chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Caesarean section, Delivery, Epilepsy, Partial seizures
Clinical narrative: Pfizer vaccine was administered outside - reported by patient-  NO LOT NUMBER WERE SUPPLIED G40.89 FOCAL MOTOR SEIZURE 4/4/2023 CESAREAN DELIVERY G40.909 EPILEPSY, UNSPECIFIED 10/27/2021 CESAREAN DELIVERY
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination error
Clinical narrative: Varicella titer on 06/27/2012 revealed pt. non-immune. No varicella vaccine received between then and now. Pt incorrectly received zoster vaccine when they turned 50.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired COVID-19 vaccine ages 6 months-4 years.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Atrial fibrillation
Clinical narrative: I20.9 ANGINA, UNSPECIFIED 3/27/2023 ANGINA, UNSPECIFIED ATRIAL FIBRILLATION, PAROXYSMAL
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Long QT syndrome, Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY 4/10/2023 ACQUIRED LONG QT SYNDROME
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Epilepsy, Obstructive sleep apnoea syndrome, Respiratory failure, Sleep apnoea syndrome
Clinical narrative: EPILEPSY, UNSPECIFIED SLEEP APNEA OBSTRUCTIVE SLEEP APNEA CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test normal, Condition aggravated, Hair colour changes, Vitiligo
Clinical narrative: Patient developed Segmental Vitiligo within 2 months of getting this shot. It progressively spread and covers her abdomen, chest, and back and she has a gray spot in her hair on one side of her body
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/15/2023 ACUTE NON ST ELEVATION MI
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Chest pain, Hypotension
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/26/2023 CHEST PAIN I95.9 HYPOTENSION 4/25/2023 CHEST PAIN
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Dyspnoea, Transient ischaemic attack
Clinical narrative: G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/26/2023 SHORTNESS OF BREATH I21.4 ACUTE NON ST ELEVATION MI 4/14/2023 SHORTNESS OF BREATH G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/26/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 4/14/2023 ACUTE NON ST ELEVATION MI
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Cyanosis, Febrile convulsion, Pyrexia, Vomiting
Clinical narrative: Patient spiked a fever and chills within hours of vaccine.  BY 6pm she threw up and had a febrile seizure while in urgent care, turned blue and was rushed to the ER by ambulance
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Diarrhoea, Discomfort, Pyrexia
Clinical narrative: Fever, diarrhea, severe chills, discomfort lasting 5-7 days
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/21/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Unevaluable event
Clinical narrative: none
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Loss of employment, Myalgia
Clinical narrative: 1-2 days after receiving the 1st dose of Shingrix vaccine, patient developed diffuse myalgias and arthralgias- worse in b/l forearms but all over. Also with extreme farigue. He lost his job in construction due to these symptoms. Still feeling some of the symptoms but they are slowly improving
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Received a 3 bivalent dose (2 within 1 week).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Obesity, Pericarditis
Clinical narrative: I30.9 ACUTE PERICARDITIS, UNSPECIFIED 3/8/2023 SEVERE OBESITY, BMI 60-69.9, ADULT. J96.00 ACUTE RESPIRATORY FAILURE 3/23/2023 SEVERE OBESITY, BMI 60-69.9, ADULT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/23/2023 SEVERE OBESITY, BMI 60-69.9, ADULT R09.02 HYPOXIA 3/23/2023 SEVERE OBESITY, BMI 60-69.9, ADULT.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute myocardial infarction
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/25/2023 NONTRAUMATIC ACUTE KIDNEY INJURY
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paresis, Hemiparesis, Paraesthesia, Vision blurred
Clinical narrative: R29.810 RIGHT FACIAL MUSCLE WEAKNESS 3/27/2023 DISTURBANCE OF SKIN SENSATION R29.810 RIGHT FACIAL MUSCLE WEAKNESS 3/27/2023 BLURRED VISION
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No significant adverse event- Vaccine expired 06/06/2023 and was administered 06/09/2023.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event- expired vaccine administered 06/09/2023. Expiration date 06/06/2023
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Endometrial cancer, Postmenopausal haemorrhage
Clinical narrative: Pt developed postmenopausal bleeding,  diagnosed with high grade endometrial cancer
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product preparation error
Clinical narrative: Patient did not have any unusual adverse event.  This is being reported because the patient was given the vaccine using a sterile water diluent made for Merck live vaccines (NDC 000006-4309-00).  The diluent used contained sterile water 0.7ml.    The diluent should have been one containing an adjuvant that comes with the shingrix package.  The patient stated she had very minimal arm soreness.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event on patient; temperature excursion; This spontaneous report was received from an office manager referring to a 13-year-old female patient. The patient had none pre-existing physician-diagnosed allergies, birth defects and medical conditions. Information of concomitant medications was not reported.  On 13-SEP-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dosage form (1 dose); strength, route and anatomical location were unknown) (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; it was not specified which one was received by the patient) for prophylaxis at private doctor's office/hospital by the ordering physician. The vaccine was purchased with public funds and the vaccine-device was purchased with private funds. The vaccine experienced temperature excursion on 09-SEP-2022, and the time of the temperature excursion was 8 mins (product storage error). Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day. This medication error occurred in the process of storage in clinical practice. This report was called because of a data logger.  No adverse event and no issues were on patient (no adverse event). The patient had no illness at time of vaccination. The patient did not die.   This was one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; HCP calling to report that PROQUAD was administered after undergoing a TE. No adverse affects reported. Caller stated this occurred in February 2023.          ?    Names of vaccines involved (including lot/exp): PROQUAD (Lot: W019631, Expiration: 1; This spontaneous report was received from a nurse, concerning to a patient of unknown gender or age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in February 2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, (lot #W019631 has been verified to be valid, expiration date: 19-DEC-2023) (strength, and route of administration were not administered) for prophylaxis, after vaccine underwent to temperature excursion at 13.5 Fahrenheit grade during 3 hours and 5 minutes (product storage error). There was not previous temperature excursion. No additional adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion.  Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC.  Names of vaccines involved (including lot/exp) VARIVAX W; No additional AE.; This spontaneous report was received from a nurse, concerning to a patient of unknown gender an age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, (lot #W031812 has been verified to be a valid lot, expiration date: 05-OCT-2024) for prophylaxis (strength, and route of administration were not provided), while the vaccine had a temperature excursion at 24.4 Fahrenheit grade during 5 hours and 51 minutes (Product storage error). There was not previous temperature excursion. No additional adverse event, and the patient was asymptomatic.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Hair disorder, Herpes zoster, Pain of skin, Skin indentation
Clinical narrative: Remnants of shingles / Suspected vaccination failure; Remnants of shingles; Painful part of my scalp; Hair issues; The indentations are still there; Felt 4 painful pimples on my scalp for about 2 weeks; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21-APR-2023, the patient received the 2nd dose of Shingrix. In DEC-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Remnants of shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Remnants of shingles), pimples (Verbatim: Felt 4 painful pimples on my scalp for about 2 weeks), scalp pain (Verbatim: Painful part of my scalp), hair disorder (Verbatim: Hair issues) and skin indentation (Verbatim: The indentations are still there). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving and the outcome of the pimples was resolved (duration 2 weeks) and the outcome of the scalp pain was resolved and the outcome of the hair disorder was not reported and the outcome of the skin indentation was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pimples, scalp pain, hair disorder and skin indentation to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pimples, scalp pain, hair disorder and skin indentation to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2023 The patient received 1st dose of Shingrix end of December 2022. Patient had no other symptoms except felt 4 painful pimples on scalp for about 2 weeks.  Patient did not thought anything about it.  Patient saw dermatologist for a body scan and commented on the painful part of her scalp (as she sees her for hair issues too).  She noticed the marks and said it looked like remnants of shingles that were healing.  The indentations were still there as patient could feel them with her finger but no more pain. The reporter did not consent to follow up. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Remnants of shingles / Suspected vaccination failure; Remnants of shingles; Painful part of my scalp; Hair issues; The indentations are still there; Felt 4 painful pimples on my scalp for about 2 weeks; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21-APR-2023, the patient received the 2nd dose of Shingrix. In DEC-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Remnants of shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Remnants of shingles), pimples (Verbatim: Felt 4 painful pimples on my scalp for about 2 weeks), scalp pain (Verbatim: Painful part of my scalp), hair disorder (Verbatim: Hair issues) and skin indentation (Verbatim: The indentations are still there). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving and the outcome of the pimples was resolved (duration 2 weeks) and the outcome of the scalp pain was resolved and the outcome of the hair disorder was not reported and the outcome of the skin indentation was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pimples, scalp pain, hair disorder and skin indentation to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pimples, scalp pain, hair disorder and skin indentation to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2023 The patient received 1st dose of Shingrix end of December 2022. Patient had no other symptoms except felt 4 painful pimples on scalp for about 2 weeks.  Patient did not thought anything about it.  Patient saw dermatologist for a body scan and commented on the painful part of her scalp (as she sees her for hair issues too).  She noticed the marks and said it looked like remnants of shingles that were healing.  The indentations were still there as patient could feel them with her finger but no more pain. The reporter did not consent to follow up. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Chest pain, Neck pain, Pain, Pruritus
Clinical narrative: itchy; dime sized hives/lesions that are painful; dime sized hives/lesions; dime sized hives/lesions; Mild pain on my right chest, right shoulder, right neck; Mild pain on my right chest, right shoulder, right neck; Mild pain on my right chest, right shoulder, right neck; This non-serious case was reported by a consumer and described the occurrence of hives in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, hyper ldl cholesterolemia, hypothyroidism, multiple allergies, neuropathy, vaginal edema and hypertension. Concomitant products included metformin hydrochloride + sitagliptin (Janumet), rosuvastatin calcium (Crestor), levothyroxine, cetirizine hydrochloride (Zyrtec) and pregabalin (Lyrica).   On 23-MAY-2023, the patient received Shingrix (left arm). In MAY-2023, less than a week after receiving Shingrix, the patient experienced chest pain (Verbatim: Mild pain on my right chest, right shoulder, right neck), shoulder pain (Verbatim: Mild pain on my right chest, right shoulder, right neck) and neck pain (Verbatim: Mild pain on my right chest, right shoulder, right neck). On 30-MAY-2023, the patient experienced hives (Verbatim: dime sized hives/lesions) and skin lesion (Verbatim: dime sized hives/lesions). On an unknown date, the patient experienced pruritus (Verbatim: itchy) and pain (Verbatim: dime sized hives/lesions that are painful). The outcome of the hives was not resolved and the outcome of the skin lesion, chest pain, shoulder pain, neck pain, pruritus and pain were not reported.   It was unknown if the reporter considered the hives, skin lesion, chest pain, shoulder pain, neck pain, pruritus and pain to be related to Shingrix.     It was unknown if the company considered the hives, skin lesion, chest pain, shoulder pain, neck pain, pruritus and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient self-reported this case. Concomitant product included Elavil for vaginal edema and Nevibial for hypertension. Mild pain on patient right chest, right shoulder, right neck started even before the hives appeared. Approximately 3 days later, a dime sized hives/lesions that were painful and itchy.  The patient had not used any treatment and asked for suggestions. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Urticaria
Clinical narrative: itchy; dime sized hives/lesions that are painful; dime sized hives/lesions; dime sized hives/lesions; Mild pain on my right chest, right shoulder, right neck; Mild pain on my right chest, right shoulder, right neck; Mild pain on my right chest, right shoulder, right neck; This non-serious case was reported by a consumer and described the occurrence of hives in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, hyper ldl cholesterolemia, hypothyroidism, multiple allergies, neuropathy, vaginal edema and hypertension. Concomitant products included metformin hydrochloride + sitagliptin (Janumet), rosuvastatin calcium (Crestor), levothyroxine, cetirizine hydrochloride (Zyrtec) and pregabalin (Lyrica).   On 23-MAY-2023, the patient received Shingrix (left arm). In MAY-2023, less than a week after receiving Shingrix, the patient experienced chest pain (Verbatim: Mild pain on my right chest, right shoulder, right neck), shoulder pain (Verbatim: Mild pain on my right chest, right shoulder, right neck) and neck pain (Verbatim: Mild pain on my right chest, right shoulder, right neck). On 30-MAY-2023, the patient experienced hives (Verbatim: dime sized hives/lesions) and skin lesion (Verbatim: dime sized hives/lesions). On an unknown date, the patient experienced pruritus (Verbatim: itchy) and pain (Verbatim: dime sized hives/lesions that are painful). The outcome of the hives was not resolved and the outcome of the skin lesion, chest pain, shoulder pain, neck pain, pruritus and pain were not reported.   It was unknown if the reporter considered the hives, skin lesion, chest pain, shoulder pain, neck pain, pruritus and pain to be related to Shingrix.     It was unknown if the company considered the hives, skin lesion, chest pain, shoulder pain, neck pain, pruritus and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient self-reported this case. Concomitant product included Elavil for vaginal edema and Nevibial for hypertension. Mild pain on patient right chest, right shoulder, right neck started even before the hives appeared. Approximately 3 days later, a dime sized hives/lesions that were painful and itchy.  The patient had not used any treatment and asked for suggestions. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm is a bit sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of illness (1st dose was received in NOV-2019, refer case US2020AMR032124).  On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm is a bit sore). The outcome of the pain in arm was not reported.  The reporter considered the pain in arm to be possibly related to Shingrix.  The company considered the pain in arm to be possibly related to Shingrix.  Linked case(s) involving the same patient: US2020AMR032124  Additional Information: GSK Receipt Date: 05-JUN-2023 This case was reported by the patient via interactive digital media.  The patient was almost forgot to go back for the second shot.  The patient just got her second Shingles shot. Arm was a bit sore and stated that if the first one was an indicator, it would be for about 3 days. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR032124:First dose case
Sex: M
Vaccine: HPVX, MENB
Symptoms: Lymphadenopathy
Clinical narrative: Swollen axillary gland; This non-serious case was reported by a other health professional via call center representative and described the occurrence of axillary lymph nodes enlarged in a 11-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.  Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis.  On 31-MAY-2023, the patient received the 1st dose of Bexsero (unknown arm) and HPV vaccine (unknown arm). On an unknown date, an unknown time after receiving Bexsero and HPV vaccine, the patient experienced axillary lymph nodes enlarged (Verbatim: Swollen axillary gland). The outcome of the axillary lymph nodes enlarged was resolving.  It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Bexsero, Bexsero Pre-Filled Syringe Device and HPV vaccine.  It was unknown if the company considered the axillary lymph nodes enlarged to be related to Bexsero, Bexsero Pre-Filled Syringe Device and HPV vaccine.  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: 05-JUN-2023 Caller was a GlaxoSmithKline (GSK) representative reporting an Adverse event (AE) with limited information. She stated that, a nurse at one of her sites said they had a patient receive the Bexsero and HPV vaccine on the same day in unknown arms. The nurse reported that the mother of the patient called stating the patient got a swollen axillary gland after getting the vaccines. The rep does not know when the swelling occurred after the vaccines or if it has resolved.  The rep had not further information about the event, patient, or vaccines themselves. The reporter consented to follow-up.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody, Therapeutic response decreased, Viral titre
Clinical narrative: titers are low; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapeutic response decreased (Verbatim: titers are low). The outcome of the therapeutic response decreased was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was an Office staff member. The reporter stated that the physicians at the practice routinely check Hepatitis B titers and if the titers were low, they give a booster dose or redo the entire series. The reporter did not consent to follow up.
Age: 3.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age; This non-serious case was reported by a consumer via sales rep and described the occurrence of inappropriate age at vaccine administration in a 3-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:05-JUN-2023 and 06-JUN-2023 The reporter stated that he/she spoke to one of his/her targets who gave Boostrix to a 3 year old patient.  The reporter stated that he/she know that it is indicated for 10 years old. The reporter wanted to contact medical information to put you in contact with the office. Attempted to call GSK vaccine sales representative back but the number provided was a general GSK phone number and unable to reach sales representative to obtain additional details regarding adverse event and healthcare professional reporting adverse event. The patient received a dose of Boostrix at an inappropriate age, which led to inappropriate age at vaccine administration
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix vaccine in 2019; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 0.5 ml in 2019 intramuscularly in unknown arm).   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: first Shingrix vaccine in 2019). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-JUN-2023 The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 79.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 79-year-old female patient who received HAB (Twinrix adult) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   On 06-JUN-2023, the patient received the 1st dose of Twinrix adult. On 06-JUN-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUN-2023 The reporter reported that they are wondering if the patient need to restart the series. The reporter reported that the vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via postal. The patient received a Twinrix adult which was already expired, which led to expired vaccine used.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administration of an expired Boostrix dose to a 11 year-old female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number J39HG, expiry date 05-JUN-2023) for prophylaxis.   On 07-JUN-2023, the patient received Boostrix. On 07-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Boostrix dose to a 11 year-old female patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 07-JUN-2023 The health care professional (HCP) asked for recommendations on this situation. The HCP provided this email address for follow up. The reporter consented to follow up. The patient received an expired dose of Boostrix, which led to expired vaccine used
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergy; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and TETANUS VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy (Verbatim: allergy). The patient was treated with antihistamine (Antihistamines). The outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Shingles vaccine.     It was unknown if the company considered the allergy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JUN-2023 The patient self-reported this case. The patient mentioned that she had allergic responses to a tetanus vaccine and also a shingles vaccine in the past. The product names and manufacturers were unknown.  The allergic response required antihistamines to treat. It was unknown if the reporter considered the allergy to be related to Tetanus vaccine. The reporter did not consent to follow-up. No additional information was provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: shingrix powder was reconstituted with sterile water and administered to a patient; shingrix powder was reconstituted with sterile water and administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 3A3TC, expiry date 05-AUG-2024) for prophylaxis.   On 03-JUN-2023, the patient received the 2nd dose of Shingrix. On 03-JUN-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: shingrix powder was reconstituted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: shingrix powder was reconstituted with sterile water and administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that Shingrix powder was reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Paraesthesia, Vaccination failure
Clinical narrative: after taking 2 dose of shingrix patient experienced shingles; Shingles with no rash; Tingling on top on left side of head; First dose of Shingix in 2017, then second dose 18 months ago; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: after taking 2 dose of shingrix patient experienced shingles) (serious criteria GSK medically significant), shingles (Verbatim: Shingles with no rash), tingling sensation (Verbatim: Tingling on top on left side of head) and drug dose administration interval too long (Verbatim: First dose of Shingix in 2017, then second dose 18 months ago). The outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles and tingling sensation were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and tingling sensation to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and tingling sensation to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 07-JUN-2023 A reporter reported about her self she received her first dose of Shingix in 2017, then second dose 18 months ago. The reporter stated that she was feeling tingling on top on left side of head, went to her doctor who diagnosed shingles with no rash.  The reporter did not consent to followup. The patient received 2nd dose late which led to lengthening of the vaccine schedule. This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles not reported.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pruritus, Rash
Clinical narrative: rash on her left arm, a rash on her neck; weakness; itchiness on her neck; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on 01-OCT-2019) and scalp pain (developed pain on her scalp because of the Shingles).   In JAN-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: rash on her left arm, a rash on her neck), weakness (Verbatim: weakness) and pruritus (Verbatim: itchiness on her neck). The outcome of the rash and weakness were resolved and the outcome of the pruritus was not resolved.   It was unknown if the reporter considered the rash, weakness and pruritus to be related to Shingrix.     It was unknown if the company considered the rash, weakness and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUN-2023 The patient self-reported this case. The patient received first dose of Shingrix in late January 2023. The patient stated that after receiving the vaccine, she developed a rash on her left arm, a rash on her neck and itchiness on her neck.  The patient also experienced weakness.  All the symptoms were resolved except for itchiness. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: he received only one dose of shingrix 3 years ago; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (3 years ago from reporting, received 1st dose).   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: he received only one dose of shingrix 3 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 07-JUN-2023 A physician reported this case for himself. The reporter consented to follow up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Was administered a dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 07-NOV-2022) for prophylaxis.   On 17-FEB-2023, the patient received Shingrix. On 17-FEB-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Was administered a dose of Shingrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received the expired Shingrix vaccine, which led to expired vaccine used. This case was one of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023080474:Same reporter US-GSK-US2023080477:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: had an expiration date of 7Nov2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 07-NOV-2022) for prophylaxis.   On 05-JUN-2023, the patient received Shingrix. On 05-JUN-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: had an expiration date of 7Nov2022). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility was the same as primary reporter. Consented to follow up.  This case is linked with case US2023080474 and US2023080475, reported by same reporter.; Sender's Comments:  US-GSK-US2023080474:Same reporter US-GSK-US2023080475:Same reporter
Age: 27.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired dose of Twinrix was given to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 27-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 07-JUN-2023, the patient received the 1st dose of Twinrix. On 07-JUN-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Twinrix was given to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUN-2023 A pharmacy operations manager called to report that an expired dose of Twinrix was given to a patient and wished to know how to proceed. Information about the event, vaccine and patient were provided. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up. The patient received Twinrix beyond the expiration date, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired dose of shingrix was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (expiry date NOV-2022) for prophylaxis.   On 05-JUN-2023, the patient received Shingrix. On 05-JUN-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired dose of shingrix was administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2023 The Vaccine Administration Facility was the same as Primary Reporter. No other information was available. The reporter consented to follow up.  The reporter reported that an expired dose of Shingrix was administered to patient, which led to expired vaccine used.
Sex: U
Vaccine: COVID19-2
Symptoms: Anaemia, COVID-19, End stage renal disease, SARS-CoV-2 test
Clinical narrative: CKD Stage 5; Anemia in chronic kidney disease; covid; This spontaneous case was reported by an other health care professional and describes the occurrence of END STAGE RENAL DISEASE (CKD Stage 5) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product EPOETIN ALFA EPBX (RETACRIT [EPOETIN ALFA EPBX]) for an unknown indication.    The patient's past medical history included Unconsciousness and Dyspnea (Severe). Concurrent medical conditions included Sulfonamide allergy (Sulfa (Sulfonamide Antibiotics): Dyspnea (Severe)) and Drug allergy (Codeine: Dyspnea (Severe) - unconsciousness).   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. and EPOETIN ALFA EPBX (RETACRIT [EPOETIN ALFA EPBX]) (unknown route) at an unspecified dose every two weeks. In 2022, the patient experienced COVID-19 (covid). On an unknown date, the patient experienced END STAGE RENAL DISEASE (CKD Stage 5) (seriousness criterion medically significant) and ANAEMIA (Anemia in chronic kidney disease). At the time of the report, END STAGE RENAL DISEASE (CKD Stage 5), ANAEMIA (Anemia in chronic kidney disease) and COVID-19 (covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Had covid 2022.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Primary diagnosis was reported as anemia in chronic kidney disease and secondary diagnosis was reported as CKD Stage 5.  It was reported as on an unknown date, the patient had Covid vaccine Moderna 2 doses. Had covid 2022.  No treatment medications reported. Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported relevant medical history, who experienced the serious (due to medically significant) unexpected event of end stage renal disease, which occurred on an unknown date after receiving mRNA-1273 Bivalent .222 (Moderna COVID-19 vaccine, bivalent (original and omicron BA.4/BA.5. Primary diagnosis was reported as anemia in chronic kidney disease and secondary diagnosis was reported as CKD Stage 5. NO further information was disclosed. EPOETIN ALFA EPBX was considered as a co-suspect drug. The benefit-risk relationship of mRNA-1273 Bivalent .222 (Moderna COVID-19 vaccine, bivalent (original and omicron BA.4/BA.5) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment medication reported.; Reporter's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the expected, serious (medically significant) event of anaphylactic reaction an unknown time after the second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 8th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)