chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: AREXVY vaccination was given to a pregnant 36 year old woman; Inappropriate age / 36 year old woman; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L7HN5) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 17-OCT-2023, the patient received Arexvy. On 17-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age / 36 year old woman). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: AREXVY vaccination was given to a pregnant 36 year old woman). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 17-OCT-2023  The reporter stated that the Arexvy vaccination was given to a pregnant 36-year-old woman (patient), which led to inappropriate age at vaccine administration. Gestational age of fetus was not available. The reporter consented to follow up.
Age: 36.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: AREXVY vaccination was given to a pregnant 36 year old woman; Inappropriate age / 36 year old woman; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L7HN5) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 17-OCT-2023, the patient received Arexvy. On 17-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age / 36 year old woman). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: AREXVY vaccination was given to a pregnant 36 year old woman). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 17-OCT-2023  The reporter stated that the Arexvy vaccination was given to a pregnant 36-year-old woman (patient), which led to inappropriate age at vaccine administration. Gestational age of fetus was not available. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Hyperhidrosis, Immediate post-injection reaction, Injection site pain
Clinical narrative: Nausea; Weakness; Sweats; Chills; tingly arm, pain at injection site; blurry/fuzzy vision (nearly fainted but did not pass out); blurry/fuzzy vision (nearly fainted but did not pass out); tingly arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 14:45 as dose 1, single (Lot number: HF9299) at the age of 12 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "One vasovagal episode caused by heat/dehydration", start date: 2022 (unspecified if ongoing), notes: 1 year ago; "One vasovagal episode caused by heat/dehydration", start date: 2022 (unspecified if ongoing), notes: 1 year ago. Concomitant medication(s) included: GARDASIL 9, on 10Oct2023 as dose 2, single; FLULAVAL QUADRIVALENT, on 10Oct2023 as dose 1, single. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE , Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE , Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE , Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023); NAUSEA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023); HYPERHIDROSIS (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "Sweats"; ASTHENIA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "Weakness"; VISION BLURRED (non-serious), DIZZINESS (non-serious) all with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023) and all described as "blurry/fuzzy vision (nearly fainted but did not pass out)"; PARAESTHESIA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "tingly arm"; VACCINATION SITE PAIN (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "tingly arm, pain at injection site". Therapeutic measures were not taken as a result of nausea, asthenia, hyperhidrosis, chills, vaccination site pain, vision blurred, dizziness, paraesthesia. Additional information: Immediate nausea, weakness, sweats/chills, tingly arm, pain at injection site, blurry/fuzzy vision (nearly fainted but did not pass out). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No known allergies.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Nausea, Pallor, Paraesthesia, Vision blurred
Clinical narrative: Nausea; Weakness; Sweats; Chills; tingly arm, pain at injection site; blurry/fuzzy vision (nearly fainted but did not pass out); blurry/fuzzy vision (nearly fainted but did not pass out); tingly arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 14:45 as dose 1, single (Lot number: HF9299) at the age of 12 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "One vasovagal episode caused by heat/dehydration", start date: 2022 (unspecified if ongoing), notes: 1 year ago; "One vasovagal episode caused by heat/dehydration", start date: 2022 (unspecified if ongoing), notes: 1 year ago. Concomitant medication(s) included: GARDASIL 9, on 10Oct2023 as dose 2, single; FLULAVAL QUADRIVALENT, on 10Oct2023 as dose 1, single. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE , Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE , Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE , Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023); NAUSEA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023); HYPERHIDROSIS (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "Sweats"; ASTHENIA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "Weakness"; VISION BLURRED (non-serious), DIZZINESS (non-serious) all with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023) and all described as "blurry/fuzzy vision (nearly fainted but did not pass out)"; PARAESTHESIA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "tingly arm"; VACCINATION SITE PAIN (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "tingly arm, pain at injection site". Therapeutic measures were not taken as a result of nausea, asthenia, hyperhidrosis, chills, vaccination site pain, vision blurred, dizziness, paraesthesia. Additional information: Immediate nausea, weakness, sweats/chills, tingly arm, pain at injection site, blurry/fuzzy vision (nearly fainted but did not pass out). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No known allergies.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Nausea; Weakness; Sweats; Chills; tingly arm, pain at injection site; blurry/fuzzy vision (nearly fainted but did not pass out); blurry/fuzzy vision (nearly fainted but did not pass out); tingly arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 14:45 as dose 1, single (Lot number: HF9299) at the age of 12 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "One vasovagal episode caused by heat/dehydration", start date: 2022 (unspecified if ongoing), notes: 1 year ago; "One vasovagal episode caused by heat/dehydration", start date: 2022 (unspecified if ongoing), notes: 1 year ago. Concomitant medication(s) included: GARDASIL 9, on 10Oct2023 as dose 2, single; FLULAVAL QUADRIVALENT, on 10Oct2023 as dose 1, single. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE , Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE , Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE , Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023); NAUSEA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023); HYPERHIDROSIS (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "Sweats"; ASTHENIA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "Weakness"; VISION BLURRED (non-serious), DIZZINESS (non-serious) all with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023) and all described as "blurry/fuzzy vision (nearly fainted but did not pass out)"; PARAESTHESIA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "tingly arm"; VACCINATION SITE PAIN (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "tingly arm, pain at injection site". Therapeutic measures were not taken as a result of nausea, asthenia, hyperhidrosis, chills, vaccination site pain, vision blurred, dizziness, paraesthesia. Additional information: Immediate nausea, weakness, sweats/chills, tingly arm, pain at injection site, blurry/fuzzy vision (nearly fainted but did not pass out). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No known allergies.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Vaccination site pain, Vision blurred
Clinical narrative: Nausea; Weakness; Sweats; Chills; tingly arm, pain at injection site; blurry/fuzzy vision (nearly fainted but did not pass out); blurry/fuzzy vision (nearly fainted but did not pass out); tingly arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 14:45 as dose 1, single (Lot number: HF9299) at the age of 12 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "One vasovagal episode caused by heat/dehydration", start date: 2022 (unspecified if ongoing), notes: 1 year ago; "One vasovagal episode caused by heat/dehydration", start date: 2022 (unspecified if ongoing), notes: 1 year ago. Concomitant medication(s) included: GARDASIL 9, on 10Oct2023 as dose 2, single; FLULAVAL QUADRIVALENT, on 10Oct2023 as dose 1, single. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE , Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE , Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE , Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023); NAUSEA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023); HYPERHIDROSIS (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "Sweats"; ASTHENIA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "Weakness"; VISION BLURRED (non-serious), DIZZINESS (non-serious) all with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023) and all described as "blurry/fuzzy vision (nearly fainted but did not pass out)"; PARAESTHESIA (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "tingly arm"; VACCINATION SITE PAIN (non-serious) with onset 18Oct2023 at 14:45, outcome "recovered" (Oct2023), described as "tingly arm, pain at injection site". Therapeutic measures were not taken as a result of nausea, asthenia, hyperhidrosis, chills, vaccination site pain, vision blurred, dizziness, paraesthesia. Additional information: Immediate nausea, weakness, sweats/chills, tingly arm, pain at injection site, blurry/fuzzy vision (nearly fainted but did not pass out). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No known allergies.
Age: 2.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU3
Symptoms: Fatigue, Incorrect dose administered, Injection site erythema, Injection site warmth, Irritability
Clinical narrative: erythema at the injection site; Patient got 3 doses of Pfizer COVID vaccine at the same time inadvertently; Patient got 3 doses of Pfizer COVID vaccine at the same time inadvertently; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative and medical information team. The reporter is the parent.  A 2-year-old male patient received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 06Oct2023 at 19:30 as dose 1, 3 ug single (Lot number: HH3252), in right leg, on 06Oct2023 at 19:30 as dose 2, 3 ug single (Lot number: HH3252), in right leg and on 06Oct2023 at 19:30 as dose 3 (booster), 3 ug single (Lot number: HH3252) at the age of 2 years, in right leg, all intramuscular for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 06Oct2023 as dose 1, single (Lot number: 7G772) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), ACCIDENTAL OVERDOSE (non-serious) all with onset 06Oct2023 at 19:30, outcome "unknown" and all described as "Patient got 3 doses of Pfizer COVID vaccine at the same time inadvertently"; VACCINATION SITE ERYTHEMA (non-serious) with onset 07Oct2023, outcome "recovered" (08Oct2023), described as "erythema at the injection site". Therapeutic measures were taken as a result of vaccination site erythema. Additional information:  Child (age 2 years) and his brother (age 4 years) were inadvertently each administered a full vial of diluted 3-dose multidose vial vaccine (total 9 ug/each) by the medical assistant in the medical clinic where the reporting HCP (also mother) works as a physician assistant. Youngest child had erythema at the injection site which developed 24 hours after injection and persisted for 48 hours before quickly resolving. Mom gave both children NSAIDs for 5-7 days after the vaccination. Clinic physician, Dr. Withheld and the Medical Assistants recognized error and instituted staff training. Treatment received for the adverse event: Mother gave children OTC NSAID. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient has been tested for COVID-19.    Follow-up (18Oct2023 and 19Oct2023): This is a spontaneous follow-up report received from a contactable Other HCP.  Updated information included: reporter details, patient details, suspect drug details, event details (added "Vaccination site erythema"), and clinical information.
Age: 2.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU3
Symptoms: Pain, Product administered at inappropriate site, Pyrexia, Rash
Clinical narrative: erythema at the injection site; Patient got 3 doses of Pfizer COVID vaccine at the same time inadvertently; Patient got 3 doses of Pfizer COVID vaccine at the same time inadvertently; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative and medical information team. The reporter is the parent.  A 2-year-old male patient received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 06Oct2023 at 19:30 as dose 1, 3 ug single (Lot number: HH3252), in right leg, on 06Oct2023 at 19:30 as dose 2, 3 ug single (Lot number: HH3252), in right leg and on 06Oct2023 at 19:30 as dose 3 (booster), 3 ug single (Lot number: HH3252) at the age of 2 years, in right leg, all intramuscular for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 06Oct2023 as dose 1, single (Lot number: 7G772) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), ACCIDENTAL OVERDOSE (non-serious) all with onset 06Oct2023 at 19:30, outcome "unknown" and all described as "Patient got 3 doses of Pfizer COVID vaccine at the same time inadvertently"; VACCINATION SITE ERYTHEMA (non-serious) with onset 07Oct2023, outcome "recovered" (08Oct2023), described as "erythema at the injection site". Therapeutic measures were taken as a result of vaccination site erythema. Additional information:  Child (age 2 years) and his brother (age 4 years) were inadvertently each administered a full vial of diluted 3-dose multidose vial vaccine (total 9 ug/each) by the medical assistant in the medical clinic where the reporting HCP (also mother) works as a physician assistant. Youngest child had erythema at the injection site which developed 24 hours after injection and persisted for 48 hours before quickly resolving. Mom gave both children NSAIDs for 5-7 days after the vaccination. Clinic physician, Dr. Withheld and the Medical Assistants recognized error and instituted staff training. Treatment received for the adverse event: Mother gave children OTC NSAID. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient has been tested for COVID-19.    Follow-up (18Oct2023 and 19Oct2023): This is a spontaneous follow-up report received from a contactable Other HCP.  Updated information included: reporter details, patient details, suspect drug details, event details (added "Vaccination site erythema"), and clinical information.
Age: 2.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU3
Symptoms: Accidental overdose, Incorrect dose administered, Vaccination site erythema
Clinical narrative: erythema at the injection site; Patient got 3 doses of Pfizer COVID vaccine at the same time inadvertently; Patient got 3 doses of Pfizer COVID vaccine at the same time inadvertently; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative and medical information team. The reporter is the parent.  A 2-year-old male patient received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 06Oct2023 at 19:30 as dose 1, 3 ug single (Lot number: HH3252), in right leg, on 06Oct2023 at 19:30 as dose 2, 3 ug single (Lot number: HH3252), in right leg and on 06Oct2023 at 19:30 as dose 3 (booster), 3 ug single (Lot number: HH3252) at the age of 2 years, in right leg, all intramuscular for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 06Oct2023 as dose 1, single (Lot number: 7G772) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), ACCIDENTAL OVERDOSE (non-serious) all with onset 06Oct2023 at 19:30, outcome "unknown" and all described as "Patient got 3 doses of Pfizer COVID vaccine at the same time inadvertently"; VACCINATION SITE ERYTHEMA (non-serious) with onset 07Oct2023, outcome "recovered" (08Oct2023), described as "erythema at the injection site". Therapeutic measures were taken as a result of vaccination site erythema. Additional information:  Child (age 2 years) and his brother (age 4 years) were inadvertently each administered a full vial of diluted 3-dose multidose vial vaccine (total 9 ug/each) by the medical assistant in the medical clinic where the reporting HCP (also mother) works as a physician assistant. Youngest child had erythema at the injection site which developed 24 hours after injection and persisted for 48 hours before quickly resolving. Mom gave both children NSAIDs for 5-7 days after the vaccination. Clinic physician, Dr. Withheld and the Medical Assistants recognized error and instituted staff training. Treatment received for the adverse event: Mother gave children OTC NSAID. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient has been tested for COVID-19.    Follow-up (18Oct2023 and 19Oct2023): This is a spontaneous follow-up report received from a contactable Other HCP.  Updated information included: reporter details, patient details, suspect drug details, event details (added "Vaccination site erythema"), and clinical information.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysuria, Erythema, Fatigue, Headache
Clinical narrative: Pt states that he had difficutly and pain during urination which started about several hours after immunization and lasted less than 24 hours.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Pt states that he had difficutly and pain during urination which started about several hours after immunization and lasted less than 24 hours.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysuria
Clinical narrative: Pt states that he had difficutly and pain during urination which started about several hours after immunization and lasted less than 24 hours.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: it hurt when she received the shot and the pharmacist pressed down on spot; arm hurt then became swollen and bruised; her arm hurt; her arm hurt then became swollen and bruised (is now red about 2 1/2 inches down); This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (it hurt when she received the shot and the pharmacist pressed down on spot ), PERIPHERAL SWELLING (arm hurt then became swollen and bruised), PAIN IN EXTREMITY (her arm hurt) and CONTUSION (her arm hurt then became swollen and bruised (is now red about 2 1/2 inches down)) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023 at 12:30 PM, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. In October 2023, the patient experienced PERIPHERAL SWELLING (arm hurt then became swollen and bruised), PAIN IN EXTREMITY (her arm hurt) and CONTUSION (her arm hurt then became swollen and bruised (is now red about 2 1/2 inches down)). On 20-Oct-2023, the patient experienced VACCINATION SITE PAIN (it hurt when she received the shot and the pharmacist pressed down on spot ). At the time of the report, VACCINATION SITE PAIN (it hurt when she received the shot and the pharmacist pressed down on spot ) outcome was unknown and PERIPHERAL SWELLING (arm hurt then became swollen and bruised), PAIN IN EXTREMITY (her arm hurt) and CONTUSION (her arm hurt then became swollen and bruised (is now red about 2 1/2 inches down)) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was provided.  No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Injection site pain, Joint swelling, Pain in extremity
Clinical narrative: it hurt when she received the shot and the pharmacist pressed down on spot; arm hurt then became swollen and bruised; her arm hurt; her arm hurt then became swollen and bruised (is now red about 2 1/2 inches down); This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (it hurt when she received the shot and the pharmacist pressed down on spot ), PERIPHERAL SWELLING (arm hurt then became swollen and bruised), PAIN IN EXTREMITY (her arm hurt) and CONTUSION (her arm hurt then became swollen and bruised (is now red about 2 1/2 inches down)) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023 at 12:30 PM, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. In October 2023, the patient experienced PERIPHERAL SWELLING (arm hurt then became swollen and bruised), PAIN IN EXTREMITY (her arm hurt) and CONTUSION (her arm hurt then became swollen and bruised (is now red about 2 1/2 inches down)). On 20-Oct-2023, the patient experienced VACCINATION SITE PAIN (it hurt when she received the shot and the pharmacist pressed down on spot ). At the time of the report, VACCINATION SITE PAIN (it hurt when she received the shot and the pharmacist pressed down on spot ) outcome was unknown and PERIPHERAL SWELLING (arm hurt then became swollen and bruised), PAIN IN EXTREMITY (her arm hurt) and CONTUSION (her arm hurt then became swollen and bruised (is now red about 2 1/2 inches down)) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was provided.  No treatment information was provided.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event; Unknown number of administrations of VARIVAX following a temperature excursion; This spontaneous report was received from a licensed practical nurse and refers to unknown number of patients of unknown age and gender. The patients' concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.    On an unknown date, the patients were vaccinated with an improperly store doses of varicella virus vaccine live (OKA/MERCK) (VARIVAX) for prophylaxis (dose, lot #, expiration date and route were not reported) (product storage error). No other adverse events and nor product quality complain were reported.  This is a non-valid case due to lack of patients' identifiers.  Follow-up information has been received from licensed practical nurse on 23-OCT-2023, referring to a 4-years-old male patient. Current conditions included allergic rhinitis.  On 25-SEP-2023, the patient was vaccinated with an improperly store doses of varicella virus vaccine live (OKA/MERCK) (VARIVAX) valid lot W034707, expiration date: 01-NOV-2024, subcutaneously for prophylaxis (dose and route were not reported) (Product storage error). Temperature excursion occurred as result of reading Digital Data Logger. Temperature was out of range as +5 Fahrenheit (F) (also reported as +7 F) for 10 minutes.  This is one of two reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reported VARIVAX  was administered after TE; see TE case. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved VARIVAX X000532 1/4/2025        ?    Temperature 8.1°F        ?    Time frame 3 hours; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications was not reported.  On an unspecified date, varicella virus vaccine live (Oka/Merck) (VARIVAX) injection experienced a temperature excursion (TE) (at 8.1 degrees Fahrenheit (°F) for a time frame of 3 hours). There was no previous TE.  On 28-SEP-2023, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # X000532 has been verified to be a valid lot number, expiration date 04-JAN-2025) (strength, dose, dose number, route of administration and anatomical location were not provided) administered as prophylaxis. No adverse event was reported.
Age: 50.0
Sex: F
Vaccine: FLUX, HPV4, HPV9, PNC15, PPV, TTOX, VARZOS
Symptoms: Malaise, Sick leave
Clinical narrative: Not feeling well after getting shots on 9/14/2023 for pneumonia, flu, tetanus, shingles and papilloma; had been sick after getting shots on 14 Sep 2023 for pneumonia, flu, tetanus, shingles and papilloma; Product origin unknown; labelled drug-drug interaction issue; This spontaneous report was received from a 50-year-old female patient referring to herself. Her concurrent conditions and medical past history was not reported. Concomitant therapies included sulfamethoxazole (+) trimethoprim (BACTRIM), furosemide, ondansetron hydrochloride (ONDANSETRON HCL), sulfamethoxazole (+) trimethoprim, spironolactone, salbutamol sulfate(PROAIR), oxygen, ambrisentan, sildenafil, fluconazole, paracetamol (TYLENOL), mycophenolate mofetil, diphenhydramine hydrochloride (BENADRYL N) and pantoprazole sodium monohydrate.     On 16-FEB-2023, the patient started therapy with treprostinil sodium (REMODULIN) 5mg/ml injection, subcutaneously (dose, frequency, lot number and expiration date were not provided) for pulmonary arterial hypertension. On 14-SEP-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) or pneumococcal 15v conj vaccine (crm197)(manufacturer unknown), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) (Product origin unknown), zoster vaccine live (manufacturer unknown) (Labelled drug-drug interaction issue), influenza vaccine (manufacturer unknown) and tetanus vaccine toxoid (manufacturer unknown) (doses, frequencies, anatomical locations, lot numbers and expiration dates were not reported) as prophylaxis. On the same date, the patient was not feeling well (Malaise) and had been sick (Illness). At the time of reporting, the outcome of malaise and sickness was unknown. The action taken with treprostinil sodium (REMODULIN) was not reported.  The reporter considered the events of malaise and sickness to be related to the suspect vaccines. The reporter did not provide causality between the events and treprostinil sodium (REMODULIN).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for patient who received improperly stored PROQUAD on 02OCT2023. No side effects reported. No other medical information known. Operator of Device was a Healthcare Professional. HCP permission to contact obtained. See addition; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 02-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot #X018582 has been confirmed as valid, expiration date: 05-JAN-2025, Therapy Type rHA), administered for prophylaxis (strength, scheme frequency and route of administration were not provided). The vaccine underwent temperature excursion that same date, with a minimum temperature of -9.8 degree Celsius in a time frame of 12 minutes (Product storage error). No previous temperature excursion and additional side effects were reported.  This is one of 7 reports received from the same reporter.; Sender's Comments:  US-009507513-2310USA007901: US-009507513-2310USA007936: US-009507513-2310USA008300: US-009507513-2310USA008237: US-009507513-2310USA007907: US-009507513-2310USA007942:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The caller said no additional adverse events were reported.; A HBP was transferred onto the line by a Merck account representative to report a temperature excursion. The caller stated doses of improperly stored VARIVAX were administered to patients.; This spontaneous report was received from a office manager and refers to a unspecified age and gender patient.  No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 17-AUG-2023, the patient was vaccinated with an improper storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W039294, who had been verified to be a valid number and expiration date was reported as 11-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was administered with a 17.4 degree Fahrenheit with a time frame of 1 hours 0 minutes and 0 seconds. There was no information about previous temperature excursion (product storage error). No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; Caller states that GARDASIL-9 was administered off-label to an 8 year old.; This spontaneous report has been received from a nurse, regarding to an 8-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 16-OCT-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (Off label use) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   No additional adverse events were reported in the patient.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; HCP reported VARIVAX was administered to a pregnant patient. Reported patient denied pregnancy at time of immunization and declined pregnancy test. No additional AE/no PQC.; This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot #X006980, expiration date: 07-MAR-2025 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.   It was reported that the varicella virus vaccine live (oka/merck)(VARIVAX) was administered to a pregnant patient (exposure during pregnancy). The patient denied pregnancy at time of immunization and declined pregnancy test. No additional adverse event reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or side effects reported; HCP called to report improperly stored VARIVAX administered to a patient on 10/2/2023.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-OCT-2023, the patient was vaccinated with an improperly storage varicella virus vaccine live (OKA/MERCK) (VARIVAX) subcutaneous injection, valid lot W022294, expiration date: 13-JUL-2023, administered for prophylaxis (strength and route of administration were not provided); diluted with sterile diluent solution for injection/infusion (strength, lot #, expiry date, route of administration, and indication were not provided) (Product storage error). Temperature excursion occurred as 32.04 Fahrenheit (F) for 8 hours. No previous temperature excursion was reported. No symptoms or side effects reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Inbound call from physician calling to report TE for ROTATEQ. Caller reports that vaccine was administered to patient following excursion.  Confirmed no symptoms or other adverse events were reported.  No other information at this time.  Permission t; Inbound call from physician calling to report TE for ROTATEQ. Caller reports that vaccine was administered to patient following excursion.  Confirmed no symptoms or other adverse events were reported.  No other information at this time.  Permission t; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 04-OCT-2023, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 2 milliliters (mL), once for prophylaxis (route of administration, and vaccination scheme frequency were not provided; valid lot number 1968393, with an expiration date of 24-MAY-2024). The administered dose of the vaccine experienced a temperature excursion of 0 degrees Celsius for 15 minutes, as recorded by a data logger. There were no previous temperature excursions. There was no adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC.; Nurse called and reported VARIVAX which had a temperature excursion on 06/01/2023 and was short-dated with the outcome "Supported-Within 3 months" was administered on 09/14/2023 after the three-month time period. See information below per attached ar; This spontaneous report was received from Other Health Professional and refers to a patient of unknown ae and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unknown by reporter/unknown by reporter, lot #W031812, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 14-SEP-2023, nurse called and reported VARIVAX which had a temperature excursion (Temperature: 47°F to 77°F for 2 minutes) on 01-JUN-2023 and was short-dated with the outcome "Supported-Within 3 months" was administered on 14-SEP-2023 after the three-month time period. See information below per attached article.  No additional AE/no PQC.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HBP calling on behalf of HCP to report AE for patient that received expired dose of PNEUMOVAX 23.  Expiration- 9/30/2023.  Per Expiry Memo dose supported for 1 month.  No adverse reaction noted.  No additional AE.; This spontaneous report was received from a non-medical healthcare worker refers to a 78-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with expired, single dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # W019533, expiration date: 30-SEP-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no averse event).
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event; Unknown number of administrations of VARIVAX following a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse and refers to a 4-year-old male patient. Current conditions included allergic rhinitis. The patient's medical history and concomitant therapies were not reported.  On 25-SEP-2023, the patient was vaccinated with an improperly store doses of varicella virus vaccine live (OKA/MERCK) (VARIVAX) valid lot W017552, expiration date: 01-JUN-2024, subcutaneously for prophylaxis (dose and route were not reported) (Product storage error). Temperature excursion occurred as result of reading Digital Data Logger. Temperature was out of range as +5 Fahrenheit (F) (also reported as +7 F) for 10 minutes. No complaints from vaccine being administered (No adverse event).  This is one of two reports from the same reporter.
Sex: U
Vaccine: FLUN4
Symptoms: Product storage error
Clinical narrative: PATIENT WAS ADMINISTERED FLUMIST QUADRIVALENT AFTER SEVERAL TEMPERATURE EXCURSIONS BELOW 35F INCLUDING ONE AT 33.98F; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender of Unknown ethnic origin born in 2013.    No medical history was reported.     Concomitant medication included amlodipine besilate, valsartan.     The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number TH2108) (expiration date 10-DEC-2023), via nasal route, on an unknown date.     A Unknown administered FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced patient was administered flumist quadrivalent after several temperature excursions below 35f including one at 33.98f (preferred term: Body temperature).    Action taken with  flumist quadrivalent was reported as not applicable.     The outcome of the event was unknown.    The event was considered non-serious.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Pyrexia, Sensitive skin, Sleep disorder
Clinical narrative: fever; woke up shivering during the night; just feel a bit sensitive on my left hand where I had seen blisters; sensitive on my left hand; This non-serious case was reported by a consumer and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles at age 59). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 13-OCT-2023 11:00, the patient received the 2nd dose of Shingrix. On 13-OCT-2023, 12 hrs after receiving Shingrix, the patient experienced fever (Verbatim: fever) and shivering (Verbatim: woke up shivering during the night). In OCT-2023, the patient experienced blister (Verbatim: just feel a bit sensitive on my left hand where I had seen blisters) and sensitive skin (Verbatim: sensitive on my left hand). The outcome of the fever, shivering, blister and sensitive skin were not reported.   It was unknown if the reporter considered the fever, shivering, blister and sensitive skin to be related to Shingrix.     It was unknown if the company considered the fever, shivering, blister and sensitive skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-OCT-2023 The reporter reported the case for herself, she reported that she had first dose of Shingrix and did not recall side effects. She reported that after the second dose about 12 hours later, she had 99.2 fever, and woke up shivering during night. Reporter thought it was just the cooler weather in their City, but she just looked up side effects on website, and it mentioned that fever and shivering. Reporter had shingles at age of 59. Reporter looked up symptoms and went to physician, who gave her shot. The physician said that patient was diagnosed the problem, but he still had to bill the insurance company for the visit. Reporter said that she was very luck she just felt a bit sensitive on her left had where she had seen blisters. The reporter requested to consent the follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: the wrong diluent - sterile water was used to reconstitute; the wrong diluent - sterile water was used to reconstitute; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) (batch number 29GB3) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: the wrong diluent - sterile water was used to reconstitute) and inappropriate dose of vaccine administered (Verbatim: the wrong diluent - sterile water was used to reconstitute). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-OCT-2023  The reporter was a GSK field staff employee. Shingrix was administered to patient after having been reconstituted with the wrong diluent - sterile water was used to reconstitute which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Patient reported no complaints after incident. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Sleepiness; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of sleepiness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sleepiness (Verbatim: Sleepiness). The outcome of the sleepiness was not reported.   It was unknown if the reporter considered the sleepiness to be related to Shingrix.     It was unknown if the company considered the sleepiness to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2023 The patient had an awful reaction to this shot. Fever, chills vomiting and sleepiness for a full day. I hope we did not have to take it every year. Never had any reaction to the Covid shots and the only reaction to Shingrix was sleepiness, but the RSV killed me.
Sex: U
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Muscle spasms, Myalgia
Clinical narrative: patient muscle pains; spasms; This non-serious case was reported by a nurse via sales rep and described the occurrence of muscle pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, immediately after receiving Arexvy, the patient experienced muscle pain (Verbatim: patient muscle pains) and spasms (Verbatim: spasms). The outcome of the muscle pain and spasms were not reported.   The reporter considered the muscle pain and spasms to be related to Arexvy.     The company considered the muscle pain and spasms to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter stated that the Arexvy caused the patient muscle pains and spasms immediately following vaccination. It was not sure if the reporter agree to follow up from GSK.