chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; very painful attack of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: very painful attack of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   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: 16-JUN-2025 This case was reported by a patient via interactive digital media. Reporter's mother-in-law had thought it was a great idea, and it had been highly recommended by her doctor.  However, in less than a year, she suffered a very painful attack of shingles.  She continued to suffer for many years.  It left us wondering what good the shot had been if it had not offered protection. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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, VARZOS
Symptoms: Eye pain, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles suffering with eye; both shots and came down 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles suffering with eye) (serious criteria GSK medically significant) and shingles (Verbatim: both shots and came down with shingles). The outcome of the vaccination failure and shingles were not reported and the outcome of the ophthalmic herpes zoster was not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a patient via interactive digital media. The patient had both shots and came down with shingles. 2 years later still suffering with eye. They thought he/she was going to lose eyesight. Thank heavens he/she did not. Still in pain every day with eye. This case was considered as suspected vaccination failure as details regarding 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; now got shingles; 1st one was painful;  This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: now got shingles) and pain (Verbatim: 1st one was painful). The outcome of the vaccination failure and pain were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the pain to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JUN-2025 This case was reported by a patient via interactive digital media The patient got shots last year in 2024 but now got shingles and was not happy that he/she got shot and the 1st one was painful The patient was so not sure if he/she should have gotten it and supposedly made it milder. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; vaccinated for shinglesand then got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: vaccinated for shinglesand then got shingles). The outcome of the vaccination failure and shingles were not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2025 This case was reported by a patient via interactive digital media. The patient was vaccinated for shingles and then got shingles.  The reporter suspect it was a reaction to the vaccine.  Now, reporter was very hesitant to get the shingles vaccine. The reporter said that yes, patient got shingles as a reaction to the vaccine. 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Age: 74.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Prevnar-20 given at doctors appointment earlier in the day, patient came to store to receive different vaccines, and asked about Capvaxive, patient accepted and was given additional pneumonia type vaccine in same day.  Doctors office called in to investigate., Other Vaccines:  VaccineTypeBrand: Prevnar-21; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/10/2025, VaccineTypeBrand: Shingrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/10/2025, VaccineTypeBrand: Boostrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/10/2025
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient got a rash on upper and lower extremities, not too severe, told to take benedryl- not hot or spreading, no fever
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Injection site pain, Injection site swelling, Lethargy, Limb injury
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: CAPVAXIVE; Manufacturer: MERCK; LotNumber: Z002626; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Flushing, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Nausea
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Contusion, Loss of personal independence in daily activities, Rash, Urticaria
Clinical narrative: Systemic: Allergic: Rash Generalized-Severe, Systemic: welts, could not dress herself in the morning painful welts, bruise feeling-Severe, Additional Details: Benadryl is helping patient a lot and symptoms are resolving., Other Vaccines:  VaccineTypeBrand: n/a; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Injection site pain, Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: blisters that are drying up-Mild, Additional Details: pt states starting blistering that look like pimples several days after vaccine and it spread to other arm and cheek on face  that is drying and still having pain at injection have not seeked medical care and just called me today about it. states will contact pcp in the morning and make appt. advsie to see medical attention sooner if condition worsens
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Mild, Additional Details: Patient seized for 15 seconds post vaccine.  patient was ok and alert after event.  Patient was taken to local ER by frient.  , Other Vaccines:  VaccineTypeBrand: havrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: heplisav; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injection site rash, Injection site swelling, Pruritus, Rash
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Pt notified the pharmacy that she had swelling, itching, and rash occur around the injection site the next day. Pt states that ever since getting the first covid shot a couple years ago, she has developed allergies and sensitivities to unknown allergens. pt had not informed the pharmacist at the time of imz and just agreed to receive the Tdap as recommended. Pt has been taking oral antihistamin to help with the symptoms & stated will reach out to primary care for further management as necessary
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I took the shots and still got 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: I took the shots and still got 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: 15-JUN-2025 This case was reported by a patient via interactive digital media. The patient took the shingles shots and still got shingles. 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 regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Presyncope, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: vasovagal response--pt knew it would happen and precautions were taken to prevent falling/injury
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Mild
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Impaired work ability, Injection site bruising, Injection site pain, Injection site swelling, Joint injury
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: pt is unable to lift his arm or use shoulder. now unable to work his job-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Mobility decreased
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: pt is unable to lift his arm or use shoulder. now unable to work his job-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: PATIENT ARRIVED AND SHOWED PHARMACIST INJECTION SITE OF WARM TO TOUCH AND SWOLLEN RED. SAYS IT DOESN'T BOTHER HIM BUT WANTED US TO BE AWARE. WILL FOLLOW UP IN A WEEK
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: pt reported pain at the injection site and armpit. she is applying ice on the injection site and warm compresses on her armpit. Advised pt to call us back if pain persists and to call her Dr as well.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Weakness-Medium
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: resident  passed away
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: pimple like rash on arms, legs and face-small amount
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient states after a week later of receiving the vaccines he develops rash all over his body and scalp but not itchy. He still has it until now. I advised him to wait to get second dose until he is seen by a provider.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: He reports not feeling well for the evening after dose number 2; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   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 feeling unwell (Verbatim: He reports not feeling well for the evening after dose number 2). The outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Additional Information: GSK receipt date: 12-JUN-2025 The patient's age was approximately of 64 years.  Patient has had both doses of Shingrix.  He reported not feeling well for the evening after dose number 2.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal discomfort
Clinical narrative: A week later the patient reported significant shoulder discomfort when raising the arm with frontward abduction. Advised she start taking ibuprofen 600mg TID for the next few days and encouraged continued ROM.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Patient called the store today 6/23/25 and reported she has a red circle on her arm with 2 bumps in it where she got the vaccine. She also stated the area is itchy.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient received vaccine Friday afternoon. Reported to pharmacy Monday morning.  Arm soreness at injection site.  There was some redness further down the arm around the bicep muscle.  RPh recommended Chlorpheniramine, tylenol/ibuprofen, and icing the spot for the pain.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Area was swollen, red and tender to touch. Arm hurt. Second day, entire body hurt and had a fever. It has been a week and my arm still hurts although the swelling has gone down and it is not as red.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Area was swollen, red and tender to touch. Arm hurt. Second day, entire body hurt and had a fever. It has been a week and my arm still hurts although the swelling has gone down and it is not as red.
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Flushing, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Received PCV21 on 6/16/25. She had some redness and swelling of the injection site following the vaccination. She developed fevers, chills, headaches, and nausea the following day. On 6/18, she developed a red, blotchy rash on her neck and chest. The rash was not itchy or painful. On 6/19, the red, blotchy rash spread to her upper abdomen and to the medial aspect of her left arm. By 6/21, the rash on her neck and trunk resolved but she woke up with facial flushing that felt similar to a sunburn. Denies any recent sun exposure. Reports that her lips also started to feel tingly intermittently. Denied any lip, tongue, or throat swelling. Denies any chest pain, shortness of breath, or difficulty breathing. On 6/22, the rash on her left arm became raised, "welty", itchy, and sore. Still endorses some intermittent nausea, cheek flushing, and intermittent lip tingling but symptoms are improving. Other symptoms have resolved.
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Paraesthesia oral, Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: Received PCV21 on 6/16/25. She had some redness and swelling of the injection site following the vaccination. She developed fevers, chills, headaches, and nausea the following day. On 6/18, she developed a red, blotchy rash on her neck and chest. The rash was not itchy or painful. On 6/19, the red, blotchy rash spread to her upper abdomen and to the medial aspect of her left arm. By 6/21, the rash on her neck and trunk resolved but she woke up with facial flushing that felt similar to a sunburn. Denies any recent sun exposure. Reports that her lips also started to feel tingly intermittently. Denied any lip, tongue, or throat swelling. Denies any chest pain, shortness of breath, or difficulty breathing. On 6/22, the rash on her left arm became raised, "welty", itchy, and sore. Still endorses some intermittent nausea, cheek flushing, and intermittent lip tingling but symptoms are improving. Other symptoms have resolved.
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Rash macular, Urticaria
Clinical narrative: Received PCV21 on 6/16/25. She had some redness and swelling of the injection site following the vaccination. She developed fevers, chills, headaches, and nausea the following day. On 6/18, she developed a red, blotchy rash on her neck and chest. The rash was not itchy or painful. On 6/19, the red, blotchy rash spread to her upper abdomen and to the medial aspect of her left arm. By 6/21, the rash on her neck and trunk resolved but she woke up with facial flushing that felt similar to a sunburn. Denies any recent sun exposure. Reports that her lips also started to feel tingly intermittently. Denied any lip, tongue, or throat swelling. Denies any chest pain, shortness of breath, or difficulty breathing. On 6/22, the rash on her left arm became raised, "welty", itchy, and sore. Still endorses some intermittent nausea, cheek flushing, and intermittent lip tingling but symptoms are improving. Other symptoms have resolved.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Chills, Hyperhidrosis, Injection site haemorrhage, Loss of consciousness
Clinical narrative: Patient DOB, received MCV4 (Meningococcal Conjugate Vaccine (Lot # 3443E) vaccine today, 6/20/2025, administered by this nurse, to L Deltoid with scant bleeding. Appointment was completed at 1514. After leaving immediately after appointment, mother returned approximately five minutes later stating her son had passed out and was sweating profusely. The patient was carried in by his brother and laid on the lobby floor and assessed by the two nurses on site. At this time client was conscious, diaphoretic, reporting chills, tingling and weakness. Pulse was weak and thready, BP 90/60. Patient reported he had not eaten anything this day. EMS was called and arrived on scene approximately 1525. At this time patient was A&Ox4, assessed by EMS and put on the stretcher and loaded into ambulance at 1534. Ambulance left parking lot at 1554.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Paraesthesia, Pulse abnormal
Clinical narrative: Patient DOB, received MCV4 (Meningococcal Conjugate Vaccine (Lot # 3443E) vaccine today, 6/20/2025, administered by this nurse, to L Deltoid with scant bleeding. Appointment was completed at 1514. After leaving immediately after appointment, mother returned approximately five minutes later stating her son had passed out and was sweating profusely. The patient was carried in by his brother and laid on the lobby floor and assessed by the two nurses on site. At this time client was conscious, diaphoretic, reporting chills, tingling and weakness. Pulse was weak and thready, BP 90/60. Patient reported he had not eaten anything this day. EMS was called and arrived on scene approximately 1525. At this time patient was A&Ox4, assessed by EMS and put on the stretcher and loaded into ambulance at 1534. Ambulance left parking lot at 1554.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient had already had a Prevnar 20 vaccine on 4/4/2023 and was given another one on 6/20/2025.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: shot given too soon from MMR administration
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pharyngeal swelling, Tremor
Clinical narrative: Patient's husband came in and conveyed that hours after leaving the pharmacy the patient started to develop swelling of the throat, shakiness, and lightheadedness. after taking some benadryl and going to the hospital the patient was admitted for supportive care. They were discharged after swelling went down
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC20
Symptoms: Febrile convulsion, Full blood count normal, Metabolic function test normal, Pyrexia, Respiratory viral panel
Clinical narrative: 14-month-old male brought into the ED due to fever and seizures.  He is up-to-date on all his vaccines on 6/2/2025 he received approximately 7 vaccines.  She states he has been very active all day, good intake of orals and solids in addition to good urine output has been playful.  She also states he has been having runny nose and she noticed tremors upper and lower extremity called EMS EMS reevaluated him and he had a temperature greater than 102 he was then brought into the ED to be evaluated.  Prior to ED presentation no recent head trauma, no sick contacts at home, no signs of any focal neurological deficits.  Also states he has been playing on his left ear. He has been given ibuprofen and Tylenol in the ER.  Discharge to home with diagnosis of Febrile seizure/viral syndrome.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC20
Symptoms: Rhinorrhoea, Seizure, Tremor, Urine analysis normal, Viral infection
Clinical narrative: 14-month-old male brought into the ED due to fever and seizures.  He is up-to-date on all his vaccines on 6/2/2025 he received approximately 7 vaccines.  She states he has been very active all day, good intake of orals and solids in addition to good urine output has been playful.  She also states he has been having runny nose and she noticed tremors upper and lower extremity called EMS EMS reevaluated him and he had a temperature greater than 102 he was then brought into the ED to be evaluated.  Prior to ED presentation no recent head trauma, no sick contacts at home, no signs of any focal neurological deficits.  Also states he has been playing on his left ear. He has been given ibuprofen and Tylenol in the ER.  Discharge to home with diagnosis of Febrile seizure/viral syndrome.
Sex: F
Vaccine: HEP
Symptoms: Device connection issue, Syringe issue
Clinical narrative: Reports by RN of liquid leaking out between syringe and needle connections. RN stated it had happened before.
Sex: M
Vaccine: HEP
Symptoms: Device connection issue, Syringe issue
Clinical narrative: Plunger fell out of syringe prior to administration and all medication leaked out.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Adenovirus test positive, Brain oedema, COVID-19, Cerebral mass effect, Computerised tomogram head abnormal
Clinical narrative: Patient was seen for well child care on 5/22/2025. No abnormalities noted on history of exam. Patient received DTaP vaccine.  Clinic received call from PICU at hospital on 5/28 notifying us that patient diagnosed with viral meningoencephalitis and plan was to withdraw care that day.  Full records from hospital not visible.  Chart review shows patient taken to hospital on 5/23/2025 with fever and seizure followed by continued altered mental status. Found to have pancytopenia. Positive for COVID-19 and Adenovirus on respiratory panel. Transferred to another hospital for further care.  Consult note from Neurosurgery on 5/24 notes that patient had progressively worsening seizures overnight 5/23-5/24 and 5/24 had dilated unreactive right pupil but with continued EEG activity, 30 minutes later left pupil also dilated and unreactive, EEG flat, CTH showed extensive cerebral edema with left midline shift, CTA showed no cerebral perfusion.   pt tested positive for both COVID and Adenovirus in PCR panel, Covid in Respiratory Panel.  RN documented telephone encounter from 5/28/25:  Intensivist was giving us an update on patient as care measures are being withdrawn today.  Provider states that Patient was here for vaccines on 05/22 and visit with PCP. Patient presented to ED for possible febrile seizure the next evening. Then transferred to PICU at hospital. Provider states that patient was diagnosed with Viral Meningoenchephalitis.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Electroencephalogram abnormal, Intensive care, Meningoencephalitis viral, Mental status changes, Pancytopenia
Clinical narrative: Patient was seen for well child care on 5/22/2025. No abnormalities noted on history of exam. Patient received DTaP vaccine.  Clinic received call from PICU at hospital on 5/28 notifying us that patient diagnosed with viral meningoencephalitis and plan was to withdraw care that day.  Full records from hospital not visible.  Chart review shows patient taken to hospital on 5/23/2025 with fever and seizure followed by continued altered mental status. Found to have pancytopenia. Positive for COVID-19 and Adenovirus on respiratory panel. Transferred to another hospital for further care.  Consult note from Neurosurgery on 5/24 notes that patient had progressively worsening seizures overnight 5/23-5/24 and 5/24 had dilated unreactive right pupil but with continued EEG activity, 30 minutes later left pupil also dilated and unreactive, EEG flat, CTH showed extensive cerebral edema with left midline shift, CTA showed no cerebral perfusion.   pt tested positive for both COVID and Adenovirus in PCR panel, Covid in Respiratory Panel.  RN documented telephone encounter from 5/28/25:  Intensivist was giving us an update on patient as care measures are being withdrawn today.  Provider states that Patient was here for vaccines on 05/22 and visit with PCP. Patient presented to ED for possible febrile seizure the next evening. Then transferred to PICU at hospital. Provider states that patient was diagnosed with Viral Meningoenchephalitis.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Pupil fixed, Pyrexia, Respiratory viral panel, SARS-CoV-2 test positive, Scan with contrast abnormal
Clinical narrative: Patient was seen for well child care on 5/22/2025. No abnormalities noted on history of exam. Patient received DTaP vaccine.  Clinic received call from PICU at hospital on 5/28 notifying us that patient diagnosed with viral meningoencephalitis and plan was to withdraw care that day.  Full records from hospital not visible.  Chart review shows patient taken to hospital on 5/23/2025 with fever and seizure followed by continued altered mental status. Found to have pancytopenia. Positive for COVID-19 and Adenovirus on respiratory panel. Transferred to another hospital for further care.  Consult note from Neurosurgery on 5/24 notes that patient had progressively worsening seizures overnight 5/23-5/24 and 5/24 had dilated unreactive right pupil but with continued EEG activity, 30 minutes later left pupil also dilated and unreactive, EEG flat, CTH showed extensive cerebral edema with left midline shift, CTA showed no cerebral perfusion.   pt tested positive for both COVID and Adenovirus in PCR panel, Covid in Respiratory Panel.  RN documented telephone encounter from 5/28/25:  Intensivist was giving us an update on patient as care measures are being withdrawn today.  Provider states that Patient was here for vaccines on 05/22 and visit with PCP. Patient presented to ED for possible febrile seizure the next evening. Then transferred to PICU at hospital. Provider states that patient was diagnosed with Viral Meningoenchephalitis.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Patient was seen for well child care on 5/22/2025. No abnormalities noted on history of exam. Patient received DTaP vaccine.  Clinic received call from PICU at hospital on 5/28 notifying us that patient diagnosed with viral meningoencephalitis and plan was to withdraw care that day.  Full records from hospital not visible.  Chart review shows patient taken to hospital on 5/23/2025 with fever and seizure followed by continued altered mental status. Found to have pancytopenia. Positive for COVID-19 and Adenovirus on respiratory panel. Transferred to another hospital for further care.  Consult note from Neurosurgery on 5/24 notes that patient had progressively worsening seizures overnight 5/23-5/24 and 5/24 had dilated unreactive right pupil but with continued EEG activity, 30 minutes later left pupil also dilated and unreactive, EEG flat, CTH showed extensive cerebral edema with left midline shift, CTA showed no cerebral perfusion.   pt tested positive for both COVID and Adenovirus in PCR panel, Covid in Respiratory Panel.  RN documented telephone encounter from 5/28/25:  Intensivist was giving us an update on patient as care measures are being withdrawn today.  Provider states that Patient was here for vaccines on 05/22 and visit with PCP. Patient presented to ED for possible febrile seizure the next evening. Then transferred to PICU at hospital. Provider states that patient was diagnosed with Viral Meningoenchephalitis.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Muscular weakness
Clinical narrative: Patient was standing by nurse station after receiving vaccines. Patient hugged mother and MA noticed leg buckle. MA lowered patient to the floor. Patient was awake the whole time and was talking to MA. No injury noted. Gave water and rest for approximately 10 mins and patient stated feeling better. Vitals checked and were WNL. Patient stated had not eat today and was hungry. Went to get food after visit.  Patient has had an incident like this in the past and passed out after cast removal.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt inadvertently administered 20yr + vaccine. No adverse side effects noted at this time.
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Hepatitis B vaccine ordered by provider.  Staff nurse administered Tdap (Boostrix) in error.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient received two doses of Varicella (patient was given MMRV instead of MMR and also given varivax). Parent was notified
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Eye swelling, Paraesthesia oral, Urticaria
Clinical narrative: Patient came in for a Yellow Fever vaccine. Mom called an hour or so later to report he was experiencing side effects from the vaccine. His lips were tingling, having trouble breathing and developed hives. Mom gave him Benadryl and an Albuterol breathing treatment which helped with wheezing he was having. I told her she had done correct on the responsive measures. Encouraged her to go Urgent Care or give them a call. She called but they could not see him. Had a family friend that was a physician that told her to give him some steroids they had at home. Called 6/23/25 to check on patient He was doing better. Did not have to go to ER. Responsive at home treatments were working. He did develop swollen eyes.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Unevaluable event
Clinical narrative: none reported
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient supposed to get COVID booster, but seasonal influenza was given.
Vaccine: HIBV
Symptoms: Device leakage, Occupational exposure to product
Clinical narrative: Product splashed onto HCP; Product splashed onto HCP; leur lock adapters becoming loose and detaching and sometimes the leur lock adaptor spinned when the cap was removed; Pharmaceutical product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of occupational exposure via skin contact with product in a patient who received Hib (Hiberix) (batch number 3A2KF, expiry date 14-JUL-2026) for prophylaxis. This case was associated with a product complaint.   On 25-FEB-2025, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced occupational exposure via skin contact with product (Verbatim: Product splashed onto HCP), inadvertent exposure to vaccine (Verbatim: Product splashed onto HCP), syringe connection issue (Verbatim: leur lock adapters becoming loose and detaching and sometimes the leur lock adaptor spinned when the cap was removed) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the occupational exposure via skin contact with product, inadvertent exposure to vaccine, syringe connection issue and pharmaceutical product complaint were not applicable.   It was unknown if the reporter considered the syringe connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.     It was unknown if the company considered the syringe connection issue to be related to Hiberix and Hiberix And Diluent 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: 25-FEB-2025 The office manager reported the complaint of the rotating and detachment of the leur lock adapters and it was confirmed a leur lock needles were used and they had several issues with the leur lock adapters becoming loose and detaching and sometimes the leur lock adaptor spinned when the cap was removed, it spin when the needle was attached and also came completely off along with the needle during the injection. The luer lock adapter detached during injection and product splashed onto the HCP, which led to occupational exposure via skin contact with product and inadvertent exposure to vaccine. The reporter was unable to tell how much of the product was given and McKesson Thin Wall Needle 25g of 1 inch was used.; Sender's Comments:  US-GSK-US2025023704:Same reporter different patient
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient supposed to get COVID booster, but seasonal influenza was given.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Blindness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient in the office for Nurse Visit for HPV vaccine. HPV vaccine was administered by office LPN. Patient had a pre-syncopal episode after the vaccine was administered. Patient became pale in the face and lips, diaphoretic, weak, nauseous, and stated her "vision going black". Patient was in chair during administration. Elevated patient' legs and feet. Unable to lower head due tom position in chair. Ice packs applied under bilateral axillas, back of neck, and forehead. Emesis bag provided to patient. As patient became more aware, small amount of glucose gel was given to patient as she stated she had not eaten anything prior to coming to appointment. Patient tolerated well and became more alert. Color returned to the patient's face and lips. Diaphoresis subsided. No vomiting. Nausea subsided. Patient alert and conversing with staff. Patient was able to drink 2 small cups of cold water. Vital signs: BP- 104/61, HR-66, RR-18, Pox RA-99%. Had patient sit for a while, then had her place her feet on the floor.  Had patient stand and move and move head around. Patient denied any further dizziness, lightheadedness, weakness, nausea, vision changes. Patient was offered to stay and lay down for a while, but patient declined and stated she felt well to leave. Patient left the office.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient in the office for Nurse Visit for HPV vaccine. HPV vaccine was administered by office LPN. Patient had a pre-syncopal episode after the vaccine was administered. Patient became pale in the face and lips, diaphoretic, weak, nauseous, and stated her "vision going black". Patient was in chair during administration. Elevated patient' legs and feet. Unable to lower head due tom position in chair. Ice packs applied under bilateral axillas, back of neck, and forehead. Emesis bag provided to patient. As patient became more aware, small amount of glucose gel was given to patient as she stated she had not eaten anything prior to coming to appointment. Patient tolerated well and became more alert. Color returned to the patient's face and lips. Diaphoresis subsided. No vomiting. Nausea subsided. Patient alert and conversing with staff. Patient was able to drink 2 small cups of cold water. Vital signs: BP- 104/61, HR-66, RR-18, Pox RA-99%. Had patient sit for a while, then had her place her feet on the floor.  Had patient stand and move and move head around. Patient denied any further dizziness, lightheadedness, weakness, nausea, vision changes. Patient was offered to stay and lay down for a while, but patient declined and stated she felt well to leave. Patient left the office.
Age: 6.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Tdap was inadvertnantly administered instead of the age appropriate DTAP.  CLient had not received any prior Dtap vaccines.  NO adverse reactions.  CLient will retrun for a DTAP vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Headache, Hypoaesthesia, Neuralgia, Syncope
Clinical narrative: Patient reported a headache that led to fainting on two occasions. Patient also had nerve pain in the mandibular area of the face on their left side. Patient's left side became swollen from the neck down to the arm on the left side of the body. Also had some numbness of the tongue and disfiguration in taste. Patient saw a chiropractor for the nerve pain and reported adverse events to us at the pharmacy.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient overdue for vaccine: DTAP. MA (myself) did not review age range for dose at the time of administration. Patient should have received TDAP - patients age greater than 7 years old.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: pt states her arm became hot and red about an inch below the injection site right away after being vaccinated. It is now 2" x 1 1/4" in size and oval in size. It is less red and not as hot to the touch at this time. She contacted a pharmacy about this reaction and said it is not a normal reaction.  She has had similar reactions from the anthrax vaccine and covid vaccine in the past where the symptoms seemed to get worse than what is happening with this vaccine. She is concerned about getting second dose.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Dyspnoea, Swelling
Clinical narrative: Patient experienced arm swelling consistent with an Arthus reaction. She presented on June 20th with noted improvement at the injection site. On Monday, June 23rd, the patient called to report that she had been hospitalized over the weekend for one day due to shortness of breath and reported "swelling in the chest cavity." She stated that hospital staff informed her she may have had an allergic reaction to the injection.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Shot given directly into shoulder joint. Intense pain when needle entered, after pain was immediate. Numbness/tingling from shoulder down to fingertips.  The more I move my arm around, the worse the tingling is. There is constant pain in the shoulder, as well as limited motion. The more i lift my arm out to my side, the more it hurts. I have seen 2 different Dr's following up on the issues and the first one blew it off while the second one actually checked it out and mentioned rotator cuff damage.  The symptoms have yet to lessen, it is frustrating, and irritating due to this impeding on daily life.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Pain, Paraesthesia, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: Shot given directly into shoulder joint. Intense pain when needle entered, after pain was immediate. Numbness/tingling from shoulder down to fingertips.  The more I move my arm around, the worse the tingling is. There is constant pain in the shoulder, as well as limited motion. The more i lift my arm out to my side, the more it hurts. I have seen 2 different Dr's following up on the issues and the first one blew it off while the second one actually checked it out and mentioned rotator cuff damage.  The symptoms have yet to lessen, it is frustrating, and irritating due to this impeding on daily life.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: PALE, DIZZY/ LIGHT HEADED, FELT LIKE HE WAS GOING TO PASS OUT
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of Moderna COVID vaccine for ages 6 months-11 years. Expiration date was 6/21/25 but medical assistant misread this as 6/27/25 and thus administered the dose on 6/23/25 after it was already expired. Barcode scanning technology was used AFTER administration and so the error was not caught until post-administration. No harm occurred to patient.