chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; ended up getting shingles from the shot twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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) and shingles (Verbatim: ended up getting shingles from the shot twice). The outcome of the vaccination failure and shingles were not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. The company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient got the shot and ended up getting shingles from the shot twice. This case was considered as suspected vaccination failure since the details regarding 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, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received the 2n dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in MAR-2020).   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: Not received the 2n dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: Follow up information received on: 11-DEC-2024 Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was ask should restart the series.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 18-month-old patient received an adult dose; 18-month-old patient received an adult dose; Drug dose administration interval too short; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-month-old male patient who received HAV (Havrix 1440) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   Previously administered products included Havrix (received first dose of Havrix on 11-JUN-2024).   On 02-DEC-2024, the patient received the 2nd dose of Havrix 1440 1 ml. On 02-DEC-2024, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: 18-month-old patient received an adult dose), adult product administered to child (Verbatim: 18-month-old patient received an adult dose) and drug dose administration interval too short (Verbatim: Drug dose administration interval too short). The outcome of the overdose, adult product administered to child and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-DEC-2024  The other health professional reported that the18-month-old patient received an adult dose (1.0 ml) of Havrix which led to overdose and adult product administered to child.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received second dose of Havrix shorter than the recommended interval which led to shortening of vaccination schedule.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness in her arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-OCT-2024, the patient received the 1st dose of Shingrix. On 10-OCT-2024, 4 hrs after receiving Shingrix, the patient experienced pain in arm (Verbatim: soreness in her arm ). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2024157530   Additional Information: GSK Receipt Date: 13-DEC-2024 The patient self-reported this case. The patient received her first Shingrix dose and that after the first dose she experienced soreness in her arm which resolved quickly. This case is linked with US2024157530, reported by same reporter.; Sender's Comments:  US-GSK-US2024157530:Same patient/ Dose 2
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Malaise
Clinical narrative: stiffness in arms and legs; chills; fatigue; Soreness at injection site; Fever of 100.4°F/low grade fever; my body hurts; I feel like I have the flu,; don't fell well; Myalgia; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for tolerance of first dose refer case US2024157532).   On 12-DEC-2024, the patient received the 2nd dose of Shingrix. On 12-DEC-2024, several hours after receiving Shingrix, the patient experienced injection site pain (Verbatim: Soreness at injection site). On 13-DEC-2024, the patient experienced limbs stiffness (Verbatim: stiffness in arms and legs), chills (Verbatim: chills) and fatigue (Verbatim: fatigue). In DEC-2024, the patient experienced fever (Verbatim: Fever of 100.4°F/low grade fever), general body pain (Verbatim: my body hurts), influenza like illness (Verbatim: I feel like I have the flu,), unwell (Verbatim: don't fell well) and myalgia (Verbatim: Myalgia). The patient was treated with paracetamol (Tylenol). The outcome of the injection site pain, general body pain, influenza like illness and unwell were not reported and the outcome of the fever was resolving and the outcome of the myalgia, limbs stiffness, chills and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, fever, general body pain, influenza like illness, unwell, myalgia, limbs stiffness, chills and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, general body pain, influenza like illness, unwell, myalgia, limbs stiffness, chills and fatigue to be related to Shingrix.   Linked case(s) involving the same patient:  US2024157532   Additional Information: GSK Receipt Date: 13-DEC-2024  The patient self-reported this case for herself. The patient took the Shingrix vaccine day before reporting and I'm trying to figure out if this was normal stuff.  The patient had a fever of 100.4 and she was, she took Tylenol at 7 o'clock and she rarely had a fever, her body hurts, she feel like she had the flu, honestly, she just don't feel well. After the second dose, the patient did experience soreness at the injection site which began a few hours after the vaccination.  The patient reported that she awoke with fatigue, stiffness in arms and legs, chills and low-grade fever, even after having taken acetaminophen.; Sender's Comments:  US-GSK-US2024157532:Sae patient/ Dose 1
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Pyrexia
Clinical narrative: stiffness in arms and legs; chills; fatigue; Soreness at injection site; Fever of 100.4°F/low grade fever; my body hurts; I feel like I have the flu,; don't fell well; Myalgia; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for tolerance of first dose refer case US2024157532).   On 12-DEC-2024, the patient received the 2nd dose of Shingrix. On 12-DEC-2024, several hours after receiving Shingrix, the patient experienced injection site pain (Verbatim: Soreness at injection site). On 13-DEC-2024, the patient experienced limbs stiffness (Verbatim: stiffness in arms and legs), chills (Verbatim: chills) and fatigue (Verbatim: fatigue). In DEC-2024, the patient experienced fever (Verbatim: Fever of 100.4°F/low grade fever), general body pain (Verbatim: my body hurts), influenza like illness (Verbatim: I feel like I have the flu,), unwell (Verbatim: don't fell well) and myalgia (Verbatim: Myalgia). The patient was treated with paracetamol (Tylenol). The outcome of the injection site pain, general body pain, influenza like illness and unwell were not reported and the outcome of the fever was resolving and the outcome of the myalgia, limbs stiffness, chills and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, fever, general body pain, influenza like illness, unwell, myalgia, limbs stiffness, chills and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, general body pain, influenza like illness, unwell, myalgia, limbs stiffness, chills and fatigue to be related to Shingrix.   Linked case(s) involving the same patient:  US2024157532   Additional Information: GSK Receipt Date: 13-DEC-2024  The patient self-reported this case for herself. The patient took the Shingrix vaccine day before reporting and I'm trying to figure out if this was normal stuff.  The patient had a fever of 100.4 and she was, she took Tylenol at 7 o'clock and she rarely had a fever, her body hurts, she feel like she had the flu, honestly, she just don't feel well. After the second dose, the patient did experience soreness at the injection site which began a few hours after the vaccination.  The patient reported that she awoke with fatigue, stiffness in arms and legs, chills and low-grade fever, even after having taken acetaminophen.; Sender's Comments:  US-GSK-US2024157532:Sae patient/ Dose 1
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: 6 months old patient received, on 12/12/2024, a Pediarix expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 7592L, expiry date 03-DEC-2024) for prophylaxis.   On 12-DEC-2024, the patient received Pediarix. On 12-DEC-2024, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: 6 months old patient received, on 12/12/2024, a Pediarix expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-DEC-2024 The patient received an expired dose of Pediarix, which led to expired vaccine used.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received Arexvy sometime last year and forgot and received another dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (Patient received first dose of Arexvy in 2023). Concurrent medical conditions included alzheimer's disease.   In NOV-2024, the patient received the 2nd dose of Arexvy. In NOV-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received Arexvy sometime last year and forgot and received another dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date:07-JAN-2025 Reporter stated his 63-year-old father who has Alzheimer's disease received Arexvy sometime last year and forgot and received another dose in November this year. Reporter did not have product lot numbers or any further details. Patient received another dose of Arexvy which led to extra dose administered.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: An adult patient received a pediatric dose of Engerix-B instead of an adult dose of Engerix-B.; underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 65-year-old female patient who received HBV (Engerix B pediatric) (batch number 95D74, expiry date 28-MAR-2025) 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: An adult patient received a pediatric dose of Engerix-B instead of an adult dose of Engerix-B.) and underdose (Verbatim: underdose). The outcome of the adult use of a child product 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: 16-DEC-2024 The medical assistant called to report that an adult patient received a pediatric dose of Engerix-B instead of an adult dose of Engerix-B which led to, adult use of a child product and underdose.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B pediatric dose administered to an Adult; Engerix-B pediatric dose administered to an Adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 55-year-old male patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis.   On 17-DEC-2024, the patient received the 2nd dose of Engerix B pediatric. On 17-DEC-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose administered to an Adult) and underdose (Verbatim: Engerix-B pediatric dose administered to an Adult). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 17-DEC-2024 The nurse reported that the adult patient received Engerix-B second dose pediatric formulation, which led to adult use of a child product and underdose. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on hands; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, 1 week after receiving Shingrix, the patient experienced rash (Verbatim: Rash on hands). The outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-DEC-2024 The patient self-reported this case. The patient received the 1st dose of Shingrix vaccine and a week after getting the 1st dose, he developed a rash on his hands The date of the vaccination and the facility location was not provided and it was unknown in which arm the vaccine was administered.   The patient did not provided lot and expiry date information.
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: they administered a pediatric dose of Havrix to an adult patient; pediatric dose of Havrix to an adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 26-year-old male patient who received HAV (Havrix pediatric) for prophylaxis.   On 13-DEC-2024, the patient received the 1st dose of Havrix pediatric. On 13-DEC-2024, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: they administered a pediatric dose of Havrix to an adult patient) and underdose (Verbatim: pediatric dose of Havrix to an adult patient). The outcome of the adult use of a child product 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: 18-DEC-2024 The pharmacist stated they administered a pediatric dose of Havrix to an adult patient back on 13th December 2024 which led to adult use of a child product and underdose. This was the first Hepatitis A dose that patient received so far. The reporter did not have lot number or expiration date for the vaccine. The vaccine administration facility was the same as primary reporter.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Havrix 1440 adult administered to a 1-year-old; Possible Overdose/Havrix 1440 adult administered to a 1-year-old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HAV (Havrix 1440 adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis.   On 19-DEC-2024, the patient received the 1st dose of Havrix 1440 adult. On 19-DEC-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: Havrix 1440 adult administered to a 1-year-old ) and overdose (Verbatim: Possible Overdose/Havrix 1440 adult administered to a 1-year-old ). The outcome of the adult product administered to child and overdose 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:19-DEC-2025 Reporter stated Havrix was administered to a 1-year-old patient, and it expired on13-DEC-2024.  The lot number provided by the HCP had a different expiration date (11-JUL-2026) when looked it up in the batch number identifier and also identified as an adult dose. The 1 year old patient received Havrix adult vaccine which led adult product administered to child and overdose.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 12-year-old male patient who received HAV (Havrix pediatric) (batch number MZ474, expiry date 24-APR-2026) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix junior).   On 24-DEC-2024, the patient received Havrix pediatric. On 24-DEC-2024, an unknown time after receiving Havrix pediatric, the patient experienced drug dose administration interval too short (Verbatim: Early second dose). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:24-DEC-2024 Nurse reported that a 12-year-old patient received Havrix pediatric early second dose which led to drug dose administration interval too short. The first dose was on November 1st, 2024, and the 2nd dose was on December 24th 2024. HCP was asking if the patient should return on 6 months for the second dose to be valid.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; Itch; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash) and PRURITUS (Itch) in a 60-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for Prophylactic vaccination.    Co-suspect product included non-company product Dupilumab (Dupixent) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis (Rashes with bumpy blisters that pop and scab, face was blood red & dried out from the scalp down. Rash was grown for past 2 years.).   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and Dupilumab (Dupixent) (Subcutaneous use) 300 milligram. On an unknown date, the patient experienced RASH (rash) and PRURITUS (Itch). At the time of the report, RASH (rash) and PRURITUS (Itch) was resolving.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No Concomitant medications provided by the reporter.  It was reported that patient experienced rash and which grew for past 2 years due to Atopic dermatitis. And patient's current condition improved since patient was received Dupixent medication and symptom was not got worse.  Patient asked if Dupixent medication was supposed to recover from symptom. Because patient experienced Rashes with bumpy blisters that pop and scab, face was blood red & dried out from the scalp down.  On an unknown date Patient was received the first dose intake of Dupixent medication and following the first dose intake of Elasomeran (Moderna -Covid-19 Vaccine).   Post Moderna -Covid-19 Vaccine patient experienced symptom of Rash with itches and it hurt the Patient. It was hard to shower for patient.   However, patient's symptom improved since patient was received Dupixent dose regimen. Now for patient there were little dots around the edges instead of solid blood red.  No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: he received a second Moderna covid-19 shot on his left arm on 24FEB2021, and that he is experiencing injection site pain; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (he received a second Moderna covid-19 shot on his left arm on 24FEB2021, and that he is experiencing injection site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (he received a second Moderna covid-19 shot on his left arm on 24FEB2021, and that he is experiencing injection site pain). At the time of the report, VACCINATION SITE PAIN (he received a second Moderna covid-19 shot on his left arm on 24FEB2021, and that he is experiencing injection site pain) had not resolved.            The patient had no medical history, concomitant disease or risk factor. Concomitant medication was not reported. The pain was ongoing, and patient had seen numerous doctors who have all been unable to help him. Patient stated the following, "It hurts me all the time. I'm tired of being in pain all the time and it hurts". It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had covid; had covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose 1, single (Batch/Lot number: unknown) and in 2023 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had covid".  Clinical course: The patient had been inoculated 2 years ago when it first came out and didn't get a reaction or anything. Her doctor said to get the booster this year so that's when the patient made the appointment with (withheld) and got it done on 21Oct2024.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash
Clinical narrative: Allergy; rash; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-017247 (BioNTech).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergy"; RASH (non-serious), outcome "unknown".  Additional information: The patient had experienced some problems in their body after taking Pfizer vaccine, allergy, rash, etc.  BNT162b2 omicron (kp.2) is under agreement with BIONTECH SE.
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Flu shots don't usually work; weaken your immune system; Initial information received on 29-Dec-2024 regarding an unsolicited valid social media serious case received from a Patient.  This case involves Adult male patient who reported flu shots don't usually work and weaken your immune system after receiving Influenza Vaccine.  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 Influenza Vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient reported flu shots don't usually work (vaccination failure) and weaken your immune system (immune system disorder) (unknown latency) following the administration of Influenza Vaccine.   Reportedly, Had the flue three times in life. Flu shots don't usually work. Most times they weaken your immune system.  Seriousness criteria: The event vaccination failure was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments: Sanofi company comment dated 06-Jan-2025: This case involves Adult male patient who reported flu shots don't usually work and weaken your immune system after receiving Influenza Vaccine.The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 9.0
Sex: F
Vaccine: MEN, MMR
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was intended to receive MMR, however, menquadfi was inadvertently used as a diluent with MMR administered to a patient with no reported adverse event; Initial information received on 06-Jan-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 9-year-old female patient who was intended to receive measles vaccine, mumps vaccine, rubella vaccine [MMR], however, meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] was inadvertently used as a diluent with MMR administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Jan-2025, patient was intended to receive MMR not produced by Sanofi Pasteur however, 0.5 ml dose suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection strength: standard of lot U8271AB and expiry date: 31-Jan-2028 via intramuscular route in the right deltoid for immunisation was inadvertently used as a diluent with mmr administered to a patient with no reported adverse event (product preparation error) (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: 1.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 3 doses of the FLUZONE was given to a 1 year old patient, patient received the extra dose 3 months later with no reported adverse event; Initial information received on 07-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 1 years old female patient who received 3 doses of the influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone], patient received the extra dose 3 months later 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 Varicella zoster vaccine (Varicella vaccine); measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation; and Hepatitis a vaccine (Hepatitis A) as all for Immunisation.  On an unknown date in 2024, the patient received an unknown dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2025 and lot U8486AA) and she also received an unknown dose 1 of same vaccine (lot U8486AA) both via unknown route in unknown administration site. On 02-Jan-2025 she also received 0.5 ml of dose 3 of same vaccine (expiry date- 30-JUN-2025 and lot U8486AA) via intramuscular route in the right deltoid as prophylactic vaccination (Immunization), patient received the extra dose 3 months later with no reported adverse event (inappropriate schedule of product administration) (latency- 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: 0.33
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered FLUZONE NP to a 4-month-old child with no reported AE; Initial information received on 07-Jan-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who had inadvertently administered Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 07-Jan-2025, the patient received a unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine  (Suspension for injection) lot UT8485NA, Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in unknown administration site for Immunization and inadvertently administered fluzone np to a 4-month-old child with no reported ae (product administered to patient of inappropriate age) (latency : 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: the last PENTACEL they gave, only the DTaP-IPV was administered and the ACTHIB component was not reconstituted with no reported AE; Initial information received on 07-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 4 months old female patient to whom the last Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel(VERO)] they gave, only the dtap-ipv was administered and the acthib component was not reconstituted with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus vaccine (Rotavirus vaccine)and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation.  On 07-Jan-2024, the patient to whom last Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Strength = standard) 1x(once) 0.5 ml Suspension for injection lot UK044AA expiry-31-Aug-2025 via intramuscular route in the left vastus lateralis for immunization only the dtap-ipv was administered and the acthib component was not reconstituted with no reported ae (single component of a two-component product administered) (latency 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: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FBE called reporting a child under the age of 12 months given VAQTA and given the 2nd dose too early (before 6 months from the 1st dose).  FBE did not have patient information at the time of the call. Consent to contact is yes. No adverse side effect; FBE called reporting a child under the age of 12 months given VAQTA and given the 2nd dose too early (before 6 months from the 1st dose).  FBE did not have patient information at the time of the call. Consent to contact is yes. No adverse side effect; No adverse event; This spontaneous report was received from physician via a company representative, concerning a child under the age of 12 year old of unknown gender.  The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the reporter called reporting a child under the age of 12 months (Inappropriate age at vaccine administration) given hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1st dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). and given the 2nd dose too early (before 6 months from the 1st dose) (Inappropriate schedule of product administration). The reporter did not have patient information at the time of the call.  No adverse side effects were reported.  No additional information available at this time.
Sex: U
Vaccine: MMRV
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: Caller has not reported any symptoms. No additional AE/PQC report; Nurse calling to report patient only received half a dose PROQUAD due to syringe improperly attached.; Nurse calling to report patient only received half a dose PROQUAD due to syringe improperly attached. Caller confirmed syringe attachment was due to user error and no PQC was reported.; This spontaneous report has been received from a nurse, regarding a patient of unspecified age and gender.  The patient's pertinent medical history, concurrent conditions, drug allergies or concomitant medications were not reported.  On 08-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, lot number Y015991, expiration date: 23-MAR-2026, administered for prophylaxis (dose, vaccination scheme, frequency, route of administration, and anatomical site of injection were not provided).  On that date, the patient experienced only received half a dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (accidental underdose) due to syringe improperly attached. The reporter confirmed syringe attachment was due to user error (device use issue). There was not reported symptoms, adverse events or product quality complaints reported (no adverse event).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got COVID after receiving the COVID vaccine; Got COVID after receiving the COVID vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2025, outcome "unknown" and all described as "Got COVID after receiving the COVID vaccine". The clinical course was reported as follows: The patient indicated she just got vaccinated this past fall and confirmed receiving the Pfizer COVID vaccine. She also mentioned that on 30Nov2024 she and her sister got exposed to COVID. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2025) Positive.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pruritus
Clinical narrative: Muscle pain and itching in right arm and shoulder; Muscle pain and itching in right arm and shoulder; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Nov2024 at 10:01 as dose 1, 0.3 ml single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), PRURITUS (non-serious), outcome "not recovered" and all described as "Muscle pain and itching in right arm and shoulder".  Additional information: Muscle pain and itching in right arm and shoulder that will not go away
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident, Hemiplegia, Physiotherapy, Speech-language therapy, Thrombosis
Clinical narrative: Stroke; Blood clot developed in the back of my head; Cannot use my left side; I have to go to speech therapy; I am in physical therapy; This spontaneous case, initially received on 24-Dec-2024, was reported by a non-health professional and concerns an adult female patient. Height: 155 cm, Weight: 188.5 lb  At the time of the event the patient had Diabetes. Concomitant medication: unspecified diabetes medication, unspecified heart medication and 12 unspecified medicines.  Administration of company suspect drug(s): On 06-Nov-2024, the patient received Flucelvax (TIV) for an unknown indication., Dose regimen: not reported, Route of administration: not reported, Site of administration: not reported, Lot number: No batch number available and will be requested upon follow-up  Non-company suspect drugs: On 06-Nov-2024, the patient received COVID-19 vaccine (COVID-19 vaccine) for an indication not reported, Dose regimen: not reported, Route of administration: not reported, Site of administration: right arm, Lot number: Not reported.  Adverse reactions/events and outcomes: On 22-Nov-2024, the patient experienced Stroke (Medically Significant, outcome: Unknown), Blood clot developed in the back of my head (Medically Significant, outcome: Unknown), Cannot use my left side (Medically Significant, outcome: Unknown), I have to go to speech therapy  (outcome: Unknown), I am in physical therapy. (outcome: Unknown),   Consumer stated, she had a blood clot developed in the backed of her head, then she had the stroke two weeks after she had the vaccine. Consumer stated, she had never had the pfizer vaccine. When requested for former probing, consumer stated, she had it. That was the paperwork that she had, but she just needed to know what that adverse event was. She was not sure what that was, but she still answered the questions. When probed if the vaccination card was handy, consumer stated, they did not gave a vaccination card. Date of vaccination: 06-Nov-2024, Site of administration: right arm, shoulder. Route of administration: intramuscular 4 weeks prior vaccination. The patient took the flu shot on the same day, name of the flu shot: flucelvax 0. 5 milligram  Flucelvax (TIV) action taken: Not Applicable  Reporter Assessment: The reporter did not provide the seriousness and causality assessment for the events.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association could not be completely ruled out in view of insufficient information, hence causality assessed as related. Of note covid-19 vaccine can be considered as confounder.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: no symptoms per son today 1/9/25
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient made appointment online for RSV vaccine. No history of RSV vaccination in registry and no issues billing through insurance. Patient said he did not get it yet. PharmD administered Arexvy to patient on 01/06/2025. Clinical Service department contacted pharmacy about possible duplicate claim / issue. After further investigation, it was realized the patient did receive Arexvy back on 10/20/2023 at a different location, but it was far back in pharmacy records and was not entered on registry. PharmD left message for patient requesting return call. On 01/08/2025, PharmD contacted original pharmacy (other Pharmacy location) to please update record for patient regarding this vaccine, which has been completed. Patient and PharmD spoke on 01/09/2025 at 05:04 pm for about 15 minutes. PharmD explained the situation to patient, reviewed information needed to complete VAERS form and discussed how the patient is feeling and any side effects he already experienced. Pharmacist counseled patient on what to expect, common side effects, possible adverse reactions, and reviewed possible risks and outcomes of the additional vaccination.  Patient stated he had some soreness around injection site for one to two days after administration but took no additional medication or other interventions; he has experienced the same aftereffects following prior vaccines and does not consider it an adverse event. He stated he "experienced no adverse events and feels fine." PharmD also counseled patient on new documentation / warning regarding Guillain-Barre syndrome seen in post-marketing data and what signs and symptoms to monitor for. He appreciated the information but is not concerned further. Over the phone, patient verbalized understanding of the situation, answered questions easily, and said he would contact pharmacy with any further questions.
Age: 20.0
Sex: M
Vaccine: COVID19, HPV9, MNQ, VARCEL
Symptoms: No adverse event
Clinical narrative: Patient arrived for his 2nd dose of the HPV vaccine on 1/7/25. He notified me when reviewing the vaccine administration record consent and screener that after his last visit on 11/26/24, he developed hives on his right thigh and lower leg about 24 hours after receiving vaccines. He took a zyrtec and the hives resolved. On 11/26/24, Patient received the HPV vaccine (Gardasil), Meningococcal ACWY (Menquadfi), Varicella (Varivax), and 2024-2025 Novavax COVID-19 vaccine. Upon further review of the vaccines administered on 11/26/24, it appears that the reaction is likely due to the Novavax vaccine as that is the only vaccine listing hives as a known side effect during clinical trials. I discussed the risk and benefit of administering the 2nd dose of HPV vaccine during the visit and he was agreeable based on the information provided. I ensured he had an antihistamine available at home to take if he has another reaction and educated him on signs of an allergic reaction and when to seek medical care. He verbalized understanding. After the administration of the HPV dose, there were no side effects observed during the 15 minute wait post-vaccination.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Facial paralysis, Seizure
Clinical narrative: At approximately 2:30 AM, the patient began having symptoms of possible stroke.  She had drooping of the face and then some mild seizures as well.  Her daughter was taking her to the hospital today.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a second dose of RSV vaccine 369 days after an initial dose (1st dose - Abrysvo on 1/5/24, 2nd dose - Arexvy on 1/8/25).  The patient has not reported any side effects at this time.
Age: 65.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient received a vaccine in her left upper arm last week.  About 3 to 4 days later it began to get red and painful.  The redness is spreading up up and down her arm.  She denies fevers, sweats or chills.  There is some pain in the area.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There is no adverse event. Patient had already received this vaccine on 10/7/23. She requested another not remembering getting the first one.
Age: 1.67
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Administered ActHiB to Right Vastus Lateralis. No symptoms/adverse reactions occurred while in office and at home. Mother notified immediately.