chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Hot flush, Nausea
Clinical narrative: Pt states that about 2 hours after receiving vaccine she started feeling very sick to stomach, nauseated, chills and hot flashes.
Sex: U
Vaccine: HEPA, HEPA, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; Customer called and reported that a consumer received a dose of MMR-II, VARIVAX, and VAQTA on 5/30/2024. The consumer was inadvertently administered all three vaccines again on 6/14/2024. No additional AE reported. No PQC reported. No additional info; This spontaneous report was received from an other health care professional (medical assistant) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 30-MAY-2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # W031980, expiration date: 06-OCT-2024 (exact dose, route of administration and anatomical location were not provided); with the first dose of hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # X025163, expiration date: 12-MAY-2025 (exact dose, route of administration and anatomical location were not provided); and with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX), formulation: injection, lot # X021284, expiration date: 20-AUG-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.   On 14-JUN-2024, the patient was inadvertently administered with the second dose of of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # W031980, expiration date: 06-OCT-2024 (exact dose, route of administration and anatomical location were not provided); with the second dose of hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # X025163, expiration date: 12-MAY-2025 (exact dose, route of administration and anatomical location were not provided); and with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX), formulation: injection, lot # X021284, expiration date: 20-AUG-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (extra dose administered). No additional adverse event reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called for TE for MMR II. Product was administered after being improperly stored.; This spontaneous report was received from a medical assistant (health care professional (HCP)) and refers to a 4-year-old of unknown gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On 24-JUN-2024, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, 0.5 milliliter, lot # reported and confirmed as: X007686, expiration date reported and confirmed as: 14-MAR-2025, administered for prophylaxis (dose number, site and route of administration were not provided) by health professional. Temperature excursion information: above 47 degree Fahrenheit (57.3 degree Fahrenheit) for 5 hours. No adverse effects reported.
Age: 1.58
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report VARIVAX was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from a nurse and refers to a 19-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 07-MAR-2024, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X021930, expiration date: 29-AUG-2025,  (strength, dose#, anatomical site of vaccination and route of administration were not provided) for prophylaxis (Product storage error). No additional adverse event was reported (no adverse event).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: FBE called to report that while at a luncheon today 7/2/2024 a Nurse practitioner reported that a 12 year old female patient received a dose of GARDASIL 9 and within 15 minutes of receiving the vaccine fainted. Nurse practitioner reports that the dos; This spontaneous report was received from a nurse and refers to a 12-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 01-JUL-2024 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1965079 and expiration date 01-FEB-2026, 0.5 milliliter, intramuscularly in the right arm for prophylaxis.  On 01-JUL-2024 (within 15 minutes of receiving the vaccine), the patient fainted. Nurse practitioner reports that the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was the only vaccine given to the patient. Nurse practitioner reported that water was given to the patient and the patient was laid down. The Nurse prescriber was informed by the patient post fainting event that she had not eaten that day and was very nervous prior to receiving the vaccine. The outcome of event was unknown. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event was not provided.   Upon internal review event syncope was considered medically significant.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood HIV RNA, CD4 lymphocytes, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles/patient has had 3 episodes of Herpes Zoster since receipt of vaccine; Drug dose administration interval too long; This serious case was reported by a pharmacist and described the occurrence of vaccination failure in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hiv infection.   In OCT-2020, the patient received the 2nd dose of Shingrix. On 04-FEB-2020, the patient received the 1st dose of Shingrix (unknown arm). In OCT-2020, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/patient has had 3 episodes of Herpes Zoster since receipt of vaccine). The outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-JUN-2024 The pharmacist reported that, the 59 year old male patient with human immunodeficiency virus who received Shingrix in 2020 (first dose in February with CD4 of 363 and second in October with CD4 of 344) which led to drug dose administration interval too long.  As per the pharmacist, the patient had 3 episodes of Herpes Zoster since receipt of vaccine.  On an unknown date of first two episodes but third episode was recent.  The patient had human immunodeficiency virus viral load suppressed for more than 2 years and CD4 at the time of reporting was 396 (previous CD4 322 in December 2023 and 244 in June 2023). This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consented to follow up.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (Dose I and Dose II).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 27-JUN-2024 This case was reported the patient via interactive digital media. The vaccine and booster sometimes do not work.  The reporter was the living proof.  If anybody thought that they had shingles get into your doctor right away, that day was best.  The antiviral and steroids knocked the reporter almost before they got started. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1) and Shingles vaccine (Dose 2).
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; uncomfortable feeling; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and discomfort (Verbatim: uncomfortable feeling). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the discomfort was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles and discomfort to be related to Shingles vaccine.   Additional Information: GSK receipt date: 30-JUN-2024 The case was received from the patient via interactive digital media.  The patient reported he/she got vaccinated but the sad part was you could still get shingles. The patient had them(shingles) two years ago and thought was not going to make it from the pain and pray did not get it again but still the patient had uncomfortable feeling from the first time. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: adult patient received pediatric dose of Engerix-B vaccine; adult patient received pediatric dose of Engerix-B vaccine; adult patient received pediatric dose of Engerix-B vaccine instead of heplisav-B; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult patient received pediatric dose of Engerix-B vaccine), underdose (Verbatim: adult patient received pediatric dose of Engerix-B vaccine) and wrong vaccine administered (Verbatim: adult patient received pediatric dose of Engerix-B vaccine instead of heplisav-B). The outcome of the adult use of a child product, underdose and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-JUN-2024 The reporter reported that the adult patient received pediatric dose of Engerix-B (manufacturer: GSK) vaccine instead of Heplisav-B (manufacturer: Dynavax), which led to adult use of child product, underdose and wrong vaccine administered. No symptoms were reported.
Sex: U
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Pain; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of pain in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced pain (Verbatim: Pain). The outcome of the pain was resolved (duration 3 days).   It was unknown if the reporter considered the pain to be related to Engerix B.     It was unknown if the company considered the pain to be related to Engerix B.   Additional Information: GSK Receipt Date: 27-JUN-2024 Patient complained of being achy for 3 days after vaccines.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product preparation error, Product preparation error
Clinical narrative: pharmacist that got the wrong diluent and mixed the shingrix, we threw them away; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product preparation error (Verbatim: pharmacist that got the wrong diluent and mixed the shingrix, we threw them away). The outcome of the intercepted product preparation error was unknown.   Additional Information: GSK receipt date: 21-JUN-2024 The reporter had a question about shingrix and the arexvy, were the diluents the same.  because they had a pharmacist that got the wrong diluent and mixed the Shingrix, but threw them away because they did not know and then, they retain them and just wanted to verify.  They did not administer the vaccine Shingrix nor Arexvy to any patient, which led to intercepted product preparation error.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 31st October 2023).   On 23-JUN-2024, the patient received the 2nd dose of Twinrix. On 23-JUN-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long 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: 24-JUN-2024 Pharmacist called to report patient received the first dose of Twinrix in 31st October 2023 and then the second dose on 23rd June 2024, which led lengthening of vaccine schedule. Did not consent to follow-up. Suspect Vaccine Start Date:10-31-2023, Call Notes:Follow up asked and declined.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of twinrix in March 2023, and second dose in May 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in March 2023).   In MAY-2024, the patient received the 2nd dose of Twinrix. In MAY-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of twinrix in March 2023, and second dose in May 2024). The outcome of the drug dose administration interval too long 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: 24-JUN-2024 The pharmacist reported that the patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. They had not yet received the third dose. The reporter declined to provide patient information or follow up.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 69 year old male patient was given Infanrix instead of Boostrix inadvertently; 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 69-year-old male patient who received DTPa (Infanrix) for prophylaxis.   On 24-JUN-2024, the patient received Infanrix. On 24-JUN-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 69 year old male patient was given Infanrix instead of Boostrix inadvertently). 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: 24-JUN-2024 69 year old male patient was given Infanrix instead of Boostrix inadvertently, which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Impaired work ability, Myalgia
Clinical narrative: Sleeps all day; Weakness; Fatigue; Muscle pain; Body aches; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleepiness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included addison's disease.   On 25-JUN-2024, the patient received the 1st dose of Shingrix. In JUN-2024, less than a day after receiving Shingrix, the patient experienced sleepiness (Verbatim: Sleeps all day), weakness (Verbatim: Weakness), fatigue (Verbatim: Fatigue), muscle pain (Verbatim: Muscle pain), general body pain (Verbatim: Body aches) and headache (Verbatim: Headache). The outcome of the sleepiness, weakness, fatigue, muscle pain, general body pain and headache were not resolved.   It was unknown if the reporter considered the sleepiness, weakness, fatigue, muscle pain, general body pain and headache to be related to Shingrix.     It was unknown if the company considered the sleepiness, weakness, fatigue, muscle pain, general body pain and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-JUN-2024 The reporter was the wife of the patient. The patient was an adult male. The patient received the first dose of Shingrix day before reporting. The patient was experiencing headache, body aches, muscle pain, fatigue, weakness, sleeps all day. Because of this, the patient did not go to work on day of reporting. The date of birth was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Somnolence
Clinical narrative: Sleeps all day; Weakness; Fatigue; Muscle pain; Body aches; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleepiness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included addison's disease.   On 25-JUN-2024, the patient received the 1st dose of Shingrix. In JUN-2024, less than a day after receiving Shingrix, the patient experienced sleepiness (Verbatim: Sleeps all day), weakness (Verbatim: Weakness), fatigue (Verbatim: Fatigue), muscle pain (Verbatim: Muscle pain), general body pain (Verbatim: Body aches) and headache (Verbatim: Headache). The outcome of the sleepiness, weakness, fatigue, muscle pain, general body pain and headache were not resolved.   It was unknown if the reporter considered the sleepiness, weakness, fatigue, muscle pain, general body pain and headache to be related to Shingrix.     It was unknown if the company considered the sleepiness, weakness, fatigue, muscle pain, general body pain and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-JUN-2024 The reporter was the wife of the patient. The patient was an adult male. The patient received the first dose of Shingrix day before reporting. The patient was experiencing headache, body aches, muscle pain, fatigue, weakness, sleeps all day. Because of this, the patient did not go to work on day of reporting. The date of birth was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not completed at time of reporting; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 5th October 2023 received 1st dose with lot number 7L777 and expiry date 22 Aug 2025).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not completed at time of reporting). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-JUN-2024 A pharmacist reported that potential late dose of Shingrix, he reports that patient received 1st Shingrix dose on 05 October 2023 and was back today for 2nd dose of Shingrix. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.42
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Unapproved age; It was an 18 months old baby and i dont know for what reason but i gave him the wrong, I give him the tdap instead of the dtap; It was an 18 months old baby and i dont know for what reason but i gave him the wrong, I give him the tdap instead of the dtap; 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 18-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   On 24-JUN-2024, the patient received the 1st dose of Boostrix. On 24-JUN-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age), wrong vaccine administered (Verbatim: It was an 18 months old baby and i dont know for what reason but i gave him the wrong, I give him the tdap instead of the dtap) and underdose (Verbatim: It was an 18 months old baby and i dont know for what reason but i gave him the wrong, I give him the tdap instead of the dtap). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUN-2024 and 03-JUL-2024 The medical assistant reported that it was an 18 months old baby and he/she did not know for what reason but he/she gave him the wrong vaccine, he/she give him the tdap instead of the dtap, which led to inappropriate age at vaccine administration, wrong vaccine administered and underdose. The healthcare professional (HCP) was not sure of what dose number was this but she said that it might be the 3rd dose. The medical assistant (MA) provided lot number and with this the vaccine boostrix was confirmed as the product administered to the patient. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Maladministration of Shingrix reconstituted with an Unapproved Diluent; Maladministration of Shingrix reconstituted with an Unapproved Diluent; 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 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 747N3, expiry date 16-JUN-2026) for prophylaxis.   On 24-JUN-2024, the patient received the 1st dose of Shingrix. On 24-JUN-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Maladministration of Shingrix reconstituted with an Unapproved Diluent) and inappropriate dose of vaccine administered (Verbatim: Maladministration of Shingrix reconstituted with an Unapproved Diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-JUN-2024 Registered nurse reported that an adult female patient received Shingrix first dose reconstituted  with sterile water instead of the approval diluent which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. Permission to storage personal information within Medical Information database declined.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Deafness, Dizziness, Hypotension, Loss of consciousness
Clinical narrative: eventually passed out; he could not hear; low blood pressure; lightheadedness; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number KX3LM, expiry date 31-JUL-2025) for prophylaxis.   On 27-JUN-2024, the patient received the 1st dose of Menveo (intramuscular, left deltoid). On 27-JUN-2024, 15 min after receiving Menveo, the patient experienced passed out (Verbatim: eventually passed out) (serious criteria GSK medically significant), no hearing (Verbatim: he could not hear) (serious criteria GSK medically significant), blood pressure decreased (Verbatim: low blood pressure) and light headedness (Verbatim: lightheadedness). On 28-JUN-2024, the outcome of the passed out, no hearing, blood pressure decreased and light headedness were resolved (duration 1 day).   It was unknown if the reporter considered the passed out, no hearing, blood pressure decreased and light headedness to be related to Menveo.   The company considered the passed out to be unrelated to Menveo. The company considered the no hearing to be related to Menveo. It was unknown if the company considered the blood pressure decreased and light headedness to be related to Menveo.   Additional Information: GSK Receipt Date: 28-JUN-2024 The patients mother was the reporter and she reported that her 11 year old son received his Menveo vaccine a day before reporting and within 15 minutes started having reaction to the medication. The mother described son said he could not hear, lightheadedness, low blood pressure and eventually passed out. These adverse events happened at the healthcare professionals (HCP) office where the vaccine was administered. Within 1 hour, the patient was over the reaction and feeling fine. The reporter stated that the patient was completely recovered morning of the day of reporting. No residual effects. The reporter consented to follow up.; Sender's Comments: Loss of consciousness is an unlisted event which is considered unrelated to GSK vaccine Menveo.  Deafness is a listed event which is considered related to GSK Menveo.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Dyspnoea, Rash macular
Clinical narrative: memory loss; shortness of breath; spots in his arms; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory loss), DYSPNOEA (shortness of breath) and RASH MACULAR (spots in his arms) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 032B21A and 03021B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AMNESIA (memory loss), DYSPNOEA (shortness of breath) and RASH MACULAR (spots in his arms). At the time of the report, AMNESIA (memory loss), DYSPNOEA (shortness of breath) and RASH MACULAR (spots in his arms) outcome was unknown.            The concomitant medication was not reported by reporter.   The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-770537 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-770537:Same reporter
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: post-administration, vaccine fluid was leaking out of her arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (post-administration, vaccine fluid was leaking out of her arm) in a 7-year-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU7106D) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine in October 2023. Past adverse reactions to the above products included No adverse effect with COVID-19 Vaccine.    On 01-Jul-2024, the patient received dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) .25 milliliter. On 01-Jul-2024,  after starting mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024), the patient experienced VACCINATION SITE DISCHARGE (post-administration, vaccine fluid was leaking out of her arm). At the time of the report, VACCINATION SITE DISCHARGE (post-administration, vaccine fluid was leaking out of her arm) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was unsure of which vaccine this was in the vaccine series. The concomitant medication was not reported by reporter. Dosage text for suspect drug was reported as unknown. A patient was given a Moderna vaccine and 10-15 seconds post-administration, vaccine fluid was leaking out of her arm. HCP stated that even though the dose 0.25ml, at least 1ml came out of her arm. HCP stated part of her body fluid came out too. The treatment medication was not reported by reporter.
Sex: M
Vaccine: COVID19, HEPA, MEN, MENB
Symptoms: Pain in extremity
Clinical narrative: patient did not have any other side effects besides expected soreness in arms [pain in arm]; Initial information received on 28-Jun-2024 regarding an unsolicited valid non-serious  courtesycase received from a Other Health Care Professional via Moderna.  This case involves male patient of unknown age who did not have any other side effects besides expected soreness in arms [pain in arm] after receiving Meningococcal A-C-Y-W135 (T CONJ) Vaccine [menquadfi] and Meningococcal Vaccine B RFHBP/NADA/NHBA OMV [Bexsero], Elasomeran [Moderna COVID-19 Vaccine], Hepatitis A Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor.  On 03-May-2024, the patient received 1 DF of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (Solution for injection) (lot U7949AA) (expiry date and strength not reported) via intramuscular route in unknown administration site for prophylactic vaccination. On same day, the patient received 1 DF of suspect Moderna COVID-19 Vaccine not produced by Sanofi Pasteur (lot AU5558B) (formulation, expiry date and strength not reported) via intramuscular route in unknown administration site for COVID-19 prophylaxis and the patient received 1 DF of suspect Hepatitis A Vaccine produced by unknown manufacturer (lot X2598) (Formulation, expiry date and strength not reported) via intramuscular route in unknown administration site for prophylactic vaccination and the patient received 1 DF of suspect Hepatitis A Vaccine produced by unknown manufacturer (lot X2598) (formulation, strength and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination.   On 03-May-2024 the patient did not have any other side effects besides expected soreness in arms [pain in arm] (pain in extremity) (Latency: same day).  Reportedly, the Moderna COVID vaccine for 6 months and up, so instead of getting the 0.5mls patient received the 0.25mls of the Moderna COVID-19 (2023-2024) [Wrong vaccine administered] [Vaccine under dose] and patient received other vaccines in the 4 weeks prior to COVID -19 Vaccine.  It was unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported that the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: QUADRACEL, administered to a 4-month-old that was supposed to be for 4-6 years old, with no reported adverse event; Initial information received on 28-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 months old unknown gender patient who was administered Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] that was supposed to be for 4-6 years old, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) and HIB Vaccine (HIB) both for Prophylactic vaccination.  On 26-Jun-2024, the 4 months old patient received 0.5 ml dose 1 of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine (Suspension for injection) that was supposed to be for 4-6 years old, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (lot U76556AA) (expiry date: 08-Mar-2025) (strength: standard) via intramuscular route in Left Quad for Immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: mistakenly gave Fluzone Quadrivalent to a patient who was 2 months old with no reported Adverse event; Initial information received on 28-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2-month-old unknown gender patient whom mistakenly gave influenza quadrival A-B vaccine [Fluzone Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 20V (CRM197) (Prevnar 20); rotavirus vaccine live reassort oral 5V (Rotateq); and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid (Pediarix) for Prophylactic vaccination (immunization).  On 28-Jun-2024, a 0.5 ml Total dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection of lot U8041DA and expiry date: 30-Jun-2024 (frequency: once and strength; standard) via intramuscular route in the left thigh as immunization was mistakenly gave to a patient who was 2 months old with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: YF-VAX was given intramuscularly with no reported Adverse event; Initial information received on 28-Jun-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient with unknown demographics whom yellow fever vaccine - [YF-VAX] was given intramuscularly with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection (strength, expiry date: not reported) of lot UK065AB via intramuscular route in unknown administration site as immunization and reported YF-VAX was given intramuscularly with no reported adverse event (incorrect route of product administration) (latency: on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Swelling face
Clinical narrative: About 2-3 weeks after receiving vaccine, patient experienced swelling on left side of face. Has seen multiple providers regarding it, and is awaiting a neurology consult, One provider suggested it may be Melkersson-Rosenthal syndrome.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the expiration date. Staff reached out to parent and was informed about incident.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Migraine, Nausea, Urticaria
Clinical narrative: MOM CALLED CLINIC ON TUESDAY STATING THAT DAUGHTER HAD LARGE RED WELT ON LEFT ARM ON SATURDAY (DAY AFTER VACCINATION) AND HAD MIGRAINIES AND NAUSEA LASTING THROUGH TUESDAY. ON MONDAY HAD HIVES ON THIGHS. GIVEN 50 MG BENADRYL ON MONDAY. FOLLOW UP PHONE CALL ON FRIDAY, JULY 5 MOM STATED ALL SYMPTOMS RESOLVED AND DAUGHTER BACK TO NORMAL. RED WELT GONE ON ARM.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, Swelling and warmness of the injection site and the surrounding area.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Immunization received on 07/01 caused patient to have swollen and red arm (golf ball size)
Age: 69.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Back pain, Laboratory test, Lower urinary tract symptoms, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called 7/5/24 to inform us of adverse sequalae from vaccinations received on 6/28/24. She experienced extreme swelling of her arm, fever, pain along the entire arm, rash, itchiness that same night in addition to UTI-like symptoms and back pain. She went to see the doctor today, 7/5/24.
Age: 69.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Pruritus, Pyrexia, Rash, Urine analysis
Clinical narrative: Patient called 7/5/24 to inform us of adverse sequalae from vaccinations received on 6/28/24. She experienced extreme swelling of her arm, fever, pain along the entire arm, rash, itchiness that same night in addition to UTI-like symptoms and back pain. She went to see the doctor today, 7/5/24.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia, Rash, Skin burning sensation
Clinical narrative: Rash, non-stop Burning of skin, joint pain, muscle pain - continues for 4 weeks
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Oropharyngeal pain, Pyrexia, Skin burning sensation
Clinical narrative: Rash, non-stop Burning of skin, joint pain, muscle pain - continues for 4 weeks
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test abnormal, Breast pain, Burning sensation, Chills, Dry skin
Clinical narrative: Rash, non-stop Burning of skin, joint pain, muscle pain - continues for 4 weeks
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Inflammatory marker increased, Malaise, Post herpetic neuralgia
Clinical narrative: Rash, non-stop Burning of skin, joint pain, muscle pain - continues for 4 weeks
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Rash, non-stop Burning of skin, joint pain, muscle pain - continues for 4 weeks
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Malignant melanoma, Skin cancer
Clinical narrative: Patient claims vaccine given in patient mole and patient developed melanoma skin cancer - Patient already has Lymphoma
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Consumer calling. Caller stated that she went into her OBGYN's office on 06/18/2024 and was supposed to receive a T-DAP vaccine. Instead, they mistakenly gave her GARDASIL 9. The caller stated that on 06/18/2024, she was 28 weeks and 4 days pregnant; She was 28 weeks and 4 days pregnant.; This spontaneous report was received from a female patient of unknown age concerning to herself. The patient's concurrent conditions included high risk pregnancy due to the umbilical cord was not attached to the placenta properly (which could restrict blood flow and possibly hinder growth of the fetus). Her medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date, the patient became pregnant with last menstrual period (LMP) of approximately 03-DEC-2023. On 18-JUN-2024, the patient was mistakenly vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose #, lot #, expiration date, route of administration, anatomical location not provided); instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (T-DAP) vaccine, which was the one supposed to receive as prophylaxis (wrong product administered) at the Obstetrician-gynecologist (OBGYN) office. The patient was 28 weeks and 4 days pregnant at the time of vaccination (exposure during pregnancy).  The outcome of the pregnancy was pending at the time of report with an estimated date of delivery (EDD) of approximately 08-SEP-2024.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of ROTATEQ expired on 26-MAY-2024 and was administered on 19-JUN-2024; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 19-JUN-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number 1947642 that was verified to be a valid lot number (expiration date reported and validated as 26-MAY-2024) administered as prophylaxis (dose, scheme frequency, route and anatomical location of administration were not provided) (expired product administered). The vaccine had no temperature excursions through date of administration. No additional adverse event (AE) was reported.