chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product preparation issue
Clinical narrative: The vaccinating pharmacist inadvertently mixed the Pfizer Covid-19 Pediatric vaccine with sterile water for injection instead of 0.9% sodium chloride. The patient was then administered the vaccine. The patient's parents report the patient had a sore arm and it was more painful than the primary series.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Product preparation issue
Clinical narrative: The vaccinating pharmacist inadvertently mixed the Pfizer Covid-19 Pediatric vaccine with sterile water for injection instead of 0.9% sodium chloride. The patient was then administered the vaccine. The patient's father reports the patient had her first menstrual spotting the next day, but unsure if it was due to the vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Muscle spasms
Clinical narrative: I was putting together boxes for moving and out of no where I started cramping in my right arm shoulder and breast area. It so hurt bad I thought I was having a heart attack.  I was having a little nerve issue in and around the same area after having light Covid about 3 weeks ago.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody negative, Cardiac monitoring, Coronavirus infection, Differential white blood cell count normal, Full blood count abnormal
Clinical narrative: -Heart palpitations about beginning of April 2021.  -Recurring petechial rash on face (always left cheek) documented photos on Aug 14 2021, then it briefly went away and recurred August 30, 2021.  Most recent episode started June 8, 2022. Nonblanchable, non raised, not itchy. Looks just like broken capillaries all over my cheek.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mean platelet volume increased, Palpitations, Petechiae, Red blood cell sedimentation rate normal
Clinical narrative: -Heart palpitations about beginning of April 2021.  -Recurring petechial rash on face (always left cheek) documented photos on Aug 14 2021, then it briefly went away and recurred August 30, 2021.  Most recent episode started June 8, 2022. Nonblanchable, non raised, not itchy. Looks just like broken capillaries all over my cheek.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Blood test normal, Echocardiogram, Immediate post-injection reaction, Infectious mononucleosis
Clinical narrative: Fever for  a few days immediately following shot. Then a low grade fever for months, then got sick and after months of drs diagnosed with POTS. Bed ridden continues. Low grade fever daily for 5 months.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Postural orthostatic tachycardia syndrome, Pyrexia
Clinical narrative: Fever for  a few days immediately following shot. Then a low grade fever for months, then got sick and after months of drs diagnosed with POTS. Bed ridden continues. Low grade fever daily for 5 months.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Coronary artery occlusion, Electrocardiogram, Myocardial infarction, Stent placement
Clinical narrative: Heart attack (STEMI) 98% blockage LAD. Stent placed
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: caught variant/sick for 10 days; caught variant/sick for 10 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Apr2021 at 10:30 as dose 1, 30 ug single (Lot number: EW0169, Expiration Date: 31Aug2021), in right arm and on 14May2021 at 10:30 as dose 2, 30 ug single (Lot number: EW0179, Expiration Date: 31Aug2021) at the age of 57 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 2020 (ongoing); "Laminectomy", start date: 21Aug2019 (ongoing); "Allergies" (ongoing); "major surgery" (unspecified if ongoing); "Cevical spondylosis", start date: 20Aug2019 (ongoing); "Myelothopy cervical stenosis", start date: 20Aug2019 (ongoing); "a lot of allergies to different meds" (unspecified if ongoing); "Myelothopy", start date: 20Aug2019 (ongoing); "allergic to the preservatives in the salads" (unspecified if ongoing); "couldn't think of the word" (unspecified if ongoing); "brain fog" (unspecified if ongoing); "reconstruction in neck", start date: 21Aug2019 (ongoing). The patient is allergic to the preservatives in the salads, couldn't think of the word, has brain fog, has cervical stenosis with myelopathies and reconstruction in neck, C3 to C6, and they removed her lamina bone from C2 and C7, this occurred in Aug2019, almost 3 years ago. That's why she got the vaccine, she is extremely high risk. There were no concomitant medications. Vaccination history included: Flu shot (either 2007 or 2008), for immunization, reaction(s): "arm swelled up". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "caught variant/sick for 10 days".
Sex: F
Vaccine: COVID19
Symptoms: Decubitus ulcer, Eye disorder, Injury, Muscle contracture, Musculoskeletal disorder
Clinical narrative: NOT HOLDING HER HEAD UP; NOT OPENING HER EYES; ARMS CONTRACTING; HANDS LOCKING INTO FIST; BED SORES; CANNOT TALK; INJURY; This spontaneous report received from a consumer (patient's daughter) concerned an female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: weakness, and concurrent conditions included: asthma, dementia, high blood pressure, kidneys stage 4, and had a walker for mobility. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) 1 total, dose was not reported, administered on 29-JUN-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in 2021, the patient was on tube feed. Patient could not talk, she was not holding her head up, not opening her eyes, her arms were contracting to her body, hands locking into fist, getting occupational therapy, she had bed sores. Patient was hospitalized on an unspecified date for an unspecified number of days and needed prescriptions. Reporter stated that no one got her mother up out of bed for about a year. Reporter stated about the patient's injury. Because her mother was not the way she was after the Johnsons vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not holding her head up, not opening her eyes, arms contracting, hands locking into fist, bed sores, cannot talk and injury was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220606164-COVID-19 VACCINE AD26.COV2.S- not holding her head up, not opening her eyes, arms contracting, hands locking into fist, bed sores, cannot talk. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Speech disorder
Clinical narrative: NOT HOLDING HER HEAD UP; NOT OPENING HER EYES; ARMS CONTRACTING; HANDS LOCKING INTO FIST; BED SORES; CANNOT TALK; INJURY; This spontaneous report received from a consumer (patient's daughter) concerned an female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: weakness, and concurrent conditions included: asthma, dementia, high blood pressure, kidneys stage 4, and had a walker for mobility. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) 1 total, dose was not reported, administered on 29-JUN-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in 2021, the patient was on tube feed. Patient could not talk, she was not holding her head up, not opening her eyes, her arms were contracting to her body, hands locking into fist, getting occupational therapy, she had bed sores. Patient was hospitalized on an unspecified date for an unspecified number of days and needed prescriptions. Reporter stated that no one got her mother up out of bed for about a year. Reporter stated about the patient's injury. Because her mother was not the way she was after the Johnsons vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not holding her head up, not opening her eyes, arms contracting, hands locking into fist, bed sores, cannot talk and injury was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220606164-COVID-19 VACCINE AD26.COV2.S- not holding her head up, not opening her eyes, arms contracting, hands locking into fist, bed sores, cannot talk. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 45.0
Sex: M
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; REBOUND OF COVID SYMPTOMS AND POSITIVITY 10 DAYS AFTER THE FIRST DAY OF TREATMENT; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. On 15-APR-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 45 years old. On 10-NOV-2021, the patient received elasomeran (Moderna vaccine) (dose number in series 2) (form of admin, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, administered to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2022, the patient received Paxlovid (form of admin, route of admin, batch number: unknown, expiry: unknown) dose was not reported, administered for COVID-19 treatment and was discontinued on 20-MAY-2022. On 23-MAY-2022 at 23:00, the patient experienced rebound of covid symptoms (coded as covid-19) (dose number in series 2) and positivity 10 days (25-MAY-2022) after the first day of treatment (coded as confirmed clinical vaccination failure) (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rebound of covid symptoms and positivity 10 days after the first day of treatment, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220606914-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 45.0
Sex: M
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; REBOUND OF COVID SYMPTOMS AND POSITIVITY 10 DAYS AFTER THE FIRST DAY OF TREATMENT; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. On 15-APR-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 45 years old. On 10-NOV-2021, the patient received elasomeran (Moderna vaccine) (dose number in series 2) (form of admin, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, administered to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2022, the patient received Paxlovid (form of admin, route of admin, batch number: unknown, expiry: unknown) dose was not reported, administered for COVID-19 treatment and was discontinued on 20-MAY-2022. On 23-MAY-2022 at 23:00, the patient experienced rebound of covid symptoms (coded as covid-19) (dose number in series 2) and positivity 10 days (25-MAY-2022) after the first day of treatment (coded as confirmed clinical vaccination failure) (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rebound of covid symptoms and positivity 10 days after the first day of treatment, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220606914-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Heavy menstrual bleeding, Thrombosis
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 at 13:15 as dose 3 (booster), single (Lot number: FJ1620) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FERROUS SULFATE, start date: 01Mar2020. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive; (26May2022) Negative; (27May2022) Negative; (28May2022) Negative; (29May2022) Negative; (30May2022) Negative; (31May2022) Negative; (01Jun2022) Negative; (02Jun2022) Negative; (03Jun2022) Negative; (05Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 at 13:15 as dose 3 (booster), single (Lot number: FJ1620) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FERROUS SULFATE, start date: 01Mar2020. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive; (26May2022) Negative; (27May2022) Negative; (28May2022) Negative; (29May2022) Negative; (30May2022) Negative; (31May2022) Negative; (01Jun2022) Negative; (02Jun2022) Negative; (03Jun2022) Negative; (05Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: HIV test, HIV test false positive
Clinical narrative: Patient was sick for a week after each dose; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Patient was sick for a week after each dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Feb-2021, 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 (Patient was sick for a week after each dose). At the time of the report, ILLNESS (Patient was sick for a week after each dose) had resolved.        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-2022-583190, MOD-2022-583164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow up received contains non significant information.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: HIV test, Injury associated with device, SARS-CoV-2 test, Stress, Weight
Clinical narrative: Patient was sick for a week after each dose; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Patient was sick for a week after each dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Feb-2021, 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 (Patient was sick for a week after each dose). At the time of the report, ILLNESS (Patient was sick for a week after each dose) had resolved.        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-2022-583190, MOD-2022-583164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow up received contains non significant information.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness
Clinical narrative: Patient was sick for a week after each dose; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Patient was sick for a week after each dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Feb-2021, 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 (Patient was sick for a week after each dose). At the time of the report, ILLNESS (Patient was sick for a week after each dose) had resolved.        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-2022-583190, MOD-2022-583164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow up received contains non significant information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Aphonia, COVID-19, Chest pain, Cough
Clinical narrative: Two weeks after 2nd dose, patient tested positive for covid; Two weeks after 2nd dose, patient tested positive for covid; Severe vomiting; couldn't eat; diarrhea; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) 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), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Six months later, she tested positive for covid for a second time"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; DYSPNOEA (non-serious), outcome "unknown", described as "hard to breath"; COUGH (non-serious), outcome "unknown", described as "bad cough"; APHONIA (non-serious), outcome "unknown", described as "voice gone"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; AGEUSIA (non-serious), outcome "unknown", described as "taste not back"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in center of chest". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Six months later, she tested positive for covid for a second time. Clinical course: Two weeks after 2nd dose, patient tested positive for covid. Severe vomiting, couldn't eat, diarrhea, shortness of breath. Lasted at least 5 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Dyspnoea, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: Two weeks after 2nd dose, patient tested positive for covid; Two weeks after 2nd dose, patient tested positive for covid; Severe vomiting; couldn't eat; diarrhea; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) 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), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Six months later, she tested positive for covid for a second time"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; DYSPNOEA (non-serious), outcome "unknown", described as "hard to breath"; COUGH (non-serious), outcome "unknown", described as "bad cough"; APHONIA (non-serious), outcome "unknown", described as "voice gone"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; AGEUSIA (non-serious), outcome "unknown", described as "taste not back"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in center of chest". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Six months later, she tested positive for covid for a second time. Clinical course: Two weeks after 2nd dose, patient tested positive for covid. Severe vomiting, couldn't eat, diarrhea, shortness of breath. Lasted at least 5 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Diarrhoea, Drug ineffective, Dyspnoea, Feeding disorder
Clinical narrative: Two weeks after 2nd dose, patient tested positive for covid; Two weeks after 2nd dose, patient tested positive for covid; Severe vomiting; couldn't eat; diarrhea; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) 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), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Six months later, she tested positive for covid for a second time"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; DYSPNOEA (non-serious), outcome "unknown", described as "hard to breath"; COUGH (non-serious), outcome "unknown", described as "bad cough"; APHONIA (non-serious), outcome "unknown", described as "voice gone"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; AGEUSIA (non-serious), outcome "unknown", described as "taste not back"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in center of chest". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Six months later, she tested positive for covid for a second time. Clinical course: Two weeks after 2nd dose, patient tested positive for covid. Severe vomiting, couldn't eat, diarrhea, shortness of breath. Lasted at least 5 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Two weeks after 2nd dose, patient tested positive for covid; Two weeks after 2nd dose, patient tested positive for covid; Severe vomiting; couldn't eat; diarrhea; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) 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), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Six months later, she tested positive for covid for a second time"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; DYSPNOEA (non-serious), outcome "unknown", described as "hard to breath"; COUGH (non-serious), outcome "unknown", described as "bad cough"; APHONIA (non-serious), outcome "unknown", described as "voice gone"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; AGEUSIA (non-serious), outcome "unknown", described as "taste not back"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in center of chest". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Six months later, she tested positive for covid for a second time. Clinical course: Two weeks after 2nd dose, patient tested positive for covid. Severe vomiting, couldn't eat, diarrhea, shortness of breath. Lasted at least 5 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Administration site cellulitis
Clinical narrative: Cellulitis formed in the area of her arm where she received the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 31May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1), for COVID-19 immunization; Moderna (DOSE 2), for COVID-19 immunization; Moderna (DOSE 3), for COVID-19 immunization. The following information was reported: ADMINISTRATION SITE CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis formed in the area of her arm where she received the vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported.; HCP reports patient was accidently administered an expired dose of MMR II on Apr 25, 2022.; Patient date of birth 06-FEB-1987/expired dose of MMR II on 25-APR-2022; This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions/ allergies was not provided.  On 25-APR-2022, the patient was accidently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, frequency, route of administration and lot number was not provided; expiration date was reported as 08-JAN-2022) for prophylaxis (expired product administered). The vaccine had no known temperature excursions. No further information was provided. No additional adverse event (AE) reported (no adverse event).  Follow up information has been received from pharmacist on 08-JUN-2022  Patient's information details were updated, the case was concerning a 35-year-old patient (product administered to patient of inappropriate age).  The patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) with lot number T000889, that was verified to be a valid number with an expiration date reported and established as 08-JUN-2022.   The outcome of the event was reported as recovered/resolved (conflicting information, assessed as unknown according to internal guidelines). It was reported that suspect vaccine was removed from inventory.  This case previous non-valid case was updated to valid as patient's identifiers were provided.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was accidently administered an expired dose of VAQTA on May 10, 2022.; indicate at which point in the process the medication error ocurred: Preparation for administration; This spontaneous report was received from a medical assistant referring to a 2-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The patient was given a hepatitis vaccine, as the patient had medical insurance. Medical assistant pulled vaccine off designated box. Expiration and lot number were not checked before administration of vaccine (Product preparation error).   On 10-MAY-2022, the patient was accidently administered the second dose with an expired dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (lot #T037788, expiration date: 30-APR-2022), administered at left thigh for prophylaxis (strength, dose, and route of administration were not provided) (Expired product administered). After vaccine was given, the patient's parent asked to schedule next appointment. As medical assistant was scheduling appointment, lot number and expiration date were also being entered. Error in expired vaccine was not identified until the following day when coordinator was continuing and doing inventory for vaccines. The vaccine was not available for return. Product had no previous temperature excursion. No additional AE reported (No adverse event).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Administered improperly stored ROTATEQ.  ?; This spontaneous report has been received from an immunization coordinator referring to a 6-month-old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions, any known allergies or reactions or concomitant medications.  On 12-APR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose (Dose was not provided,  Lot # 1742429 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ);, expiration date: 11-SEP-2022).  It was reported that the vaccine had underwent a temperature (T) excursion (Product storage error). The immunization coordinator reported that for a time frame of 2 hours (h) and 3 minutes (m) the vaccine was above 48-degree Fahrenheit (F). Additionally, previous temperature excursion was reported as following:  3h,36m, T 34F;  6h,4m, T 34F;  23m, T 34.3F; 21m T 34.3F; 22m, T 34.3F; 18m, T 34.5F; 19m, T 34.7F; 5m, T 34.3F; 18m, T 34.3F; 16m, T34.9F; 19m, T34.7F; and 7h, 31m, T 33.1F
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna Covid vaccine was wrongly given to person under 18 years old (patient was 17 years old at the time)
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Limb discomfort, Musculoskeletal discomfort, Oedema peripheral
Clinical narrative: Headache, body ache, fever, soar left arm at injection site, swelling in left underarm with discomfort, swelling of let side of neck with discomfort.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Headache, body ache, fever, soar left arm at injection site, swelling in left underarm with discomfort, swelling of let side of neck with discomfort.
Age: 41.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; RN reporting that a dose of GARDASIL9 with a labeled expiry of 5/1/2022 was administered to a patient on 5/13/2022; This spontaneous report was received from a registered nurse and referred to a 41-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-MAY-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter for prophylaxis (lot #T007035, expiration date: 01-MAY-2022, strength and route of administration were not provided) (expired product administered). No temperature excursion was involved. No additional adverse event (AE) was reported (no adverse event).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fall, Gait disturbance, Generalised tonic-clonic seizure
Clinical narrative: After complaining of lightheadedness about 8 hours post-vaccination, the patient was observed by family members to have an episode of frank syncope, collapsing to the floor and then  demonstrating generalized tonic-clonic convulsive activity lasting about 30 seconds.  He was unresponsive for 1-2 minutes.   Breathing stable throughout.  No vital signs available.  After coming around, he was able to recognize family members and converse normally but felt "woozy" and was a bit unsteady getting up.  He was able to ambulate with support and get into bed.  He felt better on awakening but still described feeling somewhat "tentative" and had to cancel activities planned for the next day.  There were no subsequent episodes of syncope or seizure.  The patient sustained a knee injury when he fell to the ground, and that was more painful on day #2.  911 was summoned during the episode, but the call was then canceled at the patient's request.  He declined medical evaluation.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Joint injury, Loss of personal independence in daily activities, Syncope, Unresponsive to stimuli
Clinical narrative: After complaining of lightheadedness about 8 hours post-vaccination, the patient was observed by family members to have an episode of frank syncope, collapsing to the floor and then  demonstrating generalized tonic-clonic convulsive activity lasting about 30 seconds.  He was unresponsive for 1-2 minutes.   Breathing stable throughout.  No vital signs available.  After coming around, he was able to recognize family members and converse normally but felt "woozy" and was a bit unsteady getting up.  He was able to ambulate with support and get into bed.  He felt better on awakening but still described feeling somewhat "tentative" and had to cancel activities planned for the next day.  There were no subsequent episodes of syncope or seizure.  The patient sustained a knee injury when he fell to the ground, and that was more painful on day #2.  911 was summoned during the episode, but the call was then canceled at the patient's request.  He declined medical evaluation.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lichen planus, Rash, Rash pruritic, Skin discolouration
Clinical narrative: Diagnosed as lichen planus. Itchy rash on elbow about day 3 after shot. Then purple, itchy rash on both lower legs, especially around the ankles. Went to dermatologist on 5/31/2022. Strongly suspected lichen planus. Prescribed triamcinolone acetonide cream (0.1%) twice per day. Rash progressed over next several days to much of lower leg (still worst near ankles) and as far on leg as slightly above the knee. Visible spots on arms, head, and back (but not very itchy). Nearly fully resolved by  6/7/2022. At this point (6/10/2022) almost all signs of the rash are gone. Never had any rash remotely like this before.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other issues or concerns noted; patient was given the 3rd dose early/ 1st dose was given November 16, 2021, 2nd dose March 16, 2022, and the 3rd dose should have been given in July 2022, but was given on 5/18/2022; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 16-NOV-2021, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On 16-MAR-2022, the patient was vaccinated with the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On 18-MAY-2022, the patient was vaccinated with the 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis, which was given early, as it should have been given in July 2022 (inappropriate schedule of product administration). No other issues or concerns were noted (no adverse event).
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hepatitis B vaccine (21-MAR-2018, 21-MAY-2018),; This spontaneous report has been received from a lawyer, via Immunization Summary from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1912USA002078), concerning to 66 years old male patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 21-MAR-2018 and 21-MAY-2018, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown) (dose, strength, route, lot number and expiration date were not reported) for prophylaxis, respectively (inappropriate schedule of product administration).         This is one of two cases concerning the same patient.; Sender's Comments:  US-009507513-1912USA002078:
Age: 19.0
Sex: U
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: This spontaneous report was received from a medical assistant referring a 19-year-old patient. The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) lot number U009261, expiration date: 19-SEP-2022 (strength, vaccination scheme, route of administration and anatomical location were not reported); the patient was intended to receive varicella virus vaccine live (oka/merck) (VARIVAX) (strength,  vaccination scheme, dose description, lot number, expiration date, route of administration and anatomical location were provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength,  vaccination scheme, dose description, lot number, expiration date, route of administration and anatomical location were not provided) it was stated that the event was due to a medical error (wrong product administered). No additional adverse event was reported.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; a 2 month old patient was inadvertently administered a pediatric dose of VAQTA on 26 MAY 2022; This spontaneous report has been received from a Registered Nurse, referring to a 2-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 26-MAY-2022, the patient was inadvertently vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular Injection, at a dose of 0.5 milliliter (ml) as prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported); lot number U012525 has been verified to be a valid lot number for hepatitis A vaccine, inactivated (VAQTA) vial formulation, expiration date reported and upon internal validation established as 06-FEB-2023) (product administered to patient of inappropriate age). Besides, no adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reporting that a patient was administered PROQUAD after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) subcutaneous injection, lot # U024508, expiration date 02-FEB-2023 (dose, route of administration, anatomical location were not reported) for prophylaxis (Product storage error).  Administered dose of the vaccine was stored in temperature of 8.3 degrees Fahrenheit for 15 minutes.  There were no previous temperature excursions reported. There was no additional adverse event reported (no adverse event). No further information was available.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: 2 month old patient immediately vomited after receiving a dose of ROTATEQ; This spontaneous report was received from a nurse and refers to a 2-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 08-JUN-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml by oral route, lot # U037810, expiration date 28-MAR-2023 for prophylaxis (also reported as routine vaccination). Immediately after receiving a dose, the patient vomited. The outcome of vomiting was reported as recovered.  The casual relationship between the event and suspect vaccine was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: VARIVAX was administered IM instead of SC; This spontaneous report was received from a registered nurse referring to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies were not provided.   On 08-JUN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (dose, vaccine scheme, and anatomical site of vaccination were not reported; lot number U007471 has been verified to be valid, expiration date reported and established as 08-MAR-2023) administered intramuscularly instead of subcutaneously (incorrect route of product administration).  No other issues or concerns were reported.
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptomatic AEs / No additional AE; Patient was given PEDVAX HIB at 5 weeks 4 days instead of 6 weeks. No symptomatic AEs. No additional AE details or PQC.; This spontaneous report has been received from a nurse, concerning a 5-week and 4-day-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 08-JUN-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number T042014 has been verified to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and confirmed as 23-JUL-2023) (dose, route of administration, and anatomical location were not provided) as prophylaxis. The patient was vaccinated at 5 weeks 4 days instead of 6 weeks (Product administered to patient of inappropriate age).  No symptomatic nor additional adverse events were reported.