chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: tested + for covid on        2-15-22  at  Center  and later on 2-21-22 at Hospital.  deceased 3-1-22
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: At the pharmacy, pt is 12+ years old (specifically 15 years old) and was given 0.25 ml moderna bivalent when it should've been 0.5 ml full dose. pt and parent were fine and we gave the remaining dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: tested + for covid on     12-27-2021       , deceased 2-6-22
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT IS 11 YEARS WAS GIVEN THE WRONG VACCINE, PT SHOULD HAVE GOT THE BIVALENT CHILDREN VACCINE SINCE HE IS LESS THAN 12 YEARS OLD AND WAS GIVEN THE REGULAR BIVALENT PFIZER VACCINE
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: at the pharmacy, pt is 12+ years old (specifically 16 years old), was given 0.25 ml moderna bivalent when it should've been 0.5 mL full dose. pt was feeling ok, parent ok
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: at the pharmacy, pt is 12+ years old (specifically 16 years old), was given 0.25 ml moderna bivalent when it should've been 0.5 mL full dose. pt was feeling ok, parent ok
Age: 51.0
Sex: F
Vaccine: FLUR4
Symptoms: Diarrhoea
Clinical narrative: Severe sudden diarrhea
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Dysgeusia, Fatigue, Joint swelling, Lethargy
Clinical narrative: Metallic taste on tongue resolved in about 4 hours since injection Hand of injection arm (left) of thumb area was sore and hurtful like a strained muscle. Swelling of the thumb/hand/wrist area. Pain subsided approximately 5 hours after injection. Swelling of hand/thumb subsided about 7 hours. Wrist is still slightly swollen and has been for about 32 hours at this reporting. Fatigue and lethargy onset about 12 hours since injection and lasting for the next 14 hours at time of onset. Chills onset 12 hours since injection and lasting for about 3 hours since onset.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Muscle strain, Pain in extremity, Peripheral swelling
Clinical narrative: Metallic taste on tongue resolved in about 4 hours since injection Hand of injection arm (left) of thumb area was sore and hurtful like a strained muscle. Swelling of the thumb/hand/wrist area. Pain subsided approximately 5 hours after injection. Swelling of hand/thumb subsided about 7 hours. Wrist is still slightly swollen and has been for about 32 hours at this reporting. Fatigue and lethargy onset about 12 hours since injection and lasting for the next 14 hours at time of onset. Chills onset 12 hours since injection and lasting for about 3 hours since onset.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy breast abnormal, Breast cancer female, Breast conserving surgery, Radiotherapy, Tinnitus
Clinical narrative: Tinnitus nonstop 24/7 both ears - primary concern Breast cancer diagnosis June 2022
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Swollen, sore lymph glands in right armpit
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Shoulder sore and unable to be used
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin, Ultrasound abdomen abnormal
Clinical narrative: Minor is pregnant pending OB appointment for accurate gestational age. HCG quantitative is 899 approximating gestational age to be 5-6 weeks.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: pt given 0.5ml per age given at checkin found out after the fact pt only 7 and should have received 0.25ml
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: In error, the patient was given 2 flu vaccines this flu season: on 9/22/22.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ, TDAP
Symptoms: Exposure during pregnancy, Ultrasound abdomen
Clinical narrative: Minor was 18 weeks gestational age at the time of vaccination. OB provider had no concerns during visits 8/30/22 and 9/27/22.
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: I went into a local pharmacy to ge the new Pfizer Bivalent vaccine at 10:30 am It was injected into my body and I went home. By 12 noon on the same day, my pharmacist called me in tears, stating that the tech in charge of the vaccines, drew the wrong medication and injected it into me. Upon further discussion I discovered that more individuals were also injected with the wrong medication. I am furious and am not sure how or to who to report this. I have been told that I can not now get the correct vaccination for 2 months. I exchanged a few emails with our state CDC office but they do not seem to be interested in this incident. Again, I am furious. This was injection into my body!!!! Age 72
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dysphemia, Leukaemia, Malaise, Tremor
Clinical narrative: After getting the second Pfizer vaccine. I was sick over a week. I lost my Ballance, and began shaking all over, including my stuttering. Then I was diagnosed with leukemia. I was doing very well, before the Pfizer vaccine. I have to take medication for the shaking. My ballance was perfectly fine before as well.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack and hospitalization. Covid-19 vaccination
Sex: M
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: pt's mom reported that pt is in the hospital as he started shedding skin after getting covid vaccine.unknown dates or length of hospital stay. it is unknown if patient is taking tadalafil in hospital. unknown if md aware. no further information available or dates are known or were reported.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Vomiting
Clinical narrative: About six hours after receiving Fluzone high dose quad flu vaccine I experienced shaking chills and vomiting that lasted about 8 hours and tiredness that lasted about 36 hours
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: pt's wife had called said on the phone that "my doctor said my husband passed away due to covid vaccine and I was told to call pharmacy"
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Rash, Skin lesion, Urticaria
Clinical narrative: I had the Moderna booster and got hives the following day. About a week later, a rash began on my ankles. It has spread through my entire body. Dermatologist said it is granuloma annulare. I am treating with cream but new lesions surface and do not see much improvement after months of treatment.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Amnesia
Clinical narrative: Patient memory and state of mind was very strong. After the shots, she went from 100% strong to about 75%, then 50%, and now she can't remember things 5-10 minutes.
Age: 36.0
Sex: M
Vaccine: COVID19-2, COVID19, FLUC3
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: I am experiencing a severe headache; fatigue; severe muscle pain; joint pain; FLUCELVAX QUADRIVALENT given on 18Oct2022; FLUCELVAX QUADRIVALENT given on 18Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 11:30 as dose 4 (booster), single (Lot number: 6J259) at the age of 36 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 18Oct2022 as dose 1, single (Lot number: 942431), in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Gout" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 01, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 02, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 03, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "FLUCELVAX QUADRIVALENT given on 18Oct2022"; HEADACHE (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "I am experiencing a severe headache"; FATIGUE (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "severe muscle pain". Therapeutic measures were not taken as a result of headache, fatigue, myalgia, arthralgia.  Additional information: No covid prior to vaccination,No covid tested post vaccination and no known allergies.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19-2, COVID19, FLUC3
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Off label use
Clinical narrative: I am experiencing a severe headache; fatigue; severe muscle pain; joint pain; FLUCELVAX QUADRIVALENT given on 18Oct2022; FLUCELVAX QUADRIVALENT given on 18Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 11:30 as dose 4 (booster), single (Lot number: 6J259) at the age of 36 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 18Oct2022 as dose 1, single (Lot number: 942431), in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Gout" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 01, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 02, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 03, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "FLUCELVAX QUADRIVALENT given on 18Oct2022"; HEADACHE (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "I am experiencing a severe headache"; FATIGUE (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "severe muscle pain". Therapeutic measures were not taken as a result of headache, fatigue, myalgia, arthralgia.  Additional information: No covid prior to vaccination,No covid tested post vaccination and no known allergies.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19-2, COVID19, FLUC3
Symptoms: Product use issue
Clinical narrative: I am experiencing a severe headache; fatigue; severe muscle pain; joint pain; FLUCELVAX QUADRIVALENT given on 18Oct2022; FLUCELVAX QUADRIVALENT given on 18Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 11:30 as dose 4 (booster), single (Lot number: 6J259) at the age of 36 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 18Oct2022 as dose 1, single (Lot number: 942431), in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Gout" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 01, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 02, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 03, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "FLUCELVAX QUADRIVALENT given on 18Oct2022"; HEADACHE (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "I am experiencing a severe headache"; FATIGUE (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "severe muscle pain". Therapeutic measures were not taken as a result of headache, fatigue, myalgia, arthralgia.  Additional information: No covid prior to vaccination,No covid tested post vaccination and no known allergies.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: the injection site hurt a little; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (the injection site hurt a little) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (the injection site hurt a little). At the time of the report, VACCINATION SITE PAIN (the injection site hurt a little) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2022-661585, MOD-2022-661589, MOD-2022-661592 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: the injection site hurt a little; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (the injection site hurt a little) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (the injection site hurt a little). At the time of the report, VACCINATION SITE PAIN (the injection site hurt a little) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2022-661585, MOD-2022-661589, MOD-2022-661592 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.      The concomitant and treatment medication was not reported.   This case was linked to MOD-2022-661563, MOD-2022-661589, MOD-2022-661592 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.      The concomitant and treatment medication was not reported.   This case was linked to MOD-2022-661563, MOD-2022-661589, MOD-2022-661592 (Patient Link).   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE's were reported and no additional AE details were provided.; was supposed to receive a dose of MMR-II and VARIVAX but received a dose of PROQUAD instead; PROQUAD administered to a 31-year-old woman; This spontaneous report was received from a medical assistance and refers to a 31-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, allergies and drug reactions were not provided.  On 03-OCT-2022 (at the age of 31 years), the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, administered subcutaneously, lot #U039259, expiration date: 09-JUN-2023, (strength and anatomical site of vaccination were not provided) for prophylaxis (product administered to patient of inappropriate age). The patient was supposed to be vaccinated with a dose of rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, but received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead (wrong product administered). The patient had not any side effects from the vaccine which she received. No additional adverse events (AEs) were reported (no adverse event) and no additional adverse event (AE) details were provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE.; HCP reporting a patient that is older than 12 years of age was accidently administered PROQUAD.; This spontaneous report was received from a registered nurse and refers to a patient of unknown exact age and unknown gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 03-OCT-2022, the patient, who was older than 12 years of age was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (strength, dose, route of administration, vaccination site, lot number, expiration date and albumin status were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; ROTATEQ involved in the temperature excursion was administered to the patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 04-OCT-2022, the patient was vaccinated with an improperly stored (temperature: 47.1 Fahrenheit (F) degrees for 9 hour and 15 minutes and 35.2 F degrees for 45 minutes) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, administered orally, lot #U038864 was found to be valid, expiration date: 22-APR-2023 (strength was not reported) for prophylaxis (product storage error). No additional adverse events were reported. There were no previous temperature excursions.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; expired PROQUAD administered to patient.; This spontaneous report was received from a Medical Assistant, concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was not provided. Concomitant therapies included sterile diluent (manufacturer unknown).   On 10-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter, lot #U010743, expiration date: 03-OCT-2022, administered for prophylaxis (route of administration and anatomical location were not provided) (product storage error).  The reporter stated that the product did not experience any temperature excursions through date of administration. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored DILUENT that had a not supported TE was used to reconstitute an MMR II vaccine; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.  On 13-OCT-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin, (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #U031360, expiration date: 07-OCT-2023, (strength, dose number, route and site of vaccination were not provided) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin, (M-M-R II) was reconstituted with a improperly stored, sterile diluent (STERILE DILUENT) solution for injection/infusion, 0.5 milliliter, administered once, lot #W009116, expiration date: 04-NOV-2023 (strength, route and site of administration were not provided) (product storage error). The suspect therapies underwent the temperature excursion of -23 Celsius (C) degrees for 17 hours. The previous temperature excursion did not occur. No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: A nurse is calling in to report an AE on an infant that received ROTATEQ as their first rotavirus vaccine and then received their second rotavirus vaccine dose as ROTARIX at another providers office. The nurse states that the infant is going to recei; No additional AE details were provided; This spontaneous report was received from a registered nurse, referring to an infant patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis, then received their second rotavirus vaccine dose as rotavirus vaccine live oral 1v (ROTARIX) at another providers office (interchange of vaccine products). The nurse stated that the infant was going to receive their third rotavirus vaccine dose as rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to complete their series. No additional adverse event details were provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.  On 15-AUG-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number 1879870 has been verified to be a valid lot number, expiry date 16-OCT-2023) indicated as prophylaxis (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine was stored at a temperature of 34.5 Fahrenheit (F) for a time frame of 1 hour 7 minutes and 0 seconds, there was  a previous temperature excursion of 66. 7 F for 13 hours 52 minutes and 0 seconds.  No additional adverse event were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005936: US-009507513-2210USA005917: US-009507513-2210USA005916:
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE.; pediatric dose of RECOMBIVAX HB was given to an adult.; This spontaneous report has been received from a medical assistant referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported   On 17-OCT-2022, an adult patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 milliliter for prophylaxis (vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (incorrect dose administered).  No additional adverse events were reported.
Age: 0.75
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product confusion, Wrong product administered
Clinical narrative: The HCP stated the patient was supposed to receive their scheduled dose of "GSK's Hep B vaccine, Engerix, but that the nurse confused the products and administered the wrong vaccine; The HCP stated the patient was supposed to receive their scheduled dose of "GSK's Hep B vaccine, Engerix, but that the nurse confused the products and administered the wrong vaccine; no adverse effects were repoerted; This spontaneous report was received from a medical assistant and refers to a 9-month-old patient.  The patient's medical history, concurrent conditions included, concomitant therapies and previous drug reaction were not reported.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml/once, lot #W006214, expiration date: 04-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) instead of and  hepatitis b vaccine rhbsag (yeast) (ENGERIX) (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided) it was mentioned that it was unknown if the patient received the schedule dose or if was missed (Wrong vaccine administered) as per nurse confused the products (product confusion). No additional adverse event were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; A medical assistant reported that an additional dose of  was administered to a patient after the patient had received the recommended dose of PROQUAD within the past two months.; This spontaneous report has been received from a medical assistant, regarding a 4-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On an unspecified date in 2022 (reported as since turning 4 years old in July 2022), the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection as prophylaxis (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported).  On 29-SEP-2022, the patient received a second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection as prophylaxis (lot number: W020551, which was determined to be valid by the validation lot team, with an expiration date on 26-DEC-2023) strength, dose, route and anatomical location of administration, lot number and expiration date were not reported). This been within the past two months of receiving the firs dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; PROQUAD was administered to a 19 year old patient; This spontaneous report was received from a medical assistant referring to a 19-year-old patient. The patient's medical and concurrent conditions were not reported. Concomitant therapies were not provided.  On 04-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (lot #U024510 with an expiration date on 02-FEB-2023), administered for prophylaxis (strength, dose and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, doses of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 12 farenheit degrees for 15 minutes. No previous temperature excursion were reported.  On 14-OCT-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025205, expiration date: 13-AUG-2023 (strength, dosage regimen, anatomical location and route of administration were not provided) as prophylaxis.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: get flu shot, still got a mild case/ suspected vaccination failure; influenza; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter reported that patient took all the vaccines in his/her lifetime the only one that so had proven to be less than reliable was the flu vaccine. The patient got the flu shot every year. One year patient still got a mild case.  Flu vaccines were usually rated between 50 and 60 percent effective. Additional supportive information: This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding Influenza were unknown at the time of reporting. Follow-up would not possible as no contact details were available. The case had been linked with US2022AMR150533 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR150533:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot and got shingles/suspected vaccination failure; Shingles/ got shingles; This 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, 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: 16-Oct-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The reporter reported that the patient (his/her friend) got the shot and got shingles. The reporter stated sorry but it did not work. The reporter prayed for soon relief. Additional supportive information: 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 shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Pruritus, Vaccination failure
Clinical narrative: Got 2 shots, experienced it/Suspected vaccintion failure; Shingles, shingles pain; Worst pain/ feeling the nerve pain; Itching; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain and pruritus. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, nerve pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and pruritus to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 16-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that the shingles shots could not protect us from shingles because he/she experienced them. The patient had 2 shots of shingles vaccine until now he/she was feeling the nerve pain and itching. The patient mentioned that it was been 8 months and it was the worse pain that you could imagine giving birth was nothing compared to shingles pain.  The patient mentioned that the correct dose of gabapentin helped him/her so much. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got the shot, still got it/suspected vaccination failure; Have it on left side of face, still got it; pain is indescribable.; This 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Oct-2022 Reporter's comment: The case was received form the patient via interactive digital media. The patient stated that he/she had heard. The patient got the shot back in 2018 but still got them. The patient had them on the left side of his/her face going on his/her 4th week also. The pain was indescribable. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As it was reported that the patient was in 4th week and shingles on left side face going on therefore time to onset was captured as more than 2 years and outcome was not recovered.
Age: 33.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Product preparation error
Clinical narrative: MMR vaccine reconstituted with Menveo liquid component; Menveo liquid portion (exp APR-2022) reconstituted with MMR, administered; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 33-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA710A, expiry date 30th April 2022) for prophylaxis.   On 13th October 2022, the patient received Menveo. On 13th October 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and expired vaccine used. On an unknown date, the outcome of the wrong solution used in drug reconstitution and expired vaccine used were unknown.   Additional Information: GSK receipt date: 13-Oct-2022 Reporter' s comment: The consumer stated that the patient received MMR vaccine from Merck (not priorix) with liquid component of Menveo. The consumer wanted safety information from GlaxoSmithKline. Referred patient to GlaxoSmithKline medical information. The healthcare professional's contact information was sent to safety team by email. The reporter consented to follow-up via email. Additional supportive information: The patient inadvertent administered expired liquid meningococcal CWY component of Menveo with MMR powder, which led to wrong solution used in drug reconstitution and expired vaccine used. The case US2022AMR147374 was identified as duplicate of US2022147498. The case US2022147498 was deleted from the database and all the future correspondence would be added in this case which stands as a case of record for this patient.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Product administered at inappropriate site, Skin discolouration
Clinical narrative: light grey dot on the thigh; Pediarix, Acthib and Prevnar were given in same leg; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   On 28th March 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, ACTHIB and PREVNAR. On 28th March 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   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: 13-OCT-2022 Reporter's Comment: Prevnar and Acthib were also given with Pediarix in same leg so were not sure which vaccine caused the reaction. The faint grey dot was the adverse event that followed vaccination. Additional Supportive Information: It was unknown if the reporter considered the skin discoloration to be related to Prevnar and Acthib. This case is linked to the case US2022AMR148962 and US2022AMR148961, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR148962:same reporter US-GSK-US2022AMR148961:same reporter
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: the patient needed her 3rd dose of Engerix-B but she refused to get it; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on an unknown date) and Engerix B (2nd dose received on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient: US2022146845, US2022AMR148351   Additional Information: GSK Receipt Date: 12-Oct-2022 Reporter's comment: The registered nurse stated that she had Havrix and Engerix-B prefilled syringes that she placed needles on but the patient changed her mind.  The reporter asked how long were they stable.  The nurse probed and she stated that the patient changed her mind because she had too many Hepatitis A vaccines (4 or 5) because she kept missing the recommended intervals for the doses and her health-care professional thought she needed to get additional doses everytime.  The health-care professional mentioned that the patient was from out of the country and could not provide any information on if the vaccines were Havrix or another Hepatitis A series.  The health-care professional mentioned that the patient needed her 3rd dose of Engerix-B but she refused to get it.  The health-care professional declined to provide any patient information and did not had any vaccine information as the doses were not administered at their facility.  The health-care professional also declined follow up. The reporter did not consent to follow-up. This case was linked with case US2022AMR148351 and US2022146845, reported by the same reporter. Additional Supportive Information: Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022AMR148351:Same reporter US-GSK-US2022146845:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Upper arm is swollen; Upper arm is red; Upper arm is warm; Upper arm is itchy; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (the patient had the old shingles vaccine about 9 years ago from reporting without incident).   On 10th October 2022, the patient received the 1st dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, skin warm and itchy upper limbs. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the swelling arm, erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the skin warm was unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and itchy upper limbs to be related to Shingrix.  Additional Information: GSK Receipt Date: 15-OCT-2022 and 17-OCT-2022 Reporter's Comment: The patient self-reported this case. The patient received Shrigrix (shingles vaccine) on Monday. The pharmacist warned him/her that, it might hurt but it did not. Instead, after 5 days his/her upper arm was still very swollen, red, warm and itchy.  The symptoms were not lessening. The reporter wanted to know how long he/she could expect this problem to last and were there any topical treatments that might help. The pharmacist advised to continue with ice packs and add Benadryl, which definitely helped. However, his/her arm was still swollen, itchy and red.