chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Cough, Influenza like illness, Pain
Clinical narrative: My symptoms began on a Saturday night with a runny nose and allergy symptoms.  Later I had a cough and flu-like symptoms.  I tested positive on May 21, 2023.  I was prescribed Paxlovid on the same day.  After taking the medication I began to feel better within 24 hours.    I had no energy, scratchy throat and aches.  I felt like I was recovered within about 10 days.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: My symptoms began on a Saturday night with a runny nose and allergy symptoms.  Later I had a cough and flu-like symptoms.  I tested positive on May 21, 2023.  I was prescribed Paxlovid on the same day.  After taking the medication I began to feel better within 24 hours.    I had no energy, scratchy throat and aches.  I felt like I was recovered within about 10 days.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory failure, End stage renal disease, Hepatitis alcoholic, Respiratory failure
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/28/2023 ESRD (END STAGE RENAL DISEASE)    ALCOHOLIC HEPATITIS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/28/2023 ALCOHOLIC HEPATITIS
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: On 5/30/2023, I began getting a sore throat. That evening, I developed a fever and started having cold-like symptoms that included sneezing, runny nose, cough, and headache. The fever was around 103 at night. The cold-like symptoms and the fever lasted for about two days. On 5/31/2023, I took a home antigen test and got a positive result. On 6/1/2023, I had a telehealth visit with my doctor, who prescribed PAXLOVID. She advised me to cease taking ranolazine and rosuvastatin while I took the PAXLOVID and suggested that I wait two days after finishing the PAXLOVID before I resumed taking them. I still have some congestion, runny nose, cough, and fever, but I feel that they are progressively getting better. Whenever I have a fever at night, the temperature is now lower and is usually around 100.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: On 5/30/2023, I began getting a sore throat. That evening, I developed a fever and started having cold-like symptoms that included sneezing, runny nose, cough, and headache. The fever was around 103 at night. The cold-like symptoms and the fever lasted for about two days. On 5/31/2023, I took a home antigen test and got a positive result. On 6/1/2023, I had a telehealth visit with my doctor, who prescribed PAXLOVID. She advised me to cease taking ranolazine and rosuvastatin while I took the PAXLOVID and suggested that I wait two days after finishing the PAXLOVID before I resumed taking them. I still have some congestion, runny nose, cough, and fever, but I feel that they are progressively getting better. Whenever I have a fever at night, the temperature is now lower and is usually around 100.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired medication. No adverse reaction noted. Left several messages for parent to call office and a letter was sent to families home asking for parent to contact office with no response as of yet. Dr. was going to give pt option as to whether they want to redo vaccine at this time or hold off for now. Pt is up to date on all of his vaccines so far.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I verified vaccine hx with Immtrac2 and noted no previous dose of seasonal flu, since patient requested, and she was eligible I went ahead and administered it.  Upon finishing documentation on TWICES it was noted that there was a previous dose that was administered in October 2022. No adverse reactions noted or voiced by patient as of today 6/6/23
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: When covid vaccine guidelines changed. We were given incorrect information regarding dosing. Patient received lower than recommended dose. Parent notified and scheduled an appointment to receive correct dose.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: One month after vaccination I am left with the condition of chronic daily hives (since January 6th 2023)
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Accidental exposure to product, Circumstance or information capable of leading to medication error, Exposure via eye contact, No adverse event
Clinical narrative: No additional AEs; Nurse called in to report that on today 10May2023 while giving a 6 month old patient ROTATEQ, the child arched their back and some of the medication got in the child's eye.  No additional information was reported.  No Additional AEs, no PQCs.; Nurse called in to report that on today 10May2023 while giving a 6 month old patient ROTATEQ, the child arched their back and some of the medication got in the child's eye.  No additional information was reported.  No Additional AEs, no PQCs.; This spontaneous report was received from Other Health Professional and refers to a 6-month-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-MAY-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 time dose, lot #1925936, expiration date: 28-MAR-2024, administered orally for prophylaxis (strength was not provided).  On 10-MAY-2023, nurse called in to report that today, while giving a 6 month old patient rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the child arched their back and some of the medication got in the child's eye (Inadvertent exposure to vaccine and Exposure via eye contact). No additional information was reported. No Additional AEs, no PQCs. No treatment was given for events.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Underdose
Clinical narrative: partial first dose; a now 15 yr old male received a partial first dose of GARDASIL 9 when he was 10 yrs old; No additional AE; This spontaneous report was received from an other reporter via company representative, concerning a 10-year-old male patient. The patient's concurrent conditions, concomitant medication and pertinent medical history was not reported. The patient had no underlying disease and no previous history of allergy to vaccines.  On an unknown date (reported as approximately 5-6 years ago), the patient was vaccinated with the partial first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 milliliter, lot #, expiration date, anatomical location and route were not provided) at age 10 years old for prophylaxis (underdose). Questions about revaccination are addressed in request case reference 02398424 (inappropriate schedule of product administration). The pediatrician at that time deemed the dose to be invalid. No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered to patient while it had a temperature excursion; Patient is asymptomatic/No additional AE.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #W031813, with an expiration date on 05-OCT-2024), administered for prophylaxis (strength, and route of administration were not provided).  Nurse reported that varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient while it had a temperature excursion. The patient was asymptomatic and no adverse events were reported.  The dose of varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature excursion of 24.4 degrees Fahrenheit (°F) during a time frame of 5 hours, 51 minutes and 0 seconds.  There was no prior temperature excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W03; No additional AE; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, dose number, route of administration and anatomical location were not provided) (lot#: W032370, expiration date: 10-OCT-2024) as prophylaxis (product storage error). No adverse event was reported. The temperature excursion was 24.4 F for a total timeframe of 5 hours and 51 minutes. No previous temperature excursion were reported. No further information was provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report that PROQUAD was administered after undergoing a TE. No adverse affects reported. Caller stated this occurred in February 2023.          ?    Names of vaccines involved (including lot/exp): PROQUAD (Lot: W019631, Expiration: 1; No adverse affects reported; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with an improperly stored dose of v Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 mL (dose number, route of administration and anatomical location were not provided) (lot#: W019631, expiration date: 19-DEC-2024) as prophylaxis (product storage error). No adverse event was reported. The temperature excursion was 13.5 F, for a total timeframe of 3 hours and 5 minutes. No previous temperature excursion were reported. No further information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided.; No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number W031813, expiration date 05-OCT-2023, dose 1 (route of administration not reported) for prophylaxis. No adverse event was reported.  The temperature excursion was of 24.4 degrees Fahrenheit for 5 hours and 51 minutes. No other excursions were detected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion; No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route were not reported) (lot # W032370, expiration date: 10-OCT-2024; 1 dosage form) for prophylaxis, which had a temperature excursion (product storage error). The vaccine underwent temperature excursion of 24.4 Fahrenheit for 5 hours 51 minutes. There were no previous temperature excursions. The patient was asymptomatic. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Joint swelling, Muscle swelling
Clinical narrative: Bicep/shoulder swelled; Bicep swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of swollen joints in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced swollen joints (Verbatim: Bicep/shoulder swelled) and muscle swelling (Verbatim: Bicep swelling ). The outcome of the swollen joints and muscle swelling were not reported.   It was unknown if the reporter considered the swollen joints and muscle swelling to be related to Shingles vaccine.     It was unknown if the company considered the swollen joints and muscle swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUN-2023 The patient experienced bicep/shoulder 2 weeks after injection of Shingles shot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: he is not feeling well because of vaccine (malaise); This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included DUPIXENT (On 21-MAY-2020, the patient started taking DUPIXENT Solution for injection subcutaneously, since 2020 (lot - 2F209A)). Concurrent medical conditions included atopic dermatitis.  On 02-MAY-2023, the patient received Shingrix. In MAY-2023, 2 days after receiving Shingrix, the patient experienced feeling unwell (Verbatim: he is not feeling well because of vaccine (malaise)). The outcome of the feeling unwell was resolving.  It was not reported if the reporter considered the feeling unwell to be related to Shingrix.  It was not reported if the company considered the feeling unwell to be related to Shingrix.  Additional Information: GSK Receipt Date: 01-JUN-2023 The initial information was received regarding a solicited valid non-serious case received from a consumer/non-hcp, while being treated with DUPILC MAB (DUPIXENT) via prefilled pen and VARICELLA ZOSTER VACCINE ROE (CEO) (SHINGRIX). The patient's past medical history, medical treatment(s), concomitant (s) and family history were not provided. On 21-MAY-2020, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength: 300 mg) with a dosage of 600 mg total, following with a dosage of 300 mg every other week (QC W) since 2020 for Atopic dermatitis. In MAY, 2023 the patient developed a non-serious event shingles vaccine 2 days ago, and that he was not feeling well because of the vaccine (malaise) (latency: approx. 3 years) following the first dose intake of DCPILUMAB and unknown latency with VARICELLA ZOSTER VACCINE RGE (CHO). It was reported that, the patient had administered the 300mg dose to his abdomen today (on the day of reporting), 04-MAY-2023, and it squirted out, he was asking whether it was a faulty prefilled pen, and if he should take another dose. He accepted to be transferred to his healthcare provider for further instructions. He also reported he had noticed an improvement in his symptoms since being on Dupixent. When asked if the patient was requesting replacement, the nurse stated that he would wait and consult his physician first, and if he needed another dose, that was when he would request for a replacement. The nurse also noted that the patient started the loading dose with a prefilled syringe, but now he was using the prefilled pen, the patient does not state, when he had switched from the prefilled syringe to the prefilled pen. Action taken: No taken for DUPILUMAB (DUPIXENT), and unknown for VARICELLA ZOSTER VACCINE RGE (CEO) (SHINGRIX). At time of reporting, the outcome was Unknown for the event shingles vaccine 2 days ago, and that he was not feeling well because the vaccine. Reporter causality: Not reported. Company Causality: Not reportable. The reporter consented to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Infection
Clinical narrative: Infection; This non-serious case was reported by a consumer via call center representative and described the occurrence of infection in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 22m3k, expiry date 04-AUG-2024) for prophylaxis.  On 24-MAY-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 26-MAY-2023, 2 days after receiving Shingrix, the patient experienced infection (Verbatim: Infection). The outcome of the infection was resolving.  It was unknown if the reporter considered the infection to be related to Shingrix.  It was unknown if the company considered the infection to be related to Shingrix.  Additional Information: GSK Receipt Date: 01-JUN-2023 The Healthcare Professional (HCP) reported that, Shingrix was administered Intramuscular (IM) slightly below deltoid but believes it may had still been in deltoid muscle. On 26-MAY-2023, he developed Infection and he went to prompt care to be seen. HCP reported that, she texted patient on One day prior of reporting (30-MAY-2023) and he stated that he was much better. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Skin lesion, Vaccination failure
Clinical narrative: received one Shingrix vaccine in 2017 and two in 2019; diagnosis of Shingles/ Suspected vaccination faliure; diagnosis of Shingles; Skin lesion; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male 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 11-MAY-2023, 4 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: diagnosis of Shingles/ Suspected vaccination faliure) (serious criteria GSK medically significant), shingles (Verbatim: diagnosis of Shingles) and skin lesion (Verbatim: Skin lesion). On an unknown date, the patient experienced drug dose administration interval too long (Verbatim: received one Shingrix vaccine in 2017 and two in 2019). The patient was treated with valaciclovir (Valacyclovir), gabapentin and cannabidiol (Cbd). The outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown and the outcome of the skin lesion was resolving.  It was unknown if the reporter considered the vaccination failure, shingles and skin lesion to be related to Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure, shingles and skin lesion to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 30-MAY-2023 The patient self-reported this case. In 2017, the patient received first and in 2019, second Shingrix vaccine. On approximately, 11 May 2023, he had noted one lesion. Two days later, two more lesions appeared, then more started coming up. He went to his healthcare professional (HCP) and was diagnosed with Shingles on 25th May 2023. His physician prescribed Valacylovir 500 mg tid and gabapentin 300 mg tid and he was also using a cannabidiol (CBD) cream which seems to be helping dry the lesions. He was referred to HCP for decision whether to vaccinated again and provided Medical Information telephone number. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Sex: U
Vaccine: RV1
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient was given a dose of Rotarix on an unknown date but it was documented as Rotateq; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect information in patient's record in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced incorrect information in patient's record (Verbatim: Patient was given a dose of Rotarix on an unknown date but it was documented as Rotateq). The outcome of the incorrect information in patient's record 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: 30-MAY-2023 The reporter was medical assistant. The reporter reported that a patient was given a dose of Rotarix on an unknown date, but it was documented as Rotateq.  Then on 25th April 2023, the patient received a 2nd dose of Rotarix.  No symptoms were reported.  The healthcare professional did not have patient details, lot number or expiration date at the time of reporting. The call was disconnected before consent or clinic of where the vaccine was administered, could be confirmed. The patient was given a dose of Rotarix, but it was documented as Rotateq which led to Incorrect information in patient's record.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (on December 2022 received 1st dose.).   On 31-MAY-2023, the patient received the 2nd dose of Twinrix. On 31-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose.). The outcome of the drug dose administration interval too long 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: 31-MAY-2023 A pharmacist reported about a patient who received the first dose of Twinrix in December 2022.  On 31 May 2023 the patient got the second dose.  The reporter wanted to know the minimum interval between the second and third dose in this situation.  The reporter did not provide patient information nor vaccine information. The reporter consented to follow up. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Breast conserving surgery, COVID-19
Clinical narrative: COVID-19; Diagnosed with breast cancer; This serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-AUG-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced covid-19 (Verbatim: COVID-19) (serious criteria hospitalization) and breast cancer (Verbatim: Diagnosed with breast cancer) (serious criteria GSK medically significant). The outcome of the covid-19 and breast cancer were not reported.   It was unknown if the reporter considered the covid-19 and breast cancer to be related to Shingrix.     It was unknown if the company considered the covid-19 and breast cancer to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAY-2023 The patient self-reported this case. The reporter stated that she had not yet receive her second dose of Shingrix because she was diagnosed with breast cancer which she had a lumpectomy for. The patient also had COVID-19 for which she was hospitalized.  Reporter did not provide any additional details.  The reporter did not consent to follow up.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose of Engerix-B administered to a female 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 20-year-old female patient who received HBV (Engerix B) (batch number LP724, expiry date 18-MAY-2023) for prophylaxis.   On 01-JUN-2023, the patient received Engerix B. On 01-JUN-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose of Engerix-B administered to a female patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 01-JUN-2023 A reporter reported about a patient who received expired dose of Engerix-B which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Developed Guillain-Barre; This serious case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   In FEB-2021, the patient received the 1st dose of Shingrix and COVID VACCINE. On an unknown date, 1 week after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Developed Guillain-Barre) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter was a Doctor of Osteopathy. Approximately in February 2021, the patient received a COVID shot and a Shingrix vaccine a week apart. About a week later after vaccination, the patient developed Guillain-Barre. Healthcare professional did not have the patient's initials nor the expiration or lot number. It was unknown if the reporter considered the guillain barre syndrome to be related to Covid vaccine.     The reporter consented to follow up via email.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: A third dose was inadvertently received today June 1; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number YC5Y7, expiry date 25-OCT-2024) for prophylaxis.   Previously administered products included Shingrix (on 2020 received 1st dose.) and Shingrix (on 2020 received second dose.).   On 01-JUN-2023, the patient received the 3rd dose of Shingrix. On 01-JUN-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: A third dose was inadvertently received today June 1). The outcome of the extra dose administered was unknown.   Additional Information: Additional Information: GSK Receipt date: 01-JUN-2023 A pharmacist reported about a patient who received a full series of Shingrix in 2020. A third dose was inadvertently received today 01 JUN 2023 which led to extra dose administered. The reporter consented to follow up by email.
Age: 51.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix was inadvertently 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 51-year-old male patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 01-JUN-2023, the patient received Havrix adult (right arm). On 01-JUN-2023, an unknown time after receiving Havrix adult, the patient experienced expired vaccine used (Verbatim: Expired Havrix was inadvertently administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUN-2023 The reporter reported that an expired Havrix dose was inadvertently administered to a patient which led to expired vaccine used. The reporter enquired if the patient should be revaccinated and mentioned patient was okay, well, healthy and has been notified. The reporter did not consent to follow-up.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 36-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA703A, expiry date 30-APR-2023) and (batch number AMXA703A, expiry date 30-APR-2023) for prophylaxis.   On 01-JUN-2023, the patient received Menveo. On 01-JUN-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 02-JUN-2023 A pharmacist reported about a patient who received expired Menveo vaccine. The reporter consented to follow up. The patient received an expired dose of Menveo vaccine, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: she got a upper respiratory tract infection after getting the first Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of upper respiratory tract infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced upper respiratory tract infection (Verbatim: she got a upper respiratory tract infection after getting the first Shingrix vaccine). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). The outcome of the upper respiratory tract infection was resolved.   It was unknown if the reporter considered the upper respiratory tract infection to be related to Shingrix.     It was unknown if the company considered the upper respiratory tract infection to be related to Shingrix.   Additional Information: GSK receipt date:02-JUN-2023 The patient stated that she got a upper respiratory tract infection after getting the first Shingrix vaccine.  She disconnected the line prior to getting anymore demographics, details of the event such as timing as to when her respiratory infection occurred after her vaccine, or information about the vaccine itself.  She did stated that she took antibiotics which she finished 5 days ago. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site, injection site hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2021).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site, injection site hurt). The outcome of the injection site pain was resolved (duration 5 days).   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUN-2023 The patient self reported this case. The patient received the first shingles vaccine in 2021 and thought she got the second one six months later in 2022. She remembered the injection site hurt for five days after the second shot. However, no one, not even her insurance company had a record of this second shot.  She questioned if is there a blood test that could determine if the second shot was in her system, Should she get a second shot/ third shot to be sure. The patient was told if she thought she had the second shot, not to get another as there could be unpleasant side effects  The patient did not consented to follow up.  The patient never spoke to caller minimum to file.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Vaccine on 9-8-2022 and wanted to know if there are any effects of waiting this long to receive the second dose; This non-serious 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 8th September 2022).   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: Vaccine on 9-8-2022 and wanted to know if there are any effects of waiting this long to receive the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2023 The patient received her Shingrix Vaccine and wanted to know if there were any effects of waiting this long to receive the second dose.  Patient information was given to the Healthcare professional. PQC was unrelated to health safety information. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: LOT OF BLOOD CLOTS RECUR; This spontaneous report received from a consumer concerned multiple (unspecified number) patients of an unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced lot of blood clots recur from one shot Janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lot of blood clots recur was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230606535- lot of blood clots recur. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Skin laceration
Clinical narrative: CHOPPED MY LEG OFF TWICE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chopped my leg off twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chopped my leg off twice was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 10-May-2023, the patient experienced UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine).    This case was for 2nd (wife) patient out of 27 patients. Patients was an over the age of 65 years.  Concomitant medications were not reported.  It was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  The vaccine was administered in the deltoid site. On 11-May-2023 26 patients were contacted, on 12-May-2023 18 patients received an additional 0.25ml, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be reached by phone.   Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error
Clinical narrative: No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before.    On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    No concomitant medications were reported. The age of the patient was reported as over 65 years. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse vent were unknown.  The vaccine was administered in the deltoid site. On 11-May-2023, 26 patient's were contacted, and on 12-May-2023 18 patient's received an additional 0.25ml.  No treatment medications were reported.  This case contains information for the 6th of 27 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if patient had acute or chronic long-standing health conditions at the time of vaccination.     On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 10-May-2023, the patient experienced UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine).    No relevant concomitant medications were reported.   Patient was over the age of 65 years.  The vaccine was administered in the deltoid site.   On 11-May-2023, 26 patients were contacted, on 12-May-2023, 18 patients received an additional 0.25ml, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be reached by phone.  No treatment medications reported.   This case contains information for the 3rd patient out of 27 patients described by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error
Clinical narrative: No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    No concomitant medications were reported. Patient's age was reported as >65 years. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse vent were unknown. It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before. The batch number was reported as 067H22A.  The vaccine was administered in the deltoid site.  On 11-May-2023, 26 patient's were contacted, and on 12-May-2023 18 patient's received an additional 0.25ml. No treatment medications were reported.  This case contains information for the 4th of 27 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case