chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient became nauseous, sweating profusely, pale in color, dizzy.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Breast swelling, Lymphadenopathy
Clinical narrative: left breast swelling and left lateral supraclavicular node enlargement several days after vaccination
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Pt received the incorrect COVID vaccine
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 51 y/o Patient with history of smoking, asthma, given Pfizer Bivalent booster on 5/22/23. Already received prior Pfizer Bivalent booster on 3/15/23, too soon for second booster. No side effects so far. Patient made aware
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: NONE
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse even, pt was given expired dose
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event, pt given expired dose
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: none
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bronchitis, Chest X-ray abnormal
Clinical narrative: Contracted a serious case of bronchitis for first time in my life.  Cleared with antibiotic in two week period.  Reoccurred once again in early May 2023.  Again healing with antibiotic treatment.  No idea whether a direct or indirect result of having Covid in early August 2022, or from the Moderna injections received in May and Sep 2022.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25vmL/25ug
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Blister, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient states her arm has redness, swelling, itching, and also has some blisters. Patient saw her doctor today and was prescribed a steroid and antibiotics. Patient stated symptoms started yesterday 5/21/23 and received vaccine on 5/15/23.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On 4/24/2023. I was on a trip when I became terribly ill. I had a fever and extreme fatigue, and all I wanted to do was sleep. When we got home, I went straight to bed and did not get up until sometime on 4/27/2023. I took a home antigen test on 4/26/2023 and got a positive result. On 4/26/2023, I spoke to my doctor. My doctor didn't prescribe anything right away, as he was concerned about the blood value of one of my kidneys. However, on 4/27/2023, he did prescribe me Paxlovid. My symptoms began improving by 4/28/2023. I finished the medicine, but I still had fatigue for another week afterwards. I took another home antigen test on 5/1/2023, and the result was negative. At the time of this writing, I am digging a ditch in my yard, so I think I'm doing okay.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Cataract operation, Central vision loss, Eye disorder, Eye operation
Clinical narrative: I went to eye doctor in Dec 2021 because I was definitely noticing a problem with my eye. About 2 months later I went to a different doctor and he found the beginning of a macular hole. I lost my center vision, It became completely distorted and I ended up having surgery to repair the hole back in April 20, 2022. The next thing that happened after having surgery, I developed a fast growing case of cataracts. I ended up having surgery for the cataracts on April 3, 2023. I still have distortion in my center vision but not as bad anymore.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Macular hole, Metamorphopsia
Clinical narrative: I went to eye doctor in Dec 2021 because I was definitely noticing a problem with my eye. About 2 months later I went to a different doctor and he found the beginning of a macular hole. I lost my center vision, It became completely distorted and I ended up having surgery to repair the hole back in April 20, 2022. The next thing that happened after having surgery, I developed a fast growing case of cataracts. I ended up having surgery for the cataracts on April 3, 2023. I still have distortion in my center vision but not as bad anymore.
Age: 1.0
Sex: F
Vaccine: COVID19, HEPA, HIBV, MMR, PNC15
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25vmL/25ug
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 10/4/2022
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25mL/25ug
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: I felt weak with headache and chills and muscle aches and at the site of injection it was red, swollen, and sore for 2 days.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: I felt weak with headache and chills and muscle aches and at the site of injection it was red, swollen, and sore for 2 days.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Hypoxia
Clinical narrative: R09.02 HYPOXIA 11/26/2021 ABDOMINAL PAIN
Age: 1.0
Sex: M
Vaccine: COVID19, HEPA, HIBV, MMR, PNC15
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25vmL/25ug
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25vmL/25ug
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Neck pain
Clinical narrative: Patient tolerated fine at time of injection, however after 1-2 days she began to feel pain from her shoulder up to her neck
Age: 27.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Oropharyngeal discomfort, Swollen tongue
Clinical narrative: Patient was vaccinated at 1300 and presented about 1.5 hrs after vaccination (1430) stating that their tongue felt a little swollen and throat felt 'funny' ongoing but not worsening for about 45 minutes. No itching or hives. No difficulty breathing. Pulse ox 99%, HR 94%. Patient had already taken one Benadryl tab about 30 mins prior to presenting to RNs. RN offered ambulance, patient declined. Explained that patient could take another Benadryl tab based on dosing if they choose. Provided guidance on s/s of anaphylaxis and importance of calling 911 immediately if they starting noticing any SOB. Rechecked all vitals at 1500, WNL. Patient states feeling about the same, not worsening. Completed one more vitals check at 1530, BP: 111/70, Pulse ox: 99%, HR: 77. Patient feels the same. Educated again on s/s of anaphylaxis.   This patient has previously received a Jynneos vaccine w/out complications in 9/2022.
Age: 0.58
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25mL/25ug
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was pregnant at time of vaccination but may not have been aware of pregnancy. She was asked at time of immunization, and she answered "No" to pregnancy question on consent form.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: PATIENTS MOTHER REQUESTED VACCINATIONS IN THE PHARMACY AFTER COMING FROM THE DOCTORS OFFICE NEEDING TO BE UPDATED ON VACCINATIONS. AFTER CONSULTING SYSTEM, PATIENT WAS GIVEN ADACEL, MENVEO, AND GARDASIL, PATIENT'S MOTHER WAS ASKED IF SHE RECEIVED ANY VACCINATIONS PRIOR TO BEING GIVEN ALL THREE VACCINATION AND PATIENTS MOTHER STATED NO, PATIENT ONLY RECEIVED BLOOD WORK. PATIENT DISPLAYED NO ADVERSE AFFECTS AFTER BEING GIVEN ALL THREE VACCINATIONS. PATIENTS MOTHER WAS CALLED 2 HOURS AFTER THE VACCINATION WAS GIVEN AND THE ERROR WAS DISCOVERED AND TOLD TO MONITOR PATIENT FOR SIGNS OF ABNORMALITIES.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was administered the vaccine after BUD. She did not experience any symptoms.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Pneumonia aspiration
Clinical narrative: Moderna vaccine was administered outside of office - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------- R09.02 HYPOXIA 12/20/2022 ASPIRATION PNEUMONIA
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25mL/25ug
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dementia Alzheimer's type, Hypoxia, Oesophageal carcinoma
Clinical narrative: HYPOXIA 12/8/2022 ESOPHAGEAL CANCER, UNSPECIFIED SITE HYPOXIA 12/8/2022 ALZHEIMERS DISEASE
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient passed out. He became pale, I gave extra apple juice, Ice packs, and I had lay back with his head up and legs elevated
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information or AE's reported; one dose of GARDASIL 9 was administered this morning prior to realizing there had been an excursion; This spontaneous report was received from an Other Health Professional and referred to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 27-APR-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter injection, 0.5 milliliter, lot #W013388, expiration date: 16-DEC-2024, administered intramuscularly for prophylaxis. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) had been an excursion before administration (Product storage error). No additional adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: Product preparation error
Clinical narrative: No additional AE; Pharmacist called to speak with agency regarding VERIVAX. On Friday (5/5/2023) a patient received VARIVAX, but the sterile diluent was not used to reconstitute, instead 0.9% sodium chloride was used to reconstitute. No additional information was provide; This spontaneous report was received from Consumer and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 05-MAY-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  sodium chloride (SODIUM CHLORIDE), unk (strength, formulation, lot #, expiry date, route of administration, and indication were not provided).  On unknown date, pharmacist called to speak with agency regarding varicella virus vaccine live (oka/merck) (VARIVAX). On 05-MAY-2023 (also reported as: Friday), a patient received varicella virus vaccine live (oka/merck) (VARIVAX), but the sterile diluent was not used to reconstitute, instead 0.9% sodium chloride was used to reconstitute (Vaccine incorrect diluent used). No additional information was provide.  Lot Number W031812 is valid for V210.
Age: 46.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; administration of a pediatric dose of PROQUAD to an adult patient; This spontaneous report was received from a medical assistant and refers to a 46-year-old patient of an unknown gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 02-MAY-2023, the patient was inadvertently vaccinated with a pediatric dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) injection, 0.5 milliliter, lot #W028565, expiration date: 06-MAR-2024 (administration site, and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). The reporter inquired about the need for revaccination and what the timing/schedule would be. No additional adverse event (AE) was reported (no adverse event).
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; no adverse event; This spontaneous report was received from an office manager referring to a 13-year-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 09-FEB-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact lot# and expiration date were not demonstrated, but was reported as: lot#: 1775811, expiration date: 07-DEC-2023; lot#: 1775827, expiration date: 27-JUN-2024; lot#: U032681, expiration date: 26-OCT-2023; lot#: 1780876, expiration date: 09-NOV-2023;lot#: W009829, expiration date: 19-OCT-2024) for prophylaxis using private funds at a private doctor's office/ hospital. The vaccine administered experienced 8-minute temperature excursion on 09-SEP-2022, 5-imnute temperature excursion on 14-SEP-2022, and 12-minute temperature excursion 03-JAN-2023 (product storage error). The excursions were due to employee error of cleaning data logger more than once a day. No adverse event occurred on the patient (no adverse event).
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; no adverse event; This spontaneous report was received from an office manager referring to a 11-year-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 15-NOV-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact lot# and expiration date were not demonstrated, but was reported as: lot#: 1775811, expiration date: 07-DEC-2023; lot#: 1775827, expiration date: 27-JUN-2024; lot#: U032681, expiration date: 26-OCT-2023; lot#: 1780876, expiration date: 09-NOV-2023; lot#: W009829, expiration date: 19-OCT-2024) for prophylaxis using private funds at a private doctor's office/ hospital. The vaccine administered experienced 8-minute temperature excursion on 09-SEP-2022, 5-imnute temperature excursion on 14-SEP-2022, and 12-minute temperature excursion 03-JAN-2023 (product storage error). The excursions were due to employee error of cleaning data logger more than once a day. No adverse event occurred on the patient (no adverse event).
Age: 11.0
Sex: U
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: no adverse event on patient; temperature excrusion; This spontaneous report was received from an office manager and referred to an 11-year-old patient of an unknown gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 07-MAR-2023, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration date: 1775811, 07-DEC-2023; or 1775827, 27-JUN-2024; or W009829, 19-OCT-2024; or U032681, 26-OCT-2023; or 1780876, 09-NOV-2023 (administration site, and route of administration were not provided) administered for prophylaxis (product storage error). Temperature excursion total time was reported as 25 minutes. There were 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day. The vaccines was purchased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice. No additional adverse events (AEs) were reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; received an expired dose of PROQUAD; This spontaneous report was received from a nurse referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 05-APR-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection (0.5 ml, lot#: U029296, expiration date: 19-MAR-2023; strength, route of administration, and anatomical location were not reported) with sterile diluent for prophylaxis (expired product administered). No adverse effects were noted (no adverse event).
Age: 7.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported.; patient received an expired dose of PROQUAD; This spontaneous report was received from a nurse referring to a 7-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 11-MAY-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA) injection (0.5 ml, once, lot#: U029296, expiration date: 19-MAR-2023; strength, route, and anatomical location were not reported) with sterile diluent for prophylaxis (expired product administered). No additional adverse events were reported (no adverse event).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Cervical dysplasia
Clinical narrative: High Grade Squamous Intraepithelial Lesion (HSIL); This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions and concomitant drugs were unknown.   On unspecified dates, the patient received a full-dose schedule of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for HPV prevention. Later, on unspecified dates, the patient received a 3-dose schedule of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5 ml; strength, route of administration, anatomical location, lot#, and expiration date were not reported) for HPV prevention.  On an unspecified date (reported as "recently"), the patient developed high grade squamous intraepithelial lesion (HSIL). The outcome of the event, and the causal relationship between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling abnormal, Gastrointestinal sounds abnormal, Renal pain
Clinical narrative: feeling "funny"; Dizzy; gurgling felt in gut; pain in kidneys; This spontaneous report was received from a 73-year-old female patient referring to herself. The patient's medical history was reported as none. The patient's drug reactions/allergies included codeine allergies and phenothiazines allergies. Concomitant therapies included "symbostatin" (5 mg) and supplements (unspecified).  On an unknown date in May 2023 (reported as recently), the patient was vaccinated pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for as prevention of pneumococcal disease (route was reported as injection; strength, dose, lot #, expiry date and anatomical location were unknown).  On an unknown date in May 2023, the patient was feeling funny afterwards (feeling abnormal), experienced dizzy, did not pass out, gurgling felt in gut (gastrointestinal sounds abnormal), pain in kidneys. Experienced symptoms very briefly while still shopping. It was reported that had not sought medical attention and did not received treatment for the events. The outcome of all events of feeling abnormal, dizzy, gastrointestinal sounds abnormal and pain in kidneys was reported as recovered.  The causal relationship between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Overdose
Clinical narrative: No Adverse Event; HCP called to state that the patient was given 2 doses of GARDASIL 9 in one day. HCP refuses to be contacted about this and wishes to not discuss this case any further.; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAY-2023, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot# w026977, expiration date: 04-JAN-2025, 0.5 dosage form/series (exact dose, route of administration and anatomical location were not reported) for prophylaxis (vaccine overdose). No additional adverse event reported (no adverse event).
Sex: F
Vaccine: HEP
Symptoms: Skin laceration, Syringe issue
Clinical narrative: finger flange that was noted to be broken off; she was cut by a sharp edge from the finger flange; she was cut by a sharp edge from the finger flange; This spontaneous report as received from an other health professional refers to a 53-year-old female patient. No information on patient medical history, current conditions and concomitant medications was provided.      On 16-MAY-2023 the patient was occupationally exposed to hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # W022795 and expiration date 19-MAY-2025 (exact dose 0.5 millilter) (syringe issue and Injury associated with device )   On 16-MAY-2023, the medical assistant experienced skin laceration. Provided treatment for skin laceration was band aid. The outcome of skin laceration was reported as recovered. Action taken with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) regarding the event was not applicable.   The causality between the hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and the event was not provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE; an expired dose was administered to a patient; This spontaneous report was received from a medical assistant, referring to a patient with unknown age and gender. The patient's concomitant therapy, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 17-MAY-2023, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (thimerosal free) (1 dosage form, lot number T035865 has been verified to be a valid lot number, expiration date was reported as 28-APR-2023, route and anatomical location were not provided) for prophylaxis (expired product administered). No other adverse event (AE) occurred (no adverse event) and the hepatitis b vaccine (recombinant) (RECOMBIVAX HB) did not have any temperature excursions prior to administration.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles after received Shingrix/Suspected vaccination failure; Shingles on face; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 3 years after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Had shingles after received Shingrix/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on face). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 17-MAY-2023 The reporter reported that the patient received second dose of Shingrix vaccine and after 3 years experienced shingles on her face. This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting.  The reporter did consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, Loss of consciousness
Clinical narrative: Unconscious; Covid 19; This serious case was reported by a other health professional via interactive digital media and described the occurrence of unconscious in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-NOV-2020, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced unconscious (Verbatim: Unconscious) (serious criteria GSK medically significant) and covid-19 (Verbatim: Covid 19). The outcome of the unconscious was not reported and the outcome of the covid-19 was resolved.   It was unknown if the reporter considered the unconscious and covid-19 to be related to Shingrix.     It was unknown if the company considered the unconscious and covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAY-2023 This case was reported by the patient via interactive digital media. The pharmacy told to the patient if had chickenpox at a risk of getting shingles free vaccination would be offered. The patient received 1st shot and after hours later the patient was unconscious in ambulance, not known. The covid end days later. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: FLUX
Symptoms: Cardiac failure
Clinical narrative: Heart failure; This serious case was reported by a consumer via market research programs and described the occurrence of cardiac failure in a elderly female patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis.   On an unknown date, the patient received Flu vaccine unspecified. On an unknown date, an unknown time after receiving Flu vaccine unspecified, the patient experienced cardiac failure (Verbatim: Heart failure) (serious criteria GSK medically significant). The outcome of the cardiac failure was not reported.   It was unknown if the reporter considered the cardiac failure to be related to Flu vaccine unspecified.   It was unknown if the company considered the cardiac failure to be related to Flu vaccine unspecified.   Additional Information: GSK receipt date: 18-May-2023  This case was reported via program. The reporter wanted to know why not likely to receive multiple vaccines at the same time. The patient said side effects of getting 2 vaccines could be double of just getting. The patient received flu vaccine 2 years gave me heart failure.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash erythematous, Rash papular
Clinical narrative: raised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site; aised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site; aised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site; This non-serious case was reported by a consumer and described the occurrence of rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (21 years ago).   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: raised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site), red rash (Verbatim: aised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site) and raised rash (Verbatim: aised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site). The outcome of the rash, red rash and raised rash were resolved (duration 6 days).   It was unknown if the reporter considered the rash, red rash and raised rash to be related to Shingrix.     It was unknown if the company considered the rash, red rash and raised rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023 The patient received first dose of Shingrix and experienced red, raised slightly burning rash antecubital fossa which was approximately 6 cm opposite arm from injection site. The events were resolved 6 days later. The patient had no lasting issues.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headaches; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headaches). The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     It was unknown if the company considered the headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAY-2023 The patient enquired that how long does the headache last after receiving Shingrix in terms of days, weeks and months.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fatigue; Fever; Chills; This non-serious case was reported by a physician via sales rep and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue), fever (Verbatim: Fever) and chills (Verbatim: Chills). The outcome of the fatigue, fever and chills were resolved (duration 4 days).   It was unknown if the reporter considered the fatigue, fever and chills to be related to Shingrix.     It was unknown if the company considered the fatigue, fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAY-2023 The patient experienced fatigue, fever, chills after receiving dose of Shingrix which lasted for 4 days.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Redness; Heat; Itching; This non-serious case was reported by a nurse via sales rep and described the occurrence of erythema in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Redness), feeling hot (Verbatim: Heat) and pruritus (Verbatim: Itching). The outcome of the erythema, feeling hot and pruritus were not reported.   It was unknown if the reporter considered the erythema, feeling hot and pruritus to be related to Shingrix.     It was unknown if the company considered the erythema, feeling hot and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAY-2023 The reporter reported that the patient received Shingrix vaccine and experienced redness, heat and itching. The reporter did consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Post herpetic neuralgia, Rash
Clinical narrative: Shingles; Fading rash; Neuralgic pain; Patient did not received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had 5 pox as a child).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles), rash (Verbatim: Fading rash), post herpetic neuralgia (Verbatim: Neuralgic pain) and incomplete course of vaccination (Verbatim: Patient did not received 2nd dose). The outcome of the shingles was resolving and the outcome of the rash and post herpetic neuralgia were not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles, rash and post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the shingles, rash and post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAY-2023 The patient reported that he or she received first dose of Shingrix vaccine few years ago and did not received second dose. The patient stated that he or she just recovering from shingles and still have fading rash and neuralgic pain. The physician told her to repeat the two dose series. The patient wanted to know how long after the rash heals and should he or she wait before repeating the two series vaccine. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did consent to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose of Menveo- 2 vial was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA701A, expiry date APR-2023) and (batch number AMAA701A) for prophylaxis.   On 11-MAY-2023, the patient received Menveo. On 11-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of Menveo- 2 vial was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-MAY-2023 Nurse reported that an expired dose of Menveo- 2 vial was administered to a patient. The Vaccine Administration Facility was the same as Primary Reporter Patient received a dose of Menveo on 11th May 2023 which was expired on April 2023, which led to expired vaccine used. The reporter consented to follow up via email or phone.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Boostrix to a 16 month-old male patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 03-NOV-2024) for prophylaxis.   On 12-MAY-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Boostrix to a 16 month-old male patient). 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: 12-MAY-2023. It was reported a nurse called in to report the administration of Boostrix to a 16 month-old male patient which led to inappropriate age at vaccine administration The HCP asked for safety information regarding this situation. The reporter did consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Social problem
Clinical narrative: due to the COVID Pandemic, she never got her 2nd dose of Shingrix; received 1st dose via intercostal route; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10-OCT-2019, the patient received the 1st dose of Shingrix (intercostal). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 10-OCT-2019, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: received 1st dose via intercostal route). On an unknown date, the patient experienced social problem (Verbatim: due to the COVID Pandemic, she never got her 2nd dose of Shingrix). The outcome of the intramuscular formulation administered by other route and social problem were unknown.   Additional Information: GSK Receipt Date: 15-MAY-2023 The reporter was the patient. The patient did not have any further information about the first dose of Shingrix, no lot or the location of the administered dose. The reporter consented to follow up. Due to covid pandemic, the patient never got 2nd dose of Shingrix, which led to social problem.. The patient received 1st dose of Shingrix via intercostal route, which led to intramuscular formulation administered by other route. The case had been linked to US2023069450, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023069450:Patient's husband report
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain, Pain in extremity, Swelling
Clinical narrative: pain in his arm/pain in his arm was not as bad before he received the Shingrix vaccine; Condition aggravated; experienced aches, pains, was very painful; Swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a adolescent male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (he had Shingles in his 40's). Previously administered products included Shingles vaccine (received Shingles vaccine in his 60's, about 15 years ago). Concurrent medical conditions included rotator cuff injury and pain in arm.   In DEC-2022, the patient received the 1st dose of Shingrix (injection). In DEC-2022, 1 day after receiving Shingrix, the patient experienced pain (Verbatim: experienced aches, pains, was very painful) and swelling (Verbatim: Swelling). On an unknown date, the patient experienced pain in arm (Verbatim: pain in his arm/pain in his arm was not as bad before he received the Shingrix vaccine) and condition aggravated (Verbatim: Condition aggravated). The outcome of the pain and swelling were resolving and the outcome of the pain in arm and condition aggravated were not reported.   It was unknown if the reporter considered the pain, swelling, pain in arm and condition aggravated to be related to Shingrix.     It was unknown if the company considered the pain, swelling, pain in arm and condition aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2023 The patient was self-reported this case. The patient also reports that he had Shingles in his 40's, and another shot for Shingles in his 60's, about 15 years ago. In his 80's, received the 1st dose of Shingrix in December 2022 (no exact date provided). It was reported that it was very painful and starting the next day after receiving the 1st dose, he experienced aches, pains, and swelling (no specific locations provided), that lasted a week or so (no specific time provided), and gradually got better.  The patient reports that he needs surgery on both shoulders for his rotator cuffs (preexisting Shingrix), and that the pain in his arm was not as bad before he received the Shingrix vaccine, and he wonders if he has GBS (this has not been diagnosed).  The reporter stated that I had reported everything the patient was willing to share with me. The reporter did consent to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 month old male received a dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   On 07-MAY-2023, the patient received Kinrix. On 07-MAY-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 16 month old male received a dose of Kinrix). 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: 17-May-2023  The reporter reported that the 16 month old child patient received Kinrix vaccine. The reporter stated that the patient did not experienced any symptoms. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via email. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Possible only diluent administered.; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Possible only diluent administered.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: 17-MAY-2023 The reporter called to inform that there were vials of powder component of Rotarix left in that facility, which might have had indicated that it was probable that only the diluent was administered. The reporter did not consented to follow up. The patient received only diluent of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired dose of Boostrix was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired drug administered in a 10-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22-APR-2023) for prophylaxis.   On 16-MAY-2023, the patient received Boostrix. On 16-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired drug administered (Verbatim: Expired dose of Boostrix was administered to a patient). The outcome of the expired drug administered was unknown.   Additional Information: GSK receipt date: 17-May-2023 The reporter was a license nurse practitioner.  Forgot to ask about follow up. The patient was administered an expired dose of Boostrix, which led to expired vaccine used.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Adult dose of Havrix was administered to a pediatric patient; Adult dose of Havrix was administered to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 19-month-old female patient who received HAV (Havrix adult) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   On 17-MAY-2023, the patient received Havrix adult. On 17-MAY-2023, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Adult dose of Havrix was administered to a pediatric patient) and overdose (Verbatim: Adult dose of Havrix was administered to a pediatric patient). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 17-MAY-2023 Medical assistant calls to report an adult dose of Havrix was administered to a pediatric patient. The reporter consented to follow up via mail. An adult dose of Havrix was administered to a pediatric patient which led to adult product administered to child and overdose.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in June 2019, plan dose 2 as soon as possible; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in June 2019 in an unknown arm intramuscularly).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose in June 2019, plan dose 2 as soon as possible). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-May-2023 The pharmacist reported that the pharmacy planned to give the patient's Shingrix dose 2 as soon as possible. The reporter did not ask the patient for permission to contact health care professional. The patient did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.