chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site reaction, Neck pain, Urticaria
Clinical narrative: Patient states that she got the 2nd dose of Shingrix on 5/6/25 at pharmacy and reports persistent bilateral neck pain, HA, and redness/"welts" to her left upper arm since then. Pt has been taking ibuprofen at home for her s/s. Pt presented to Urgent Care clinic on 5/8/25 for evaluation with MD who prescribed the patient motrin to be sent to her pharmacy.
Age: 0.5
Sex: M
Vaccine: PNC15
Symptoms: Feeling abnormal
Clinical narrative: Following the second dose of Vaxneuvance, Patient had 4 days of decreased activity, decreased smiling and social responsiveness, parents described him as "just zoned out". He has never had this reaction with other vaccines.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient developed syncope immediately after the Gardasil vaccine was given. I had the patient lied back in a reclining position. Gave water to drink and a cold compress was applied to the forehead. Patient stated feeling better after 10-20 minutes.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient developed syncope immediately after the Gardasil vaccine was given. I had the patient lie back in a reclining position gave water to drink and a cold compress was applied to forehead. Patient stated feeling better after 10-20 minutes.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient developed syncope immediately after the Gardasil vaccine was given. I had the patient lie back in a reclining position gave water to drink and a cold compress was applied to forehead. Patient stated feeling better after 10-20 minutes
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Chronic spontaneous urticaria, Urticaria
Clinical narrative: Feb 27, 2025 hives after HPV vaccine & cont. until today. Sees allergist   HPV Lot # Y008986 Gardasil Merck
Vaccine: DTPPVHBHPB, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event/ HCP confirmed that  there were no symptomatic events; T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. See T/E case #02777949. HCP reported that  VAXELIS and GARDASIL-9 were administered. HCP reported that PNEUMOVAX-23 was not administered to any patients.; This spontaneous report has been received from a Nurse Practitioner, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 24-Mar-2025, the patient was vaccinated with an improperly storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported) and of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine Suspension for injection (VAXELIS) (lot number: U8265AA, which was determined to be valid, with an expiration date on 31-Aug-2027 (also reported to be 31-Oct-2026, conflicting information) both as prophylaxis.  The administered Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine Suspension for injection (VAXELIS) dose underwent a temperature excursion of 47.5 degrees Fahrenheit (F) for 36 minutes and 51 seconds with a previous one of 48 F for 1 hour and 13 minutes. For Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), it was reported that there was a temperature excursion but details were not given (within the product disclaimer administration allowance per the PI). HCP confirmed that there were no symptomatic events (no adverse event). Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: did not have protective HBV antibody titers after 3 doses of HBV vaccine;   This literature marketed report has been received from the authors of a published article, and refers to a 24-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included obesity. Concomitant therapies were not reported.   On unknown dates, the patient received the series of 3 vaccinations with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (doses, route of administration, lot # and expiration dates were not reported) for prophylaxis. On an unknown date, the patient did not have protective HBV antibody titers after 3 doses of HBV vaccine. The outcome of the event was not reported.  The reporter considered the event to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).  This is one of two cases derived from the same literature article (cross referenced with case# 2284106).
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: No additional AE/PQC.; during administration of PROQUAD to a child, the child moved their arm near the end of the dose which caused some of the residual liquid from the syringe to splash into the mother's eyes (; This spontaneous report was received from a Licensed practical nurse and refers to a 4-year-old patient of unknown gender.   The patient's medical history, concurrent conditions were not reported, and concomitant therapies were not reported.   On 05-MAY-2025, the patient was vaccinated with dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z003308, expiration date: 21-JUL-2026), dose: 0.5 mL with sterile diluent (MERCK STERILE DILUENT), dose: 0.5 mL (lot # and expiration date were not reported) for prophylaxis. It was reported the child moved their arm near the end of the dose which caused some of the residual liquid from the syringe to splash into the mother's eyes (case#: 2282967 ), on  05-MAY-2025 (Accidental underdose). However, it was reported the licensed practical nurse believed that the child has received the full dose.  No additional adverse event reported.  This is a several reports from the same reporter.
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/PQC.; first dose was given on 12/07/2024; second dose given on 02/05/2025; third dose given on 03/05/2025; This spontaneous report was received from a pharmacist and refers to a 26-year-old patient of unknown gender.   The patient's medical, concurrent conditions and concomitant therapies were not reported.   The patient was vaccinated with on 07-DEC-2024 and on 05-FEB-2025 with a first and second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, anatomical location, lot # and expiration date were not reported) respectively for prophylaxis (Inappropriate schedule of product administration). Pharmacist reported that a patient received their third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) prefilled syringe, too early on 05-MAR-2025(lot #X025116, expiration date: 19-MAY-2026), dose:  0.5 mL ( anatomical location was not reported) for prophylaxis (Inappropriate schedule of product administration). Pharmacist reported that the patient was not experiencing any symptoms.
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored vaccine administered before it expired.; No additional AE; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.   The patients' medical history, concurrent conditions and concomitant therapies were not reported.   It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced a temperature excursion on 19-MAR-2025. Because they did not know that temp TRED 30-16R was temperature. Excursion by power outage in the morning, and they did not know, Why we didn't know:  On 24-MAR-2025, the patient was vaccinated with  an improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #X024656, expiration date: 09-APR-2025) (doses and routes of administration, were not reported) with  sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis (Product storage error).   The administered dose of the vaccine experienced a temperature excursion 66 degrees Fahrenheit for 3 hours. There was no adverse effect reported, No product quality complaint was involved.  This is one of several reports form the same source.
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Extra dose administered, Hepatitis B surface antigen positive
Clinical narrative: HBsAg positive after booster dose;   This literature marketed report has been received from the authors of a published article, and refers to a 24-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included obesity. Concomitant therapies were not reported.   On unknown dates, the patient received the series of 3 vaccinations with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (doses, route of administration, lot # and expiration dates were not reported) for prophylaxis. On an unknown date, the patient received additional dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis, due to not having protective HBV antibody titers after 3 doses of HBV vaccine (captured in case# 2277533).  On an unknown date, hepatitis B surface antigen (HBsAg) showed positive, which was considered to be a false positive test due to the vaccine. On an unknown date, the patient recovered from the event, as later, on an unknown date (reported as now), the HBsAg was negative.   The reporter considered the event to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).  This is one of two cases derived from the same literature article (cross referenced with case# 2277533).
Sex: F
Vaccine: VARZOS
Symptoms: Fibromyalgia
Clinical narrative: diagnosed with fibromyalgia after receiving Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of fibromyalgia in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fibromyalgia (Verbatim: diagnosed with fibromyalgia after receiving Shingrix). The outcome of the fibromyalgia was not resolved.   It was unknown if the reporter considered the fibromyalgia to be related to Shingrix.     It was unknown if the company considered the fibromyalgia to be related to Shingrix.   Additional Information: GSK receipt date: 29-APR-2025 The patient reported that after receiving Shingrix vaccine she diagnosed with fibromyalgia. The patient reported fibromyalgia was reported as worsened. The batch/lot number of Shingrix were unknown at the time of reporting.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that got a few days ago he/she received dose and also reported that other than a sore arm, no issues was there.
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in an unspecified number of patients 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 allergic reaction (Verbatim: Allergic reaction). The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.     It was unknown if the company considered the allergic reaction to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2025 The 27 percent peoples get vaccinated with Shingles vaccine and had allergic reaction.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: just a sore arm for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: just a sore arm for a few days). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 30-APR-2025 This case was reported by a patient via interactive digital media. Just a sore arm for a few days. He/she had both and the shot hurts just as much as the shingles.
Vaccine: VARZOS
Symptoms: Herpes zoster, Inflammation, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; just was diagnosed with 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: just was diagnosed with 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.     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: 26-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient just was diagnosed with shingles, it was very mild.  Had very little inflammation and small spots mildly itchy.  If he/she did not get the immunization shot it would have been hell.  He/she broke out under his/her hair on his/her neck. 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: DTAP
Symptoms: Abdominal pain, Screaming
Clinical narrative: colic might not be about an upset stomach/ was in agony for four months; Screaming; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of colic in a patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced colic (Verbatim: colic might not be about an upset stomach/ was in agony for four months) and screaming (Verbatim: Screaming). The outcome of the colic was not reported and the outcome of the screaming was resolved.   The reporter considered the colic and screaming to be related to Infanrix and Infanrix Pre-Filled Syringe Device.     The company considered the colic and screaming to be related to Infanrix and Infanrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-APR-2025 This case was reported by the reporter via interactive digital media. The reporter (parent) think colic might not be about an upset stomach.  The parent stated that kid was in agony for four months and was screaming for hours. This case is linked with US2025AMR055504, reported by same reporter.; Sender's Comments:  US-GSK-US2025AMR055504:same reporter
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 7 years later, i developed 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 (Shingrix) for prophylaxis.   The patient's past medical history included influenza and bronchial infection.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 7 years later, i developed 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that had the series of Shingrix when it first came out and 7 years later, consumer developed shingles and had the flu and a bronchial infection earlier. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 Shingrix.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling hot, Headache, Malaise, Pain
Clinical narrative: Pain, swelling, severe bruising, heat. Headache, malaise lasting 2 weeks.  I also got a flu vaccine in the right arm that day. No adverse symptoms on that arm.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Pain, swelling, severe bruising, heat. Headache, malaise lasting 2 weeks.  I also got a flu vaccine in the right arm that day. No adverse symptoms on that arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Upon waking up the morning after the vaccines, 5/7/25, mom noticed his right arm was swollen with slight redness around the band-aid and the child complained of pain in his arm where he had received the vaccines.  At about 4:45 pm, mom notice the redness and swelling was worst and had spread down to his elbow.  She also noticed a rash in the area of redness and child stated it was itching.  Mom marked the area of redness and swelling to note the area.  Mom took him to urgent care.  Child was examined, had his temperature taken (it was normal at this time).  Mom was told it was probably a reaction to the Dtap in his vaccine. Mom was told to treat with Benadryl and to give him Tylenol or Motrin for the fever and pain.  Mom continued the Benadryl every 4 hours after going home.  Mom states he slept all night, but he tossed and turned all night.  The swelling in his arm was worse this morning, 5/8/25 and the redness was still present and had moved up into his right shoulder.   He was given Benadryl at 6:30 am and again at 11:00 am today.  At 11:00 the redness did not look as bad, but the swelling was still there.    Mom picked child up from school at 4:15 and his arm was still very swollen and red, but the redness seems to be a little better, but has spread to under his arm. He denied having pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site swelling, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient had Kinrix & ProQuad administered to left arm on 5/5/2025. On 5/7/2025, she presented to clinic now displaying symptoms of tender/painful & swollen left arm. Symptoms reportedly began 5/7/2025 according to parent. Doctor noted quarter-sized induration & erythema accompanying swelling on the left deltoid. Doctor recommended use of cold pack & children's Motrin to control symptoms. Advised follow-up in 24 hours if symptoms had not subsided. On 5/9/2025, the patient was unable to be reached by phone in order to ascertain if symptoms persisted. Submitted an online MyChart message to the parent inquiring about the status of the patient. No follow-up appointment has been made by the parent at this time.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injury associated with device, Product administration error
Clinical narrative: This nurse inadvertently picked up the  meningococcal B syringe that she had just administered into this patient's   R deltoid  and inserted it into the L Deltoid, pushed the plunger and noted the plunger had already been depressed. Nurse then realized she had not picked up the Meningococcal (Menquadfi) that she intended to administer, but instead had picked up the used Men B syringe she had just injected into this patient. The needle cover was covering the needle, but had not locked into place. Patient did receive both intended vaccines.
Age: 39.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On April 08/ 2025 , A nurse inadvertently administered varicella vaccine before the minimum interval.
Age: 2.75
Sex: F
Vaccine: IPV, PNC15, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: CLIENT PRESENTED TO CLINIC WITH MOTHER. BEHIND ON VACCINES. NURSE ADMINISTERED OVERDUE VACCINES. CLIENT MONITORED FOR 15 MINUTES. NO ADVERSE REACTION. AFTER CLIENT LEFT CLINIC NURSE WENT TO DOCUMENT VACCINES GIVEN AND NOTICED ERROR MADE. TDAP LOT# U8252AA WAS GIVEN INSTEAD OF DTAP.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient reported development of an itchy rash on or about 5/2/2025 that started on the right shoulder and spreading across her chest.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chest discomfort, Chest pain
Clinical narrative: My father had a severe adverse reaction after receiving the Moderna COVID-19 vaccine. He experienced chest tightness and pain, along with intense stiffness and severe pain in his neck when turning his head in any direction. The pain radiated into his shoulder and upper back. He also experienced weakness and dizziness, which made it difficult for him to walk or stand for extended periods, and he was unable to drive for several days.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Dysstasia, Gait disturbance, Impaired driving ability
Clinical narrative: My father had a severe adverse reaction after receiving the Moderna COVID-19 vaccine. He experienced chest tightness and pain, along with intense stiffness and severe pain in his neck when turning his head in any direction. The pain radiated into his shoulder and upper back. He also experienced weakness and dizziness, which made it difficult for him to walk or stand for extended periods, and he was unable to drive for several days.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, X-ray
Clinical narrative: My father had a severe adverse reaction after receiving the Moderna COVID-19 vaccine. He experienced chest tightness and pain, along with intense stiffness and severe pain in his neck when turning his head in any direction. The pain radiated into his shoulder and upper back. He also experienced weakness and dizziness, which made it difficult for him to walk or stand for extended periods, and he was unable to drive for several days.
Age: 11.0
Sex: M
Vaccine: DTPPVHBHPB, HPV9, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: VAXELIS WAS GIVEN BY MA IN ERROR. WHEN SHE CHECKED THE VACCINES OUT TO ME I REALIZED SHE HAD PULL VAXELIS INSTEAD OF TDAP. SHE AND I WENT TO PULL THE TDAP AND RETURN VAXELIS TO THE ACCUVAX. SHE PULLS UP THE VAXELIS TO RETURN IT AND PLACE THE HPV VACCINE INTO THE MACHINE INSTEAD OF VAXELIS. AFTER GIVING VACCINES UPON DOCUMENTING SHE NOTICED THE ERROR. SHE THEN NOTIFIED ME, HER SUPERVISOR THAT VAXELIS, TDAP, MCV4 WAS GIVEN. PROVIDER, PATIENT'S MOTHER AND PATIENT NOTIFIED OF ERROR. THE HPV WAS THEN PULLED AND GIVEN TO PATIENT, SO HE RECEIVED ALL VACCINES NEEDED TO BE UP TO DATE. PATIENT WAS OBSERVED IN OFFICE FOR 15MINS. NO SIGN OR SYMPTOMS NOTED. PATIENT'S MOTHER WAS ADVISED TO CALL US OR SEEK MEDICAL CARE, IF ANY SYMPTOM OCCURS. SHE VOICED UNDERSTAND.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse outcome, dose was expired.  Expiration date was 5/7/2025, it was given on 5/9/2025.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: No adverse event, Product preparation issue, Wrong technique in product usage process
Clinical narrative: Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib portion of vaccine.  Manufacturer of vaccine Sanofi Paseur consulted. Writer instructed to give HIB portion of vaccine with 0.4% Chloride, no time frame recommended.                                                                                                                                            Patient has no known signs or symptoms, or adverse reactions over the course of incident.                                                                                                                                                                                                       Patients' legal guardian will be notified of diversion and instructed to bring patient into clinic to receive HIB portion of vaccine                        Staff retrained on how to properly administer vaccine to prevent future mistakes.
Age: 75.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient states she experienced extreme redness and swelling in her left arm that radiated from injection site down her arm. After 1 week of the redness and pain persisting, she visited the local emergency department and was diagnosed with cellulitis. She was prescribed steroid and antibiotic therapy
Age: 75.0
Sex: F
Vaccine: PNC21
Symptoms: Peripheral swelling
Clinical narrative: Patient states she experienced extreme redness and swelling in her left arm that radiated from injection site down her arm. After 1 week of the redness and pain persisting, she visited the local emergency department and was diagnosed with cellulitis. She was prescribed steroid and antibiotic therapy
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Atrial Fibrillation- August 2023
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV1
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib portion of vaccine.  Manufacturer of vaccine Sanofi Pasteur consulted, instructed to give Hib portion of vaccine with 0.4% Chloride, no time frame recommended.                                                                                                                                            Patient has no known signs, symptoms, or adverse reactions over the course of incident.                                                                                                                                                                                                       Patients' legal guardian will be notified of diversion and instructed to bring patient into clinic to receive HIB portion of vaccine                        Staff retrained on how to properly administer vaccine to prevent future mistakes.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: diffuse, itchy hives
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Feeling hot, Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity, Tenderness
Clinical narrative: STIFFNESS, PAIN AND HEAT IN THE LEFT ARM, DIFFICULTY LIFTING THE ARM AND PRESSING FORCE ON IT.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia, Ultrasound scan
Clinical narrative: patient stated after receiving vaccine his right arm is tingling, and possible nerve pain.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus beginning 4 weeks after immunization
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient states that her arm pain and weakness after the vaccinations on 09/26/2024.  Her symptoms are present only upon exertion (sports, yoga, swimming. etc...)
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Colitis ulcerative, Crohn's disease, Frequent bowel movements, Haematochezia
Clinical narrative: Developed major ulcerative colitis and crohns disease. Never had any health issues ever! He developed stabbing pains in his stomach early December then started having blood in his stools frequently and unusual amounts.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash papular, Swelling face
Clinical narrative: Patient had raised bumps on left arm and swelling on chin and itching on arms and face. The patient was administered 50 mg of benadryl in the right arm (deltoid) leading to a reduction in swelling. Furthermore, 25 mg of benadryl tablets were prescribed for ongoing use as needed until symptoms subsided.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Parosmia, Phantosmia
Clinical narrative: I have developed an extreme sensitivity to smells.  I have had an MRI and seen a ENT specialist and they can find nothing wrong.  I also smell "phantom smells" such as chemical smells and exhaust even though there are no sources nearby.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Patient had numbness on the left cheek as well as numbness/weakness on the left arm/leg. Patient was administered 50 mg of benadryl in the right arm leading to a reduction in numbness. Furthermore, 25 ng of benadryl tablets were dispensed for ongoing use as needed until symptoms subsided.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Vomiting
Clinical narrative: Donor called the center disclosing he threw up one time and felt tired once he arrived home. Denies any other symptoms. He stated he felt better after vomiting.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain upper, Nausea, Pruritus, Rash
Clinical narrative: 5/2/25: Dose #1, no significant side effects 5/4/25: Dose #2 - approximately 90 minutes after taking, began experiencing a rash on her face, itchiness on both hands, and "mild hives" on one hand. Denies dyspnea, wheezing, or swelling. Went to sleep and those symptoms were resolved by the morning without intervention. The morning of 5/5, pt experience stomach pain and nausea, which became more severe by bedtime. Took Tums and Pepto Bismol. Today, pt continues to have some pain, but reports it is less severe than yesterday.  Advised pt to stop taking. Continued to have stomach discomfort for 2 more days, but improved each day.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: 5/2/25: Dose #1, no significant side effects 5/4/25: Dose #2 - approximately 90 minutes after taking, began experiencing a rash on her face, itchiness on both hands, and "mild hives" on one hand. Denies dyspnea, wheezing, or swelling. Went to sleep and those symptoms were resolved by the morning without intervention. The morning of 5/5, pt experience stomach pain and nausea, which became more severe by bedtime. Took Tums and Pepto Bismol. Today, pt continues to have some pain, but reports it is less severe than yesterday.  Advised pt to stop taking. Continued to have stomach discomfort for 2 more days, but improved each day.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20
Symptoms: Extra dose administered
Clinical narrative: Accidental administration of extra vaccine
Age: 38.0
Sex: F
Vaccine: PNC15
Symptoms: Blister, Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: On day of vaccination, patient developed erythema at injection site, along w/ swelling, warmth, pain, and decreased range of motion. Over next few days, these symptoms have improved, on day 4 after vaccination, does still have warmth, swelling, and tenderness at the site. Erythema resolved. Has also been itching throughout this time. Using benadryl and cool compresses. On the same day, the patient also developed an area of erythema on the left lower extremity. This reduced in size, but on day 3 after vaccination, a 1 cm blister developed in the center of the region of erythema.  Unclear if this leg rash is related or coincidental
Age: 38.0
Sex: F
Vaccine: PNC15
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Rash
Clinical narrative: On day of vaccination, patient developed erythema at injection site, along w/ swelling, warmth, pain, and decreased range of motion. Over next few days, these symptoms have improved, on day 4 after vaccination, does still have warmth, swelling, and tenderness at the site. Erythema resolved. Has also been itching throughout this time. Using benadryl and cool compresses. On the same day, the patient also developed an area of erythema on the left lower extremity. This reduced in size, but on day 3 after vaccination, a 1 cm blister developed in the center of the region of erythema.  Unclear if this leg rash is related or coincidental
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Hot flush, Nausea, Syncope, Trismus
Clinical narrative: Jaw locking, vasovagal syncope, nausea, L eye headaches, hot flashes
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Kinrix when below acceptable age for administration. Given in error. Patient had no immediate adverse reaction when vaccine was administered, none reported by mom since vaccine administered.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC20
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib portion of vaccine.  Manufacturer of vaccine Sanofi Paseur consulted. Writer instructed to give HIB portion of vaccine with 0.4% Chloride, no time frame recommended.                                                                                                                                            Patient has no known signs, symptoms, or adverse reactions over the course of incident.                                                                                                                                                                                                       Patients' legal guardian will be notified of diversion and instructed to bring patient into clinic to receive Hib portion of vaccine                        Staff retrained on how to properly administer vaccine to prevent future mistakes.
Age: 0.67
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: none at this time
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Swelling  and localized reaction where MMR administered
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site rash
Clinical narrative: Patient presented with a non-itchy rash surrounding vaccine site.  Will mark the margins and monitor with help from daughter. will also take picture. We will follow up in 2 days
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib portion of vaccine.  Manufacturer of vaccine Sanofi Paseur consulted. Writer instructed to give HIB portion of vaccine with 0.4% Chloride, no time frame recommended.                                                                                                                                            Patient has no known signs, symptoms, or adverse reactions over the course of incident.                                                                                                                                                                                                       Patients' legal guardian will be notified of diversion and instructed to bring patient into clinic to receive HIB portion of vaccine                        Staff retrained on how to properly administer vaccine to prevent future mistakes.
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: None    Vaccine outdated
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: n/A
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient called describing having pain in left, little redness (05/08/2025) no fever. Patient was advised to contact primarycare immedaitely or go to emergency.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Eye movement disorder, Generalised tonic-clonic seizure, Loss of consciousness, Posture abnormal
Clinical narrative: Pt. Given Men A vaccine on  right deltoid and Men B on left deltoid Pt. Started to feel dizzy- as he was walking to waiting room (said after) Sat in the chair CMA went to get water and mother notes- eyes and head drifted to side and passed out leaning towards her. As I ran to the waiting room- pt. With tonic clonic seziure of arms lasted < 5 sec, Pt. Immediately talking to mother afterwards Stood up and with some difficulty, slowly forced into laying position with legs elevated   B/P: 96/63 HR:60   Gave about 8 of water and lollipop and 16 oz Pedialyte Repeat B/P: 107/73 HR:73 Given approx around 30 oz of water as started to finish Pedialyte and transferred to chair- sitting position- feeling better B/P: 119/80 HR: 64 Pt. Monitored in office for total of 30 min -- walked in waiting room
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: urticarial rash
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Call from mother 5-9-25 . Left arm (deltoid)  swollen at injection site. 2x 4-5 inches "welt" noted. Swelling is red and warm to touch. Did not check body temp. Has tried oral Benadryl on 5-8-25. Swelling did not improve and is worse today 5-9-25. Left arm is sore at injection site. No other complaints.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Call from mother 5-9-25 . Left arm (deltoid)  swollen at injection site. 2x 4-5 inches "welt" noted. Swelling is red and warm to touch. Did not check body temp. Has tried oral Benadryl on 5-8-25. Swelling did not improve and is worse today 5-9-25. Left arm is sore at injection site. No other complaints.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Pain, Scar, Vaccination failure
Clinical narrative: Suspected vaccination failure; I did everything right but yet I continue to suffer from neuropathy; i got shingles/ received both vaccines approximately 1.5 years ago; I did everything right but yet I continue to suffer from scaring; 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, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), neuropathy (Verbatim: I did everything right but yet I continue to suffer from neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: i got shingles/ received both vaccines approximately 1.5 years ago) and scar (Verbatim: I did everything right but yet I continue to suffer from scaring). The outcome of the vaccination failure and shingles were not reported and the outcome of the neuropathy and scar were not resolved.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and scar to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and neuropathy to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and scar to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that got shingles very much like the woman in this photo.  It was terribly painful, and this was after received both vaccines approximately 1.5 years ago. On the day the rash broke out and went on a regimen of antiviral medication. Consumer did everything right but yet continue to suffer from neuropathy and scaring. Reporter is also reported that the opinion is this outbreak could not have been any worse.  He/ she also reported that it feels the vaccine did nothing for consumer. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 (Dose 1 & 2). Neuropathy peripheral is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
Age: 58.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Patient experienced severe soreness rating 8/10, redness, and warmth at the injection site. Her symptoms are improving, however the injection site remains red and warm. The injections seem to be have administered in the wrong location, below the deltoid muscle. This happened over the course of around 2 days.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Shortly after receiving the vaccine the patient became dizzy and lightheaded.  She laid on a bench in the pharmacy for a few minutes until it stopped. I gave her a cold rag for her head and a bottle of water and observed the patient until she felt comfortable to leave the pharmacy.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given too early.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: pt says she had pain in her left arm around the injection site the day of the vaccine.  Within in the next couple of days in the area around the injection  site it became hard. By 5/5/2025 it was hard and red. The size of the swelling around the injection site was 8cc wide x 10 cc long.  The redness and the pain is starting to finally decrease but the size is still the same size. Pt will contact the pharmacy to let them know her symptoms and that she has reported.
Age: 46.0
Sex: M
Vaccine: COVID19, FLU3, HEP, HEPA, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event has been witnessed, vaccine was expired
Age: 16.0
Sex: F
Vaccine: JEV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was given 2nd dose of vaccine to soon.  It was given 7 days after the initial dose, later discovered it should have been 28 days.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered dose of DTaP at the age of 7 years old 7 months.  Client should have been given Tdap vaccine for catch-up.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with an adverse injection site reaction....redness and swelling around area.   Urgent care prescribed her, and antibiotic, Steroid cream, antihistamine and an oral steroid
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Patient stated soreness and swelling followed by redness, itching and warmness to the touch
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Mobility decreased, Pain in extremity
Clinical narrative: On 4/30/25 patient received Garadsil 9 (NDC:00006412102, Lot: XO24560) in her right arm, but on 05/01/25 they experienced extreme pain in the left arm, redness, and couldn't move her left arm. She informed me that she went to the emergency room and recieved cetirizine, oral naproxen, and toradol injection to help with the pain. She has a follow up appointment with her primary doctor soon.