chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia since 07-May-2021 and Hypothyroidism since 07-May-2021. Concomitant products included ROSUVASTATIN from 07-May-2021 to an unknown date for Hyperlipidemia, LEVOTHYROXINE from 07-May-2021 to an unknown date for Hypothyroidism.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications are provided.  Patient reported allergic to Humira.   This case was linked to MOD-2021-407640, MOD-2021-407570 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: Unwell; Headache; Tired/exhaustion/fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Unwell), HEADACHE (Headache) and FATIGUE (Tired/exhaustion/fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Unwell), HEADACHE (Headache) and FATIGUE (Tired/exhaustion/fatigue). At the time of the report, MALAISE (Unwell), HEADACHE (Headache) and FATIGUE (Tired/exhaustion/fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-408578 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Plantar fasciitis
Clinical narrative: plantar fasciitis on the left foot [after second dose]; bad heel pain; This spontaneous case was reported by a consumer and describes the occurrence of PLANTAR FASCIITIS (plantar fasciitis on the left foot [after second dose]) and PAIN IN EXTREMITY (bad heel pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PLANTAR FASCIITIS (plantar fasciitis on the left foot [after second dose]) and PAIN IN EXTREMITY (bad heel pain). At the time of the report, PLANTAR FASCIITIS (plantar fasciitis on the left foot [after second dose]) and PAIN IN EXTREMITY (bad heel pain) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to  (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 30 patients were administered a dose past the expiration date/ Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients were administered a dose past the expiration date/ Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients were administered a dose past the expiration date/ Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (30 patients were administered a dose past the expiration date/ Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received booster dose before 6 months after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster dose before 6 months after the second dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 054C21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster dose before 6 months after the second dose). On 28-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster dose before 6 months after the second dose) had resolved.            The patient received booster dose before 6 months after the second dose.  No Concomitant product use was reported. No treatment information was provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment product use was provided by the reporter.    This case was linked to MOD-2021-408551 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-408551 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was sick; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (I was sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was sick). At the time of the report, ILLNESS (I was sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-408953, MOD-2021-408707 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Raise blood sugar; This spontaneous case was reported by a nurse and describes the occurrence of BLOOD GLUCOSE INCREASED (Raise blood sugar) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Raise blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (Raise blood sugar) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Vaccination complication
Clinical narrative: he had a sly bad reaction,; bruising and still hard tissue about 4 inch about 2 and a half inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (he had a sly bad reaction,) and CONTUSION (bruising and still hard tissue about 4 inch about 2 and a half inches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (he had a sly bad reaction,) and CONTUSION (bruising and still hard tissue about 4 inch about 2 and a half inches). At the time of the report, VACCINATION COMPLICATION (he had a sly bad reaction,) and CONTUSION (bruising and still hard tissue about 4 inch about 2 and a half inches) outcome was unknown.            No concomitant medications reported. No treatment information was provided.  The patient have bruising and still hard tissue about 4 inch about 2 and a half inches , visible bruise and one time discolored the whole arm.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram pelvis
Clinical narrative: Fever/is getting more often than it was; Booster dose; Booster dose; Feeling very weak; Pain started after her booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 20Aug2021 (Lot number: FC3180) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; immunoglobulin human normal (HIZENTRA), administration date 20Aug2021 (Batch/Lot number: unknown) as 8 g. Relevant medical history included: "Wears hearing aids" (unspecified if ongoing), notes: Verbatim: Caller wears hearing aids; "Immunodeficiency", start date: 2013 (ongoing). Concomitant medication(s) included: DOXYCYCLINE MONOHYDRATE, start date: 16Jul2021. Past drug history included: Hizentra, notes: A couple years ago. Vaccination history included: Bnt162b2 (First dose, lot E1926S, Dose #1 on 31Jan2021 in her muscle of arm at 10:55), administration date: 31Jan2021, when the patient was 65 years old, for Covid-19 Immunisation, reaction(s): "Cramping/locking started in July"; Bnt162b2 (Second dose, Dose #2 on 20Feb2021 in her arm at 14:15), administration date: 20Feb2021, when the patient was 65 years old, for Covid-19 Immunisation, reaction(s): "Cramping/locking started in July"; Flu vaccine (Flu shot as a child around 7 years), for Immunization, reaction(s): "rash". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "Booster dose"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Feeling very weak"; PYREXIA (non-serious) with onset 12Sep2021, outcome "unknown", described as "Fever/is getting more often than it was"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain started after her booster dose". The events "feeling very weak", "fever/is getting more often than it was" and "pain started after her booster dose" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She did her infusion (Hizentra) 2 hours ahead of her Covid vaccine,3rd dose. The lot number of dose 2 was EL1926, it was hard to tell or EL9267 and stated 31May2021 under it; Dose 3 was taken in her arm, she doesn't recall which arm or what time. Patient stated that she was seeing like 19 doctors and has many papers and is behind. Vaccine Administered at Facility: No.  Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Electroencephalogram, Electromyogram, Immunisation, Laboratory test
Clinical narrative: Fever/is getting more often than it was; Booster dose; Booster dose; Feeling very weak; Pain started after her booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 20Aug2021 (Lot number: FC3180) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; immunoglobulin human normal (HIZENTRA), administration date 20Aug2021 (Batch/Lot number: unknown) as 8 g. Relevant medical history included: "Wears hearing aids" (unspecified if ongoing), notes: Verbatim: Caller wears hearing aids; "Immunodeficiency", start date: 2013 (ongoing). Concomitant medication(s) included: DOXYCYCLINE MONOHYDRATE, start date: 16Jul2021. Past drug history included: Hizentra, notes: A couple years ago. Vaccination history included: Bnt162b2 (First dose, lot E1926S, Dose #1 on 31Jan2021 in her muscle of arm at 10:55), administration date: 31Jan2021, when the patient was 65 years old, for Covid-19 Immunisation, reaction(s): "Cramping/locking started in July"; Bnt162b2 (Second dose, Dose #2 on 20Feb2021 in her arm at 14:15), administration date: 20Feb2021, when the patient was 65 years old, for Covid-19 Immunisation, reaction(s): "Cramping/locking started in July"; Flu vaccine (Flu shot as a child around 7 years), for Immunization, reaction(s): "rash". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "Booster dose"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Feeling very weak"; PYREXIA (non-serious) with onset 12Sep2021, outcome "unknown", described as "Fever/is getting more often than it was"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain started after her booster dose". The events "feeling very weak", "fever/is getting more often than it was" and "pain started after her booster dose" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She did her infusion (Hizentra) 2 hours ahead of her Covid vaccine,3rd dose. The lot number of dose 2 was EL1926, it was hard to tell or EL9267 and stated 31May2021 under it; Dose 3 was taken in her arm, she doesn't recall which arm or what time. Patient stated that she was seeing like 19 doctors and has many papers and is behind. Vaccine Administered at Facility: No.  Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Off label use, Pain, Pyrexia, Ultrasound scan
Clinical narrative: Fever/is getting more often than it was; Booster dose; Booster dose; Feeling very weak; Pain started after her booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 20Aug2021 (Lot number: FC3180) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; immunoglobulin human normal (HIZENTRA), administration date 20Aug2021 (Batch/Lot number: unknown) as 8 g. Relevant medical history included: "Wears hearing aids" (unspecified if ongoing), notes: Verbatim: Caller wears hearing aids; "Immunodeficiency", start date: 2013 (ongoing). Concomitant medication(s) included: DOXYCYCLINE MONOHYDRATE, start date: 16Jul2021. Past drug history included: Hizentra, notes: A couple years ago. Vaccination history included: Bnt162b2 (First dose, lot E1926S, Dose #1 on 31Jan2021 in her muscle of arm at 10:55), administration date: 31Jan2021, when the patient was 65 years old, for Covid-19 Immunisation, reaction(s): "Cramping/locking started in July"; Bnt162b2 (Second dose, Dose #2 on 20Feb2021 in her arm at 14:15), administration date: 20Feb2021, when the patient was 65 years old, for Covid-19 Immunisation, reaction(s): "Cramping/locking started in July"; Flu vaccine (Flu shot as a child around 7 years), for Immunization, reaction(s): "rash". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "Booster dose"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Feeling very weak"; PYREXIA (non-serious) with onset 12Sep2021, outcome "unknown", described as "Fever/is getting more often than it was"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain started after her booster dose". The events "feeling very weak", "fever/is getting more often than it was" and "pain started after her booster dose" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She did her infusion (Hizentra) 2 hours ahead of her Covid vaccine,3rd dose. The lot number of dose 2 was EL1926, it was hard to tell or EL9267 and stated 31May2021 under it; Dose 3 was taken in her arm, she doesn't recall which arm or what time. Patient stated that she was seeing like 19 doctors and has many papers and is behind. Vaccine Administered at Facility: No.  Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Rash, Vaccination site rash
Clinical narrative: Rashes around area of the shot. Neck has severe rash and small bumps around body. Raised bumps on back; Rashes around area of the shot. Neck has severe rash and small bumps around body. Raised bumps on back; Raised bumps on back; This is a spontaneous report received from contactable Consumer or other non-HCP. The reporter is the patient.  A 11-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 10:00 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: other medical history: No, known_allergies No. Concomitant medication(s) included: TYLENOL. The following information was reported: VACCINATION SITE RASH (non-serious), RASH (non-serious) all with onset 17Nov2021 17:00, outcome "not recovered" and all described as "Rashes around area of the shot. Neck has severe rash and small bumps around body. Raised bumps on back"; MASS (non-serious) with onset 17Nov2021 17:00, outcome "not recovered", described as "Raised bumps on back". Therapeutic measures were not taken as a result of vaccination site rash, rash, mass.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had tested with covid 19. No known allergies and other medical history reported for the patient.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Immunisation, Pain
Clinical narrative: fever; severe joints aching; severe headache day two; severe fatigue; Severe stinging down to my finger tip on left arm at time of injetion; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 03:00 (Lot number: FH8027) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 06Oct2021. Past drug history included: Sulphur, reaction(s): "known allergies: Sulphur". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 06Mar2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021 03:00, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "fever"; ARTHRALGIA (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "severe joints aching"; HEADACHE (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "severe headache day two"; FATIGUE (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "severe fatigue"; PAIN (non-serious) with onset 15Nov2021 03:00, outcome "recovering", described as "Severe stinging down to my finger tip on left arm at time of injetion". Therapeutic measures were not taken as a result of pyrexia, arthralgia, headache, fatigue, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not been tested for COVID-19.   Follow-Up (22Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; severe joints aching; severe headache day two; severe fatigue; Severe stinging down to my finger tip on left arm at time of injetion; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 03:00 (Lot number: FH8027) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 06Oct2021. Past drug history included: Sulphur, reaction(s): "known allergies: Sulphur". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 06Mar2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021 03:00, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "fever"; ARTHRALGIA (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "severe joints aching"; HEADACHE (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "severe headache day two"; FATIGUE (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "severe fatigue"; PAIN (non-serious) with onset 15Nov2021 03:00, outcome "recovering", described as "Severe stinging down to my finger tip on left arm at time of injetion". Therapeutic measures were not taken as a result of pyrexia, arthralgia, headache, fatigue, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not been tested for COVID-19.   Follow-Up (22Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Swelling face
Clinical narrative: Huge vertical long bulge/bulging lump to the left side of the her face in the jowl area/a quarter-sized round bulge/bulging lump on her right cheek; Huge vertical long bulge/bulging lump to the left side of the her face in the jowl area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-110221-25735 (RA).  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; poly-l-lactic acid (SCULPTRA AESTHETIC), since 01May2021 (Batch/Lot number: unknown) for plastic surgery to the face. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious) with onset 2021, outcome "unknown", described as "Huge vertical long bulge/bulging lump to the left side of the her face in the jowl area/a quarter-sized round bulge/bulging lump on her right cheek"; MASS (non-serious) with onset 2021, outcome "unknown", described as "Huge vertical long bulge/bulging lump to the left side of the her face in the jowl area". Therapeutic measures were not taken as a result of swelling face, mass. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling, Tenderness
Clinical narrative: Armpits are swollen; Armpit  sore; Armpits are swollen and they are tender and sore; I got the Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FF8839) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Anatomical site of vaccine administration: Left arm), administration date: 04Feb2021, when the patient was 50 years old, for COVID-19 Immunization; Bnt162b2 (2nd Dose, Anatomical site of vaccine administration: Left arm), administration date: 25Feb2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "I got the Pfizer booster"; SWELLING (non-serious) with onset 17Nov2021, outcome "unknown", described as "Armpits are swollen"; AXILLARY PAIN (non-serious) with onset 17Nov2021, outcome "unknown", described as "Armpit  sore"; TENDERNESS (non-serious) with onset 17Nov2021, outcome "unknown", described as "Armpits are swollen and they are tender and sore". Therapeutic measures were taken as a result of swelling, axillary pain, tenderness.  Additional information: The patient took Ibuprofen and they were 200 mg and she took two of them, so total of 400 mg (treatment) to relief the discomfort. Consumer stated, "I had the two Pfizer vaccinations back in Feb of this year, on 04Feb2021 and 25Feb2021 and then on 15Nov2021, two days ago, I got the Pfizer booster. So, I woke up this morning and my armpits are swollen and I looked at all the side effects because I didn't had it before and it is like swollen. So, I thought I should call and report that my armpits are swollen and they are tender and sore. I have taken Ibuprofen (treatment) to relief the discomfort but it didn't list that as a possible side effect. So, one, I want to know if that is normal or you know."  -No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pollakiuria, Urinary tract infection
Clinical narrative: UTI; an increased in frequency of her urine; got her booster shot last 27Oct2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose, Location: Right arm, NDC, Lot, Expiration: Unknown), administration date: 09Mar2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (Second dose, Location: Left arm, NDC, Lot, Expiration: Unknown), administration date: 30Mar2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Oct2021, outcome "unknown", described as "got her booster shot last 27Oct2021"; URINARY TRACT INFECTION (non-serious) with onset 28Oct2021, outcome "not recovered", described as "UTI"; POLLAKIURIA (non-serious) with onset 28Oct2021, outcome "not recovered", described as "an increased in frequency of her urine". The events "got her booster shot last 27oct2021", "uti" and "an increased in frequency of her urine" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of immunisation, urinary tract infection, pollakiuria. Additional information: Patient got her booster shot last 27Oct2021 and the next day, 28Oct2021, she noticed an increased in frequency of her urine, like a UTI. She stated she already had it checked and got two rounds of antibiotic. She also said that she was still experiencing this. She also stated she found others online who received the Pfizer covid19 vaccine who also experienced the same side effect as hers. Her question was, if this has been a reported side effect of the vaccine and if yes, how long did it last. No investigation assessment. She has been having a side effect of frequent urination. Caller states she has come to the conclusion that was from the booster shot. Caller states that it feels like a UTI, but there was no medicine and no cure. Caller states she had her booster dose on 27Oct2021 and she had no issue, then she woke up on 28Oct2021 the following day with frequent urinating and she has taken 2 different antibiotics that did nothing so it was not an infection, the only thing that was different was the booster. Caller states it was Bactrim 800mg and Nitrofurantoin, the generic Macrobid. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. Any AE(s) require a visit to: Emergency Room: yes, Physician Office: yes.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: booster; swollen lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Feb he was diagnosed with COVID-19; "Breathing issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Apr he received the Pfizer COVID -19 vaccine and he had minor issues of fever and chills), administration date: Apr2021, for Covid-19 immunization, reaction(s): "Chills", "Fever"; Bnt162b2 (Second dose), administration date: 2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "unknown", described as "swollen lymph node".  Additional information: Call was transferred from Pfizer by (Withheld) (CEP-ID: 159558). Transferring agent stated, "I have a consumer on the line that is calling to report an adverse event and in Feb he was diagnosed with COVID-19 and he was having breathing issues with having the COVID and in Apr he received the Pfizer COVID -19 vaccine and he had minor issues of fever and chills he said it didn't last very long but he said that having the vaccine alleviated the breathing issue that he was having from having COVID and then two nights ago he received the booster dose and he said that he has the swollen lymph node that is about the size half a lemon." Product details (Expiration date, NDC# UPC#) Treatment and other details could not be probed as consumer was unwilling to share further information. Hence, Limited information available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Lethargy, Lymphadenopathy, Vaccination site pain
Clinical narrative: dose_received: 3; injection site soreness; joint pains; minor swollen axillary lymph node (unilateral to injection site side); lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 10:15 (Lot number: FF 8841) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma & severe allergies" (unspecified if ongoing); "severe allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN 5318, Location of injection: Arm Left), administration date: 17Feb2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN 5318, Location of injection: Arm Left), administration date: 27Jan2021, when the patient was 32 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 18:00, outcome "unknown", described as "dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "injection site soreness"; ARTHRALGIA (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "joint pains"; LYMPHADENOPATHY (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "minor swollen axillary lymph node (unilateral to injection site side)"; LETHARGY (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "lethargy". Therapeutic measures were not taken as a result of vaccination site pain, arthralgia, lymphadenopathy, lethargy.    Additional Information: Facility type vaccine was workplace clinic. No other vaccines were given within 4 weeks. Other medications were given within 2 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Lymphadenopathy
Clinical narrative: lump in her breast; a lymph node; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Batch/Lot number: unknown) 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: BREAST MASS (non-serious), outcome "unknown", described as "lump in her breast"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "a lymph node". The events "lump in her breast" and "a lymph node" were evaluated at the physician office visit.  Additional information: Female child (unknown age but 5 through 11y) had first Pfizer-BioNTech Covid 19 vaccine. An unknown time after child had a lump in her breast thought to be a lymph node. Parent was taking child to the pediatrician.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age, Vaccination site warmth
Clinical narrative: Patient age : 10 Years; Feeling warm at injection site for 10 min; arm soreness 1 day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 18:00 (Lot number: FK5127) at the age of 10 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: VACCINATION SITE WARMTH (non-serious) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Feeling warm at injection site for 10 min"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "arm soreness 1 day"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 19Nov2021 18:00, outcome "unknown", described as "Patient age : 10 Years". Therapeutic measures were not taken as a result of vaccination site warmth, pain in extremity.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Nov2021 10:45 (Lot number: FE3590) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin for Allergy. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 19Nov2021 15:30, outcome "not recovered" and all described as "Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site mass, vaccination site erythema, feeling hot.  Additional information: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Facility type vaccine was Pharmacy or Drug Store. Device Date was 20Nov2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Muscular weakness, Off label use, Pain in extremity
Clinical narrative: Used Pfizer for booster; First does of J&J vaccine; First does of J&J vaccine; Whole arm was weak and soar; Whole arm was weak and soar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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 (Dose 1, Single (First does of J&J vaccine)), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Used Pfizer for booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "First does of J&J vaccine"; PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "unknown" and all described as "Whole arm was weak and soar".  The lot number for bnt162b2 was not provided and will be requested during follow up.