chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms reported; HCP reported 14 year old patient receiving PROQUAD inadvertently; This spontaneous report was received from a physician assistant and refers to a 14-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-Jun-2025, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), solution for injection (lot #Y019173, expiration date: 18-May-2026), the vaccine was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot# 1973239, expiration date: 14-Feb-2026), dose at 0.5 mL, administered as prophylaxis (route of administration, anatomical site and dose number in series were not provided) (Product administered to patient of inappropriate age). No symptoms reported (No adverse event). In addition, it was stated that they planned to complete a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R II) series for this patient.
Sex: F
Vaccine: PNC21
Symptoms: Unevaluable event
Clinical narrative: been admitted to the hospital; This spontaneous report was received from a pharmacist and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On unknown date in June 2025 (reported as 22-Jun-2025 or 24-Jun-2025 but unable to confirm), the patient was vaccinated with pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), 0.5 mL, lot number Z004301, expiration date was not reported but was established as 07-Sep-2026 upon internal validation, administered by intramuscular route for immunization and prevention of pneumonia (strength and anatomical location were not reported). Unknown if product was available for retrieval.  On unknown date in June 2025, the patient was admitted to the hospital (hospitalization). Hospital name and address unknown.   At the reporting time, the outcome of event hospitalization was unknown.  The reporter considered the event of hospitalization to be related to pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (reporter felt the AE was related to the specific lot # as he also reported a second patient adverse event related to this lot).  This is one of two reports received from the same reporter.  This is a non-valid case due to lack of patient identifiers.  Follow-up information has been received from pharmacist, on 10-JUL-2025. The patient's information and contact information has been updated, it refers to a 96-years-old female patient.; Sender's Comments: Priority : 2 , Is case serious : Yes , MNSC number : 02829466-02829461 , CLIC number : , ESTAR number : , IRMS number : 500UW00000eSGu1YAG|10072025230029|6503 , Central date : 2025-07-11 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2301181 , MNSC case number : 02829466 , MNSC interaction number : 02829461 , Integration log UniqueID : 500UW00000eSGu1YAG|10072025230029|6503 , Service cloud CaseID : 500UW00000eSGu1YAG
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site rash, Rash
Clinical narrative: presented with a rash located at injection site, under belly, arms, and legs.; presented with a rash located at injection site, under belly, arms, and legs.; This spontaneous report was received from a medical assistant and referred to a 16-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 24-Mar-2025, the patient was vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) (lot #Y012865, expiration date: 10-Oct-2026, 0.5ml/ series, intramuscular injection left arm) for prophylaxis.  On unknown date in April 2025 (sometime during the first week of April 2025), the patient presented with a rash located at injection site, under belly, arms, and legs. The patient sought medical attention. On unknown date in 2025 (a few days later), the patient recovered fully from the events with no intervention.  The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as not applicable.   The causal relationship between all events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HCP called and reported that a patient received a first dose of GARDASIL 9 on 09MAY2025 at age 45 years old, and the patient is now due for her second dose of GARDASIL 9 and is currently 46 years old. Second dose has not yet been administered, but pr; No additional AE; This spontaneous report was received from a nurse and refers to a currently 46-year-old female patient.    The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On 09-May-2025 (at age 45 years old), the patient received a first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), administered for prophylaxis (strength, dose, route, anatomical site, lot # and expiration date were not reported).  The patient was now due for her second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) and was currently 46 years old. Second dose has not yet been administered (Inappropriate schedule of product administration). Limited patient demographics provided. No additional information was known by reporter. No additional AE/PQC (No adverse event).  Lot# is being requested and will be submitted if received.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient age of 18 months, received Heplisav-B today in the office; Initial report received on 12-Jun-2025.    A nurse reported that an 18-month-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No medical history or concomitant medications were reported.      On 12-Jun-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available). The patient was 18 months at the time she received the vaccine.      No additional information was reported.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient Took First Dose On 12/6/2024, Is It Too Late For The Second Dose?; Initial report received on 16-Jun-2025.    A pharmacist reported that a patient (age, gender, race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet.  No medical history or concomitant medication were reported.      On 06-Dec-2024, the patient received dose 1 of a hepatitis B HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not available).    At the time of this report, the patient has not received the second dose yet.    No additional information was provided. Reporter did not give consent to contact them for additional data.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Heplisav-B Dose On 6 March 2025, Engerix-B Given As Second Dose By Accident On 15 May 2025.; Inappropriate Schedule of Vaccine Administered; Initial report received on 23-Jun-2025.  A nurse reported that a 54-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given ENGERIX-B as the second dose by accident.  No medical history or concomitant medications were reported.  On 06-Mar-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)].   On 15-May-2025, 71 days after receiving HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot number not provided)]. The reporter was inquiring about the time interval between HEPLISAV-B doses in the event ENGERIX-B was given as the second dose by accident.  No additional information was reported.  The reporter declined to provide further information.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 16 Year Old Received Heplisav-B on 24Jun25, Is There Anything We Should Monitor ?; Initial report received on 24-Jun-2025.  A nurse reported that a 16-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications were reported.  On 24-Jun-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not reported). The patient was 16 years old at the time of vaccination.  No additional information was reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Patient had Heplisav-B Doses Two Years Apart; Initial report received on 25-Jun-2025.  A nurse reported that a 46-year-old male received doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization two years apart.  No medical history or concomitant medications were reported.  On 03-Jul-2023, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided).  On 11-Jun-2025, 710 days after receiving dose 1 of HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided).   The reporter declined to provide further information.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: VARZOS
Symptoms: Paralysis
Clinical narrative: partially paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis 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 paralysis (Verbatim: partially paralyzed) (serious criteria GSK medically significant). The outcome of the paralysis was not reported.   It was unknown if the reporter considered the paralysis to be related to Shingles vaccine.     The company considered the paralysis to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter stated that his/her coworker was partially paralyzed from the Shingle shot and in pain.; Sender's Comments: A case of Paralysis, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Vaccine: RVX
Symptoms: Unevaluable event
Clinical narrative: After getting the shot I ended in the hospital; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced hospitalization (Verbatim: After getting the shot I ended in the hospital) (serious criteria hospitalization). The outcome of the hospitalization was not reported.   It was unknown if the reporter considered the hospitalization to be related to RSV vaccine.     The company considered the hospitalization to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a patient via interactive digital media. The patient mentioned that after getting the RSV shot, he/she ended up in the hospital.; Sender's Comments: A case of Hospitalisation, unknown time after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained.  Consent for further follow up has not been received.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: KINRIX was administered to a 2 month old child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-week-old male patient who received DTPa-IPV (Kinrix) (batch number 25G23D, expiry date 21-AUG-2026) for prophylaxis.   On 07-JUL-2025, the patient received Kinrix. On 07-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: KINRIX was administered to a 2 month old child). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 07-JUL-2025 The heath care professional reported that a dose of Kinrix was administered to a 2 month old child (inappropriate age), which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed dose/never received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missed dose/never received the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 30-JUN-2025 and 02-JUL-2025 The reporter was the patient. The patient received the first dose of Shingrix in 2019, and never received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2025082464:husband case
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; everyone i know who got vax got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: everyone i know who got vax 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: 08-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter reported that everyone he/she knows who got vaccine and got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt Date: 11-JUL-2025 This case was reported by a patient via interactive digital media. The patient got one shot and then a week later had shingles and not received the second dose.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Immediate pain at the injection site radiating down the left arm following brachial plexus. Pain has been persistent since the injection. No other known injuries. Checking lateral neck xray to r/o C7 compression. Will start gabapentin for symptomatic pain relief. Start PT. Referred to ortho. Consider EMG studies.
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: she administered the first vial, just the suspension liquid; she administered the first vial, just the suspension liquid; 46 year old received Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 46-year-old male patient who received Herpes zoster (Shingrix) (batch number 5Y49C) for prophylaxis.   On 30-JUN-2025, the patient received Shingrix. On 30-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: she administered the first vial, just the suspension liquid), inappropriate dose of vaccine administered (Verbatim: she administered the first vial, just the suspension liquid) and inappropriate age at vaccine administration (Verbatim: 46 year old received Shingrix). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were not applicable.   Additional Information: GSK receipt date: 30-JUN-2025 Other HCP reported that a patient was due to the Shingrix vaccine and the medical assistant who administered the vaccine did not reconstitute with the second vial, she administered the first vial, just the suspension liquid.  Reporter asked if they go ahead and make another vaccine reconstituted and administer to the patient on the day of reporting and will they be any adverse effects if they do that. The patient received only 1 vial of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient states site of pneumonia vaccine is swollen, hot, & has approx 4inch red band on left arm  Denies Fever, SOB, CP, Trouble swallowing  Allergies: is allergic to prednisone and extract of poison oak. Symptoms started Friday 7/11/25
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Hand size hot rash at injection site 4 days+. Starting day after injection
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HIBV, IPV, PNC15, RV5
Symptoms: Acidosis, Alpha-1 anti-trypsin increased, Biopsy intestine abnormal, Blood albumin decreased, Blood culture negative
Clinical narrative: Adverse Event: Following administration of routine 2-month vaccines on April 15, 2025 including the oral rotavirus vaccine my daughter developed persistent diarrhea, poor weight gain, hypoalbuminemia, and elevated inflammatory markers within days. Stools became green, watery, and mucousy with visible intestinal sloughing. She was ultimately diagnosed with severe intestinal inflammation with crypt dropout and eosinophilic infiltration on biopsy, consistent with an early inflammatory bowel disease process or severe immune dysregulation. She required bowel rest, TPN (total parenteral nutrition), and hospitalization for over 6 weeks.  Treatment: She was made NPO and placed on TPN. She was started on steroids (methylprednisolone then transitioned to prednisolone) and famotidine. Elemental formula (Neocate) was introduced slowly via NG and PO feeds as symptoms improved.  Outcome: We were discharged on in early June and she has continued to do very well. She is now gaining weight, having normal stools, and is tolerating feeds by mouth. She is currently titrating off of both steroids and famotidine. No further signs of active inflammation or diarrhea since discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HIBV, IPV, PNC15, RV5
Symptoms: Blood sodium decreased, Blood urea increased, C-reactive protein increased, CSF culture negative, Carbon dioxide decreased
Clinical narrative: Adverse Event: Following administration of routine 2-month vaccines on April 15, 2025 including the oral rotavirus vaccine my daughter developed persistent diarrhea, poor weight gain, hypoalbuminemia, and elevated inflammatory markers within days. Stools became green, watery, and mucousy with visible intestinal sloughing. She was ultimately diagnosed with severe intestinal inflammation with crypt dropout and eosinophilic infiltration on biopsy, consistent with an early inflammatory bowel disease process or severe immune dysregulation. She required bowel rest, TPN (total parenteral nutrition), and hospitalization for over 6 weeks.  Treatment: She was made NPO and placed on TPN. She was started on steroids (methylprednisolone then transitioned to prednisolone) and famotidine. Elemental formula (Neocate) was introduced slowly via NG and PO feeds as symptoms improved.  Outcome: We were discharged on in early June and she has continued to do very well. She is now gaining weight, having normal stools, and is tolerating feeds by mouth. She is currently titrating off of both steroids and famotidine. No further signs of active inflammation or diarrhea since discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HIBV, IPV, PNC15, RV5
Symptoms: Chemokine increased, Cholelithiasis, Culture urine negative, Diarrhoea, Endoscopy gastrointestinal abnormal
Clinical narrative: Adverse Event: Following administration of routine 2-month vaccines on April 15, 2025 including the oral rotavirus vaccine my daughter developed persistent diarrhea, poor weight gain, hypoalbuminemia, and elevated inflammatory markers within days. Stools became green, watery, and mucousy with visible intestinal sloughing. She was ultimately diagnosed with severe intestinal inflammation with crypt dropout and eosinophilic infiltration on biopsy, consistent with an early inflammatory bowel disease process or severe immune dysregulation. She required bowel rest, TPN (total parenteral nutrition), and hospitalization for over 6 weeks.  Treatment: She was made NPO and placed on TPN. She was started on steroids (methylprednisolone then transitioned to prednisolone) and famotidine. Elemental formula (Neocate) was introduced slowly via NG and PO feeds as symptoms improved.  Outcome: We were discharged on in early June and she has continued to do very well. She is now gaining weight, having normal stools, and is tolerating feeds by mouth. She is currently titrating off of both steroids and famotidine. No further signs of active inflammation or diarrhea since discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HIBV, IPV, PNC15, RV5
Symptoms: Faecal calprotectin increased, Faeces discoloured, Full blood count, Gastritis, Gastroenteritis eosinophilic
Clinical narrative: Adverse Event: Following administration of routine 2-month vaccines on April 15, 2025 including the oral rotavirus vaccine my daughter developed persistent diarrhea, poor weight gain, hypoalbuminemia, and elevated inflammatory markers within days. Stools became green, watery, and mucousy with visible intestinal sloughing. She was ultimately diagnosed with severe intestinal inflammation with crypt dropout and eosinophilic infiltration on biopsy, consistent with an early inflammatory bowel disease process or severe immune dysregulation. She required bowel rest, TPN (total parenteral nutrition), and hospitalization for over 6 weeks.  Treatment: She was made NPO and placed on TPN. She was started on steroids (methylprednisolone then transitioned to prednisolone) and famotidine. Elemental formula (Neocate) was introduced slowly via NG and PO feeds as symptoms improved.  Outcome: We were discharged on in early June and she has continued to do very well. She is now gaining weight, having normal stools, and is tolerating feeds by mouth. She is currently titrating off of both steroids and famotidine. No further signs of active inflammation or diarrhea since discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HIBV, IPV, PNC15, RV5
Symptoms: Gastrointestinal mucosal exfoliation, Gastrointestinal tube insertion, Genetic testing, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Adverse Event: Following administration of routine 2-month vaccines on April 15, 2025 including the oral rotavirus vaccine my daughter developed persistent diarrhea, poor weight gain, hypoalbuminemia, and elevated inflammatory markers within days. Stools became green, watery, and mucousy with visible intestinal sloughing. She was ultimately diagnosed with severe intestinal inflammation with crypt dropout and eosinophilic infiltration on biopsy, consistent with an early inflammatory bowel disease process or severe immune dysregulation. She required bowel rest, TPN (total parenteral nutrition), and hospitalization for over 6 weeks.  Treatment: She was made NPO and placed on TPN. She was started on steroids (methylprednisolone then transitioned to prednisolone) and famotidine. Elemental formula (Neocate) was introduced slowly via NG and PO feeds as symptoms improved.  Outcome: We were discharged on in early June and she has continued to do very well. She is now gaining weight, having normal stools, and is tolerating feeds by mouth. She is currently titrating off of both steroids and famotidine. No further signs of active inflammation or diarrhea since discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HIBV, IPV, PNC15, RV5
Symptoms: Hypoalbuminaemia, Immunology test normal, Inflammatory bowel disease, Milk allergy, Mucous stools
Clinical narrative: Adverse Event: Following administration of routine 2-month vaccines on April 15, 2025 including the oral rotavirus vaccine my daughter developed persistent diarrhea, poor weight gain, hypoalbuminemia, and elevated inflammatory markers within days. Stools became green, watery, and mucousy with visible intestinal sloughing. She was ultimately diagnosed with severe intestinal inflammation with crypt dropout and eosinophilic infiltration on biopsy, consistent with an early inflammatory bowel disease process or severe immune dysregulation. She required bowel rest, TPN (total parenteral nutrition), and hospitalization for over 6 weeks.  Treatment: She was made NPO and placed on TPN. She was started on steroids (methylprednisolone then transitioned to prednisolone) and famotidine. Elemental formula (Neocate) was introduced slowly via NG and PO feeds as symptoms improved.  Outcome: We were discharged on in early June and she has continued to do very well. She is now gaining weight, having normal stools, and is tolerating feeds by mouth. She is currently titrating off of both steroids and famotidine. No further signs of active inflammation or diarrhea since discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HIBV, IPV, PNC15, RV5
Symptoms: Parenteral nutrition, Platelet count increased, Procalcitonin increased, Stool analysis, Stool sodium increased
Clinical narrative: Adverse Event: Following administration of routine 2-month vaccines on April 15, 2025 including the oral rotavirus vaccine my daughter developed persistent diarrhea, poor weight gain, hypoalbuminemia, and elevated inflammatory markers within days. Stools became green, watery, and mucousy with visible intestinal sloughing. She was ultimately diagnosed with severe intestinal inflammation with crypt dropout and eosinophilic infiltration on biopsy, consistent with an early inflammatory bowel disease process or severe immune dysregulation. She required bowel rest, TPN (total parenteral nutrition), and hospitalization for over 6 weeks.  Treatment: She was made NPO and placed on TPN. She was started on steroids (methylprednisolone then transitioned to prednisolone) and famotidine. Elemental formula (Neocate) was introduced slowly via NG and PO feeds as symptoms improved.  Outcome: We were discharged on in early June and she has continued to do very well. She is now gaining weight, having normal stools, and is tolerating feeds by mouth. She is currently titrating off of both steroids and famotidine. No further signs of active inflammation or diarrhea since discharge.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HIBV, IPV, PNC15, RV5
Symptoms: Ultrasound abdomen abnormal, Weight gain poor, White blood cell count increased
Clinical narrative: Adverse Event: Following administration of routine 2-month vaccines on April 15, 2025 including the oral rotavirus vaccine my daughter developed persistent diarrhea, poor weight gain, hypoalbuminemia, and elevated inflammatory markers within days. Stools became green, watery, and mucousy with visible intestinal sloughing. She was ultimately diagnosed with severe intestinal inflammation with crypt dropout and eosinophilic infiltration on biopsy, consistent with an early inflammatory bowel disease process or severe immune dysregulation. She required bowel rest, TPN (total parenteral nutrition), and hospitalization for over 6 weeks.  Treatment: She was made NPO and placed on TPN. She was started on steroids (methylprednisolone then transitioned to prednisolone) and famotidine. Elemental formula (Neocate) was introduced slowly via NG and PO feeds as symptoms improved.  Outcome: We were discharged on in early June and she has continued to do very well. She is now gaining weight, having normal stools, and is tolerating feeds by mouth. She is currently titrating off of both steroids and famotidine. No further signs of active inflammation or diarrhea since discharge.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: no adverse reactions noted.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Myelitis transverse
Clinical narrative: diffuse myelitis C3-lumbar spine
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site reaction
Clinical narrative: The following day he developed a large local reaction at the site of injection.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Retching, Syncope
Clinical narrative: Pt was stressed prior to receiving vaccine. Upon receiving vaccine pt fainted for a moment. Pt was caught by pt's mom, no injuries sustained. While laying down pt started gagging. Sat pt up and she threw up, minimal to moderate amount.  Pt received glass of water to rinse mouth and family stated this wasn't an unexpected reaction. Pt started feeling fine and after an assessment from provider she was cleared to leave. Pt walked out on her own.
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: During vaccine administration, patient jerked and withdrew her arm triggering vaccine administrator to withdraw needle to prevent injury, some of the vaccine content from the syringe leaked and dripped down patient's arm. A full dose of vaccine was not delivered to the patient. No other adverse events reported. Primary care physician was contacted, prescriber does not want patient to repeat the dose immediately, patient to repeat the dose in a year per prescriber's instruction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: experienced itching and inflammation in the site of administration; experienced itching and inflammation in the site of administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) (batch number H97H2, expiry date 28-FEB-2027) for prophylaxis.   On 20-MAY-2025, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site itching (Verbatim: experienced itching and inflammation in the site of administration) and injection site inflammation (Verbatim: experienced itching and inflammation in the site of administration). The outcome of the injection site itching and injection site inflammation were unknown.   It was unknown if the reporter considered the injection site itching and injection site inflammation to be related to Shingrix.     It was unknown if the company considered the injection site itching and injection site inflammation to be related to Shingrix.   Additional Information: GSK receipt date: 30-JUN-2025 Other HCP needed guidance after a 56-year-old female patient that received the first dose of Shingrix on 20 May 2025, experienced itching and inflammation in the site of administration of the vaccine for a couple of weeks. She wanted to know how to proceed and if the scheduled second dose could be administered.  Also, the health care provider mentioned that the patient received simultaneously the same day another vaccine whose name was not known, and she does not know which vaccine triggered the reaction.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Muscular weakness
Clinical narrative: About November 7, noticed pain in arm at area of injection.  Pain continued to spread and is now felt from the top of my shoulder to my wrist.  Result is continual pain whether using the arm or not, weakness
Age: 80.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Cerebrovascular accident, Death
Clinical narrative: Death, suspected stroke
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test positive, Biopsy skin abnormal, Blood test, Delivery, Erythema multiforme
Clinical narrative: mother (reporter) states that  her daughter was born. She was diagnosed 2 heart murmurs. She had hypertrophic cardiomyopathy that is genetic from her biological grandfather.  The mother herself then developed a rash all of her body. She saw multiple doctors. She ended up having to have a biopsy performed by Dr. and diagnosed with Erythema multiforme. They also found an antibody in her blood and may have either APS or a blood clot disorder. At this time she is waiting for blood results to confirm diagnosis.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Neonatal disorder, Rash
Clinical narrative: mother (reporter) states that  her daughter was born. She was diagnosed 2 heart murmurs. She had hypertrophic cardiomyopathy that is genetic from her biological grandfather.  The mother herself then developed a rash all of her body. She saw multiple doctors. She ended up having to have a biopsy performed by Dr. and diagnosed with Erythema multiforme. They also found an antibody in her blood and may have either APS or a blood clot disorder. At this time she is waiting for blood results to confirm diagnosis.
Age: 58.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Arthralgia, Asthenia, Condition aggravated, Fibromyalgia, Mobility decreased
Clinical narrative: Worsening of fibromyalgia and all -over body and joint pain. Patient states she could not get out of bed for a week. Very weak. Patient went to PCP one month later and is still experiencing symptoms.
Age: 58.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Pain
Clinical narrative: Worsening of fibromyalgia and all -over body and joint pain. Patient states she could not get out of bed for a week. Very weak. Patient went to PCP one month later and is still experiencing symptoms.
Age: 0.42
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Fatigue, Pyrexia
Clinical narrative: also got prevenar vaccine same day, developed fever that lasted for 5 days, up to 101, and he was very tired x 5 days, just concerned about length of fever, no other viral symptoms at that time
Age: 75.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Death, Pneumonia
Clinical narrative: Patient was hospitalized for pneumonia and died while admitted on 7/9
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Extra dose administered
Clinical narrative: MEMBER WAS GIVEN EXTRA DOSES OF VACCINE THAT WERE NOT INDICATED AT THAT TIME.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: The patient has had 2 years of pain in the right deltoid muscle following the PCV vaccine she received in that location. She states she still feels like the needle is going into her arm in the site of the injection. There are  no shoulder joint symptoms.
Age: 80.0
Sex: M
Vaccine: PNC20
Symptoms: Pruritus
Clinical narrative: Patient came in today stating he had itching about a week after he got the Prevnar vaccine. He started itching a bout a week after injection. It was more local initially then spread to the back/trunk etc. He stated it is a better today since he started using cortisone ointment. He will follow up with his doctor to see if he should do anything else
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Fatigue, Head injury, Syncope
Clinical narrative: Post administration mom and son (patient) were checking out at front desk and patient experienced syncope, fell backwards. Vitals taken immediately (all WNL). Patient stated he hit the back of his head and was feeling "tired".  911 was called for ED evaluation. Mom did state that patient was very anxious about receiving the vaccine and had not eaten or drank anything today.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given in office for 6 month well visit. Patient was given Hep B Adult 1ml vs the ordered Hep B Pediatric 0.5ml dose in error. As soon as staff realized the error she informed the provider and clinic supervisor. We reported immediately to the parents and completed an internal accident/incident report. Mom will monitor and report any infant fever, increased fussiness and/or redness and swelling to injection sight.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient unknowingly received 2 Arexvy vaccines (1 on 12/5/23, and another on 7/14/25). The first vaccine did not show up in the vaccine registry . In addition, the patient did not remember receiving the first dose. She is fine and has not experienced any side effects after receiving the second dose, as per our conversation on 7/15/25.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Ear pain, Nausea, Oropharyngeal pain, Pruritus, Throat irritation
Clinical narrative: Pt experienced itchy, painful throat and ears along with nausea about 30 mins after receiving HPV #1. Noi SOB, rash/hives, swelling or vomiting . Was given Zyrtec 10 mg at home with improvement in sx an hour later.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Maladministration of Adult Dose on a Pediatric Patient; Maladministration of Adult Dose on a Pediatric Patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number 5JX2E, expiry date 14-DEC-2026) for prophylaxis.   On 07-JUL-2025, the patient received the 1st dose of Engerix B adult. On 07-JUL-2025, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Maladministration of Adult Dose on a Pediatric Patient) and adult product administered to child (Verbatim: Maladministration of Adult Dose on a Pediatric Patient). The outcome of the overdose and adult product administered to child were not applicable.   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: 07-JUL-2025 The patient had administered a twenty microgram (adult dose) on a nineteen year old patient (first and only dose administered) which led to adult product administered to child and overdose. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Hypertension
Clinical narrative: After my 2nd dose of the Moderna covid vaccine, after i left the facility and got home i noticed i could feel/hear my heart beat in my left ear non stop as well as chest pains (which hasn't gone away). I also experienced shortness of breath which i've NEVER felt ANY of these symptoms ever in my life. After checking my blood pressure level was critical i went to the ER, however after explaining to the nurses i just had my 2nd covid shot i was told NOT to bring that up to the doctor that would be treating me! That it would only confuse the doctor trying to treat me. They did an EKG said it was "the most beautiful EKG the nurse ever seen," A1C was normal & lungs showed fine. They gave me some high blood pressure med to lower it & sent me on my way. However i still to this day have the same symptoms i went to the ER for, & noticed only recently the FDA added warnings to the Pfizer & Moderna of possible heart side effects like swelling of the heart which i believe i have
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt woke up next day with red raised area around vaccine area.  Next day it progressed from the shoulder down to the elbow. Mom gave Benadryl BID x 2 days and then it resolved
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Biopsy muscle, Blood test, Computerised tomogram, Dysphagia
Clinical narrative: pt states  after getting second dose that she had fever and she her arm was stiff.  Then her entire body started becoming stiff. She started having trouble turning her head from side to side. Her legs were feeling very heavy. She felt like she had inflammation and was very weak.  She was getting worse and started having a hard time swallowing.  She saw a NP at her doctors office and was referred to a rheumatologist. She was prescribed steroids. This helped a little but she at this point was not able to get up from the commode and if she laid or sat down she would become very stiff and weak and couldn't get up. Her muscles felt like they were shutting down. She was at work on 3/29/2025 when she became very weak, passed out and fell.  She went to hospital. She had a CT, MRI, biopsy on her thigh of her muscle and then she was admitted. She was given infusion for treating the inflammation and her boosting her immune system. She was in the hospital for 7 days and released to go home on physical therapy. She is still recovering but has not felt the same since getting this vaccine.  It has changed her life as she feels like she will never be the same.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Inflammation, Limb discomfort, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: pt states  after getting second dose that she had fever and she her arm was stiff.  Then her entire body started becoming stiff. She started having trouble turning her head from side to side. Her legs were feeling very heavy. She felt like she had inflammation and was very weak.  She was getting worse and started having a hard time swallowing.  She saw a NP at her doctors office and was referred to a rheumatologist. She was prescribed steroids. This helped a little but she at this point was not able to get up from the commode and if she laid or sat down she would become very stiff and weak and couldn't get up. Her muscles felt like they were shutting down. She was at work on 3/29/2025 when she became very weak, passed out and fell.  She went to hospital. She had a CT, MRI, biopsy on her thigh of her muscle and then she was admitted. She was given infusion for treating the inflammation and her boosting her immune system. She was in the hospital for 7 days and released to go home on physical therapy. She is still recovering but has not felt the same since getting this vaccine.  It has changed her life as she feels like she will never be the same.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pyrexia, Quality of life decreased
Clinical narrative: pt states  after getting second dose that she had fever and she her arm was stiff.  Then her entire body started becoming stiff. She started having trouble turning her head from side to side. Her legs were feeling very heavy. She felt like she had inflammation and was very weak.  She was getting worse and started having a hard time swallowing.  She saw a NP at her doctors office and was referred to a rheumatologist. She was prescribed steroids. This helped a little but she at this point was not able to get up from the commode and if she laid or sat down she would become very stiff and weak and couldn't get up. Her muscles felt like they were shutting down. She was at work on 3/29/2025 when she became very weak, passed out and fell.  She went to hospital. She had a CT, MRI, biopsy on her thigh of her muscle and then she was admitted. She was given infusion for treating the inflammation and her boosting her immune system. She was in the hospital for 7 days and released to go home on physical therapy. She is still recovering but has not felt the same since getting this vaccine.  It has changed her life as she feels like she will never be the same.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy breast abnormal, Breast cancer female, Fatigue, Full blood count, Haemoglobin decreased
Clinical narrative: Fainting spells, Low hemoglobin tested and shown, Low blood pressure, Blurry vision, Breast cancer, fatigue, Parasities
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Infection parasitic, Mammogram abnormal, Parasitic test positive, Syncope
Clinical narrative: Fainting spells, Low hemoglobin tested and shown, Low blood pressure, Blurry vision, Breast cancer, fatigue, Parasities
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: Fainting spells, Low hemoglobin tested and shown, Low blood pressure, Blurry vision, Breast cancer, fatigue, Parasities
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Head injury, Lip injury, Syncope
Clinical narrative: Patient ad a syncopal episode in the lobby on check out about 2:50pm. He collapsed and hit his chin on the counter resulting in him biting his lower lip.  No teeth loose or damaged.  No tongue injury.  He also thinks he hit his forehead on the counter but no marks, bruises, swelling or deformity on his head exam.  He was brought back to an exam room and laid down on exam table.  Vitals: BP 119/73, HR 58, O2 sat 97%.  He was observed for 15 minutes and repeat vitals: BP 121/69, HR 64, O2 sat 99%.  He was awake, alert, oriented and able to converse normal.  He was able to sit up and then also stand and walk without further dizziness or syncope.  D/c home, mom given instructions to call the clinic prn any new or worsening symptoms.