chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypokinesia, Loss of personal independence in daily activities, Maternal exposure before pregnancy, Migraine, Mobility decreased
Clinical narrative: miscarriage; ovarian cysts/ovarian pain/dysmenorrhea; chronic migraines/headaches; chronic pelvic congestion syndrome; decreased or slow movements; The patient has been unable to engage in activities that a young person her age would normally enjoy; Her educational performance suffered; GERD; The patient endured difficult pregnancies thereafter; rash on her arm; chronic fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a 14-year-old female patient. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On unknown dates, the patient was inoculated with the first, second and third doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, strength, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, subsequently after receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the patient experienced a rash on her arm, decreased or slow movements, headaches, ovarian pain, dysmenorrhea, gastrointestinal problems such as gastrooesophageal reflux disease (GERD), chronic migraines, chronic fatigue, pelvic congestion, and she developed cysts on her ovaries. She was seen by multiple physicians and frequently visited the Emergency Room for these complaints. She suffered a miscarriage and endured difficult pregnancies (pregnancy disorder) thereafter. The first-time patient discovered that her injuries could have been caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was in February 2021. Furthermore, the patient had been unable to engage in activities that a young person her age would normally enjoy. She had suffered chronic fatigue and pain which made it difficult to function. Her educational performance suffered because of her symptoms and daily tasks became burdensome. Moreover, the patient suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The outcome of the event of the events was unknown. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the events of abortion spontaneous, ovarian cysts, GERD, migraine, pelvic congestion, hypokinesia, pregnancy disorder, loss of personal independence in daily activities, educational problem, rash and fatigue were considered to be disabling events. The event of abortion spontaneous was determined to be medically significant event.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst, Pain, Pelvic congestion, Rash
Clinical narrative: miscarriage; ovarian cysts/ovarian pain/dysmenorrhea; chronic migraines/headaches; chronic pelvic congestion syndrome; decreased or slow movements; The patient has been unable to engage in activities that a young person her age would normally enjoy; Her educational performance suffered; GERD; The patient endured difficult pregnancies thereafter; rash on her arm; chronic fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a 14-year-old female patient. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On unknown dates, the patient was inoculated with the first, second and third doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, strength, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, subsequently after receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the patient experienced a rash on her arm, decreased or slow movements, headaches, ovarian pain, dysmenorrhea, gastrointestinal problems such as gastrooesophageal reflux disease (GERD), chronic migraines, chronic fatigue, pelvic congestion, and she developed cysts on her ovaries. She was seen by multiple physicians and frequently visited the Emergency Room for these complaints. She suffered a miscarriage and endured difficult pregnancies (pregnancy disorder) thereafter. The first-time patient discovered that her injuries could have been caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was in February 2021. Furthermore, the patient had been unable to engage in activities that a young person her age would normally enjoy. She had suffered chronic fatigue and pain which made it difficult to function. Her educational performance suffered because of her symptoms and daily tasks became burdensome. Moreover, the patient suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The outcome of the event of the events was unknown. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the events of abortion spontaneous, ovarian cysts, GERD, migraine, pelvic congestion, hypokinesia, pregnancy disorder, loss of personal independence in daily activities, educational problem, rash and fatigue were considered to be disabling events. The event of abortion spontaneous was determined to be medically significant event.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; adult patient received pediatric dose (0.5mg) of VAQTA; This spontaneous report was received from a medical assistant referring to 29-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 27-OCT-2023, the patient was vaccinated with second and pediatric dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (0.5 mg, 1 dosage form, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (Adult use of a child product). No adverse effects reported (No adverse event). No additional adverse event (AE) or product quality complaint (PQC).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Office manager calling to report that a dose of MMR II was administered 5 days after its labeled expiration date. Administration date: 10/26/2023, expiration date: 10/21/2023. Caller confirmed the product has never experienced a temperature excursion; This spontaneous report was received from the office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) lot # U033041, expiration date:21-OCT-2023, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis.   It was reported that a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) was administered 5 days after its labeled expiration date. Caller confirmed the product has never experienced a temperature excursion (expired product administered).
Sex: U
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported.; Medical assistant reported that a 4 month old patient received PROQUAD.; This spontaneous report was received from other health care professional concerning to a 4-month-old patient of unknown race and gender.   The patient's pertinent medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot number X18576, expiration date: 05-JAN-2025, administered as prophylaxis (strength, vaccination scheme and route and anatomical site of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: U
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: No additional AEs were reported.; Medical assistant reported that a 4 month old patient received PROQUAD.; This spontaneous report was received from other health care professional concerning to a 4-month-old patient of unknown race and gender.   The patient's pertinent medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot number X18576, expiration date: 05-JAN-2025, administered as prophylaxis (strength, vaccination scheme and route and anatomical site of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: HBP states there are no symptoms; Pharmacist calling to report the administration of an expired dose of GARDASIL 9 on 10/30/2023.  Caller confirmed no previous temperature excursions for this product and stored in the recommended range.  HBP states there are no symptoms or further de; This spontaneous report has been received from a pharmacist, regarding a patient of unreported age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 30-OCT-2023, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (lot number: U032636, which was determined to be valid as syringe formulation, with an expiration date on 26-OCT-2023) (strength, dose, schemer, route and anatomical location of administration were not reported) (Expired product administered).  Caller requested if this Administration Period was Supported Beyond the Labeled Expiry  No additional adverse event was reported.
Age: 0.33
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Product confusion, Wrong product administered
Clinical narrative: No additional AE/PQC reported; HCP calling to report an AE regarding the VARIVAX vaccine. HCP reported that two 4 month old patients received VARIVAX instead of VAXELIS. HCP stated that they administered the wrong vaccine. HCP administered the vaccines due to product confusion bec; HCP calling to report an AE regarding the VARIVAX vaccine. HCP reported that two 4 month old patients received VARIVAX instead of VAXELIS. HCP stated that they administered the wrong vaccine. HCP administered the vaccines due to product confusion bec; This spontaneous report was received from a physician referred to a 4 month old patient of unknown gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On 31-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # X000532, Expiration date 04-JAN-2025, (strength, dose, dose number, frequency, route, and anatomical location were not reported), for prophylaxis; the dose of varicella virus vaccine live (oka/merck)(VARIVAX) was administered instead of a dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS). The reporter stated that they administered the wrong vaccine due to product confusion because "the vaccines sounded similar" (wrong product administered and product confusion). The patient did not experience any adverse event.  This is one of two reports from the same reporter.
Age: 0.33
Sex: U
Vaccine: VARCEL
Symptoms: Product name confusion, Wrong product administered
Clinical narrative: No additional AE reported; reported that two 4 month old patients received VARIVAX instead of VAXELIS. HCP stated that they administered the wrong vaccine.; HCP administered the vaccines due to product confusion because " the vaccines sounded similar/The names of the VARIVAX and VAXELIS vaccines sounds similar; This spontaneous report was received from a physician and refers to a 4-month-old of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number reported and validated as: X000532, expiration date 04-JAN-2025; dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) as prophylaxis, instead of  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (which lot number and expiration date were not reported). The health care professional (HCP) stated that they administered the wrong vaccine (Wrong product administered) due to product confusion because "the names of the vaccines sounded similar" (Product name confusion).  No additional adverse event was reported.   This is one of two reports from  same reporter.; Sender's Comments:  US-009507513-2311USA000285:
Sex: U
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Vomited; A spontaneous report was received from a pharmacist on 11OCT2023 regarding a patient of unknown age and gender who "vomited" (PT: Vomiting) following the administration of oral Vivotif capsules (typhoid vaccine live oral Ty21A; route; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that a patient took the first dose of Vivotif and vomited after 4 hours and 30 minutes of administration.  The outcome of the reported event was unknown. The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Significant follow up information was received from the pharmacist on 20OCT2023.  It was reported that the patient had no known allergies/intolerances/sensitivities.  Reportedly, the patient vomited only once, and no treatment was taken by the patient for vomiting. Further, it was reported that the patient took the subsequent doses of Vivotif.  The patient had recovered from the reported event on an unknown date.  No action was taken with Vivotif with respect to the reported event.  Company comment: It was reported that a patient of unknown age and gender took the first dose of Vivotif and vomited after 4 hours and 30 minutes of administration. The patient had recovered from the reported event. Considering a temporal association (between the onset of the event and Vivotif intake), the causality for the event of vomiting is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient of unknown age and gender took the first dose of Vivotif and vomited after 4 hours and 30 minutes of administration. The patient had recovered from the reported event. Considering a temporal association (between the onset of the event and Vivotif intake), the causality for the event of vomiting is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Therapy cessation
Clinical narrative: Infection; Took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic; Took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic; A spontaneous report was received from a pharmacist on 24OCT2023 regarding a female patient of unknown age who "took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic" (PT: Incomplete course of vaccination and PT: Therapy cessation) for an "infection" (PT: Infection). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took the first dose of Vivotif and needed to take antibiotics for an infection. Thus, the reporter had to stop Vivotif to start the course of antibiotics of the patient. Reportedly, the patient had two months before she would be "exposed to Typhoid".  The outcome for the event "took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic" was not applicable and for event "infection" it was unknown.  The action taken with Vivotif with respect to the event "infection" was withdrawn and it was not applicable for event "took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic".  No additional information was reported.  Company comment: This case concerns a female patient who took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic (incomplete course of vaccination and therapy cessation) for an infection (infection NOS). This case lacks information on the event of infection, start date, and relevant medical history of the patient. Hence, the causality for the event of infection NOS is not assessable until further information is received.  The causality for the events of incomplete course of vaccination and therapy cessation is assessed as not applicable considering the nature of the events.; Sender's Comments: This case concerns a female patient who took 1 dose of Vivotif and had her stop the Vivotif to start the antibiotic (incomplete course of vaccination and therapy cessation) for an infection (infection NOS). This case lacks information on the event of infection, start date, and relevant medical history of the patient. Hence, the causality for the event of infection NOS is not assessable until further information is received.  The causality for the events of incomplete course of vaccination and therapy cessation is assessed as not applicable considering the nature of the events.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Retinal detachment, Vaccine positive rechallenge
Clinical narrative: Retinal detachment; Retinal detachment; This serious case was reported by a lawyer and described the occurrence of retinal detachment in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13-NOV-2020, the patient received the 2nd dose of Shingrix. On 05-AUG-2020, the patient received the 1st dose of Shingrix. On 09-AUG-2020, not applicable after receiving Shingrix and 4 days after receiving Shingrix, the patient experienced retinal detachment (Verbatim: Retinal detachment) (serious criteria GSK medically significant). On 15-NOV-2020, the patient experienced retinal detachment (Verbatim: Retinal detachment) (serious criteria GSK medically significant). Rechallenge with Shingrix was positive. The outcome of the retinal detachment and retinal detachment were not reported.   It was unknown if the reporter considered the retinal detachment to be related to Shingrix. It was unknown if the reporter considered the retinal detachment to be related to Shingrix.     It was unknown if the company considered the retinal detachment to be related to Shingrix. It was unknown if the company considered the retinal detachment to be related to Shingrix.   Additional Information: GSK receipt date: 30-Oct-2023 As per legal complaint, The plaintiff consumed Shingrix vaccines on 05 Aug 2020 and on 13 Nov 2020. As a result of use of above Shingrix vaccine the plaintiff was diagnosed with retinal detachment.  On or about 15 November 2020 two days after her second Shingrix vaccine, Patient experienced a recurrence of her retinal detachment.
Sex: M
Vaccine: RVX
Symptoms: Erythema, Pain
Clinical narrative: pain; redness; This non-serious case was reported by a consumer and described the occurrence of pain in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concomitant products included rosuvastatin calcium (Crestor).   On 20-OCT-2023, the patient received RSV vaccine. On 23-OCT-2023, 3 days after receiving RSV vaccine, the patient experienced pain (Verbatim: pain) and erythema (Verbatim: redness). The outcome of the pain and erythema were not resolved.   It was unknown if the reporter considered the pain and erythema to be related to RSV vaccine.     It was unknown if the company considered the pain and erythema to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 23-OCT-2023 The patient self-reported this case, and this report was submitted via the online direct entry reporting system.  The patient received concomitant product Crestor, was ongoing till the time of reporting. The patient received RSV vaccine and experienced pain and redness which was ongoing. The symptoms were not treated. The reporter gave permission to contact GlaxoSmithKline.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Nausea, Pain
Clinical narrative: weak; nauseated; body aches; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of weakness in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAR-2023, the patient received Shingrix. On 17-MAR-2023, less than a day after receiving Shingrix, the patient experienced weakness (Verbatim: weak), nausea (Verbatim: nauseated) and general body pain (Verbatim: body aches). On 11-MAY-2023, the outcome of the weakness, nausea and general body pain were resolved (duration 1 month 24 days).   The reporter considered the weakness, nausea and general body pain to be related to Shingrix.     The company considered the weakness, nausea and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-OCT-2023 The reporter called to provide the allergic reaction patient had to vaccine first shot. The patient felt nauseated, was weak and had body aches for 2 to 3 weeks and did not get 2nd dosage
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Oedema peripheral
Clinical narrative: edema extremity; allergic reaction; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of edema extremities in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JUN-2023, the patient received the 1st dose of Shingrix. On 30-AUG-2023, 77 days after receiving Shingrix, the patient experienced edema extremities (Verbatim: edema extremity) and allergic reaction (Verbatim: allergic reaction). The outcome of the edema extremities was unknown and the outcome of the allergic reaction was not reported.   The reporter considered the edema extremities to be related to Shingrix. It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     The company considered the edema extremities to be related to Shingrix. It was unknown if the company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK receipt date: 23-OCT-2023 The patient received 1st dosage and reported allergic reaction, edema extremity to provider The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body aches; This non-serious case was reported by a physician via sales rep and described the occurrence of general body pain in an unspecified number of patients 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 general body pain (Verbatim: body aches). The outcome of the general body pain was not reported.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     It was unknown if the company considered the general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2023 HCP stated that in general patients get body aches. No specific details were provided The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Sore arm; Baseball size reddened area around injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site erythema (Verbatim: Baseball size reddened area around injection site) and pain in arm (Verbatim: Sore arm). The outcome of the injection site erythema was resolved (duration 5 days) and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Arexvy.     It was unknown if the company considered the injection site erythema and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 23-OCT-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient had baseball size reddened area around injection site. Reddened area around injection site was for 5 days. The patient's arm was also sore. The patient never had reaction to any vaccines.
Sex: U
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: Site isand swelled up; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site swelling (Verbatim: Site isand swelled up). The outcome of the injection site swelling was not reported.   It was unknown if the reporter considered the injection site swelling to be related to Arexvy    It was unknown if the company considered the injection site swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 23-OCT-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. The reporter stated that after the patient received a dose of Arexvy, the site was swelled up.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia
Clinical narrative: site pain; fatigue; joint and muscle pain; muscle pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain (Verbatim: site pain), fatigue (Verbatim: fatigue), joint pain (Verbatim: joint and muscle pain) and muscle pain (Verbatim: muscle pain). The outcome of the pain, fatigue, joint pain and muscle pain were not reported.   It was unknown if the reporter considered the pain, fatigue, joint pain and muscle pain to be related to Arexvy.   It was unknown if the company considered the pain, fatigue, joint pain and muscle pain to be related to Arexvy.   Additional Information: GSK receipt date: 23-OCT-2023 This case was reported by a consumer via (Open field AE monitoring) interactive Digital Media.  The patient felt site pain, fatigue, joint and muscle pain. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: injection was given with just adjuvant, no powder was mixed; injection was given with just adjuvant, no powder was mixed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 97-year-old 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 inappropriate preparation of medication (Verbatim: injection was given with just adjuvant, no powder was mixed) and inappropriate dose of vaccine administered (Verbatim: injection was given with just adjuvant, no powder was mixed). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 23-Oct-2023 The reporter calling to get a replacement. The reporter did not consent to follow-up. The patient was given Shingrix injection with just adjuvant, no powder was mixed, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Needle issue, Product preparation issue
Clinical narrative: Inappropriate reconstitution technique; Incorrect dose administered; leaked out of the needle puncture; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 95TA2, expiry date 10-DEC-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate reconstitution technique (Verbatim: Inappropriate reconstitution technique), inappropriate dose of vaccine administered (Verbatim: Incorrect dose administered) and needle leak (Verbatim: leaked out of the needle puncture). The outcome of the inappropriate reconstitution technique, inappropriate dose of vaccine administered and needle leak were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2023 The pharmacist reported that he was preparing a dose of Arexvy vaccine. He took an antigen vial from Lot number LM7J7 and adjuvant vial Lot number 9G793 and from the middle 2nd row of a multi dose carton / box. Pharmacist stated that he injected 0.2ml into the adjuvant vile and withdrew liquid. He then cleared the syringe of any air and started to inject the adjuvant into the antigen. The reporter stated half the liquid went into the vial containing the antigen and half leaked out of the needle puncture which led to needle leak. The reporter stated that the liquid came out of the stopper at the puncture point like a little explosion. The reporter then proceeded to get another adjuvant vial from the multi dose pack and withdrew 0.3ml into the syringe then he added the 0.3ml adjuvant to the antigen vial, withdrew 0.5ml total reconstituted liquid and administered to a customer which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertently administered 0.5 mL of 2 vials of Arexvy Adjuvants mixed together instead of the Arexvy lyophilized component on 10/19/23; inadvertently administered 0.5 mL of 2 vials of Arexvy Adjuvants mixed together instead of the Arexvy lyophilized component on 10/19/23; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3524C, expiry date 31-MAR-2025) for prophylaxis.   On 19-OCT-2023, the patient received Arexvy. On 19-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered 0.5 mL of 2 vials of Arexvy Adjuvants mixed together instead of the Arexvy lyophilized component on 10/19/23) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered 0.5 mL of 2 vials of Arexvy Adjuvants mixed together instead of the Arexvy lyophilized component on 10/19/23). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2023 The registered pharmacist reported a patient was inadvertently administered 0.5 mL of 2 vials of Arexvy adjuvants mixed together instead of the Arexvy lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The reporter did not consent to follow-up from safety.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: given using sterile diluent instead of the adjuvant included for use; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA946A, expiry date 31-JUL-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: given using sterile diluent instead of the adjuvant included for use) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2023 The nurse reported that a Menveo vaccination was given using sterile diluent instead of the adjuvant included for use, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo + Reconstitution of powder portion with sterile saline water; Menveo + Reconstitution of powder portion with sterile saline water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMZA9838, expiry date 30-SEP-2024) for prophylaxis.   On 23-OCT-2023, the patient received Menveo. On 23-OCT-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo + Reconstitution of powder portion with sterile saline water) and inappropriate dose of vaccine administered (Verbatim: Menveo + Reconstitution of powder portion with sterile saline water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 The reporter stated patient received a dose of Menveo powder reconstituted with saline water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Shingrix 1.5 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 1.5 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: patient received the first dose of Shingrix 1.5 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-Oct-2023 The pharmacist called to inquired that the patient would have to repeat the series. The reporter did not consent to follow-up. Till the time of reporting, the patient did bot receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: reports a rash all over the body; This non-serious case was reported by a nurse via call center representative and described the occurrence of generalized rash in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 3 days after receiving Menveo, the patient experienced generalized rash (Verbatim: reports a rash all over the body). The outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Menveo.     It was unknown if the company considered the generalized rash to be related to Menveo.   Additional Information: GSK receipt date: 25-Oct-2023 The reporter was nurse.   The reporter reported that an adverse event for Menveo vaccine.  A patient received a Menveo vaccine and 3 days later reports a rash all over the body. Adverse event was documented with limited information.  The reporter called and only provided the name, phone number and zip code of the medical facility. It was unknown the date when the event happened.  It was unknown the patient's initials, sex, date of birth, lot/ expiry date of the vaccine.  No additional information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: they have no record of the patient ever receiving a 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: they have no record of the patient ever receiving a 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-Oct-2023 Reporter was the son calling on behalf of the patient.  The reporter reported that they had no record of the patient ever receiving a 2nd dose. Reporter had no further information about lot/expiry, route of administration, or location of administration. Did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received Shingrix second dose 2 weeks after the first dose instead of 2 months; 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 75-year-old female patient who received Herpes zoster (Shingrix) (batch number F4LD5, expiry date 27-SEP-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 26-OCT-2023, the patient received the 2nd dose of Shingrix. On 26-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received Shingrix second dose 2 weeks after the first dose instead of 2 months). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 26-Oct-2023 The reporter did not consent to follow-up. The patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: U
Vaccine: UNK
Symptoms: Device issue, No adverse event
Clinical narrative: We have had some problems with the prefilled syringes, difficulty with the plunger; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (We have had some problems with the prefilled syringes, difficulty with the plunger) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (We have had some problems with the prefilled syringes, difficulty with the plunger) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (We have had some problems with the prefilled syringes, difficulty with the plunger) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (We have had some problems with the prefilled syringes, difficulty with the plunger).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (We have had some problems with the prefilled syringes, difficulty with the plunger).    No concomitant or treatment medications were provided. The pharmacist reported that there was some problems with the prefilled syringes, difficulty with the plunger. The Device problem code for Spikevax syringe include FDA code 2588, code A0203 which include Defective Device. The device was malfunctioned, and the malfunction type was CIRM.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule
Clinical narrative: it is on forearm, on some days it is more red, sometimes it is shiny, it feels hard, with a small hard bump and white spot inside; a growing quite beige-red spot on the exact place i got a jab; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE NODULE (it is on forearm, on some days it is more red, sometimes it is shiny, it feels hard, with a small hard bump and white spot inside) and VACCINATION SITE ERYTHEMA (a growing quite beige-red spot on the exact place i got a jab) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (it is on forearm, on some days it is more red, sometimes it is shiny, it feels hard, with a small hard bump and white spot inside) and VACCINATION SITE ERYTHEMA (a growing quite beige-red spot on the exact place i got a jab). At the time of the report, VACCINATION SITE NODULE (it is on forearm, on some days it is more red, sometimes it is shiny, it feels hard, with a small hard bump and white spot inside) and VACCINATION SITE ERYTHEMA (a growing quite beige-red spot on the exact place i got a jab) had not resolved.            Concomitant and treatment medications were not reported.  The patient got 2 Moderna jabs few years ago and experienced side effects. It was a growing quite beige-red spot on the exact place got a jab. It was on forearm, on some days it was more red, sometimes it was shiny, it feels hard, with a small hard bump and white spot inside. In 3 years, it had grown to approximate 6-7 mm. It was reported that the, current growth rate was 2 mm in a year. The patient visited doctors and they failed to deliver an explanation.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Malaise, Nausea, Pain in extremity
Clinical narrative: Felt sick; Left arm is sore; Nauseous; Tired; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt sick), PAIN IN EXTREMITY (Left arm is sore), NAUSEA (Nauseous) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 immunization.    Co-suspect products included non-company products TREPROSTINIL inhalation powder for Pulmonary arterial hypertension and TREPROSTINIL SODIUM (TYVASO) inhalation powder for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included CALCIFEDIOL MONOHYDRATE (RAYALDEE), FUROSEMIDE, APIXABAN (ELIQUIS), POTASSIUM CHLORIDE, RIOCIGUAT (ADEMPAS), SPIRONOLACTONE, OXYGEN, ALBUTEROL SULFATE, FAMOTIDINE (PEPCID [FAMOTIDINE]), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA), GUAIFENESIN, PARACETAMOL (TYLENOL), MACITENTAN (OPSUMIT) and PREDNISONE for an unknown indication.   On 24-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL (Inhalation use) at an unspecified dose and TREPROSTINIL SODIUM (TYVASO) (Inhalation use) 32 microgram. On an unknown date, TREPROSTINIL SODIUM (TYVASO) (Inhalation use) dosage was changed to 48 microgram four times per day. In October 2023, the patient experienced MALAISE (Felt sick), PAIN IN EXTREMITY (Left arm is sore), NAUSEA (Nauseous) and FATIGUE (Tired). At the time of the report, MALAISE (Felt sick), PAIN IN EXTREMITY (Left arm is sore), NAUSEA (Nauseous) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered MALAISE (Felt sick), PAIN IN EXTREMITY (Left arm is sore), NAUSEA (Nauseous) and FATIGUE (Tired) to be related.    No treatment medications were reported.  The current dose of Tyvaso DPI was reported as 48 µg, four times a day (QID) via inhalation (IH) route.   Reporter did not allow further contact