chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Myalgia, Paraesthesia
Clinical narrative: Then at 30 hours post injection experienced very severe sciatic nerve pain that lasted 48 hours total; 11 hours after 2nd vaccine injection; experienced pins and needles all over body including head and face; That night experienced flu like symptoms; Severe muscle ache; Chills; Fever 103 F; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 22Apr2021 at 11:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sensitivities to a number of medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included thyroid (MANUFACTURER UNKNOWN) (reported as thyroid hormone), ketotifen (MANUFACTURER UNKNOWN) and typical supplements (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 22:00, 11 hours after the second vaccine injection, the patient experienced pins and needles all over body including head and face, that night experienced flu-like symptoms, severe muscle aches, chills - fever of 103 F; then after 30 hours post injection (23Apr2021 at 17:30), experienced very severe sciatic nerve pain that lasted forty-eight hours total. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events pins and needles, flu like symptoms, severe muscle aches, chills, fever of 103 F was recovering whereas that of sciatic nerve pain was recovered on 25Apr2021 at 17:30, after the duration of forty-eight hours.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sciatica
Clinical narrative: Then at 30 hours post injection experienced very severe sciatic nerve pain that lasted 48 hours total; 11 hours after 2nd vaccine injection; experienced pins and needles all over body including head and face; That night experienced flu like symptoms; Severe muscle ache; Chills; Fever 103 F; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 22Apr2021 at 11:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sensitivities to a number of medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included thyroid (MANUFACTURER UNKNOWN) (reported as thyroid hormone), ketotifen (MANUFACTURER UNKNOWN) and typical supplements (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 22:00, 11 hours after the second vaccine injection, the patient experienced pins and needles all over body including head and face, that night experienced flu-like symptoms, severe muscle aches, chills - fever of 103 F; then after 30 hours post injection (23Apr2021 at 17:30), experienced very severe sciatic nerve pain that lasted forty-eight hours total. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events pins and needles, flu like symptoms, severe muscle aches, chills, fever of 103 F was recovering whereas that of sciatic nerve pain was recovered on 25Apr2021 at 17:30, after the duration of forty-eight hours.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: I'm having a large amount of pain and stiffness in my neck, on the back, right at the top of the spine; I'm having a large amount of pain and stiffness in my neck, on the back, right at the top of the spine; I'm having a large amount of pain and stiffness in my neck, on the back, right at the top of the spine; This is a spontaneous report from a contactable consumer, the patient. A 32-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 on 25Apr2021 at 09:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Apr2021, it had been 5 days since the first dose of Pfizer vaccine and the patient was not 100% sure if it was related nor did the patient currently plan to go to a doctor but the patient had large amount of pain and stiffness in the neck, on the back, right at the top of the spine. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large amount of pain and stiffness in the neck, on the back, right at the top of the spine was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This is a spontaneous report from a contactable consumer, the patient. A 50-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 03Mar2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received other medication within two weeks of vaccination which were not specified on an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 18:00, the patient experienced sore arm and felt tired. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and felt tired was resolved on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Lymph node pain, Lymphadenopathy
Clinical narrative: Right under arm lymph node extremely swollen visible through the skin; Right under arm lymph node extremely swollen visible through the skin - the size of orange, painful for aprox 4 days;; Type 1 insulin dependent diabetic experienced veryhigh blood glucose readings begining day after second vaccine - over 250 mg/dL - and continuing through 5 days; This is a spontaneous report from a non-contactable consumer, the patient. A 38-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 23Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetic and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced right under arm lymph node extremely swollen visible through the skin - the size of orange, painful for approximately four days; type 1 insulin dependent diabetic experienced very high blood glucose readings began day after second vaccine over 250 mg/dL and was continued through five days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. On 24Apr2021, the patient underwent blood glucose test and the result was 250 mg/dL. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event right under arm lymph node extremely swollen visible through the skin - the size of orange, painful for approximately four days and high blood glucose readings began day after second vaccine over 250 mg/dL was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Polymenorrhoea
Clinical narrative: Cramps started again even though just had it last week; Period started again even though just had it last week; This is a spontaneous report from a non-contactable consumer, the patient. A 42-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 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date, the patient experienced cramps and period started again even though just had it in last week. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events cramps and period started again were unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vertigo, Vomiting
Clinical narrative: The day after the 2nd shot "I" had severe vertigo, nausea, & vomiting/April 26th, 2 weeks & 1 day after 2nd shot, again had severe vertigo, nausea, &vomiting.; The day after the 2nd shot "I" had severe vertigo, nausea, & vomiting./April 26th, 2 weeks & 1 day after 2nd shot, again had severe vertigo, nausea, &vomiting.; Day of 2nd shot, after a couple of hours "I" had moderate vertigo/The day after the 2nd shot "I" had severe vertigo/April 26th, 2 weeks & 1 day after 2nd shot, again had severe vertigo.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Apr2021 at 11:30(at the age of 48-years-old) as a single dose for COVID-19 immunisation. The medical history included obesity and allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included fluticasone (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) and levocetirizine dihydrochloride (XYZAL), all from unknown dates for unknown indications and unknown if ongoing. 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 14Mar2021 at 11:30(at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 11Apr2021 at 14:00, day of 2nd shot, after a couple of hours the patient had moderate vertigo and it lasted around 1 hour. On 12Apr2021, the day after the 2nd shot the patient had severe vertigo, nausea and vomiting which lasted for 2-3 hours. On 26Apr2021, 2 weeks and1 day after 2nd shot the patient again had severe vertigo, nausea and vomiting which lasted for 2-3 hours. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, nausea and vomiting were recovered on 26Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmenorrhoea, Headache, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Headache; Fever; Body and muscle aches; Body and muscle aches; light headed ness; Rash appeared on vaccine arm several days later and lasted for several days; Menstrual cycle started 4 or 5 days earlier than usual; Menstrual cycle started 4 or 5 days earlier than usual and was heavier; Menstrual cycle started 4 or 5 days earlier than usual and was heavier and more painful than usual; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first does of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021, the patient experienced headache, fever, body and muscle aches, light headedness, rash appeared on vaccine arm several days later and lasted for several days, menstrual cycle started four or five days earlier than usual and was heavier and more painful than usual. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fever, body and muscle aches, light headedness, rash appeared on vaccine arm several days later and lasted for several days, menstrual cycle started 4 or 5 days earlier than usual and was heavier and more painful than usual was unknown at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Rash
Clinical narrative: Headache; Fever; Body and muscle aches; Body and muscle aches; light headed ness; Rash appeared on vaccine arm several days later and lasted for several days; Menstrual cycle started 4 or 5 days earlier than usual; Menstrual cycle started 4 or 5 days earlier than usual and was heavier; Menstrual cycle started 4 or 5 days earlier than usual and was heavier and more painful than usual; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first does of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021, the patient experienced headache, fever, body and muscle aches, light headedness, rash appeared on vaccine arm several days later and lasted for several days, menstrual cycle started four or five days earlier than usual and was heavier and more painful than usual. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fever, body and muscle aches, light headedness, rash appeared on vaccine arm several days later and lasted for several days, menstrual cycle started 4 or 5 days earlier than usual and was heavier and more painful than usual was unknown at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Feeling cold, Head discomfort
Clinical narrative: Pressure in eyes; Pressure in head; Severe chills; Headache; Dizziness; Blurred vision; Feeling very cold; Weakness; Could not sleep all night; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 17:00, the patient experienced pressure in eyes and head, severe chills, headache, dizziness, blurred vision, feeling very cold, weakness and could not sleep all night. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pressure in eyes and head, severe chills, headache, dizziness, blurred vision, feeling very cold, weakness and could not sleep all night was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Intraocular pressure increased, Vision blurred
Clinical narrative: Pressure in eyes; Pressure in head; Severe chills; Headache; Dizziness; Blurred vision; Feeling very cold; Weakness; Could not sleep all night; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 17:00, the patient experienced pressure in eyes and head, severe chills, headache, dizziness, blurred vision, feeling very cold, weakness and could not sleep all night. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pressure in eyes and head, severe chills, headache, dizziness, blurred vision, feeling very cold, weakness and could not sleep all night was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal stiffness
Clinical narrative: Severe back pain; Stiff back muscles; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male 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 25Apr2021 at 09:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination which included measles vaccine; mumps vaccine; rubella vaccine (MMR) and tetanus vaccine toxoid; diphtheria vaccine toxoid; pertussis vaccine acellular (Tdap); both on 04Apr2021. Concomitant medications taken within two weeks of vaccination was not reported. On 25Apr2021 at 23:00, the patient experienced severe back pain and stiff back muscles. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe back pain and stiff back muscles was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Period came two days after the shot, which was earlier than expected; Usually the flow is light at the first half day. But this time, it is very heavy at the very beginning. This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Apr2021 at 23:00, two days after the shot, the patient experienced her period, which was earlier than expected and there was no cramp feeling at all this time. The patient used to experience some sort of cramp feeling before and during the first half day and her body tells that period was coming. But this time, it came very silently and had no feelings at all and usually, the flow was light at the first half day, but this time, it was very heavy at the very beginning. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period came two days after the shot, which was earlier than expected and usually, the flow was light at the first half day, but this time, it was very heavy at the very beginning was resolved on an unknown date in Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV, TTOX
Symptoms: Headache, Peripheral swelling, Rash
Clinical narrative: headache; swollen arm; rash/rashness; This is a spontaneous report from a contactable nurse (patient). An 86-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 protein, solution for injection in pre-filled syringe), and tetanus vaccine toxoid (TETANUS VACCINE [TETANUS VACCINE TOXOID]); both via an unspecified route of administration on an unspecified date (reported as some years ago) (batch/lot number was not reported) as single dose for immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, ongoing genetic / chromosomal abnormalities (not specified), ongoing endocrine abnormalities (including diabetes), obesity. The patient's concomitant medications were not reported. The patient previously took flu vaccine from unspecified date for immunization and didn't react. On an unspecified date, the patient experienced headache, swollen arm, rash/rashness. The patient informed that she did react to pneumonia vaccine and tetanus vaccine with a headache, swollen arm and rash/rashness. The patient informed that her body didn't want any more vaccine. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: 3 days after second shot "I" have hives all over "my" face.; Slight swelling; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 26Apr2021 at 12:00(at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient's known allergies were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. The concomitant medications included aciclovir (ACYCLOVIR) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 20Mar2021 at 13:00(at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021, 3 days after the second shot, the patient had hives all over her face and slight swelling. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives all over the face and slight swelling were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Started menstruating the day after first shot which was 1.5 weeks early.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 11:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 06Apr2021 at 12:00, the patient experienced menstruating the day after the first shot which was 1.5 weeks early. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event early menstruation was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival ulceration
Clinical narrative: Mouth ulcers in various locations along the gum line.; This is a spontaneous report from a contactable consumer, the patient. A 46-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 02Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 10:00, the patient experienced mouth ulcers in various locations along the gum line. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the reported events. The clinical outcome of the event mouth ulcers in various locations along the gum line was not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: I haven't have a menstrual cycle since receiving the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 29-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 18Feb2021 at 18:45 (at the age of 29-years-old), as a single dose for COVID-19 immunisation.The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021 at 00:00, the patient did not have a menstrual cycle since receiving the vaccine and pregnancy had been ruled out. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event did not have a menstrual cycle since receiving the vaccine was unknown at the time of this report. The 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 18Mar2021 at 20:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation..   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Myalgia
Clinical narrative: Headache; Low temperature (100); Myalgia; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 11:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate cancer and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medication within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 09:00, the patient experienced headache, myalgia and had low temperature (100). On that day, the patient underwent body temperature test and the result was 100 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events headache, myalgia and low temperature (100) was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Insomnia, Joint swelling, Pain in extremity
Clinical narrative: swollen, red, and painful toes; swollen, red, and painful toes; swollen, red, and painful toes; having a hard time sleeping; ankle swelling; the toe next to her big toe, on both feet is beet red and swollen was reported as worsened/ankle swelling, and redness on the outside of both feet was reported as worsened; This is a spontaneous case received from a contactable consumer (patient).  A 79-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8736), via an unspecified route administered in right arm on 27Apr2021 (age at vaccination 79-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included ongoing COPD (Chronic obstructive pulmonary disease) from 2006, ongoing atrial fibrillation from 2006 and pollen allergy. Concomitant medications included guaifenesin (MUCINEX). The patient reported that the toe right next to her big toe, on the right foot, is beet red and swollen and painful, on May2021 her ankles are also swollen, and she had redness on the outside of her foot on both feet, they have worsened because it started on her right foot, now it was both feet and now the sides of her feet in the morning are red as well, and she was having a hard time sleeping because of the pain from her feet. The outcome of the event ankle swelling and he toe next to her big toe, on both feet is beet red and swollen was reported as worsened/ankle swelling, and redness on the outside of both feet was reported as worsened was not recovered, and outcome of other events was unknown.  No follow-up attempts are needed. No further information was expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swollen, red, and painful toes; swollen, red, and painful toes; swollen, red, and painful toes; having a hard time sleeping; ankle swelling; the toe next to her big toe, on both feet is beet red and swollen was reported as worsened/ankle swelling, and redness on the outside of both feet was reported as worsened; This is a spontaneous case received from a contactable consumer (patient).  A 79-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8736), via an unspecified route administered in right arm on 27Apr2021 (age at vaccination 79-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included ongoing COPD (Chronic obstructive pulmonary disease) from 2006, ongoing atrial fibrillation from 2006 and pollen allergy. Concomitant medications included guaifenesin (MUCINEX). The patient reported that the toe right next to her big toe, on the right foot, is beet red and swollen and painful, on May2021 her ankles are also swollen, and she had redness on the outside of her foot on both feet, they have worsened because it started on her right foot, now it was both feet and now the sides of her feet in the morning are red as well, and she was having a hard time sleeping because of the pain from her feet. The outcome of the event ankle swelling and he toe next to her big toe, on both feet is beet red and swollen was reported as worsened/ankle swelling, and redness on the outside of both feet was reported as worsened was not recovered, and outcome of other events was unknown.  No follow-up attempts are needed. No further information was expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle discomfort, Pain in extremity
Clinical narrative: left arm around my elbow is painful and sore and painful to move; second dose of the vaccine is bothering his joint and muscle; second dose of the vaccine is bothering his joint and muscle; This is a spontaneous report from a contactable consumer. This 68-year-old male consumer (patient) reported for himself. A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: ER8732, expiry date: 31Jul2021) via unknown route in left arm on 31Mar2021 at 03:30PM as single dose (at the age of 68 years old) for COVID-19 immunisation. The patient medical history included Blood Pressure High from an unknown date in May2021. The concomitant medications were not reported. It was reported that he was diagnosed with high blood pressure several years ago and was taking medication for that regularly. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: unknown, expiry date: 31Jul2021) via unknown route in right arm on 10Mar2021 as single dose (at the age of 68 years old) for COVID-19 immunisation and never bothered his right arm. After the one week ago, his left arm where he had the injection at and his elbow are painful and sore, and painful to move and his second dose of the vaccine was bothering his joint and muscle, which started about a week ago. He said when it started he was not sure if it was something he did that day, but he hadn't done anything strenuous. Patient received treatment with Ibuprofen (LOT number: P121258, EXP: Aug2023) 200mg via orally in the morning two days ago, then used Aspirin 81 mg (LOT number: P113296, EXP: Dec2020) took four of them, at different times, starting probably Tuesday 04May2021, he was not sure if they helped or not, because his arm still hurt. He says he didn't take them today. He also reported the bottle had 300 small, coated tablets, and it was sealed and intact when he got it. It was reported that his arm pain is maybe a little better on its own, after he uses it a while it seems to be a little less painful. At the time of this report the outcome of the events were recovering.  Follow up attempts were completed. No further information was expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Arthralgia, Bone pain, Feeling abnormal, Headache
Clinical narrative: fever; headache; my hands and the soles of my feet hurt; I have a ball under my armpit; pains in her joints; cold; She has a pimple below her armpit and it is swollen now; I felt bone pain; She spent the whole day in bed. She was unable to stand up/It feels like a car slammed into her; I have muscle pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736; Expiration Date: 03Mar2022), dose 2 via an unspecified route of administration on 03May2021 (at age of 50-year-old) as dose 2, single for covid-19 immunisation. Medical history included renal pain (left kidney pain). Concomitant medication included ciprofloxacin hydrochloride, tinidazole (ciprofloxacin + tinidazole) taken for renal pain, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced i felt bone pain, i have muscle pain, she spent the whole day in bed. she was unable to stand up/it feels like a car slammed into her on 04May2021; fever, headache, my hands and the soles of my feet hurt, i have a ball under my armpit, pains in her joints, cold, she has a pimple below her armpit and it is swollen now on 05May2021. The outcome of events was not recovered.  Follow up(05May2021): New information received from a contactable consumer included: vaccine details (Lot number: First vaccine: EP7533, second: ER8736; expiration date for second vaccine 03mar2022), medical history (left kidney pain), concomitant medication (ciprofloxacin), new events (pains in her joints, cold, She spent the whole day in bed. She was unable to stand up/It feels like a car slammed into her, She has a pimple below her armpit and it is swollen now)  Follow up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Pain in extremity, Pyrexia, Swelling
Clinical narrative: fever; headache; my hands and the soles of my feet hurt; I have a ball under my armpit; pains in her joints; cold; She has a pimple below her armpit and it is swollen now; I felt bone pain; She spent the whole day in bed. She was unable to stand up/It feels like a car slammed into her; I have muscle pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736; Expiration Date: 03Mar2022), dose 2 via an unspecified route of administration on 03May2021 (at age of 50-year-old) as dose 2, single for covid-19 immunisation. Medical history included renal pain (left kidney pain). Concomitant medication included ciprofloxacin hydrochloride, tinidazole (ciprofloxacin + tinidazole) taken for renal pain, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced i felt bone pain, i have muscle pain, she spent the whole day in bed. she was unable to stand up/it feels like a car slammed into her on 04May2021; fever, headache, my hands and the soles of my feet hurt, i have a ball under my armpit, pains in her joints, cold, she has a pimple below her armpit and it is swollen now on 05May2021. The outcome of events was not recovered.  Follow up(05May2021): New information received from a contactable consumer included: vaccine details (Lot number: First vaccine: EP7533, second: ER8736; expiration date for second vaccine 03mar2022), medical history (left kidney pain), concomitant medication (ciprofloxacin), new events (pains in her joints, cold, She spent the whole day in bed. She was unable to stand up/It feels like a car slammed into her, She has a pimple below her armpit and it is swollen now)  Follow up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Condition aggravated, Fatigue, Illness
Clinical narrative: joint pain and body aches; joint pain and body aches; she had body and joint pain and exhaustion after the first dose; her left arm hurt; exhausted; sick; This is a spontaneous report from a contactable consumer (patient).   This is one of two reports. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, administered in left arm on 19Mar2021 09:48 (at the age of 57-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing Interstim Implant for Bladder from 2016, ongoing Inverted T waves all her life, clarifying she had issues since college, ongoing hypoglycaemia since high school, ongoing gluten intolerance (she stated in her 40s, she was told she had gluten intolerance, and another autoimmune issue referred to as leaky gut. She said she wasn't formally tested for leaky gut, but her leaky gut diagnosis was done by elimination), ongoing asthma diagnosed with moderate asthma as a child and Lobular Carcinoma-Right Breast from Dec2020 to an unknown date, she had a lumpectomy on her right breast in Dec2020. She said at that time, she was diagnosed with a lobular carcinoma that was not cancerous, but considered a high risk lesion, and was removed. The patient's concomitant medications were not reported. No any additional vaccine administered on same date of the Pfizer vaccine. No prior vaccination within four weeks. On an unspecified date in Mar2021, patient got sick. She said she had joint pain and body aches, and her arm, and all that stuff. She clarified the day she got her first COVID-19 Vaccine shot (on 19Mar2021), her (left) arm hurt, and she was exhausted. She said she went to bed at 7:00PM that night (19Mar2021), and the next morning (20Mar2021), she woke up with the joint pain and body aches, condition aggravated. She said the (left) arm pain, joint pain, and body aches hurt less the second day, and eventually went away. Patient stated she didn't go to her doctor because she kept thinking her joint pain would be gone soon, and it hasn't and took ginger (clarified as Nature's Way Brand Ginger Root 1.1g capsule), and turmeric (clarified as Solgar Curcumin) for her joint pain. Outcome of the event joint pain was not recovered and rest all events was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.