chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: the second dose has not yet been administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on 5th April 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: the second dose has not yet been administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-JAN-2025 The patient never received the second dose of Shingrix. The pharmacist did not have the product lot number/expiration date information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose 1 Shingrix was given in 2021 and wants to get her 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Dose 1 Shingrix was given in 2021 and wants to get her 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-FEB-2025 The registered pharmacist reported that the patient wanted to get her 2nd dose of Shingrix and the patient asked if she needed to restart Shingrix series since 1st dose was given in 2021.  She stated she was told she had to restart by another pharmacy.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.25
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: 4th dose of Engerix-B was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 1-year-old female patient who received HBV (Engerix B) (batch number GC3N4, expiry date 04-AUG-2026) for prophylaxis.   Previously administered products included Engerix b (received 3 doses on an unknown dates).   On 30-JAN-2025, the patient received the 4th dose of Engerix B. On 30-JAN-2025, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: 4th dose of Engerix-B was administered to a patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-FEB-2025 The certified medical assistant reported that a 4th dose of Engerix-B was administered to a patient, which led to extra dose administered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: The child experienced large amount of swelling and redness at vaccine site on left thigh. Onset 10/18/2024, 1 day after 4 year shots. He was seen at local ER on 10/18 due to swelling and pain. Diagnosed with vaccine reaction. Follow-up on 10/21 with me. Swelling started to improve by then  ARTHUS Reaction
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Myalgia
Clinical narrative: Reported Symptoms: 10028411:MYALGIA; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: Other: weakness
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Pt reported rash to primary care provider 2 months after receiving influenza-HD vaccine. By this time rash had self resolved. Provider flagged pt chart with allergy. Other Relevant HX: Other: RASH
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Erythema, Nausea, Paraesthesia
Clinical narrative: Redness, itching, warm, swelling, chills, low grade fever, nausea, confusion, tingling in face, b/l legs, and b/l feet
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Skin warm, Swelling
Clinical narrative: Redness, itching, warm, swelling, chills, low grade fever, nausea, confusion, tingling in face, b/l legs, and b/l feet
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions reported as of 4/16/21. Patient was under age for administration.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy oesophagus, Biopsy small intestine abnormal, Chest pain, Duodenitis, Dysphagia
Clinical narrative: On the evening of 1/16, I developed very painful, mid-sternum pain with swallowing anything. This was severe and noted with every swallow, even just saliva. It was difficult and painful to swallow for 12 hours. Dysphagia continued for 2 months and I was only able to eat softs, high water content foods and liquids. I was unable to eat foods that formed a bolus such as bread, pasta, meat, etc. Eating and drinking took much longer than normal and I had to take very small bites and chew for an extended period of time. This resolved on its own gradually after 2 months and I am now able to eat normally.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy normal, Endoscopy upper gastrointestinal tract, Odynophagia, Swallow study
Clinical narrative: On the evening of 1/16, I developed very painful, mid-sternum pain with swallowing anything. This was severe and noted with every swallow, even just saliva. It was difficult and painful to swallow for 12 hours. Dysphagia continued for 2 months and I was only able to eat softs, high water content foods and liquids. I was unable to eat foods that formed a bolus such as bread, pasta, meat, etc. Eating and drinking took much longer than normal and I had to take very small bites and chew for an extended period of time. This resolved on its own gradually after 2 months and I am now able to eat normally.
Age: 16.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMRV, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt given MMRV and VZV vaccine on same day. No adverse reaction while in clinic.
Sex: F
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: seizure; This serious case was reported by a consumer and described the occurrence of seizure in a female 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 seizure (Verbatim: seizure) (serious criteria GSK medically significant). The outcome of the seizure was resolved.   It was unknown if the reporter considered the seizure to be related to Shingrix.     The company considered the seizure to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2025 Consumer commented that they had a seizure response to the first dose of the Shingrix vaccine. The reporter also mentioned that yes, even people should be cautious, because drugs were tested on rats before.  She was personally know (as a woman) that my seizure response to the shingrix vax wasn't reported, as she  kept getting text reminders to get the second one.; Sender's Comments: Seizure is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old patient was given Infanrix instead of Boostrix; 11 year old patient was given Infanrix instead of Boostrix; This non-serious case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 11-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 10-JUN-2024, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 10-JUN-2024, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 11 year old patient was given Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: 11 year old patient was given Infanrix instead of Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-FEB-2025 The healthcare professional reported that the patient of an inappropriate age was given Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The reporter asked what actions should they take.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Pyrexia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles/itchy spot on the upper back of their right thigh/slight fever; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/itchy spot on the upper back of their right thigh/slight fever). The patient was treated with valaciclovir hydrochloride (Valtrex). 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 28-JAN-2025 Patient reported that he/she got Shingles even he/she was vaccinated. Patient stated that he/she woke up with an itchy spot on the upper back of their right thigh, about the size of a half dollar, also had a slight fever. Patient received Valtrex for treatment and it made them feel worse than they did before taking it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding herpes zoster 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 completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: RSV
Symptoms: Cough, Dyspnoea
Clinical narrative: slight cough; breathing labored frequently; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In JAN-2025, the patient received Arexvy. On an unknown date, less than a week after receiving Arexvy, the patient experienced cough (Verbatim: slight cough) and labored breathing (Verbatim: breathing labored frequently). The outcome of the cough and labored breathing were not reported.   It was unknown if the reporter considered the cough and labored breathing to be related to Arexvy.     It was unknown if the company considered the cough and labored breathing to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient via interactive digital media. The patient 's wife reported that her husband got Arexvy shot 6 days ago and had slight cough and breathing labored frequently. She enquired how long it would last. The follow-up could not be possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This non-serious case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-JAN-2025, the patient received the 2nd dose of Shingrix. In JAN-2025, less than a week after receiving Shingrix, the patient experienced fever (Verbatim: fever). The outcome of the fever was resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2025 Patient got second shot of Shingrix and experienced fever.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still contracted Shingles on my forehead and scalp; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In AUG-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still contracted Shingles on my forehead and scalp). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient got both Shingrix vaccines in 2020 and still contracted shingles on forehead and scalp in August of last year.  It did not affect patient 's eye.  The course of the disease was not long, which might have been due to the fact that patient had received the 2 doses of Shingrix in 2020. This case was considered as suspected vaccination failure as details regarding time 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1 and Shingrix dose 2..
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got first shot when turned 50. now turning 55 do have to get the shot again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received when patient turned 50).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got first shot when turned 50. now turning 55 do have to get the shot again). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-FEB-2025 At the time of reporting, the patient was turning 55 years. The patient asked did have to get the Shingrix shot again. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: RVX
Symptoms: Injury
Clinical narrative: I have a vaccine injured son; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injury 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 injury (Verbatim: I have a vaccine injured son). The outcome of the injury was not reported.   It was unknown if the reporter considered the injury to be related to RSV vaccine.     It was unknown if the company considered the injury to be related to RSV vaccine.   Additional Information: GSK receipt date: 02-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had a vaccine injured son after taking a RSV vaccine. This case had been link with US2025AMR016146, reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR016146:same  reporter
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the adult dose was given to an 18-year-old; the adult dose was given to an 18-year-old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) (batch number J3952, expiry date 01-DEC-2026) for prophylaxis.   On 14-JAN-2025, the patient received the 1st dose of Engerix B adult. On 14-JAN-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: the adult dose was given to an 18-year-old) and overdose (Verbatim: the adult dose was given to an 18-year-old). The outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JAN-2025 Pharmacist reported that the adult dose was given to an 18-year-old, which led to adult product administered to child and overdose. According to reporter, it was the 1st dose of the series for such patient.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: a patient received a dose of Menveao with an unapproved diluent; a patient received a dose of Menveao with an unapproved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB044A, expiry date 31-JUL-2025) for prophylaxis.   Previously administered products included Menveo (1st dose on unknown date).   On 15-JAN-2025, the patient received the 2nd dose of Menveo. On 15-JAN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: a patient received a dose of Menveao with an unapproved diluent) and inappropriate dose of vaccine administered (Verbatim: a patient received a dose of Menveao with an unapproved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-JAN-2025 Other healthcare professional reported that a patient received a dose of Menveo with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: they have not received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 9 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: they have not received a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-JAN-2025 The pharmacist reported that a patient got a first dose of Shingrix 9 months ago and they had not received a second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: A 70 years old female patient received a dose of Arexvy in 2023 and this year the patient received a second dose of Arexvy.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose in 2023 ).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: A 70 years old female patient received a dose of Arexvy in 2023 and this year the patient received a second dose of Arexvy.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2025 The patient received Arexvy in 2023 and now in reporting year the patient received a second dose of Arexvy, which led to extra dose administered.  The reporter wanted to know if they had any studies regarding this situation or was there any concern for possible adverse reactions.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave a 33 years old a Shingrix; supposed to give a varicella vaccine, and they gave a Shingrix instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 33-year-old female patient who received Herpes zoster (Shingrix) (batch number HA5HL, expiry date 13-NOV-2026) for prophylaxis.   Co-suspect products included Varicella zoster vaccine (Varicella vaccine) for prophylaxis.   On 22-JAN-2025, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive Varicella vaccine. On 22-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: gave a 33 years old a Shingrix) and wrong vaccine administered (Verbatim: supposed to give a varicella vaccine, and they gave a Shingrix instead). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-FEB-2025  The nurse had a medical assistant that actually gave a 33 years old patient a Shingrix which led to inappropriate ae at vaccine administration, and he/she need to know if that was gonna harm that patient at all. The nurse reported it was supposed to give a varicella vaccine, and they gave a Shingrix instead which led to wrong vaccine administered. Also, the nurse mentioned that the patient was not immunocompromised. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: adult patient was administered by mistake another BOOSTRIX dose "...too early; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis.   Previously administered products included BOOSTRIX (13-JAN-2020 the patient received a booster dose).   On 30-JAN-2025, the patient received Boostrix. On 30-JAN-2025, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: adult patient was administered by mistake another BOOSTRIX dose "...too early). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-FEB-2025 Medical Assistant reported the patient was administered by mistake another Boostrix dose too early, which led to shortening of vaccination schedule.  The reporter consented to follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received her second dose of Shingrix 15 days after the first; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 24-JAN-2025, the patient received the 2nd dose of Shingrix. On 24-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received her second dose of Shingrix 15 days after the first). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date : 04-FEB-2025 Pharmacist stated that a patient received her second dose of Shingrix 15 days after the first (earlier than the recommended interval), which led to shortening of  vaccine schedule.
Sex: U
Vaccine: DTAPIPV, HEP
Symptoms: Product storage error
Clinical narrative: vaccines probably administered after above temperature excursions/temperature excursion for Kinrix and Engerix-B during 8 minutes with a maximum temperature of 8.63 degree Celsius; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) (batch number D947X) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 42B22) for prophylaxis.   On an unknown date, the patients received Kinrix and Engerix B. On an unknown date, an unknown time after receiving Kinrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: vaccines probably administered after above temperature excursions/temperature excursion for Kinrix and Engerix-B during 8 minutes with a maximum temperature of 8.63 degree Celsius). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 05-FEB-2025 The office manager called to reported that a temperature excursion for Kinrix and Engerix-B during 8 minutes with a maximum temperature of 8.63 degree Celsius which led to, incorrect storage of drug. The reporter also mentioned a prior temperature excursion for those same vaccines of 7 minutes with a maximum temperature of 8.75degreree Celsius already reported in this case. The reporter explained that some of those vaccines were probably administered to patients after the temperature excursions, but she was not sure (no patient details provided by caller).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: received only the adjuvant portion of Shingrix as a second dose; received only the adjuvant portion of Shingrix as a second dose; 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 56-year-old female patient who received Herpes zoster (Shingrix) (batch number N35N9, expiry date 15-NOV-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 13-JAN-2025, the patient received the 2nd dose of Shingrix. On 13-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only the adjuvant portion of Shingrix as a second dose) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant portion of Shingrix as a second dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 06-FEB-2025 The medical assistant reported that they accidentally administered only the adjuvant portion of Shingrix to a patient which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient already had the first dose of Shingrix, but for the second dose she only got the adjuvant portion of Shingrix. The reporter had a question what could potentially happened to the patient or any adverse event that they should look for.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient received only the diluent; patient received only the diluent; 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 female patient who received Herpes zoster (Shingrix) (batch number 5Y4TL, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the diluent ) and inappropriate dose of vaccine administered (Verbatim: patient received only the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-FEB-2025 A medical assistant called to report that a patient received only the diluent portion of Shingrix.  The Healthcare professional asked for recommendations on this situation and if she could get an additional diluent vial.  The patient received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was administered to a 4-month-old patient instead of Pediarix; Kinrix was administered to a 4-month-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 27-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Pediarix. On 27-JAN-2025, an unknown time after receiving Kinrix and Pediarix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was administered to a 4-month-old patient instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 4-month-old patient). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-FEB-2025 The Healthcare professional reported that Kinrix was administered to a 4 month old patient instead of Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration. She stated they had always revaccinated after 30 days because it was considered an invalid dose but their nurse stated, they did not had to revaccinate because it was the same dose.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: frozen shoulder; This spontaneous report received from a patient concerned a female patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose and frequency not reported, administered on 2020, additional dosage information included: dose number in series: 1, for prevention of coronavirus. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced frozen shoulder. (dose number in series: 1).  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of frozen shoulder was not reported.  The reporter considered the causality between janssen covid-19 vaccine and frozen shoulder as related. Company causality between janssen covid-19 vaccine and frozen shoulder as possible.  This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot behind left knee; This spontaneous report received from a consumer concerned a male patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805020) dose and frequency not reported, administered on 09-Mar-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis.  Concomitant medications included: multivitamin [ascorbic acid;calcium pantothenate;colecalciferol;cyanocobalamin;nicotinamide;pyridoxine hydrochloride;retinol;riboflavin;thiamine hydrochloride]; vitamin d3; turmeric +. The patient had no significant medical history prior to receiving vaccine. The patient was feeling bad and convinced him to go to hospital.    On an unspecified date, the patient experienced blood clot behind left knee. (dose series 1) The patient was lucky he went in when he did or he could have died. The patient has been on blood thinners since diagnosis (Dabigatran etexilate 150 mg, 2 capsules daily) and inquired about possible reimbursement for medication.  Treatment medications included: dabigatran etexilate for blood thinner.  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of blood clot behind left knee was not reported.  This report was serious (other medically important condition).; Sender's Comments: V0: Thrombosis :. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Death, Surgery
Clinical narrative: death; BLOOD CLOTS in brain; third surgery; This spontaneous report received from a consumer concerned an 18 year old female patient. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced death, blood clots in brain, and third surgery. (dose series 1) It was reported that the patient had to have 2 surgeries for her blood clot in her brain and on the third surgery the patient died. The patient died around august or september-2021.  It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable.  Reported cause of death was unknown cause of death.  The patient died on an unspecified date. The outcome of blood clots in brain and third surgery was not reported.  This report was serious (death and other medically important condition).; Sender's Comments: V0: Death and  surgery. -. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: NATURE OF EVENT. Therefore, this event is considered inconsistent with vaccine administration.  Cerebral thrombosis: 000-. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cellulitis, Death, Herpes virus infection, Influenza
Clinical narrative: possible pneumonia of both lungs; herpes virus that went to the brain; Covid-19; possible cellulitis; influenza B; influenza A; death; This spontaneous report received from a consumer concerned an 81 year old female patient. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. dose series 1. Batch number was not reported and has been requested.  No concomitant medications were reported.  On 02-Jun-2024, the patient experienced death. On an unspecified date, the patient experienced possible pneumonia of both lungs, covid-19, possible cellulitis, herpes virus that went to the brain, influenza b, and influenza a. (dose series 1) The patient got the vaccine because she was working around elderly people. After the patient received the Covid vaccine, she got real sick. She was in and out of the hospital. Patient had influenza A and B and had herpes virus that went to the brain. The patient contacted Janssen pharmaceuticals and explained her side effects and the caller's side effects. They wrote her a letter and addressed it to her mom. She had pneumonia in both lungs and cellulitis, she thinks. The reporter thinks her mom may have had Covid too. The reporter has all her mom's medical records and also reported, when she was cleaning her mom's home before bringing her home for hospice care, she was going through her mom's mail, and she found the envelope that her mom had addressed to reporter. The patient had already filed a claim.  It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable.  Reported cause of death was unknown cause of death.  The outcome of possible pneumonia of both lungs, covid-19, possible cellulitis, herpes virus that went to the brain, influenza b and influenza a was not reported. The patient died on 02-Jun-2024.  This report was serious (death and other medically important condition).; Sender's Comments: V0; Death, Herpes simplex and Pneumonia: The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: possible pneumonia of both lungs; herpes virus that went to the brain; Covid-19; possible cellulitis; influenza B; influenza A; death; This spontaneous report received from a consumer concerned an 81 year old female patient. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. dose series 1. Batch number was not reported and has been requested.  No concomitant medications were reported.  On 02-Jun-2024, the patient experienced death. On an unspecified date, the patient experienced possible pneumonia of both lungs, covid-19, possible cellulitis, herpes virus that went to the brain, influenza b, and influenza a. (dose series 1) The patient got the vaccine because she was working around elderly people. After the patient received the Covid vaccine, she got real sick. She was in and out of the hospital. Patient had influenza A and B and had herpes virus that went to the brain. The patient contacted Janssen pharmaceuticals and explained her side effects and the caller's side effects. They wrote her a letter and addressed it to her mom. She had pneumonia in both lungs and cellulitis, she thinks. The reporter thinks her mom may have had Covid too. The reporter has all her mom's medical records and also reported, when she was cleaning her mom's home before bringing her home for hospice care, she was going through her mom's mail, and she found the envelope that her mom had addressed to reporter. The patient had already filed a claim.  It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable.  Reported cause of death was unknown cause of death.  The outcome of possible pneumonia of both lungs, covid-19, possible cellulitis, herpes virus that went to the brain, influenza b and influenza a was not reported. The patient died on 02-Jun-2024.  This report was serious (death and other medically important condition).; Sender's Comments: V0; Death, Herpes simplex and Pneumonia: The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: PPV
Symptoms: Laboratory test normal, Malaise, Pneumonia
Clinical narrative: I have a good taste of pneumonia; I am a very sick woman from your vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 91-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in Jan2025 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "I have a good taste of pneumonia"; ILLNESS (non-serious), outcome "unknown", described as "I am a very sick woman from your vaccine". The patient underwent the following laboratory tests and procedures: lab work: Normal, notes: Lab work: Consumer stated, "Yes, I had lab work and it was all normal. Therapeutic measures were taken as a result of pneumonia, illness.  Additional information: The consumer stated, "I am having a bad reaction from your Pneumococcal Conjugate." When probed for the reactions experienced by the consumer, consumer stated, "What I am experienced is, I have a good taste of pneumonia." The consumer stated, "I am calling about the Pneumococcal Conjugate that you have recently been pushing." When clarified if consumer want to report it, consumer stated, "I am reporting it to Pfizer. I am a very sick woman from your vaccine." The consumer stated, "Yes, I had lab work and it was all normal." The consumer stated, "I am on Azithromycin."   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  Clinical course: During an inbound call to complete enrollment for financial assistance, the patient stated, that he was really sick and not feeling good, and wants to do everything over the phone because he was laying down. If he sit, headache like crazy. Patient stated" I can't go on the computer; I'm laying down talking." The agent advised they would need to play the consent recordings.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: DTAP, UNK
Symptoms: Wrong product administered
Clinical narrative: inappropriate use due to inadvertently administered Dtap instead of Tdap with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who experienced inappropriate use due to inadvertently administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine [tdap] with no reported adverse event.  On an unknown date, the patient received an unknown  dose of suspect  Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, suspension for injection, lot number: 3CA03C3, expiry date not reported was  inadvertently administered dtap instead of received a  unknown dose of suspect Diphtheria, Tetanus And Acellular Pertussis Vaccine (tdap) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site both for Immunization. tdap with no reported adverse event (wrong product administered) (latency:same day).  Reportedly,Relayed the information to the school nurse which they got a little upset because they just want to make sure the student will not receive an extra dose of what was already given to them..  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.