chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore throat, fever, chills, fatigue
Age: 19.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second Hep A dose given too early.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: heart failure
Age: 42.0
Sex: M
Vaccine: HPV9, PNC20
Symptoms: Eye pruritus, Headache, Nasal pruritus, Pruritus
Clinical narrative: Vaccine administered on 12/28. 12/30, eyes and nose began itching severely "like my seasonal allergies were going into overdrive", and Sunday 12/31, began itching all over the rest of body, constantly scratching, intense headache. By 1/1, headache improved and itching decreasing.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Pharyngeal hypoaesthesia
Clinical narrative: SYMPTONS: SHORTNESS OF BREATH, NUMB THROAT, DIZZINESS, CHEST TIGHTNESS; TREATMENT: 25MG DIPHENHYDRAMINE AT 4:05PM; OUTCOME: PT SLOWLY FELT BETTER AND CONTINUTED TO SIT FOR ANOTHER 20 MINUTES. EMERGENCY CONTACT WAS NOTIFIED. NO FURTHER ACTION WAS NEEDED
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness
Clinical narrative: Pt was given vaccinations in clinic, within a few minutes of receiving, pt lost consciousness for less than a minute, pt did not fall or hit her head at any time, she was immediately alert and oriented, speaking without difficulty, pt was diaphoretic and stated she was dizzy, vital signs and finger stick blood sugar obtained, all wnl, mother requested for child to be transported to ER via ambulance, EMS notified and transported child.
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given incorrect dose of vaccine. Patient received 0.5ml instead of 0.25ml.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Infant was administered Beyfortus (RSV) 50 mg dosage on November 9, 2023 Lot 2022830. VIS info provided to mother on RSV vaccine at this time.  On December 26, 2023, mother requested  infant to have RSV vaccine because she was traveling out of country. Record for vaccine schedule did not have prior RSV vaccine interfaced. Dose of Beyfortus 100 mg as per weight dose schedule was given to infant. Duplicate vaccine realized 3 hours later. Sanofi was contacted and advised to review side effects listed in literature.Reviewed potential symptoms for which she should be aware of : fever, redness at injection site, nausea. vomiting/ Mother did not report any reaction by infant. Different nurse/MD on Nov 9 and Dec 26
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Undiluted baby Covid 19 vaccine (6month to 4 years) was administered to patient(adult) as a single dose. there are no adverse reaction yet.
Age: 66.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient reported on 1/2/24 that she had received a flu vaccine from her doctor prior to receiving the flu vaccine from Pharmacy. She said she had wanted a COVID vaccine, but flu and RSV were on her form.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Concussion, Dizziness, Face injury, Head injury, Seizure
Clinical narrative: After receiving the immunization, pt. was told she could go to check out. She walked to checkout with her mother, and quickly became light headed. She fainted, hit her head on a brick wall, and had a seizure. She was taken to the emergency room where she received six stitches to close the wound over her eye and she was diagnosed with a concussion.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Suture insertion, Syncope
Clinical narrative: After receiving the immunization, pt. was told she could go to check out. She walked to checkout with her mother, and quickly became light headed. She fainted, hit her head on a brick wall, and had a seizure. She was taken to the emergency room where she received six stitches to close the wound over her eye and she was diagnosed with a concussion.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle ache and joint pain
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PAtient was given a 12-18 year old pfizer and she was not 12 years old yet she was only 11 years old at time of vaccine. No adverse reaction reported.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient first experienced redness which grew over time.  Site became painful to touch, warm, and swollen. Pain began to radiate to right shoulder. Patient is currently being treated with Keflex for cellulitis. Injection site appeared to be administered lower than recommended area.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Patient first experienced redness which grew over time.  Site became painful to touch, warm, and swollen. Pain began to radiate to right shoulder. Patient is currently being treated with Keflex for cellulitis. Injection site appeared to be administered lower than recommended area.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given PROQUAD on 04-DEC-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-DEC-2023, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, 0.5 milliliter, lot # reported and confirmed as: X018584, expiration date reported and confirmed as: 05-JAN-2025 (site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius ) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius ) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given PROQUAD on 04-DEC-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-DEC-2023, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, 0.5 milliliter, lot # reported and confirmed as: X018584, expiration date reported and confirmed as: 05-JAN-2025 (site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given PROQUAD on 05-DEC-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2023, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # was reported as: X0108584, expiration date was reported as: 05-JAN-2025 (exact dose, albumin status, site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.  Lot number X0108584 is not valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD).; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given PRO on 05-DEC-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2023, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (also reported as "PRO") injection, 0.5 milliliter, lot # reported and confirmed as: X018584, expiration date reported as confirmed as: 05-JAN-2025 (site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given PROQUAD on 05-DEC-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2023, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, 0.5 milliliter, lot # reported and confirmed as: X018584, expiration date reported and confirmed as: 05-JAN-2025 (site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given PROQUAD on 06-DEC-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender.The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-DEC-2023, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, 0.5 milliliter, lot # reported and confirmed as: X018584, expiration date reported and confirmed as: 05-JAN-2025 (site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius ) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; the patient was administered an expired dose of the VAQTA vaccine.; This spontaneous report was received from other health care professional referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number W008110, with expiration date of 27-OCT-2023) (expired product administered). No additional adverse event was provided.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC.; HCP calling to report a 2 month old inadvertently received VARIVAX. No side effects reported. No additional information/clarification provided. No additional AE/no PQC.; This spontaneous report was received from a nurse and refers to a 2-month-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 17-NOV-2023, the patient was vaccinated  with a varicella virus vaccine live (oka/merck) (VARIVAX), lot #X012281, expiration date: 30-APR-2025, (strength, dose, dose#, route of administration, and anatomical site of vaccination were not provided), diluted  with sterile diluent, solution for injection/infusion, 0.5 ml (lot#, and expiration date was not provided)  for prophylaxis, (product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
Age: 0.33
Sex: U
Vaccine: PNC15, PNC15, RV5
Symptoms: Product storage error
Clinical narrative: no patient symptoms have been reported/No additional AE; patient received 1 dose of ROTATEQ and 1 dose of VAXNEUVANCE after the products were involved in a temperature excursion.; This spontaneous report was received from a nurse and refers to a 4-month-old patient (gender not reported). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-DEC-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot# 1947628 which was found as valid lot# for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date: 11-JUN-2024, administered orally (strength, dose description were not provided); and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot#X022026 which was found as a valid lot# for pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) , expiration date 22-OCT-2025 or lot #X022028, expiration date: 22-OCT-2025, the reporter was unable to confirm which lot number was administered (strength, dose description, anatomical location of administration, and route of administration were not provided), both vaccines administered as prophylaxis following a temperature excursion of 13.08 degree Celsius for 1 hour 15 minutes, it was stated that no previous temperature excursion was reported (Improper storage of product in use). No patient symptoms have been reported (no adverse event).   This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2312USA010648: US-009507513-2312USA010641: US-009507513-2312USA010665: US-009507513-2312USA010768: US-009507513-2312USA010711: US-009507513-2312USA010625:
Age: 0.5
Sex: U
Vaccine: PNC15, PNC15, RV5
Symptoms: Product storage error
Clinical narrative: no patient symptoms have been reported/No additional AE; patient received 1 dose of ROTATEQ and 1 dose of VAXNEUVANCE after the products were involved in a temperature excursion; This spontaneous report was received from a nurse and refers to a 6-month-old patient (gender not reported). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-DEC-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot# 1947628, expiration date: 11-JUN-2024, administered orally (strength, dose description were not provided); and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot#X022026 expiration date 22-OCT-2025 or lot #X022028, expiration date: 22-OCT-2025, the reporter was unable to confirm which lot number was administered (strength, dose description, anatomical location of administration, and route of administration were not provided), both vaccines administered as prophylaxis following a temperature excursion of 13.08 degree Celsius for 1 hour 15 minutes, it was stated that no previous temperature excursion was reported (Improper storage of product in use). No patient symptoms have been reported (no adverse event).   This is one from several reports from the same reporter. ; Sender's Comments:  US-009507513-2312USA010597: US-009507513-2312USA010648: US-009507513-2312USA010641: US-009507513-2312USA010665: US-009507513-2312USA010711: US-009507513-2312USA010768: US-009507513-2312USA010625: US-009507513-2312USA010641:
Age: 0.5
Sex: U
Vaccine: PNC15, PNC15, RV5
Symptoms: Product storage error
Clinical narrative: no patient symptoms have been reported/No additional AE; patient received 1 dose of ROTATEQ and 1 dose of VAXNEUVANCE after the products were involved in a temperature excursion. Caller stated no patient symptoms have been re; This spontaneous report was received from a nurse and refers to a 6-month-old patient (gender not reported). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-DEC-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot# 1947628, expiration date: 11-JUN-2024, administered orally (strength, dose description were not provided); and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot#X022026, expiration date 22-OCT-2025 or lot #X022028, expiration date: 22-OCT-2025, the reporter was unable to confirm which lot number was administered (strength, dose description, anatomical location of administration, and route of administration were not provided), both vaccines administered as prophylaxis following a temperature excursion of 13.08 degree Celsius for 1 hour 15 minutes, it was stated that no previous temperature excursion was reported (Improper storage of product in use). No patient symptoms have been reported (no adverse event).   This is one from several reports from the same reporter. ; Sender's Comments:  US-009507513-2312USA010597: US-009507513-2312USA010641: US-009507513-2312USA010648: US-009507513-2312USA010665: US-009507513-2312USA010711: US-009507513-2312USA010768: US-009507513-2312USA010625: US-009507513-2312USA010648:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC; inadvertent administration of expired VAQTA to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medications were not reported.  On 28-DEC-2023, the patient was inadvertently vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (lot # W017819 has been verified to be a valid lot number for hepatitis A vaccine, inactivated, expiration date was reported as 27-DEC-2023), administered by a health professional for prophylaxis (concentration, dose and route of administration were not reported) (expired product administered). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. The product expired on 10OCT2023 and was administered to a patient on 27DEC2023. Limited patient demographics provided. No AE follow-up letter could be sent due to; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-DEC-2023, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #W021636, expiration date: 01-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) ()Expired product used). No additional adverse event was reported. .
Age: 0.5
Sex: U
Vaccine: PNC15, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient received 1 dose of ROTATEQ and 1 dose of VAXNEUVANCE after the products were involved in a temperature excursion; This spontaneous report was received from a nurse and refers to a 6-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-DEC-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1947628, expiration date: 11-JUN-2024, administered orally for prophylaxis (strength was not provided) and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #X022026, expiration date: 22-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided); or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, unk, lot #X022028, expiration date: 22-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided). The reporter was unable to confirm which lot number was administered to a patient. Those vaccines underwent temperature excursion in 13.08 degree Celsius for 1 hour 15 minutes with no previous excursion (Product storage error). No additional adverse events were reported.
Age: 0.33
Sex: U
Vaccine: PNC15, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient received 1 dose of ROTATEQ and 1 dose of VAXNEUVANCE after the products were involved in a temperature excursion; This spontaneous report was received from a nurse and refers to a 4-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-DEC-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1947628, expiration date: 11-JUN-2024, administered orally for prophylaxis (strength was not provided);and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #X022026, expiration date: 22-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided); or  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, unk, lot #X022028, expiration date: 22-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided). The reporter was unable to confirm which lot numbers was administered to a patient. Those vaccine underwent temperature excursion in 13.08 degree Celsius for 1 hour 15 minutes (Product storage error). No additional adverse event was reported.
Age: 0.33
Sex: U
Vaccine: PNC15, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient received 1 dose of ROTATEQ and 1 dose of VAXNEUVANCE after the products were involved in a temperature excursion; This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 27-DEC-2023, the patient was vaccinated with improperly stored doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dose, lot # 1947628 was confirmed to be valid, expiration date 11-JUN-2024 (exact dose and route of administration were not reported) and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 1 dose, lot # reported as X022026 or X022028, both confirmed to be valid with expiration date 22-OCT-2025 (exact dose and route of administration were not reported), all vaccines for prophylaxis. The administered doses were exposed to the temperature of 13.08 degrees Celsius for 1 hour and 15 minutes. There was no previous temperature excursion. No additional adverse event or patient's symptom were reported.
Age: 0.17
Sex: U
Vaccine: PNC15, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient received 1 dose of ROTATEQ and 1 dose of VAXNEUVANCE after the products were involved in a temperature excursion; This spontaneous report was received from a registered nurse and refers to a 9-week-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 26-DEC-2023, the patient was vaccinated with improperly stored doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dose, lot # 1947628 was confirmed to be valid, expiration date 11-JUN-2024 (exact dose and route of administration were not reported) and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 1 dose, lot # reported as X022026 or X022028, both confirmed to be valid with expiration date 22-OCT-2025 (exact dose and route of administration were not reported), all vaccines for prophylaxis. The administered doses were exposed to the temperature of 13.08 degrees Celsius for 1 hour and 15 minutes. There was no previous temperature excursion. No additional adverse event or patient's symptom were reported.
Age: 0.5
Sex: U
Vaccine: PNC15, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient received 1 dose of ROTATEQ and 1 dose of VAXNEUVANCE after the products were involved in a temperature excursion; This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 26-DEC-2023, the patient was vaccinated with improperly stored doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dose, lot # 1947628 was confirmed to be valid, expiration date 11-JUN-2024 (exact dose and route of administration were not reported) and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 1 dose, lot # reported as X022026 or X022028, both confirmed to be valid with expiration date 22-OCT-2025 (exact dose and route of administration were not reported), all vaccines for prophylaxis. The administered doses were exposed to the temperature of 13.08 degrees Celsius for 1 hour and 15 minutes. There was no previous temperature excursion. No additional adverse event or patient's symptom were reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; now have shingles and said it's worse than they've had before; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: now have shingles and said it's worse than they've had before). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 22-MAY-2023 The patient received 2 Shingrix vaccines and now had shingles and said it's worse than they've had before. The patient swore when they received the second vaccine the syringe did not appear to be filled as full as first vaccine syringe. It was not sure how patient could gauge this due to the vaccines administration being 2 months apart. Nonetheless, the patient was wondering if the second vaccine was not effective and wanted to know if they could get a third shot to make sure they have received full effectiveness. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: RSV
Symptoms: Pneumonia
Clinical narrative: pneumonia; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pneumonia (Verbatim: pneumonia) (serious criteria GSK medically significant). The outcome of the pneumonia was not reported.   It was unknown if the reporter considered the pneumonia to be related to Arexvy.     It was unknown if the company considered the pneumonia to be related to Arexvy.   Additional Information: GSK receipt date: 30-DEC-2023 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient was first diagnosed with pneumonia. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: The MenA component was reconstituted with sterile diluent instead of the MenCYW-135 component; The vaccine was improperly administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA950A, expiry date JUL-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: The MenA component was reconstituted with sterile diluent instead of the MenCYW-135 component) and inappropriate dose of vaccine administered (Verbatim: The vaccine was improperly administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 19-DEC-2023 The reporter reported that the Menveo vaccine was improperly administered to patient, which led to inappropriate dose administered. The MenA component was reconstituted with sterile diluent instead of the MenCYW-135 component, which led to wrong solution used in drug reconstitution. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: No got very ill after first; This non-serious case was reported by a consumer and described the occurrence of illness 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 illness (Verbatim: No got very ill after first). The outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingrix.     It was unknown if the company considered the illness to be related to Shingrix.   Additional Information: RA Receipt Date: 24-DEC-2023 The patient reported that they received shingrix dose. The reported that patient experienced illness after the first dose
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix dose approximately 2 years ago and did not go back for the second dose 6 months later; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date approximately 2 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: Shingrix dose approximately 2 years ago and did not go back for the second dose 6 months later). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA receipt date: 21-DEC-2023 The patient did not go back for the second dose 6 months later after the 1st dose. The reporter asked if/she need to start all over with the 2-dose series? Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertently administered Shingrix adjuvant portion only (without antigen); inadvertently administered Shingrix adjuvant portion only (without antigen); This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: inadvertently administered Shingrix adjuvant portion only (without antigen)) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered Shingrix adjuvant portion only (without antigen)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA Receipt Date: 28-DEC-2023 The reporter stated that one of their staff inadvertently administered Shingrix adjuvant portion only (without antigen), which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. They consulted with pharmacy colleagues, but they were not able to find any information regarding consequences of receiving adjuvant only and if there was a waiting period before administering correct/whole vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Fatigue, Injection site pain, Inner ear disorder
Clinical narrative: Arm pain at injection site; Dizzy; stuffy nose; inner ear balance problems; stuffy head; tired; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for rheumatoid arthritis.   On an unknown date, the patient received Shingrix (unknown arm). On 18-JUL-2023, the patient started Humira (subcutaneous) 40 mg once a day (40 mg daily). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Arm pain at injection site), dizziness (Verbatim: Dizzy), nasal stuffiness (Verbatim: stuffy nose), inner ear disorder (Verbatim: inner ear balance problems), sinus congestion (Verbatim: stuffy head) and tiredness (Verbatim: tired). Humira was continued with no change. The outcome of the injection site pain was unknown and the outcome of the dizziness, nasal stuffiness, inner ear disorder, sinus congestion and tiredness were not resolved.   The reporter considered the injection site pain and dizziness to be probably related to Shingrix. It was unknown if the reporter considered the nasal stuffiness, inner ear disorder, sinus congestion and tiredness to be related to Shingrix.     The company considered the injection site pain and dizziness to be probably related to Shingrix. It was unknown if the company considered the nasal stuffiness, inner ear disorder, sinus congestion and tiredness to be related to Shingrix.   Additional Information: Additional Information: GSK Receipt Date: 26-DEC-2023 The patient received Shingrix vaccine 2 doses in 2023. The patient was dizzy, she had arm pain at injection site, inner ear balance problems, stuffy head and nose, sinus congestion and tired. The causality with Humira suspect as per market authorization holder (MAH) and non-health care professional, global introspection, for dizzy and injection site pain was not related, for tiredness, nasal stuffiness, inner ear disorder and sinus congestion was not reported. The reporter did not consent to follow-up. Note: As per narrative information, it was unknown that after which dose of Shingrix patient had adverse events, hence single suspect of Shingrix captured without dose number.
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Respiratory tract congestion, Rheumatoid arthritis
Clinical narrative: Arm pain at injection site; Dizzy; stuffy nose; inner ear balance problems; stuffy head; tired; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for rheumatoid arthritis.   On an unknown date, the patient received Shingrix (unknown arm). On 18-JUL-2023, the patient started Humira (subcutaneous) 40 mg once a day (40 mg daily). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Arm pain at injection site), dizziness (Verbatim: Dizzy), nasal stuffiness (Verbatim: stuffy nose), inner ear disorder (Verbatim: inner ear balance problems), sinus congestion (Verbatim: stuffy head) and tiredness (Verbatim: tired). Humira was continued with no change. The outcome of the injection site pain was unknown and the outcome of the dizziness, nasal stuffiness, inner ear disorder, sinus congestion and tiredness were not resolved.   The reporter considered the injection site pain and dizziness to be probably related to Shingrix. It was unknown if the reporter considered the nasal stuffiness, inner ear disorder, sinus congestion and tiredness to be related to Shingrix.     The company considered the injection site pain and dizziness to be probably related to Shingrix. It was unknown if the company considered the nasal stuffiness, inner ear disorder, sinus congestion and tiredness to be related to Shingrix.   Additional Information: Additional Information: GSK Receipt Date: 26-DEC-2023 The patient received Shingrix vaccine 2 doses in 2023. The patient was dizzy, she had arm pain at injection site, inner ear balance problems, stuffy head and nose, sinus congestion and tired. The causality with Humira suspect as per market authorization holder (MAH) and non-health care professional, global introspection, for dizzy and injection site pain was not related, for tiredness, nasal stuffiness, inner ear disorder and sinus congestion was not reported. The reporter did not consent to follow-up. Note: As per narrative information, it was unknown that after which dose of Shingrix patient had adverse events, hence single suspect of Shingrix captured without dose number.
Sex: U
Vaccine: RSV
Symptoms: Feeling abnormal
Clinical narrative: Side effects not feeling; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 29-DEC-2023, the patient received Arexvy. In DEC-2023, an unknown time after receiving Arexvy, the patient experienced feeling abnormal (Verbatim: Side effects not feeling). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Arexvy.     It was unknown if the company considered the feeling abnormal to be related to Arexvy.   Additional Information: GSK receipt date: 30-DEC-2023 This case was reported by a consumer via (Open field AE monitoring) interactive digital media.  The reporter was patient. The patient was received Arexvy vaccine and experienced the moderate side effect feeling abnormal after the vaccination. The reporter did not consent to follow up.
Age: 39.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: the administration of Arexvy during pregnancy; 39 year old patient received Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 39-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9754D, expiry date 07-DEC-2024) for prophylaxis.   On 27-DEC-2023, the patient received the 1st dose of Arexvy. On 27-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 year old patient received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: the administration of Arexvy during pregnancy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 27-DEC-2023 A pharmacist contacted GlaxoSmithKline via phone inquiring about Arexvy and what information was available about any information available for the administration of Arexvy during pregnancy. The vaccine administration facility was the same as primary reporter. The Arexvy administered during pregnancy to a patient below than the recommended age limit, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Arexvy second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number PK74B, expiry date 22-FEB-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 27-DEC-2023, the patient received the 2nd dose of Arexvy. On 27-DEC-2023, an unknown time after receiving Arexvy and an unknown time after receiving AREXVY, the patient experienced extra dose administered (Verbatim: Arexvy second dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 27-DEC-2023 The pharmacist called and reported that a second dose of the Arexvy vaccine was administered to a patient on the day of reporting inadvertently, which led to extra dose administered. It was reported that a first dose had already been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to the follow up via email
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Underdose; an adult patient that was administered a pediatric dose of Engerix-B.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On 28-DEC-2023, the patient received Engerix B pediatric. On 28-DEC-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: an adult patient that was administered a pediatric dose of Engerix-B.). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt date: 28-DEC-2023 The reporter reported that on reporting day an adult patient that was administered a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. At the time of call, reporter did not have any patient details, or product lot number or expiration date information. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.