chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Laboratory test, X-ray
Clinical narrative: patient developed redness and swelling at the injection site.; patient developed redness and swelling at the injection site.; This spontaneous report has been received from a nurse referring to a 4-year-old male patient.   The patient's concurrent conditions and medical history were reported as none. Concomitant therapies were not provided.  On 28-FEB-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA) (+) sterile diluent, 1 dose (route of administration not reported) with lot # y010306 which was verified to be valid and expiration date not reported but upon internal validation established as 01-DEC-2025, for vaccination.   On the same date, the patient went to an emergency room (ER) because he developed redness and swelling at the injection site (Vaccination site erythema and vaccination site swelling). He was treated with Cefazolin 1000mg, Dexamethasone 4mg, Diphenhydramine 50mg and went home. Basic laboratory tests (unspecified) and X-ray were performed, however results were not provided.  The patient was not admitted into the hospital.  On 02-MAR-2025, the patient was fully recovered from both events.    The causal relationship between vaccination site erythema and vaccination site swelling with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (+) sterile diluent was not reported.
Sex: M
Vaccine: RVX
Symptoms: Genital herpes
Clinical narrative: Activated genital Herpes; This non-serious case was reported by a consumer and described the occurrence of genital herpes in a 77-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 28-FEB-2025, the patient received RSV vaccine. On 01-MAR-2025, 1 days after receiving RSV vaccine, the patient experienced genital herpes (Verbatim: Activated genital Herpes). The patient was treated with docosanol (Abreva). On 15-MAR-2025, the outcome of the genital herpes was resolved (duration 14 days).   It was unknown if the reporter considered the genital herpes to be related to RSV vaccine.     It was unknown if the company considered the genital herpes to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2025 The patient self-reported this case. The patient stated that he applied Abreva twice daily, until the outbreak dried up and started healing. The patient had activated genital herpes and the symptoms were treated.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got vaccinated and got it anyway; This serious case was reported by a consumer and described the occurrence of vaccination failure in a adult female 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Got vaccinated and got it anyway). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was unknown.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2025 This case was reported by a patient via interactive digital media Consumer reported that she got vaccinated and got it anyway.  She reported it takes forever to get over it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming RSV 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Respiratory syncytial virus infection  is an unlisted event which is considered unrelated to GSK RSV vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; They are terrible my Dr said that if I had not had the shot, they would have been worse; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: They are terrible my Dr said that if I had not had the shot, they would have been worse). 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: 20-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that they were terrible his/her physician said that if patient had not had the shot, they would have been worse. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine  Shingles vaccine.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: patient was administered with a priorix vaccine intramuscularly instead of subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a 44-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 15-MAR-2025, the patient received Priorix (intramuscular). On 15-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate route of vaccination (Verbatim: patient was administered with a priorix vaccine intramuscularly instead of subcutaneous). The outcome of the inappropriate route of vaccination 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: 17-MAR-2025 Pharmacist called to report that a patient was administered with a Priorix vaccine intramuscularly instead of subcutaneous, which led to Inappropriate route of vaccination.
Sex: F
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 1 month 4 days old female patient received a dose of Rotarix (liquid); 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 1-month-old female patient who received Rota (Rotarix liquid formulation) (batch number 7E9Y2, expiry date 30-MAY-2026) for prophylaxis.   On an unknown date, the patient received Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: A 1 month 4 days old female patient received a dose of Rotarix (liquid)). 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: 17-MAR-2025 A medical assistant called to report that they administered a dose of Rotarix (liquid) to a 1 month and 4 days old female patient which led to inappropriate age at vaccine administration. The reporter asked are there any side effects to consider?
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: over 2 years past for her 3rd one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Patient received first dose on 17-AUG-2022) and Twinrix (Patient received second dose 2 years ago).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: over 2 years past for her 3rd one). The outcome of the incomplete course of vaccination 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: 17-MAR-2025 Reporter stated that a patient that have received 2 of her Twinrix vaccination, and she was over 2 years past for her 3rd one, they were just calling to make sure that she does not have to restart the series. Till the time of reporting the patient did not receive the third dose of Twinrix, which led to invomplete course of vaccination.
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Hiberix only diluent administered; Hiberix only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 14-month-old male patient who received Hib (Hiberix) (batch number TC3N5, expiry date 17-MAR-2026) for prophylaxis.   On 17-MAR-2025, the patient received Hiberix. On 17-MAR-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Hiberix only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Hiberix only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 17-MAR-2025 The nurse reported that on the reporting day only the diluent portion of the Hiberix vaccine was administered to a 14-month-old patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received a second dose yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 47-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of twinrix on 9th December 2024, batch no D4774 and expiry date 12th September 2026).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: hasn't received a second dose yet). The outcome of the incomplete course of vaccination 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 : 24-MAR-2025 A patient received Twinrix first dose on December 9, 2024 and had not received a second dose yet. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 0.5
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE; The office administered the first ROTATEQ dose to a patient that is 6 months of  age. This patient has not received any previous doses; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 27-Feb-2025, the 6-month-old patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot #2088619, expiration date: 09-Mar-2026) (dose, vaccination site and route of administration was not reported) for prophylaxis (product administered to patient of inappropriate age). This patient has not received any previous doses. No symptoms were reported, and no additional details were provided. No other adverse event (AE) pr product quality complaint (PQC) was reported (no adverse event).
Age: 11.0
Vaccine: VARCEL
Symptoms: Device connection issue, No adverse event
Clinical narrative: No adverse side effects were reported.; HCP called to report a patient was being administered VARIVAX and the needle came off during administration, received about half of the dose. Requested information on revaccination see request case 02768484. STERILE DILUENT Lot and Expiration were un; Patient received about half of the dose; anyone was injured; This spontaneous report was received from Other health professional and refers to an 11-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 11-Mar-2025, the patient was vaccinated with of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (strength, frequency, route of administration, site of administration, and vaccination scheme were not provided; lot # Y015100 which has been verified as a valid number, and expiration date reported and validated as 06-Sep-2026), and was used with a sterile diluent (strength, frequency, route of administration, site of administration, vaccination scheme, lot #, and expiration date were not provided) as a prophylaxis. however, the needle came off during administration since it came detached at the luer lock. Luer lock remained on the syringe, and product leaked out from between the space between luer lock and where neeedle was attached (syringe connection issue), received about half of the dose (accidental underdose), and an injury (unspecified) was performed. Nevertheless, no adverse side effects were reported. At the reporting time, the outcome of the event of injury NOS was not provided.   The causal relationship between the event of injury NOS and the suspect vaccine was not provided.
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; HCP called to state that the patient received a third dose of PEDVAXHIB at 6 months of age. No symptomatic adverse events were reported. The AE onset date reflects the date of administration. HCP has declined to answer any further questions and has a; This spontaneous report was received from a Nurse and refers to a(n) 6-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 05-Dec-2024, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), lot #Y003145, expiration date: 12-Sep-2026, 0.5 mL (0.5ml/ series) (route of administration and anatomical location were not provided) for prophylaxis (extra dose administered). No additional adverse event reported (no adverse event).
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; shorter than recommended interval between 2nd and 3rd dose; delayed 2nd dose; This spontaneous report was received from a nurse practitioner and referred to a 25-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 02-OCT-2014, the patient was vaccinated with the first dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (dose, strength, route, anatomical site, lot # and expiration date were not reported) for prophylaxis.  On 16-SEP-2024, the patient was vaccinated with the second dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9), and on 18-OCT-2024, the patient was vaccinated with the third dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (for both doses: 0.5 mL, lot # Y011500, expiration date was reported as 18-OCT-2024, but upon internal validation was established as 29-MAY-2026; strength, route and anatomical site were unknown) for prophylaxis. The second dose was delayed and the interval between the second and the third dose was shorter than recommended (inappropriate schedule of product administration, inappropriate schedule of product administration). No additional adverse event (no adverse event). The outcome of the events was unknown.
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was administered diluent for Priorix; patient was administered diluent for Priorix; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered diluent for Priorix) and inappropriate dose of vaccine administered (Verbatim: patient was administered diluent for Priorix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 10-MAR-2025 The reporter did not know this was which dose of the Priorix vaccine. The patient was administered diluent for Priorix which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The healthcare professional submitted claim and stated diluent for Priorix was broken and then later confirmed only diluent was administered to a patient. This was not related to an existing case.
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: patient was given saline diluent only; only received the saline diluent; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: patient was given saline diluent only) and inappropriate dose of vaccine administered (Verbatim: only received the saline diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 17-MAR-2025 The reporter reported that patient received only received the saline diluent. The patient received only adjuvant of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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: 21-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that the reporter husband had shingles, got the vaccine and got them again, terrible pain. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles and 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, VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I got shingles a year after I had the shingles vaccine; second one made the patient ill for 2 months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got shingles a year after I had the shingles vaccine) and unwell (Verbatim: second one made the patient ill for 2 months). The outcome of the vaccination failure and shingles were not reported and the outcome of the unwell was resolved (duration 2 months).   It was unknown if the reporter considered the vaccination failure, shingles and unwell to be related to Shingles vaccine. 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 and Shingles vaccine. It was unknown if the company considered the shingles and unwell to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2025 and 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient got shingles a year after he/she had the Shingles vaccine. The patient said yes he/she did and the second one made the patient ill for 2 months. This case was considered as suspected vaccination failure since the details regarding the 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  details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got the Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got the 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: 20-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she got the shingles vaccines and still got the shingles although it was painful and had a mild case with no nerve pain or scarring . This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: accidentally gave him your hepatitis B vaccine, 0 months to 19 years and he needed the 19 years and up; accidentally gave him your hepatitis B vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 64-year-old male patient who received HBV (Engerix B pediatric) (batch number K45H7) for prophylaxis.   On 17-MAR-2025, the patient received the 1st dose of Engerix B pediatric. On 17-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: accidentally gave him your hepatitis B vaccine, 0 months to 19 years and he needed the 19 years and up) and accidental underdose (Verbatim: accidentally gave him your hepatitis B vaccine). The outcome of the adult use of a child product and accidental underdose 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: 17-MAR-2025 The certified Medical assistant reported that patient had a 64 years old, male here in the office at the day of reporting and had accidentally gave him hepatitis B vaccine, 0 months to 19 years and he needed the 19 years and up, which led to adult use of a child product and accidental underdose. He came on Friday for something else and just wondering if it was okay to give him the adult hepatitis B vaccination on Friday or had to wait certain amount of time in between mess up and the correction.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Joint swelling, Muscular weakness, Myalgia
Clinical narrative: Pain in knees; Swelling of knees; Muscle pain; swelling of the ankles; weakness in legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a 81-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On 24-SEP-2024, the patient received Arexvy (intramuscular). On 24-SEP-2024, less than a day after receiving Arexvy, the patient experienced swelling of knees (Verbatim: Swelling of knees), muscle pain (Verbatim: Muscle pain), ankle swelling (Verbatim: swelling of the ankles) and lower extremities weakness of (Verbatim: weakness in legs). On an unknown date, the patient experienced knee pain (Verbatim: Pain in knees). The outcome of the swelling of knees, muscle pain, ankle swelling and lower extremities weakness of were not resolved and the outcome of the knee pain was unknown.   It was unknown if the reporter considered the swelling of knees, muscle pain, ankle swelling, lower extremities weakness of and knee pain to be related to Arexvy.     It was unknown if the company considered the swelling of knees, muscle pain, ankle swelling, lower extremities weakness of and knee pain to be related to Arexvy.   Additional Information: GSK receipt date: 17-MAR-2025 Consumer stated he received an RSV shot in Sept 2024 from Pharmacy. Reporter was unable to verify if he received Arexvy, just stated it was an RSV vaccine. This vaccine was administered in left arm as he recalled. Consumer asked questions in regards to his symptoms for swelling of the knees and ankles, weakness in knees and muscle pain and how long will it last. Consumer stated that he saw in the advertisement on tv that muscle pain and pains all over are side effects of the vaccine. He stated that he had a lot of muscle pain after 6 months of receiving it. He has had a lot of pain in the knees, weakness in knees, and a lot of swelling in the legs. The pain started about 2 days after the injection. He had to use both hands to get up from the chair because of the weakness in his knees. He went to the emergency room about a week or so after receiving the shot  and they could not tell him what the problem could be. The pain and swelling were not as bad as the first few days, he still had some swelling in his legs. His doctor prescribed water pills and they didn't helped him much, it helped a little with the swelling. This case is linked with US2023000765 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090108:same reporter US-GSK-US2023000765:same reporter
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 and a half year old patient received a Kinrix vaccine; 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 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   Previously administered products included Pediarix (received a dose on 02-MAY-2023).   On 10-MAR-2025, the patient received Kinrix. On 10-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 and a half year old patient received a Kinrix vaccine). 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: 18-MAR-2025 The nurse mentioned that a 2 and a half year old patient received a Kinrix vaccine on 10th March 2025 which led to inappropriate age at vaccine administration. The patient got a Vaxelis vaccine on 20th March 2024 and Pediarix on 2nd May 2023.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: I was a little fluish; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (I was a little fluish) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (I was a little fluish). At the time of the report, INFLUENZA (I was a little fluish) outcome was unknown.      The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   No concomitant medications were reported.  The patient did not experience any reactions, except for the very first dose, she was little fluish.  No treatment medications were reported.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: got covid; got covid; This is a spontaneous report received from a Consumer or other non HCP.  A female patient in her 70's received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in right arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Arth." (ongoing), notes: Onset date: Child, bad in hands, hurts to write. The patient took concomitant medication within 2 weeks prior to the event onset. The patient didn't received other vaccines on the same date as the Pfizer vaccine. Vaccination history included: Flu shot, for immunization, reaction(s): "allergic", "sick/flu". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "got covid".Clinical details: Every covid shot patient received, she got covid. Extremely tired- fever 102 degree - body aches, can't breath properly - headache. The patient refused to get the flu shot & covid -vacs because she got so sick from them. So sick for 3 to 4 days each time. No culture performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500017839 Same patient/Vaccine, different event, different vaccine dose;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time; Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in right arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 15Oct2021 as dose 3, (booster) single (Lot number: 30155BA) and on 26May2022 as dose 4 (booster), single (Lot number: FN19992) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Arth" (ongoing), notes: Onset date: Child; So bad in hands, hurts to write. The patient took concomitant medications. The patient didn't receive any other vaccines on the same date as the Pfizer vaccine. Vaccination history included: Flu shot, for Immunization, reaction(s): "allergic", "Flu/ sick". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time". The patient underwent the following laboratory tests and procedures: Body temperature: 102, notes: fever 102 degree centigrade. Clinical course: she has had Covid-19 for 4x's, every covid shot she received, she got Covid. Extremely tired, fever 102 degree centigrade, body aches, can't breath properly, headache. She refused to get the flu shot & covid -vaccines because she get so sick from them, she was so sick for 3 to 4 days each time.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500017839 Same patient/Vaccine, different event, different vaccine dose;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiomegaly
Clinical narrative: Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time; Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in right arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 15Oct2021 as dose 3, (booster) single (Lot number: 30155BA) and on 26May2022 as dose 4 (booster), single (Lot number: FN19992) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Arth" (ongoing), notes: Onset date: Child; So bad in hands, hurts to write. The patient took concomitant medications. The patient didn't receive any other vaccines on the same date as the Pfizer vaccine. Vaccination history included: Flu shot, for Immunization, reaction(s): "allergic", "Flu/ sick". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time". The patient underwent the following laboratory tests and procedures: Body temperature: 102, notes: fever 102 degree centigrade. Clinical course: she has had Covid-19 for 4x's, every covid shot she received, she got Covid. Extremely tired, fever 102 degree centigrade, body aches, can't breath properly, headache. She refused to get the flu shot & covid -vaccines because she get so sick from them, she was so sick for 3 to 4 days each time.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500017839 Same patient/Vaccine, different event, different vaccine dose;
Sex: F
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: got really tired; Is the patient allergic: RSV vac. Got really tired; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Illness: Arth (arthritis)" (unspecified if ongoing), notes: Onset date: Child. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (I get the flu), for immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "got really tired"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Is the patient allergic: RSV vac. Got really tired".  Additional information: The patient got really tired d slept for 2 days. But did not get sick.  The information on the batch/lot number for RSV VACCINE PROT.SUBUNIT PREF 2V will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old female 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2025, outcome "unknown" and all described as "COVID positive". Clinical course: The patient has been having fever then cough for the past 3,4 days Uh, today (24Mar2025), no past 2 days. And today (24Mar2025), patient got tested, and was COVID positive. Last time when patient had COVID, had to admit to the ICU because it went really serious. This time, even though she was fully vaccinated, she was still having a lot of symptoms. Her doctor prescribed Paxlovid. That was the time when COVID first came, and she had only the first shot. So, when the COVID came, right. The first time, so it was two shots, she only got one shot. And before she got her second shot, she got infected. And she had to be in ICU for like a week. And so, she reacted very badly with COVID. Even though she was fully vaccinated, so that's why she wanted to get the medication.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old female 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2025, outcome "unknown" and all described as "COVID positive". Clinical course: The patient has been having fever then cough for the past 3,4 days Uh, today (24Mar2025), no past 2 days. And today (24Mar2025), patient got tested, and was COVID positive. Last time when patient had COVID, had to admit to the ICU because it went really serious. This time, even though she was fully vaccinated, she was still having a lot of symptoms. Her doctor prescribed Paxlovid. That was the time when COVID first came, and she had only the first shot. So, when the COVID came, right. The first time, so it was two shots, she only got one shot. And before she got her second shot, she got infected. And she had to be in ICU for like a week. And so, she reacted very badly with COVID. Even though she was fully vaccinated, so that's why she wanted to get the medication.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid; Covid; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 01May2024, this case now contains all required information to be considered valid.   This is a spontaneous report and received from Consumer or other non HCPs, Program ID. An 89-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immobile" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: During an inbound call for financial assistance, the caller states, "I have COVID and I am supposed to be on this new medication. I'm in assisted living." When advised that the processing information can be provided to the pharmacy over the phone or in person, the caller responds "Well I'm immobile. " At the end of the call, the caller states" Covid has really thrown me for a loop because this is the second time I've had it, and I've had three shots, all Pfizer and it's just that, I don't know I never have any symptoms all I know is that test procedure's great". Patient was treated with Paxlovid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: was itching like crazy / Legs, arms, back, feet, hands, etc.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: PRURITUS (non-serious), outcome "unknown", described as "was itching like crazy / Legs, arms, back, feet, hands, etc.". Therapeutic measures were taken as a result of pruritus. Additional information: When patient got the covid shot, patient was itching like crazy and the people came and checked on the patient because the patient couldn't stop itching and they wanted to call the rescue squad. The patient thought it would pass but months later, patient was told that some anti itching cream would be sent to the patient but never sent anything. Patient had to buy 4% lidocaine spray and cream and put it on when the patient wake up and during and at night before going to bed. It was horrible. Legs, arms, back, feet, hands, etc.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.