chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: Patient received Tdap vaccine (Boostrix) in right deltoid muscle on 4/8/2025. Pt called pharmacy on 5/19 (44 days later) to report that she was still having muscular pain. Said her arm did not bruise but recalls some swelling after the injection. Did not report joint pain in shoulder, just muscular pain.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Feeling hot, Headache, Nausea
Clinical narrative: Employee reported warmness, headache, and nausea 4 minutes after receiving Hep-B vaccination ( 1:07 pm).  He reported feeling better by 1:50pm with no treatment.
Age: 31.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Arthralgia
Clinical narrative: Patient reported approximately 2 weeks after vaccines were given that she experienced shoulder pain.  She states she felt this pain 2 days after the vaccines but did not report it until about 2 weeks later.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Mass
Clinical narrative: redness with a bump
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: hive with erythema to the injection site
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Dyspnoea, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal
Clinical narrative: I had no pre existing conditions. Around 8/30/2023 I began having shortness of breath and using my Smart Watch it showed me in A-fib. I messaged my doctors office and they called me immediately to set up an appointment. I had an ECG and it confirmed/diagnosed Atrial Fibrillation. I was set up with a Cardiologist at the Hospital on 8/31/23 and wore a Holter Monitor for a week which saw me in and out of A-fib. I was sent to Electrophysiologist at the Hospital for appt 1/10/2024 and told I needed an Ablation to correct it. I had the Ablation procedure 10/3/2024. I have all paperwork associated if needed. The procedure fixed most of the Afib but I still have residual afib according to my Smart Watch
Age: 1.42
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gave dose 2 of Hepatitis A too early.  Previous dose given 1/20/2025, was not due until 6/20/2025, but was accidently given on 4/14/2025.
Age: 65.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Fatigue, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: 9-12-2023: After returning from the Dr. office where I received the vaccine, I felt very fatigued and took a nap. I was awakened by severe pain in my right arm and realized my right arm was completely numb and I was unable to move it. I took scheduled doses of ibuprofen, using ice/heat on my arm while having to keep it close to my right side to lessen the pain. The pain went down to my fingers and up to the right side of me neck. After hard night of trying to rest, on 9/13/2023 I contacted PCP's office with my symptoms, treatment I had done, and current status of right arm; elbow down was somewhat better, upper arm was still restrictive/painful. The response said I was doing all I could-going to take time. After much time my right arm became less restrictive, allowing cautious use, but intermittent pain in the bicep of arm and the area where shoulder meets the deltoid part of arm. At 4/2024 appt. with PCP, I discussed this. PCP showed me an excersise to use on my arm, which I did. At 11/2024 appt. with PCP, I discussed the continued symptoms from the 4/2024 visit I was still having. PCP sent referral for Physical Therapy. Received 9 PT treatments with some improvement esp. with bicep. Currently, I have intermittent pain/soreness in right bicep again with shoulder/deltoid area intermittently "catching and popping".
Age: 65.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: 9-12-2023: After returning from the Dr. office where I received the vaccine, I felt very fatigued and took a nap. I was awakened by severe pain in my right arm and realized my right arm was completely numb and I was unable to move it. I took scheduled doses of ibuprofen, using ice/heat on my arm while having to keep it close to my right side to lessen the pain. The pain went down to my fingers and up to the right side of me neck. After hard night of trying to rest, on 9/13/2023 I contacted PCP's office with my symptoms, treatment I had done, and current status of right arm; elbow down was somewhat better, upper arm was still restrictive/painful. The response said I was doing all I could-going to take time. After much time my right arm became less restrictive, allowing cautious use, but intermittent pain in the bicep of arm and the area where shoulder meets the deltoid part of arm. At 4/2024 appt. with PCP, I discussed this. PCP showed me an excersise to use on my arm, which I did. At 11/2024 appt. with PCP, I discussed the continued symptoms from the 4/2024 visit I was still having. PCP sent referral for Physical Therapy. Received 9 PT treatments with some improvement esp. with bicep. Currently, I have intermittent pain/soreness in right bicep again with shoulder/deltoid area intermittently "catching and popping".
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Consumer calling to report that they did not receive their 2nd and 3rd dose of GARDASIL 9. Patient did not report any side effects. Permission to contact HCP was not given. No Additional AE/ No PQC; No adverse event; This spontaneous report was received from a patient  of unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), administered by intravenous route (dose, anatomical location, lot # and expiration date were not reported) as HPV vaccine.  It was reported that the patient did not receive their 2nd and 3rd dose of the suspect vaccine (incomplete course of vaccination). In addition, the patient did not report any side effects.   Additional information is not expected.
Vaccine: RV5
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No adverse event; Nurse reported that near the "neck or side" of the ROTATEQ ODT, the solution "shot out" from a tiny hole while administering the vaccine to a child.; Nurse reported that near the "neck or side" of the ROTATEQ ODT, the solution "shot out" from a tiny hole while administering the vaccine to a child.  The previous 9 tubes did not have any issues.  The product was discarded so it can not be returned a; This spontaneous report was received from a nurse and refers to a Child patient of unknown gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 29-APR-2025, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (valid lot #2096663, expiration date reported and confirmed as 17-MAY-2026; exact dose not provided) administered by oral route as prophylaxis. On that same day, the nurse reported that near the "neck or side" of the suspect vaccine ODT, the solution "shot out" from a tiny hole while administering the vaccine to a child (syringe issue / accidental underdose). The previous 9 tubes did not have any issues. The product was discarded so it could not be returned. No adverse event reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site discharge
Clinical narrative: The patient did not complain about the injection or any other issues.; The pharmacist is unsure if the problem was the prefilled Gardasil 9 syringe or something else but a significant amount of the medication came out of the injection site.; significant amount of the medication came out of the injection site; Does the syringe have a broken component? YES; The cap came off of the the syringe prior to administration and the pharmacist needed to put the cap and the syringe in the sharps container/LUER LOCK DETACHED; This spontaneous report was received from a Pharmacist and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant therapies were not provided.   On 26-APR-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9), administered by intramuscular route in the left arm for prophylaxis (lot # and expiration date were not reported). The pharmacist was unsure if the problem was the prefilled Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) or something else, but a significant amount of the medication came out of the injection site (Accidental underdose); it leaked from the same location, also potentially due to a luer lock breakage during administration, however HCP could not confirm the exact malfunction (Syringe issue, Poor quality device used). The patient did not complain about the injection or any other issues (No adverse event). The pharmacist also stated that another prefilled syringe of the suspect vaccine from the same box had an issue, but was not administered to a patient; the luer lock fell off and became detached from the rest of the syringe/ the cap came off of the syringe prior to administration and the pharmacist needed to put the cap and the syringe in the sharps container (Device connection issue). The syringe carton was not damaged prior to use. The syringe tray was intact and undamaged on receipt. Products and pictures were not available. At the reporting time, the outcome of the events was not known. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported but established as not applicable.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC20, UNK
Symptoms: Product storage error
Clinical narrative: No AE; vaccine storage issue; This spontaneous report was received from a nurse practitioner and refers to a 12-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 31-Mar-2025, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y007178, expiration date: 07-Nov-2026), the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y014440, expiration date: 22-Feb-2026) reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported), the first dose of Hepatitis A vaccine) (lot# DN273, expiration date: 28-Aug-2026) and the third dose of Pneumococcal vaccine conj 20v (CRM197) (lot# LK6653, expiration date: 30-Jun-2026) all administered by intramuscular route for prophylaxis.  On 09-Apr-2025, at compliance visit, upon review by state, temperature excursion was noted from 03-Mar-2025 to 10-Mar-2025 (product storage error). Upon further investigation and review by the DDL manufacturer, it was noted as a "glitch" "most likely caused by an electronical interference". The VFC program advised revaccination and that process was currently in progress with the patients involved. No adverse event was reported.  This is one of several cases from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :, Index date : 2025-05-14 , MNSC number : 02785949 , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Cough, Morbillivirus test positive, Pyrexia, Rash
Clinical narrative: patient they had recently vaccinated with MMR II tested positive for measles.; This spontaneous report was received from a Physician and refers to currently 1-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 29-APR-2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, lot #Y015995, expiration date was not reported, but upon internal validation was established as 24-SEP-2026, diluted with sterile diluent (MERCK STERILE DILUENT) (Lot #, expiration date, dose, frequency were not reported) administered subcutaneously for Prophylaxis.  In 2025, the patient presented symptoms like rash, cough and high fever. The patient was seen in an emergency room and tested positive for measles. The patient was not admitted to the hospital.  At the reporting time, the outcome event was unknown. An epidemiologist reported that was the third case reported from this lot number.   The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was unknown.  This is one of several cases from the same reporter.; Reporter's Comments: Keywords : MUL
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects/symptoms reported; HCP called to report a patient received pediatric VAQTA that expired on 5/17/2025 and was administered on 5/19/2025.; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 19-May-2025, the patient was vaccinated with pediatric Hepatitis A Vaccine, Inactivated (VAQTA), (expiration date: 17-May-2025) (dose, strength, route, lot # were not reported) for prophylaxis (expired product administered). Expired Hepatitis A Vaccine, Inactivated (VAQTA) dose was supported by post expiry memo. No side effects/symptoms reported (no adverse event).   Lot# is being requested and will be submitted if received.
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: serious bruise; This serious case was reported by a consumer via interactive digital media and described the occurrence of contusion in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced contusion (Verbatim: serious bruise) (serious criteria other: Serious as per reporter). The outcome of the contusion was not resolved.   It was unknown if the reporter considered the contusion to be related to Shingrix.     The company considered the contusion to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2025 This case was reported by the reporter via (Pharmacy Shingrix Program) interactive digital media. The reporter stated patient still have a serious bruise on his/her arm from the 1st Shingrix shot he/she received from.  The patient would be going elsewhere for his/her 2nd shot.; Sender's Comments: Contusion is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Parkinsonism
Clinical narrative: some man who got Parkinson like symptoms from his Shingles It developed within two daysof the but he died 3 years later.; I took care of some man who got Parkinson like symptoms from his Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: some man who got Parkinson like symptoms from his Shingles It developed within two daysof the but he died 3 years later.) (serious criteria death and GSK medically significant) and parkinsonism (Verbatim: I took care of some man who got Parkinson like symptoms from his Shingles) (serious criteria GSK medically significant). The outcome of the parkinsonism was not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death and parkinsonism to be related to Shingles vaccine.     The company considered the unknown cause of death and parkinsonism to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 15-MAY-2025 This case was reported by a consumer via interactive digital media. The reporter reported that we all had it latent in our bodies Vitamins A and C and boosting immunity helped prevent severe cases. The reporter reported that he/she took care of some man who developed Parkinson-like symptoms from his shingles vaccine. The symptoms appeared within two days of the vaccine, and he passed away three years later. The reporter had advised if someone had the (MTHFR) methylenetetrahydrofolate reductase gene, they were more likely to have vaccine reactions.; Sender's Comments: Death and Parkinsonism are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine US-GSK-US2025AMR062976:Same Patient/ Different reporter; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: She has not yet had the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in MAR-2023).   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: She has not yet had the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 19-MAY-2025 The patient received her first Shingrix dose and she has not yet had the second dose, which led to an incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles/ a rashon her right buttock; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose on an unknown date and 2 days after dose, she experienced a rash on her right buttock that was diagnosed as shingles, refer case US2025060452). Concurrent medical conditions included blood cholesterol increased and blood pressure high. Concomitant products included atenolol, losartan, simvastatin and acetylsalicylic acid (Aspirin).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles/ a rashon her right buttock). The patient was treated with calamine and aciclovir sodium (Acyclovir). Rechallenge with Shingrix was positive. The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Linked case(s) involving the same patient:  US2025060452   Additional Information: GSK receipt date: 15-MAY-2025  The reporter was the patient who received 2 doses of Shingrix last year.  2 days after each dose, she experienced a rash on her right buttock that was diagnosed as shingles.  It was the size of a silver dollar and in both instances, the rash was in the same spot.  It did not get bigger or spread.  Her doctor prescribed acyclovir 400 mg and the rash went away after 1 or 2 weeks.  She also applied calamine lotion to the rash in addition to taking acyclovir. One day prior to the reporting date, she saw redness in the same spot and on the day of reporting, the rash reappeared on her right buttock.; Sender's Comments:  US-GSK-US2025060452:same patient/Dose 1
Vaccine: RVX
Symptoms: Cough, Influenza, Lacrimation increased, Oropharyngeal pain, Pain
Clinical narrative: flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza 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 influenza (Verbatim: flu). The outcome of the influenza was not reported.   It was unknown if the reporter considered the influenza to be related to RSV vaccine.     It was unknown if the company considered the influenza to be related to RSV vaccine.   Additional Information: GSK receipt date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The patient had been coughing for months and initially blamed it on pollen. Then the cough worsened, and his/her eyes and nose started running. He/she developed a sore throat, along with body aches and pain. He/she was planning to see the doctor in the morning (On the day of reporting). He/she had already received an RSV shot but was worried that it might have been the flu.
Vaccine: RVX
Symptoms: Rhinorrhoea
Clinical narrative: flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza 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 influenza (Verbatim: flu). The outcome of the influenza was not reported.   It was unknown if the reporter considered the influenza to be related to RSV vaccine.     It was unknown if the company considered the influenza to be related to RSV vaccine.   Additional Information: GSK receipt date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The patient had been coughing for months and initially blamed it on pollen. Then the cough worsened, and his/her eyes and nose started running. He/she developed a sore throat, along with body aches and pain. He/she was planning to see the doctor in the morning (On the day of reporting). He/she had already received an RSV shot but was worried that it might have been the flu.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: been over six months since my first shot of shingrix; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose over six 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: been over six months since my first shot of shingrix). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 18-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient mentioned that it has been over six months since his/her first shot of Shingrix vaccine which led to incomplete course of vaccination. The patient enquired if is was too late to get the second dose of Shingrix vaccine.
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Took the shot when I first saw the blisters and have had the 2nd shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug use for unapproved indication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash, pain (Then the wrap around pain on the left side of my thorax was unbearable as well), pruritus (internal itching on the left side of my thorax), breast pain (I still feel it in my breast), skin pain (skin is very tender), nerve pain (Deep nerve pain starting in the armpit), breast lump (5 clusters on the left breast), knee replacement (I've had 2 knee replacements), cesarean section (I've had 2 knee replacements and 2 cesarean) and shingles (in July 2024 had shingles).   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 drug use for unapproved indication (Verbatim: Took the shot when I first saw the blisters and have had the 2nd shot). The patient was treated with pregabalin (Lyrica). The outcome of the drug use for unapproved indication was not applicable.   Additional Information: GSK receipt date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that it was meant to take out the nerve pain so at least she/he could sleep again. He had it in July 2024 it ran from deep in his/her armpit across his/her left breast and gave him/her five clusters on the left breast. Initially, he/she thought he/she was having a heart attack because of the intense, deep feeling he/she was experiencing. By morning, he/she had developed a rash. That rash felt like somebody had dragged me on a gravel road behind a truck. Then the wrap-around pain and internal itching on the left side of my thorax became unbearable as well. He/she still felt it in his/her breast, and his/her skin remained very tender at times, with the internal itching still present. He/she had not been vaccinated in time. He/she took the shot when he/she first saw the blisters and later received the second shot. The pain would take his/her breath away. It used to wake him/her up screaming in pain. His/her physician prescribed Lyrica, which helped tremendously. It was prescribed for shingles. The pain without Lyrica was the worst he/she had ever been through and he/she had undergone two knee replacements and two cesarean sections. He/she could only imagine what people went through before treatments like this existed.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; i got shingles after taking vaccine; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i got shingles after taking vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   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: 17-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got shingles after taking the Shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles  were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about   primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: eczema outbreak; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of eczema 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 eczema (Verbatim: eczema outbreak). The outcome of the eczema was not reported.   The reporter considered the eczema to be related to Shingles vaccine.     The company considered the eczema to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAY-2025 This case was reported by a patient via interactive digital media. The patient said that don't do it (don't do the vaccine). He/she still blame his/her eczema outbreak on it.
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; just got Shingles Mild on top of  my head; 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 VARICELLA ZOSTER VACCINE for prophylaxis and VARICELLA ZOSTER VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine, the 2nd dose of VARICELLA ZOSTER VACCINE and the 1st dose of VARICELLA ZOSTER VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, VARICELLA ZOSTER VACCINE and VARICELLA ZOSTER VACCINE, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: just got Shingles Mild on top of  my head). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The patient got 2 shot in 2019 and improved version in 2023. The patient got Shingles mild on top of the head. The doctor said that it would have been worse if he/she would not vaccinated. It was reported as ten percent patients could get even vaccinated. The reporter was one of them. It was unknown if the reporter considered the vaccination failure and shingles to be related to Varicella zoster vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to Shingles vaccine.
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles/itching, burning, and the worst agonizing pain; 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/itching, burning, and the worst agonizing pain). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAY-2025 This case was reported by the patient via interactive digital media. The patient got the Shingles vaccine, but he/she still got shingles, and now he/she had this terrible itching, burning and the worst agonizing pain ever had.  The patient would not wish shingles on his/her enemies if he/she had any. 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.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles again anyway; 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.   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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles again anyway). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The patient got shingles and then got the shot and got shingles again anyways. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 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: 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: 18-MAY-2025 This case was reported by a patient via interactive digital media. Patient got the vaccine and still got the shingles and stated it was horrible. 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: F
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: feeling unwell; chills; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pulmonary embolism. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   In JAN-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: feeling unwell) and chills (Verbatim: chills). The outcome of the feeling unwell and chills were resolved (duration 1 day).   It was unknown if the reporter considered the feeling unwell and chills to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell and chills to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAY-2025 The patient reported that the start of xeljanz 5 mg tablet by mouth twice daily, many years, at least 10 years, est 2015, for rheumatoid arthritis. The patient reported in 2015 was diagnosed with a pulmonary embolism, she was unable to recall if this was before or after start of xeljanz therapy, no further occurrences, md aware, first dose of shingles vaccine given in January 2025 (after start of therapy), exact date unknown, after vaccine one evening if chills, not feeling well, resolved by next day, patient reports taking her xeljanz during this time, unknown if md aware, advised to update.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: severe headache (it resolved with Tylenol); She also complained of arm soreness.; This non-serious case was reported by a nurse via sales rep and described the occurrence of headache in a adult 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 headache (Verbatim: severe headache (it resolved with Tylenol)) and pain in arm (Verbatim: She also complained of arm soreness.). The patient was treated with paracetamol (Tylenol). The outcome of the headache was resolved and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the headache and pain in arm to be related to Shingrix.     It was unknown if the company considered the headache and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAY-2025 The patient was approximately 55 years old The nurse reported that she took Shingrix herself and she developed a severe headache (it resolved with Tylenol).  She also complained of arm soreness.
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: He reported experiencing chills about 6 hours after both doses of Shingrix; This non-serious case was reported by a nurse via sales rep and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced chills (Verbatim: He reported experiencing chills about 6 hours after both doses of Shingrix). Rechallenge with Shingrix was positive. The outcome of the chills was not reported.   It was unknown if the reporter considered the chills to be related to Shingrix.     It was unknown if the company considered the chills to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR063168   Additional Information: GSK Receipt Date: 20-MAY-2025 The patient experiencing chills about 6 hours after both doses of Shingrix.; Sender's Comments:  US-GSK-US2025AMR063168:Same patient/another dose
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: He reported experiencing chills about 6 hours after both doses of Shingrix.; This non-serious case was reported by a nurse via sales rep and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced chills (Verbatim: He reported experiencing chills about 6 hours after both doses of Shingrix.). The outcome of the chills was not reported.   It was unknown if the reporter considered the chills to be related to Shingrix.     It was unknown if the company considered the chills to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR063165   Additional Information: GSK Receipt Date: 20-MAY-2025 The reporter reported that the patient took both doses of Shingrix.  He reported experiencing chills about 6 hours after both doses of Shingrix. This case is linked with US2025AMR063165, reported by same reporter.
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9°F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 44TR9) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9°F as the minimum reached). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 The registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported of 29.9 degree Fahrenheit as the lowest reached for these products that were administered to a patient which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter.; Sender's Comments:  US-GSK-US2025061537:same reporter US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9 degree Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) and (batch number 44TR9) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree Fahrenheit). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 The nurse asked the recommendations after giving several vaccines that were exposed to a temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Arexvy. The Vaccine Administration Facility was the same as Primary Reporter; Sender's Comments:  US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached). The outcome of the incorrect storage of drug 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: 15-MAY-2025 The Vaccine Administration Facility was the same as Primary Reporter A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Boostrix, which led to incorrect storage of vaccine. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2025061548:SAME REPORTER US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: administration after a below temperature excursion of 29.9 degree F as the minimum reached). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Shingrix, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061547:Same patient,different suspect US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient