chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: temperature excursion for Fluzone NP exposed to negative 13 F for 4 hours with no reported adverse event.; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to US-SA-2025SA100631.  This case involves an unknown age and unknown gender patient who administered influenza USP trival A-B subvirion vaccine [Fluzone] and that had temperature excursion exposed to negative 13 F for 4 hours with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Jan-2025, the patient received an unknown dose of suspect influenza USP trival A-B subvirion vaccine, suspension for injection (lot UT8415MA and expiry date: 30-Jun-2025) via unknown route in unknown administration site for immunization and that had temperature excursion exposed to negative 13 F for 4 hours with no reported adverse event (poor quality product administered).  Reportedly, Previous Excursion: 31-Dec-2024: 48 F for 30 minutes. Extended stability data did not cover the excursion. Human error was No. Reason: Fridge malfunction and product was administered.  Action taken was not applicable.  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-2025SA100631:
Vaccine: MEN
Symptoms: Product storage error
Clinical narrative: Menquadfi  was given to a patient after the excursion with no ae; Initial information received on 08-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an elderly and unknown gender patient who was administered with Meningococcal A-C-Y-W135 (T CONJ) vaccine [MenquadfI] after the excursion.   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 Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength-unknown) (lot U82718C, expiry date- 31-Jan-2028) via unknown route in unknown administration site for Immunization after excursion (poor quality product administered) (latency-same day).  Reportedly- Caller states that one their providers called previously to report a temperature excursion and some of the vaccines were not viable. She is calling to get information if they need to re-vaccinate the patient if the vaccine that was given were not viable. MENQUADFI that was no longer viable was given to a patient after temperature excursion  Action taken) was not applicable.  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: 11.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered improperly stored GARDASIL 9 and VAQTA following a TE; This spontaneous report was received from a vaccine coordinator and refers to a 11-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 26-Oct-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) administered for prophylaxis (lot #Y007193, expiration date: 06-Jun-2026) (dose, scheme, route of administration, and injection site were not reported), which underwent a temperature excursion of 25F for 1 hour (product storage error). No additional adverse event was reported.
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure; have had the shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have had the shingles 3 times). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-APR-2025 This case was reported by a patient via interactive digital media. The patient stated that get the vaccine. It would not prevent but it would make it less dangerous. Patient further stated he/she knew because he/she had the vaccination and had the shingles 3 times since and each time had a very light rash. The patient said he/she was grateful for science. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine."
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: my muscle started becoming weaker number; my muscle started becoming weaker number; hands and back hurt; hands and back hurt; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (COMIRNATY), on 12Aug2021 as dose number unknown, 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: MUSCULAR WEAKNESS (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "my muscle started becoming weaker number"; PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "hands and back hurt".  Additional information: The patient took the vaccine on 12Aug2021 and muscle started becoming weaker and number. Should the patient's hands and back hurt, the patient doesn't have health insurance.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Brain fog, Depression, Fatigue, Impaired work ability
Clinical narrative: Extreme fatigue, depression,  brain fog, panic attacks, anxiety, and stiffness, had to quit my job
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Panic attack
Clinical narrative: Extreme fatigue, depression,  brain fog, panic attacks, anxiety, and stiffness, had to quit my job
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Anti-NMDA antibody positive, Barium swallow normal, Blood lactic acid normal, C-reactive protein normal, CSF cell count normal
Clinical narrative: 5 days after immunizations, infant developed encephalitic symptoms including fussiness, stiff neck, fluttering eye movements, poor feeding.  Infant was hospitalized and evaluation negative, including labs, cultures, pcr's and imaging. lumbar puncture done mildly abnormal. Testing for autoantibodies on csf mildly +NMDR Infant has spontaneous resolution of symptoms over hospital stay.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: CSF glucose normal, CSF protein normal, Culture negative, Cytomegalovirus test negative, Differential white blood cell count normal
Clinical narrative: 5 days after immunizations, infant developed encephalitic symptoms including fussiness, stiff neck, fluttering eye movements, poor feeding.  Infant was hospitalized and evaluation negative, including labs, cultures, pcr's and imaging. lumbar puncture done mildly abnormal. Testing for autoantibodies on csf mildly +NMDR Infant has spontaneous resolution of symptoms over hospital stay.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Electroencephalogram, Encephalitis, Enterovirus test negative, Epstein-Barr virus test negative, Eyelid function disorder
Clinical narrative: 5 days after immunizations, infant developed encephalitic symptoms including fussiness, stiff neck, fluttering eye movements, poor feeding.  Infant was hospitalized and evaluation negative, including labs, cultures, pcr's and imaging. lumbar puncture done mildly abnormal. Testing for autoantibodies on csf mildly +NMDR Infant has spontaneous resolution of symptoms over hospital stay.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Full blood count normal, Herpes simplex test negative, Infant irritability, Laboratory test normal, Lumbar puncture abnormal
Clinical narrative: 5 days after immunizations, infant developed encephalitic symptoms including fussiness, stiff neck, fluttering eye movements, poor feeding.  Infant was hospitalized and evaluation negative, including labs, cultures, pcr's and imaging. lumbar puncture done mildly abnormal. Testing for autoantibodies on csf mildly +NMDR Infant has spontaneous resolution of symptoms over hospital stay.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Magnetic resonance imaging abdominal normal, Magnetic resonance imaging head normal, Magnetic resonance imaging pelvic, Magnetic resonance imaging thoracic normal, Metabolic function test normal
Clinical narrative: 5 days after immunizations, infant developed encephalitic symptoms including fussiness, stiff neck, fluttering eye movements, poor feeding.  Infant was hospitalized and evaluation negative, including labs, cultures, pcr's and imaging. lumbar puncture done mildly abnormal. Testing for autoantibodies on csf mildly +NMDR Infant has spontaneous resolution of symptoms over hospital stay.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Musculoskeletal stiffness, Polymerase chain reaction negative, Poor feeding infant, Procalcitonin normal, Urine analysis normal
Clinical narrative: 5 days after immunizations, infant developed encephalitic symptoms including fussiness, stiff neck, fluttering eye movements, poor feeding.  Infant was hospitalized and evaluation negative, including labs, cultures, pcr's and imaging. lumbar puncture done mildly abnormal. Testing for autoantibodies on csf mildly +NMDR Infant has spontaneous resolution of symptoms over hospital stay.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large red area at site of injection, pt reported it was bandaid-sized (1x2in) on the first day then grew to about 2x3 inches within 48 hours. She reported site as painful and warm to the touch with mild swelling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: redness, warmth, swelling, dx cellulitis, treating with bactrim
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Rash erythematous
Clinical narrative: injection site reaction with pain, itchiness, and erythematous rash to injection site area
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Fall
Clinical narrative: Patient reports phobia for needles.  Fell while sitting at the waiting area
Age: 56.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: PATIENT WOKE UP NEXT MORNING AFTER RECEIVING VACCINE WITH FEVER, CHILLS, SORE ARM, SWOLLEN ARM, AND WARM TO TOUCH
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Dizziness, Nausea, Vomiting
Clinical narrative: Sick to stomach dizzy, light headed, vomit..also had a widow maker heart attack after vaccines. No prob with heart prior
Age: 43.0
Sex: F
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: Developed pain redness swelling extending into her shoulder region. No treatment.
Age: 43.0
Sex: F
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Arthralgia, Electrocardiogram normal, Erythema, Pain
Clinical narrative: Developed pain redness swelling extending into her shoulder region. No treatment.
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; infant patient was  inadvertently administered an adolescent dose of GARDASIL 9; This spontaneous report has been received from a consumer regarding an infant patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  On 03-MAR-2025, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis, 0.5 milliliter, lot number Y010656 which has been verified to be valid, expiration date reported and validated as 29-NOV-2026 (strength, scheme, route of administration, anatomical site not reported).  Medical assistant stated that an infant patient was inadvertently administered an adolescent dose that was meant for their older sibling who was of age to receive their first dose. Medical Assistant confirmed the patient involved has not experienced any medical concerns or symptoms after the dose of the vaccine was inadvertently administered to the infant patient. No additional information provided. (Product administered to patient of inappropriate age) (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02763078-02763070 , CLIC number : , ESTAR number : , IRMS number : 500UW00000V7QvFYAV|04042025230052|4876 , Central date : 2025-04-05 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2260612 , MNSC case number : 02763078 , MNSC interaction number : 02763070 , Integration log UniqueID : 500UW00000V7QvFYAV|04042025230052|4876 , Service cloud CaseID : 500UW00000V7QvFYAV
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal pain, Abdominal pain upper, Alopecia, Amnesia, Arthralgia
Clinical narrative: memory loss; rash; itchy skin; stomach pain; liver pain; abdominal pain; dizziness; eye problem; inflammation of the ankle; vomiting; red face; hair loss; shoulder and arm pain of the injection; shoulder and arm pain of the injection; reduction of muscular tissue; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Dec2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years for immunisation. The patient's relevant medical history included: "Cardiac ablation", start date: 2024 (unspecified if ongoing); "Lung cancer", start date: 2019 (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported.   The following information was reported: ABDOMINAL PAIN (non-serious) with onset 09Dec2024, outcome "not recovered"; DIZZINESS (non-serious) with onset 09Dec2024, outcome "not recovered"; EYE DISORDER (non-serious) with onset 09Dec2024, outcome "not recovered", described as "eye problem"; ALOPECIA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "hair loss"; ARTHRITIS (non-serious) with onset 09Dec2024, outcome "not recovered", described as "inflammation of the ankle"; PRURITUS (non-serious) with onset 09Dec2024, outcome "not recovered", described as "itchy skin"; HEPATIC PAIN (non-serious) with onset 09Dec2024, outcome "not recovered", described as "liver pain"; AMNESIA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "memory loss"; RASH (non-serious) with onset 09Dec2024, outcome "not recovered"; ERYTHEMA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "red face"; MUSCLE ATROPHY (non-serious) with onset 09Dec2024, outcome "not recovered", described as "reduction of muscular tissue"; VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 09Dec2024, outcome "not recovered" and all described as "shoulder and arm pain of the injection"; ABDOMINAL PAIN UPPER (non-serious) with onset 09Dec2024, outcome "not recovered", described as "stomach pain"; VOMITING (non-serious) with onset 09Dec2024, outcome "not recovered". Therapeutic measures were not taken as a result of amnesia, rash, pruritus, abdominal pain upper, hepatic pain, abdominal pain, dizziness, eye disorder, arthritis, vomiting, erythema, alopecia, vaccination site pain, arthralgia, muscle atrophy.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Erythema, Eye disorder, Hepatic pain, Inflammation
Clinical narrative: memory loss; rash; itchy skin; stomach pain; liver pain; abdominal pain; dizziness; eye problem; inflammation of the ankle; vomiting; red face; hair loss; shoulder and arm pain of the injection; shoulder and arm pain of the injection; reduction of muscular tissue; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Dec2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years for immunisation. The patient's relevant medical history included: "Cardiac ablation", start date: 2024 (unspecified if ongoing); "Lung cancer", start date: 2019 (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported.   The following information was reported: ABDOMINAL PAIN (non-serious) with onset 09Dec2024, outcome "not recovered"; DIZZINESS (non-serious) with onset 09Dec2024, outcome "not recovered"; EYE DISORDER (non-serious) with onset 09Dec2024, outcome "not recovered", described as "eye problem"; ALOPECIA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "hair loss"; ARTHRITIS (non-serious) with onset 09Dec2024, outcome "not recovered", described as "inflammation of the ankle"; PRURITUS (non-serious) with onset 09Dec2024, outcome "not recovered", described as "itchy skin"; HEPATIC PAIN (non-serious) with onset 09Dec2024, outcome "not recovered", described as "liver pain"; AMNESIA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "memory loss"; RASH (non-serious) with onset 09Dec2024, outcome "not recovered"; ERYTHEMA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "red face"; MUSCLE ATROPHY (non-serious) with onset 09Dec2024, outcome "not recovered", described as "reduction of muscular tissue"; VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 09Dec2024, outcome "not recovered" and all described as "shoulder and arm pain of the injection"; ABDOMINAL PAIN UPPER (non-serious) with onset 09Dec2024, outcome "not recovered", described as "stomach pain"; VOMITING (non-serious) with onset 09Dec2024, outcome "not recovered". Therapeutic measures were not taken as a result of amnesia, rash, pruritus, abdominal pain upper, hepatic pain, abdominal pain, dizziness, eye disorder, arthritis, vomiting, erythema, alopecia, vaccination site pain, arthralgia, muscle atrophy.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Muscle atrophy, Pruritus, Rash, Vomiting
Clinical narrative: memory loss; rash; itchy skin; stomach pain; liver pain; abdominal pain; dizziness; eye problem; inflammation of the ankle; vomiting; red face; hair loss; shoulder and arm pain of the injection; shoulder and arm pain of the injection; reduction of muscular tissue; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Dec2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years for immunisation. The patient's relevant medical history included: "Cardiac ablation", start date: 2024 (unspecified if ongoing); "Lung cancer", start date: 2019 (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported.   The following information was reported: ABDOMINAL PAIN (non-serious) with onset 09Dec2024, outcome "not recovered"; DIZZINESS (non-serious) with onset 09Dec2024, outcome "not recovered"; EYE DISORDER (non-serious) with onset 09Dec2024, outcome "not recovered", described as "eye problem"; ALOPECIA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "hair loss"; ARTHRITIS (non-serious) with onset 09Dec2024, outcome "not recovered", described as "inflammation of the ankle"; PRURITUS (non-serious) with onset 09Dec2024, outcome "not recovered", described as "itchy skin"; HEPATIC PAIN (non-serious) with onset 09Dec2024, outcome "not recovered", described as "liver pain"; AMNESIA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "memory loss"; RASH (non-serious) with onset 09Dec2024, outcome "not recovered"; ERYTHEMA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "red face"; MUSCLE ATROPHY (non-serious) with onset 09Dec2024, outcome "not recovered", described as "reduction of muscular tissue"; VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 09Dec2024, outcome "not recovered" and all described as "shoulder and arm pain of the injection"; ABDOMINAL PAIN UPPER (non-serious) with onset 09Dec2024, outcome "not recovered", described as "stomach pain"; VOMITING (non-serious) with onset 09Dec2024, outcome "not recovered". Therapeutic measures were not taken as a result of amnesia, rash, pruritus, abdominal pain upper, hepatic pain, abdominal pain, dizziness, eye disorder, arthritis, vomiting, erythema, alopecia, vaccination site pain, arthralgia, muscle atrophy.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vomiting
Clinical narrative: vomiting; being in bed all night; ROUTE: subcutaneously; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "recovered"; MALAISE (non-serious), outcome "recovered", described as "being in bed all night"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "recovered", described as "ROUTE: subcutaneously".  Additional information: Patient described vomiting and being in bed all night after receiving the Pfizer COVID-19 vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of ipol with no reported adverse events; Initial information received on 07-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old female patient received an expired dose of IPV (Vero) [Ipol] with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W Conj (Tet Tox) (Menquadfi) for Immunisation.  On 07-Apr-2025, the patient received an expired, 0.5ml dose (once) of suspect IPV (Vero), Suspension for injection, Strength standard, lot W1A191M Expiry date 16-Feb-2025 via subcutaneous route in the left arm for prophylactic vaccination (immunisation) with no reported adverse events (expired product administered) (Latency same day).  Action taken was not applicable.  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.
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received IPOL After excursion with no reported adverse events; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2025SA100789 (same reporter)  This case involves an unknown age and unknown gender patient who received IPV (Vero) [IPol] (opened) after temperature excursion with no reported adverse events.  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 IPV (Vero) (opened), Suspension for injection, lot W1PS11M, (Unknown Strength) and expiry date 08-Sep-2025 via unknown route in unknown administration site for immunisation, after being exposed to temperature excursion with no reported adverse events (poor quality product administered) (Latency Same day).  Reportedly, Duration and temperature of excursion: 22-Jan-25: negative 13 F for 4 Hours; Previous Excursion: 31-Dec-24: 48 F for 30 minutes; Reason: Fridge malfunction; Was product administered: Yes, for opened IPol (opened); Was it related to a human error: No.  Action taken was not applicable.  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-2025SA100789:FLUZONE
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC20, VARCEL
Symptoms: Crying, Feeling abnormal, Irritability, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Within 48 hrs of shot, my son was crying everytime he tried to walk and his sleep was disrupted but he began feeling a little better. 7-8 days after the vaccines, he developed a fever of 101, was lethargic, so fussy, miserable. He fevered off and on for three days, then developed raspy breathing and a clear runny nose. The next day he developed a red bumpy rash on his cheeks, along with very watery, bloodshot eyes. It seems like he has a full on measles infection.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC20, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Sleep disorder, Stridor
Clinical narrative: Within 48 hrs of shot, my son was crying everytime he tried to walk and his sleep was disrupted but he began feeling a little better. 7-8 days after the vaccines, he developed a fever of 101, was lethargic, so fussy, miserable. He fevered off and on for three days, then developed raspy breathing and a clear runny nose. The next day he developed a red bumpy rash on his cheeks, along with very watery, bloodshot eyes. It seems like he has a full on measles infection.
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: had been diagnosed with Guillain-Barre syndrome after vaccination with SHINGRIX; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: had been diagnosed with Guillain-Barre syndrome after vaccination with SHINGRIX) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 07-APR-2025 The reporter reported that he found a on line group of consumers posting they had been diagnosed with Guillain-Barre syndrome after vaccination with Shingrix. This case is linked with US2025041538, reported by same reporter.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025041538:Same reporter 1 of 2
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she has not received the 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine 0.5 ml on 23-APR-2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she has not received the 2nd dose yet). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 04-APR-2025 The reporter was a 76-year-old female patient.  The patient reported on April 4th, 2025, that she received her 1st dose of Shingrix vaccine on April 23, 2022, at a local pharmacy.  The patient did not know in which arm she received the vaccine.  The patient reported she had not received the 2nd dose yet.  She reported she was not aware that she had not taken the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient took frist dose of Shingrix several years ago but not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose several years ago).   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: The patient took frist dose of Shingrix several years ago but not yet received the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 07-APR-2025 The patient received the first dose of Shingrix several years ago and unable to provide a date of vaccination, lot number with expiry date. The patient had not yet received the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain
Clinical narrative: had the first shingles shot, but got the shingles/second time all over my head, near my eye; patient received 3 doses of shingles vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had the first shingles shot, but got the shingles/second time all over my head, near my eye) and extra dose administered (Verbatim: patient received 3 doses of shingles vaccine). The outcome of the shingles was not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-APR-2025 This case was reported by a patient via interactive digital media.  Patient had the first shingles shot, but got the shingles, later the doctor said the first shot was no good. Patient got the shingles second time all over head, near eye. They were very, very painful. Patient then got next two shots, that were suppose to be good ones, thank goodness. Patient had 3 doses of shingles vaccine which led to extra dose administered. The follow-up could not be possible as no contact details were available.
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix stored at 33.8F for 16hrs 45 mins/ Boostrix used in patients since 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 an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number 9YB4G, expiry date 20-NOV-2026) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix stored at 33.8F for 16hrs 45 mins/ Boostrix used in patients since excursion). The outcome of the incorrect storage of drug was not applicable.   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: 28-MAR-2025 The HCP (health care professional) requested stability data for Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at 33.8F for 16 hours and 45 mins.  No prior excursions and Boostrix used in patients since excursion, which led to an incorrect storage of drug.
Age: 65.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; 65 year-old male received Gardasil 9; This spontaneous report was received from a Licensed Nurse and refers to a 65-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 25-Feb-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y014510, expiration date: 01-Nov-2026) for prophylaxis (product administered to a patient of inappropriate age). No adverse event was reported.
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; HCP called to report a 17-year-old patient received a dose of PEDVAX HIB.  HCP verified patient was previously vaccinated 11/01/2007; This spontaneous report was received from a Physician Assistant and refers to a 17-year-old female patient.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 01-NOV-2001, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (dose, route of administration, vaccination scheme frequency, anatomical site of injection, lot number and expiration date were not reported). On 04-APR-2025, when the patient was 17-years-old, she was vaccinated with a second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Injection 0.5 mL, (lot number Y005457 has been verified to be valid for Haemophilus b Conjugate Vaccine [Meningococcal Protein Conjugate] [LIQUID PEDVAX HIB], expiration date 06-NOV-2026; route of administration, vaccination scheme frequency and anatomical site of injection were not provided); both doses were administered as prophylaxis (Inappropriate schedule of product administration). No additional adverse event was reported for the patient.
Sex: M
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; HCP called to report one patient received VARIVAX after improperly stored. Np side effects or symptoms reported. No additional information provided. No Additional AE/ No PQC.; This spontaneous report was received from the nurse regarding 22-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 09-Apr-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lyophilisate and solvent for solution for injection 0.5 mL, lot#Y002061 (expiration date: 09-JAN-2026), along with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not reported) as prophylaxis after being improperly stored (product storage error). Np side effects or symptoms were reported. No additional information was provided. No additional adverse event (AE) was reported.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: the rash as "red, raised, not fluid-filled, and maculopapular" which started on the chest and now has spread to the face and groin area; HCP stated that she believes the rash is measles; This spontaneous report was received from a physician and refers to a 12-month-old female patient.   The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.   On 25-MAR-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), both vaccines reconstituted with sterile diluent (BAXTER STERILE DILUENT) (strengths, dose descriptions, lot #s and expiration dates were not reported) for Routine vaccination.   On 08-APR-2025, the patient experienced red, raised, not fluid-filled, and maculopapular rash which started on the chest and now has spread to the face and groin area, then the patient was taken to the emergency room on 08-APR-2025 and was treated with Vaseline, but was not admitted to the hospital. The patient then had an appointment with the reporting HCP on 09-APR-2025 and HCP stated that she believes the rash is measles. At the reporting time, the patient had not recovered from events.  The causal relationship between the events and the suspect vaccines and its constituents was not provided.  Lot# would be submitted upon request.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Product administered to patient of inappropriate age
Clinical narrative: COVID-19; currently has shingles now, APR 2025; Shingles NOV 2024; Shingles MAR 2024; Shingles Mild case in OCT-2023; 39 year old patient her first dose of Shingrix in June 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 39-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 11 times with the first time at 19 years old).   In JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 year old patient her first dose of Shingrix in June 2023). In OCT-2023, the patient experienced shingles (Verbatim: Shingles Mild case in OCT-2023). In MAR-2024, the patient experienced shingles (Verbatim: Shingles MAR 2024). In NOV-2024, the patient experienced shingles (Verbatim: Shingles NOV 2024) and covid-19 (Verbatim: COVID-19). In APR-2025, the patient experienced shingles (Verbatim: currently has shingles now, APR 2025). The patient was treated with aciclovir sodium (Acyclovir). In NOV-2024, the outcome of the covid-19 was resolved. The outcome of the shingles, shingles and shingles were not reported and the outcome of the shingles was not resolved and the outcome of the inappropriate age at vaccine administration was not applicable.   It was unknown if the reporter considered the shingles, shingles, shingles, shingles and covid-19 to be related to Shingrix.     It was unknown if the company considered the shingles, shingles, shingles, shingles and covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-APR-2025 The patient self-reported this case. The patient received her first dose of Shingrix in June 2023 (no specific date provided) and she never received her second dose. The patient had shingles four times since receiving her first dose of Shingrix at the following times in October 2023 (Mild case), March 2024, November 2024 and she currently had shingles now in April 2025. The patient last two times she had shingles in March 2024 and November 2024 were the worst she ever had it.   The patient had shingles 11 times in her life, with the first time when she was 19 years old. The patient stated that all four cases of shingles since her first dose of Shingrix presented on the right side of her tailbone or butt area and she took Acyclovir in November 2024 for her shingles outbreak because she also had COVID at that time (no specific dates provided). The patient states the Acyclovir made her nauseous and was so she no longer took antivirals for her shingles outbreaks The patient received 1st dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Rash, Skin warm, Tenderness
Clinical narrative: Tenderness/ her arm was tender to the touch; Redness; Skin warm/ her arm was warm to the touch; had a rash around the area; her temperature increased by 1 degree; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-APR-2025, the patient received Arexvy. On 06-APR-2025, 1 days after receiving Arexvy, the patient experienced pain in arm (Verbatim: Tenderness/ her arm was tender to the touch), erythema (Verbatim: Redness), skin warm (Verbatim: Skin warm/ her arm was warm to the touch) and rash (Verbatim: had a rash around the area). In APR-2025, the patient experienced body temperature increased (Verbatim: her temperature increased by 1 degree). The outcome of the pain in arm, erythema and skin warm were not resolved and the outcome of the rash and body temperature increased were not reported.   It was unknown if the reporter considered the pain in arm, erythema, skin warm, rash and body temperature increased to be related to Arexvy.     It was unknown if the company considered the pain in arm, erythema, skin warm, rash and body temperature increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-APR-2025 The patient self reported this case for herself. The patient had taken the Arexvy vaccine on Saturday, 5th April 2025, at the pharmacy.  She had noticed the following day, on Sunday, 6th April 2025, that her arm was tender to the touch, warm to the touch, and had developed a rash around the area.  She had been planning to follow up with her doctor and had wanted to report the events.  She had mentioned that her temperature had increased by 1 degree.
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: headache; fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: headache) and fatigue (Verbatim: fatigue). The outcome of the headache and fatigue were resolved (duration 3 days).   It was unknown if the reporter considered the headache and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the headache and fatigue to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-APR-2025 This case was reported by a patient via interactive digital media. The patient said vaccine knocked him/her for a loop twice: headache and fatigue for three days.  But compared to the infection patient felt worth it.