbone were resolved on an unknown date in May2021 and the clinical outcome of the events stinging feeling while injection, nausea, headache and tiredness were resolved on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Dysmenorrhoea, Eye pain, Fatigue, Lip dry
Clinical narrative: Fever; Sore neck; Dry lips; Bleeding lips; Chapped lips; Sore eyes; Tired; Sore arm; Menstrual cramps; This is a spontaneous report from a contactable consumer, the patient. A 48-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 right arm on 11May2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included corneal transplant and sulfonamide allergy. Concomitant medication included birth control (unspecified). The patient previously took Codeine and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 17:00, the patient experienced fever, sore neck, dry/chapped/bleeding lips, gooey sore eyes, tired, sore arm and menstrual cramps (no menses). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events and included treatment with TYLENOL. The clinical outcome of the events fever, sore neck, dry lips, chapped lips, bleeding lips, sore eyes, tired, sore arm and menstrual cramps (no menses) was resolved on an unknown date in May2021  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information expected.