chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: FLU4, PNC20, RSV
Symptoms: Chills, Discomfort, Feeling abnormal, Impaired work ability, Nausea
Clinical narrative: HORRIBLE BODY ACHES,   FEVER 102 (CONCURRENT ALTERNATING THERAPY TYLENOL AND IBUPROFEN) SHIVERS, NAUSEA, NIGHT SWEATS, CANT GO TO WORK NEXT DAY,, PATIENT CAME IN THE PHARMACY TO TELL US HOW HORRIBLE SHE FEELS AND CANT GO TO WORK AND IS GOING BACK HOME, AND INSISTED WE FILL OUT THIS REPORT. I (RPH) EXPLAINED THIS WAS NOT UNCOMMON REACTION TO RECEIVING 3 VACCINES AND THIS IS MOST LIKELY THE PEAK OF HER DISCOMFORT. SHE SAID SHE IS GOING HOME.
Age: 63.0
Sex: F
Vaccine: FLU4, PNC20, RSV
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: HORRIBLE BODY ACHES,   FEVER 102 (CONCURRENT ALTERNATING THERAPY TYLENOL AND IBUPROFEN) SHIVERS, NAUSEA, NIGHT SWEATS, CANT GO TO WORK NEXT DAY,, PATIENT CAME IN THE PHARMACY TO TELL US HOW HORRIBLE SHE FEELS AND CANT GO TO WORK AND IS GOING BACK HOME, AND INSISTED WE FILL OUT THIS REPORT. I (RPH) EXPLAINED THIS WAS NOT UNCOMMON REACTION TO RECEIVING 3 VACCINES AND THIS IS MOST LIKELY THE PEAK OF HER DISCOMFORT. SHE SAID SHE IS GOING HOME.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Cold sweat, Depressed level of consciousness, Hyperhidrosis, Hypotonia, Unresponsive to stimuli
Clinical narrative: Diaphoretic, clammy, unresponsive for brief time, loss of muscle tone- occurred approximately 5 minutes post vaccination.  Patient verbalized history of "passing out" with vaccines in the past.  Blood pressure 102/64, HR 90, O2 98%.  Assisted to floor with feet elevated and cool packs applied to forehead, neck and wrists.  Slowly became more alert within minutes.  Parent notified of incident as this occurred at a school-based flu vaccine clinic.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Feeling hot, Injection site reaction, Pain, Swelling
Clinical narrative: injection site reaction, pain , swelling, heat
Age: 60.0
Sex: F
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Blister, Bone disorder, Chills, Feeling abnormal, Headache
Clinical narrative: so after injection on the left arm, it bled. Then Thursday morning she woke up and didn't feel right and by thur afternoon fever started lowe grade and then by 4pm it shot up to 103.6 degrees and at that time the patient had a massive headache, body aches, bones felt like cracking and chills, patient developed a huge not on left arm and each day the knot got bigger and bigger. cool and warm compress made left arm worse. pt took covid test and it was negative.  right now it is blistery on top and knot at bottom of blister
Age: 60.0
Sex: F
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Injection site haemorrhage, Pain, Peripheral swelling, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: so after injection on the left arm, it bled. Then Thursday morning she woke up and didn't feel right and by thur afternoon fever started lowe grade and then by 4pm it shot up to 103.6 degrees and at that time the patient had a massive headache, body aches, bones felt like cracking and chills, patient developed a huge not on left arm and each day the knot got bigger and bigger. cool and warm compress made left arm worse. pt took covid test and it was negative.  right now it is blistery on top and knot at bottom of blister
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE.; GARDASIL 9 given during a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 01-SEP-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, one time, lot #w029724, expiration date: 08-JAN-2025, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) which temperature excursion occurred. No further adverse event (AE). Temperature excursion occurred on 02-AUG-2023 and 04-AUG-2023.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No related effects; HCBP calling to report AE on 3 patients that received dose of VARIVAX after short dated from previous excursion.  No related effects noted. Caller states initial TE completed on line- 47-77 F for 1 Hour 22 Minutes. Eval ID # C19FB14 Original Exp. dat; new short date exp. date 7/19/2023.; This spontaneous report was received from a Non-Medical Healthcare Worker referring to a 4-year-old patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 30-AUG-2023, the patient was vaccinated varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, lot #W031815, expiration date: 05-OCT-2024 which new short date expiration date 7/19/2023, administered for prophylaxis (expired product administered ) (strength, dose, and route of administration were not provided). Reporter reported that temperature excursion completed on line- 47-77 F for 1 Hour 22 Minutes (product storage error). No related effects noted.
Sex: F
Vaccine: PNC15
Symptoms: Poor quality device used, Syringe issue
Clinical narrative: No injuries to Nurse or patient reported.; when the Nurse went to push the last bit of product into the patient the syringe broke into 2 pieces at the Luer Lock/Hub area; when the Nurse went to push the last bit of product into the patient the syringe broke into 2 pieces at the Luer Lock/Hub area; the patient did not receive a full dose; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 12-SEP-2023, the patient was vaccinated with a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) for prophylaxis (lot # X004289 has been verified to be a valid lot number, expiration date reported as unknown, but upon internal validation established as 10-DEC-2024; strength and route of administration were not reported), administered by a nurse who is an experienced repeat user. There was no defect or damage noted prior to the vaccination. However, when the nurse was pushing plunger to give the last bit of the vaccine to the patient, the syringe completely broke off into 2 pieces at the Luer lock/hub area, and the needle and Luer lock fell to the table (also reported that the broken portion landed on the bed next to the patient) (syringe issue, poor quality device used). The patient did not receive a full dose (should be vaccinated with a dose of 0.5 mL) (incorrect dose administered). The nurse and the patient were not injured (no adverse event). The product was disposed of in the biohazard box on the same day, so the syringe was not available for retrieval.  Follow-up information was received from the pharmacist on 21-SEP-2023. The patient's information was updated who was a female. The information of her medical doctor (MD) was provided. The expiration date of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) was reported as 10-DEC-2024, same as internal validation. It was confirmed that only 1 syringe was affected.  This case was previously considered as non-valid due to lack of patient identifiers, but upon receipt of follow-up it was determined to be valid.
Sex: U
Vaccine: RV1, RV5
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: No AE reported; Caller reports child received ROTATEQ on 3/21/2023, 7/12/2023 and ROTARIX on 9/19/2023.  No other information provided.  No additional AEs or PQC reported.; Caller reports child received ROTATEQ on 3/21/2023, 7/12/2023 and ROTARIX on 9/19/2023.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report has been received from a medical assistant concerning a child of unknown age and gender..  The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 21-MAR-2023, the patient was vaccinated with the first dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, taken orally for prophylaxis (strength, lot #, and expiry date were not provided); and on 12-JUL-2023, the patient received the second dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ( Inappropriate schedule of vaccine administered).   Then on 19-SEP-2023, the patient received the third dose of rotavirus vaccine live oral 1v (ROTARIX), (interchange of vaccine products) taken orally for prophylaxis (strength, formulation, lot #, and expiry date were not provided). No adverse events reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who was administered improperly stored PROQUAD. No symptoms reported. Obtained consent to contact HCP. TE Filed (Case #02476362). No additional AE/PQC. Product Name: PROQUAD-- SUPPORTED Lot: X014622 Exp: 11/1; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 15-SEP-2023 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X014622 and expiration date 18-NOV-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product storage error and no adverse event). The temperature excursion lasted for 4 Hours 15 Minutes 0 Seconds in temperature -14 Celsius degrees (°C) up to-10°C and for 7 Hours 45 Minutes 0 Seconds in -8.33C / -10°C up to 8°. Total duration was 12 hours.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported.; patient who was administered improperly stored VARIVAX.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-SEP-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/dose, lot #W031813, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -14 Celsius degrees (C) up to -10 C for 4 hours and 15 minutes, -8.33 C / -10 C up to 8 C for 7 hours and 45 minutes, total duration: 12 Hours.  No symptoms reported (no adverse event).
Sex: U
Vaccine: TYP
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: COVID; Postponed taking the oral typhoid capsule; A spontaneous report was received from a nurse practitioner on 15SEP2023 regarding a patient of unknown age and gender who had "COVID" (PT: COVID-19) and "postponed taking the oral typhoid capsule" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 07SEP2023, the patient took the first dose of Vivotif. Reportedly, the patient had COVID, hence postponed taking the second dose and took the dose on 15SEP2023.  The outcome of the event "COVID" was unknown at the time of this report while it was not applicable for "postponed taking the oral typhoid capsule".  The action taken with Vivotif with respect to the event "COVID" was dose interrupted and for event "postponed taking the oral typhoid capsule" it was not applicable.  No additional information was reported.  Company comment: It was reported that a patient received Vivotif and had COVID (COVID-19) due to which the patient postponed taking the oral typhoid capsule (inappropriate schedule of product administration). Considering the limited case information, the role of Vivotif  cannot be ruled out and the causality of COVID-19 is assessed as possible. Furthermore the causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient received Vivotif and had COVID (COVID-19) due to which the patient postponed taking the oral typhoid capsule (inappropriate schedule of product administration). Considering the limited case information, the role of Vivotif  cannot be ruled out and the causality of COVID-19 is assessed as possible. Furthermore the causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: I had the horrible vaccine and still got shingles/ suspected vaccination failure; shingles started on forehead and went down into my eyes; still got shingles; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: I had the horrible vaccine and still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles started on forehead and went down into my eyes) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and pain (Verbatim: painful).  The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.   Additional Information: Gsk receipt date 17 Sep 2023 This case was reported by a consumer via interactive digital media. The patient had horrible vaccine and still got the shingles. It started on forehead and went down into his/her eyes. It was really painful. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not reported
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/had 5 episodes; have had 5 episodes, all different; all extremely painful; external breakout on my left arm; 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.   The patient's past medical history included shingles (had internal shingles around abdomen into and around back for over a year) and pain (had pain was unbearable and almost ended his/her life).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/had 5 episodes ) (serious criteria GSK medically significant), shingles (Verbatim: have had 5 episodes, all different), shingles (Verbatim: external breakout on my left arm) and pain (Verbatim: all extremely painful).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the shingles was resolved (duration 3 months) and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023 The case was received from the patient via interactive digital media. The patient have had the shingles vaccine and upon receiving the second one, the patient immediately had an external breakout on his or her left arm. No more vaccines for him or her. The patient have had 5 episodes, all different but all extremely painful. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUC4, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient has a large local inflammatory reaction with warmth & erythema on the right upper arm at area of vaccinations 2 days ago. Recommend benadryl q4-6hrs x 24 hrs, ice to area and possible start of Keflex if concern for infection arises over the next 24 hours
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Dental caries, Dental restoration failure, Device physical property issue, Tooth restoration
Clinical narrative: Tooth rot from the anthrax vaccine. All dental visits while at work resulted in more fillings. After retiring they began to chip away with many completely breaking.
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Guillain-Barre syndrome, Hypersensitivity, Hypoaesthesia, Tremor
Clinical narrative: GBS deficits of hypersensitivity; numbness; hand tremor; could not walk; Guillian-Barre Syndrome; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In JUN-2023, less than a week after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillian-Barre Syndrome) (serious criteria hospitalization and GSK medically significant) and unable to walk (Verbatim: could not walk) (serious criteria hospitalization). On an unknown date, the patient experienced hypersensitivity (Verbatim: GBS deficits of hypersensitivity) (serious criteria hospitalization), numbness (Verbatim: numbness) (serious criteria hospitalization) and tremor of hands (Verbatim: hand tremor) (serious criteria hospitalization).  The outcome of the guillain barre syndrome, hypersensitivity, numbness, tremor of hands and unable to walk were not reported.   It was unknown if the reporter considered the guillain barre syndrome, hypersensitivity, numbness, tremor of hands and unable to walk to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome, hypersensitivity, numbness, tremor of hands and unable to walk to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-SEP-2023 The patient reported approximately one week or less following first Shingles vaccine she acquired Guillain-Barre Syndrome and was not able to walk and spent 3 weeks in hospital and received the treatment to prevent further neurological damage to nerves and underwent PT and OT (occupational therapy and physical therapy) to relearn to walk and function independently. During the reporting she was in outpatient PT and was working hard in recovery. It was uncertain if her acquired Guillain-Barre Syndrome deficits of hypersensitivity, numbness and hand tremor would improve. Prior to acquiring Guillain-Barre Syndrome there were no infections or other vaccines which contributed to Guillain-Barre Syndrome.
Sex: M
Vaccine: RVX
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This non-serious case was reported by a consumer and described the occurrence of sore throat in a 77-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 16-SEP-2023, the patient received RSV vaccine. On 17-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced sore throat (Verbatim: Sore throat).  The outcome of the sore throat was not resolved.   It was unknown if the reporter considered the sore throat to be related to RSV vaccine.     It was unknown if the company considered the sore throat to be related to RSV vaccine.   Additional Information: GSK Receipt date: 18-SEP-2023 The patient reported him-self. The symptoms was not treated. The reporter consent to follow up by email.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Illness
Clinical narrative: really sick; felt pressured; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: really sick) and sensation of pressure (Verbatim: felt pressured).  The outcome of the sickness and sensation of pressure were not reported.   It was unknown if the reporter considered the sickness and sensation of pressure to be related to Shingles vaccine.     It was unknown if the company considered the sickness and sensation of pressure to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-SEP-2023 This case was reported the patient via interactive digital media. The reporter mother in law got the vaccine and got really sick and said she regretted getting the shot she felt pressured. The reporter mother got the Shingles they were painful and uncomfortable but did not last very long. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 2days arm still hurts; Chills; Fever; Nausea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills 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 chills (Verbatim: Chills), fever (Verbatim: Fever), nausea (Verbatim: Nausea) and pain in arm (Verbatim: 2days arm still hurts).  The outcome of the chills, fever and nausea were resolved (duration 2 days) and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the chills, fever, nausea and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the chills, fever, nausea and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 The case was received from the patient interactive digital media. The patient stated that same here chills, fever could not get warm nausea for 2 days arm still hurt. The patient had scary side effects if you ask him/her. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain, Pruritus
Clinical narrative: Allergy; Pain; 2 years after all started again/Allergy; 2 years after all started again/pain; itching on arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy 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 allergy (Verbatim: Allergy), pain (Verbatim: Pain), allergy (Verbatim: 2 years after all started again/Allergy), pain (Verbatim: 2 years after all started again/pain) and itchy upper limbs (Verbatim: itching on arm).  The patient was treated with aciclovir (Acyclovir) and probiotics (nos) (Probiotic). The outcome of the allergy, pain and itchy upper limbs were resolved and the outcome of the allergy was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the allergy, pain, allergy, pain and itchy upper limbs to be related to Shingles vaccine.     It was unknown if the company considered the allergy, pain, allergy, pain and itchy upper limbs to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-Sep-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she was vaccinated with Shingles and it took him/her a while to get rid of it. The patient used used aloe vera, Acyclovir, nothing calmed it down. The patient took everything for allergies and pain and it calmed down for a few hours, until he/she discovered Daily probiotic, they ordered it and luckily it was remedy for about 2 years. The patient reported that now it had started again. The last night before reporting the patient had a lot of itching on his/her arm. The patient took it for the allergy and it calmed down basically. The follow up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity
Clinical narrative: was allergic to it; 3rd round of shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy to vaccine (Verbatim: was allergic to it) and shingles (Verbatim: 3rd round of shingles).  The outcome of the allergy to vaccine and shingles were not reported.   It was unknown if the reporter considered the allergy to vaccine and shingles to be related to Shingles vaccine.     It was unknown if the company considered the allergy to vaccine and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023 The case was received from the patient via interactive digital media. The patient called and stated that he or she got the first shot and was allergic to it. The patient had his or her 3rd round of shingles. The patient stated that he or she could not take the second.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fever; body aches; Fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever), general body pain (Verbatim: body aches) and fatigue (Verbatim: Fatigue).  The outcome of the fever, general body pain and fatigue were not reported.  It was unknown if the reporter considered the fever, general body pain and fatigue to be related to Shingles vaccine.  It was unknown if the company considered the fever, general body pain and fatigue to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 17-Sep-2023 This case was reported via interactive digital media. The patient reported that last month before reporting he/she had the first dose, and it went badly. The patient had fever, body aches, fatigue, but stated that after reading 10 things that you get with shingles, it was worth having gone through the effects of the vaccine. In October, patient was going to receive for the second dose. The follow up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX, UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 74-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included FLU SHOT (INFLUENZA VACCINE) NO FURTHER INFORMATION AVAILABLE. (FLU SHOT (INFLUENZA VACCINE) NO FURTHER INFORMATION AVAILABLE) for prophylaxis.   On an unknown date, the patient received RSV vaccine and FLU SHOT (INFLUENZA VACCINE) NO FURTHER INFORMATION AVAILABLE. On an unknown date, several days after receiving RSV vaccine and an unknown time after receiving FLU SHOT (INFLUENZA VACCINE) NO FURTHER INFORMATION AVAILABLE, the patient experienced pain in arm (Verbatim: sore arm).  The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The patient received flu and RSV shot and for couple of days had soreness in arm.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My (right) arm still aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: My (right) arm still aches).  The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 18-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that he/she had the shingles vaccine, his/her (right) arm still aches even tho it had been over a year since.  The vaccine needs more research and work and would not recommend anyone getting the vaccine until it was made better.  Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: RVX, RVX
Symptoms: Overdose, Pain in extremity
Clinical narrative: I got both shots yesterday in the same arm and it hurts; I got both shots yesterday in the same arm and it hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 16-SEP-2023, the patient received the 1st dose of RSV vaccine (unknown arm) and the 2nd dose of RSV vaccine (unknown arm). In SEP-2023, an unknown time after receiving RSV vaccine and RSV vaccine, the patient experienced pain in arm (Verbatim: I got both shots yesterday in the same arm and it hurts). On 16-SEP-2023, the patient experienced overdose (Verbatim: I got both shots yesterday in the same arm and it hurts).  The outcome of the pain in arm was not reported and the outcome of the overdose was unknown.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine and RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The patient received both the RSV shots in same arm which hurted like a heck. The patient also got his/her pharmacy. The patient received both the RSV shots in same arm on same day which led to overdose. The follow-up would not required per process.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 15-SEP-2023, the patient received the 1st dose of Shingles vaccine. In SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm).  In SEP-2023, the outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-Sep-2023 This case was reported via interactive digital media. The patient reported that he/she had shingles 3 times and finally got the vaccine last Friday before reporting. The patient experienced sore arm for a day and reported that 2nd dose will be at the end of October. The follow up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-Sep-2023 This case was reported via interactive digital media. The patient reported that she had a sore arm. This case was linked with US2023AMR129911, same reporter. The follow up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR129911:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-Sep-2023 This case was reported via interactive digital media. The reporter reported that her husband had a sore arm. This case was linked with US2023AMR129907, same reporter. The follow up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR129907:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm still hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-SEP-2023, the patient received Shingles vaccine. In SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm still hurt).  The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023 The case was received from the patient's wife via interactive digital media. The patient got the vaccine three days ago and less than a week after vaccination, the patient 's arm still hurts.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Put me down; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on unknown date and shots were horrible).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: Put me down). The outcome of the feeling unwell was resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The patient reported the shingles shots were horrible. The second shot of shingles vaccine put the patient down for few days. The patient was not sure if he/she will do the vaccine again or not. The follow-up would not required per process.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Sore body; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In SEP-2023, the patient received Shingles vaccine. In SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever) and general body pain (Verbatim: Sore body).  The outcome of the fever and general body pain were resolving.   It was unknown if the reporter considered the fever and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the fever and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine on Monday, 3 days ago today and that's how he or she felt.  The reporter stated that they already told me that patient could get a fever and sore body these are the symptoms of the vaccine and today patient felt better. Follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: it does hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: it does hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient had the first vaccine, and it did hurt. The patient thought it would be worse if he/she got the disease.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: little soreness at the shot site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: little soreness at the shot site). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.    It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient got vaccine and had a little soreness at the shot site for the rest of the day for the second shot, but far less than even a mild case of shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: received doses and they hurt a lot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: received doses and they hurt a lot). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient already took Shingles vaccine dose and they hurt a lot. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Headache; Feverish; This non-serious case was reported by a nurse via sales rep and described the occurrence of fatigue in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 36 hrs after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue), headache (Verbatim: Headache) and fever (Verbatim: Feverish).  The outcome of the fatigue, headache and fever were not reported.   It was unknown if the reporter considered the fatigue, headache and fever to be related to Arexvy.     It was unknown if the company considered the fatigue, headache and fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-SEP-2023 The patient was self-reported this case. The patient received Arexvy vaccine and 36 hours after the vaccine she reported typical vaccine side effects such as fatigue, headache and feverish. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: just bit sore on the arm for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: just bit sore on the arm for 2 days).  The outcome of the pain in arm was resolved (duration 2 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023 The case was received from the patient via interactive digital media. The patient took the vaccine and had no problems, just bit sore on the arm for 2 days.
Sex: U
Vaccine: FLUX, RVX
Symptoms: Injection site pain
Clinical narrative: Just sore when touched where it the shot was.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received RSV vaccine and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: Just sore when touched where it the shot was.).  The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to RSV vaccine.     It was unknown if the company considered the injection site pain to be related to RSV vaccine.   Additional Information: GSK Receipt date: 21-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that no problem with the shot, just sore when touched where it the shot was and got the flu shot same time. It was unknown if the reporter considered the injection site pain to be related to Flu vaccine.  Follow up was not possible, as no contact details were available.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on her chest and stomach; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-SEP-2023, the patient received Shingrix (left deltoid). On 16-SEP-2023, 1 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash on her chest and stomach). The patient was treated with benadryl (nos) (Benadryl). The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-SEP-2023 The reporter was a patient's husband. The reporter reported that the patient received Shingrix vaccine on Friday.  The reporter stated that when the patient woke up on Saturday morning, she had a rash on her chest and stomach.  The patient took Benedryl on Sunday and the rash cleared up. The reporter did not had the paperwork with lot number and since his wife had not been to a doctor in years. The reporter did not consent to follow up.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 20-JUL-2023) for prophylaxis.   On 15-SEP-2023, the patient received Boostrix. On 15-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Boostrix).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 18-SEP-2023 The vaccine administration facility was the same as primary reporter The pharmacist reporting having administered an expired dose of Boostrix on 15 September 2023 which was expired on 20th July 2023, which led to expired dose used. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: employee received an expired dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B adult) (batch number 39tz2, expiry date 07-SEP-2023) for prophylaxis.   In SEP-2023, the patient received Engerix B adult. In SEP-2023, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: employee received an expired dose of Engerix-B).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-SEP-2023 Regular pharmacist did not wish to share additional information as it was an employee  not a patient. Regular Pharmacist reported an employee received an expired dose of Engerix-B which expired 7 days before administration, which led to expired vaccine used. The reporter did not consent to follow-up.