chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: baby patient received Arexvy vaccine; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a infant patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: baby patient received Arexvy vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, the vaccine was administered to 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The 25 patients received Arexvy vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was 1 of 25 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020863:Same reporter US-GSK-US2024AMR027429:Same reporter US-GSK-US2024AMR027430:Same reporter US-GSK-US2024AMR027431:Same reporter US-GSK-US2024AMR027432:Same reporter US-GSK-US2024AMR027433:Same reporter US-GSK-US2024AMR027434:Same reporter US-GSK-US2024AMR027448:Same reporter US-GSK-US2024AMR027436:Same reporter US-GSK-US2024AMR027437:Same reporter US-GSK-US2024AMR027438:Same reporter US-GSK-US2024AMR027439:Same reporter US-GSK-US2024AMR027440:Same reporter US-GSK-US2024AMR027441:Same reporter US-GSK-US2024AMR027335:Same reporter US-GSK-US2024AMR027443:Same reporter US-GSK-US2024AMR027444:Same reporter US-GSK-US2024AMR027445:Same reporter US-GSK-US2024AMR027446:Same reporter US-GSK-US2024AMR027447:Same reporter US-GSK-US2024AMR027428:Same reporter US-GSK-US2024AMR027427:Same reporter US-GSK-US2024AMR027426:Same reporter US-GSK-US2024AMR027435:Same reporter
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: baby patient received Arexvy vaccine; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a infant patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: baby patient received Arexvy vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, the vaccine was administered to 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The 25 patients received Arexvy vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was 1 of 25 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020863:Same reporter US-GSK-US2024AMR027435:Same reporter US-GSK-US2024AMR027426:Same reporter US-GSK-US2024AMR027427:Same reporter US-GSK-US2024AMR027428:Same reporter US-GSK-US2024AMR027429:Same reporter US-GSK-US2024AMR027430:Same reporter US-GSK-US2024AMR027431:Same reporter US-GSK-US2024AMR027432:Same reporter US-GSK-US2024AMR027433:Same reporter US-GSK-US2024AMR027434:Same reporter US-GSK-US2024AMR027448:Same reporter US-GSK-US2024AMR027436:Same reporter US-GSK-US2024AMR027437:Same reporter US-GSK-US2024AMR027438:Same reporter US-GSK-US2024AMR027439:Same reporter US-GSK-US2024AMR027440:Same reporter US-GSK-US2024AMR027441:Same reporter US-GSK-US2024AMR027442:Same reporter US-GSK-US2024AMR027335:Same reporter US-GSK-US2024AMR027444:Same reporter US-GSK-US2024AMR027445:Same reporter US-GSK-US2024AMR027446:Same reporter US-GSK-US2024AMR027447:Same reporter
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: baby patient received Arexvy vaccine; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a infant patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: baby patient received Arexvy vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, the vaccine was administered to 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The 25 patients received Arexvy vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was 1 of 25 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020863:Same reporter US-GSK-US2024AMR027429:Same reporter US-GSK-US2024AMR027430:Same reporter US-GSK-US2024AMR027431:Same reporter US-GSK-US2024AMR027432:Same reporter US-GSK-US2024AMR027433:Same reporter US-GSK-US2024AMR027434:Same reporter US-GSK-US2024AMR027448:Same reporter US-GSK-US2024AMR027436:Same reporter US-GSK-US2024AMR027437:Same reporter US-GSK-US2024AMR027438:Same reporter US-GSK-US2024AMR027439:Same reporter US-GSK-US2024AMR027440:Same reporter US-GSK-US2024AMR027441:Same reporter US-GSK-US2024AMR027442:Same reporter US-GSK-US2024AMR027443:Same reporter US-GSK-US2024AMR027335:Same reporter US-GSK-US2024AMR027445:Same reporter US-GSK-US2024AMR027446:Same reporter US-GSK-US2024AMR027447:Same reporter US-GSK-US2024AMR027428:Same reporter US-GSK-US2024AMR027427:Same reporter US-GSK-US2024AMR027426:Same reporter US-GSK-US2024AMR027435:Same reporter
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: baby patient received Arexvy vaccine; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a infant patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: baby patient received Arexvy vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, the vaccine was administered to 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The 25 patients received Arexvy vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was 1 of 25 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020863:Same reporter US-GSK-US2024AMR027429:Same reporter US-GSK-US2024AMR027430:Same reporter US-GSK-US2024AMR027431:Same reporter US-GSK-US2024AMR027432:Same reporter US-GSK-US2024AMR027433:Same reporter US-GSK-US2024AMR027434:Same reporter US-GSK-US2024AMR027448:Same reporter US-GSK-US2024AMR027436:Same reporter US-GSK-US2024AMR027437:Same reporter US-GSK-US2024AMR027438:Same reporter US-GSK-US2024AMR027439:Same reporter US-GSK-US2024AMR027440:Same reporter US-GSK-US2024AMR027441:Same reporter US-GSK-US2024AMR027442:Same reporter US-GSK-US2024AMR027443:Same reporter US-GSK-US2024AMR027444:Same reporter US-GSK-US2024AMR027335:Same reporter US-GSK-US2024AMR027446:Same reporter US-GSK-US2024AMR027447:Same reporter US-GSK-US2024AMR027428:Same reporter US-GSK-US2024AMR027427:Same reporter US-GSK-US2024AMR027426:Same reporter US-GSK-US2024AMR027435:Same reporter
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: baby patient received Arexvy vaccine; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a infant patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: baby patient received Arexvy vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, the vaccine was administered to 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The 25 patients received Arexvy vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was 1 of 25 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020863:Same reporter US-GSK-US2024AMR027429:Same reporter US-GSK-US2024AMR027430:Same reporter US-GSK-US2024AMR027431:Same reporter US-GSK-US2024AMR027432:Same reporter US-GSK-US2024AMR027433:Same reporter US-GSK-US2024AMR027434:Same reporter US-GSK-US2024AMR027448:Same reporter US-GSK-US2024AMR027436:Same reporter US-GSK-US2024AMR027437:Same reporter US-GSK-US2024AMR027438:Same reporter US-GSK-US2024AMR027439:Same reporter US-GSK-US2024AMR027440:Same reporter US-GSK-US2024AMR027441:Same reporter US-GSK-US2024AMR027442:Same reporter US-GSK-US2024AMR027443:Same reporter US-GSK-US2024AMR027444:Same reporter US-GSK-US2024AMR027445:Same reporter US-GSK-US2024AMR027335:Same reporter US-GSK-US2024AMR027447:Same reporter US-GSK-US2024AMR027428:Same reporter US-GSK-US2024AMR027427:Same reporter US-GSK-US2024AMR027426:Same reporter US-GSK-US2024AMR027435:Same reporter
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: baby patient received Arexvy vaccine; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a infant patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: baby patient received Arexvy vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, the vaccine was administered to 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The 25 patients received Arexvy vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was 1 of 25 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020863:Same reporter US-GSK-US2024AMR027429:Same reporter US-GSK-US2024AMR027430:Same reporter US-GSK-US2024AMR027431:Same reporter US-GSK-US2024AMR027432:Same reporter US-GSK-US2024AMR027433:Same reporter US-GSK-US2024AMR027434:Same reporter US-GSK-US2024AMR027448:Same reporter US-GSK-US2024AMR027436:Same reporter US-GSK-US2024AMR027437:Same reporter US-GSK-US2024AMR027438:Same reporter US-GSK-US2024AMR027439:Same reporter US-GSK-US2024AMR027440:Same reporter US-GSK-US2024AMR027441:Same reporter US-GSK-US2024AMR027442:Same reporter US-GSK-US2024AMR027443:Same reporter US-GSK-US2024AMR027444:Same reporter US-GSK-US2024AMR027445:Same reporter US-GSK-US2024AMR027446:Same reporter US-GSK-US2024AMR027335:Same reporter US-GSK-US2024AMR027428:Same reporter US-GSK-US2024AMR027427:Same reporter US-GSK-US2024AMR027426:Same reporter US-GSK-US2024AMR027435:Same reporter
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: baby patient received Arexvy vaccine; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a infant patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: baby patient received Arexvy vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, the vaccine was administered to 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The 25 patients received Arexvy vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was 1 of 25 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020863:SAME REPORTER US-GSK-US2024AMR027435:Same reporter US-GSK-US2024AMR027426:Same reporter US-GSK-US2024AMR027427:Same reporter US-GSK-US2024AMR027428:Same reporter US-GSK-US2024AMR027429:Same reporter US-GSK-US2024AMR027430:Same reporter US-GSK-US2024AMR027431:Same reporter US-GSK-US2024AMR027432:Same reporter US-GSK-US2024AMR027433:Same reporter US-GSK-US2024AMR027434:Same reporter US-GSK-US2024AMR027335:Same reporter US-GSK-US2024AMR027436:Same reporter US-GSK-US2024AMR027437:Same reporter US-GSK-US2024AMR027438:Same reporter US-GSK-US2024AMR027439:Same reporter US-GSK-US2024AMR027440:Same reporter US-GSK-US2024AMR027441:Same reporter US-GSK-US2024AMR027442:Same reporter US-GSK-US2024AMR027443:Same reporter US-GSK-US2024AMR027444:Same reporter US-GSK-US2024AMR027445:Same reporter US-GSK-US2024AMR027446:Same reporter US-GSK-US2024AMR027447:Same reporter
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy, Productive cough
Clinical narrative: he is experiencing lethargy; he is experiencing a productive cough; too tired to do anything; This non-serious case was reported by a consumer via call center representative and described the occurrence of lethargy in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-FEB-2024, the patient received the 1st dose of Shingrix. On 23-FEB-2024, 1 days after receiving Shingrix, the patient experienced lethargy (Verbatim: he is experiencing lethargy), productive cough (Verbatim: he is experiencing a productive cough) and tiredness (Verbatim: too tired to do anything). The outcome of the lethargy, productive cough and tiredness were not resolved.   It was unknown if the reporter considered the lethargy, productive cough and tiredness to be related to Shingrix.     It was unknown if the company considered the lethargy, productive cough and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-FEB-2024 The patient received Shingrix yesterday (day before reporting) and this morning (on the day of reporting) he experienced a productive cough and lethargy and too tired to do anything.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age
Clinical narrative: Intramuscular administration of Rotarix (lyo) to a patient; 6 months 29 days old patient received Rotarix (lyo) vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate route of vaccination in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 379JY, expiry date 25-FEB-2024) for prophylaxis.   On 23-FEB-2024, the patient received Rotarix lyophilized formulation (intramuscular). On 23-FEB-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: Intramuscular administration of Rotarix (lyo) to a patient) and inappropriate age at vaccine administration (Verbatim: 6 months 29 days old patient received Rotarix (lyo) vaccine). The outcome of the inappropriate route of vaccination and inappropriate age at vaccine administration were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 23-FEB-2024 The MA (medical assistant) reported that Intramuscular administration of Rotarix (lyophilized) to a 6-months 29-days old patient, which led to an inappropriate route of vaccination and inappropriate age at vaccine administration.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Maladministration of the AS01B Adjuvant of Shingrix (Without the Lyophilized Antigen Component); Maladministration of the AS01B Adjuvant of Shingrix (Without the Lyophilized Antigen Component); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 3924D, expiry date 29-SEP-2025) for prophylaxis.   On 23-FEB-2024, the patient received the 1st dose of Shingrix. On 23-FEB-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix (Without the Lyophilized Antigen Component)) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix (Without the Lyophilized Antigen Component)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 23-FEB-2024 A reporter reported that a patient received Shingrix adjuvant component alone and after that, patient received a full dose of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Swelling
Clinical narrative: EGG SHAPED SWELLING APPROX 3" IN DIAMETER. VERY ITCHY, BUT NOT HOT OR PAINFULL.
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Tremor
Clinical narrative: Patient return to clinic at around 11:50 reporting tremors on the right hand starting about 5 minutes after vaccines were administered. Vital signs were taken:Blood pressure 132/79, O2 Sat 99%, and Temperature 97.8, Heart Rate 66. Patient was assessed by FNP, sensation, strength and mobility were all WNL as well. Patient declined going to hospital at this time. Patient was called around 4:30 PM same day (3/1/24) and reported all signs and symptoms had resolved.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC20, RSV
Symptoms: Influenza virus test positive, Mycoplasma test positive, Myocardial necrosis marker increased, Respiratory distress
Clinical narrative: the patient arrived at the hospital with respiratory distress and elevated cardiac enzymes. When laboratory tests were performed he tested positive for influenza and mycoplasma. He had not reported it at the time of administering the vaccines because he felt well and did not known he had it. he also did not notify her medical conditions (Diabetes and Hypertension)
Sex: U
Vaccine: HEP, TDAP
Symptoms: Product packaging confusion, Wrong product administered
Clinical narrative: received Tdap (Boostrix) vaccine instead of Hepatitis B vaccine.; confusion due to box color of Boostrix and Engerix B; 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 adult patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On 01-SEP-2023, the patient received Boostrix (intramuscular). On an unknown date, the patient received Engerix B. On 01-SEP-2023, an unknown time after receiving Boostrix and not applicable after receiving Engerix B, the patient experienced wrong vaccine administered (Verbatim: received Tdap (Boostrix) vaccine instead of Hepatitis B vaccine.) and product packaging confusion (Verbatim: confusion due to box color of Boostrix and Engerix B). The outcome of the wrong vaccine administered and product packaging confusion were unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter was an officer in charge of initial processing center, reported that a trainee (patient) received Tdap (Boostrix) vaccine instead of Hepatitis B vaccine, which led to wrong vaccine administered. The reporter did not had information about lot number, expiry date, patient initials, gender, date of birth, healthcare professional (HCP) contact information of the trainee and mailing address of the camp she was calling from. The reporter stated that, she would need to contact her internal team to collect detailed information. This was 1 of the 112 cases, reported by the same reporter.   Follow-up information received on 16-SEP-2023. The caller mentioned to change the box color of Boostrix and Hepatitis B vaccine (Engerix-B) due to that confusion occurred, which led to product packaging confusion. Summary of Changes: Product details, event details and narrative updated.   Follow-up information received on 27-FEB-2024. The patient was between 18 to 25 years of age. The vails were similar in color. 112 trainees received Tdap instead of Hep B  There were no adverse reactions. All trainees were notified and will receive Hepatitis B at their 1st duty station. Summary of changes: Patient's demographic details, product details and narrative were updated.; Sender's Comments:  US-GSK-US2023121025:Same reporter (1st Master case US2023121025 out of 112 cases)
Age: 71.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Dizziness, Vision blurred
Clinical narrative: Fatigue; Loss of appetite; Blurriness; Dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 22-FEB-2024, the patient received the 1st dose of Arexvy (intramuscular). On 23-FEB-2024, 1 days after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue), appetite lost (Verbatim: Loss of appetite), blurred vision (Verbatim: Blurriness) and dizziness (Verbatim: Dizziness). On 25-FEB-2024, the outcome of the fatigue, appetite lost, blurred vision and dizziness were resolved.   It was unknown if the reporter considered the fatigue, appetite lost, blurred vision and dizziness to be related to Arexvy.     It was unknown if the company considered the fatigue, appetite lost, blurred vision and dizziness to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-FEB-2024 The reporter was the patient who stated 12 hours after she received her Arexvy vaccine she developed the following symptoms, dizziness, blurriness, loss of appetite  and fatigue.  Reporter stated these had all resolved. Reporter stated she did not receive a card with the lot of Arexvy.
Age: 71.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Decreased appetite, Dizziness, Fatigue, Vision blurred
Clinical narrative: Fatigue; Loss of appetite; Blurriness; Dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 22-FEB-2024, the patient received the 1st dose of Arexvy (intramuscular). On 23-FEB-2024, 1 days after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue), appetite lost (Verbatim: Loss of appetite), blurred vision (Verbatim: Blurriness) and dizziness (Verbatim: Dizziness). On 25-FEB-2024, the outcome of the fatigue, appetite lost, blurred vision and dizziness were resolved.   It was unknown if the reporter considered the fatigue, appetite lost, blurred vision and dizziness to be related to Arexvy.     It was unknown if the company considered the fatigue, appetite lost, blurred vision and dizziness to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-FEB-2024 The reporter was the patient who stated 12 hours after she received her Arexvy vaccine she developed the following symptoms, dizziness, blurriness, loss of appetite  and fatigue.  Reporter stated these had all resolved. Reporter stated she did not receive a card with the lot of Arexvy.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Gastrointestinal disorder, Headache, Hyperhidrosis
Clinical narrative: Flue/ flu like symptoms; Painful hands; hand blisters; itching hands; stomach issues; body ache; headache; sweating; chills; Tight skin on hands; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-FEB-2024, the patient received the 2nd dose of Shingrix (intramuscular, right arm). In FEB-2024, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flue/ flu like symptoms), pain in hand (Verbatim: Painful hands), blister (Verbatim: hand blisters), pruritus (Verbatim: itching hands), stomach discomfort (Verbatim: stomach issues), general body pain (Verbatim: body ache), headache (Verbatim: headache), sweating (Verbatim: sweating), chills (Verbatim: chills) and skin tightness (Verbatim: Tight skin on hands). The outcome of the influenza-like symptoms was not reported and the outcome of the pain in hand, blister and skin tightness were not resolved and the outcome of the pruritus, stomach discomfort, general body pain, headache, sweating and chills were resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain in hand, blister, pruritus, stomach discomfort, general body pain, headache, sweating, chills and skin tightness to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms, pain in hand, blister, pruritus, stomach discomfort, general body pain, headache, sweating, chills and skin tightness to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The reporter was the patient.  The patient reported that she received the 2nd dose for Shingrix and patient was sick for 2 days with flu like symptoms. The patient reported chills, sweating, headache, body ache, stomach issues and the symptoms had subsided and then both the hands started itching. The patient reported she had small blisters in the palms of both hands. The patient stated the small blisters on the palms of hands could have been because the patient was scratching. The patient reported a day after the flu symptoms subsided, that was when the itching in hands started they were itchy the next day of the vaccine and for the next 2 days. The blisters were almost gone but the hands hurt and had tightness on the skin of both hands.  The pain was on the skin mainly but when bending fingers, the skin was so tight, even bending fingers hurt. Lot and expiry date were not provided. The reporter did not consent to follow-up. Not all information was available. The patient stated If symptoms did not subside she would follow up with healthcare professional and GlaxoSmithKline.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pain in extremity, Pruritus, Skin tightness
Clinical narrative: Flue/ flu like symptoms; Painful hands; hand blisters; itching hands; stomach issues; body ache; headache; sweating; chills; Tight skin on hands; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-FEB-2024, the patient received the 2nd dose of Shingrix (intramuscular, right arm). In FEB-2024, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flue/ flu like symptoms), pain in hand (Verbatim: Painful hands), blister (Verbatim: hand blisters), pruritus (Verbatim: itching hands), stomach discomfort (Verbatim: stomach issues), general body pain (Verbatim: body ache), headache (Verbatim: headache), sweating (Verbatim: sweating), chills (Verbatim: chills) and skin tightness (Verbatim: Tight skin on hands). The outcome of the influenza-like symptoms was not reported and the outcome of the pain in hand, blister and skin tightness were not resolved and the outcome of the pruritus, stomach discomfort, general body pain, headache, sweating and chills were resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain in hand, blister, pruritus, stomach discomfort, general body pain, headache, sweating, chills and skin tightness to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms, pain in hand, blister, pruritus, stomach discomfort, general body pain, headache, sweating, chills and skin tightness to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The reporter was the patient.  The patient reported that she received the 2nd dose for Shingrix and patient was sick for 2 days with flu like symptoms. The patient reported chills, sweating, headache, body ache, stomach issues and the symptoms had subsided and then both the hands started itching. The patient reported she had small blisters in the palms of both hands. The patient stated the small blisters on the palms of hands could have been because the patient was scratching. The patient reported a day after the flu symptoms subsided, that was when the itching in hands started they were itchy the next day of the vaccine and for the next 2 days. The blisters were almost gone but the hands hurt and had tightness on the skin of both hands.  The pain was on the skin mainly but when bending fingers, the skin was so tight, even bending fingers hurt. Lot and expiry date were not provided. The reporter did not consent to follow-up. Not all information was available. The patient stated If symptoms did not subside she would follow up with healthcare professional and GlaxoSmithKline.
Age: 55.0
Sex: U
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Wrong technique in product usage process
Clinical narrative: administration of an incomplete dose of Engerix-B; Inappropriate schedule of vaccine; nurse removed needle prior to completion of dose; Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (1st dose received in 00-JAN-2023).   On 26-FEB-2024, the patient received the 3rd dose of Engerix B adult. On 25-JUL-2023, the patient received the 2nd dose of Engerix B adult. On 25-JUL-2023, not applicable after receiving Engerix B adult and an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). On 26-FEB-2024, the patient experienced incomplete dose administered (Verbatim: administration of an incomplete dose of Engerix-B), drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine) and wrong technique in drug usage process (Verbatim: nurse removed needle prior to completion of dose). The outcome of the drug dose administration interval too long, incomplete dose administered, drug dose administration interval too long and wrong technique in drug usage process 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: 26-FEB-2024 The pharmacist reported administration of an incomplete dose of Engerix-B. As per healthcare professional (HCP), the nurse removed needle prior to completion of dose; therefore, it was unknown how much of the vaccine was administered and this was patient's 3rd dose, which led to wrong technique in drug usage process. The patient received 2nd and 3rd dose of Engerix B Adult delayed than the recommended time interval, which led to lengthening of the vaccination schedule.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient was inadvertently administered the Engerix pediatric dose; Adult patient was inadvertently administered the Engerix pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number 9731K4, expiry date 07-APR-2025) for prophylaxis.   Previously administered products included Engerix B (1st dose received on an unknown date).   On 29-JAN-2024, the patient received Engerix B pediatric. On 29-JAN-2024, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Adult patient was inadvertently administered the Engerix pediatric dose) and adult use of a child product (Verbatim: Adult patient was inadvertently administered the Engerix pediatric dose). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 26-FEB-2024 The clinic manager called to inquired how to proceed for an adult patient to whom inadvertently administered the Engerix pediatric dose, which led to accidental underdose and adult use of a child product. The healthcare professional (HCP) mentioned this was an attempt at the second dose in the Engerix series.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Medical assistant inadvertently administered an expired Hiberix; 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 6-month-old female patient who received Hib (Hiberix) (batch number 74YN7, expiry date 30-DEC-2023) for prophylaxis.   On 27-FEB-2024, the patient received Hiberix. On 27-FEB-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Medical assistant inadvertently administered an expired Hiberix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2024 The manager reported a medical assistant inadvertently administered an expired Hiberix to a patient today (on the day of reporting). The reporter asked how to proceed.
Age: 54.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Arexvy vaccine to patient under the age of 60; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 54-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GX3T4, expiry date 20-AUG-2025) for prophylaxis.   On 26-FEB-2024, the patient received Arexvy. On 26-FEB-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered Arexvy vaccine to patient under the age of 60). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2024 The reporter called to inform that one of the locations that he/she worked for inadvertently administered Arexvy vaccine to patient under the age of 60, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024025761:Same reporter / different patient US-GSK-US2024025758:Same reporter / different patient US-GSK-US2024025765:SAME REPORTER/DIFFERENT PATIENT
Age: 12.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Shingrix in a child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received Herpes zoster (Shingrix) (batch number 4335G, expiry date 18-APR-2026) for prophylaxis.   On 27-FEB-2024, the patient received the 1st dose of Shingrix. On 27-FEB-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Shingrix in a child). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2024 A medical assistant called in to request information about the administration of Shingrix and children after it had accidentally been given to one. The vaccine administration facility was the same as primary reporter. The patient received Shingrix below than the recommended age limit, which led to inappropriate age at vaccine administration.
Age: 7.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: report the administration of an expired dose of Engerix-B to a patient; 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 7-year-old male patient who received HBV (Engerix B) (batch number 39A3L, expiry date 23-FEB-2024) for prophylaxis.   On 27-FEB-2024, the patient received Engerix B. On 27-FEB-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: report the administration of an expired dose of Engerix-B to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-FEB-2024 The medical assistant called to report the administration of an expired dose of Engerix- B to a patient, which led to an expired vaccine used. The health care professional asked for guidance on this situation.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received HBV (Engerix B) (batch number 7B2YL, expiry date 25-FEB-2024) for prophylaxis.   On 27-FEB-2024, the patient received Engerix B. On 27-FEB-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used 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: 28-FEB-2024 The nurse informed they gave a GSK vaccine yesterday (day before reporting), a Hepatitis B vaccine, and it was afterwards when the person who gave the vaccine that realized that the vaccine was two days expired, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis
Clinical narrative: Cold; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19). At the time of the report, NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that after three moderna vaccine over two years patient felt better with covid-19 than the other cold patient had, Covid took nasty cold away. Patient had covid-19 for second time last fall.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-760030 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760030:Patient 1(Wife)