chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2, FLU4, VARZOS
Symptoms: Chest X-ray, Cogwheel rigidity, Computerised tomogram head, Dehydration, Dizziness
Clinical narrative: 10/12/22 and 10/13/22:  seen in clinic for chest wall pain and extensive shingles rash / pain Rt anterolateral chest and axilla day after vaccines, then spread to back in following week. 10/24/22 Seen in ER for : Weakness, fatigue, dizziness, dehydration, medication side effects, discharged home.  11/1/22 Seen in ER for:  Weakness, fatigue/malaise, orthostatic hypotension 11/1/22 -11/4/22 Admit to hospital ACF inpatient  - MD suspicious of pt developing Parkinson's like disorder d/t hand tremor at rest, cogwheel rigitity, flat facies, slow shuffling gait and changes in handwriting - referral to neurologist, PT, OT, ST were made. 11/7/22 Follow up with PCP, Dr.  11/16/22 Follow up with FNP,
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2, FLU4, VARZOS
Symptoms: Dysgraphia, Electrocardiogram, Fatigue, Full blood count, Gait disturbance
Clinical narrative: 10/12/22 and 10/13/22:  seen in clinic for chest wall pain and extensive shingles rash / pain Rt anterolateral chest and axilla day after vaccines, then spread to back in following week. 10/24/22 Seen in ER for : Weakness, fatigue, dizziness, dehydration, medication side effects, discharged home.  11/1/22 Seen in ER for:  Weakness, fatigue/malaise, orthostatic hypotension 11/1/22 -11/4/22 Admit to hospital ACF inpatient  - MD suspicious of pt developing Parkinson's like disorder d/t hand tremor at rest, cogwheel rigitity, flat facies, slow shuffling gait and changes in handwriting - referral to neurologist, PT, OT, ST were made. 11/7/22 Follow up with PCP, Dr.  11/16/22 Follow up with FNP,
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2, FLU4, VARZOS
Symptoms: Herpes zoster, Malaise, Metabolic function test, Musculoskeletal chest pain, Orthostatic hypotension
Clinical narrative: 10/12/22 and 10/13/22:  seen in clinic for chest wall pain and extensive shingles rash / pain Rt anterolateral chest and axilla day after vaccines, then spread to back in following week. 10/24/22 Seen in ER for : Weakness, fatigue, dizziness, dehydration, medication side effects, discharged home.  11/1/22 Seen in ER for:  Weakness, fatigue/malaise, orthostatic hypotension 11/1/22 -11/4/22 Admit to hospital ACF inpatient  - MD suspicious of pt developing Parkinson's like disorder d/t hand tremor at rest, cogwheel rigitity, flat facies, slow shuffling gait and changes in handwriting - referral to neurologist, PT, OT, ST were made. 11/7/22 Follow up with PCP, Dr.  11/16/22 Follow up with FNP,
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2, FLU4, VARZOS
Symptoms: Red blood cell sedimentation rate, Reduced facial expression, Tremor, Urine analysis
Clinical narrative: 10/12/22 and 10/13/22:  seen in clinic for chest wall pain and extensive shingles rash / pain Rt anterolateral chest and axilla day after vaccines, then spread to back in following week. 10/24/22 Seen in ER for : Weakness, fatigue, dizziness, dehydration, medication side effects, discharged home.  11/1/22 Seen in ER for:  Weakness, fatigue/malaise, orthostatic hypotension 11/1/22 -11/4/22 Admit to hospital ACF inpatient  - MD suspicious of pt developing Parkinson's like disorder d/t hand tremor at rest, cogwheel rigitity, flat facies, slow shuffling gait and changes in handwriting - referral to neurologist, PT, OT, ST were made. 11/7/22 Follow up with PCP, Dr.  11/16/22 Follow up with FNP,
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pfizer Covid-Monovalent Booster given erroneously instead of Bivalent. No symptoms reported
Age: 29.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: accidently gave me a double dose of Pfizer (Covid 19 vaccine bivalent) instead of Pfizer (Covid 19 vaccine bivalent) and Flu shot (Unspecified Flu Shot); little light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 17:05 as dose number unknown (booster), single (Lot number: GJ6665, Expiration Date: Jun2023) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing), notes: Seasonal allergy medication (not clarified). Concomitant medication(s) included: IBUPROFEN; ALBUTEROL [SALBUTAMOL] taken for asthma. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset 10Nov2022, outcome "recovering", described as "little light headed"; ACCIDENTAL OVERDOSE (non-serious) with onset 10Nov2022 at 17:05, outcome "unknown", described as "accidently gave me a double dose of Pfizer (Covid 19 vaccine bivalent) instead of Pfizer (Covid 19 vaccine bivalent) and Flu shot (Unspecified Flu Shot)".
Age: 29.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Accidental overdose, Dizziness
Clinical narrative: accidently gave me a double dose of Pfizer (Covid 19 vaccine bivalent) instead of Pfizer (Covid 19 vaccine bivalent) and Flu shot (Unspecified Flu Shot); little light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 17:05 as dose number unknown (booster), single (Lot number: GJ6665, Expiration Date: Jun2023) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing), notes: Seasonal allergy medication (not clarified). Concomitant medication(s) included: IBUPROFEN; ALBUTEROL [SALBUTAMOL] taken for asthma. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset 10Nov2022, outcome "recovering", described as "little light headed"; ACCIDENTAL OVERDOSE (non-serious) with onset 10Nov2022 at 17:05, outcome "unknown", described as "accidently gave me a double dose of Pfizer (Covid 19 vaccine bivalent) instead of Pfizer (Covid 19 vaccine bivalent) and Flu shot (Unspecified Flu Shot)".
Age: 14.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2, FLUC4
Symptoms: Eye movement disorder, Injection site haemorrhage, Syncope, Tremor
Clinical narrative: THE PFIZER BOOSTER WAS ADMINISTERED FIRST.  THEN THE FLUCELVAX.  PATIENT WAS BLEEDING SLIGHTLY.   PATIENT'S ARMS STARTED TO JERK AND SHE PASSED OUT.  MOTHER AND I CAUGHT PATIENT BEFORE SHE SLUMPED COMPLETELY FORWARD.  MOTHER SAID HER EYES ROLLED SLIGHTLY.  SHE WAS ONLY OUT FOR A BRIEF TIME.  HER MOTHER AND I INQUIRED ABOUT WHO SHE WAS, WHERE SHE WAS AND THE TIME OF DAY.  SHE WAS ABLE TO ANSWER ALL QUESTIONS.
Age: 14.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2, FLUC4
Symptoms: Dyskinesia, Eye movement disorder, Haemorrhage, Loss of consciousness
Clinical narrative: THE PFIZER BOOSTER WAS ADMINISTERED FIRST.  THEN THE FLUCELVAX.  PATIENT WAS BLEEDING SLIGHTLY.   PATIENT'S ARMS STARTED TO JERK AND SHE PASSED OUT.  MOTHER AND I CAUGHT PATIENT BEFORE SHE SLUMPED COMPLETELY FORWARD.  MOTHER SAID HER EYES ROLLED SLIGHTLY.  SHE WAS ONLY OUT FOR A BRIEF TIME.  HER MOTHER AND I INQUIRED ABOUT WHO SHE WAS, WHERE SHE WAS AND THE TIME OF DAY.  SHE WAS ABLE TO ANSWER ALL QUESTIONS.
Age: 29.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Muscle swelling
Clinical narrative: Redness, swelling around the injection site that has spread down out and around the upper deltoid and into the left side axilla bicep.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Anxiety, Back pain
Clinical narrative: I developed severe and long lasting gastrointestinal problems including but not limited too severe abdominal pain, lack of appetite resulting in a weight loss of over 10 pounds in 2 months, constant nausea, diarrhea, constant urination lasting for months, constant high heart rate, lightheadedness and dizziness, itching, feeling flush, chills, foggyness and confusion, severe back pain and acid indigestion, issues with blood sugar, gastritis, easily brusied, development of anxiety and depression, stomach feeling inflamed bloated and irritated, heart palpitations and chest pain
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood test, Chest pain, Chills, Confusional state
Clinical narrative: I developed severe and long lasting gastrointestinal problems including but not limited too severe abdominal pain, lack of appetite resulting in a weight loss of over 10 pounds in 2 months, constant nausea, diarrhea, constant urination lasting for months, constant high heart rate, lightheadedness and dizziness, itching, feeling flush, chills, foggyness and confusion, severe back pain and acid indigestion, issues with blood sugar, gastritis, easily brusied, development of anxiety and depression, stomach feeling inflamed bloated and irritated, heart palpitations and chest pain
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Depression, Diarrhoea, Dizziness, Dyspepsia
Clinical narrative: I developed severe and long lasting gastrointestinal problems including but not limited too severe abdominal pain, lack of appetite resulting in a weight loss of over 10 pounds in 2 months, constant nausea, diarrhea, constant urination lasting for months, constant high heart rate, lightheadedness and dizziness, itching, feeling flush, chills, foggyness and confusion, severe back pain and acid indigestion, issues with blood sugar, gastritis, easily brusied, development of anxiety and depression, stomach feeling inflamed bloated and irritated, heart palpitations and chest pain
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Endoscopic ultrasound, Feeling abnormal, Flushing, Gastritis
Clinical narrative: I developed severe and long lasting gastrointestinal problems including but not limited too severe abdominal pain, lack of appetite resulting in a weight loss of over 10 pounds in 2 months, constant nausea, diarrhea, constant urination lasting for months, constant high heart rate, lightheadedness and dizziness, itching, feeling flush, chills, foggyness and confusion, severe back pain and acid indigestion, issues with blood sugar, gastritis, easily brusied, development of anxiety and depression, stomach feeling inflamed bloated and irritated, heart palpitations and chest pain
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Heart rate increased, Increased tendency to bruise, Laboratory test, Nausea
Clinical narrative: I developed severe and long lasting gastrointestinal problems including but not limited too severe abdominal pain, lack of appetite resulting in a weight loss of over 10 pounds in 2 months, constant nausea, diarrhea, constant urination lasting for months, constant high heart rate, lightheadedness and dizziness, itching, feeling flush, chills, foggyness and confusion, severe back pain and acid indigestion, issues with blood sugar, gastritis, easily brusied, development of anxiety and depression, stomach feeling inflamed bloated and irritated, heart palpitations and chest pain
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pollakiuria, Pruritus, Weight decreased
Clinical narrative: I developed severe and long lasting gastrointestinal problems including but not limited too severe abdominal pain, lack of appetite resulting in a weight loss of over 10 pounds in 2 months, constant nausea, diarrhea, constant urination lasting for months, constant high heart rate, lightheadedness and dizziness, itching, feeling flush, chills, foggyness and confusion, severe back pain and acid indigestion, issues with blood sugar, gastritis, easily brusied, development of anxiety and depression, stomach feeling inflamed bloated and irritated, heart palpitations and chest pain
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oedema peripheral, Swelling
Clinical narrative: Swollen under armpit for three days now, also neck is swollen slightly
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Headache, Pain, Somnolence
Clinical narrative: Chills, dizziness,mild body aches , headache and drowsy
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye swelling, Hypersensitivity, Pruritus
Clinical narrative: Right eye swollen, allergic reaction Body itching
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphthous ulcer, Vulvovaginal ulceration
Clinical narrative: Oral and vulvar/vaginal aphthous ulcers.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Urticaria, Vomiting
Clinical narrative: high fever; vomiting; hives (lower body); This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 06Nov2021, for COVID-19 immunization; BNT162b2 (Dose 2), administration date: 27Nov2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever"; VOMITING (non-serious), outcome "unknown"; URTICARIA (non-serious), outcome "unknown", described as "hives (lower body)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: Event took place after use of product. Patient took TYLENOL for the fever.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; HCP reporting an expired dose of GARDASIL 9 (Lot: 1687291, Expiration Date: 11SEP2022) was administered to a patient today; This spontaneous report was received from registered nurse and refers to a 26-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-OCT-2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection syringe, 0.5 milliliter, lot #1687291, expiration date: 11-SEP-2022 (expired product administered), administered intramuscularly in left deltoid for prophylaxis. The vaccine was not available for return/evaluation as it was last dose in box. The vaccine was administered inadvertently to the patient by trained healthcare professional (registered nurse). The vaccine did not need to be repeated as there was no temperature excursions prior to use. The patient was notified and she denied any concerns at the time of notification. No adverse event was reported.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE was reported; her son received an expired MMR 2 vaccine; This spontaneous report was received from the patient's grandmother concerning a 12-month-old male patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.   On an unspecified date in 2022 (reported as "a couple of weeks ago"), the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) as prophylaxis (Expired product administered) (dose, route of administration, injection anatomical location, lot # and expiration date were not reported). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available. No additional AE reported.; 1 dose of ROTATEQ was administered to 1 patient/Temperature ABOVE 9°C (11.9C) for 1 hour 9 minutes and 0 seconds; This spontaneous report has been received from a licensed practical nurse referring to a patient of unspecified age or gender. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported.  On 27-OCT-2022, the patient administered with improperly stored 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot# W02562, expiration date 12-OCT-2023, anatomical location and strength were unknown) orally for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions above 9 degree Celsius (C) (11.9 C) for 1 hour 9 minutes and 0 seconds (product storage error). There were no previous temperature excursions. No additional AE was provided (no adverse event).
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; administered his second dose of VAQTA too early; This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On 21-JUN-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) first dose (strength, dose description, lot #, expiration date and route of administration were not provided) for prophylaxis. On 28-OCT-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) second dose, 0.5 milliliter, lot #W021491, expiration date: 14-DEC-2023 (strength and route of administration were not provided) for prophylaxis (Inappropriate schedule of product administration) No adverse events were reported (No adverse event).  It was stated that the patient received numerous other vaccines too early (names of other vaccines were not provided). It was confirmed that hepatitis a vaccine, inactivated (VAQTA) was the only Merck product given too early and the remainder of the other vaccines administered were other company vaccines.
Sex: F
Vaccine: COVID19, PPV, VARZOS
Symptoms: Muscle spasms
Clinical narrative: muscle spams; This spontaneous report was received from a consumer referring to herself, a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  The patient reported experiencing muscle spasms on an unknown date after being vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), zoster vaccine live (ZOSTAVAX), and an unspecified covid-19 vaccine (dose, vaccination scheme frequency, route of administration, anatomical site of vaccination, lot # and expiration date were not reported). Additionally, the consumer elaborated that she received the zoster vaccine live (ZOSTAVAX) and unspecified covid-19 vaccine shot concomitantly. However, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was given during a separate appointment. She stated she experienced the muscle spasms long after being vaccinated with all three vaccines. The consumer also mentioned that she had been previously prescribed gabapentin 300 mg before to treat an earlier experienced spasm (strength, formulation, frequency, lot #, expiry date, and route of administration were not provided). This separate experience was prior to the consumer being vaccinated pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), zoster vaccine live (ZOSTAVAX), and the unspecified covid-19 vaccine. The outcome of muscle spasms was unknown. No further information provided. No additional adverse events reported. No product quality complaints reported.  The causal relationship between muscle spasms and the suspect therapies was unknown.
Age: 81.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was accidently administered VAXNEUVANCE instead of a flu vaccine; No additional AE; This spontaneous report was received from a registered nurse concerning an 81-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 10-NOV-2022, the patient was administered accidentally a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 ml/once, administered as prophylaxis, lot number U036156 with expiration date 25-MAY-2023 (route of administration was not provided), instead of a flu vaccine (unspecified) (Wrong product administered). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; administered Improperly Stored M-M-R II lot; This spontaneous report has been received from a registered nurse referring a patient of unknown age and gender patient. The pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unspecified date on October 2022 (also reported as 05-OCT-2022, 06-OCT-2022, 07-OCT-2022, 11-OCT-2022, 13-OCT-2022, 14-OCT-2022, 18-OCT-2022, 20-OCT-2022, 24-OCT-2022) the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot number W009107 with expiration date 04-DEC-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error).   The administered vaccine experienced a temperature excursion of 47.5 degree fahrenheit (F) for 5 minutes. There was no previous temperature excursion. No additional adverse event reported.   This is one of several reports from same reporter.; Sender's Comments:  US-009507513-2210USA010278:
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product prescribing issue
Clinical narrative: a 47 year old female was given a prescription by her physician for GARDASIL 9; No additional AE reported; This spontaneous report was received from a consumer referring to herself a 47 years-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included  divorced. Concomitant therapies were not reported. Previous drugs reactions or allergies were not reported.  On an unknown date, the patient was given a prescription by her physician for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (Product prescribing issue). No additional adverse event were reported
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; administered Improperly Stored M-M-R II lot; This spontaneous report has been received from a registered nurse referring a patient of unknown age and gender patient. The pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unspecified date on October 2022 (also reported as 05-OCT-2022, 06-OCT-2022, 07-OCT-2022, 11-OCT-2022, 13-OCT-2022, 14-OCT-2022, 18-OCT-2022, 20-OCT-2022, 24-OCT-2022) the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot number W009107 with expiration date 04-DEC-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error).   The administered vaccine experienced a temperature excursion of 47.5 degree fahrenheit (F) for 5 minutes. There was no previous temperature excursion. No additional adverse event reported.   This is one of several reports from same reporter.; Sender's Comments:  US-009507513-2210USA010278: US-009507513-2210USA010278:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; administered Improperly Stored M-M-R II lot; This spontaneous report has been received from a registered nurse referring a patient of unknown age and gender patient. The pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unspecified date on October 2022 (also reported as 05-OCT-2022, 06-OCT-2022, 07-OCT-2022, 11-OCT-2022, 13-OCT-2022, 14-OCT-2022, 18-OCT-2022, 20-OCT-2022, 24-OCT-2022) the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot number W009107 with expiration date 04-DEC-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error).   The administered vaccine experienced a temperature excursion of 47.5 degree fahrenheit (F) for 5 minutes. There was no previous temperature excursion. No additional adverse event reported.   This is one of several reports from same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; administered Improperly Stored M-M-R II lot; This spontaneous report was received from Other Health Professional and refers to a.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-OCT-2022, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   On an unknown date, the patient experienced No additional AE.. On an unknown date in October 2022, the patient experienced administered Improperly Stored M-M-R II lot. At the time of reporting, the outcome of the event administered Improperly Stored M-M-R II lot was not known. The action taken with M-M-R II regarding administered Improperly Stored M-M-R II lot was reported as Not Applicable. The action taken with M-M-R II regarding No additional AE. was reported as Not Applicable.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was administered a pediatric dose of VAQTA; the patient had received his first dose of VAQTA as a child, but did not receive the second dose within the time frame recommended within the prescribing information; No additional AE reported; This spontaneous report was received from a pharmacist, via a company representative, referring to a 19-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA), 0.5 milliliter for prophylaxis. (strength, route of administration, lot # and expiration date were not reported). Caller stated the health care professional (HCP) did not provide the date the pediatric dose of hepatitis a vaccine, inactivated(VAQTA) was administered. Caller stated the patient was following the "catch up" vaccination schedule as the patient had received his first dose of hepatitis a vaccine, inactivated(VAQTA) as a child, but did not receive the second dose within the time frame recommended within the prescribing information. Caller did not have any information about the dates of administration. No additional adverse event (AE) was reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 1st Dose of Heplisav-B Then Received 2nd Dose Engerix-B; Initial Report Received on 13-Jun-2022  A pharmacist reported that a 41-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose instead of HEPLISAV-B.  No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On 30-Oct-2021, the patient received the first dose of HEPLISAV-B (Lot # 934967, expiration date 11-Apr-2022, NDC # 43528-003-05) intramuscularly in the left deltoid at a pharmacy.   On an unspecified date in Dec-2021, after having been vaccinated with HEPLISAV-B, the patient received the second dose at the doctor's office but with Engerix-B instead (Lot #, expiration date, NDC #, route, and injection site unknown). The patient did not experience any adverse effects from the doses she received.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles come back with vengeance/ Suspected vaccination failure; shingles come back with vengeance; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05-Nov-2022 Reporter's comment: This case was reported via interactive digital media. The physician told that it could get the shingles vaccines right after having the shingles. The pharmacist and chiropractor said no 6 months to a year as they could come back with a vengeance taking it so soon after. They had several patients that had that experienced. Additional Supportive Information: 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. This case had been linked with US2022AMR104807, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR104807:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis acneiform, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure/Received both Shingrix, then started to break out; Broke out, near/above eyes, face. Spots like pimple; This 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.   In March 2022, the patient received the 2nd dose of Shingrix. In November 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 8-Nov-2022 Reporter's comment: The patient received both of his/her shingrix vaccination and noticed after his/her 2nd vaccination he/she started to break out.  The patient developed a spot above his/her left eye, a spot on his/her nose and cheek. The 1 on his/her cheek went away. But the other spots did not.  The patient recently developed another spot now close to his/her right eye.  The patient did not fully understand what was going on. The spots almost looks like a pimple or a boil. The patient was told it only meant it was working. But he/she had heard other medical professions that he/she need to had it checked out by a dermatologist. The patient was wondering was this normal after the shingrix vaccination. If you could let him/her know that he/she would appreciate it so much. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Didn't feel good; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-Nov-2022 Reporter's comment: This case was reported by a patient via  interactive digital media. The patient did not felt good after the first dose.  The patient told them that he/she had every side effect. Additional Supportive Information: Follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received Havrix that had expired; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: The physician reported that a patient (no identifiers available) received a dose each of Havrix (no lot number available) that had expired on 30th September 2022.  The reporter wanted to know was the dose valid. The reporter consent to follow up. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used. This case is linked to the case US2022163626, US2022AMR163547 and US2022AMR163515 reported by the same reporter.; Sender's Comments:  US-GSK-US2022163626:same reporter US-GSK-US2022AMR163547:same reporter US-GSK-US2022AMR163515:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose was not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th June 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 07-NOV-2022 Reporters comment:  The patient received the first dose of shingrix and the second dose was not administered yet. The reporter asked should restart the series or administer 2nd dose. The vaccine administration facility was the same as primary reporter. No lot number nor expiration date of the dose was available. The age nor date of birth for the patient was requested for omission. The reporter did not consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 66.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Havrix. On 3rd November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's comment: Clinic manager stated that that a patient was administered dose of Havrix that had expired.  The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up via email. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022162501:Same reporter US-GSK-US2022162505:Same reporter US-GSK-US2022162503:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162508:Same reporter US-GSK-US2022162509:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162503:Same reporter
Age: 59.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Havrix. On 3rd November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's comment: The reporter stated that that a patient was administered dose of Havrix that had expired.  The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up via email. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022162503:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162505:Same reporter US-GSK-US2022162501:Same reporter US-GSK-US2022162509:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: just the adjuvant portion; received just the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment:  Office reported that a patient received just the adjuvant portion of Shingrix. The vaccine administration facility was the same as primary reporter. HCP could not read lot number for the Shingrix. Consented to follow up via email. Additional supportive information: As patient received only the adjuvant portion of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 4 months-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comments: The reporter reported that the patient inadvertently received a dose of Kinrix at the age of 4 months.  The reporter consented to follow up. Additional Supportive information: The patient received a dose of Kinrix at the age of 4 months, which led to inappropriate age at vaccine administration.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The registered nurse reported that inadvertently a dose of Havrix given to the patient into left deltoid in their facility and it was already expired.  The reporter asked any efficacy information and should patient be revaccinated. The reporter did not consent to follow up.  Additional Supportive Information: The use of Havrix dose, which was already expired on 30th September 2022, which led to expired vaccine used.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Nausea, Somnolence
Clinical narrative: extreme diarrhea; nausea; slept 11 hours last night; tired and left early from work/ fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2022 16:00, the patient received Shingrix. On 9th November 2022, 1 days after receiving Shingrix, the patient experienced fatigue and sleepiness. On 10th November 2022, the patient experienced diarrhea and nausea. On an unknown date, the outcome of the fatigue, diarrhea and nausea were not recovered/not resolved and the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the fatigue, diarrhea, nausea and sleepiness to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-NOV-2022  Reporter's comment: The case was self reported by the patient. The patient received a dose of Shingrix vaccine this past Tuesday around 4pm (post meridiem) and reported that she was tired yesterday and slept 11 hours last night and left early from work. The patient reported that on the day of reporting she now had nausea, extreme diarrhea and fatigue. No other information reported to the agent by the patient.  No other information could be collected as patient immediately disconnected the call after having her questions about Shingrix addressed.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose years ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose into unknown arm).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-NOV-2022  Reporter's comment: The case was self reported by the patient. The patient received only one dose of Shingles vaccine through her employer doctor over three years ago. Upon probing for vaccination date, the patient reported that it could have been ten years ago. The patient could not provide the name or brand of the administered Shingles vaccine nor the exact vaccination date, hence Shingles vaccine brand could not be identified.  The patient could not provide HCP's phone number and shingles vaccine information details. The patient declined providing her date of birth and reported that she was in her 60s, exact age was not provided. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.