chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Tremor, Vaccination site pain, Vomiting
Clinical narrative: Severe nausea, shaking, muscular pain, vomiting, insomnia, restless leg/feet for at  least 36 hours after injection
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: AFTER PATIENT RECEIVED VACCINE, ARM ON OUTSIDE FROM INJECTION SITE DOWN TO ELBO TURNED RED/PINK AND WAS HOT TO TOUCH.  PROBLEM HAD NOT RESOLVED AND WAS STILL PERSISTING 7 DAYS LATER AT THE TIME PATIENT REPORTED THE ADVERSE EVENT TO THE PHARMACY. PATIENT IS PLANNING TO FOLLOW UP WITH DR.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: About 24 hours after vaccination (afternoon of 9-13-2024), my arm became very sore and swollen, my body started aching all over, I started itching intermittently, sweating off and on and generally feeling bad as though I may have a fever (didn't take my temperature . This discomfort has continued for three days and I'm concerned if I have Covid  or someother illness.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: About 24 hours after vaccination (afternoon of 9-13-2024), my arm became very sore and swollen, my body started aching all over, I started itching intermittently, sweating off and on and generally feeling bad as though I may have a fever (didn't take my temperature . This discomfort has continued for three days and I'm concerned if I have Covid  or someother illness.
Age: 72.0
Sex: F
Vaccine: CHIK
Symptoms: Chills, Dizziness, Heart rate decreased, Heart rate irregular, Nausea
Clinical narrative: three days after the vaccination I started having fever and chills and body aches.  Around 23:45 on the 13th I started to feel very nauseous and then dizzy even lying in bed. My heart rate was slow irregular and thready.  Ambulance was called and as time passed my symptoms resolved just by laying flat and drinking water.  No specific medical intervention was needed.
Age: 72.0
Sex: F
Vaccine: CHIK
Symptoms: Pain, Pyrexia
Clinical narrative: three days after the vaccination I started having fever and chills and body aches.  Around 23:45 on the 13th I started to feel very nauseous and then dizzy even lying in bed. My heart rate was slow irregular and thready.  Ambulance was called and as time passed my symptoms resolved just by laying flat and drinking water.  No specific medical intervention was needed.
Age: 90.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Chills, Erythema, Flushing, Vomiting
Clinical narrative: PATIENT REPORTED FLUSHING/REDNESS IN FACE, VOMITING AND CHILLS
Age: 92.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: A FluAd vaccine was also given on 7/29/24 in addition to the FluAd vaccine given on 9/12/24.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Accidentally gave Adult the Pediatric dose of covid vaccine
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller reported PROQUAD administered after temperature excursions.; This spontaneous report has been received from a registered nurse, regarding to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, as prophylaxis, (lot number Y004547 which has been verified to be valid, expiration date reported and established as: 19-AUG-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of -12 degrees Celsius (C), during a time frame of 37 minutes (product storage error). There was a previous temperature excursion.  No additional adverse events were reported in the patient.  This case is considered to be non-valid due to the lack of patient's identifiers.   Follow up information has been received from the registered nurse on 12-SEP-2024. The case became valid with patient identifiers, a 5-year-old male patient.   On 06-AUG-2024, the patient was vaccinated with the first dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, administered subcutaneously via left arm for prophylaxis (lot number Y004547 which has been verified to be valid, expiration date reported and established as: 19-AUG-2025) (strength and dose were not provided). It was stated that vaccine administered before vaccine was cleared by manufacturer. Vaccine had been cleared for use. In addition, vaccine administration details were updated.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2409USA005155:
Age: 1.08
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; PROQUAD and VARIVAX were inadvertently administered to a 13 month old male patient on the same day.; This spontaneous report was received from a nurse and referred to a 13-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-AUG-2024, the patient concomitant inadvertently administrated of first dose varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #x026790, expiration date: 14-NOV-2025, administered subcutaneously and first dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #x025820, expiration date: 29-APR-2025, administered subcutaneously for prophylaxis (strength and anatomical location was not provided) (accidental overdose). No additional adverse event was reported (no adverse event).
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: inadverntly administered the PROQUAD vaccine instead of the VARIVAX vaccine; patient received the MMR II, PROQUAD, VAQTA; the patient was inadverntly administered the PROQUAD vaccine; No additional AE/PQC reported; This spontaneous report was received from an other health professional (registered nurse) and refers to a 12-month-old patient of an unknown gender.  The patient's medical history and concurrent conditions were not provided. Concomitant medications included hepatitis a vaccine (+) inactivated (VAQTA) and influenza vaccine (reported as unknown flu vaccine).   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) injection, lot #X022412, expiration date: 05-SEP-2025 (strength, dose, anatomical location, and route of administration were not provided); measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) injection, lot #Y008787, expiration date: 30-OCT-2025 (strength, dose, anatomical location, and route of administration were not provided) both for prophylaxis. On the same day, he/she was also administered hepatitis a vaccine (+) inactivated (VAQTA) and influenza vaccine (reported as unknown flu vaccine). It was reported that the patient was supposed to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX), hepatitis a vaccine (+) inactivated (VAQTA), and an unknown flu vaccine. But the patient was inadvertently administered  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine instead of varicella virus vaccine live (oka/merck) (VARIVAX) vaccine (Wrong product administered, Accidental overdose). No additional adverse event (AE) was reported (no adverse event).
Age: 60.0
Sex: M
Vaccine: MMR
Symptoms: Off label use
Clinical narrative: 60-year-old patient received M-M-R II; Literature report:   This literature marketed report was received from the authors in a published literature article titled as stated above, regarding a 60-year-old male patient whose past medical history included pre-repair left ventricular ejection fraction (LVEF) of 60 percent, severe mitral regurgitation secondary to mitral valve prolapse and prior mitral valve repair with a post-repair LVEF of 35 percent. On an unknown date, the patient presented to a hospital with volume overload that progressed to cardiogenic shock complicated by cardiac arrest and was hospitalized for transplant evaluation. His pretransplant rubeola IgG was negative.   On an unknown date ("hospital day 2"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, dose, route and frequency were not reported), along with pneumococcal 23v polysaccharide vaccine (manufacturer unknown), varicella zoster vaccine rge (cho) (SHINGRIX), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and hepatitis a vaccine inact (HAVRIX); all of them for prophylaxis for pretransplant vaccinations (Off label use in unapproved age group).    A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Merck Employee relayed Physician reported the following AE for ROTATEQ: " In June 2024, female patient at 2-month visit developed prolonged diarrhea after vaccine and did not receive additional doses in series."  No further information provided.  Phy; This spontaneous report was received from physician and refers to a 2-month-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in June 2024, the patient experienced prolonged diarrhea after vaccine. At the time of reporting, the outcome of the event was not known.  The causal relationship between adverse event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Merck Employee relayed Physician reported the following AE for ROTATEQ: "Physician was not able to remember adverse event, but boy patient and possibly diarrhea."  Physician granted permission to follow up.  No further information provided.  No addit; This spontaneous report was received from physician and refers to a male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced possibly diarrhea. At the time of reporting, the outcome of the event was not known.   The causal relationship between all adverse event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Age: 2.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller reported PROQUAD administered after temperature excursions.; This spontaneous report has been received from a registered nurse, regarding to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, as prophylaxis, (lot number Y004547 which has been verified to be valid, expiration date reported and established as: 19-AUG-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).  Administered doses were stored at a temperature of -12 degrees Celsius (C), during a time frame of 37 minutes (product storage error). There was a previous temperature excursion.  No additional adverse events were reported in the patient.  This case is considered to be non-valid due to the lack of patient's identifiers.   Follow up information has been received from the registered nurse on 12-SEP-2024. The case became valid with patient identifiers, a 2-year-old female patient.   On 13-AUG-2024, the patient was vaccinated with the first dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, administered subcutaneously via left arm for prophylaxis (lot number Y004547 which has been verified to be valid, expiration date reported and established as: 19-AUG-2025) (strength and dose were not provided). On that day, the patient was also vaccinated with the third dose of hepatitis B vaccine (HEP B VAX) administered intramuscularly via right arm for prophylaxis (Batch/lot# 42B22, expiration date reported as 07-MAR-2026; strength, formulation, and dose were not provided). It was stated that vaccine administered before vaccine was cleared by manufacturer. Vaccine had been cleared for use. In addition, vaccine administration details were updated.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2408USA005168:
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Proquad administered after temperature excursions; This spontaneous report has been received from a registered nurse, regarding to a 5-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 26-JUL-2024, the patient was vaccinated with the second dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered subcutaneously (sc) in the left arm (LA) for prophylaxis (lot number Y004547 which has been verified to be valid, expiration date reported and established as: 19-AUG-2025) (exact dose was not provided). The vaccine was administered after un-noticed temperature excursions occurred (temperature: -12 degrees Celsius (C), during a time frame of 37 minutes) (product storage error). There was a previous temperature excursion. It was stated that vaccine was administered before vaccine was cleared by manufacturer. Vaccine had been cleared for use. No other information was provided. No additional adverse effects (AEs) or product quality complaint (PQC) was reported (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2408USA005168:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported. No PQC reported.; Nurse reported PROQUAD was administered after a temperature excursion. Date of administration: Aug 13, 2024.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On an unspecified date, the following vaccine underwent a temperature excursion (temperature -14 degree Celsius for 16 minutes): measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human Albumin) (PROQUAD) injection, lot #X021130 has been verified to be valid, expiration date: 12-FEB-2025.   On 13-AUG-2024, the patient was vaccinated with the improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human Albumin) (PROQUAD) injection, once, lot #X021130, expiration date was reported and confirmed as 12-FEB-2025, administered for prophylaxis (strength, exact dose and route of administration were not provided) (Product storage error). On an unspecified date, there was a previous temperature excursion of -0.4 degree Celsius for 1 Hour 31 minutes. Operator of device was reported as health professional. No further information provided. No additional adverse event reported. No product quality complaint reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2409USA005357:
Age: 34.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Behcet's syndrome, Product administered to patient of inappropriate age, Rash, Rash macular
Clinical narrative: have an unofficial diagnoses of Behcets.; rash in my left armpit /is getting more painful each day; 34 years patient received Shingrix; This serious case was reported by a consumer and described the occurrence of behcet's disease in a 34-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   Concomitant products included lisdexamfetamine mesilate (Vyvanse), bupropion hydrochloride (Wellbutrin), clonidine, buspirone hydrochloride (Buspar), mirtazapine, cetirizine hydrochloride (Zyrtec) and ubidecarenone (Co Q-10).   On 27-AUG-2024, the patient received Shingrix and Influenza vaccine. On 27-AUG-2024, an unknown time after receiving Shingrix and not applicable after receiving Influenza vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: 34 years patient received Shingrix). On 30-AUG-2024, the patient experienced painful rash (Verbatim: rash in my left armpit /is getting more painful each day). On an unknown date, the patient experienced behcet's disease (Verbatim: have an unofficial diagnoses of Behcets.) (serious criteria GSK medically significant). The outcome of the behcet's disease and inappropriate age at vaccine administration were not reported and the outcome of the painful rash was not resolved.   It was unknown if the reporter considered the behcet's disease and painful rash to be related to Shingrix.     The company considered the behcet's disease to be unrelated to Shingrix. It was unknown if the company considered the painful rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-SEP-2024 The patient self-reported this case. The patient had an unofficial diagnoses of Bechet's and also got the flue vaccine at the same time.  The patient got the rash in her left armpit, same side as the shot and it was in a C shape with some extra dotting of rash.  It started out non noticeable and was getting more painful each day. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments: Behcet's syndrome  is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; the most painful areas; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: the most painful areas). The patient was treated with lidocaine, fentanyl, ethanol (Alcohol), hydrocodone, oxycodone and cannabidiol. The outcome of the vaccination failure and shingles were not reported and the outcome of the pain was resolving.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-SEP-2024 This case was reported by a patient via interactive digital media. The patient reported that he/she took the shots and still got shingles. Lidocaine cream applied directly to the most painful areas helped the patient some, but nothing from doctors so far. Possibly fentanyl or alcohol, opioids such as hydro-codone and oxycodone, even Tetrahydrocannabinol nor Cannabidiol helped the patient. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccine schedule, clinical description, medical history and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: RVX
Symptoms: Pneumonia, Product communication issue
Clinical narrative: pneumonia; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pneumonia (Verbatim: pneumonia) (serious criteria GSK medically significant). The outcome of the pneumonia was not resolved.   It was unknown if the reporter considered the pneumonia to be related to RSV vaccine.     The company considered the pneumonia to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 11-SEP-2024 This case was reported by a patient via interactive digital media. The reporter reported that his/her physician recommended not to get RSV vaccine because he/she had a chronic obstructive pulmonary disorder and the vaccine although generally safe had a some known side effects. The patient was misunderstood him/her and ended up with pneumonia. The patient was trying to deal with that along with chronic obstructive pulmonary disorder and it was not fun.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: they were slightly over 10 years apart, are they effective; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, the patient received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: they were slightly over 10 years apart, are they effective). The outcome of the drug dose administration interval too long was not reported.   Additional Information: GSK Receipt Date:01-NOV-2023 The reporter asked if the patient had 2 doses of Shingrix, but they were slightly over 10 years apart. The reporter asked if the doses were effective and if the patient should have another shot. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: MEN, MENB
Symptoms: Swelling
Clinical narrative: reaction swelling at the which was severe; This non-serious case was reported by a physician via sales rep and described the occurrence of swelling in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero and Menquadfi. On an unknown date, an unknown time after receiving Bexsero, the patient experienced swelling (Verbatim: reaction swelling at the which was severe). The outcome of the swelling was not reported.   It was unknown if the reporter considered the swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-SEP-2024 Healthcare professional (HCP) mentioned there was adverse reaction swelling at the which was severe. Bexsero was co-administered with Menquadfi. It was unknown if the reporter considered the swelling to be related to Menquadfi.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Insomnia, Pain, Pruritus
Clinical narrative: head burns; hurts; Itches all the time; couldn't sleep; got shingles in March/i had them on the right side of my head in my hair and on my neck but only on the right side; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included death of daughter (in March lost his/her daughter).   On an unknown date, the patient received the 1st dose of Shingles vaccine. In MAR-2024, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles in March/i had them on the right side of my head in my hair and on my neck but only on the right side). On an unknown date, the patient experienced burn (Verbatim: head burns), pain (Verbatim: hurts), pruritus (Verbatim: Itches all the time) and sleeplessness (Verbatim: couldn't sleep). The outcome of the shingles, burn, pain, pruritus and sleeplessness were not resolved.   It was unknown if the reporter considered the shingles, burn, pain, pruritus and sleeplessness to be related to Shingles vaccine.   It was unknown if the company considered the shingles, burn, pain, pruritus and sleeplessness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-SEP-2024 This case was reported by a patient via interactive digital media. The patient got shingles in March after the patient lost his/her daughter. At the time of reporting it was September and his/her head still burns hurts itches all the time and he/she had them on the right side of head in hair and on neck but only on the right side. The patient had half of the shot months ago it made so sick that he/she did not get the other half and made big mistake. The patient had suffered with them about 6 weeks in and was hurt burned itches so bad and the patient was ready to end it and that's not a joke. At night when his/her got so bad that the patient could not sleep and was went to doctor 5 times also taken medicine available. The pain medicine did not touch it. The shingles were no joke and was 6 months in this.
Sex: F
Vaccine: HEP, HEP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: recived 3rd dose on 09th may 2024/interval too short; administered an Engerix B expired vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 57-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number DZ747, expiry date 12-JUL-2024) for prophylaxis.   On 05-SEP-2024, the patient received the 3rd dose of Engerix B. On 24-JUL-2024, the patient received the 2nd dose of Engerix B. On 24-JUL-2024, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administered an Engerix B expired vaccine). On 05-SEP-2024, the patient experienced drug dose administration interval too short (Verbatim: recived 3rd dose on 09th may 2024/interval too short). The outcome of the drug dose administration interval too short was not reported and 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: 05-SEP-2024 The reporter reported that the patient had received Engerix B expired dose twelve days latter which led to expired vaccine used. The reporter reported that this expire dose was supposed to be the 2nd dose, but as this was not valid, on 05th September 2024 they revaccinate the patient with a valid dose by this, the patient had received 3 Engerix-B doses. The patient received 3rd dose of Engerix B vaccine earlier than the recommended interval, which led to shortening of the vaccination scheduled. The vaccine administration facility was the same as Primary Reporter The reporter consented to the follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Back pain, Gait disturbance, Pain
Clinical narrative: arthritis; pain/severe pain; lower back pain; pain in her hip; difficulty time walking; This non-serious case was reported by a consumer via call center representative and described the occurrence of low back pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-AUG-2024, the patient received the 1st dose of Shingrix. In AUG-2024, 3 days after receiving Shingrix, the patient experienced low back pain (Verbatim: lower back pain), pain in hip (Verbatim: pain in her hip) and walking difficulty (Verbatim: difficulty time walking). On an unknown date, the patient experienced arthritis (Verbatim: arthritis) and pain (Verbatim: pain/severe pain). The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). The outcome of the low back pain, pain in hip, arthritis and pain were not resolved and the outcome of the walking difficulty was unknown.   It was unknown if the reporter considered the low back pain, pain in hip, walking difficulty, arthritis and pain to be related to Shingrix.     It was unknown if the company considered the low back pain, pain in hip, walking difficulty, arthritis and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2024 The patient self-reported this case. The patient received Shingrix and stated three days after the injection she began to experience lower back pain, pain in her hips, difficulty time walking and expresses that she was experiencing severe pain in hips/lower back. The patient sated she tried taking Tylenol for arthritis, Advil and using arthritis pain joint cream. The patient stated using medication did not alleviate the pain. The pain has gotten progressively worse since onset.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Incomplete course of vaccination
Clinical narrative: A 5 years old male patient got vaccinated with a partial pediatric dose of Flulaval.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 5-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 3NJ7A, expiry date 07-JUN-2025) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incomplete dose administered (Verbatim: A 5 years old male patient got vaccinated with a partial pediatric dose of Flulaval.). The outcome of the incomplete dose administered 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: 06-SEP-2024 The patient was given a partial dose of Flulaval, which led incomplete dose administered and needed to verify how to proceed. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: there's two vials, we just gave one of them, we didn't constitute it; there's two vials, we just gave one of them, we didn't constitute it; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number BT59B, expiry date 10-AUG-2026) for prophylaxis.   On 06-SEP-2024 09:00, the patient received Shingrix. On 06-SEP-2024 09:00, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: there's two vials, we just gave one of them, we didn't constitute it) and inappropriate dose of vaccine administered (Verbatim: there's two vials, we just gave one of them, we didn't constitute it). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-SEP-2024 The nurse reported that they had a Shingrix vaccine administered to a patient was a vial. The nurse reported that you know there's two vials, they just gave one of them, they didn't constitute it which led to inappropriate preparation of medication inappropriate dose of vaccine administered. The nurse reported that the dose was given at 9 'clock am that morning.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: felt pain/soreness at the injection site for about one week; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose several years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: felt pain/soreness at the injection site for about one week). The outcome of the injection site pain was resolved (duration 1 week).   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: 06-SEP-2024 The patient self-reported this case. He received both doses of Shingrix vaccine several years ago and stated that he felt pain or soreness at the injection site for about one week following 2nd dose of Shingrix.
Sex: U
Vaccine: HEP
Symptoms: Intercepted product storage error
Clinical narrative: the vaccine is Engerix-B, it was actually out of range, low, for 1 hour and 5 minutes, the lowest temp was negative 1.1°C. Ok. And, if we gave it to a patient, what is the recommendation; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient did not receive Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced intercepted product storage error (Verbatim: the vaccine is Engerix-B, it was actually out of range, low, for 1 hour and 5 minutes, the lowest temp was negative 1.1°C. Ok. And, if we gave it to a patient, what is the recommendation). The outcome of the intercepted product storage error 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: 06-SEP-2024 The practice manager reported that there was an excursion event for one of your products, the vaccine was Engerix-B, it was actually out of range and low for 1 hour and 5 minutes as the lowest temperature was negative 1.1 degree Celsius and asked if they can gave it to a patient and what was the recommendation, which led to intercepted product storage error.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in specified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms). The outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2024 The reporter states her friend has two relatives who had flu-like symptoms after receiving Shingrix. The reporter did not consent to follow-up.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: already had an Arexvy vaccine/Extra Dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X723B, expiry date 08-DEC-2024) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 15-DEC-2023 with batch number X723B and expiry date on 08-DEC-2024).   On 06-SEP-2024, the patient received the 2nd dose of Arexvy. On 06-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: already had an Arexvy vaccine/Extra Dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-SEP-2024 The pharmacist reported that she administered a dose of Arexvy vaccine to a patient on the day of reporting and afterwards the patient informed her he had already had an Arexvy vaccine, which led to an extra dose administered. The vaccine administration facility was the same as primary reporter.
Age: 79.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash, Skin warm, Tenderness
Clinical narrative: tender to the touch and beginning of a rash/rash has spread from shoulder to middle of her arm,; swollen arm which was warm; swollen arm which was warm; painful, swollen arm/swollen arm tender to the touch; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) (batch number B4942, expiry date 06-APR-2026) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On 29-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) and PNEUMOCOCCAL VACCINE (intramuscular, left deltoid). On an unknown date, less than a week after receiving Shingrix, the patient experienced rash (Verbatim: tender to the touch and beginning of a rash/rash has spread from shoulder to middle of her arm,), skin warm (Verbatim: swollen arm which was warm), swelling arm (Verbatim: swollen arm which was warm) and pain in arm (Verbatim: painful, swollen arm/swollen arm tender to the touch). The patient was treated with triamcinolone acetonide (Triamcinolone) and cetirizine hydrochloride (Zyrtec). The outcome of the rash was not resolved and the outcome of the skin warm, swelling arm and pain in arm were unknown.   It was unknown if the reporter considered the rash, skin warm, swelling arm and pain in arm to be related to Shingrix.     It was unknown if the company considered the rash, skin warm, swelling arm and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2024 The pharmacist reported that his patient received her first Shingrix vaccination along with a pneumonia vaccination (manufacturer not specified) both in her left deltoid. She returned to the pharmacy on 3rd September 2024 with painful, swollen arm which was warm, tender to the touch and beginning of a rash and the reporter marked the rash to determine if it was spreading.   She returned today (on the reporting day) and he observed that the rash had spread from shoulder to middle of her arm and was going into her underarm area and saw her doctor, who did not offered a diagnosis, but prescribed triamcinolone and Zyrtec as treatment.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administration of only liquid component; received only the liquid portion of this vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMDBO208, expiry date 03-APR-2025) for prophylaxis.   On 27-AUG-2024, the patient received the 1st dose of Menveo. On 27-AUG-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administration of only liquid component) and inappropriate dose of vaccine administered (Verbatim: received only the liquid portion of this vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-SEP-2024 The reporter stated that he/she was the manager of a primary care office, and was reconciling vaccines, and noticed that missed 2 diluents of Menveo vaccine, and knew that somebody received the liquid portion of the 2 dose vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The HCP called to report that 3 patients received only the liquid part of the Menveo (2 vial) vaccine, by this, first she said that she could not find 2 liquid portion of the vaccine, so she supposed that 2 patients only received the liquid portion. Later, she said that probably 3 patients received only the liquid portion of this vaccine and she provide the information of this patients. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024111370:same reporter/different patient US-GSK-US2024111420:same reporter/different patient
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: bruising; a rash that was about 3 inches below the band-aid; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-SEP-2024, the patient received the 1st dose of Shingrix (left arm). In SEP-2024, less than a week after receiving Shingrix, the patient experienced injection site bruising (Verbatim: bruising) and rash (Verbatim: a rash that was about 3 inches below the band-aid). The outcome of the injection site bruising and rash were not resolved.   It was unknown if the reporter considered the injection site bruising and rash to be related to Shingrix.     It was unknown if the company considered the injection site bruising and rash to be related to Shingrix.   Additional Information: GSK receipt date: 06-SEP-2024 The patient received had his first dose of Shingrix administered into the left arm.   The patient stated that when he removed the band-aid on 6th September 2024  he noticed a bruise at the injection site and a rash that was about 3 inches below the band-aid and one inch above the band-aid.   The bruising was the size of a quarter.  The patient stated their was no pain involved.   Consented to follow up.
Age: 77.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Chest pain, Pain in extremity
Clinical narrative: shoulder soreness; soreness in his chest; He experienced soreness in his right arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On 05-SEP-2024, the patient received Shingrix (right arm) and Influenza vaccine (left arm). In SEP-2024, an unknown time after receiving Shingrix, the patient experienced shoulder soreness (Verbatim: shoulder soreness), chest pain (Verbatim: soreness in his chest) and pain in arm (Verbatim: He experienced soreness in his right arm). The outcome of the shoulder soreness and chest pain were unknown and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the shoulder soreness, chest pain and pain in arm to be related to Shingrix.     It was unknown if the company considered the shoulder soreness, chest pain and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2024  The patient self-reported this case for himself. The patient received a dose of Shingrix and a dose of flu vaccine day before reporting.  The patient did not know the manufacturer for the flu vaccine but said that it was the higher dose flu vaccine.  The patient experienced soreness in his right arm and soreness in his chest. It was unknown if the reporter considered the shoulder soreness, chest pain and pain in arm to be related to Influenza vaccine.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discharge, Underdose
Clinical narrative: Pharmacist administered Boostrix to an adult female patient but a good portion of the vaccine came out; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 64-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4RF9D, expiry date 16-JUN-2026) for prophylaxis.   On 06-SEP-2024, the patient received Boostrix. On 06-SEP-2024, an unknown time after receiving Boostrix, the patient experienced accidental underdose (Verbatim: Pharmacist administered Boostrix to an adult female patient but a good portion of the vaccine came out). The outcome of the accidental underdose 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: 06-SEP-2024 and 07-SEP-2024 The pharmacist administered Boostrix to an adult patient but a good portion of the vaccine came out. The patient had a big arm and the needle size used was 1 inch. The pharmacist inquired about a replacement for Boostrix. According to the MI (medical information) agent, the pharmacist attached a 1 inch needle. The patient received less than 1/2 of the vaccine because the vaccine came out, which led to accidental underdose.  The vaccine administration facility was the same as primary reporter.