chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: he has afib and has a history of sinusitis that keeps cycling and he cant seem to get rid of it, however it does go away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 03Aug2021 as dose 1, single (Lot number: AWO173) for covid-19 immunisation. The patient's relevant medical history included: "Sinusitis" (unspecified if ongoing); "afib" (unspecified if ongoing). The patient's medical history, reported also as family history included: "Parkinsons" (unspecified if ongoing), notes: his wife has Parkinsons and severe scoliosis of 28 years; "scoliosis" (unspecified if ongoing), notes: his wife has Parkinsons and severe scoliosis of 28 years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "he has afib and has a history of sinusitis that keeps cycling and he cant seem to get rid of it, however it does go away".  Additional information: Caller provided that his wife and himself had two primary, Pfizer Covid-19 shots in 2021 within 3 weeks a part. Caller provided per their vaccination card they received "AWO173 on 03Aug2021 and the second vaccine on 08Sep2021." The caller provided that they never received a booster. The caller is asking if his wife and himself are able eligible to receive the Pfizer Covid-19 bivalent booster enquired. Caller provided that they are going to be traveling this month and decided that they feel they should get vaccinated. Caller stated that his wife has Parkinson's and severe scoliosis of 28 years. The caller provided that he has afib and has a history of sinusitis that "keeps cycling and he can't seem to get rid of it, however it does go away."  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300214134 same reporter/patient/event, different vaccine dose;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The last 3 hurt after she received them; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Lot number: EW0172) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden bleeding disorder" (unspecified if ongoing), notes: not on blood thinners or statins. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: EW0150), administration date: 01Apr2021, when the patient was 61-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "The last 3 hurt after she received them".  Additional information: In 1977, her mom got the first flu shot, and 30 years later got Guillain-Barre from the shot. The vaccines hurt except for the first one. The last 3 hurt after she received them. Body Weight (kg): 50.8.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300218053 Same patient/vaccine, different dose and event;US-PFIZER INC-202300218569 Same patient/vaccine/event, different dose;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: hurt after she received; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 05Jan2022 as dose 3 (booster), single (Lot number: 33036BD) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden bleeding disorder" (unspecified if ongoing), notes: not on blood thinners or statins. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EW0150), administration date: 01Apr2021, when the patient was 61-year-old, for COVID-19 immunisation; BNT162b2 (Dose 2, single, Lot: EW0172), administration date: 23Apr2021, when the patient was 61-year-old, for COVID-19 immunisation, reaction(s): "hurt after she received".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "hurt after she received".  Additional information: It was reported that the vaccine was given in left shoulder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300218053 Same patient/vaccine/event, different dose;US-PFIZER INC-202300218534 Same patient/vaccine/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 test
Clinical narrative: Was never allergic to anything until I got these vaccinations now I'm allergic to everything; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FP7137) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (disability, life threatening), outcome "not recovered", described as "Was never allergic to anything until I got these vaccinations now I'm allergic to everything". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: If covid tested post vaccination: Yes/Nasal Swab.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (HYPERSENSITIVITY) and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300218333 same reporter/patient/drug, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration
Clinical narrative: lot of hair loss after 16Apr2022 shot; BNT162B2 dose 1: 13Mar2021, dose 2: 16Apr2022 shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 16Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE), administration date: 13Mar2021, for COVID-19 immunization, reaction(s): "hair in my sink". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Apr2022, outcome "unknown", described as "BNT162B2 dose 1: 13Mar2021, dose 2: 16Apr2022 shot"; ALOPECIA (non-serious), outcome "unknown", described as "lot of hair loss after 16Apr2022 shot". Therapeutic measures were taken as a result of alopecia.  Additional information: The patient had platelet-rich plasma (PRP) blood platelet treatments in Feb2023 for the hairloss.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300104044 same patient, product and event; different dose;US-PFIZER INC-202300219429 same patient, product and event; different dose;
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Have lost a lot of hair; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, single; lot number: unknown), administration date: 13Mar2021, for COVID-19 immunization, reaction: "Hair loss"; Comirnaty (dose 2, single; lot number: unknown), administration date: 16Apr2022, for COVID-19 immunization, reactions: "Inappropriate schedule of vaccine administered", "Hair loss". The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Have lost a lot of hair". Therapeutic measures were taken as a result of alopecia. Additional information: The patient have lost a lot of hair due to getting the COVID-19 vaccine and booster. The patient's hair was great until he/she got the vaccine on 13Mar2023 and noticed his/her hair on the sink and then a lot of hair loss after the 16Apr2022 shot and the 20Sep2022 booster. The patient had bangs all his/her life and now has no bangs, the hair on top was so thin. It was devastating. The patient have before and after photos and loss of hair can be seen in them. The patient spent close to $3,000 on platelet-rich plasma (PRP) blood platelet treatments in Feb2023, and a topper costing $811.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300104044 same patient, drug, and event; different dose;US-PFIZER INC-202300219428 same patient and drug; different dose and event;
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue
Clinical narrative: it looks like there is some particulate in the syringe; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "it looks like there is some particulate in the syringe". Additional information: The pharmacist had a vaccine that was about to be given to a patient and it looks like there is some particulate in the syringe.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Chills, Gait inability, Headache, Hypoaesthesia
Clinical narrative: hands and feet cold; jaw aching; chills; shaky; lethargic; unable to walk or move; Blood pressure was elevated; bad headache; numbness in my limbs, jaw, and face/numbness in left thigh; swelling of her neck; itchiness; swelling of her face; hives on her face; Initial information received on 08-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 60 years old female patient who experienced swelling of her face, lethargic, unable to walk or move, blood pressure was elevated, hands and feet cold, jaw aching, hives on her face, bad headache, numbness in my limbs, jaw, and face/numbness in left thigh, swelling of her neck, itchiness, chills and shaky after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included BETAMETHASONE; HYDROXYCHLOROQUINE; RIZATRIPTAN; SERTRALINE; MONTELUKAST SODIUM (SINGULAIR); TRAZODONE; and FAMOTIDINE (PEPCID [FAMOTIDINE]).  On 25-May-2023, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, expiry date and lot number: not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On 27-May-2023 the patient developed swelling of her face (swelling face), hives on her face (urticaria), swelling of her neck (swelling), itchiness (pruritus) (latency: 2 days).  On 04-Jun-2023 the patient developed lethargic (lethargy), unable to walk or move (gait inability), blood pressure was elevated (blood pressure increased), bad headache (headache), numbness in my limbs, jaw, and face/numbness in left thigh (hypoesthesia) (latency: 10 days).  On 06-Jun-2023 the patient developed hands and feet cold (peripheral coldness), jaw aching (pain in jaw), chills, shaky (tremor) (latency: 12 days).  Relevant laboratory test results included: Blood pressure measurement - On 04-Jun-2023:  [175/140]  Action taken: not applicable.  The patient was treated with EPINEPHRINE for swelling of her face, hives on her face/neck, itchiness and Urticaria and was unknown for other events (bad headache, numbness in my limbs, jaw, and face/numbness in left thigh, lethargic, unable to walk or move, Blood pressure was elevated, hands and feet cold, chills, shaky, jaw aching).  At time of reporting, the outcome was Unknown for the events.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Mobility decreased, Pain in jaw, Peripheral coldness, Pruritus
Clinical narrative: hands and feet cold; jaw aching; chills; shaky; lethargic; unable to walk or move; Blood pressure was elevated; bad headache; numbness in my limbs, jaw, and face/numbness in left thigh; swelling of her neck; itchiness; swelling of her face; hives on her face; Initial information received on 08-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 60 years old female patient who experienced swelling of her face, lethargic, unable to walk or move, blood pressure was elevated, hands and feet cold, jaw aching, hives on her face, bad headache, numbness in my limbs, jaw, and face/numbness in left thigh, swelling of her neck, itchiness, chills and shaky after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included BETAMETHASONE; HYDROXYCHLOROQUINE; RIZATRIPTAN; SERTRALINE; MONTELUKAST SODIUM (SINGULAIR); TRAZODONE; and FAMOTIDINE (PEPCID [FAMOTIDINE]).  On 25-May-2023, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, expiry date and lot number: not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On 27-May-2023 the patient developed swelling of her face (swelling face), hives on her face (urticaria), swelling of her neck (swelling), itchiness (pruritus) (latency: 2 days).  On 04-Jun-2023 the patient developed lethargic (lethargy), unable to walk or move (gait inability), blood pressure was elevated (blood pressure increased), bad headache (headache), numbness in my limbs, jaw, and face/numbness in left thigh (hypoesthesia) (latency: 10 days).  On 06-Jun-2023 the patient developed hands and feet cold (peripheral coldness), jaw aching (pain in jaw), chills, shaky (tremor) (latency: 12 days).  Relevant laboratory test results included: Blood pressure measurement - On 04-Jun-2023:  [175/140]  Action taken: not applicable.  The patient was treated with EPINEPHRINE for swelling of her face, hives on her face/neck, itchiness and Urticaria and was unknown for other events (bad headache, numbness in my limbs, jaw, and face/numbness in left thigh, lethargic, unable to walk or move, Blood pressure was elevated, hands and feet cold, chills, shaky, jaw aching).  At time of reporting, the outcome was Unknown for the events.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Swelling face, Tremor, Urticaria
Clinical narrative: hands and feet cold; jaw aching; chills; shaky; lethargic; unable to walk or move; Blood pressure was elevated; bad headache; numbness in my limbs, jaw, and face/numbness in left thigh; swelling of her neck; itchiness; swelling of her face; hives on her face; Initial information received on 08-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 60 years old female patient who experienced swelling of her face, lethargic, unable to walk or move, blood pressure was elevated, hands and feet cold, jaw aching, hives on her face, bad headache, numbness in my limbs, jaw, and face/numbness in left thigh, swelling of her neck, itchiness, chills and shaky after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included BETAMETHASONE; HYDROXYCHLOROQUINE; RIZATRIPTAN; SERTRALINE; MONTELUKAST SODIUM (SINGULAIR); TRAZODONE; and FAMOTIDINE (PEPCID [FAMOTIDINE]).  On 25-May-2023, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, expiry date and lot number: not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On 27-May-2023 the patient developed swelling of her face (swelling face), hives on her face (urticaria), swelling of her neck (swelling), itchiness (pruritus) (latency: 2 days).  On 04-Jun-2023 the patient developed lethargic (lethargy), unable to walk or move (gait inability), blood pressure was elevated (blood pressure increased), bad headache (headache), numbness in my limbs, jaw, and face/numbness in left thigh (hypoesthesia) (latency: 10 days).  On 06-Jun-2023 the patient developed hands and feet cold (peripheral coldness), jaw aching (pain in jaw), chills, shaky (tremor) (latency: 12 days).  Relevant laboratory test results included: Blood pressure measurement - On 04-Jun-2023:  [175/140]  Action taken: not applicable.  The patient was treated with EPINEPHRINE for swelling of her face, hives on her face/neck, itchiness and Urticaria and was unknown for other events (bad headache, numbness in my limbs, jaw, and face/numbness in left thigh, lethargic, unable to walk or move, Blood pressure was elevated, hands and feet cold, chills, shaky, jaw aching).  At time of reporting, the outcome was Unknown for the events.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose administered to a patient with no reported adverse event; Initial information received on 09-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of an unknown age and gender and reporter reported that expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received expired dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE suspension for injection (strength, expiry date and lot number: not reported) via unknown route in unknown administration site for immunization and (expired product administered) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Back pain, Chromaturia, Illness, Spinal cord disorder, Urinary incontinence
Clinical narrative: Fever, nauseas, headache that night   The following week had difficult controlling bwols, extreme headache all the time, purple lines on back, extreme pain, also extreme pain in back.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Anal incontinence, Back pain, Headache, Nausea, Pain
Clinical narrative: Fever, nauseas, headache that night   The following week had difficult controlling bwols, extreme headache all the time, purple lines on back, extreme pain, also extreme pain in back.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Skin discolouration
Clinical narrative: Fever, nauseas, headache that night   The following week had difficult controlling bwols, extreme headache all the time, purple lines on back, extreme pain, also extreme pain in back.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Urticaria like rash all over the trunk. Applied Calamine lotion and Fluocinolone body oil ( 0.1%).  After which the rash started to fade. Was gone by the next day with no other symptoms developing, or the rash getting worse.
Age: 7.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: No adverse event
Clinical narrative: No adverse event
Age: 7.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: unable to lift arm over head
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The medical assistant is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA x004813   7/28/2024 Temperature: 46.74F Tim; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAY-2023, the vaccine was improperly stored at 46.74 F degrees for 2 minutes. There were no previous temperature escursions. On an unknown date in May 2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, once, lot #x004813, expiration date: 28-JUL-2024, administered as prophylaxis (strength, and route of administration were not provided). No additional adverse events were reported.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Slight swelling, redness and tenderness at the site of injection; Slight swelling, redness and tenderness at the site of injection; Slight swelling, redness and tenderness at the site of injection; This spontaneous report was received from the patient' mother who was a creative services company representative  regarding her daughter, a 15-month-old female. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient experienced slight swelling, redness and tenderness at the site of injection (Vaccination site swelling) (Vaccination site erythema) (Vaccination site tenderness). Therefore, the patient's mother called her pediatrician and alerted her, but was told that these were common side effects of this vaccination  (also reported as post-vaccination reaction), so she kept monitoring the patient in order to document new events and or her recovery. Furthermore, the mother stated that the patient's symptoms resolved within two days on an unspecified date.   The causal relationship between all the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptomatic side effects/No additional AE; administration of improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAY-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 1 dose, 0.5 ml, lot # X011437, expiration date: 18-JUL-2024, administered for prophylaxis (route of administration was not provided) (product storage error).   No Previous temperature excursions. No additional adverse events (AEs) were provided.
Age: 0.92
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 11-month-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004086: US-009507513-2306USA004087: US-009507513-2306USA004090: US-009507513-2306USA004089: US-009507513-2306USA004085: US-009507513-2306USA004084: US-009507513-2306USA004088: US-009507513-2306USA004082: US-009507513-2305USA007959:
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 3-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event). .; Sender's Comments:  US-009507513-2306USA004088: US-009507513-2306USA004087: US-009507513-2306USA004086: US-009507513-2306USA004089: US-009507513-2306USA004085: US-009507513-2306USA004082: US-009507513-2306USA004090: US-009507513-2306USA004083: US-009507513-2305USA007959:
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 12-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004082: US-009507513-2306USA004088: US-009507513-2306USA004089: US-009507513-2306USA004090: US-009507513-2306USA004087: US-009507513-2306USA004086: US-009507513-2305USA007959: US-009507513-2306USA004083: US-009507513-2306USA004084:
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; HCP called to report that they administered GARDASIL 9 to their patient as follows: first dose at age 13, second dose at age 14, and a third dose today on 06/08/2023. No additional AE/PQC.; This spontaneous report was received from a pharmacist referring to a 20-year-old patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.     In approximately 2016, when she was 13-year-old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), then in approximately 2017 when she was 14-year-old, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). Finally, on 08-JUN-2023, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) once for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported) (inappropriate schedule of product administration). No additional adverse event (AE) was reported.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of an expired dose of MMR II. MMR II expired on 6/3/2023 and was administered on 6/7/2023.; This spontaneous report was received from a registered nurse referring to a 12-month-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 07-JUN-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) injection (0.5 ml, lot#: U017524, expiration date: 03-JUN-2023; strength was not reported) orally for prophylaxis (expired product administered). No adverse effects were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient received MMR II expired 4/23/2023.; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAY-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHa) (M-M-R II) injection, lot #U013036, expiration date 23-APR-2023 and administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Expired product administered). No additional adverse events were reported.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered
Clinical narrative: The second dose of Jynneos vaccine was administered 0.5 milliliter intradermally instead of 0.1 milliliter.; Case reference number US-BN-2023-000895 is a spontaneous case report initially received from a pharmacist (reference number: USBAV23-0650) on 16-May-2023 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at unknown dose, via unknown route and at an unknown site of administration for an unknown indication.  On 16-May-2023, an unknown amount of time after receiving the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at a dose of 0.5 millilitre, intradermally (explicitly coded as 'intradermal injection') at an unknown site of administration. It was reported that a nurse accidentally administered 0.5 millilitre instead of 0.1 millilitre.   At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received on 17-May-2023 included the local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos, at a dose of 0.5 millilitre, intradermally, which is considered as intradermal injection. At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. Intradermal injection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos, at a dose of 0.5 millilitre, intradermally, which is considered as intradermal injection. At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. Intradermal injection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: The second dose of Jynneos vaccine was used eight weeks beyond use date; The patient received the second dose of Jynneos on 64 day; Case reference number US-BN-2023-000949 is a spontaneous case report initially received from a health care professional (reference number: USBAV23-0703) on 30-May-2023 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 01-Feb-2023, the patient was vaccinated with the first dose of Jynneos (batch number: FDP00019; expiration date: 31-Oct-2024), at a dose of 0.5 milliliter, subcutaneously, at an unknown site of administration, for smallpox/monkeypox prophylaxis.  On 06-Apr-2023, 64 days after the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00019; expiration date: 31-Oct-2024), at a dose of 0.5 milliliter, subcutaneously, at an unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). It was reported that vaccine was used eight weeks beyond use date (explicitly coded as 'expired vaccine used').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 31-May-2023, included local case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the second dose of Jynneos, at a dose of 0.5 milliliter, subcutaneously, at an unknown site of administration (considered as inappropriate schedule of vaccine administered). It was reported that vaccine was used eight weeks beyond use date (considered as expired vaccine used). Expired product administered and inappropriate schedule of product administration are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Expired product administered and inappropriate schedule of product administration are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the second dose of Jynneos, at a dose of 0.5 milliliter, subcutaneously, at an unknown site of administration (considered as inappropriate schedule of vaccine administered). It was reported that vaccine was used eight weeks beyond use date (considered as expired vaccine used). Expired product administered and inappropriate schedule of product administration are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Expired product administered and inappropriate schedule of product administration are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I've had 3 outbreaks of shingles since my initial set, with the last shot in Nov 2022./ Suspected vaccination failure; I've had 3 outbreaks of shingles since my initial set; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (8 prior cases of shingles).   In NOV-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: I've had 3 outbreaks of shingles since my initial set, with the last shot in Nov 2022./ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've had 3 outbreaks of shingles since my initial set). 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 Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 07-JUN-2023 The patient enquired that is there another set of Shingrix recommended if the 1st vaccinations did not worked as she had 3 outbreaks of shingles since initial set. The patient also enquired that, how long does shingles last. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the shot and then a month later I got shingles; it was still painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got the shot and then a month later I got shingles) and pain (Verbatim: it was still painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUN-2023 This case was reported by a patient via interactive digital media. The reporter stated that did it and still anyone could get it.  The patient received the shot and then a month later got shingles. The reporter mentioned it was not bad, at least they said it was not a bad case. The patient had the shingles which was still painful. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: 3 shingles shots and still got shingles/suspected vaccination failure; Shingles; Three doses of Shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: 3 shingles shots and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: Three doses of Shingles vaccine). The outcome of the vaccination failure and extra dose administered were 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, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received three doses of Shingles vaccine still experienced Shingles. The patient stated that the Shingles vaccine works as good as the Covid vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received extra dose of Shingrix in error, which led to extra dose administered. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles eventhough i had both vaccines/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 got shingles eventhough i had both vaccines/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: 12-Jun-2023 The case was received from the patient via interactive digital media. The patient got shingles even though he or she had both vaccines. The patient stated that however it was a very very mild case. The patient was glad he or she got the vaccine. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.