chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood chloride abnormal, Blood sodium increased, Diarrhoea, Discoloured vomit, Fall
Clinical narrative: On 5/10 at 1:45pm it was noted that resident at episode of emesis an order was obtained for zofran and if emesis continues to obtain KUB by ARNP, On the same day (5/10) resident had a fall at 2:34pm and noted with green emesis next to her. There was a small area to her right hip that appeared as pustules/shingles new orders obtained for KUB and Antibiotic treatment Acyclovir 800mg q6h for 7 days with a diagnosis of shingles, airborne isolation was initiated. 5/10 at 9:58pm resident noted to have hypoactive bowel sounds. on 5/11 documented she had large watery bowel movement after receiving medication to assist bowel movement.  Then on 5/11 at 7:13pm critical labs were recieved regarding sodium and chloride, the NP ordered IV 1/2 NS at 75cc/hr for 2 days and repeat BMP on Monday as well as increasing Potassium to 20meq BID. On 5/12 at 12:53pm resident was being sent to hospital for abnormal labs and altered mental status, order to send out received by ARNP. Admitted with Hypernatremia and other abnormal labs per ER Nurse at hospital.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal sounds abnormal, Herpes zoster, Hypernatraemia, Laboratory test abnormal, Mental status changes
Clinical narrative: On 5/10 at 1:45pm it was noted that resident at episode of emesis an order was obtained for zofran and if emesis continues to obtain KUB by ARNP, On the same day (5/10) resident had a fall at 2:34pm and noted with green emesis next to her. There was a small area to her right hip that appeared as pustules/shingles new orders obtained for KUB and Antibiotic treatment Acyclovir 800mg q6h for 7 days with a diagnosis of shingles, airborne isolation was initiated. 5/10 at 9:58pm resident noted to have hypoactive bowel sounds. on 5/11 documented she had large watery bowel movement after receiving medication to assist bowel movement.  Then on 5/11 at 7:13pm critical labs were recieved regarding sodium and chloride, the NP ordered IV 1/2 NS at 75cc/hr for 2 days and repeat BMP on Monday as well as increasing Potassium to 20meq BID. On 5/12 at 12:53pm resident was being sent to hospital for abnormal labs and altered mental status, order to send out received by ARNP. Admitted with Hypernatremia and other abnormal labs per ER Nurse at hospital.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pustule, Vomiting
Clinical narrative: On 5/10 at 1:45pm it was noted that resident at episode of emesis an order was obtained for zofran and if emesis continues to obtain KUB by ARNP, On the same day (5/10) resident had a fall at 2:34pm and noted with green emesis next to her. There was a small area to her right hip that appeared as pustules/shingles new orders obtained for KUB and Antibiotic treatment Acyclovir 800mg q6h for 7 days with a diagnosis of shingles, airborne isolation was initiated. 5/10 at 9:58pm resident noted to have hypoactive bowel sounds. on 5/11 documented she had large watery bowel movement after receiving medication to assist bowel movement.  Then on 5/11 at 7:13pm critical labs were recieved regarding sodium and chloride, the NP ordered IV 1/2 NS at 75cc/hr for 2 days and repeat BMP on Monday as well as increasing Potassium to 20meq BID. On 5/12 at 12:53pm resident was being sent to hospital for abnormal labs and altered mental status, order to send out received by ARNP. Admitted with Hypernatremia and other abnormal labs per ER Nurse at hospital.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC20, VARCEL
Symptoms: Hypersensitivity, Rash
Clinical narrative: The patient's mother noticed an allergic reaction to patient right after leaving the clinic on 5/13/24. Patient's mother noted the patient had a rash and a lot of little bumps under her chin, back, chest, and some on her arm and was taken to an urgent care. The patient received Dexamethasone and the patient's condition improved a few hours later.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A vaccine was administered to the wrong age group by mistake.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A vaccine was administered to the wrong age group by mistake.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Mom first noticed red raised area on left lateral thigh on 5/10/2024. According to mom the site was getting worse as child was scratching at the site.  Dr. has prescribed triamcinolone cream and ice to treat the reaction. Diagnosis is local reaction to an immunization.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Local hive reaction to left arm began about 1 day after vaccinations. Persisted for a week, when family sought medical evaluation. NO anaphylactic type symptoms
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary, COVID-19, Deep vein thrombosis, Detoxification, Echocardiogram
Clinical narrative: MODERNA #1 2/11/2021 MODERNA #2 3/10/2021 MODERNA #3 10/20/2021 PFIZER #4 10/18/2022 DEVELOPED BILATERAL DVT'S RIGHT LEG LARGER AND MORE PROXIMAL FALL 2021 SUFFERED MULTIPLE PULMONARY EMBOLI.  CLOTS DID NOT RESOLVE ON ELIQUIS 5 BID SO HERE PHYSICIAN USED ABOVE LABELLED DOSING.  LEFT LEG VEIN SCLEROTHERAPY WORSENED EDEMA AND BLOOD CLOTS.  STARTED 2024 ON PROTOCOL.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Laboratory test, Oedema, Pulmonary embolism, Sclerotherapy
Clinical narrative: MODERNA #1 2/11/2021 MODERNA #2 3/10/2021 MODERNA #3 10/20/2021 PFIZER #4 10/18/2022 DEVELOPED BILATERAL DVT'S RIGHT LEG LARGER AND MORE PROXIMAL FALL 2021 SUFFERED MULTIPLE PULMONARY EMBOLI.  CLOTS DID NOT RESOLVE ON ELIQUIS 5 BID SO HERE PHYSICIAN USED ABOVE LABELLED DOSING.  LEFT LEG VEIN SCLEROTHERAPY WORSENED EDEMA AND BLOOD CLOTS.  STARTED 2024 ON PROTOCOL.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler, Venogram
Clinical narrative: MODERNA #1 2/11/2021 MODERNA #2 3/10/2021 MODERNA #3 10/20/2021 PFIZER #4 10/18/2022 DEVELOPED BILATERAL DVT'S RIGHT LEG LARGER AND MORE PROXIMAL FALL 2021 SUFFERED MULTIPLE PULMONARY EMBOLI.  CLOTS DID NOT RESOLVE ON ELIQUIS 5 BID SO HERE PHYSICIAN USED ABOVE LABELLED DOSING.  LEFT LEG VEIN SCLEROTHERAPY WORSENED EDEMA AND BLOOD CLOTS.  STARTED 2024 ON PROTOCOL.
Age: 1.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: No adverse event
Clinical narrative: Covid 19 Vaccine was given Intramuscular in the Left Deltoid; No reactions or side effects noted. Immunization given 05/14/24 @ 1:25pm.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Covid 19 Vaccine was given Intramuscular in the Left Deltoid; No reactions or side effects noted. Immunization given 05/14/24 @ 1:25pm.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: No adverse event
Clinical narrative: none
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Unevaluable event
Clinical narrative: none
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient's arm at injection site was red, swollen, and warm to the touch
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This nurse administered a MMR immunization into the patients left thigh muscle. The vaccines expiration date was 5/10/24. The vaccine was administered 3 days past it's expiration date; it was administered on 5/13/24.
Age: 1.92
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient received an expired dose of vaccine. The vaccine expired 05/11/2024. The vaccine was given on 05/13/2024. He did not have a reaction
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine PROQUAD was administered. Patient developed swelling and erythema on left thigh.
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Fatigue, Feeling cold, Headache, Heart rate abnormal
Clinical narrative: I felt ice cold. I had a headache. Very tired, exhausted. I ached from head to toe. I had dizziness and light headedness. A change in heart rate but it didnt last very long. Also nauseous and still am. This lasted until 5/13 and even some today. I still feel lightheaded.
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Nausea, Pain
Clinical narrative: I felt ice cold. I had a headache. Very tired, exhausted. I ached from head to toe. I had dizziness and light headedness. A change in heart rate but it didnt last very long. Also nauseous and still am. This lasted until 5/13 and even some today. I still feel lightheaded.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Arteriosclerosis, Atrial fibrillation, Cardiac monitoring, Cardiac pacemaker insertion
Clinical narrative: MODERNA #1 8/13/2021 MODERNA #2 10/8/2021 PATIENT SHORTLY AFTWARDS DEVELOPED CONVUSIONS , PERIODIC APOPLEXY, COGNITIVE IMPAIRMENT,  RECURRENT AFIB, INSERTION OF PACEMAKER, ACCLERATION OF ATHEROSCLEROTIC CARDIOVASCULAR DISEASE WITH CORONARY STENTING.  DIAGNOSIS IS COVID-19 VACCINE INDUCED ATYPICAL SEIZURES.    FOUN TO BE ANA POSITIVE ANTIBODIES TO SPIKE 6110.  TREATED WITH ELIQUIS, NALTREXONE, HCQ, SERTRALINE, NICOTINE PATIENT, MULTIPLE FAILED ANTICONVULSANTS.  2024 STARTED PROTOCOL
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Cognitive disorder, Condition aggravated, Coronary arterial stent insertion, Detoxification
Clinical narrative: MODERNA #1 8/13/2021 MODERNA #2 10/8/2021 PATIENT SHORTLY AFTWARDS DEVELOPED CONVUSIONS , PERIODIC APOPLEXY, COGNITIVE IMPAIRMENT,  RECURRENT AFIB, INSERTION OF PACEMAKER, ACCLERATION OF ATHEROSCLEROTIC CARDIOVASCULAR DISEASE WITH CORONARY STENTING.  DIAGNOSIS IS COVID-19 VACCINE INDUCED ATYPICAL SEIZURES.    FOUN TO BE ANA POSITIVE ANTIBODIES TO SPIKE 6110.  TREATED WITH ELIQUIS, NALTREXONE, HCQ, SERTRALINE, NICOTINE PATIENT, MULTIPLE FAILED ANTICONVULSANTS.  2024 STARTED PROTOCOL
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Percutaneous coronary intervention, Scan brain
Clinical narrative: MODERNA #1 8/13/2021 MODERNA #2 10/8/2021 PATIENT SHORTLY AFTWARDS DEVELOPED CONVUSIONS , PERIODIC APOPLEXY, COGNITIVE IMPAIRMENT,  RECURRENT AFIB, INSERTION OF PACEMAKER, ACCLERATION OF ATHEROSCLEROTIC CARDIOVASCULAR DISEASE WITH CORONARY STENTING.  DIAGNOSIS IS COVID-19 VACCINE INDUCED ATYPICAL SEIZURES.    FOUN TO BE ANA POSITIVE ANTIBODIES TO SPIKE 6110.  TREATED WITH ELIQUIS, NALTREXONE, HCQ, SERTRALINE, NICOTINE PATIENT, MULTIPLE FAILED ANTICONVULSANTS.  2024 STARTED PROTOCOL
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: MODERNA #1 8/13/2021 MODERNA #2 10/8/2021 PATIENT SHORTLY AFTWARDS DEVELOPED CONVUSIONS , PERIODIC APOPLEXY, COGNITIVE IMPAIRMENT,  RECURRENT AFIB, INSERTION OF PACEMAKER, ACCLERATION OF ATHEROSCLEROTIC CARDIOVASCULAR DISEASE WITH CORONARY STENTING.  DIAGNOSIS IS COVID-19 VACCINE INDUCED ATYPICAL SEIZURES.    FOUN TO BE ANA POSITIVE ANTIBODIES TO SPIKE 6110.  TREATED WITH ELIQUIS, NALTREXONE, HCQ, SERTRALINE, NICOTINE PATIENT, MULTIPLE FAILED ANTICONVULSANTS.  2024 STARTED PROTOCOL
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Sinus disorder
Clinical narrative: Got  a sore throat, headache, sinus problems, low fever 101.1
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Bursitis, Injection site mass, Injection site oedema, Injection site pruritus
Clinical narrative: Patient received Tdap (Adacel) vaccine on 01/26/24 in office.  Patient reported on 01/31/24 that her arm was very sore, stiff to move, itches, and was swollen at injection site which started the following day after she received the vaccine (1/27/24). By day 3 patient stated symptoms worsened which prompted her to contact our office on 01/31/24.  Patient was seen in office for evaluation of her left arm/shoulder on 02/02/24. Patient reported lessened grip strength and tingling in arm and left hand. Patient had small golf-ball size mass on left arm/deltoid area. Soft tissue ultrasound was ordered same day was within normal limits with mild edema to area.  Patient then returned to our office on 3/1/24 for same issue of pain to left arm. Diagnosed with subacromial bursitis of left shoulder joint by PCP. She was referred to physical therapy.   Patient then contacted our office on 04/17/24 stating she still has tremendous amounts of pain in her left shoulder.  Patient has first physical therapy appointment on 5/17/24.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Patient received Tdap (Adacel) vaccine on 01/26/24 in office.  Patient reported on 01/31/24 that her arm was very sore, stiff to move, itches, and was swollen at injection site which started the following day after she received the vaccine (1/27/24). By day 3 patient stated symptoms worsened which prompted her to contact our office on 01/31/24.  Patient was seen in office for evaluation of her left arm/shoulder on 02/02/24. Patient reported lessened grip strength and tingling in arm and left hand. Patient had small golf-ball size mass on left arm/deltoid area. Soft tissue ultrasound was ordered same day was within normal limits with mild edema to area.  Patient then returned to our office on 3/1/24 for same issue of pain to left arm. Diagnosed with subacromial bursitis of left shoulder joint by PCP. She was referred to physical therapy.   Patient then contacted our office on 04/17/24 stating she still has tremendous amounts of pain in her left shoulder.  Patient has first physical therapy appointment on 5/17/24.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan abnormal
Clinical narrative: Patient received Tdap (Adacel) vaccine on 01/26/24 in office.  Patient reported on 01/31/24 that her arm was very sore, stiff to move, itches, and was swollen at injection site which started the following day after she received the vaccine (1/27/24). By day 3 patient stated symptoms worsened which prompted her to contact our office on 01/31/24.  Patient was seen in office for evaluation of her left arm/shoulder on 02/02/24. Patient reported lessened grip strength and tingling in arm and left hand. Patient had small golf-ball size mass on left arm/deltoid area. Soft tissue ultrasound was ordered same day was within normal limits with mild edema to area.  Patient then returned to our office on 3/1/24 for same issue of pain to left arm. Diagnosed with subacromial bursitis of left shoulder joint by PCP. She was referred to physical therapy.   Patient then contacted our office on 04/17/24 stating she still has tremendous amounts of pain in her left shoulder.  Patient has first physical therapy appointment on 5/17/24.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: unknown at this time
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal disorder, Headache, Influenza virus test negative, Malaise
Clinical narrative: I have always had the Pfizer Booster and never had any side effects or reactions.  I was told by Pharmacy Moderna only one available on the day I came  and was told it was totally fine and safe to take the Moderna Booster.  The day after the shot, I woke up very sick....head pains, stomach problems, diarrhea and a general sense of malaise.....I am still feeling sick as of this day....(May 14) and have actually gotten worse....I  feel like I have some horrible virus and I'm not getting better...I regret taking the Moderns Booster...I have never been this sick from any shots including the flue, shingles, and Pfizer...I need to know if Moderna has permanently affected my immune system???
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: I have always had the Pfizer Booster and never had any side effects or reactions.  I was told by Pharmacy Moderna only one available on the day I came  and was told it was totally fine and safe to take the Moderna Booster.  The day after the shot, I woke up very sick....head pains, stomach problems, diarrhea and a general sense of malaise.....I am still feeling sick as of this day....(May 14) and have actually gotten worse....I  feel like I have some horrible virus and I'm not getting better...I regret taking the Moderns Booster...I have never been this sick from any shots including the flue, shingles, and Pfizer...I need to know if Moderna has permanently affected my immune system???
Sex: F
Vaccine: HPV9
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: The patient recovered and became pregnant again and delivered a baby without an issue; This spontaneous retrospective pregnancy report as received from a physician refers to a female patient of unknown age. No information on patient's medical history, current conditions and concomitant medication was provided.       On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) while pregnant and had miscarriage (Exposure during pregnancy) (capture in #2404USA010164). On unknown date, the patient recovered and became pregnant again and delivered a baby without an issue (maternal exposure before pregnancy). The last menstrual period (LMP) and estimated due date (EDD) was not known.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects reported; HCP calling to report AE for administration of MMRII less than 28 days after the first dose of MMRII. Second dose of MMRII was administered on 09APR2024, but the first dose date of administration of MMRII could not be confirmed.; This spontaneous report was received from a pharmacist concerning to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On an unknown date in March 2024 (date could not be confirmed), the patient received the 1st dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiry date, anatomical location and route of administration were not provided). Then, on 09-APR-2024, less than 28 days after the 1st dose, the patient received the 2nd dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) lot # X002058, expiry date 19-JAN-2025 (anatomical location and route of administration were not provided) (inappropriate schedule of product administration) administered by a healthcare professional. Both vaccine doses were administered as prophylaxis. No side effects were reported (no adverse event).  1st dose lot # is being requested and will be submitted if received.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Maternal exposure before pregnancy, No adverse event
Clinical narrative: LMP 9/11/2023 and and third dose on 4/23/2024; he patient received first dose on 11/8/2021, second dose on 8/8/2022; LMP 9/11/2023; No additional AEs were reported; The patient received first dose on 11/8/2021, second dose on 8/8/2022, and third dose on 4/23/2024; This spontaneous prospective pregnancy report was received from other health professional (nurse) and refers to a 17-year-old female patient.  The patient's medical history and concurrent conditions were not provided. Concomitant medications included minerals not otherwise specified (nos) (+) vitamins nos (PRENATAL VITAMINS), levothyroxine, iron, and docusate sodium.   On 08-NOV-2021 (when she was 15-years-old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for vaccination (exact dose, lot #, expiry date, anatomical location, and route of administration were not provided). On 08-AUG-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for vaccination (exact dose, lot #, expiry date, anatomical location, and route of administration were not provided).   The patient became pregnant with last menstrual period (LMP) on 11-SEP-2023 (maternal exposure before pregnancy). Estimated date of delivery (EDD) was calculated (as on 17-JUN-2024).   On 23-APR-2024 (when she was 32 weeks pregnant), the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (formulation pre-filled syringe), lot #1957407 with established expiration date: 23-JAN-2026, administered for vaccination (exact dose, anatomical location, and route of administration were not provided) (exposure during pregnancy and inappropriate schedule of product administration). No additional adverse events (AEs) were reported (no adverse event). Pregnancy outcome was outcome pending. Fetal outcome was unknown. Number of fetus was 1 (as default).  Lot # (for 1st and 2nd dose) is being requested and will be submitted if received.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HBP calling with an inquiry on GARDASIL-9 alternate dosing schedule for a male patient who received his first dose of GARDASIL-9 at age 25 and his second dose around 3 years after the first dose.; No additional AE/PQC.; This spontaneous report was received from other reporter regarding to an adult male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On an unspecified date (also reported as "at age 25"), the patient was vaccinated with the first dose of human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection and his second dose around 3 years after the first dose (strengths, doses, frequencies, routes of administration, anatomical injection sites, lot numbers and expiration dates were not provided) for prophylaxis (inappropriate schedule of product administration).   HBP calling with an inquiry on HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) alternate dosing schedule. Caller declined to report the adverse event (AE) at this time and declined consent to follow up with the health care professional (HCP) regarding the AE. No additional AE/product quality complaint (PQC) (no adverse event).  Additional information is not expected.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional information available on AE/No PQC.; Mother of patient reports that her son received the first dose of VAQTA on 3/4/2022 and the second dose 4 months later.; This spontaneous report was received from a consumer (the patient's mother) regarding to her son, a male patient of unspecified age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 04-MAR-2022, the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection and on approximately 04-JUL-2022 (also reported as "4 months later"), he was vaccinated with the second dose (strengths, doses, frequencies, routes of administration, anatomical injection sites, lot numbers and expiration dates were not provided) for prophylaxis (inappropriate schedule of product administration).  No side effects reported. No additional information available on adverse event (AE)/no product quality complaint (PQC) (no adverse event).  Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who was administered improperly stored VARIVAX on 4/29/2024.; This spontaneous report was received from other health professional (medical assistant) regarding to a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 29-APR-2024, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml)/dose, lot number X023323 (lot number X023323 had been verified to be valid lot number for varicella virus vaccine live [Oka/Merck] [VARIVAX]), expiration date 20-SEP-2025, (strength, route of administration and anatomical injection site were not provided) for prophylaxis, that was improperly stored (temperature/duration: 18.5 fahrenheit / 14 fahrenheit up to 46 fahrenheit for 53 hours 28 minutes 0 seconds) (product storage error).   No symptoms reported. Obtained consent to contact health care professional (HCP). No additional adverse event (AE)/product quality complaint (PQC) (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported. No additional AE; patient who was administered improperly stored VARIVAX on 4/29/2024; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, and drug reactions or allergies were not reported.  On 29-APR-2024, the patient received an improperly stored dose of varicella virus vaccine live (VARIVAX) injection, 0.5 ml/dose, lot # X023323 with expiration date 20-SEP-2025 (strength and route of administration were not reported), for prophylaxis. The dose of varicella virus vaccine live (VARIVAX) was exposed to a temperature excursion of 18.5 degrees Fahrenheit (F), 14 F up to 46 F during a timeframe of 23 minutes and 28 minutes. There were no previous temperature excursions. No symptoms or additional adverse event reported.    This is one of several reports received from the same reporter.
Age: 0.33
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no side effects have been reported; HCP calling to report a 4-month-old inadvertently received PNEUMOVAX 23 instead of the 2nd dose of VAXNEUVANCE; CP calling to report a 4-month-old inadvertently received PNEUMOVAX 23 instead of the 2nd dose of VAXNEUVANCE; The spontaneous report was received by a nurse, regarding a 4-months-old male patient. The patient's medical history, concurrent condition, and concomitant medication were not provided.   On unspecified date, the patient was vaccinated with the first dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (formulation, strength, dose, route of administration, vaccination scheme, anatomical site of vaccination, lot number, and expiration date were not reported) as a prophylaxis.   On 30-APR-2024, the patient was inadvertently vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX 23) (product use issue) (formulation, strength, dose, route of administration, vaccination scheme, anatomical site of vaccination, lot number W011148, which had been verified to be valid, expiration date was not reported, but upon internal validation established as 06-MAY-2024) as a prophylaxis; instead of the second dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (wrong product administered) (product dose omission in error event captured in MARRS# 2405USA001810). No further information was given. No additional adverse event (AE) had been reported.
Age: 0.33
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no side effects have been reported; HCP stated patient missed their second dose of VAXNEUVANCE; The spontaneous report was received by a nurse, regarding a 4-months-old male patient. The patient's medical history, concurrent condition, and concomitant medication were not provided.   On unspecified date, the patient was vaccinated with the first dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (formulation, strength, dose, route of administration, vaccination scheme, anatomical site of vaccination, lot number, and expiration date were not reported) as a prophylaxis.   On 30-APR-2024, the patient did not received the second dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (product dose omission in error) because of he inadvertently received pneumococcal 23v polysaccharide vaccine (PNEUMOVAX 23) (formulation, strength, dose, route of administration, vaccination scheme, anatomical site of vaccination, lot number W011148, which had been verified to be valid, expiration date was not reported, but upon internal validation established as 06-MAY-2024) as a prophylaxis (product use issue and wrong product administered events captured in MARRS # 2405USA001320). No further information was given. No additional adverse event (AE) had been reported.
Sex: F
Vaccine: HPV4
Symptoms: Endometriosis, Fibromyalgia, Pain
Clinical narrative: endometriosis; fibromyalgia; Information has been received from a physician via social media regarding a case in litigation, concerning a female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  The injured patient was diagnosed with endometriosis and fibromyalgia after suffering excruciating pain. The outcome was not reported. The causality was related.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2405USA002786: US-009507513-2405USA002824:
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: patient had serologic testing done and her titer for rubella immunity were low at 0.94.; This spontaneous report was received from a medical assistant and referred to a 43-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) injection, (strength, dose description, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date, the patient had a serologic testing done and her titer for rubella immunity were low at 0.94 (units not provided) (rubella antibody negative) (it was stated that the reporter believed that the patient was previously vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live [reported as a "measles, mumps and rubella vaccine"]; however, the medical assistant was unable to provide the name of the vaccine or dates of administration). No further information was provided. No additional adverse event (AE) reported. No product quality complaint (PQC) reported. At the reporting time, the outcome of the event rubella antibody negative was unknown.  The causal relationship between the event of rubella antibody negative and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not provided.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired dose of ROTATEQ was administered inadvertently; This spontaneous report was received from a nurse and refers to a 4-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-MAY-2024, the patient was inadvertently vaccinated with second and expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (2nd dose, vial 2, lot #1947622, expiration date: 04-MAY-2024, administered orally, exact dose was not provided) for prophylaxis (Expired vaccine used). The product did not have a temperature excursion. No additional AE/PQC (No adverse event)..
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: No adverse reactions; Product was mistakenly put into clinic stock and administered; Shipment was delayed; This spontaneous report was received from a healthcare worker concerning a 12-months-old female patient. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 28-FEB-2024, the product was ordered and shipment was supposed to be received on or before 02-MAR-2024, however shipment was delayed for 6 additional days and was received on 08-MAR-2024 (shipment delay issue). On 19-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, lot #X023876, expiration date: 27-MAR-2025, administered subcutaneously in the right leg for prophylaxis (strength, dose and frequency were not provided). The vaccine was mistakenly put into clinic stock and was administered (incorrect product storage). The staff was educated on the cold chain, storage and handling of vaccines to avoid future mistakes. Patient was notified and scheduled for a repeat dose.  No adverse reactions were reported with initial dose or repeat dose.  This is one of several cases from the same reporter.
Sex: U
Vaccine: RVX
Symptoms: Cough, Influenza like illness, Respiratory syncytial virus infection, Rhinorrhoea, Sneezing
Clinical narrative: Coughing; sneezing; clogged up with mucus; Feels like the flu; suspected vaccination failure/I have had it for about six months; Respiratory syncytial virus infection/I have had it for about six months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/I have had it for about six months) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection/I have had it for about six months), cough (Verbatim: Coughing), sneezing (Verbatim: sneezing), nasal mucus increased (Verbatim: clogged up with mucus) and influenza like illness (Verbatim: Feels like the flu). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was resolved (duration 6 months) and the outcome of the cough, sneezing, nasal mucus increased and influenza like illness were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, cough, sneezing, nasal mucus increased and influenza like illness to be related to RSV vaccine.     It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection, cough, sneezing, nasal mucus increased and influenza like illness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 07-MAY-2024 The case was received from the patient via interactive digital media.   The patient reported he/she received the RSV vaccine and had them for about six months. The patient also suffered from coughing, sneezing and clogged up with mucus.  The patient also felt like the flu and did not thought that he/she was going to get over it. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of respiratory syncytial virus infection were unknown at the time of reporting.
Sex: U
Vaccine: RVX
Symptoms: Vaccination failure
Clinical narrative: Coughing; sneezing; clogged up with mucus; Feels like the flu; suspected vaccination failure/I have had it for about six months; Respiratory syncytial virus infection/I have had it for about six months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/I have had it for about six months) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection/I have had it for about six months), cough (Verbatim: Coughing), sneezing (Verbatim: sneezing), nasal mucus increased (Verbatim: clogged up with mucus) and influenza like illness (Verbatim: Feels like the flu). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was resolved (duration 6 months) and the outcome of the cough, sneezing, nasal mucus increased and influenza like illness were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, cough, sneezing, nasal mucus increased and influenza like illness to be related to RSV vaccine.     It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection, cough, sneezing, nasal mucus increased and influenza like illness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 07-MAY-2024 The case was received from the patient via interactive digital media.   The patient reported he/she received the RSV vaccine and had them for about six months. The patient also suffered from coughing, sneezing and clogged up with mucus.  The patient also felt like the flu and did not thought that he/she was going to get over it. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of respiratory syncytial virus infection were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the vaccine and I have them / Suspected vaccination failure; Shingles; Its been a month and are so painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the vaccine and I have them / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Its been a month and are so painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAY-2024 The patient had the vaccine and still had them. Its been a month. It was so painful. This case was considered as suspected vaccination failure since the details regarding completion of primary  vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: MEN
Symptoms: Feeling abnormal, Meningitis, Vaccination failure
Clinical narrative: got spinal meningitis; almost died; got spinal meningitis/couple weeks after the vaccine/Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 15-year-old patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, several weeks after receiving Meningococcal B vaccine, the patient experienced vaccination failure (Verbatim: got spinal meningitis/couple weeks after the vaccine/Suspected vaccination failure) (serious criteria GSK medically significant), spinal meningitis (Verbatim: got spinal meningitis) (serious criteria hospitalization and GSK medically significant) and near death experience (Verbatim: almost died) (serious criteria hospitalization and GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the spinal meningitis and near death experience were not reported.   It was unknown if the reporter considered the vaccination failure, spinal meningitis and near death experience to be related to Meningococcal B vaccine.   It was unknown if the company considered the vaccination failure, spinal meningitis and near death experience to be related to Meningococcal B vaccine.   Additional Information: GSK Receipt Date: 08-MAY-2024 This case was reported by a patient via interactive digital media. The patient had got spinal meningitis when he/she was 15, a couple weeks after the vaccine and the patient was almost died. The patient was hospitalized for two weeks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation regarding meningitis were unknown at the time of reporting.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Needle issue, Underdose
Clinical narrative: needle popped off, due to this the patient did not receive full dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number L995Y, expiry date 15-MAY-2026) for prophylaxis.   On 01-MAY-2024, the patient received the 1st dose of Shingrix. On 01-MAY-2024, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: needle popped off, due to this the patient did not receive full dose). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 01-MAY-2024 The pharmacist stated that her technician was administering 1st dose of Shingrix to the patient. The needle popped off (GlaxoSmithKline did not supply syringes or needles for this product thus there was no product quality complaint nor did she ask for a replacement), and due to this the patient did not receive the full dose, which led to accidental underdose. The reporter was contacting GlaxoSmithKline to speak to GlaxoSmithKline medical information (GSK) regarding what they advise she to help this patient.  No further details were obtained as call was transferred to GlaxoSmithKline medical information (GSK). The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: The patient is saying he got it, but the records are showing the second dose was refused/in a mental health; This serious case was reported by a pharmacist via call center representative and described the occurrence of hospitalization in a male patient 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 hospitalization (Verbatim: The patient is saying he got it, but the records are showing the second dose was refused/in a mental health) (serious criteria hospitalization). The outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Engerix B.     It was unknown if the company considered the hospitalization to be related to Engerix B.   Additional Information: GSK Receipt Date: 30-MAR-2024 The reporter asked if a patient only got 1 of 3 Engerix-b (hep B) vaccines, they would need to restart the series.  Upon callback to speak with pharmacist on 1st May2024, pharmacist provided the following that they were still trying to investigate but they could not find the records.  The patient was saying he got it but the records were showing the second dose was refused. She added the patient was in a mental health hospital and was not the best historian but they were currently trying to determine whether in fact the second dose of the Engerix-B series was missed. No further details were provided by pharmacist on the call, as investigation was still ongoing but pharmacist consented to follow up from safety. The reporter consented to follow up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness to the left arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number C27N4) for prophylaxis.   On 02-APR-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 02-APR-2024, 2 hrs after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm soreness to the left arm). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date 2 May 2024: The pharmacist reported that patient received his 2nd SHINGRIX vaccine on 02-APR-2024 and complains of arm soreness to the left arm ever since he received the vaccine. This adverse event was ongoing. 2nd vaccine given in the left deltoid. The reporter consented to follow up. The permission granted to contact.