chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number NG9E2, expiry date 30-JUN-2024) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 333BM, expiry date 17-AUG-2026) for prophylaxis.   On 18-OCT-2024, the patient received Menveo and Boostrix. On an unknown date, an unknown time after receiving Menveo and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug 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: 21-OCT-2024 The reporter stated that their fridge had a temperature excursion, so just called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered which led to incorrect storage of drug. The Healthcare professional mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix. Healthcare professional reported to administer this vaccines to 13 different patients. The Healthcare professional mentioned that all of this patients received the vaccines on 18th October 2024. This was 1 of the 13 cases, reported by the same reporter.
Sex: U
Vaccine: COVID19, FLU3, RSV, COVID19, FLU3, RSV
Symptoms: Erythema, Injection site rash, Rash erythematous
Clinical narrative: Injection site rash; Rash erythematous; Erythema; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site rash in a 80-year-old patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2FP37) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) (batch number U8429CA) for prophylaxis and COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) (batch number 6024MF013) for prophylaxis.   On 16-SEP-2024, the patient received Arexvy (intramuscular), FLUZONE HIGH DOSE (intramuscular) and Novavax COVID-19 Vaccine (intramuscular). On 17-SEP-2024, 1 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Injection site rash), red rash (Verbatim: Rash erythematous) and erythema (Verbatim: Erythema). The outcome of the injection site rash, red rash and erythema were not resolved.   The reporter considered the injection site rash, red rash and erythema to be possibly related to Arexvy.     The company considered the injection site rash, red rash and erythema to be possibly related to Arexvy.   Additional Information: GSK Receipt Date:22-OCT-2024 The consumer via Centers for Disease Control and Prevention (CDC Wonder) via Vaccine Adverse Event Reporting System (VAERS ID: 2791813-1) reported that the patient experienced erythema, injection site rash and rash erythematous on 17th September 2024 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula), Fluzone high dose and Arexvy on Day 1.  At the time of the report, the outcome of the erythema, vaccination site rash, rash erythematous was not recovered or not resolved or ongoing.  The patient came back into pharmacy on 19th September 2024 and said he noticed on 17th September 2024 (day after vaccine administration) a rash (red, non-itchy, no bumps) area on  each arm where the vaccines were administered.  The patient said he did not took or apply anything to the affected areas on arm as a treatment He noticed a red area on his chest on 19th September 2024 thinking it looked similar to the red areas on his arms. The patient was still non itchy, no bumps and not warm to the touch)   The events erythema, vaccination site rash and rash erythematous were reported as non-serious Based on the spontaneous nature of the report, the causal relationship between the events erythema, vaccination site rash and rash erythematous were possible. The reporter considered the injection site rash, red rash and erythema to be possibly related to Novavax Covid-19 vaccine and Fluzone high dose.
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: she had terrible aches all over from head to toe and she had pains and aches; bad chills and patient reports she was shivering; she was shaking; she experienced a cold sweat; The patient reports she was vomiting; she was sick; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L7Y3G, expiry date 13-OCT-2025) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 5th November 2019, batch number: 9X374 and expiry date:10th October 2021), Shingrix with an associated reaction of pain (received 1st dose on 24th February 2020, batch number: LD3N8) and Flu Vaccine High Dose with an associated reaction of injection site pain (tiny sore spot at the injection after Flu vaccine High Dose on 27-SEP-2024).   On 25-OCT-2024 11:00, the patient received Arexvy (left arm). In OCT-2024, an unknown time after receiving Arexvy, the patient experienced general body pain (Verbatim: she had terrible aches all over from head to toe and she had pains and aches), chills (Verbatim: bad chills and patient reports she was shivering), tremor (Verbatim: she was shaking), cold sweat (Verbatim: she experienced a cold sweat), vomiting (Verbatim: The patient reports she was vomiting), sickness (Verbatim: she was sick) and headache (Verbatim: Headache). The patient was treated with paracetamol (Tylenol). In OCT-2024, the outcome of the general body pain, chills, tremor, cold sweat, vomiting, sickness and headache were resolved (duration 36 hrs).   It was unknown if the reporter considered the general body pain, chills, tremor, cold sweat, vomiting, sickness and headache to be related to Arexvy.     It was unknown if the company considered the general body pain, chills, tremor, cold sweat, vomiting, sickness and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2024 The patient was healthy who reported that she received the Arexvy vaccine last week in her left arm and had a really terrible reaction to it.  The patient reported that she had terrible aches all over from head to toe. The patient reported that she had pains, really bad chills, shivering, shaking, cold sweat, vomiting. The patient reported that she was on the floor of her bathroom for 12 hours. The patient reported that she was sick from all of these side effects for 36 hours. The patient reported that she took 2 Tylenol (unknown product information) as soon as she got home after receiving Arexvy, and it did not help.  The patient did not provide the route of administration for Arexvy but, did state a pharmacist, at a pharmacy (unknown information) administered the vaccine. This was 1 of 3 linked cases, reported by the same reporter.
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Chills, Cold sweat, Coronary artery bypass, Headache, Malaise
Clinical narrative: she had terrible aches all over from head to toe and she had pains and aches; bad chills and patient reports she was shivering; she was shaking; she experienced a cold sweat; The patient reports she was vomiting; she was sick; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L7Y3G, expiry date 13-OCT-2025) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 5th November 2019, batch number: 9X374 and expiry date:10th October 2021), Shingrix with an associated reaction of pain (received 1st dose on 24th February 2020, batch number: LD3N8) and Flu Vaccine High Dose with an associated reaction of injection site pain (tiny sore spot at the injection after Flu vaccine High Dose on 27-SEP-2024).   On 25-OCT-2024 11:00, the patient received Arexvy (left arm). In OCT-2024, an unknown time after receiving Arexvy, the patient experienced general body pain (Verbatim: she had terrible aches all over from head to toe and she had pains and aches), chills (Verbatim: bad chills and patient reports she was shivering), tremor (Verbatim: she was shaking), cold sweat (Verbatim: she experienced a cold sweat), vomiting (Verbatim: The patient reports she was vomiting), sickness (Verbatim: she was sick) and headache (Verbatim: Headache). The patient was treated with paracetamol (Tylenol). In OCT-2024, the outcome of the general body pain, chills, tremor, cold sweat, vomiting, sickness and headache were resolved (duration 36 hrs).   It was unknown if the reporter considered the general body pain, chills, tremor, cold sweat, vomiting, sickness and headache to be related to Arexvy.     It was unknown if the company considered the general body pain, chills, tremor, cold sweat, vomiting, sickness and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2024 The patient was healthy who reported that she received the Arexvy vaccine last week in her left arm and had a really terrible reaction to it.  The patient reported that she had terrible aches all over from head to toe. The patient reported that she had pains, really bad chills, shivering, shaking, cold sweat, vomiting. The patient reported that she was on the floor of her bathroom for 12 hours. The patient reported that she was sick from all of these side effects for 36 hours. The patient reported that she took 2 Tylenol (unknown product information) as soon as she got home after receiving Arexvy, and it did not help.  The patient did not provide the route of administration for Arexvy but, did state a pharmacist, at a pharmacy (unknown information) administered the vaccine. This was 1 of 3 linked cases, reported by the same reporter.
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pain, Vomiting
Clinical narrative: she had terrible aches all over from head to toe and she had pains and aches; bad chills and patient reports she was shivering; she was shaking; she experienced a cold sweat; The patient reports she was vomiting; she was sick; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L7Y3G, expiry date 13-OCT-2025) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 5th November 2019, batch number: 9X374 and expiry date:10th October 2021), Shingrix with an associated reaction of pain (received 1st dose on 24th February 2020, batch number: LD3N8) and Flu Vaccine High Dose with an associated reaction of injection site pain (tiny sore spot at the injection after Flu vaccine High Dose on 27-SEP-2024).   On 25-OCT-2024 11:00, the patient received Arexvy (left arm). In OCT-2024, an unknown time after receiving Arexvy, the patient experienced general body pain (Verbatim: she had terrible aches all over from head to toe and she had pains and aches), chills (Verbatim: bad chills and patient reports she was shivering), tremor (Verbatim: she was shaking), cold sweat (Verbatim: she experienced a cold sweat), vomiting (Verbatim: The patient reports she was vomiting), sickness (Verbatim: she was sick) and headache (Verbatim: Headache). The patient was treated with paracetamol (Tylenol). In OCT-2024, the outcome of the general body pain, chills, tremor, cold sweat, vomiting, sickness and headache were resolved (duration 36 hrs).   It was unknown if the reporter considered the general body pain, chills, tremor, cold sweat, vomiting, sickness and headache to be related to Arexvy.     It was unknown if the company considered the general body pain, chills, tremor, cold sweat, vomiting, sickness and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2024 The patient was healthy who reported that she received the Arexvy vaccine last week in her left arm and had a really terrible reaction to it.  The patient reported that she had terrible aches all over from head to toe. The patient reported that she had pains, really bad chills, shivering, shaking, cold sweat, vomiting. The patient reported that she was on the floor of her bathroom for 12 hours. The patient reported that she was sick from all of these side effects for 36 hours. The patient reported that she took 2 Tylenol (unknown product information) as soon as she got home after receiving Arexvy, and it did not help.  The patient did not provide the route of administration for Arexvy but, did state a pharmacist, at a pharmacy (unknown information) administered the vaccine. This was 1 of 3 linked cases, reported by the same reporter.
Age: 16.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given by MA after exp date 10/7/24, given 10/9/24
Age: 16.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: Vaccine was given by MA after exp date 10/7/24, given 10/9/24
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE.; HCP reported that a dose of PROQUAD was inadvertently administered to a 16 year old patient and a 17 year old patient on 11/08/2024. No additional details were provided. Patient demographic information was not provided. Permission given to contact HC; This spontaneous report was received from a medical assistant and refers to a 16-year-old patient of unknown gender and a 17-year-old patient (captured in MARRS case #2411USA006007).The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 08-NOV-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, valid lot #Y008786, expiration date reported and confirmed as 30-OCT-2025, administered for prophylaxis by a health care professional (strength, dose, route of administration, and anatomical location were not provided) (product administered to patient of inappropriate age). No additional adverse events reported (no adverse event).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2411USA006007:
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE.; HCP reported that a dose of PROQUAD was inadvertently administered to a 16 year old patient and a 17 year old patient on 11/08/2024. No additional details were provided. Patient demographic information was not provided. Permission given to contact HC; This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender and a 16-year-old patient (captured in MARRS case # 2411USA005995). The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 08-NOV-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, valid lot #Y008786, expiration date reported and confirmed as 30-OCT-2025, administered for prophylaxis by a health care professional (strength, dose, route of administration, and anatomical location were not provided) (product administered to patient of inappropriate age). No additional adverse events reported (no adverse event).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2411USA005995:
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: swollen glands; This spontaneous report has been received from a female patient of unknown age, referring to herself. Information regarding the patient's current conditions, previous drug reactions or allergies and concomitant medications was not provided.  The patient was tested for Measles, Mumps, and Rubella (MMR) titers; however, she came back as the result showed low to no titers for measles. Therefore, on approximately 24-OCT-2024 (also reported as three weeks ago), the patient was vaccinated with a booster of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, indication reported as vaccination (dose, route of administration, anatomical location, lot number and expiration date were not provided).  In 2024, the patient experienced swollen glands (lymphadenopathy). Additionally, she performed Human Immunodeficiency Virus (HIV) testing annually, however, the result was not provided.  The outcome of the event was not provided.  The causality assessment between lymphadenopathy and the suspect vaccine was not provided.  Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient has experienced no symptoms. No additional AE/PQC reported; Pharmacist calling to report inadvertently administering an expired dose of PNEUMOVAX 23 to a patient.; This spontaneous report was received from a pharmacist regarding to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 15-NOV-2024, the patient was inadvertently administering an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) lot number W027449 (lot number W027449 had been verified to be valid lot number for pneumococcal 23v polysaccharide vaccine), expiration date reported as 25-SEP-2024 (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis (expired product administered).   Patient had experienced no symptoms. Product did not have any temperature excursions and was not supported per post-expiry memo. Permission to contact HCP was granted. No additional information provided. No additional AE/PQC reported.
Sex: U
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm; Initial information received on 04-Nov-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-healthcare professional.  This case involves an unknown age and gender patient who experienced slightly sore arm after receiving diphtheria, tetanus and acellular pertussis vaccine.  The patient's past vaccination(s) included BNT162B2, Influenza vaccine, pneumonia vaccine and Abrysvo all in 2024 in same arm. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date in Oct-2024, the patient received an unknown dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for Immunisation.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.  On an unknown date in Oct-2024, the patient had slightly sore arm (pain in extremity) (unknown latency).  Reportedly, the patient's arm wasn't even sore with all the previous vaccines.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: heavy night sweats; feeling of fever; chills; occasional headaches; joint aches; full body muscle and joint aches; Initial information received on 04-Nov-2024 regarding an unsolicited valid  non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who had heavy night sweats, feeling of fever, chills, occasional headaches, joint aches and full body muscle and joint aches after receiving  Elasomeran (Spikevax) and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication and medical histpry information were reported.   On an unknown date in October 2024, the patient received 1 DF (dose form) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe lot U85078A via unknown route in unknown administration site for product use for unknown indication (strength, expiry date unknown). On 24-Oct-2024, the patient received 0.5 ml of suspect Spikevax not produced by Sanofi Pasteur lot 3043822 via intramuscular route in unknown administration site for COVID-19 vaccination (COVID-19 immunisation) (strength, for, expiry date unknown).  On 24-OCT-2024 the patient had heavy night sweats (night sweats), feeling of fever (pyrexia), chills, occasional headaches (headache), joint aches (arthralgia) and full body muscle and joint aches (myalgia) (unknown latency).  Relevant laboratory test results included: Body temperature -Oct-2024:  [96.0 -98.6] Fahrenheit  Action taken: not applicable.  No treatment information was reported  At time of reporting, the outcome was Unknown for the events
Sex: U
Vaccine: COVID19, FLU3
Symptoms: Night sweats, Pyrexia
Clinical narrative: heavy night sweats; feeling of fever; chills; occasional headaches; joint aches; full body muscle and joint aches; Initial information received on 04-Nov-2024 regarding an unsolicited valid  non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who had heavy night sweats, feeling of fever, chills, occasional headaches, joint aches and full body muscle and joint aches after receiving  Elasomeran (Spikevax) and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication and medical histpry information were reported.   On an unknown date in October 2024, the patient received 1 DF (dose form) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe lot U85078A via unknown route in unknown administration site for product use for unknown indication (strength, expiry date unknown). On 24-Oct-2024, the patient received 0.5 ml of suspect Spikevax not produced by Sanofi Pasteur lot 3043822 via intramuscular route in unknown administration site for COVID-19 vaccination (COVID-19 immunisation) (strength, for, expiry date unknown).  On 24-OCT-2024 the patient had heavy night sweats (night sweats), feeling of fever (pyrexia), chills, occasional headaches (headache), joint aches (arthralgia) and full body muscle and joint aches (myalgia) (unknown latency).  Relevant laboratory test results included: Body temperature -Oct-2024:  [96.0 -98.6] Fahrenheit  Action taken: not applicable.  No treatment information was reported  At time of reporting, the outcome was Unknown for the events
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received Fluzone post excusrion with no adverse event; the refrigerator and left the door open for too long.Max/low temperature reached: 1.7CDuration: 170 minutes, with no reported adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Punctured influenza USP TRIVAL A-B subvirion vaccine [Fluzone] exposed to temperature excursion due to the refrigerator and left the door open for too long. max/low temperature reached: 1.7c duration: 170 minutes, and a 14 years old female patient received after the excursion 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 Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for; and Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) both for Immunisation.  On 09-Oct-2024 Punctured influenza USP TRIVAL A-B subvirion vaccine [Fluzone] exposed to temperature excursion due to the refrigerator and left the door open for too long. max/low temperature reached: 1.7c duration: 170 minutes with no reported adverse event (product storage error).   On 25-Oct-2024, the patient received 0.5 ml of Punctured influenza USP TRIVAL A-B subvirion vaccine Suspension for injection (strength- standard, lot UA435AA and expiry date- 30-Jun-2025) once via intramuscular route in the right deltoid for Influenza after the excursion with no reported adverse event (poor quality product administered) (latency- same day). Human error was involved.  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.; Sender's Comments:  02295215: 02295215: 02295353: 02295354: 022953555: 02295360: 02295361: 02295362: US-SA-2024SA327135:
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: Patient got exposed to some on his leg a little bit with no reported adverse event; Patient got exposed to some on his leg a little bit with no reported adverse event; Initial information received on 08-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient who got exposed to some influenza USP trival A-B subvirion no preservative vaccine [Fluzone] on his leg a little bit with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Nov-2024, the patient got exposed to some influenza USP trival A-B subvirion no preservative vaccine, Suspension for injection (strength and dose not reported) (lot UT8423JA; Expiration date: 30-JUN-2025) via intramuscular route in the right thigh for Immunization on his leg a little bit with no reported adverse event (exposure via skin contact) (accidental exposure to product) (latency same day).  Reporter states that when she went to push on the plunger, the liquid was leaking everywhere and the patient was unable to receive the shot. They said that, it was during vaccination with a 3 year old pediatric patient. She is not sure if it is the needle or the prefilled syringe malfunction but when she push on the plunger, it was shooting out of the syringe not going into the vastus lateralis of the patient it was spilling out of the syringe onto the table paper. Patient got exposed to some on his leg a little bit. The physician told the lead medical assistant to get the patient revaccinate with a different FLUZONE.  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: 17.0
Sex: M
Vaccine: MEN, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Menquadfi was given to a patient instead of Bexsero to complete the patient's MenB vaccination series (with no reported adverse event); Initial information received on 06-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17-year-old male patient whom meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was given to a patient instead of meningococcal vaccine B rfHbp/NadA/NHBA OMV [Bexsero] to complete the patient's menb vaccination series (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 Influenza vaccine (Fluzone) for prophylactic vaccination (Immunisation).  On 05-Nov-2024, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection frequency: once and strength: standard of lot U8113CB and expiry date: 30-Jun-2025 via intramuscular route in the left arm for immunization  patient instead of Bexsero not produced by Sanofi Pasteur to complete the patient's menb vaccination series (with no reported adverse event) (wrong product administered) (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: 6.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patients received FLUZONE T after the excursion with no reported adverse event; Max/low temperature reached: 1.7CDuration: 170 minutes with no reported adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases- 2024SA327426 and 2024SA327135.  This case involves a 6 years old female patient who received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] after the excursion and max/low temperature reached: 1.7cduration: 170 minutes 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 Hepatitis a vaccine (Hepatitis A); Immunoglobulin antihepatitis b (Hepatitis b); Varicella zoster vaccine (Varicella vaccine); and Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for Immunisation.   On 09-OCT-2024 max/low temperature reached: 1.7cduration: 170 minutes with no reported adverse event (product storage error).  On 28-Oct-2024, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE  0.5 ml 1x (once) Suspension for injection lot UA435AA expiry-30-Jun-2025 via intramuscular route in the left deltoid for influenza Immunisation (strength standard) after the excursion with no reported adverse event (poor quality product administered) (latency same day).  Cause: The exact reason is unknown to the reporter; states that it may have been because they were in and out of the refrigerator and left the door open for too long, human error   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.; Sender's Comments:  US-SA-2024SA327135: US-SA-2024SA327426:
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patients received FLUZONE T after the excursion with no reported adverse event; Max/low temperature reached: 1.7CDuration: 170 minutes with no reported adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases- 2024SA327658, 2024SA327025, 2024SA329148, 2024SA327426, 2024SA329242, 2024SA327349 and 2024SA327135.  This case involves a 8 years old male patient who received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] after the excursion and max/low temperature reached: 1.7cduration: 170 minutes with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-OCT-2024 max/low temperature reached: 1.7cduration: 170 minutes with no reported adverse event (product storage error).  On 24-Oct-2024, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE  0.5 ml 1x (once) Suspension for injection lot UA435AA expiry-30-Jun-2025 via intramuscular route in the left deltoid for influenza Immunisation (strength standard) after the excursion with no reported adverse event (poor quality product administered) (latency same day).  Cause: The exact reason is unknown to the reporter; states that it may have been because they were in and out of the refrigerator and left the door open for too long, human error   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.; Sender's Comments:  US-SA-2024SA327349: US-SA-2024SA327658: US-SA-2024SA327025: US-SA-2024SA329148: US-SA-2024SA329242: US-SA-2024SA327135:
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: administering a dose of ACT-HIB that was reconstituted with sterile water instead of the 0.4 % Sodium Chloride; administering a dose of ACT-HIB that was reconstituted with sterile water instead of the 0.4 % Sodium Chloride; Initial information received on 06-Nov-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case was linked to other case US-SA-2024SA331847.   This case involves an unknown age and unknown gender patient who received a dose of HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with sterile water instead of the 0.4 % sodium chloride vaccine.   The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date the patient developed a non-serious administering unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization that was reconstituted with sterile water instead of the 0.4 % sodium chloride (product preparation error) (latency same day) following the administration of HIB (PRP/T) vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.    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.; Sender's Comments:  US-SA-2024SA331847:02296620
Age: 72.0
Sex: M
Vaccine: PPV, RVX, VARZOS
Symptoms: Biopsy skin abnormal, Pruritus, Rash, Urticaria, Urticaria chronic
Clinical narrative: chronic urticaria; itching; broke out in a rash; broke out in a hives; This non-serious case was reported by a consumer via call center representative and described the occurrence of chronic urticaria in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis and Pneumococcal vaccine for prophylaxis.   Concurrent medical conditions included dementia and prostate cancer stage ii (Prostate cancer grade 2 Gleason score 3+4).   On 24-APR-2024, the patient received Shingrix, the 1st dose of RSV vaccine and the 1st dose of Pneumococcal vaccine. On 26-APR-2024, 2 days after receiving Shingrix and RSV vaccine, the patient experienced rash (Verbatim: broke out in a rash) and hives (Verbatim: broke out in a hives). On an unknown date, the patient experienced chronic urticaria (Verbatim: chronic urticaria) and pruritus (Verbatim: itching). The patient was treated with ammonium chloride, diphenhydramine hydrochloride, sodium citrate (Diphenhydramine). The outcome of the chronic urticaria was unknown and the outcome of the rash, hives and pruritus were not reported.   It was unknown if the reporter considered the chronic urticaria, rash, hives and pruritus to be related to Shingrix and RSV vaccine.     It was unknown if the company considered the chronic urticaria, rash, hives and pruritus to be related to Shingrix and RSV vaccine.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter reported that a patient received Shingrix vccine, RSV vaccine and a Pneumococcal vaccine which was administered on same time. Two days after receiving vaccine the patient had broke out in hives/rash that was diagosed as chronic urticaria. The reporter states prior to the time the consumer had the vaccines administered he was diagnosed with prostate cancer grade 2, Gleason score of 3+4.   Consumer was also told his A1c was elevated so the reporter made drastic dietary changes.   The consumer was diagnosed with dementia around this time as well.   The consumer was diagnosed by a dermatologist as having chronic urticaria after a skin biopsy was performed.   The dermatologist prescribed creams for the consumer to use topically. Consumer states for the itching Diphenhydramine was recommended, however, that was discontinued after the reported learned that the Diphenhydramine could negatively impact the consumers' dementia. On 26-APR-2024, 2 days after receiving Pneumococcal vaccine, the patient experienced rash and hives. On an unknown date, the patient experienced chronic urticaria and pruritus. It was unknown if the reporter considered the chronic urticaria, rash, hives and pruritus to be related to Pneumococcal vaccine.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Extra dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 06-NOV-2023 ).   On 30-OCT-2024, the patient received the 2nd dose of Arexvy. On 30-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra dose ). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2024 The patient received a dose of Arexvy on 6th November 2023 and a second dose on 30th October 2024, which led to extra dose administered. The reporter did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. No lot number or expiration date were available.
Age: 4.0
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received the adacel instead of the dtap with no reported adverse event; Initial information received on 07-Nov-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 4 years old and unknown gender patient who received the Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of the DTAP (Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid) 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 an unknown date, the patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (suspension for injection) instead of DTAP with no reported adverse event (wrong product administrated) (latency : same day) lot U7983AA, Expiry date: 18-Jan-2026, strength was unknown via unknown route in unknown administration site  for prophylactic vaccination (Immunization).  Reportedly,The nurse would like to know if the patient needs a DTaP dose now still or how does that work. The nurse would also like to know what side effects to watch out for and what she can tell the mother.   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: M
Vaccine: FLUA4
Symptoms: Computerised tomogram limb, Computerised tomogram normal, Intervertebral disc operation, Intervertebral disc protrusion, Magnetic resonance imaging spinal abnormal
Clinical narrative: Herniated lumbar disc; This clinical trial case, initially received on 11-Nov-2024, Additional follow up received on 12-Nov-2024 was reported by a health professional and concerns an elderly male subject.  Weight: 154.4 kg; Height: 175 cm  The subject was enrolled in the study  Past medical history included Surgery ACL repair, Atrial fibrillation, Cardiac Ablation, Left Anterior Cruciate Ligament Tear. At the time of the event the subject had Angina / chest pain, Seasonal allergies, Hypertension, Hyperlipidemia, Diabetes mellitus type II, Posttraumatic Stress Disorder, Insomnia, Gastro esophageal reflux disease, Chronic back pain, Right Leg sciatica unknown etiology, Osteoarthritis of knees and back, Chronic right leg swelling unknown etiology, Testosterone deficiency, Gout.Concomitant medication: refer to appropriate report section.  The subject's historical vaccines included influenza vaccine (influenza recombinant quadrivalent injection), received on 01-Oct-2021   Administration of company suspect drug(s):  On 27-Nov-2023 12:48, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza, Dose: 0.5 ml , Route of administration : Intramuscular,  Lot number: No batch number available. The study vaccine was administered as per the protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes:  On 06-Nov-2024, the subject experienced Herniated lumbar disc (Hospitalized, outcome: Recovering / Resolving).  The subject's wife notified site that subject had outpatient MILD (Minimally invasive lumbar decompression)  procedure on 05-Nov-2024 for his chronic DDD. This procedure has been recommended to him since before study entry, but he had been postponing intervention for personal reasons. Starting the day after procedure, on 06-Nov-2024, he started experiencing severe pain radiating down the back of his right leg. He presented to ER on 08-Nov-2024. Doppler US of right leg was negative for DVT. CT right leg was wnl. MRI of lumbar spine on 09-Nov-2024 showed acutely bulging lumbar disc. He was transferred to another hospital for surgery and underwent partial discectomy on 10-Nov-2024. He was still hospitalized and expects to remain inpatient for a few more days.  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment: The reporter considered the event Herniated lumbar disc as serious and assessed the causality as not related to the administration of the investigational drug. Alternative cause for Herniated lumbar disc was reported as other.  The subject remains blinded in the study.; Reporter's Comments: Causality: Not related based on implausible temporal and biological relationship (11 months 9 days) after administration of study vaccine. Of note, elderly age and underlying Osteoarthritis of knees and back considered as risk factors. Listedness was assessed using IB version 5.
Sex: M
Vaccine: FLUA4
Symptoms: Pain, Pain in extremity, Spinal decompression, Ultrasound Doppler normal
Clinical narrative: Herniated lumbar disc; This clinical trial case, initially received on 11-Nov-2024, Additional follow up received on 12-Nov-2024 was reported by a health professional and concerns an elderly male subject.  Weight: 154.4 kg; Height: 175 cm  The subject was enrolled in the study  Past medical history included Surgery ACL repair, Atrial fibrillation, Cardiac Ablation, Left Anterior Cruciate Ligament Tear. At the time of the event the subject had Angina / chest pain, Seasonal allergies, Hypertension, Hyperlipidemia, Diabetes mellitus type II, Posttraumatic Stress Disorder, Insomnia, Gastro esophageal reflux disease, Chronic back pain, Right Leg sciatica unknown etiology, Osteoarthritis of knees and back, Chronic right leg swelling unknown etiology, Testosterone deficiency, Gout.Concomitant medication: refer to appropriate report section.  The subject's historical vaccines included influenza vaccine (influenza recombinant quadrivalent injection), received on 01-Oct-2021   Administration of company suspect drug(s):  On 27-Nov-2023 12:48, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza, Dose: 0.5 ml , Route of administration : Intramuscular,  Lot number: No batch number available. The study vaccine was administered as per the protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes:  On 06-Nov-2024, the subject experienced Herniated lumbar disc (Hospitalized, outcome: Recovering / Resolving).  The subject's wife notified site that subject had outpatient MILD (Minimally invasive lumbar decompression)  procedure on 05-Nov-2024 for his chronic DDD. This procedure has been recommended to him since before study entry, but he had been postponing intervention for personal reasons. Starting the day after procedure, on 06-Nov-2024, he started experiencing severe pain radiating down the back of his right leg. He presented to ER on 08-Nov-2024. Doppler US of right leg was negative for DVT. CT right leg was wnl. MRI of lumbar spine on 09-Nov-2024 showed acutely bulging lumbar disc. He was transferred to another hospital for surgery and underwent partial discectomy on 10-Nov-2024. He was still hospitalized and expects to remain inpatient for a few more days.  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment: The reporter considered the event Herniated lumbar disc as serious and assessed the causality as not related to the administration of the investigational drug. Alternative cause for Herniated lumbar disc was reported as other.  The subject remains blinded in the study.; Reporter's Comments: Causality: Not related based on implausible temporal and biological relationship (11 months 9 days) after administration of study vaccine. Of note, elderly age and underlying Osteoarthritis of knees and back considered as risk factors. Listedness was assessed using IB version 5.