chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: HPV; This spontaneous report was received from a female pharmacy technician (also reported as a healthcare professional (HCP), conflict information) via Customer Center referring to herself. Information about the patient's pertinent medical history, concomitant medications, and drug reactions/allergies was reported as unknown. Information about the patient's concurrent conditions was not reported.  On an unknown date (when the patient was 11 or 12 years old), the patient was vaccinated with what was assumed (by the patient) to be quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) via injection for prophylaxis (vaccination by her mother's choice) (strength and dose were not reported). The vaccine was not available for retrieval and the lot# and expiration date were unknown by the patient. It was unknown where the patient received the vaccine and by whom.    On an unknown date (between the age of 16-20, exact time/date were unknown by the patient), the patient was contracted and diagnosed with human papillomavirus (HPV). On an unknown date, the patient sought for treatment. When she was 20 years old, she was advised by her physician that the HPV was gone and she was medically cleared (outcome reported as recovered). Details of the symptoms or adverse events were not disclosed by the patient. The patient wanted to know if her partner should be vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) due to her own personal medical history. No additional adverse events details were able to be provided.   The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and event human papillomavirus infection was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported.; HCP calling to report an AE regarding VARIVAX. HCP calling to report that a patient was administered a improperly stored vaccine. Permission to contact HCP was provided. Case 02428709 filed. AE cases 02428861, 02428862, 02428865 ,02428868, 024287; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 28-JUN-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # W031810 with expiration date 05-OCT-2024 (dose, route and anatomical location were not reported) for prophylaxis (product storage error). No additional AE/PQC reported.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No event/No adverse effects; Indicate at which point in the process the medication error occurred? Storage in clinical practice/Temperature excursion - vaccine not viable according to manufacturer; This spontaneous report has been received from a physician and refers to a 4-year-old female patient. Her pertinent medical history, current conditions and previous drug reactions or allergies were not provided. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL), multivitamins (unspecified) and levocetirizine dihydrochloride (ZYZAL). Historical vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP vaccine), influenza vaccine, HIB vaccine, hepatitis B vaccine, measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR vaccine), diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) and rotavirus vaccine live reassort oral 5v (ROTATEQ).  On an unknown date, a temperature excursion of improperly storage vaccines occurred in a clinical practice; therefore, according to the manufacturer, the vaccines were not viable; however, on 01-JUN-2023, at the private doctor's office/hospital, one of those vaccines, a hepatitis A vaccine, inactivated (manufacturer unknown) intramuscular injection, was administered to the patient in her right arm, as prophylaxis (lot number X003791 has been verified to be valid, expiration date 01-JUN-2024; strength, dose and route of administration were not provided) (product storage error). The vaccine was purchased with public funds. There was not required a drug treatment prescription for that experience. Additionally, there was a Data Logger involved; it was believed to be due to sensory issues. Subsequently, a monitoring of temperatures with back up logger was performed, and the temperature was in range; a new data logger was in use at the reporting time (also reported as now). It was reported that the suspect vaccines were returned to manufacturer and the waste was in progress. No adverse events reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA010113: US-009507513-2307USA011295: US-009507513-2306USA013096:
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Temperature excursion; This spontaneous report was received from physician referring to a 3-month-old (also reported as 4 months, conflict information) male patient. The patient's historical vaccine included hepatitis b vaccine (recombinant) (RECOMBIVAX HB) on 15-FEB-2023 and 18-APR-2023 (basic series and booster series, respectively), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (basic series) on 18-APR-2023, pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (basic series) on 18-APR-2023 and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (basic series) on 18-APR-2023. Concomitant medications included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (booster series) and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (booster series). The patient's concurrent condition was not reported.  On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion, and the vaccine was not viable according to manufacture. On 12-JUN-2023, the patient was vaccinated with the second dose of (booster series) improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1968385, expiration date: 22-MAY-2024, administered orally (PO) by a physician in private doctor's office/hospital for prophylaxis (strength and dose were not provided) (product storage error). The vaccine was purchased with private funds. Alarm believed to be due to sensory issues, and temperatures were monitored with back up logger. Temperature was in range, new data logger was currently in use. No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Temperature excursion; This spontaneous report was received from physician referring to a 4-month-old male patient. The patient's historical vaccine included hepatitis b vaccine (recombinant) (RECOMBIVAX HB) on 05-FEB-2023 and 04-APR-2023, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on 04-APR-2023, pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) on 04-APR-2023 and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) on 04-APR-2023. Concomitant medications included colecalciferol (VITAMINE D), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL). The patient's concurrent condition was not reported.  On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion, and the vaccine was not viable according to manufacture. On 05-JUN-2023, the patient was vaccinated with the second dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1968386, expiration date reported as 24-MAY-2024 but upon internal validation established as 23-MAY-2024, administered orally (PO) by a physician in private doctor's office/hospital for prophylaxis (strength and dose were not provided) (product storage error). The vaccine was purchased with public funds. Alarm believed to be due to sensory issues, and temperatures were monitored with back up logger. Temperature was in range, new data logger was currently in use. No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Temperature excursion; This spontaneous report was received from physician referring to a 2-month-old female patient. The patient's historical vaccine included hepatitis b vaccine (recombinant) (manufacture unknown) on 29-MAR-2023. Concomitant medications included hepatitis b vaccine (recombinant) (manufacture unknown), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL). The patient's concurrent condition was not reported.  On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion, and the vaccine was not viable according to manufacture. On 05-JUN-2023, the patient was vaccinated with the first dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1968386, expiration date 23-MAY-2024, administered orally (PO) by a physician in private doctor's office/hospital for prophylaxis (strength and dose were not provided) (product storage error). The vaccine was purchased with public funds. Alarm believed to be due to sensory issues, and temperatures were monitored with back up logger. Temperature was in range, new data logger was currently in use. No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No Additional AE; HCP called to report that the patient was administered  PROQUAD and VARIVAX in the same day. No Additional AE/PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 18-JUL-2023 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # w039840 and expiration date 12-JUN-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) and varicella virus vaccine live (oka/merck)(VARIVAX) lot # x006981 (valid for varicella virus vaccine live (oka/merck)(VARIVAX)) and expiration date established as 07-MAR-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (overdose and no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored administered ROTATEQ; This spontaneous report was received from a customer (reported also as "other") and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-JUL-2023, the patient was vaccinated with improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, administered orally, lot # reported and confirmed as: 1968385, expiration date reported and confirmed as: 22-MAY-2024 for prophylaxis. Temperature excursion details: 34.9 degree Fahrenheit for 6 hours 34 minutes (20-JUN-2023); 51.4 degree Fahrenheit for 7 hours 33 minutes (03-JUL-2023); 51.1 degree Fahrenheit for 24 hours (04-JUL-2023); 50.7 degree Fahrenheit for 9 hours 27 minutes (05-JUL-2023); no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009292:Original Case # (no patients' identifiers)
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored administered ROTATEQ that was not supported; This spontaneous report was received from a customer (reported also as "other") and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUL-2023, the patient was vaccinated with improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, administered orally, lot # reported and confirmed as: 1968385, expiration date reported and confirmed as: 22-MAY-2024 for prophylaxis. Temperature excursion details: 34.9 degree Fahrenheit for 6 hours 34 minutes (20-JUN-2023); 51.4 degree Fahrenheit for 7 hours 33 minutes (03-JUL-2023); 51.1 degree Fahrenheit for 24 hours (04-JUL-2023); 50.7 degree Fahrenheit for 9 hours 27 minutes (05-JUL-2023); no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009292:Original Case # (no patients' identifiers)
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; HCP reported patient received first dose of GARDASIL 9 vaccine in 2019 and will be receiving second dose outside of dosing schedule.; This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-SEP-2019, the patient was vaccinated with the first dose of human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and would be receiving second dose outside of dosing schedule (inappropriate schedule of product administration). No additional information or adverse event was provided (No adverse event).
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No symptoms reported; improperly stored administered PROQUAD; This spontaneous report was received from a nurse and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) underwent a temperature excursion of 0.6 to -10 up to 8 Celsius degrees during 6 hours and 15 minutes.  On 03-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) 0.5 milliliter, lot #W024551, expiration date reported as 31-JAN-2023 but upon internal validation it was established as 31-JAN-2024 (strength, and route of administration were not provided) as prophylaxis. No symptoms were reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2308USA001053: US-009507513-2308USA000844: US-009507513-2308USA001031: US-009507513-2308USA001156:
Age: 14.0
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no other AE occurred; patient received their first dose of GARDASIL 9 on 7/27/2022 at the age of 14, their 2nd dose on 2/23/2023, and their 3rd dose on 7/31/2023; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-JUL-2022, the patient was vaccinated with the first dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) pre-filled syringe, lot #1780867, expiration date: 08-AUG-2023 (strength, and route of administration were not provided) as prophylaxis. On 23-FEB-2023, the patient the patient was vaccinated with the second dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) lot#m031076 (lot# is an invalid lot number for Gardasil 9) (strength, expiry date, and route of administration were not provided) as prophylaxis. On 31-JUL-2023, the patient received the third dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) pre-filled syringe, lot #W011455, expiration date: 11-DEC-2024 (strength, and route of administration were not provided) as prophylaxis (inappropriate schedule of product administration). No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; patient was inadvertently administered  an expired dose of MMR II.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-AUG-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II), 0.5 milliliter, lot #U022983, expiration date: 22-JUL-2023 (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Blood glucose normal, Fall, Immediate post-injection reaction, Laboratory test normal
Clinical narrative: the patient fainted; had no energy when she left the office; This spontaneous report was received from a medical assistant and refers to a 11-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was not provided.      On 01-AUG-2023 the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # X005044 and expiration date 02-JAN-2025, 0.5 milliliter, intramuscularly for prophylaxis (site of administration was not provided).    On 01-AUG-2023, the patient experienced asthenia and syncope (medically significant). Patient was standing up when vaccine was given, and immediately after giving the dose as the health care professional  (HCP) turned to grab cotton/bandage the patient fainted and fell to the floor (syncope). Patient was unconscious for several seconds. Once feeling better patient was given water and patient's vitals were checked. Vitals were all within normal limits. Labs were also drawn to check blood sugar and anemia, both tests came back normal. HCP reported to the FBE that this patient came into the office very energetic and had no energy when she left the office (asthenia). The outcome of syncope and asthenia was reported as recovered. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable.   The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.   Upon internal review event syncope was considered medically significant based on list. ; Sender's Comments:  US-009507513-2308USA003657:
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: the patient fainted; had no energy when she left the office; This spontaneous report was received from a medical assistant and refers to a 11-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was not provided.      On 01-AUG-2023 the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # X005044 and expiration date 02-JAN-2025, 0.5 milliliter, intramuscularly for prophylaxis (site of administration was not provided).    On 01-AUG-2023, the patient experienced asthenia and syncope (medically significant). Patient was standing up when vaccine was given, and immediately after giving the dose as the health care professional  (HCP) turned to grab cotton/bandage the patient fainted and fell to the floor (syncope). Patient was unconscious for several seconds. Once feeling better patient was given water and patient's vitals were checked. Vitals were all within normal limits. Labs were also drawn to check blood sugar and anemia, both tests came back normal. HCP reported to the FBE that this patient came into the office very energetic and had no energy when she left the office (asthenia). The outcome of syncope and asthenia was reported as recovered. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable.   The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.   Upon internal review event syncope was considered medically significant based on list. ; Sender's Comments:  US-009507513-2308USA003657:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: HCP reporting misuse AE for VAQTA. Caller reported an adult patient received less than the recommended dose on 02/03/2023 and will be revaccinated. No additional details provided. Patient demographics were not provided. No additional AE. No PQC.; No additional AE.; This spontaneous report was received from Consumer and refers to an adult patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, HCP reported misuse AE for VAQTA. Caller reported an adult patient received less than the recommended dose on 03-FEB-2023 and will be revaccinated. No additional details provided. Patient demographics were not provided. No additional AE. No PQC.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose received on 10-DEC-2021 and last dose received on 18-AUG-2022 (8 months schedule); This spontaneous report was received from a nurse and refers to an 8-month-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 10-DEC-2021, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (unknown manufacturer) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 21-JAN-2022, the patient was vaccinated with second dose of hepatitis b vaccine (recombinant) (unknown manufacturer) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 18-AUG-2022, the patient was vaccinated with third dose of hepatitis b vaccine (recombinant) (unknown manufacturer) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided)(inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2307USA009402:Same Patient
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number SKBAMVA721A) for prophylaxis.   On 03-AUG-2023, the patient received Menveo. On 03-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Menveo reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 9-Aug-2023 A nurse wished to know how to proceed. Information about vaccine, event and patient were given. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. The patient received a dose of Menveo reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the lyophilized portion only with a non-approved diluent; administered the lyophilized portion only with a non-approved diluent; 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 patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered the lyophilized portion only with a non-approved diluent) and inappropriate dose of vaccine administered (Verbatim: administered the lyophilized portion only with a non-approved diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 09-AUG-2023 The health care professional (HCP) reported that they had 4-vials of Menveo lyophilized vials and no matching diluents in their supply.  The HCP did not know if diluent only was provided to patients or if vials were broken and not reported. The HCP was not sure if patients were administered the lyophilized portion only with a non-approved diluent. The HCP gave permission for Safety follow-up so perhaps the HCP could provide additional clarity. No additional details are available. The reporter consented to follow up.  The patient potentially received lyophilized portion with a non approved diluent of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEP, TDAP
Symptoms: Product storage error
Clinical narrative: administered Boostrix, Engerix-B to patients that was stored at 12.6degree Celsius; This non-serious case was reported by a consumer via call center representative and described the occurrence of product storage error in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Boostrix and Engerix B. On an unknown date, an unknown time after receiving Boostrix and Engerix B, the patient experienced product storage error (Verbatim: administered Boostrix, Engerix-B to patients that was stored at 12.6degree Celsius). The outcome of the product storage error was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 09-Aug-2023 Wholesaler reported that the health care professional (HCP) administered Boostrix, Engerix-B to patients that was stored at 12.6 degree Celsius for 28 days. Wholesaler reported that 4 doses of Boostrix and 1 dose of Engerix-B were administered after the 168 hours stability window.  Specialist advised wholesaler to have HCP call into Information to provide more specific details of excursion. No additional details was available as healthcare professional was not available to provide additional granularity to the adverse event and storage issue. The temperature excursed Engerix-B and Boostrix was administered, which led to Product storage error. The reporter did not consent to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Feeling hot, Injection site rash, Rash, Rash erythematous, Rash morbilliform
Clinical narrative: It was very itchy; he developed a symmetrical morbilliform pink skin rash in his lateral flank that irradiated to his chest; symmetrical morbilliform pink skin rash; He was also feeling warm; This non-serious case was reported by a physician via call center representative and described the occurrence of feeling of warmth in a 71-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GX45D, expiry date 19-OCT-2024) for prophylaxis.   On 07-AUG-2023, the patient received Arexvy (left arm). On 07-AUG-2023, 2 hrs after receiving Arexvy, the patient experienced itchy rash (Verbatim: It was very itchy), rash (Verbatim: he developed a symmetrical morbilliform pink skin rash in his lateral flank that irradiated to his chest) and morbilliform rash (Verbatim: symmetrical morbilliform pink skin rash). In AUG-2023, the patient experienced feeling of warmth (Verbatim: He was also feeling warm). The patient was treated with antihistamine (Antihistamines). The outcome of the feeling of warmth, itchy rash, rash and morbilliform rash were resolving.   It was unknown if the reporter considered the feeling of warmth, itchy rash, rash and morbilliform rash to be related to Arexvy.     It was unknown if the company considered the feeling of warmth, itchy rash, rash and morbilliform rash to be related to Arexvy.   Additional Information: Receipt date: 9-AUG-2023 The reporter was a physician who received the Arexvy vaccine at 2:30PM in his left arm. According to reporter, 2 and a half hours later he developed a symmetrical morbilliform pink skin rash in his lateral flank that irradiated to his chest and upper left arm a day after. It was very itchy. Reporter states he used antihistamines 3 doses and dry powder to reduce the itchiness. No blisters, no vesicles or anaphylaxis reported. The reporter was also feeling warm. The symptoms persisted until the time of this report but its decreasing. Reporter states he was in good health, not medical conditions to report. Consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Rash pruritic
Clinical narrative: It was very itchy; he developed a symmetrical morbilliform pink skin rash in his lateral flank that irradiated to his chest; symmetrical morbilliform pink skin rash; He was also feeling warm; This non-serious case was reported by a physician via call center representative and described the occurrence of feeling of warmth in a 71-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GX45D, expiry date 19-OCT-2024) for prophylaxis.   On 07-AUG-2023, the patient received Arexvy (left arm). On 07-AUG-2023, 2 hrs after receiving Arexvy, the patient experienced itchy rash (Verbatim: It was very itchy), rash (Verbatim: he developed a symmetrical morbilliform pink skin rash in his lateral flank that irradiated to his chest) and morbilliform rash (Verbatim: symmetrical morbilliform pink skin rash). In AUG-2023, the patient experienced feeling of warmth (Verbatim: He was also feeling warm). The patient was treated with antihistamine (Antihistamines). The outcome of the feeling of warmth, itchy rash, rash and morbilliform rash were resolving.   It was unknown if the reporter considered the feeling of warmth, itchy rash, rash and morbilliform rash to be related to Arexvy.     It was unknown if the company considered the feeling of warmth, itchy rash, rash and morbilliform rash to be related to Arexvy.   Additional Information: Receipt date: 9-AUG-2023 The reporter was a physician who received the Arexvy vaccine at 2:30PM in his left arm. According to reporter, 2 and a half hours later he developed a symmetrical morbilliform pink skin rash in his lateral flank that irradiated to his chest and upper left arm a day after. It was very itchy. Reporter states he used antihistamines 3 doses and dry powder to reduce the itchiness. No blisters, no vesicles or anaphylaxis reported. The reporter was also feeling warm. The symptoms persisted until the time of this report but its decreasing. Reporter states he was in good health, not medical conditions to report. Consented to follow up.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Underdose; Adult patient was administered a pediatric dose of Engerix; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 09-AUG-2023, the patient received Engerix B pediatric (left deltoid). On 09-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: Adult patient was administered a pediatric dose of Engerix). The outcome of the underdose and adult use of a child product 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: 10-AUG-2023 Nurse Practitioner called to inquire the way to proceed. NP reported an adult patient was administered a pediatric dose of Engerix instead of the full adult dose which led to underdose and adult use of a child product. The reporter did not consent to follow up from safety. Call Notes:HCP declined follow-up from safety.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero exposed to RT 22 C (72 F) for 53 hrs, 12 min and administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis.   On 03-AUG-2023, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero exposed to RT 22 C (72 F) for 53 hrs, 12 min and administered to a patient). The outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 10-AUG-2023 Clinical stated Bexsero exposed to room temperature (RT) 22 degree C (72 Fahrenheit) for 53 hours, 12 minutes and administered to a patient. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up. The patient received Bexsero vaccine after temperature excursion, which led to incorrect storage of drug.
Age: 7.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Product label confusion
Clinical narrative: Infanrix was administered to a patient came in who is 7; Product label confusion; 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 7-year-old patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis. This case was associated with a product complaint.   On 09-AUG-2023, the patient received Infanrix. On 09-AUG-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix was administered to a patient came in who is 7) and product label confusion (Verbatim: Product label confusion). The outcome of the inappropriate age at vaccine administration and product label confusion were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 10-AUG-2023 The reporter reported that the Infanrix was administered to patient came in who was 7 and they wanted to know the way to proceed. The reporter stated that there was some confusion with the Infanrix as it stated on the box that it could be administered to patients who were 6-7 years of age but the package insert said administer prior to the 7th birthday. Health care professional (HCP) did not have the patient's demographics at time of call.  The vaccine administration facility was the same as primary reporter. The 7 year old patient received Infanrix, which led to inappropriate age at vaccine administration. The reporter had confusion on the box label, which led product label confusion. The reporter consented to follow up via post.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received Havrix on 10AUG2023 that expired on 17JUN2023; 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 25-year-old female patient who received HAV (Havrix 1440 adult) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 10-AUG-2023, the patient received Havrix 1440 adult. On 10-AUG-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced expired vaccine used (Verbatim: patient received Havrix on 10AUG2023 that expired on 17JUN2023). The outcome of the expired vaccine used was unknown.   Additional Information: Receipt Date: 10-AUG-2023 The health care professional (HCP) reported that the patient received a dose of Havrix on 10th August 2023 which was expired on 17th June 2023, which led to expired vaccine used. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ, VARZOS
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: Shingrix diluent mixed with Menveo diluent administered; Inappropriate dose of vaccine administered; Inappropriate age at vaccine administration; 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 11-year-old male patient who received Herpes zoster (Shingrix) (batch number 7S279, expiry date 20-AUG-2024) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMXA950A, expiry date 30-SEP-2025) for prophylaxis.   On 10-AUG-2023, the patient received Shingrix and Menveo. On 10-AUG-2023, an unknown time after receiving Shingrix and Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix diluent mixed with Menveo diluent administered), inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: Receipt date: 10-AUG-2023 The vaccine administration facility was the same as primary reporter The reporter asked if there were any safety information available and when the dose of Menveo could be repeated. Shingrix diluent mixed with Menveo diluent administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The 11 year old patient received Shingrix diluent which led to inappropriate age of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Underdose; Received a pediatric dose of Engerix B; Drug dose administration interval too short; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 18-year-old female patient who received HBV (Engerix B pediatric) (batch number EM9E4, expiry date 17-DEC-2025) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 31-JUL-2023, the patient received the 2nd dose of Engerix B pediatric. On 31-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose), adult use of a child product (Verbatim: Received a pediatric dose of Engerix B) and drug dose administration interval too short (Verbatim: Drug dose administration interval too short). The outcome of the underdose, adult use of a child product and drug dose administration interval too short 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: 10-Aug-2023 The Medical assistant reported a patient received an adult dose of Engerix B and next day received a pediatric dose of Engerix B.  The reporter asked if there were any safety information The vaccine administration facility was the same as primary reporter. The 18 year old patient received a pediatric dose of Engerix B, which led to underdose and adult of a child product. The patient received an adult dose of Engerix B on July 30th 2023 and on July 31st 2023 received a pediatric dose of Engerix B, which led to shortening of dose schedule. The reporter did not consented to follow up.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient was given a pediatric dose of Engerix-B.; adult patient was given a pediatric dose of Engerix-B.; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 56-year-old male patient who received HBV (Engerix B 10 mcg) (batch number 4ZN3H, expiry date 28-MAR-2025) for prophylaxis.   On 25-JUL-2023, the patient received Engerix B 10 mcg. On 25-JUL-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: adult patient was given a pediatric dose of Engerix-B.) and adult use of a child product (Verbatim: adult patient was given a pediatric dose of Engerix-B.). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: Receipt date: 10-AUG-2023 The nurse reported an adult patient was given a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: extra Engerix-B adult dose administered by error instead of Menveo (5th dose); extra Engerix-B adult dose administered by error instead of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 333M4, expiry date 07-APR-2024) for prophylaxis.   On 23-SEP-2022, the patient received the 5th dose of Engerix B adult. On 23-SEP-2022, an unknown time after receiving Engerix B adult, the patient experienced extra dose administered (Verbatim: extra Engerix-B adult dose administered by error instead of Menveo (5th dose)) and wrong vaccine administered (Verbatim: extra Engerix-B adult dose administered by error instead of Menveo). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: Receipt date: 10-AUG-2023 Physician was looking for information of an extra Engerix-B adult dose administered by error instead of Menveo, which led to wrong vaccine administered and extra dose administered. This last dose was administered as a 5th dose. The reporter consented to follow up. Fax: preferred
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Illness
Clinical narrative: were just ill the first one; made him sick for a day or so; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (were just ill the first one), ILLNESS (made him sick for a day or so) and HEADACHE (Headache) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included VITAMIN D3, SERTRALINE and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (were just ill the first one), ILLNESS (made him sick for a day or so) and HEADACHE (Headache). At the time of the report, ILLNESS (were just ill the first one), ILLNESS (made him sick for a day or so) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had received total of 3 moderna vaccines. and the patient had a different effects and were just ill with first one and felt good and it makes to sit down for 15-20 minutes. The second one had a headache before left the building, the third one were down for the day and each time it got felt worse and with 2nd and 3rd vaccinations made sick for a day or so. No treatment medications were reported.