chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "high BP" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID; METOPROLOL; ROSUVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Took covid test and positive results were immediate; (02Dec2022) positive, notes: Tested positive for covid on 02Dec2022; (12Dec2022) negative, notes: Tested neg for covid on 12Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: This is a notification generated from the system. As part of the simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in  Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 Adult 10 X 2.25 ml Multidose Bivalent Ba.1 Lot-# (CR): GJ5342 Conclusion of Previously Completed Investigation: The complaint for "Pfizer BioNTech Covid-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GJ5342. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. concluded that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. PR ID of Previously Completed Inv: 7704736.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; administration of an expired dose of ROTATEQ to a patient; This spontaneous report was received from Medical Assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-DEC-2022, the expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1742421, expiration date: 07-DEC-2022 (formulation, dose, strength were not provided) was administered to a patient for prophylaxis (expired product administered). No additional adverse events were reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; PROQUAD administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-SEP-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U028180, expiration date: 08-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error).  Administered dose of vaccine experienced the temperature excursion of 23.73 degrees Celsius for 28 hours 45 minutes on 24-AUG-2022.  No adverse event reported.  This is one of 2 reports received from the same reporter.
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No adverse event; PROQUAD administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 07-SEP-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U028180, expiration date: 08-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error).  On 24-AUG-2022, administered dose of vaccine experienced the temperature excursion of 23.73 degrees Celsius for 28 hours 45 minutes.  No adverse event reported.  This is one of 2 reports received from the same reporter.
Sex: M
Vaccine: HPV4
Symptoms: Autopsy, Death
Clinical narrative: The Gardasil/HPV Vaccine killed my 14 year old son on 8-14-2018; This spontaneous report was received from consumer (the patient's parent) via social media, referring to a 14-year-old male patient. The patient's medical history was not reported. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were unknown.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection for prophylaxis (strength, dose, lot #, expiration date and route of administration were not provided).  On 14-AUG-2018, the patient died (reported as "The Gardasil/HPV Vaccine killed my 14 year old son on 14-AUG-2018"). The cause of death was not reported. It was unknown whether medical attention was sought, an autopsy was performed, treatment was provided or lab diagnostics/ studies were performed.  The event death was determined to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller reports patient received his first dose of MMR II in 2020 at 9 years old and his 2nd dose on 12/15/2022.; no adverse event; This spontaneous report has been received from a pharmacist concerning a 9-year-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On unspecified date in 2020, the patient received the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 milliliter, subcutaneously, (Lot # and expiration date were not provided), and on 15-DEC-2022 the patient received a second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 milliliter, subcutaneously, Lot # U039664 (rHA), expiration date on 15-DEC-2023, both doses administered for prophylaxis purposes (inappropriate schedule of vaccine administered). No additional adverse events were reported.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: she has had them take one of the 9 valent at age 17 as a booster; she has had them take one of the 9 valent at age 17 as a booster; No additional AE; This spontaneous report was received from a consumer and referred to a 17-year-old patient of unknown gender (one of twins). The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On an unknown date (at age 11 of patient), when centers for disease control and prevention (CDC) said the patient only needed the two doses' series, the patient received 2 of quadrivalent human papillomavirus (types 6,11,16,18) recombination vaccine (4 valent) (GARDASIL) (strength, dose description, lot#, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date (at age 17), the patient took one of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (9 valent) (GARDASIL 9) (strength, dose description, lot#, expiry date, and route of administration were not provided) for prophylaxis as a booster (Inappropriate schedule of vaccine administered) (Interchange of vaccine products). The reporter provided no further information. There was no additional adverse event.  This is one of two reports received from the same reporter.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: she has had them take one of the 9 valent at age 17 as a booster; she has had them take one of the 9 valent at age 17 as a booster; No additional AE; This spontaneous report was received from a consumer and referred to a 17-year-old patient of unknown gender (one of twins). The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On an unknown date (at age 11 of patient), when disease control said the patient only needed the two doses' series, the patient received 2 of quadrivalent human papillomavirus (types 6,11,16,18) recombination vaccine (4 valent) (GARDASIL) (strength, dose description, lot#, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date (at age 17), the patient took one of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (9 valent) (GARDASIL 9) (strength, dose description, lot#, expiry date, and route of administration were not provided) for prophylaxis as a booster (Interchange of vaccine products) (Inappropriate schedule of vaccine administered). The reporter provided no further information. There was no additional adverse event.  This is one of two reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the patient did not experience any adverse reactions with the doses; the patient received two doses of MMR II too close together; a college aged student (under 19 years old) is receiving catch up vaccinations of MMR II.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age (reported as "collage aged, under 19 years old") and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 11-NOV-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, site, and route of administration were not provided). The second dose was administered on 18-NOV-2022. The patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) too close together (inappropriate schedule of product administration) at collage age (product administered to patient of inappropriate age). The reporter confirmed that the patient did not experience any adverse reactions with the doses (no adverse event). No additional adverse events details or product quality complaints were reported.
Age: 0.17
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/No adverse event has been observed as of yet; a medical assistant at the facility gave a two month old male child a dose of Gardasil 9 in the left leg on 16Dec2022; This spontaneous report was received from a physician and refers to a 2-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-DEC-2022, the patient of 2-month-old was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis, in the left leg (strength, lot number, expiration date, and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; inadvertently administered an expired dose of RECOMBIVAX HB; This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medication were not provided.    On 19-DEC-2022, the patient was inadvertently vaccinated with an expired dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0.5 milliliter, lot # U008328, expiration date 16-DEC-2022, for prophylaxis (route of administration and anatomical vaccination location were not reported) (Expired product administered). It was confirmed that the vaccine did not experience any temperature excursions. No additional adverse events were reported (No adverse event).
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Influenza B virus test positive, Nasal congestion, Nasopharyngitis, Respiratory syncytial virus test positive
Clinical narrative: POSITIVE RESULT OF INFLUENZA B; POSITIVE TEST RESULT OF RSV; COLD SYMPTOMS; COUGH; CONGESTION; GREEN MUCUS; A spontaneous report has been received from a health professional. The report concerns a female patient age (4 years, height 108 cm, weight 22 kg).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number PH3533) (expiration date 27-NOV-2022) once/single administration, via nasal route, on 24-OCT-2022.     A unknown administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On 28-OCT-2022, the patient experienced cold symptoms (preferred term: Nasopharyngitis), cough (preferred term: Cough), congestion (preferred term: Nasal congestion) and green mucus (preferred term: Secretion discharge). On 02-NOV-2022, the patient experienced positive result of influenza b (preferred term: Influenza B virus test positive) and positive test result of rsv (preferred term: Respiratory syncytial virus test positive).     Treatment with Flumist Quadrivalent (influenza vaccine live reassort 4v) was not changed.     The patient recovered from the event(s) of cold symptoms, cough, congestion and green mucus on an unspecified date. The outcome of the event(s) of positive result of influenza b and positive test result of rsv was unknown.     The events were considered non-serious.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Secretion discharge
Clinical narrative: POSITIVE RESULT OF INFLUENZA B; POSITIVE TEST RESULT OF RSV; COLD SYMPTOMS; COUGH; CONGESTION; GREEN MUCUS; A spontaneous report has been received from a health professional. The report concerns a female patient age (4 years, height 108 cm, weight 22 kg).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number PH3533) (expiration date 27-NOV-2022) once/single administration, via nasal route, on 24-OCT-2022.     A unknown administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On 28-OCT-2022, the patient experienced cold symptoms (preferred term: Nasopharyngitis), cough (preferred term: Cough), congestion (preferred term: Nasal congestion) and green mucus (preferred term: Secretion discharge). On 02-NOV-2022, the patient experienced positive result of influenza b (preferred term: Influenza B virus test positive) and positive test result of rsv (preferred term: Respiratory syncytial virus test positive).     Treatment with Flumist Quadrivalent (influenza vaccine live reassort 4v) was not changed.     The patient recovered from the event(s) of cold symptoms, cough, congestion and green mucus on an unspecified date. The outcome of the event(s) of positive result of influenza b and positive test result of rsv was unknown.     The events were considered non-serious.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Jynneos vaccine was administered intradermally instead of subcutaneously; Jynneos was administered intradermally at dose of 0.5 mL instead of 0.1 mL; Case reference number US-BN-2022-004690 is a spontaneous case received from other health professional on 15-Nov-2022 via Communication (reference number: USBAV22-1954) and concerns a *30-year-old* male patient.  The patient's medical history and concomitant medication details were not provided.  On 12-Nov-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, *batch number: FDP00003; expiration date: on unspecified date in May-2023*) at dose of 0.5 ml, administered intradermally (explicitly coded as 'intradermal injection' and 'incorrect dose administered') at *right forearm* for monkeypox prophylaxis.  *It was confirmed that it was unknown if the patient experienced any adverse events.*  The case is linked to US-BN-2022-004689 (same reporter).  Additional information received on 15-Sep-2022 from Bavarian Nordic included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from other health care professional on 02-Dec-2022: included patient details, vaccine details and information that it was unknown if the patient experienced any adverse event.; Reporter's Comments: A 30-year-old male patient received 0.5 mL of Jynneos, applied intradermally for monkeypox prophylaxis, which is considered incorrect dose administered. Intradermal injection and incorrect dose administered are considered listed per company conventions. No associated adverse events were reported. The patient's medical history and concomitant medications were not reported. Intradermal injection and incorrect dose administered are considered not related to Jynneos, but to the human factor.; Sender's Comments: A 30-year-old male patient received 0.5 mL of Jynneos, applied intradermally for monkeypox prophylaxis, which is considered incorrect dose administered. Intradermal injection and incorrect dose administered are considered listed per company conventions. No associated adverse events were reported. The patient's medical history and concomitant medications were not reported. Intradermal injection and incorrect dose administered are considered not related to Jynneos, but to the human factor.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was given IM instead of subcutaneously; Case reference number US-BN-2022-004702 is a spontaneous case report initially received on 16-Nov-2022 from pharmacist via Communication (reference number: USBAV22-1962) and concerns an adult male patient.  The patient's medical history and concomitant medication details were not provided.  On 14-Nov-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016, expiration date 10-Jan-2023), at dose reported as 0,5 mL administered intramuscularly (IM) (explicitly coded as 'inappropriate route of vaccination') at an unknown site, for monkeypox prophylaxis. As reported, Jynneos was given to the patient with a one-inch needle instead of a 5/8 inch, so it was given IM instead of subcutaneously.  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 16-Nov-2022 included local BN case ID.; Reporter's Comments: An adult male patient born in 1977 was vaccinated with the first dose of Jynneos vaccine, at dose reported as 0,5 mL administered intramuscularly (IM), which is considered as inappropriate route of vaccination, at an unknown site, for monkeypox prophylaxis. Reportedly, at the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The event of incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult male patient born in 1977 was vaccinated with the first dose of Jynneos vaccine, at dose reported as 0,5 mL administered intramuscularly (IM), which is considered as inappropriate route of vaccination, at an unknown site, for monkeypox prophylaxis. Reportedly, at the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The event of incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos vaccine was given intramuscularly in the deltoid instead of subcutaneously; Case reference number US-BN-2022-004760 is a spontaneous case report initially received on 29-Nov-2022 from other health professional via Communications (reference number: USBAV22-2015) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at an unknown dose, intramuscularly in the deltoid (explicitly coded as 'inappropriate route of vaccination'), for an unknown indication.  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 29-Nov-2022 included the local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos vaccine at an unknown dose, intramuscularly in the deltoid for an unknown indication, which is considered as inappropriate route of vaccination. No associated adverse events were reported. Inappropriate route of vaccination is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate route of vaccination is not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos vaccine at an unknown dose, intramuscularly in the deltoid for an unknown indication, which is considered as inappropriate route of vaccination. No associated adverse events were reported. Inappropriate route of vaccination is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate route of vaccination is not related to Jynneos, but to a human factor. The case is non-serious.
Age: 17.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The patient received Jynneos intradermally (ID), instead of subcutaneously (SQ); The patient was 17 years old when received Jynneos; Case reference number US-BN-2022-004821 is a spontaneous case report initially received on 02-Dec-2022 from a nurse via Communications (reference number: USBAV22-2050) and concerns a 17-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On *04-Nov-2022*, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, *batch number: FDP00016, expiration date: 19-Dec-2022), at a dose of 0.1 ml*, administered intradermally, *in the left arm*, for prophylaxis (explicitly coded as 'intradermal injection' and 'inappropriate age at vaccine administration').  At the time of this report, *the patient did not experience any adverse event due to Jynneos vaccination.*  Additional information received from Bavarian Nordic on 02-Dec-2022 included the local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a nurse on 06-Dec-2022: New information included vaccine details: batch number, expiration date, anatomical site location, dose for the first Jynneos vaccine and confirmation that the patient did not experience any adverse event.; Reporter's Comments: A 17-year-old male patient was vaccinated with the first dose of Jynneos vaccine at a dose of 0.1 ml, administered intradermally in the left arm, for prophylaxis (considered as intradermal injection and inappropriate age at vaccine administration). Injection and product administered to patient of inappropriate age are both considered listed per company conventions. It was confirmed that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Injection and product administered to patient of inappropriate age are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 17-year-old male patient was vaccinated with the first dose of Jynneos vaccine at a dose of 0.1 ml, administered intradermally in the left arm, for prophylaxis (considered as intradermal injection and inappropriate age at vaccine administration). Injection and product administered to patient of inappropriate age are both considered listed per company conventions. It was confirmed that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Injection and product administered to patient of inappropriate age are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Product administration error
Clinical narrative: The patient was vaccinated with Jynneos on 01-Dec-2022, which an expiration date was on 29-Nov-2022; The patient was vaccinated with Jynneos on 01-Dec-2022, which an expiration date was on 29-Nov-2022; Case reference number US-BN-2022-004840 is a spontaneous case initially received on 05-Dec-2022 from a nurse via Communication (reference number: USBAV22-2061) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medications were not provided.  On 01-Dec-2022, the patient was vaccinated with the expired first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating); batch number: unknown; expiration date: 29-Nov-2022) at an unknown dose, route or site of administration, for unknown indication. (Explicitly coded as 'expired product administered' and 'product administration error').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 06-Dec-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the expired first dose of Jynneos, at an unknown dose, route or site of administration, for unknown indication, which is considered as expired product administered and product administration error. At the time of this report, it was unknown if the patient experienced any adverse event. The events of expired product administered and product administration error are considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Expired product administered and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the expired first dose of Jynneos, at an unknown dose, route or site of administration, for unknown indication, which is considered as expired product administered and product administration error. At the time of this report, it was unknown if the patient experienced any adverse event. The events of expired product administered and product administration error are considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Expired product administered and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site vesicles
Clinical narrative: Bullae and vesicle development, induration, and redness to posterior arm where Jynneos was injected; Bullae and vesicle development, induration, and redness to posterior arm where Jynneos was injected; Bullae and vesicle development, induration, and redness to posterior arm where Jynneos was injected; Case reference number US-BN-2022-004858 is a spontaneous case report initially received from a nurse on 01-Dec-2022 and concerns a patient of unknown demographics.  The patient's relevant medical history and concomitant medication details were not provided.  On 16-Nov-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live modified vaccinia virus ankara; batch number not provided) administered subcutaneously at a dose of 0.5 mL, at an unknown site of administration for an unknown indication.  On an unspecified date, an unknown amount of time after the first dose, the patient developed a significant localized reaction, including bullae and vesicles development, induration and redness to posterior arm where Jynneos was injected.  At the time of this report, the outcome of the events 'blister', 'induration' and 'erythema' was unknown.   The reporter did not provide seriousness or causality assessment.  No further information was provided.; Reporter's Comments: A patient of unknown demographics developed a significant localized reaction including bullae and vesicles development, induration and redness to posterior arm (where Jynneos was injected), within approximately two weeks after vaccination with the first dose of Jynneos. Blister is unlisted and unexpected while injection site induration and injection site erythema are both listed and expected according to RA v1 and RA for Jynneos. The outcome of all reported events was unknown. The patient's relevant medical history and concomitant medication details were not provided. All reported events are assessed as related due to compatible temporal relationship, known product safety profile (for injection site erythema and injection site induration) and since contributory role of the suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A patient of unknown demographics developed a significant localized reaction including bullae and vesicles development, induration and redness to posterior arm (where Jynneos was injected), within approximately two weeks after vaccination with the first dose of Jynneos. Blister is unlisted and unexpected while injection site induration and injection site erythema are both listed and expected according to RA v1 and RA for Jynneos. The outcome of all reported events was unknown. The patient's relevant medical history and concomitant medication details were not provided. All reported events are assessed as related due to compatible temporal relationship, known product safety profile (for injection site erythema and injection site induration) and since contributory role of the suspect product cannot be excluded. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Jynneos was administered around 3.5 hours past it's beyond use date; Case reference number US-BN-2022-004859 is a spontaneous case report initially received on 08-Dec-2022 from a pharmacist via  Communications (reference number: USBAV22-2086) and concerns a patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 01-Dec-2022, at 2:44 PM, the patient was vaccinated with a dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), approximately 3.5 hours past it's beyond use date (01-Dec-2022, 11:15AM), at an unknown dose, administered via an unspecified route of administration, in an unspecified anatomical site location, for smallpox/monkeypox prophylaxis (explicitly coded as 'expired product administered').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 08-Dec-2022 included the local BN case ID.; Reporter's Comments: A patient of unknown age was vaccinated with a dose of Jynneos vaccine for smallpox/monkeypox prophylaxis approximately 3.5 hours past it's beyond use date, which is considered expired product administered. Expired product administered is listed by convention. It is unknown whether the patient experienced any adverse event. Expired product administered is not related to the suspect product, but to a human action. The case is non-serious.; Sender's Comments: A patient of unknown age was vaccinated with a dose of Jynneos vaccine for smallpox/monkeypox prophylaxis approximately 3.5 hours past it's beyond use date, which is considered expired product administered. Expired product administered is listed by convention. It is unknown whether the patient experienced any adverse event. Expired product administered is not related to the suspect product, but to a human action. The case is non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Head injury, Influenza like illness, Syncope
Clinical narrative: fainted; hit head; shivering; flu like symptoms; This case was reported by a consumer via sales rep and described the occurrence of faint in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (on18 October 2019 received 1st dose refer link case US2022AMR189646).   On 13th March 2020, the patient received the 2nd dose of Shingrix. On 14th March 2020, 1 days after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant) and head injury. In March 2020, the patient experienced shivering and influenza-like symptoms. The patient was treated with intravenous fluid (nos) (Iv Fluids (Not Specified)). On an unknown date, the outcome of the faint, head injury, shivering and influenza-like symptoms were unknown.   It was unknown if the reporter considered the faint, head injury, shivering and influenza-like symptoms to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR189646   Additional Information: GSK Receipt Date: 19-DEC-2022 Reporter's Comment: The patient self-reported this case. The reporter reported that after the 2nd dose patient arm was not hurt but, experienced systemic adverse effects of shivering and flu like symptoms, the next morning patient fainted and hit her head. The patient went to a walk-in clinic and received IV (intravenous) liquids. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2022AMR189646:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test negative
Clinical narrative: we just tested negative long bout with COVID; This case was reported by a consumer and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was recovered/resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK receipt date: 12-DEC-2022 Reporters comment: The reporter was the patient, he/she stated that, we juts tested negative after a long bout with covid, yesterday (one day before the day of reporting) was six month after our first injection of shingrix and asked which was  too late Additional Supportive information: This case has been linked to the case US2022AMR186479 reported by the same reporter for other patients.; Sender's Comments:  US-GSK-US2022AMR186479:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: we jut tested negative aftr a long bout with covid; This case was reported by a consumer and described the occurrence of covid-19 in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was recovered/resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK receipt date: 12-DEC-2022 Reporters comment: The reporter reported we just tested negative after a long bout with covid, yesterday (one day before the day of reporting) was six month after our first injection of shingrix and asked was it too late. Additional Supportive information: This case has been linked to the case US2022AMR186444 reported by the same reporter for single patient.; Sender's Comments:  US-GSK-US2022AMR186444:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscles pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 2nd December 2022, the patient received Shingles vaccine. In December 2022, between 1 and 2 weeks after receiving Shingles vaccine, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and now he/she felt muscles pain. The patient asked was that normal. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on my back, elbow and inner thigh; This case was reported by a nurse via sales rep and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced hives. The patient was treated with prednisone, benadryl (nos) (Benadryl) and antipruritics nos (Anti-Itch Cream (Medication Unknown)). On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-DEC-2022 Reporter's Comment: The registered nurse reported that the patient received first dose of Shingrix in early October 2022 and developed hives and stated it was not too bad, some on back, elbow and inner thigh.  The patient went back to the clinic and they gave low dose Prednisone for 5 days and to continue with Benadryl and anti-itch cream. The reporter agrees to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: 1st shot made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (happened around 2017 before covid), blister (had blisters from the right side of back, up neck to around right ear), pruritus (itched) and pain (hurt a little).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient previously had shingles happened around 2017 before covid and she had not gotten the shingles shots yet and reported no, the vaccination or covid had nothing to do with it. The patient reported that like the other lady, her case was rather mild and had blisters from the right side of back, up neck to around right ear. It itched and hurt a little, but nowhere near what these other people were describing. The patient went to the doctor and took her medications later it cleared up. The patient got the first Shingles shot which made her sick. The patient reported that her doctor told her that might just want pass on the second shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 35.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Oral discharge, Tongue discomfort
Clinical narrative: White oral discharge; Burning sensation to tongue; Dizziness turning head; This case was reported by a other health professional via call center representative and described the occurrence of oral discharge in a 35-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX ADULT).   On 6th October 2022, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced oral discharge, burning tongue and dizziness. The patient was treated with nystatin, lidocaine and prednisone. On an unknown date, the outcome of the oral discharge, burning tongue and dizziness were unknown.   It was unknown if the reporter considered the oral discharge, burning tongue and dizziness to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022187385   Additional Information: GSK Receipt Date: 14-DEC-2022 Reporter's Comment: The medical assistant reported that the patient received second dose of Twinrix and at an unknown date after the second dose, the patient developed white oral discharge, a burning sensation to tongue and dizziness when turning head. In November 2022, the physician prescribed Nystatin suspension, Lidocaine and Prednisone and gave instructions to return to doctor's office if symptoms persist. It was unknown if symptoms remain. Nothing else was reported. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2022187385:Same reporter
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received liquid portion only; Received liquid portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA762A, expiry date 30th November 2023) for prophylaxis.   On 12th December 2022, the patient received Menveo. On 12th December 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received the liquid portion only of Menveo without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.5
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 Month old received bexsero; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received Men B NVS (Bexsero) (batch number TP294, expiry date 31st October 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd December 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 12-Dec-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received a dose of Bexsero at an inappropriate age (younger than 10 years), which led to inappropriate age at vaccine administration.