chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Pyrexia, Vaccination site pain
Clinical narrative: The patient experienced pain at the vaccination site; Mild fever (around 100.8 degree Fahrenheit); Dose received: 3; This is a spontaneous report from a contactable reporter (physician).   A 16-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 15Jan2022 at 11:00 (Lot number: 30135BA) at the age of 16 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP6955, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 27May2021, when the patient was 15 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EP6955, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 17Jun2021, when the patient was 15 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Jan2022 at 11:00, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset 16Jan2022, outcome "recovered" (16Jan2022), described as "The patient experienced pain at the vaccination site"; PYREXIA (non-serious) with onset 16Jan2022, outcome "recovered" (16Jan2022), described as "Mild fever (around 100.8 degree Fahrenheit)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain and pyrexia.  Additional Information: The patient experienced the events on the day after vaccination. The patient did not require any medical attention or treatment and recovered the same day. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pyrexia
Clinical narrative: Dose received: 3; Fever; Nausea; This is a spontaneous report from a non-contactable reporter (healthcare professional).  A 45-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1; MANUFACTURER UNKNOWN, Lot Number: UNKNOWN), for COVID-19 immunisation and Covid-19 vaccine manufacture unknown (DOSE 2; MANUFACTURER UNKNOWN, Lot Number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pyrexia
Clinical narrative: Dose number: 3; Fever; Nausea; This is a spontaneous report received from a non-contactable reporter (other healthcare professional).  A 40-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation and Covid-19 vaccine (DOSE 2, MANUFCATURER UNKNOWN, Lot number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report from a non-contactable reporter (other healthcare professional).  A 51-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 51 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report from a non-contactable reporter (healthcare professional).  A 26-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 26 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot Number: unknown, Route of administration: unspecified.), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pyrexia
Clinical narrative: Dose received: 3; Fever; Nausea; This is a spontaneous report from a non-contactable reporter (other healthcare professional).  A 24-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 24 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN; Lot number: unknown; Route of administration: unspecified), for COVID-19 immunisation and Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN; Lot number: unknown; Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid in Jan2022; I tested positive for Covid in Jan2022; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 24Nov2021 (Lot number: FJ8762) at the age of 33 years as dose 3 (booster), single, administration date 24Mar2021 (Lot number: EP6955) as dose 2, single and administration date Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jan2022, outcome "unknown" and all described as "I tested positive for Covid in Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Nasal Swab. No other vaccine was administered in four weeks. None medications in two weeks. No covid prior vaccination. The patient was tested for covid post vaccination. Known allergies were none.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report from a non-contactable reporter (other healthcare professional).  A 38-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 38 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot Number: Unknown, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pyrexia
Clinical narrative: Dose number 3; Fever; Nausea; This is a spontaneous report from a non-contactable reporter (other healthcare professional).   A 55-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot Number: Unknown, Route of Administration: unspecified), for COVID-19 immunisation and Covid 19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, Lot Number: Unknown, Route of Administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever; nausea; This is a spontaneous report from a non-contactable reporter (healthcare professional).   A 51-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 51 year(s) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN;  Lot number: Unknown;  Route of administration: Unspecified.), for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "nausea".   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough
Clinical narrative: Tightness in chest; Cough; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2022 at 11:00 (Lot number: unknown) at the age of 44 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillins. Concomitant medications included: C; D3; B6; ZINC; FOLIC ACID; MACROBID; IBUPROFEN and B12. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 14Jan2022 at 00:00, outcome "unknown", described as "Tightness in chest"; COUGH (non-serious) with onset 14Jan2022 at 00:00, outcome "unknown", described as "Cough". Therapeutic measures were taken as a result of chest discomfort and cough.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the reported events included Levalbuterol. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pyrexia
Clinical narrative: Dose received: 3; Fever; Nausea; This is a spontaneous report from a non-contactable reporter (healthcare professional).   A 53-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1; MANUFACTURER UNKNOWN, Lot Number: UNKNOWN), for COVID-19 immunisation and Covid-19 vaccine manufacture unknown (DOSE 2; MANUFACTURER UNKNOWN, Lot Number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Nausea, Off label use, Pyrexia
Clinical narrative: Primary immunisation: Janssen covid-19 vaccine; Booster: Pfizer covid-19 vaccine; Primary immunisation: Janssen covid-19 vaccine; Booster: Pfizer covid-19 vaccine; Primary immunisation: Janssen covid-19 vaccine; Booster: Pfizer covid-19 vaccine; Fever; Nausea; This is a spontaneous report received from a non-contactable reporter (Other healthcare professional).   A 51-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 51 years as dose 2 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (johnson & johnson) (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 12Jan2022, outcome "unknown", and all described as "Primary immunisation: Janssen covid-19 vaccine; Booster: Pfizer covid-19 vaccine"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia oral
Clinical narrative: Feel numbness on lower lip since December of 2021; Also feel pain on right shoulder especially during night; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 58-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13May2021 at 13:00 (Lot number: unknown) at the age of 58 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Administration time: 12:30; Anatomical site: Left arm; Route of administration: Unspecified), administration date: 21Apr2021, when the patient was 58 years old, for COVID-19 immunisation.  The following information was reported: HYPOAESTHESIA ORAL (non-serious) with onset 01Dec2021 at 00:00, outcome "not recovered", described as "Feel numbness on lower lip since December of 2021"; ARTHRALGIA (non-serious) with onset 01Dec2021 at 00:00, outcome "not recovered", described as "Also feel pain on right shoulder especially during night". Therapeutic measures were not taken as a result of hypoaesthesia oral and arthralgia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Skin discolouration, Skin swelling
Clinical narrative: Right arm has pain that radiates down from elbow to hand; Swelling, discoloration of skin (turns purple as if bruised); Swelling, discoloration of skin (turns purple as if bruised); Extreme pain; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date an unknown date in Sep2021 at 10:30 (Lot number: unknown) at the age of 30 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset an unknown date in Nov2021, outcome "not recovered", described as "Right arm has pain that radiates down from elbow to hand"; SKIN SWELLING (non-serious), SKIN DISCOLOURATION (non-serious), both with onset an unknown date in Nov2021, outcome "not recovered", and both described as "Swelling, discoloration of skin (turns purple as if bruised)"; PAIN (non-serious), with onset an unknown date in Nov2021, outcome "not recovered", and described as "Extreme pain". Therapeutic measures were not taken as a result of pain in extremity, skin swelling, skin discolouration and pain.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Headache, SARS-CoV-2 test
Clinical narrative: Severe headaches; High blood sugars; This is a spontaneous report from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 06Jan2022 at 12:00 (Lot number: unknown) at the age of 42 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication included: INSULIN.  The following information was reported: HEADACHE (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Severe headaches"; BLOOD GLUCOSE INCREASED (non-serious) with onset 07Jan2022, outcome "not recovered", described as "High blood sugars". The events "Severe headaches" and "High blood sugars" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache and blood glucose increased.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment taken as a result of headache and blood glucose increased included treatment at doctors office.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Eye pain, Immunisation, Interchange of vaccine products
Clinical narrative: 15Jan2022 follow up: once patient got up and moving, patient felt better; arm pit sore.; Time of awareness: 14Jan2022. patient in bed all day; aches and eyes hurt; fever; no energy.; Patient in bed all day; aches and eyes hurt; fever; no energy.; Patient in bed all day; aches and eyes hurt; fever; no energy.; Patient in bed all day; aches and eyes hurt; fever; no energy.; Primary immunisation: Moderna; Booster: BNT162B2; dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Jan2022 at 15:00 (Lot number: unknown)at the age of 40 Year(s) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE; Lot number: Unknown; Route of administration: unspecified), for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE; Lot number: Unknown; Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Jan2022 at 15:00, outcome "unknown", described as "Primary immunisation: Moderna; Booster: BNT162B2"; IMMUNISATION (non-serious) with onset 13Jan2022 at 15:00, outcome "unknown", described as "dose number=3"; PAIN (non-serious) with onset 14Jan2022, outcome "recovering", described as "time of awareness: 14Jan2022. patient in bed all day; aches and eyes hurt; fever; no energy"; EYE PAIN (non-serious), PYREXIA (non-serious), ASTHENIA (non-serious) all with onset 14Jan2022, outcome "recovering", and all described as "patient in bed all day; aches and eyes hurt; fever; no energy"; AXILLARY PAIN (non-serious) with onset 15Jan2022, outcome "recovering", described as "15Jan2022 follow up: once patient got up and moving, patient felt better; arm pit sore". It was unknown whether any therapeutic measures were taken as a result of the events.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 15Jan2022 follow up: once patient got up and moving, patient felt better; arm pit sore.; Time of awareness: 14Jan2022. patient in bed all day; aches and eyes hurt; fever; no energy.; Patient in bed all day; aches and eyes hurt; fever; no energy.; Patient in bed all day; aches and eyes hurt; fever; no energy.; Patient in bed all day; aches and eyes hurt; fever; no energy.; Primary immunisation: Moderna; Booster: BNT162B2; dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Jan2022 at 15:00 (Lot number: unknown)at the age of 40 Year(s) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE; Lot number: Unknown; Route of administration: unspecified), for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE; Lot number: Unknown; Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Jan2022 at 15:00, outcome "unknown", described as "Primary immunisation: Moderna; Booster: BNT162B2"; IMMUNISATION (non-serious) with onset 13Jan2022 at 15:00, outcome "unknown", described as "dose number=3"; PAIN (non-serious) with onset 14Jan2022, outcome "recovering", described as "time of awareness: 14Jan2022. patient in bed all day; aches and eyes hurt; fever; no energy"; EYE PAIN (non-serious), PYREXIA (non-serious), ASTHENIA (non-serious) all with onset 14Jan2022, outcome "recovering", and all described as "patient in bed all day; aches and eyes hurt; fever; no energy"; AXILLARY PAIN (non-serious) with onset 15Jan2022, outcome "recovering", described as "15Jan2022 follow up: once patient got up and moving, patient felt better; arm pit sore". It was unknown whether any therapeutic measures were taken as a result of the events.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Heart rate, Heart rate increased, Hypertension
Clinical narrative: Elevated heart rate; High blood pressure with a headache; High blood pressure with a headache; Dose received: 3; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 at 12:00 (Lot number: FE3594) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL0140; Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EL3246; Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Jan2022 at 12:00, outcome "unknown", described as "Dose received: 3"; HEART RATE INCREASED (non-serious) with onset 15Jan2022, outcome "not recovered", described as "Elevated heart rate"; HYPERTENSION (non-serious), HEADACHE (non-serious) all with onset 15Jan2022, outcome "not recovered", and all described as "High blood pressure with a headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hypertension and headache.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation
Clinical narrative: Elevated heart rate; High blood pressure with a headache; High blood pressure with a headache; Dose received: 3; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 at 12:00 (Lot number: FE3594) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL0140; Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EL3246; Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Jan2022 at 12:00, outcome "unknown", described as "Dose received: 3"; HEART RATE INCREASED (non-serious) with onset 15Jan2022, outcome "not recovered", described as "Elevated heart rate"; HYPERTENSION (non-serious), HEADACHE (non-serious) all with onset 15Jan2022, outcome "not recovered", and all described as "High blood pressure with a headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hypertension and headache.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Dose number: 3; Arm pain at the site of injection; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).  A 18-year-old female patient received bnt162b2 (BNT162B2), administration date 15Jan2022 (Lot number: FE3594) at the age of 18 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? : Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0171, Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Jan2022, outcome "unknown", described as "Dose number: 3"; VACCINATION SITE PAIN (non-serious) with onset 15Jan2022, outcome "recovering", described as "Arm pain at the site of injection". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Immunisation, Mammogram
Clinical narrative: Random pain on side of left breast. Stabbing at times then goes away; Dose received: 3; This is a spontaneous report from a contactable reporter (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 at 12:30 (Lot number: unknown) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Mild HTN. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical site: left arm; Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical site: left arm; Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 at 12:30, outcome "unknown", described as "Dose received: 3"; BREAST PAIN (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Random pain on side of left breast. Stabbing at times then goes away". The event "Random pain on side of left breast. Stabbing at times then goes away" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown whether any therapeutic measures were taken as a result of the event Breast pain.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. About 2 weeks after booster started with random pain on side of left breast. Stabbing at times then goes away. No lumps or other breast changes noted. Appointment to see gynecologist and had mammogram. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pain in extremity, Pyrexia
Clinical narrative: Very mild fever after about 24 hours that lasted a couple hours; Full body aches after about 10 hours and all through the night; Very sore arm after about 6 hours; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2022 at 11:30 (Lot number: FL3198) at the age of 29 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot Number: EP6955; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 24Mar2021, when the patient was 29 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL3248; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 04Mar2021, when the patient was 29 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 15Jan2022 at 11:30, outcome "unknown", described as "Dose number: 3"; PAIN IN EXTREMITY (non-serious) with onset 15Jan2022 at 17:30, outcome "recovered" (an unknown date in Jan2022), described as "Very sore arm after about 6 hours"; PAIN (non-serious) with onset 15Jan2022 at 21:30, outcome "recovered" (an unknown date in Jan2022), described as "Full body aches after about 10 hours and all through the night"; PYREXIA (non-serious) with onset 16Jan2022, outcome "recovered" (16Jan2022), described as "Very mild fever after about 24 hours that lasted a couple hours". Therapeutic measures were taken as a result of pain in extremity, pain and pyrexia.  Additional information: Therapeutic measures included treatment with IBUPROFEN. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pain in extremity
Clinical narrative: Sore arm; Painful to move; dose number=3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP).   A 13-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Jan2022 at 14:15 (Lot number: FJ6369) at the age of 13 year(s) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Lactose intolerance" (unspecified if ongoing). The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0185, Anatomical site: Arm left, Route of administration: Intramuscular.), administration date: 06Jun2021, when the patient was 12 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0185, Anatomical site: Arm left, Route of administration: Intramuscular.), administration date: 16May2021, when the patient was 12 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 16Jan2022 at 14:15, outcome "unknown", described as "dose number=3"; PAIN IN EXTREMITY (non-serious) with onset 16Jan2022 at 16:00, outcome "recovering", described as "Sore arm"; PAIN (non-serious) with onset 16Jan2022 at 16:00, outcome "recovering", described as "Painful to move". Therapeutic measures were taken as a result of pain in extremity and pain.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the reported events included Tylenol and cold compresses.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Vaccination site pain
Clinical narrative: dose number=3; "My" arm has been sore since November at the site of the i he run. The injection site is still tender.; In addition, "I" have pain in the arm now which "I" did not have before I took the vaccine.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 at 16:00 (Lot number: unknown)at the age of 50 year(s) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: TRINTELLIX; PHENTERMINE; LUNESTA and LEVOTHYROXINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical Location: Left arm; Route of Administration: Unspecified; Time of Administration: 16:00), administration date: 05Mar2021, when the patient was 49 year(s) old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Anatomical Location: Left arm; Route of Administration: Unspecified; Time of Administration: 16:00), administration date: 26Mar2021, when the patient was 49 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 at 16:00, outcome "unknown", described as "dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2021 at 16:00, outcome "not recovered", described as ""My" arm has been sore since November at the site of the i he run. The injection site is still tender"; PAIN IN EXTREMITY (non-serious) with onset 20Nov2021 at 16:00, outcome "not recovered", described as "In addition, "I" have pain in the arm now which "I" did not have before I took the vaccine". The events ""My" arm has been sore since November at the site of the i he run. The injection site is still tender." and "In addition, "I" have pain in the arm now which "I" did not have before I took the vaccine." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site pain and pain in extremity.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Diarrhoea, Metamorphopsia
Clinical narrative: On day 5 diarrhea and twitching of the right eyebrow (also never before); On day 5 diarrhea and twitching of the right eyebrow (also never before); 72 hours after vaccine; vision distortion on right eye which went away after a few mins (never happened before); This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 12Jan2022 at 10:15 (Lot number: unknown) at the age of 35 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: IRON SUPPLEMENT and VITAMIN C SUPPLEMENT.  The following information was reported: METAMORPHOPSIA (non-serious) with onset 15Jan2022 at 10:15, outcome "recovered" (15Jan2022), described as "72 hours after vaccine; vision distortion on right eye which went away after a few mins (never happened before)"; DIARRHOEA (non-serious), BLEPHAROSPASM (non-serious) all with onset 17Jan2022, outcome "unknown", and all described as "On day 5 diarrhea and twitching of the right eyebrow (also never before)".Therapeutic measures were not taken as a result of metamorphopsia, diarrhoea and blepharospasm.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Vomiting
Clinical narrative: Became sick after 6 hours; Vomited uncontrollably with a fever for 12 hours; Vomited uncontrollably with a fever for 12 hours; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 37-year-old female patient received bnt162b2 (BNT162B2), administered in left arm, administration date 13Jan2022 at 10:30 (Lot number: FL3198) at the age of 37 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: 3013BA, Anatomical location: Left arm, Administration time: 13:00), administration date: 21Dec2021, when the patient was 37 years old, for COVID-19 immunisation.  The following information was reported: ILLNESS (non-serious) with onset 13Jan2022 at 16:30, outcome "recovering", described as "Became sick after 6 hours"; VOMITING (non-serious), PYREXIA (non-serious) all with onset 13Jan2022 at 16:30, outcome "recovering", and all described as "Vomited uncontrollably with a fever for 12 hours". Therapeutic measures were not taken as a result of illness, vomiting and pyrexia.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lump in left armpit; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 17-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 27Dec2021 at 01:45 (Lot number: 33025BD) at the age of 17 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Patient did not receive any concomitant medications. The following information was reported: AXILLARY MASS (non-serious) with onset 28Dec2021 at 09:00, outcome "recovered", described as "Lump in left armpit". Therapeutic measures were not taken as a result of axillary mass.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID case; Breakthrough COVID case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL3297) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Prev Dose Product: Covid-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: EL3247, Prev dose lot unknown: False, Prev dose administration date: 22Jan2021, Dose Number: 1), administration date: 22Jan2021, when the patient was 25 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "recovered" (Jan2022) and all described as "Breakthrough COVID case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No other vaccine in four weeks. No covid prior vaccination. No known allergies reported.  No follow-up attempts are possible. No further information is expected.