chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: 5 episodes of severe vomiting; Running diarrhea; Slight fever; A spontaneous report was received from a physician assistant on 19APR2023 regarding a 20-year-old male patient who had "5 episodes of severe vomiting" (PT: Vomiting), "running diarrhea" (PT: Diarrhoea) and "slight fever" (PT: Pyrexia) following the administration of Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical/surgical history, concomitant medications, or known allergies were reported as none.   On 17APR2023, Monday afternoon the patient received the first dose of Vivotif and felt completely fine on Monday and Tuesday. However, on 19APR2023 morning, about 40 hours after the first dose, the patient had five episodes of severe vomiting, a bit of running diarrhea and a slight fever. It was reported that there was a possibility of the patient being infected with viral illness in the household as his roommate who was not taking Vivotif had some vomiting and diarrhea yesterday evening (18APR2023).  Reportedly, the patient did not receive any treatment for the reported events and was doing well.  The patient recovered from the event "5 episodes of severe vomiting" on an unknown date in APR2023 while he was recovering from the events of "running diarrhea" and "slight fever".  The action taken with Vivotif with respect to the reported events was unknown.  No additional information was provided.  Based on the information available in the document three individual case safety reports 23000151 (patient-1), 23000152 (patient-2) and 22000250 (patient-3) were created and cross-linked in the database.  Company comment: It was reported that a consumer took Vivotif for immunisation and he had 5 episodes of severe vomiting (vomiting), running diarrhea (diarrhoea) and slight fever (pyrexia). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting, diarrhoea and pyrexia is assessed as possible (confounded by viral illness). The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif for immunisation and he had 5 episodes of severe vomiting (vomiting), running diarrhea (diarrhoea) and slight fever (pyrexia). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting, diarrhoea and pyrexia is assessed as possible (confounded by viral illness). The case is considered non serious as per medical assessment. 23000151:Linked case (Patient 1) 22000250:Linked case (Patient 3)
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 4-month old female patient received an expired pentacel dose with no reported adverse event; Initial information received on 14-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old female patient who had received an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine; and Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination.  On 13-Jun-2023, the patient received 0.5 mL dose 1 of expired suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ666AAA; expiry date: 04-May-2023) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event 4-month old female patient received an expired pentacel dose with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The area around the injection site , and extending 4? across at the widest part, was red, raised, warm and sensitive to the touch. There was also a red line, about 1.5-2? in length, streaking across my arm from the injection site, that lasted a day.  So far, it has been 4 days that I have experienced this redness, soreness, etc. I took a shower about 3 hours after the vaccine and I wonder if I accidentally moved the dose around, I don?t think I was being that rough on my skin though.
Age: 42.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Pain in extremity
Clinical narrative: The area around the injection site , and extending 4? across at the widest part, was red, raised, warm and sensitive to the touch. There was also a red line, about 1.5-2? in length, streaking across my arm from the injection site, that lasted a day.  So far, it has been 4 days that I have experienced this redness, soreness, etc. I took a shower about 3 hours after the vaccine and I wonder if I accidentally moved the dose around, I don?t think I was being that rough on my skin though.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: 06/07/2023; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 06/07/2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 06/07/2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 06/07/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 06/07/2023).    Concomitant medication was not reported. Individual vials or intact cartons were 4 of vial size 2.5 ml. Date the vial was initially stored in the refrigerator was 07-Jun-2023. Vial did not under go temperature excursion. Treatment medication was not reported.  This case contains information for the 2nd of 5 doses described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728778 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728778:master case
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; Caller reported GARDASIL 9 was administered to a pregnant patient; This spontaneous report was received from a registered nurse concerning a 32-year-old female pregnant patient. Information concerning the patient's pertinent medical history concurrent conditions and concomitant medications was not provided.   On approximately 13-OCT-2022, the patient became pregnant. The patient's last menstrual period (LPM) was not provided, however it was calculated as 29-SEP-2022.  On 31-MAY-2023, at 33 weeks and 6 days of gestation, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL, administered intramuscular in the deltoid (not specified which one) as prophylaxis, lot #W017539 and expiration date reported as 04-JAN-2025 (strength and frequency were not provided) (Maternal exposure during pregnancy). No adverse additional adverse event was not provided.   At the time of reporting, the outcome of patient's pregnancy was pending.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; Medical Assistant called to report that an 18 month old was mistakenly given VARIVAX and PROQUAD at the same time. Caller stated patient has not had any side effects at this time. No additional AE/no PQC.    Dr. , okay to contact; This spontaneous report was received from a medical assistant referring to a 18-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 07-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) (doses, routes of administration, lot numbers and expiration dates not reported) for prophylaxis (extra dose administered). No adverse event were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No further AE; HCP called to report that a dose of VARIVAX was given less then 4 weeks apart from a dose of MMR II. HCP became aware of this today. No symptoms reported. HCP gave permission to contact. No further AE details/No PQC; This spontaneous report was received from a nurse referring to a 2-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      In May- 2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter (route of administration, lot number and expiration date not reported) for prophylaxis, and less than 4 weeks, on 07-JUN-2023, was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot number W031811, expiration date 05-OCT-2024, 0.5 milliliter for prophylaxis (inappropriate schedule of product administration). No adverse event was reported.  Both vaccines were diluted with sterile diluent.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Hepatic cirrhosis, Immunodeficiency common variable, Immunoglobulin therapy, Immunoglobulins decreased
Clinical narrative: he had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23; he had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a currently 62-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (exact dose, dose #, route of administration, anatomical location, lot # and expiration date were not reported).  Since an unknown date, reported as 17 years ago, he was experiencing recurrent sinopulmonary infections. He was found to have low immunoglobulin (Ig) levels: IgG was 296 mg/dL, IgA was 6 mg/dL, and IgM was 76 mg/dL. He had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23 (vaccination failure, antibody test negative). Immune workup was also notable for T cell lymphopenia requiring prophylactic trimethoprim/sulfamethoxazole. He was diagnosed with common variable immunodeficiency and Hennekam syndrome. He was placed on immunoglobulin replacement therapy (IGRT) but even therapy serum IgG remained in the 400500 mg/dL range, likely due to "thirdspacing" from his lymphatic disorder. However he did not have any significant infections while on IGRT. On an unknown date, reported as past year, the patient was diagnosed with cirrhosis secondary to non-alcoholic steatohepatitis, and was undergoing liver transplant evaluation. He self-discontinued IGRT at the time of diagnosis. Six months after stopping IGRT the patient remained infection-free. Immunoglobulin panel revealed a serum IgG of 819 mg/dL, the patient's highest recorded value. Interestingly, at follow up the patient was found to have protective titers to S. pneumoniae, likely reflecting lingering antibodies from his infusions months prior.  The outcome of the event of vaccination failure was unknown. The outcome of the event of antibody test negative was considered as resolved.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: PPV
Symptoms: Infection, Lymphatic disorder, Non-alcoholic steatohepatitis, Respiratory tract infection, Sinusitis
Clinical narrative: he had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23; he had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a currently 62-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (exact dose, dose #, route of administration, anatomical location, lot # and expiration date were not reported).  Since an unknown date, reported as 17 years ago, he was experiencing recurrent sinopulmonary infections. He was found to have low immunoglobulin (Ig) levels: IgG was 296 mg/dL, IgA was 6 mg/dL, and IgM was 76 mg/dL. He had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23 (vaccination failure, antibody test negative). Immune workup was also notable for T cell lymphopenia requiring prophylactic trimethoprim/sulfamethoxazole. He was diagnosed with common variable immunodeficiency and Hennekam syndrome. He was placed on immunoglobulin replacement therapy (IGRT) but even therapy serum IgG remained in the 400500 mg/dL range, likely due to "thirdspacing" from his lymphatic disorder. However he did not have any significant infections while on IGRT. On an unknown date, reported as past year, the patient was diagnosed with cirrhosis secondary to non-alcoholic steatohepatitis, and was undergoing liver transplant evaluation. He self-discontinued IGRT at the time of diagnosis. Six months after stopping IGRT the patient remained infection-free. Immunoglobulin panel revealed a serum IgG of 819 mg/dL, the patient's highest recorded value. Interestingly, at follow up the patient was found to have protective titers to S. pneumoniae, likely reflecting lingering antibodies from his infusions months prior.  The outcome of the event of vaccination failure was unknown. The outcome of the event of antibody test negative was considered as resolved.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: he had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23; he had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a currently 62-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (exact dose, dose #, route of administration, anatomical location, lot # and expiration date were not reported).  Since an unknown date, reported as 17 years ago, he was experiencing recurrent sinopulmonary infections. He was found to have low immunoglobulin (Ig) levels: IgG was 296 mg/dL, IgA was 6 mg/dL, and IgM was 76 mg/dL. He had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23 (vaccination failure, antibody test negative). Immune workup was also notable for T cell lymphopenia requiring prophylactic trimethoprim/sulfamethoxazole. He was diagnosed with common variable immunodeficiency and Hennekam syndrome. He was placed on immunoglobulin replacement therapy (IGRT) but even therapy serum IgG remained in the 400500 mg/dL range, likely due to "thirdspacing" from his lymphatic disorder. However he did not have any significant infections while on IGRT. On an unknown date, reported as past year, the patient was diagnosed with cirrhosis secondary to non-alcoholic steatohepatitis, and was undergoing liver transplant evaluation. He self-discontinued IGRT at the time of diagnosis. Six months after stopping IGRT the patient remained infection-free. Immunoglobulin panel revealed a serum IgG of 819 mg/dL, the patient's highest recorded value. Interestingly, at follow up the patient was found to have protective titers to S. pneumoniae, likely reflecting lingering antibodies from his infusions months prior.  The outcome of the event of vaccination failure was unknown. The outcome of the event of antibody test negative was considered as resolved.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Physician reported pediatric patient received adult dose of VAQTA.; Physician reported pediatric patient received adult dose of VAQTA.; No Adverse Event; This spontaneous report was received from a physician refers to a patient of unknown age (reported as: pediatric patient) and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2023, the patient was vaccinated with adult dose of hepatitis a vaccine, inactivated (VAQTA) lot #W017819, expiration date: 27-DEC-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.   It was reported that, the pediatric patient received adult dose of hepatitis a vaccine, inactivated (VAQTA) on 13-JUN-2023 (product administered to patient of inappropriate age, incorrect dose administered). No additional adverse event (no adverse event).
Sex: U
Vaccine: PNC15
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No Adverse Event; Medical assistant reports Vaxneuvance given oral not IM.  No side effects reported.  No further AE.  No PQC.; This spontaneous report was received from an other health professional refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE), oral ((lot #, expiration date, exact dose, and anatomical location were not reported) for prophylaxis (incorrect route of product administration). No adverse event reported (no adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles; Received two doses year or so ago and diagnosed yesterday with shingles/suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 14-JUN-2014, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received two doses year or so ago and diagnosed yesterday with shingles/suspected vaccination failure) (serious criteria GSK medically significant). On 14-JUN-2023, the patient experienced shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two doses of Shingles vaccine a year or so ago. The patient diagnosed with shingles. The patient stated that he or she tolerated very well and never regretted for getting those shots for sure. The patient reported that the vaccine do not keep you from possibly getting shingles but if you do it is much milder and leave quicker, get those shots you will not regret it. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I just had my 2nd vaccine and it sucked too/ 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I just had my 2nd vaccine and it sucked too/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two doses of shingles vaccine and it sucks. The patient stated that he or she jut had his or her second dose of Shingles vaccine and it sucked too as experienced shingles. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Been feeling little under the weather today as wel; This non-serious case was reported by a consumer via sales rep and described the occurrence of unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-JUN-2023, the patient received Shingrix. On 09-JUN-2023, 1 days after receiving Shingrix, the patient experienced unwell (Verbatim: Been feeling little under the weather today as wel). The outcome of the unwell was not resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.     It was unknown if the company considered the unwell to be related to Shingrix.   Additional Information: GSK receipt date: 12-JUN-2022 The patient stated that he/she already read on site, but nothing says how long do side effects should last. The patient got the shot on Thursday and definitely felt side effects on Friday and was been feeling little under the weather on the day of reporting as well.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: my arm still hurts a lot; Drug dose administration interval too short; 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 the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm still hurts a lot) and drug dose administration interval too short (Verbatim: Drug dose administration interval too short). The outcome of the pain in arm was not resolved and the outcome of the drug dose administration interval too short was unknown.   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: 11-JUN-2023. This case was reported by a patient via interactive digital media. The patient received first dose of vaccine on unknown date. The reporter reported that thank you that he/she just got vaccinated.  The patient was told to take the second one after 2 months but patient had to give it after 3 days and patient arm still hurts a lot which led to shortening of vaccinations schedule.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported via interactive digital media. The reporter knowns the patient who got the Shingles vaccine shot immediately got shingles. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR084564 and US2023AMR084559, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR084559:Same reporter/Original case US-GSK-US2023AMR084564:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: pain disappears the first vaccine hurt me more the second; 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.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date, refer case US2023AMR082918).   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 pain (Verbatim: pain disappears the first vaccine hurt me more the second). Rechallenge with Shingles vaccine was positive. The outcome of the pain was resolved.   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.   Linked case(s) involving the same patient:  US2023AMR082918   Additional Information: GSK Receipt Date: 09-JUN-2023 This case was reported by the patient via interactive digital media. The patient stated that the first vaccine hurt more than the second and almost not but if it hurts a lot. The patient stated that put patches of warm water and everything would be fine. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR082918:Same patient
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Movement disorder, Nausea
Clinical narrative: difficulty closing hands; fatigue which is still ongoing; experienced weakness; experienced nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of movement disorder in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-MAY-2023, the patient received the 1st dose of Shingrix. On 20-MAY-2023, 10 hrs after receiving Shingrix, the patient experienced movement disorder (Verbatim: difficulty closing hands), nausea (Verbatim: experienced nausea), fatigue (Verbatim: fatigue which is still ongoing) and weakness (Verbatim: experienced weakness). The outcome of the movement disorder was resolved and the outcome of the nausea was resolved (duration 5 days) and the outcome of the fatigue and weakness were not resolved.   It was unknown if the reporter considered the movement disorder, nausea, fatigue and weakness to be related to Shingrix.     It was unknown if the company considered the movement disorder, nausea, fatigue and weakness to be related to Shingrix.   Additional Information: GSK receipt date: 12-JUN-2023 The reporter reported that about 10 hours after receiving Shingrix first dose he had difficulty closing his hands. This was resolved.  The reporter also stated that for about five day he experienced nausea. This was also resolved.  The reporter also stated he experienced weakness and fatigue which was ongoing. Adverse Event was filed for all events. The reporter did not consent to follow up.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: it was given one month after the supposed expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HAV (Havrix) (batch number GP75A, expiry date 04-OCT-2018) for prophylaxis.   On 20-NOV-2018, the patient received Havrix. On 20-NOV-2018, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: it was given one month after the supposed expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter reported expiration of a vaccine lot number and stated that it was given one month after the supposed expiration date.  It was reported that the lot number was searched for in system but no information appeared. Information about the vaccine, event and patient were collected. The Vaccine Administration Facility is the same as Primary Reporter. Havrix was given one month after the supposed expiration date which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Experienced swelling at the injections site; Experienced pain at the injections site.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Experienced swelling at the injections site) and injection site pain (Verbatim: Experienced pain at the injections site.). The outcome of the injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site swelling and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter did not provide any demographic information. Caller was the contact and reports on behalf of his niece. During the call the caller states that his niece previously had received the Shingrix vaccine and experienced pain and swelling at the injections site. Limited details were given during the call. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Vaginal lesion
Clinical narrative: Vaginal cold sore; This non-serious case was reported by a nurse via call center representative and described the occurrence of vaginal lesion in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes. Concomitant products included valaciclovir (Valacyclovir).   On 12-JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-JUN-2023, 1 days after receiving Shingrix, the patient experienced vaginal lesion (Verbatim: Vaginal cold sore). The outcome of the vaginal lesion was not resolved.   It was unknown if the reporter considered the vaginal lesion to be related to Shingrix.     It was unknown if the company considered the vaginal lesion to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter stated when she woke up this (on the day of reporting) morning she had a vaginal cold sore. She mentioned she had a history of genital herpes and takes Valacyclovir. Medical disclaimer, medical information phone number was provided. The reporter would like to be transferred to medical information. Did not consent to follow-up.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 47-year-old female patient who received HAV (Havrix) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Previously administered products included Havrix (1st dose received on 8th May 2023).   On 13-JUN-2023, the patient received the 2nd dose of Havrix. On 13-JUN-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 13-JUN-2022 A pharmacist called to inform that earlier that day, a patient received the 2nd dose of Havrix.  The reporter consented to follow up.  The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal stiffness, Pain, Pruritus, Swelling
Clinical narrative: with extreme itching; red ring band around the arm; painful; was stiff; swelled; This non-serious case was reported by a physician via sales rep and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-JUN-2023, the patient received the 1st dose of Shingrix (left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: with extreme itching), erythema of extremities (Verbatim: red ring band around the arm), pain (Verbatim: painful), stiffness (Verbatim: was stiff) and swelling (Verbatim: swelled). The outcome of the pruritus was resolved and the outcome of the erythema of extremities was resolving and the outcome of the pain, stiffness and swelling were unknown.   It was unknown if the reporter considered the pruritus, erythema of extremities, pain, stiffness and swelling to be related to Shingrix.     It was unknown if the company considered the pruritus, erythema of extremities, pain, stiffness and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter stated patient administered first dose of Shingrix in left arm. She experienced swelling, stiffness, painful with extreme itching and red ring band form around the arm. On 12th June 2023 the extreme itching lasted and the redness started to dissipate. No further information was known. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: another vaccine diluent was used to reconstitute Shingrix and administered it to a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 5NT4N) for prophylaxis.   On 07-JUN-2023, the patient received the 2nd dose of Shingrix. On 07-JUN-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: another vaccine diluent was used to reconstitute Shingrix and administered it to a patient). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 13-JUN-2022 The physician reported that another vaccine diluent was used to reconstitute Shingrix and administered it to a patient. The vaccine administration facility was the same as primary reporter. No expiration date reported. The health care professional (HCP) reported a diluent for MMR vaccine was the one used, no further details reported. The reporter consented to follow up.  The patient received diluent of MMR to reconstitute Shingrix vaccine, which led to wrong solution used in drug reconstitution.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: the maladministration of Rotarix via IM; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 422GF, expiry date 24-FEB-2025) for prophylaxis.   On 13-JUN-2023, the patient received Rotarix lyophilized formulation (intramuscular). On 13-JUN-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: the maladministration of Rotarix via IM). The outcome of the inappropriate route of vaccination 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: 14-JUN-2023 The reporter reported that the maladministration of Rotarix to patient. The healthcare professional wanted to know how to proceed with this patient. The reporter consented to follow up. The Rotarix vaccine was administered via intramuscular route, which led to inappropriate route of vaccination.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 18-FEB-2023 and second dose on 8-Mar-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 9372K, expiry date 05-AUG-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 08-MAR-2023, the patient received the 2nd dose of Shingrix. On 08-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first dose of Shingrix on 18-FEB-2023 and second dose on 8-Mar-2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The patient received 1st dose of Shingrix on 18th February 2023. The reporter declined permission to collect her contact details but did give permission to follow up via email which was listed in adverse event form. The reporter consented to follow up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received the first Shingrix dose a year ago and did not received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 1 year ago prior to the reporting).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient received the first Shingrix dose a year ago and did not received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter wanted to know if patient can receive the second dose or the patient need to restart the doses. The reporter did not provided patient information age, gender or initials nor the information about the first dose of Shingrix vaccine lot number, expiry date and date of administratiion The reporter did consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose of Shingrix about 4 years ago and never received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 4 years 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: dose of Shingrix about 4 years ago and never received a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The patient never received a second dose of Shingrix. The reporter did not have exact DOB (date of birth) or initials at time of chat. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Overdose
Clinical narrative: 2 injections of Shingrix Vaccine on the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JUN-2023, the patient received Shingrix (intramuscular). On 14-JUN-2023, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: 2 injections of Shingrix Vaccine on the same day). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter reported that the patient received two doses of Shingrix vaccine on the same day, which led to overdose. The reporter was warm transferred medical information for inquiry. The reporter did consent to follow up. This case had been linked with US2023083881 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023083881:Same reporter
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: body aches; headache; shivering; fever; Flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, 6 hrs after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches), headache (Verbatim: headache), shivering (Verbatim: shivering), fever (Verbatim: fever) and influenza-like symptoms (Verbatim: Flu like symptoms). The outcome of the general body pain, headache, shivering, fever and influenza-like symptoms were resolved.   It was unknown if the reporter considered the general body pain, headache, shivering, fever and influenza-like symptoms to be related to Shingrix.  It was unknown if the company considered the general body pain, headache, shivering, fever and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter asked if there was a smaller dose of Shingrix available for her 2nd dose, as she experienced flu-like symptoms of headache, fever, shivering and body aches that began about 6 hours after her first dose of Shingrix, approximately 3 months ago. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: the total volume of the dose was not administered to the patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 34EC5, expiry date 02-JUL-2024) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Shingrix. On 20-MAR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: the total volume of the dose was not administered to the patient). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter asked if this dose is considered as valid. The reporter consented to follow up. The reporter reported that during administration of the Shingrix to a patient, the total volume of the dose was not administered to the patient, which led to incomplete dose administered.