chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Arthralgia, Immediate post-injection reaction, Musculoskeletal discomfort
Clinical narrative: Patient states following immediately following vaccination she did not have much discomfort however her shoulder and arm are becoming increasingly more painful.  She has been to the doctor and had an ultrasound done and waiting to figure out what is going on.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Moderna vaccine for Covid 6m - 11y was given instead of the Moderna covid vaccine greater than 11 y  Per Moderna representative the Covid 6m - 11y needs to be repeated so that patient receives the full dose. 2nd  Dose of the Covid 6m - 11y was repeated on the same day per Moderna recommendations
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: PER MOM: LOCALIZED RASH/ERYTHEMA, SWELLING AND HARDNESS AT INJECTION SITE TO RIGHT ARM BEGAN YESTERDAY EVENING AFTER ADMINISTRATION OF VACCINES.  RECEIVED TYLENOL LAST EVENING.  ENCOURAGED TYLENOL/IBUPROFEN USE, ALTERNATIONS OF HEAT AND ICE.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; inadvertent administration of a 5th dose of ROTATEQ; inadvertent administration of a 5th dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a 7-month-old of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On an unspecified date in 2023, the patient was vaccinated with a fourth dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by oral route (dose, lot number and expiration date were not reported) (extra dose administered). On 19-DEC-2023, the patient was vaccinated with a fifth dose of dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by oral route (dose was not reported; lot number 1989398 has been verified to be valid, expiration date reported and established as 25-NOV-2024) (extra dose administered). Both doses were administered as prophylaxis.    No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs; patient received improperly stored vaccine; This spontaneous report was received from nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-DEC-2023, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (product storage error) (lot # x018952 has been verified to be a valid lot number varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 29-OCT-2025 and then established as 13-JUL-2025) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 17.2° Fahrenheit (F) for 50 minutes respectively.  If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.  No adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA000630: US-009507513-2401USA000623:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs; patient received improperly stored vaccine; This spontaneous report was received from nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 29-DEC-2023, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (product storage error) (lot # x018952 has been verified to be a valid lot number varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 29-OCT-2025 and then established as 13-JUL-2025) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 17.2° Fahrenheit (F) for 50 minutes respectively.  If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.  No adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA000616: US-009507513-2401USA000630:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; a patient received improperly stored vaccine; This spontaneous report was received from nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 29-DEC-2023, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (product storage error) (lot # x018730 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and established as 06-JAN-2025) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were 17.2° Fahrenheit (F) for 50 minutes respectively.  If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.  No adverse event reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA000616: US-009507513-2401USA000623:
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No adverse event; A total of 5 patients received doses of the vaccines during and after the potential excursion.; Inappropriate age at vaccine administration; This spontaneous report as received from certified medical assistant refers to a 15 years patient of unknown gender and race. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.   Temperature excursion was between 05-JAN-2024 through 07-JAN-2024.  On 09-JAN-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (PROQUAD) lot # X018577, expiration date: 05-JAN-2025, dose: 0.5 milliliter (dose number, route of administration was not reported) and included sterile diluent (dose, route of administration, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age and product storage error).  The caller stated that the cord from the data logger became dislodged and stopped tracking data during the time frame reported. The caller was unaware of the issue until today (10-JAN-2024) and was unable to provide the data necessary to perform a stability evaluation due to insufficient data.  The administered dose of the vaccine experienced a temperature excursion minus 2 degrees Fahrenheit for 72 hours. There was no adverse effect reported. No product quality complaint was involved.  This is one of several reports received from the same reporter (reported as a total of 5 patients received doses of the vaccines during and after the potential excursion).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report AE.  Patient received supported post expiry dose of ROTATEQ. Product administered 1/12/2024 with expiration date of 12/11/2023.  No additional AE. No PQC.; This spontaneous report was received from a nurse refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-JAN-2024, the patient was vaccinated with expired dose (single dose) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # 1892791, expiration date: 11-DEC-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: RSV
Symptoms: Diabetes mellitus, Fatigue
Clinical narrative: diabetic fatigue; diabetic fatigue; This serious case was reported by a consumer via interactive digital media and described the occurrence of diabetes in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced diabetes (Verbatim: diabetic fatigue) (serious criteria GSK medically significant) and fatigue (Verbatim: diabetic fatigue). The outcome of the diabetes and fatigue were not resolved.   It was unknown if the reporter considered the diabetes and fatigue to be related to Arexvy.     It was unknown if the company considered the diabetes and fatigue to be related to Arexvy.   Additional Information: GSK Receipt date: 11-JAN-2024 This case was reported by consumer via (Open field AE monitoring) interactive digital media. The reporter was a patient. The patient was diabetic fatigue day after shot and was nonstop since rising in am. The follow-up could not be possible as the as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: second bout of the shingles/suspected vaccination failure; second bout of the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: second bout of the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: second bout of the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date:12-JAN-2024 This case was reported by a patient via interactive digital media. The patient received both doses of Shingles vaccine and now was on second bout of the shingles. The patient said that the shots did not work and the physician said it could be worse if patient did not get the shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: FLUX, RVX
Symptoms: Drug intolerance, Full blood count abnormal, Incorrect dosage administered, Pneumonia, Transfusion
Clinical narrative: pneumonia in my left lung; blood count was low; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On an unknown date, the patient received RSV vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving RSV vaccine and an unknown time after receiving Influenza vaccine, the patient experienced pneumonia (Verbatim: pneumonia in my left lung) (serious criteria hospitalization and GSK medically significant) and blood test abnormal (Verbatim: blood count was low) (serious criteria hospitalization). The outcome of the pneumonia and blood test abnormal were not reported.   It was unknown if the reporter considered the pneumonia and blood test abnormal to be related to RSV vaccine.     It was unknown if the company considered the pneumonia and blood test abnormal to be related to RSV vaccine.   Additional Information: GSK Receipt date: 11-JAN-2024 This case was reported by patient via interactive digital media. The patient reported that got mine and flu shot at the same time, he/she already had copd.  It was ended up in hospital for four bad days and he/she had pneumonia in his/her left lung and blood count was low, had a 2liter transfusion.  Hospital messed up his/her dosage of one medicine and gave one that he/she could not tolerate. It was unknown if the reporter considered the pneumonia and blood test abnormal to be related to Flu vaccine Follow up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; Headache occurring; Chills; This non-serious case was reported by a consumer and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 05-JAN-2024, an unknown time after receiving Shingles vaccine, the patient experienced chills (Verbatim: Chills). On 06-JAN-2024, the patient experienced fever (Verbatim: fever) and headache (Verbatim: Headache occurring). The outcome of the fever, headache and chills were not resolved.   It was unknown if the reporter considered the fever, headache and chills to be related to Shingles vaccine.     It was unknown if the company considered the fever, headache and chills to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JAN-2024 The patient was self-reported. The patient had received Shingles vaccine and had fever, chills and headache (occurring). Headache occurring was treated and fever and chills were not treated. The reporter did not consent to follow up.
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Arthritis
Clinical narrative: Severe pain in all joints and inflammation; Severe pain in all joints and inflammation; This non-serious case was reported by a consumer and described the occurrence of joint pain in a 71-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 58160084811, expiry date 15-DEC-2024) for prophylaxis.   On 16-DEC-2023, the patient received Arexvy. On 21-DEC-2023, 5 days after receiving Arexvy, the patient experienced joint pain (Verbatim: Severe pain in all joints and inflammation) and joint inflammation (Verbatim: Severe pain in all joints and inflammation). The patient was treated with prednisone acetate (Prednisone). The outcome of the joint pain and joint inflammation were resolving.   It was unknown if the reporter considered the joint pain and joint inflammation to be related to Arexvy.     It was unknown if the company considered the joint pain and joint inflammation to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-JAN-2024 The patient self-reported this case. It was reported that he experienced severe pain in all joints and inflammation and intervention was required. The reporter did not consented to the follow-up.
Sex: M
Vaccine: RVX
Symptoms: Dyspnoea
Clinical narrative: hard to breathe when patient get up to the bathroom; This non-serious case was reported by a consumer and described the occurrence of difficulty breathing in a 68-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced difficulty breathing (Verbatim: hard to breathe when patient get up to the bathroom). The outcome of the difficulty breathing was not resolved.   It was unknown if the reporter considered the difficulty breathing to be related to RSV vaccine.     It was unknown if the company considered the difficulty breathing to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 10-JAN-2024 This report was submitted via the online direct entry reporting system.  The patient self-reported this case. The patient received RSV vaccine and it was hard to breath when he gets up to the bathroom. It was reported the required intervention. From 01 January 2024 patient started using other product which was Comblvent inhaler for chronic obstructive pulmonary disease (COPD) and he was still using it (till the time of reporting). The reporter consented to follow up via email.
Sex: U
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Arexvy stinging during administration of the vaccine; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of stinging in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced stinging (Verbatim: Arexvy stinging during administration of the vaccine). The outcome of the stinging was not reported.   The reporter considered the stinging to be related to Arexvy.     The company considered the stinging to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-JAN-2024 The pharmacist communicated that patients have complained more about Arexvy stinging during administration versus other vaccines like flu vaccine, shingles vaccine, Covid vaccine.
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pharyngeal swelling, Swelling face
Clinical narrative: Throat swelled; Face turned red; Face swelled; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of throat swelling in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced throat swelling (Verbatim: Throat swelled), red face (Verbatim: Face turned red) and facial swelling (Verbatim: Face swelled). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the throat swelling, red face and facial swelling were resolved.   The reporter considered the throat swelling, red face and facial swelling to be possibly related to Arexvy.     The company considered the throat swelling, red face and facial swelling to be possibly related to Arexvy.   Additional Information: GSK Receipt Date: 10-JAN-2024 This case was reported by a consumer via interactive digital media via. The consumer reported face and throat reactions to taking the Arexvy vaccine. The patient's face turned red and swelled and her throat started to swell as well. The liquid Benadryl to the rescue. The reporter thought that the event might had been related to the product. The follow-up could not be possible as no contact details were available.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis
Clinical narrative: Cellulitis; This non-serious case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In NOV-2023, the patient received Arexvy. On 17-NOV-2023, less than a month after receiving Arexvy, the patient experienced cellulitis (Verbatim: Cellulitis). The outcome of the cellulitis was resolving.   It was unknown if the reporter considered the cellulitis to be related to Arexvy.     It was unknown if the company considered the cellulitis to be related to Arexvy.   Additional Information: GSK receipt date: 10-JAN-2024 The reporter reported that patient was received Arexvy vaccine in November. The reporter reported cellulitis on 17th November, cellulitis was not at injection site. The patient had given injection included a inject-safe barrier bandage. The reporter stated photos included of cellulitis progression not certain that it was related to vaccine, but potentially due to the onset time of it in proximity to vaccination. The reporter consent to follow up.
Sex: U
Vaccine: RVX
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This non-serious case was reported by a physician via sales rep and described the occurrence of shortness of breath in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, immediately after receiving RSV vaccine, the patient experienced shortness of breath (Verbatim: shortness of breath). The outcome of the shortness of breath was not reported.   The reporter considered the shortness of breath to be possibly related to RSV vaccine.     The company considered the shortness of breath to be possibly related to RSV vaccine.   Additional Information: GSK Receipt Date:11-JAN-2024 The patient had 1 dose of RSV vaccine at a pharmacy but not sure which brand or which pharmacy. The reporter said shortly after receiving a RSV vaccine, the patient had shortness of breath and had to call 911 and went to hospital. The patient informed the reporter on another visit of the experience but the reporter did not remember who the patient was at the moment of this report. The reporter thought that the event was related to the product. The reporter was asked to follow up when she could remember more details.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nystagmus
Clinical narrative: Nystagmus; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of nystagmus in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date received, first dose). Concomitant products included escitalopram oxalate (Lexapro).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced nystagmus (Verbatim: Nystagmus) and chills (Verbatim: chills). The outcome of the nystagmus and chills were not reported.   It was unknown if the reporter considered the nystagmus and chills to be related to Shingrix.     It was unknown if the company considered the nystagmus and chills to be related to Shingrix.   Additional Information: GSK Receipt date: 12-JAN-2024 The reporter was a patient's sister. The reporter reported that the patient received her second dose of Shingrix approximately 6 months after her first one. The reporter stated on reporting day that the patient had the second dose of Shingrix sometime during the past 2 weeks, the exact date was unknown. Reporter had limited information and stated that the vaccine was administered at local pharmacy. Reporter did not know in which arm it was administered, neither the lot nor the expiry date of the vaccine. Reporter stated that the patient had started a new medication Lexapro around the same time that the vaccine was administered. This medication had been discontinued. Reporter stated that after the vaccine, patient had chills, nystagmus. No additional information was provided. The reporter requested to consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: more sore; more sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (In April 2022,received first dose in left arm, for the tolerance of first dose refer case US2024005213).   On an unknown date, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: more sore) and sickness (Verbatim: more sick). Rechallenge with Shingrix was positive. The outcome of the pain in arm was unknown and the outcome of the sickness was unknown (duration 1 day).   It was unknown if the reporter considered the pain in arm and sickness to be related to Shingrix.     It was unknown if the company considered the pain in arm and sickness to be related to Shingrix.   Additional Information: GSK Receipt date: 11-JAN-2024 The reporter reported that the patient received second dose of Shingrix 3 months later of first dose (no specific date was provided). After receiving vaccine patient complained that he was more sore and more sick after the 2nd dose of Shingrix. The reporter did not consent to follow-up. This case had been linked to the case US2024005213, reported by same reporter for 1st dose.; Sender's Comments:  US-GSK-US2024005213:same patient / sameproduct
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix dose was administered instead of Dtap; Boostrix dose was administered to a 5-year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 05-JAN-2024, the patient received Boostrix. On 05-JAN-2024, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix dose was administered instead of Dtap) and inappropriate age at vaccine administration (Verbatim: Boostrix dose was administered to a 5-year-old patient). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JAN-2024 The physician assistant reported that the Boostrix dose was administered to a 5-year-old patient instead of Dtap, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter mentioned that patient was the daughter of one of the team members of the medical staff at the reporter's facility. No other information shared by reporter. The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered the 1-vial formulation of Menveo to a 6 month old baby; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 3553D, expiry date 28-FEB-2025) for prophylaxis.   On 11-DEC-2023, the patient received the 1st dose of Menveo. On 11-DEC-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: administered the 1-vial formulation of Menveo to a 6 month old baby). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2024 The certified medical assistant (CMA) stated that a nurse possibly administered the 1-vial formulation of Menveo to a 6-month-old baby (patient), which led to an inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received his 2nd dose of Havrix 18 days early; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 17-month-old male patient who received HAV (Havrix pediatric) (batch number 95R7C, expiry date 05-MAY-2025) for prophylaxis.   Previously administered products included Havrix pediatric (received 1st dose of Havrix on 26-JUL-2023).   On 08-JAN-2024, the patient received the 2nd dose of Havrix pediatric (intramuscular, unknown thigh). On 08-JAN-2024, an unknown time after receiving Havrix pediatric, the patient experienced drug dose administration interval too short (Verbatim: patient received his 2nd dose of Havrix 18 days early). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JAN-2024 The reporter reported that a patient received his 2nd dose of Havrix 18 days early. The patient was due for his 2nd dose of Havrix at 6 months on 26-JAN-2024.  The reporter was not sure in which thigh the patient received the 2nd dose. The Vaccine Administration Facility was the same as Primary Reporter The reporter consented to follow up. The patient received 2nd dose of Havrix Pediatric earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: patient experiencing significant pain in the arm after; weakness in the arm; unable to lift her arm.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   On 06-DEC-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced pain in arm (Verbatim: patient experiencing significant pain in the arm after), weakness of arms (Verbatim: weakness in the arm) and mobility decreased (Verbatim: unable to lift her arm.). The outcome of the pain in arm and weakness of arms were unknown and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the pain in arm, weakness of arms and mobility decreased to be related to FluLaval Quadrivalent 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the pain in arm, weakness of arms and mobility decreased to be related to FluLaval Quadrivalent 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-JAN-2024 The reporter had a patient experiencing significant pain and weakness in the arm after receiving the flulaval vaccine. The patient was unable to lift her arm. The patient was not completely sure. The patient had been having a lot of pain in the left bicep since vaccination. The reporter asked about the incidence of the happening a month after the injection. The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: infant was supposed to receive pediatric RSV monoclonal antibody, but inadvertently administered Arexvy; Nurse reports a 6 month old female infant was supposed to receive pediatric RSV monoclonal antibody, but a nurse inadvertently administered Arexvy; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9G393, expiry date 22-FEB-2025) for prophylaxis.   On 22-DEC-2023, the patient received Arexvy. On 22-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: infant was supposed to receive pediatric RSV monoclonal antibody, but inadvertently administered Arexvy) and wrong vaccine administered (Verbatim: Nurse reports a 6 month old female infant was supposed to receive pediatric RSV monoclonal antibody, but a nurse inadvertently administered Arexvy). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JAN-2024 The nurse reported the patient was supposed to receive pediatric RSV monoclonal antibody, but a nurse inadvertently administered Arexvy. The nurse was not aware of any ill effects after the dose.  The vaccine administration facility was the same as primary reporter. The patient received Arexvy instead of pediatric RSV monoclonal antibody, which led to wrong vaccine administered and inappropriate age at vaccine administration.            The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: which had an expiration date of 13 September 2023.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number J9B25, expiry date 13-SEP-2023) for prophylaxis.   On 12-JAN-2024, the patient received the 2nd dose of Shingrix. On 12-JAN-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: which had an expiration date of 13 September 2023.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-JAN-2024 The medical assistant reported that the patient was administered the 2nd dose of expired Shingrix vaccine, which led to expired vaccine used.  At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to the follow up.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: reconstituted two Arexvy Adjuvant suspension components; reconstituted two Arexvy Adjuvant suspension components; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 54HN2, expiry date 04-FEB-2026) for prophylaxis.   On 10-JAN-2024, the patient received Arexvy. On 10-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: reconstituted two Arexvy Adjuvant suspension components) and inappropriate dose of vaccine administered (Verbatim: reconstituted two Arexvy Adjuvant suspension components). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-JAN-2024 The reporter reported that they reconstituted two Arexvy adjuvant components(liquid)without the lyophilized components and inadvertently administered to a patient. The patient received only adjuvant of Arexvy, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects or issues were experienced by the patient after the administered dose; HCP reported a dose of PEDVAX HIB was administered to a patient on 12/18/2023 after a TE that also occurred on 12/18/2023. The TE evaluation resulted in a "not supported" outcome; This spontaneous report was received from a licensed practical nurse (L.P.N.) regarding a 4-month-old patient of unknown gender.  Information regarding the patient's pertinent medical history, drug reactions and allergies, and concomitant medications was not reported.  On 18-DEC-2023, the patient was vaccinated with Haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (reported lot # X00754 with expiration date 20-NOV-2025 was determined to be an invalid lot # for Haemophilus B conjugate vaccine [meningococcal protein conjugate] [LIQUID PEDVAXHIB]), 0.5 milliliter (mL) administered once as prophylaxis (strength, dose number, route of administration, and anatomical location were not provided) after a temperature excursion (TE) at 18.8 degrees Fahrenheit (F) during 1 hour, 25 minutes, and 0 seconds that occurred that same day (Product storage error). There had been no previous TE and the call was not because of a "data logger". A TE evaluation resulted in a "not supported" outcome. The patient did not experience any adverse side effects or issues after the administered dose.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA007247: US-009507513-2312USA007311:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient received 1 dose of MMR II after the product was involved in a temperature excursion; This spontaneous report was received from a nurse and refers to a 12-month-old patient.  Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 27-DEC-2023, the patient was vaccinated with an improperly stored dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) injection, 1 dosage form, lot #W017557, expiration date: 07-JAN-2024, administered for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No patient symptoms were reported.  The vaccine was stored in a temperature of 13.08C for 1 Hour 15 Minutes. There was no previous temperature excursion reported.; Sender's Comments:  US-009507513-2312USA010804:
Sex: F
Vaccine: RSV
Symptoms: Underdose
Clinical narrative: only partial went in the rest came back out of the syringe plunger/Didn't receive full RSV dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of accidental underdose in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-DEC-2023, the patient received Arexvy (left arm). On 15-DEC-2023, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: only partial went in the rest came back out of the syringe plunger/Didn't receive full RSV dose). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 18-DEC-2023 The patient self-reported this case. She stated that when the vaccine was injected into arm only partial went in the rest came back out of the syringe plunger, which led to accidental underdose. She knew that the registered pharmacist (RPH) called somewhere to find out next steps to take but was not sure if the adverse event (AE) was reported.  The reporter consented to the follow up.   Upon internal review the case was updated on 04-JAN-2024. On follow-up/following internal review it was determined that the Initial Manufacturer Receipt Date was 16-DEC-2023, which was earlier than initially reported. Summary of changes: GSK receipt date and narrative details were updated.
Age: 0.5
Sex: M
Vaccine: COVID19, FLUC3
Symptoms: Accidental overdose, Cough, Pyrexia, Vaccination site pain, Wrong product administered
Clinical narrative: Cough; Fever; Achy shot site; Was given 0.5 ml when it needed to be 0.25 ml; 7 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula; This spontaneous case was reported by a medical assistant and describes the occurrence of COUGH (Cough), PYREXIA (Fever), VACCINATION SITE PAIN (Achy shot site), ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) and WRONG PRODUCT ADMINISTERED (7 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula) in a 7-month-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU5558B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for an unknown indication.    No Medical History information was reported.   On 26-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter and second dose of INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) (Intramuscular use) 1 dosage form. On 26-Oct-2023, the patient experienced ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) and WRONG PRODUCT ADMINISTERED (7 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula). On an unknown date, the patient experienced COUGH (Cough), PYREXIA (Fever) and VACCINATION SITE PAIN (Achy shot site). At the time of the report, COUGH (Cough), PYREXIA (Fever), VACCINATION SITE PAIN (Achy shot site) and WRONG PRODUCT ADMINISTERED (7 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula) outcome was unknown and ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter considered ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) to be not related. No further causality assessments were provided for COUGH (Cough), PYREXIA (Fever), VACCINATION SITE PAIN (Achy shot site) and WRONG PRODUCT ADMINISTERED (7 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula).    Patient had no known allergies. Patient had not been diagnosed/tested positive for COVID-19. Patient had no acute or chronic long-standing health conditions at the time of vaccination.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information for 26th patient out of 29 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747540:Patient 1 (Master case)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: vitiligo / developed white patches over dorsal hand veins which progressed to larger patches on hands, sides of face and neck; This spontaneous case was reported by a patient and describes the occurrence of VITILIGO (vitiligo / developed white patches over dorsal hand veins which progressed to larger patches on hands, sides of face and neck) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058f21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VITILIGO (vitiligo / developed white patches over dorsal hand veins which progressed to larger patches on hands, sides of face and neck). At the time of the report, VITILIGO (vitiligo / developed white patches over dorsal hand veins which progressed to larger patches on hands, sides of face and neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  The patient did not experience any additional symptoms/events.
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: The flip-offs were missing and the rubber stoppers were pierced.; The adapters were attached to the vials and diluent syringes or the syringe only.; The spikes of two adapters were normal and the spike of one adapter was broken; The initial case was missing the following minimum  criteria: [no adverse event]. Upon receipt of follow-up information on [DDMmmYYYY], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5020, Expiration Date: 28Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "The flip-offs were missing and the rubber stoppers were pierced."; DEVICE CONNECTION ISSUE (non-serious), outcome "unknown", described as "The adapters were attached to the vials and diluent syringes or the syringe only."; DEVICE BREAKAGE (non-serious), outcome "unknown", described as "The spikes of two adapters were normal and the spike of one adapter was broken". Additional information:The vials were partially filled with partially reconstituted cake or contained normal looking clear solution for lot 2. The flip-offs were missing and the rubber stoppers were pierced. The adapters were attached to the vials and diluent syringes or the syringe only. The spikes of two adapters were normal and the spike of one adapter was broken. Conclusion: The complaint for "The vaccines adapter is bad or defective." of Abrysvo injectable (Vaccine) was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lots of the reported lot HF5020. The reported defect was present on the returned complaint sample. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. Regulatory Agency (site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Regulatory Agency process determined that no regulatory notification was required. The reported defect could be confirmed on the returned complaint sample. No root cause or CAPA were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release. Causality for "the flip-offs were missing and the rubber stoppers were pierced.", "the adapters were attached to the vials and diluent syringes or the syringe only." and "the spikes of two adapters were normal and the spike of one adapter was broken" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).