chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: PATIENT CAME IN WANTING A COVID VACCINE. WHEN REGISTERING HIM, WE PROCESSED A FLU SHOT INSTEAD. PATIENT ALREADY RECEIVED THE SAME FLU SHOT ON JULY 28, 2024 (FLUAD). PATIENT WAS TOLD THE NEXT DAY OF THE ERROR AND PATIENT REPORTS NO SYMPTOMS
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Perioral dermatitis, Rash
Clinical narrative: patient reported that she developed a reaction 20 minutes after receiving the vaccine; her face was flushed and she developed a rash around her mouth and eyes. She has not taken anything and has been using lotion. She reports receiving her last flu shot "a long time ago." Her symptoms have not gotten any better. She was advised to take an antihistamine and/or follow up with a provider for further evaluation; she denies any throat swelling or breathing problems.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: We had an agency nurse give 2 doses of the Moderna 6 month- 11 year vaccine to an 18 year old patient, who should have received the Moderna 12+ yrs vaccine. One dose was given in right deltoid, the other dose was given in the left deltoid. Patient had no reaction and was notified of the mistake.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Influenza like illness, Psoriasis
Clinical narrative: Flu-like symptoms, plus stomach cramping, began about two weeks after vaccination and continued for six weeks. Then those symptoms lessened and were replaced with plaque psoriasis, which covered my body. (I?d never had psoriasis before).  I sought treatment at dermatologist, who prescribed Cosentyx 300mg.
Age: 20.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: varicella titter showed no immunity, requested evidence of additional chicken pox vaccine as needed for adm into education program because titer was low.  Extraneous dose given. Booster dose not indicated per protocol/ CDC guidelines
Age: 22.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Asthenia, Cold sweat, Dizziness, Hyperhidrosis, Inappropriate schedule of product administration
Clinical narrative: Patient was instructed to remain in a seated reclined position after vaccination for 15 minutes.  RN exited the room to enter vaccination administration into the EHR.  When RN returned patient was in seated reclined position she was sweating profusely and clammy.  She reported feeling very light headed and weak.  She was able to have a conversation.  Patient was given several cold packs, one for the back of her neck, and one to place on chest, shoulders and side of neck.  Patient was given fruit snacks, fruit juice and water.  Patient remained in seated recline position for approximately 45 minutes.    Patient was instructed to gradually rise to standing position and return to seated position should she feel faint. Patient was able to stand and exited patient room with the help of her spouse.
Age: 5.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Client reported to our clinic for catch up vaccinations. She was last seen in our clinic October of 2023 and was in progress, they had not returned since.  Upon check in it was noted the child had 2 show me vax accounts and the state was asked to merge them. Client was screened, parent had no questions, and vaccines were given. It was not discovered until after the merge that the client had been to another clinic in February of 2024, resulting in the child getting a varicella vaccine they did not need. 2 attempts made to contact parent on 8/26. Voicemail not set up, unable to leave a message. Called again on 08/27 and father asked to call back with interpreter. Called back with interpreter and parent did not answer. Called again with interpreter and dad answered. Name and DOB of patient confirmed.  Explained to parent patient received an extra dose of Varicella that was not needed. He asked about any concerns to watch for. Father reports patient is doing great today, and was at school. No additional questions.  Medical director was notified of the vaccine error. He responded this is very low-risk incident for the patient.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Ear pain, Injection site bruising, Injection site erythema, Pyrexia
Clinical narrative: Patient was administered vaccines at a school vaccine clinic. Patient presented to clinic with left arm bruising. Patient's mother reports getting 4 injections to the left arm at school 4 days ago. no report of immunization found in system. . Patient has redness and bruising to the left arm. Patient's mother reports patient received 2 vaccines (components MMR, Var, Dtap, Ipv) but something happened with one injection so she ended up getting poked 3 times. Reassured patient's mother that local redness of the injection site and bruising is an expected reaction. She also reports patient having a fever last night, along with ear pain. Relayed fever can be expected after vaccine administration. Ear pain likely a result of the patient using cotton swabs and her finger to clean the ear, patient also has ear tubes. Patient is not complaining of ear pain today.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Abscess drainage, Arthralgia, Bone abscess, Culture positive, Magnetic resonance imaging abnormal
Clinical narrative: Patient was given HPV vaccine on 8/12/24 in the left deltoid. On 8/17, patient developed severe shoulder pain. He underwent shoulder MRI on 8/24/24 for persistent shoulder pain which revealed an 11.4 x 11.1 x 8 cm abscess in the shoulder girdle. This was surgically drained, and intraoperative cultures grew Group A strep.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Streptococcus test positive
Clinical narrative: Patient was given HPV vaccine on 8/12/24 in the left deltoid. On 8/17, patient developed severe shoulder pain. He underwent shoulder MRI on 8/24/24 for persistent shoulder pain which revealed an 11.4 x 11.1 x 8 cm abscess in the shoulder girdle. This was surgically drained, and intraoperative cultures grew Group A strep.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Syringe issue, Underdose
Clinical narrative: The bevel on the syringe leaked and we are unsure how much vaccine pt received, if any.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Patient was administered the spike vax when the new formulation had just been approved with hours.. there were no adversed  events for the administration of the vaccine. unfortunately, the vaccine was no longer FDA approved.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope within minutes of receiving the vaccine
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Laboratory test abnormal
Clinical narrative: Bloody stools for around 36 hours. Blood eventually became less and less until none was present.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropathy, Chills, Muscular weakness, Myalgia, Pain
Clinical narrative: I STARTED WITH CHILLS AND SEVERE MUSCALE ACHES AROUND 10PM THAT EVENING, I TOOK A HOME COVID TEST TO MAKE SURE THAT WASN'T THE ISSUE - IT WAS NEGATIVE. AS THE NIGHT WENT ON I CONTINUED TO FEEL WORSE, AND THE NEXT MORNING I FLET LIKE I HAD BEEN HIT BY A TRUCK. I HAD NO STRENGTH IN MY LIMBS AND I FELT LIKE IT TOOK EVERYTHING IN ME TO JUST GET OUT OF BED.  I TOOK TYLENOL AND MORTIN. THIS WENT ON FOR SEVERAL DAYS - THEN IT STARTED TO EASE UP SLIGHTLY BUT THE MUSLE ACHES AND JOINT WEAKNESS WAS STILL THERE. I KHAVE JUST IN THE PAST WEEK STARTED TO FEEL MORE LIKE MYSELF.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I STARTED WITH CHILLS AND SEVERE MUSCALE ACHES AROUND 10PM THAT EVENING, I TOOK A HOME COVID TEST TO MAKE SURE THAT WASN'T THE ISSUE - IT WAS NEGATIVE. AS THE NIGHT WENT ON I CONTINUED TO FEEL WORSE, AND THE NEXT MORNING I FLET LIKE I HAD BEEN HIT BY A TRUCK. I HAD NO STRENGTH IN MY LIMBS AND I FELT LIKE IT TOOK EVERYTHING IN ME TO JUST GET OUT OF BED.  I TOOK TYLENOL AND MORTIN. THIS WENT ON FOR SEVERAL DAYS - THEN IT STARTED TO EASE UP SLIGHTLY BUT THE MUSLE ACHES AND JOINT WEAKNESS WAS STILL THERE. I KHAVE JUST IN THE PAST WEEK STARTED TO FEEL MORE LIKE MYSELF.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal discomfort, Erythema, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Patient experienced side effects symptoms such as swollen arms, itching, redness, nausea, vomiting, and upset stomach. She has tried ice pack and has helped a little. The arm is still warm to the touch. Reported symptoms has not gotten any worse. Patient did not want to take ibuprofen or tylenol due to history of GERD. She will try benadryl to see if it will help
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm, Vomiting
Clinical narrative: Patient experienced side effects symptoms such as swollen arms, itching, redness, nausea, vomiting, and upset stomach. She has tried ice pack and has helped a little. The arm is still warm to the touch. Reported symptoms has not gotten any worse. Patient did not want to take ibuprofen or tylenol due to history of GERD. She will try benadryl to see if it will help
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Syncope, Vomiting
Clinical narrative: Patient fainted post-vaccination. Cx of nausea/vomitting, dizziness, and sweating. Ammonia used to arouse pt and feet raised.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: There were no adverse events.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Seizure
Clinical narrative: 10 minutes after receiving the Tdap vaccine patient started to have seizure
Age: 61.0
Sex: M
Vaccine: RSV, TDAP
Symptoms: Blood test normal, Condition aggravated, Dysphagia, Goitre, Lymphadenopathy
Clinical narrative: At 7-10 days after vaccination, patient experienced swollen lymph nodes in the groin area, arm pits, and neck area. The enlarged lymph nodes were on both sides of the body. In the neck, he had difficulty swallowing for a time period due to the enlargement of the lymph nodes with the enlarged thyroid.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of the injection site.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Vaccine was given after FDA and CDC approval but before Act finalized
Age: 30.0
Sex: F
Vaccine: FLUC4, HPV9
Symptoms: Abdominal discomfort, Back pain, Cold sweat, Erythema, Limb mass
Clinical narrative: Got shots on Friday 8/23  Felt clammy/ stomach upset on day of and day after  Lower back pain started on  8/26                                                                                                                                                  BEGINING on morning of 8/27 around 9 am PATIENT EXPERIENCED A BIG RED LUMP ON THEIR INJECTION ARM  Went into urgent care that blamed us for giving 2 shots in 1 arm-> urgent care told them to take benadryl, and if it gets bigger it could be an infection  Patient took tylenol
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Meningococcal Conjugate (Menveo) was administered to patient instead of the Meningococcal B (Bexsero), which was the actual order by a doctor. Patient/ patient's parent was informed of the event and asked to return the next day for the correct vaccine. Patient's parent stated they will return the next day on 7/26/2024, however, patient did not return for the correct vaccine as directed. Patient's parent was called three times since then, but still have not returned for the vaccine.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Muscle tightness, Nervousness
Clinical narrative: PATIENT  EXPERIENCED SHORTNESS OF BREATH, DIZZINESS, MUSCLE TIGHTNESS AND SHAKY
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient requested covid vaccine, but received flu vaccine. Received the same vaccine 8/24/24 at pharmacy. No side effects reported at time of vaccination.
Sex: M
Vaccine: MNP
Symptoms: Dyskinesia, Neck pain, Vomiting
Clinical narrative: vomit; involuntary movements; neck pain; This is a spontaneous report received from a Nurse from a sales representative.  An adolescent male patient received meningococcal group abcwy vaccine (PENBRAYA), on 16Aug2024 at 10:45 as dose 1, single (Lot number: HR2002), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSKINESIA (medically significant) with onset 16Aug2024 at 11:45, outcome "unknown", described as "involuntary movements"; NECK PAIN (medically significant) with onset 16Aug2024 at 11:45, outcome "unknown"; VOMITING (medically significant) with onset 16Aug2024 at 11:45, outcome "unknown", described as "vomit". The events "vomit", "involuntary movements" and "neck pain" required emergency room visit. It was unknown if therapeutic measures were taken as a result of vomiting, dyskinesia, neck pain. Additional information:Patient go to emergency room and translated to other hospital. Don't know if the patient require hospitalization.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events vomit, involuntary movements and neck pain based on the known safety profile and temporal association.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Consumer did not have any side effects after receiving the vaccinations; she received  2 vaccinations of PNEUMOVAX 23 three months apart the 1st one in 2020 and the second vaccine in 2021; This spontaneous report was received from a female patient of unknown age. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2020, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis; and three months later, on an unknown date in 2021, the patient was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (inappropriate schedule of product administration). The patient did not have any side effects after receiving vaccinations (no adverse event).   Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: dose 1 and dose 2 of VARIVAX were administered one month apart; No additional AE; This spontaneous report was received from a nurse and refers to a child patient under 13 years of age and of unknown gender.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown).  On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (dose, lot #, expiry date, route of administration and vaccination site were not provided) administered for prophylaxis. On an unknown date, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (dose, lot #, expiry date, route of administration and vaccination site were not provided) administered for prophylaxis. Dose one and dose two of varicella virus vaccine live (oka/merck) (VARIVAX) were administered one month apart (inappropriate schedule of product administration). At this time there were no additional details available. No additional adverse event (AE) was reported and no product quality complaint (PQC) was noted.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; The caller said both of the products were administered to a patient on 7/29/2024. The caller said prior to administration, the products were in a temperature excursion.; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JUL-2024, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dose, lot #X025091, expiration date reported as and upon internal validation confirmed to be: 04-JUL-2026 (exact dose, route of administration and vaccination site were not provided), and with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #2032349, expiration date reported as and upon internal validation confirmed to be: 10-OCT-2025 (exact dose, route of administration and vaccination site were not provided), both administered for prophylaxis. Prior to administration, the products were in a temperature excursion (temperature: 8.78degrees Celsius [C], time frame: 18 minutes, previous temperature excursion: yes) (product storage error). No other adverse event (AE) and no product quality complaint (PQC) were reported.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No side effects at this time./No additional AE/no PQC.; HCP calling to report a patient inadvertently received PROQUAD and VARIVAX a the same time. No side effects at this time. No additional information/clarification provided. No additional AE/no PQC.; This spontaneous report was received from a physician assistant regarding to a 4-year-old patient of unknown gender. The patient's medical history, dug reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 16-AUG-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, lot number Y008281 (lot number Y008281 had been verified to be valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [PROQUAD]), expiration date 21-OCT-2025; and with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot number X026326 (lot number X026326 had been verified to be valid lot number for varicella virus vaccine live [Oka/Merck] [VARIVAX]), expiration date 07-NOV-2025, both vaccines administered at a dose of 0.5 milliliter (mL), for prophylaxis (strength, frequency, route of administration and anatomical injection site were not provided), at the same time (inappropriate schedule of product administration).  No side effects at this time. No additional information/clarification provided. No additional adverse event (AE)/no product quality complaint (PQC) (no adverse event).
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MMR II administered on 14-JUL-2005 and 03-JUN-2011; This spontaneous report has been received from a physician, via a medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2407USA010097), concerning a currently 23-year-old female patient.  The patient's medical history, her concurrent conditions and concomitant therapies were not reported.  On 14-JUL-2005 (at the age of 4-year-old), the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection. Subsequently, on 03-JUN-2011, she received the second dose of the vaccine (inappropriate schedule of product administration). Both doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided).  This is one of the 3 cases received from the same reporter.; Sender's Comments:  US-009507513-2407USA010097: US-009507513-2408USA007711: US-009507513-2407USA010097:
Age: 5.0
Sex: F
Vaccine: DTAP, PNC15
Symptoms: No adverse event, Product confusion
Clinical narrative: no reported adverse event; patient received DAPTACEL and PCV15, instead of Kinrix and Proquad; Product confusion; This spontaneous report was received from a consumer referring to a 5 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported  On 22-JUL-2024, the patient was vaccinated in her left arm with a dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DAPTACEL) 0.5 ml, intramuscular, lot #: 2CA2AC1 and expiration date: 04-NOV-2024 (strength and dose number were not provided) and with a dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) (strength, dose, dose number, route, anatomical location , lot number and expiration date were not provided) for prophylaxis instead of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid(KINRIX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (wrong product administered and product confusion).   No adverse events reported.
Sex: U
Vaccine: HEP
Symptoms: Computerised tomogram normal, Headache, Pain
Clinical narrative: Sharp Pain Through Entire Body; Short Term Memory Was Affected; Sharp Pain In Head; Scraping Sensation In Genital Area; Initial report received on 21-Aug-2024.  A consumer reported that she, a female (age, race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications were not reported.    On 19-Sep-2023, the patient received the first dose of HEPLISAV-B (lot #, expiration date, and NDC #, site not reported) intramuscularly.   On the same day after having been vaccinated with HEPLISAV-B, the patient had sharp pain in the back of her head that was traveling through her body.  Her short-term memory "was affected to a degree."  On an unknown date, "months later," the patient experienced a scraping sensation in her genital area that is still ongoing.  On an unknown date, the patient had a CT scan of her head and the results were "normal."  The patient believes that these events were related to HEPLISAV-B.    No other information was available.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; eye shingles; 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, 7 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: eye shingles) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt date: 21-AUG-2024 This case was reported by patient via interactive digital media. He/she got the shot 7 years, later got shingles in his/her eye. Doctor Stated they were only good for 6 years, wish he/she had known and no more shots or Vaccine of any kind. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles.                                                                                                                                                                     Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: SOOO painful; Suspected vaccination failure; STILL got them; 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. In FEB-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: STILL got them). On an unknown date, the patient experienced pain (Verbatim: SOOO painful). The outcome of the vaccination failure and pain were not reported and the outcome of the shingles was not resolved.   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: 20-AUG-2024 The case was received from the patient via (social media) interactive digital media. The patient self-reported this case for himself/herself. The reporter reported that he/she had the shot for shingles and still got them in February and they were still bothering the reporter. The reporter won't wish them on anyone.  The reporter reported that it was so painful. 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 clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine  Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-AUG-2024 This case was reported by the patient via (social media) interactive digital media. The patient got both the shots and still got the shingles.  The patient further said that it was not fun at all. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine (Dose 1 and dose 2).
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Injection site pain - bad; Very bad Flu like symptoms; including fever 103.5; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hyperlipidemia. Concomitant products included atorvastatin.   On 13-AUG-2024 09:00, the patient received Shingrix. On 13-AUG-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain - bad), influenza-like symptoms (Verbatim: Very bad Flu like symptoms) and fever (Verbatim: includin fever 103.5). The outcome of the injection site pain, influenza-like symptoms and fever were not resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, influenza-like symptoms and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-AUG-2024 The patient self-reported this case for himself. The patient had the vaccine on tuesday at 9 am, the symptoms started early evening and had persisted. The patient had injection site pain was bad, very bad flu like symptoms including fever 103.5. The symptoms were not treated.
Age: 0.17
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Child product given to infant; 2 month old received Tdap instead of dtap; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 15-AUG-2024, the patient received the 1st dose of Boostrix. On 15-AUG-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Child product given to infant) and wrong vaccine administered (Verbatim: 2 month old received Tdap instead of dtap). The outcome of the inappropriate age at vaccine administration was unknown and the outcome of the wrong vaccine administered was not reported.   Additional Information: GSK Receipt Date: 15-AUG-2024 The physician reported that the patient received 1st doe of Boostrix The physician reported, the nurse gave a 2 month old patient a Tdap instead of Dtap which led to inappropriate age at vaccine administration and wrong vaccine administered. The physician needed direction about what to do moving forward with dosing.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: pain at injection site; fever; shivering; weakness; muscle pain; tiredness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4n9pf, expiry date 12-DEC-2025) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose in FEB-2024 and had muscle pain, tiredness, weakness, shivering and fever, For tolerance to 1st dose, refer case US2024102709).   On 15-AUG-2024, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In AUG-2024, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), fever (Verbatim: fever), shivering (Verbatim: shivering), weakness (Verbatim: weakness), muscle pain (Verbatim: muscle pain) and tiredness (Verbatim: tiredness). The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. The outcome of the injection site pain, fever, shivering, weakness, muscle pain and tiredness were not resolved.   It was unknown if the reporter considered the injection site pain, fever, shivering, weakness, muscle pain and tiredness to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, shivering, weakness, muscle pain and tiredness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024102709   Additional Information: GSK Receipt Date: 16-AUG-2024 The patient self-reported this case. She received her second dose of Shingrix prior to the reporting day and was experiencing muscle pain, tiredness, pain at the injection site, weakness, shivering and fever.  She took 2 dose of Advil this morning (on the reporting day) which seemed to have helped with the symptoms but they had not resolved. This case is linked with US2024102709, reporter by same reporter.; Sender's Comments:  US-GSK-US2024102709:same reporter, same patient, 1st dose
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: pain at injection site; fever; shivering; weakness; muscle pain; tiredness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4n9pf, expiry date 12-DEC-2025) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose in FEB-2024 and had muscle pain, tiredness, weakness, shivering and fever, For tolerance to 1st dose, refer case US2024102709).   On 15-AUG-2024, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In AUG-2024, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), fever (Verbatim: fever), shivering (Verbatim: shivering), weakness (Verbatim: weakness), muscle pain (Verbatim: muscle pain) and tiredness (Verbatim: tiredness). The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. The outcome of the injection site pain, fever, shivering, weakness, muscle pain and tiredness were not resolved.   It was unknown if the reporter considered the injection site pain, fever, shivering, weakness, muscle pain and tiredness to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, shivering, weakness, muscle pain and tiredness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024102709   Additional Information: GSK Receipt Date: 16-AUG-2024 The patient self-reported this case. She received her second dose of Shingrix prior to the reporting day and was experiencing muscle pain, tiredness, pain at the injection site, weakness, shivering and fever.  She took 2 dose of Advil this morning (on the reporting day) which seemed to have helped with the symptoms but they had not resolved. This case is linked with US2024102709, reporter by same reporter.; Sender's Comments:  US-GSK-US2024102709:same reporter, same patient, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: arm feels like it was shot with a bullet instead of a needle; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included pruritus and burning sensation.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: arm feels like it was shot with a bullet instead of a needle). The outcome of the arm discomfort was not reported.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-AUG-2024 The patient still has the itching and burning 2 years. The patient received 2nd dose of shingles shot and arm feels like it was shot with a bullet instead of a needle.
Sex: M
Vaccine: MEN
Symptoms: Rash
Clinical narrative: Rash/rash from head to toe starting; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 11-year-old male patient who received Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis.   On 31-JUL-2024, the patient received the 1st dose of Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On 11-AUG-2024, 11 days after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced generalized rash (Verbatim: Rash/rash from head to toe starting). The patient was treated with diphenhydramine hydrochloride (Benadryl) and cetirizine hydrochloride (Zyrtec). The outcome of the generalized rash was not resolved.   It was unknown if the reporter considered the generalized rash to be related to Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine.     It was unknown if the company considered the generalized rash to be related to Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine.   Additional Information: GSK Receipt Date: 15-AUG-2024 The patient's parents reported this case. The patient received the GSK vaccine Meningococcal (Groups A, C, Y, and W-135) and developed a rash from head to toe starting (rash all over his body). She took him to physician (HCP) on 12th August 2024 and was prescribed steroid pack, Benadryl and Zyrtec. The reporter didn't know if the vaccine received was the Menveo or Bexsero, the only thing they knew was that it was a GSK product. The reporter said that was the 1st time their son (patient) received a meningococcal vaccine, and that at the time of administration they also received another vaccine (they didn't specify which one).  According to reporter, the patient has been on steroids and antihistamines and the rash had not gotten any better. The reporter consent to follow-up.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Incorrect preparation; administered only the liquid component of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 1-year-old male patient who received MMR (Priorix) (batch number X3M3D, expiry date 01-APR-2025) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Incorrect preparation ) and inappropriate dose of vaccine administered (Verbatim: administered only the liquid component of Menveo ). The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   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: 15-AUG-2024 The reporter called to report that they had a situation where just  the diluent was given to a patient and not the vaccine portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered Consented to follow up.; Sender's Comments:  US-GSK-US2024101901:Same reporter, different patient US-GSK-US2024101909:Same reporter, different patient US-GSK-US2024101918:Same reporter, different patient
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: delayed vaccination" of Twinrix. According to reporter, the patient "got it in May (18th, 2024), and then she came in August (17th, 2024) for the 2nd 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 female patient who received HAB (Twinrix) (batch number 429JJ, expiry date 01-APR-2026) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 18-MAY-2024).   On 17-AUG-2024, the patient received the 2nd dose of Twinrix. On 17-AUG-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: delayed vaccination" of Twinrix. According to reporter, the patient "got it in May (18th, 2024), and then she came in August (17th, 2024) for the 2nd 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: 19-AUG-2024 The patient received 2nd dose at longer time interval, which led to lengthening of vaccination schedule. The reporter reported since the patient was out of the country she could not come before.  The reporter did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: A second dose of Arexvy was administered to a female patient almost a year apart of the first dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number BL473, expiry date 13-OCT-2026) for prophylaxis.   Previously administered products included Arexvy (first dose was given on October 2023).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: A second dose of Arexvy was administered to a female patient almost a year apart of the first dose.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 19-AUG-2024 The pharmacist called to report that they administered a second dose of Arexvy to a female patient with almost a year apart from the first dose, which led extra dose administered. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: HEPAB
Symptoms: Incorrect product administration duration
Clinical narrative: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug administration duration too long in a 67-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 10th June 2023).   On 17-AUG-2024, the patient received the 2nd dose of Twinrix adult. On 17-AUG-2024, an unknown time after receiving Twinrix adult, the patient experienced drug administration duration too long (Verbatim: Late 2nd dose). The outcome of the drug administration duration 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: 17-AUG-2024 The pharmacist asked about how to proceed with the schedule of Twinrix when the patient only received the first dose in 2023.  The patient received 2nd dose of Twinrix adult later than the recommended schedule, which led to lengthening of the vaccination schedule. The pharmacist asked when should the 3rd dose be administered. The Vaccine Administration Facility was the same as Primary Reporter. No other information provided since the pharmacist was in a hurry.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 doses of Shingrix back in January 23rd 2023 and October 23rd 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug administration duration too long in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 7FF7C, expiry date 28-MAY-2024) and (batch number 2Z9N3, expiry date 26-MAY-2026) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23 January 2023). Concurrent medical conditions included blood pressure high and diabetes. Concomitant products included metformin.   On 23-OCT-2023, the patient received the 2nd dose of Shingrix. On 23-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug administration duration too long (Verbatim: 2 doses of Shingrix back in January 23rd 2023 and October 23rd 2023.). The outcome of the drug administration duration too long was unknown.   Additional Information: GSK Receipt Date: 19-AUG-2024 The patient received 2nd dose at longer interval than recommended, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug ineffective, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/lack of effect; shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/lack of effect) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 20-AUG-2024 The GlaxoSmithKline sales representative reported on behalf of physician that the patient that had the complete series of Shingrix and developed shingles. No further information was known such as date of administration for vaccine, date of shingles outbreak, or resolve of shingles.  Lot number not provided. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (Dose 1 and Dose 2).