chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Injection site pruritus, Malaise, Pyrexia
Clinical narrative: Documentation copied from provider's office visit note today (5/12/25):  "Patient is a 65 y.o. female who presents today to walk-in clinic regarding vaccine reaction.   Had tetanus and COVID vaccines on Friday (5/9/25). Afterwards, was not feeling well. Was fatigued, had fever 100.8 over the weekend. Was taking Benadryl and Tylenol over the weekend. Has noticed redness at injection sites on both her arms. Describes the areas as intermittently painful and pruritic. Was advised not to get her routine allergy shot today due to the symptoms. Her next shot is tomorrow, and following one will be Friday. Suspect patient's symptoms are due to recent vaccination injections. Notably, injections were administered to the mid-upper arm bilaterally, rather than higher in the deltoid. Suspect inflammatory and/or allergic reaction. Advised to continue with Zyrtec or Benadryl, Tylenol as needed for pain control, local ice/cold compresses to reduce inflammation. Cannot take NSAIDs due to prior stroke. Follow up if symptoms worsen or persist.  Skin Comments: Erythematous macular region present on bilateral upper arms, at sites of previous injections."
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 16 years old. Was given Heplisav B which is indicated for patients 18 years and older. Did not experience any adverse event or side effects per mother.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Erythema, Eye pruritus, Rash
Clinical narrative: The patient presented to the clinic for routine vaccinations, including TDaP, meningococcal, and HPV immunizations. The vaccines were administered successfully, and the patient was monitored for 15 minutes with no adverse reactions observed. Approximately 80 minutes later, the mother returned with her son, who exhibited a mild rash on the jaw extending to the neck and partially to the cheeks bilaterally. After five minutes, the patient developed facial redness and reported itching of the eyes. The patient was evaluated promptly, and appropriate treatment was administered, including intramuscular epinephrine (0.3 mg/mL) and 25 mg of diphenhydramine (Benadryl) The patient presented to the clinic for routine vaccinations, including TDaP, meningococcal, and HPV immunizations. The vaccines were administered successfully, and the patient was monitored for 15 minutes with no adverse reactions observed.  Approximately 80 minutes later, the mother returned with her son, who exhibited a mild rash on the jaw extending to the neck and partially to the cheeks bilaterally. After five minutes, the patient developed facial redness and reported itching of the eyes.  The patient was evaluated promptly, and appropriate treatment was administered, including intramuscular epinephrine (0.3 mg/mL) and 25 mg of diphenhydramine (Benadryl)The patient presented to the clinic for routine vaccinations, including TDaP, meningococcal, and HPV immunizations. The vaccines were administered successfully, and the patient was monitored for 15 minutes with no adverse reactions observed.  Approximately 80 minutes later, the mother returned with her son, who exhibited a mild rash on the jaw extending to the neck and partially to the cheeks bilaterally. After five minutes, the patient developed facial redness and reported itching of the eyes.  The patient was evaluated promptly, and appropriate treatment was administered, including intramuscular epinephrine (0.3 mg/mL) and 25 mg of diphenhydramine (Benadryl)The patient presented to the clinic for routine vaccinations, including TDaP, meningococcal, and HPV immunizations. The vaccines were administered successfully, and the patient was monitored for 15 minutes with no adverse reactions observed.  Approximately 80 minutes later, the mother returned with her son, who exhibited a mild rash on the jaw extending to the neck and partially to the cheeks bilaterally. After five minutes, the patient developed facial redness and reported itching of the eyes.  The patient was evaluated promptly, and appropriate treatment was administered, including intramuscular epinephrine (0.3 mg/mL) and 25 mg of diphenhydramine (Benadryl)  The rash and facial redness resolved shortly after treatment..
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Erythema, Eye pruritus, Rash, Swelling face
Clinical narrative: The patient presented to the clinic for routine vaccinations, including TDaP, meningococcal, and HPV immunizations. The vaccines were administered successfully, and the patient was monitored for 15 minutes with no adverse reactions observed. Approximately 80 minutes later, the mother returned with her son, who exhibited a mild rash on the jaw extending to the neck and partially to the cheeks bilaterally. After five minutes, the patient developed facial redness and reported itching of the eyes. The patient was evaluated promptly, and appropriate treatment was administered, including intramuscular epinephrine (0.3 mg/mL) and 25 mg of diphenhydramine (Benadryl) The patient presented to the clinic for routine vaccinations, including TDaP, meningococcal, and HPV immunizations. The vaccines were administered successfully, and the patient was monitored for 15 minutes with no adverse reactions observed.  Approximately 80 minutes later, the mother returned with her son, who exhibited a mild rash on the jaw extending to the neck and partially to the cheeks bilaterally. After five minutes, the patient developed facial redness and reported itching of the eyes.  The patient was evaluated promptly, and appropriate treatment was administered, including intramuscular epinephrine (0.3 mg/mL) and 25 mg of diphenhydramine (Benadryl)The patient presented to the clinic for routine vaccinations, including TDaP, meningococcal, and HPV immunizations. The vaccines were administered successfully, and the patient was monitored for 15 minutes with no adverse reactions observed.  Approximately 80 minutes later, the mother returned with her son, who exhibited a mild rash on the jaw extending to the neck and partially to the cheeks bilaterally. After five minutes, the patient developed facial redness and reported itching of the eyes.  The patient was evaluated promptly, and appropriate treatment was administered, including intramuscular epinephrine (0.3 mg/mL) and 25 mg of diphenhydramine (Benadryl)The patient presented to the clinic for routine vaccinations, including TDaP, meningococcal, and HPV immunizations. The vaccines were administered successfully, and the patient was monitored for 15 minutes with no adverse reactions observed.  Approximately 80 minutes later, the mother returned with her son, who exhibited a mild rash on the jaw extending to the neck and partially to the cheeks bilaterally. After five minutes, the patient developed facial redness and reported itching of the eyes.  The patient was evaluated promptly, and appropriate treatment was administered, including intramuscular epinephrine (0.3 mg/mL) and 25 mg of diphenhydramine (Benadryl)  The rash and facial redness resolved shortly after treatment..
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash erythematous
Clinical narrative: red bumpy rash starting at inside of elbow and extending to top of hand, seems to be getting worse. has tried hydrocortisone cream with no relieve, has also tried eczema cream.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Patient reported having fluid filled bumps that are itchy, patient declined any shortness of breath, tightness in the throat or difficulty breathing, stated that bumps are all over his body and that steroid cream is not helpful in getting rid of them but do help with the itching. Patient was advised to take Benadryl, and to follow up if symptoms did not resolve in a week, or if new symptoms arised.
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination. The outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 45.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Dose was accidentally administered IM versus subq. Patient stayed in clinic for 15 minutes following immunization reporting no adverse symptoms at this time. Encouraged patient to reach out with current questions or concerns. Charge notified.
Age: 35.0
Sex: M
Vaccine: SMALLMNK, VARZOS
Symptoms: No adverse event
Clinical narrative: Treatment was first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event
Clinical narrative: No Adverse even
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: 12-18 Hours following the vaccine, tingling and swelling in both hands and arms began.  It has continued until this date (9 days post-vaccine) even with anti-inflammatories (Naproxen) and compression gloves.
Age: 31.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 54.0
Sex: M
Vaccine: PNC20, SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Apnoea, Hypotonia, Lethargy, Pallor
Clinical narrative: patient received vaccinations. Within 5-8 minutes of administration, patient had an episode of apnea. This episode was prolonged requiring supplemental oxygen. Once patient was breathing, she appeared awake from with poor color, hypotonia and lethargy until she arrived at the emergency department about 15minutes later.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was out of age range for kinrix vaccine, no adverse reactions.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report a patient may have inadvertently received a dose of PROQUAD that was beyond expiration on 04/02/2025.  The HCP stated the PROQUAD's expiration date was "short-dated" after a temperature excursion on 01/02/2025 with a "short-date; The patient  did not report any adverse issue or side effect; This spontaneous report was received from a Medical assistant and refers to a 4-year-old female patient. The patient's concurrent conditions, medical history, Concomitant medications, drug reactions or allergies were not reported.   On 02-Jan-2025, a dose of Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y014307, expiration date: 18-Feb-2026) underwent a temperature excursion at 69 Fahrenheit (F) for 4 hours 20 minutes (product storage error). Therefore, the site shortened the expiration date of the vaccine to 02-Apr-2025.  On this date, the patient was inadvertently vaccinated with the dose of Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y014307, expiration date: 18-Feb-2026) 0.5 mL (route of administration, anatomical location not provided) as prophylaxis (discrepant information, as the reporter stated that the dose was given beyond shortened expiration date). The patient did not report any adverse event issue or side effect from the administrated dose. No previous temperature excursions were reported.; Reporter's Comments:
Age: 63.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness around injection site
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 45.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Nodule
Clinical narrative: 1 inch x 0.5in nodule over the right anterolateral thigh.  There is no overlying erythema or warmth.  Range of motion intact
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Cough, Diarrhoea, Injection site reaction, Rash, Rash erythematous
Clinical narrative: On 5/9/25, Hep A vaccine given on left vastus lateralis and MMRV given on the right vastus lateralis. She developed an evanescent pink rash on face, trunk and extremities on 5/10/25 and seen at ER where she was prescribed cetirizine 2 ml once daily. Rash is improving but still intermittent. She had 1-2 loose stools on Saturday but now stooling normally. Has a mild cough and runny nose. She does attend daycare. She has no fever, vomiting, or irritability. She is eating and sleeping well.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Rhinorrhoea
Clinical narrative: On 5/9/25, Hep A vaccine given on left vastus lateralis and MMRV given on the right vastus lateralis. She developed an evanescent pink rash on face, trunk and extremities on 5/10/25 and seen at ER where she was prescribed cetirizine 2 ml once daily. Rash is improving but still intermittent. She had 1-2 loose stools on Saturday but now stooling normally. Has a mild cough and runny nose. She does attend daycare. She has no fever, vomiting, or irritability. She is eating and sleeping well.
Age: 53.0
Sex: M
Vaccine: HEPAB, MMR
Symptoms: Dizziness, Feeling hot, Flushing
Clinical narrative: patient became lightheaded/dizzy and felt flushed/hot after receiving immunizations
Age: 68.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site erythema
Clinical narrative: PCV21 adverse reactions:  injection day 0, day 1 soreness, swelling, heat and redness at injection site in the morning.  By noonish, chills, nausea, diarrhea, headache, fatigue in addition to original symptoms.  Day 2 fatigue, redness, heat, soreness, swelling and pruritis at site.  Day 3 Redness, swelling, heat, pruritis, axillary edema.  Day 4 (Today) Redness, swelling, heat, pruritis and axillary edema at injection site.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: PCV21 adverse reactions:  injection day 0, day 1 soreness, swelling, heat and redness at injection site in the morning.  By noonish, chills, nausea, diarrhea, headache, fatigue in addition to original symptoms.  Day 2 fatigue, redness, heat, soreness, swelling and pruritis at site.  Day 3 Redness, swelling, heat, pruritis, axillary edema.  Day 4 (Today) Redness, swelling, heat, pruritis and axillary edema at injection site.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Oedema peripheral
Clinical narrative: PCV21 adverse reactions:  injection day 0, day 1 soreness, swelling, heat and redness at injection site in the morning.  By noonish, chills, nausea, diarrhea, headache, fatigue in addition to original symptoms.  Day 2 fatigue, redness, heat, soreness, swelling and pruritis at site.  Day 3 Redness, swelling, heat, pruritis, axillary edema.  Day 4 (Today) Redness, swelling, heat, pruritis and axillary edema at injection site.
Age: 14.0
Sex: F
Vaccine: HPV9, IPV, TDAP, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient is an underimmunized otherwise healthy child who came in for WCC and to update immunizations. Originally, TDaP, Meningitis ACWY, polio, and varicella were ordered. It was planned that two weeks later patient would return for HPV, Hepatitis A, Hepatitis B. Gardisil/HPV was given accidentally in place of Menveo. The next day when PCP (reporter) was informed, patient's guardian was notified and this was reported via clinic reporting system. On 5/12, PCP was notified that VAERs also needed to be reported to, and so this report was filed
Age: 42.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 53.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Arthropod bite, Immunisation reaction
Clinical narrative: Pt went to emergency room. Unknown if vaccine reaction or spider bite as patient was playing outside.
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 85.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site erythema
Clinical narrative: redness at injection site lasting 5 days. I advised patient to consult with physician and I called the physician, leaving message to advise of reaction.
Age: 22.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 50.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: swelling/redness patient said it didn't hurt when and it resolved spoke with patient 5/12/25
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Redness and rash around the injection site, with warmth and redness.  These symptoms were present approximately 4-5 hours after injection.  The next day a red circle around the injection site appeared, similar to a bullseye an area was hard and raised.  Frank left shoulder joint pain began on Wednesday, May 5/7 and has been present since.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Injection site warmth
Clinical narrative: Redness and rash around the injection site, with warmth and redness.  These symptoms were present approximately 4-5 hours after injection.  The next day a red circle around the injection site appeared, similar to a bullseye an area was hard and raised.  Frank left shoulder joint pain began on Wednesday, May 5/7 and has been present since.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-APR-2025, the was vaccinated with improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection (lot #y014868, expiration date: 03-SEP-2026) (exact dose, dose number, route of administration and anatomical location was not provided), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiry date were not reported). On an unknown date, the vaccine underwent a temperature excursion of 5.5 Fahrenheit degrees up to 14.4 Fahrenheit degrees for 40 minutes and 14.5 Fahrenheit degrees up to 46.4 Fahrenheit degrees/15.8 Fahrenheit degrees for 10 minutes. There was no previous temperature excursion. No additional adverse events were reported.
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; patient was administered GARDASIL9 during a temperature excursion.; This spontaneous report was received from a non-health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 25-Apr-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) 1 dose (route of administration, vaccination site, and vaccination scheme were not provided; lot #Y012508 which has been verified to be a valid number, expiration date reported and validated as 01-Jan-2027) as a prophylaxis. The vaccine administered was stored at temperature of 0 degrees Celsius (C) for a time frame of 1 hours. It was unknown if a data logger was used. There was no previous temperature excursion. No additional AE details were reported.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; inadvertent administration of an expired dose of VAQTA to a patient; This invalid spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-May-2025, the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot #X025908, expiration date reported as and upon internal validation confirmed to be: 24-Apr-2025) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. On that day, an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) was inadvertently administered to the patient (expired product administered). No symptoms were reported and no additional details were provided. No other adverse event (AE) and no product quality complaint (PQC) was reported (no adverse event).  This case was considered to be invalid due to lack of patient's identifiers.
Age: 11.0
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms reported as of now; inadvertently administered an extra dose of the PEDVAXHIB Vaccine.  This patient was already fully vaccinated; Patient 11 years old; This spontaneous report was received from a nurse and refers to a(n) 11-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-May-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y011267, expiration date: 08-Nov-2026) as prophylaxis.  On 07-May-2025, the patient experienced inadvertently administered an extra dose of the PEDVAXHIB Vaccine (Extra dose administered). This patient was already fully vaccinated . The patient was 11 years old (Product administered to patient of inappropriate age). No symptoms reported as of now (No adverse event).   At the reporting time, the outcome of the events was reported as unknown.   The action taken with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) was reported as not applicable.
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Hot flush, Syncope, Urticaria, Vomiting
Clinical narrative: Consumer to report their child experienced vomiting; Consumer to report their child experienced hot flashes; Consumer to report their child experienced syncope; Consumer to report their child experienced shortness of breath; Consumer to report their child experienced hives; This spontaneous report was received from a consumer or other non health professional and refers to a 21-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date (also reported as when the patient was 14-years-old), the patient was vaccinated  with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL, intramuscularly, for the treatment of routine vaccination. (scheme, strength, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient hot flashes, syncope, vomiting, shortness of breath and hives. At the reporting time, the outcome of the events was unknown.  The causal relationship between the events and the suspect vaccine was unknown.   Upon internal review, the event of syncope was determined to be medically significant.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: the patient experienced immediate syncope; This spontaneous report was received from a Physician Assistant (medical assistant) and refers to a 16-year-old female patient.   The patient´s concomitant therapies included meningococcal vaccine (reported as ¨meningococcal [GFK]¨). The patient's medical history, concurrent conditions, past drug reactions and allergies were reported as none.    On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered as prophylaxis (dose, formulation, anatomical site of injection, route of administration, lot number and expiration date were not provided).   On 06-MAY-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL, administered by Intramuscular route for HPV prevention (lot number Y007197 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 18-AUG-2026; vaccination scheme frequency and anatomical site of injection were not provided). On that same date, the patient experienced immediate syncope. The patient laid down and the syncope resolved within 15 minutes (recovered). The reporter stated the patient was also vaccinated with meningococcal vaccine (reported as meningococcal ¨[GFK]¨) a few minutes before the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) vaccination and did not experience any immediate symptoms with that vaccine nor the syncope until the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was administered. It was reported the patient sought medical attention for the event.   The reporter stated this was a brand-new box of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and so far, they have given 3 doses out of this box and have had the same issue with each patient. They were told to discontinue the use of the product with this lot number. Additionally, they said they have been giving this vaccine for 8 years and have never seen a lot so consistently cause a reaction like this. Patient has not experienced any other issues.   The causal relationship between the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and the event was not provided. The reporter considered the event of syncope to be related to the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (reported as have never seen a lot so consistently cause a reaction like this).   Upon internal review, the event of Syncope was considered to be medically significant.   This is one of three reports from the same reporter.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report was received from a Certified Medical Assistant and refers to a 17-year-old male patient. The patient had no pertinent medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient received the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9), for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).   On 08-MAY-2025, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9), pre-filled syringe, 0.5ml, intramuscularly, lot #Y007197 expiring on 18-AUG-2026, for prophylaxis.  On 08-May-2025, the patient experienced syncope. The patient sought medical attention. As treatment, the patient laid down and the syncope resolved within 15 minutes.  The reporter states this was a brand new box of Human Papillomavirus 9-valent Vaccine, Recombinant Injection, (GARDASIL 9) and so far they have given 3 doses out of this box and have had the same issue with each patient. The reporter said they have been giving this vaccine for 8 years and have never seen a lot so consistently cause a reaction like this. The reporter considered the event of syncope to be related to Human Papillomavirus 9-valent Vaccine, Recombinant. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant and Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable.    Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Nop side effects or symptoms have been reported. No additional AE; HCP called to report a patient received extra doses of MMR II, VARIVAX, IPOL, and Daptacel after series completions; This spontaneous report was received from a Consumer and refers to a 7-year-old male patient.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter.   On 02-APR-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, 0.5 mL (lot number Y013172 has been verified to be valid for Measles, Mumps, and Rubella [Wistar RA 27-3] Virus Vaccine, Live [M-M-R II], expiration date 31-JUL-2026), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (expiration date, and lot number were not reported); with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, 0.5 mL (lot number Y014181 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date 20-AUG-2026), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (expiration date, and lot number were not reported); with Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid (DAPTACEL) (lot number reported as 3ca20c1, expiration date 28-FEB-2026; formulation not provided); and with Polio vaccine inact 3v (Vero) (IPOL) (lot number reported as y1a201m, expiration date 31-JAN-2027; formulation not reported). All doses were administered as vaccination (dose, vaccination scheme frequency, route of administration and anatomical site of injection were not provided for any of the vaccines). The patient received extra doses of all the previously reported vaccines after series completions (Extra dose administered). No side effects or symptoms have been reported and no additional adverse event was reported for the patient.   No additional information provided.
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects/symptoms reported.; Nurse reports MMR II with expiry date of 5/2/2025 was administered to a patient today 5/8/2025.; 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 and concomitant therapies were not reported.   On 08-May-2025, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X012616, expiration date: 02-May-2025) as prophylaxis (Expired product administered). The vaccine was reconstituted with sterile diluent (lot #W037058, expiration date: 27-Jun-2025). The nurse confirmed no temperature excursions occurred through the date of administration. No side effects/symptoms reported (No adverse event).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Injection site swelling, Paraesthesia, Pruritus
Clinical narrative: swelling at the injection site; Patient experienced burning in her arm after receiving Shingrix; Patient experienced tingling in her arm after receiving Shingrix; Patient experienced itching in her arm after receiving Shingrix; Patient experienced numbness in her arm after receiving Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number L995Y) for prophylaxis.   Concurrent medical conditions included diabetes, blood pressure high and tension headache. Concomitant products included rizatriptan benzoate, semaglutide (Ozempic), amlodipine, hydrochlorothiazide and pravastatin.   On 13-AUG-2024, the patient received Shingrix. On 13-AUG-2024, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site), burning sensation (Verbatim: Patient experienced burning in her arm after receiving Shingrix), tingling of extremity (Verbatim: Patient experienced tingling in her arm after receiving Shingrix), itchy upper limbs (Verbatim: Patient experienced itching in her arm after receiving Shingrix) and numbness of upper extremities (Verbatim: Patient experienced numbness in her arm after receiving Shingrix). The outcome of the injection site swelling, burning sensation, tingling of extremity and itchy upper limbs were resolved and the outcome of the numbness of upper extremities was not resolved.   It was unknown if the reporter considered the injection site swelling, burning sensation, tingling of extremity, itchy upper limbs and numbness of upper extremities to be related to Shingrix.     It was unknown if the company considered the injection site swelling, burning sensation, tingling of extremity, itchy upper limbs and numbness of upper extremities to be related to Shingrix.   Additional Information: GSK receipt date: 01-MAY-2025 The reporter reported that the patient received Shingrix vaccine and experienced burning, tingling, itching and numbness in her arm. The patient also reported swelling at the injection site.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule/had his second dose administered approximately 8 months later; 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 adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 21 Apr 2016, intramuscular).   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: Inappropriate schedule/had his second dose administered approximately 8 months later). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient had his first dose of Shingrix administered 21 APR 2016 (unknown site of administration.) Consumer stated he had his second dose administered approximately 8 months later (exact date unknown) which led to Drug dose administration interval too long. No further information was provided/obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Oral pain, Toothache
Clinical narrative: This appears to be nerve pain; tooth pain; Mouth pain; This non-serious case was reported by a consumer and described the occurrence of toothache in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-OCT-2024, the patient received Shingrix. On 23-NOV-2024, 42 days after receiving Shingrix, the patient experienced toothache (Verbatim: tooth pain) and oral pain (Verbatim: Mouth pain). On an unknown date, the patient experienced nerve pain (Verbatim: This appears to be nerve pain). The outcome of the toothache and oral pain were not resolved and the outcome of the nerve pain was not reported.   It was unknown if the reporter considered the toothache, oral pain and nerve pain to be related to Shingrix.     It was unknown if the company considered the toothache, oral pain and nerve pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-MAY-2025 The reporter reported that she had been experiencing excruciating pain in mouth and teeth. The reporter seen her dentist twice and there was no visible signs of tooth damage. This appears to be nerve pain that began after she was vaccinated with Shingrix. The reporter understanding was that trigeminal neuralgia could be a side effect of shingles. The reporter would like to speak with someone in medical information regarding this and know if there were any reports of this in the clinical trials or if it was looked for in the clinical protocols. The reporter had no history of having shingles. The symptoms were treated.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body aches; 7 nights of fevers; chills; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 445TK, expiry date 09-AUG-2026) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included sertraline hydrochloride (Sertraline).   On 25-APR-2025, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In APR-2025, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches), fever (Verbatim: 7 nights of fevers) and chills (Verbatim: chills). The outcome of the general body pain, fever and chills were not resolved.   It was unknown if the reporter considered the general body pain, fever and chills to be related to Shingrix.     It was unknown if the company considered the general body pain, fever and chills to be related to Shingrix.   Additional Information: GSK receipt date: 05-MAY-2025 The patient experienced 7 nights of fever, chills and body aches.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still had a repeat of the virus; 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) and shingles (Verbatim: still had a repeat of the virus). 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.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. I had gotten vaccinated and still had experienced a repeat of the virus three times in total. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: lived with outbreaks ever since; 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.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: lived with outbreaks ever since). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by a patient via interactive digital media. Patient took the first shot and have lived with outbreaks ever since.
Vaccine: VARZOS
Symptoms: Nasal congestion
Clinical narrative: congestion after Shingrix vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nasal congestion in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced nasal congestion (Verbatim: congestion after Shingrix vaccine). The outcome of the nasal congestion was not reported.   It was unknown if the reporter considered the nasal congestion to be related to Shingrix.     It was unknown if the company considered the nasal congestion to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-MAY-2025 The patient asked was it normal to had congestion after Shingrix vaccine.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: 1st made me sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: 1st made me sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2025AMR056756   Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that first dose of Shingles vaccine made him/her sick. For tolerance to second dose refer case US2025AMR056756.; Sender's Comments:  US-GSK-US2025AMR056756:
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; I thought of it got vaccinated and still got it!; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I thought of it got vaccinated and still got it!). 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.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAY-2025 This case was reported by a patient via interactive digital media. The reporter thought of it got vaccinated and still got it. 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 Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: 3rd week for me with shingles; 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.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: 3rd week for me with shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAY-2025 The patient had one shot of Shingles vaccine and was going for second the week he/she broke out. The patient reported 3rd week for her/his with shingles. The patient had incredible itching, pain over. Those first 2 days and nights back hurt so bad.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: we didn receive our second dose until 12/11/2021; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19-JUN-2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: we didn receive our second dose until 12/11/2021). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 06-MAY-2025 The reporter reported that a patient received first dose of the Shingrix vaccine on 19-JUN-2018.  The reporter understand the next dose is recommended to be 2 to 6 months apart.  For some reason that it might have been availability and then forgetfulness, did not receive our second dose until 11-DEC-2021.  The reporter was ask the effectiveness of the timing of these two doses. This case is linked with US2025AMR057409, reported by same reporter.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2025AMR057409:same reporter different patient