chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine brand other Moderna/vaccine brand Pfizer / BioNTech; testing positive on 31Jan2024; testing positive on 31Jan2024; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Mar2021 at 11:15 as dose 1, single (Lot number: 036A21A), in left arm, on 11Apr2021 at 11:15 as dose 2, single (Lot number: 038BA1A), in left arm, on 21Aug2021 at 10:15 as dose 3 (booster), single (Lot number: 052E21A), in left arm, on 29May2022 at 11:00 as dose 4 (booster), single (Lot number: 045C211A), in left arm and on 20Oct2023 at 10:30 as dose 6 (booster), single (Lot number: 3032086), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Sulfa based drugs" (unspecified if ongoing); "Addison's disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE, start date: 27Jan2011; FLUDROCORTISONE ACETATE, start date: 27Jan2011; LEVOTHYROXINE SODIUM, start date: 13Mar1980. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jan2024, outcome "unknown" and all described as "testing positive on 31Jan2024"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other Moderna/vaccine brand Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2024) Positive; (07Feb2024) Negative; (09Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested positive for Covid two days after testing negative. Started Paxlovid on 01Feb2024, a day after testing positive on 31Jan2024. Her negative test occurred on day 7, 07Feb2024. Tested positive again with symptoms on 09Feb2024.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: cephalexin, reaction(s): "known allergies". Vaccination history included: Moderna initial vax dose 1 (DOSE 1, SINGLE, vaccine brand=Other, vaccine brand other=Moderna initial vax dose 1, spring 2021, vaccine brand unknown=False, vaccine lot unknown=True, vaccine lot unknown reason=Misplaced/discarded,,  vaccine dose number=1, vaccine dose number unknown=False, vaccine location=Left arm), administration date: 2021, for COVID-19 immunization; Moderna initial vax dose 2 (DOSE 2, SINGLE, vaccine brand=Other, vaccine brand other=Moderna initial vax dose 2, spring 2021, vaccine brand unknown=False, vaccine lot unknown=True, vaccine lot unknown reason=Unable to locate or read the details, vaccine dose number=2, vaccine dose number unknown=False), administration date: 2021, for COVID-19 Immunization; Moderna booster (DOSE 3 (BOOSTER), SINGLE, vaccine brand=Other, vaccine brand other=Moderna booster spring , 2022, vaccine brand unknown=False, vaccine lot unknown=True, vaccine lot unknown reason=Unable to locate or read the details, vaccine dose number unknown=True, vaccine dose number unknown reason=UNKNOWN,,  vaccine location=Left arm), administration date: 2022, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Feb2024) Positive, notes: Day 9 (after treatment); (2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course information: Patient took Paxlovid from 01Feb2024 to 05Feb2024. Felt well upon completing Paxlovid day 5 (05Feb2024). On Day 9 (09Feb2024) started feeling fatigue, scratchy throat, congestion, tested positive for Covid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in left arm and on 22May2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 64 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Reduced immunity due to Humira for Rheumatoid Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Humira, reaction(s): "Rheumatoid Arthritis". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jan2024) Positive; (03Feb2024) Negative; (05Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID Rebound.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID treatment; COVID treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Raynauds" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Allergy Doxycycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jan2024) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID; COVID; Pfizer COVID vaccine for initial 2, then 2 Moderna COVID vaccines; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EN6204), in arm and on 17Apr2021 as dose 2, single (Lot number: EWASO) at the age of 50 years, in arm, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 3 (booster), single (Lot number: 939902), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Nov2021, outcome "unknown", described as "Pfizer COVID vaccine for initial 2, then 2 Moderna COVID vaccines"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID".
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Mild malaise/feeling sick and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Jan2024, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Jan2024, outcome "unknown", described as "Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)". Additional information: The worst events experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Friday, 26Jan2024 and Saturday, 27Jan2024 were recorded: Moderate injection site pain interfering with activity, moderate injection site tenderness (tenderness with movement), no injection site redness, no injection site swelling, no fever (< 100.4 F), fatigue not present, mild malaise/feeling sick and no interference with activity, muscle pain not present, joint pain not present, no nausea/vomiting present, and no headache.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Jan2024, outcome "unknown", described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset Jan2024, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Jan2024, outcome "unknown", described as "Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)"; MALAISE (non-serious) with onset Jan2024, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset Jan2024, outcome "unknown", described as "Mild muscle pain and no interference with activity". Additional information: events experienced anytime during the 2 days after COVID-19 vaccination, which occurred on 27Jan2024 (Saturday) and on 28Jan2024 (Sunday).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: I've been getting sick with really bad colds; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid vaccine (Dose 1), for vaccine; Covid vaccine (Dose 2), for vaccine; Flu vaccine, for vaccine. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I've been getting sick with really bad colds". Additional information: The reporter stated "I had 2 Covid vaccines plus the booster, 3 altogether. I've been getting sick with really bad colds more than ever. I've also heard of many people having health problems they didn't have before. I regret having taken the vaccine. I will not take any of these vaccines, including the flu vaccine ever again. Or anybody in my family for that matter. Thanks."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-platelet factor 4 antibody test, Arthralgia
Clinical narrative: left shoulder pain; This is a spontaneous report received from a Physician.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: FF8841) at the age of 52 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 09Sep2021, outcome "recovering", described as "left shoulder pain". The event "left shoulder pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia. Additional information: The reporter does not consider that the Pfizer product had a causal effect to the adverse event.
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: I have ash; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 68-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's family history included: "Patient has a husband who had a heart transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "I have ash". Therapeutic measures were taken as a result of rash.  Additional information: Patient reported she has "ash" (intent: rash) and she takes medication for it every (unspecified frequency). Patient has a husband who had a heart transplant, and  his transplant pharmacist wants me to have the shot to protect him.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Skin haemorrhage, Skin lesion
Clinical narrative: scattering of lesions across my upper back/ i had then lesions all over the trunk of my body, legs+arms, and they itch + bled; scattering of lesions across my upper back/ i had then lesions all over the trunk of my body, legs+arms, and they itch + bled; This is a spontaneous report received from a Consumer or other non HCP.  An 85-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN LESION (non-serious), SKIN HAEMORRHAGE (non-serious), outcome "unknown" and all described as "scattering of lesions across my upper back/ i had then lesions all over the trunk of my body, legs+arms, and they itch + bled". Additional information: The patient had these lesions all over the trunk of body, legs and arms, and they itched and bled. This all started after she took the Pfizer COVID Vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: FLU4
Symptoms: Catatonia, Incorrect route of product administration
Clinical narrative: catatonic state after fluzone injection; vaccine was administered intracutaneously instead of intramuscularlyto patient; Initial information received on 07-Feb-2024 regarding an unsolicited valid serious case received from a Physician.  This case involves an unknown age male patient who experienced catatonic state after influenza quadrival a-b vaccine [Fluzone QIV] injection and vaccine was administered intracutaneously instead of intramuscularly to patient.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine lot number not reported via subcutaneous route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation (incorrect route of product administration) (latency- same day)  On an unknown date the patient developed catatonic state after fluzone injection (catatonia) (unknown latency) following the administration of influenza quadrival a-b vaccine. This event was assessed as medically significant.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events (catatonic state after fluzone injection).  At time of reporting, the outcome was Unknown for the events.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.; Sender's Comments: Sanofi Company Comment dated 09-Feb-2024: This case involves an unknown age male patient who experienced catatonic state after influenza quadrival a-b vaccine [Fluzone QIV] injection and vaccine was administered intracutaneously instead of intramuscularly to patient. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 3.0
Sex: F
Vaccine: COVID19, FLUC3, HEPA, PNC15, VARCEL
Symptoms: Product administration error, Vaccination site pain
Clinical narrative: Achy shot site; The 3-year-old patient received Flucelvax Quadrivalent and Varivax on the same date on te same site; This spontaneous case was received on 06-Feb-2024 from other non-healthcare professional via Med Communications (reference number SEQW24-00529) and concerned a 3-year-old, female patient.   The patient's medical history and concomitant medications were not reported.    On 26-Oct-2023, the patient was vaccinated with non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; dose: 0.5ml, route of administration: intramuscular (IM), anatomical location: right thigh (RT) and indication: not reported). The batch number reported was AU55588.  On the same date, the patient was vaccinated with non-company, co-suspect Vaxneuvance (pneumococcal vaccine conj 15v (CRM197); route of administration: intramuscular (IM), anatomical location: right tight (RT); dose and indication: not reported). The batch number reported was XO11424.  On the same date, the patient was vaccinated with non-company, co-suspect Varivax (varicella zoster vaccine live (Oka/Merck); route of administration: subcutaneous (sq), anatomical location: left thigh (LT); dose and indication: not reported). The batch number reported was XO10374.  On the same date, the patient was vaccinated with non-company, co-suspect Vaqta (hepatitis A vaccine inact; route of administration: intramuscular (IM), anatomical location: right thigh (RT); dose and indication: not reported). The batch number reported was XO10374.  On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4V; route of administration: intramuscular (IM), anatomical location left thigh (LT); dose: not reported) (explicitly coded as 'Product administration error') for influenza immunization. The batch number reported was 373546.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspects Moderna COVID-19 vaccine, Vaxneuvance, Varivax and Vaqta, the patient experienced achy shot site.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.    The case was assessed as non-serious.  Company comment: The event of 'vaccination site pain' is assessed as possibly related to Flucelvax Quadrivalent due to anatomical plausibility.'Product administration error' is assessed as unrelated per company's conventions.; Sender's Comments: The event of 'vaccination site pain' is assessed as possibly related to Flucelvax Quadrivalent due to anatomical plausibility.'Product administration error' is assessed as unrelated per company's conventions.
Age: 66.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose given.  No known adverse outcome at this time.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Regular dose flu vaccine was given instead of the high-dose flu vaccine.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient stated that 2 days after the vaccine hives started to develop and informed the doctor right away
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was given the 12 and older moderna vaccine and should have been given the 6month- 12 year old vaccine . the patient age was 3 months off .
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Rash - redness of skin:  Right eye, groin, scrotum, left forearm - fever
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: Patient experienced a lot of pain the evening after receiving the Comirnaty covid vaccine on 12-26-2023. It was administered in the right upper arm. He  said he did not have pain right away. It was later that evening when his arm began to hurt. He went to MD and MD seemed to feel like the vaccine may not have been put in the "triangle area" on the arm. His arm  was also bruised where the shot was administered. Patient said he had been receiving physical therapy and pain treatment since receiving vaccine.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Cough, Oropharyngeal pain, Sputum discoloured
Clinical narrative: A day after the shot a slight deep cough in the lungs that got progressively worse and lasted for 3 week. Occasional yellow sputum. 1/10/2024 sore throat that lasted 3 days.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Cough, Oropharyngeal pain, Pain in extremity
Clinical narrative: A day after the shot a slight deep cough in the lungs that got progressively worse and lasted for 3 week. Occasional yellow sputum. 1/10/2024 sore throat that lasted 3 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: site reaction, bump
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Given vaccine 3 days after it expired according to it's beyond use date (was stored in fridge for more than 30 days).
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Neuropathy peripheral, Scan, Scan brain
Clinical narrative: Peripheral Neuropathy
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea
Clinical narrative: Trouble breathing patient went to hospital for it
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Rash vesicular, Varicella
Clinical narrative: broke out with chickenpox; rash looked like a chicken pox spots; This non-serious case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (as a child).   In FEB-2023, the patient received the 2nd dose of Shingrix. On an unknown date, 9 days after receiving Shingrix, the patient experienced chickenpox (Verbatim: broke out with chickenpox) and varicella-like rash (Verbatim: rash looked like a chicken pox spots). The outcome of the chickenpox was resolving and the outcome of the varicella-like rash was not reported.   It was unknown if the reporter considered the chickenpox and varicella-like rash to be related to Shingrix.     It was unknown if the company considered the chickenpox and varicella-like rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-FEB-2024 and 08-FEB-2024 The patient received the 2nd dose of Shingrix and broke out with chickenpox 9 days later. The spots cleared up within a week but then again broke out about another week later. This continued for 6 months. The patient had many doctor visits and treatments to finally get them to subside. During this time, the patient also passed on chickenpox to two other adults One was her adult daughter and one was her adult cousin.  The patient said their rashes did blister and crust (over) and mentioned that her cousin had previously been vaccinated with both doses of Shingrix. Patient's out of pocket expenses to clear them up have reached and was wondering if they had any type of compensation program to reimburse for these expenses. Not to mention all the times the patient had to isolate when had active spots. The reporter stated that she did have the lot number of the suspect vaccine but she was not home at the time of the outbound call so she did not have it in front of her. The patient said she had a folder of documentation such as pictures of the rash and blood work results that she would like to share with GSK. The patient said that her rash did not look like a shingles rash but looked like a chicken pox spots. The doctor told her that it was not shingles. The patient said that her spots did not blister or crust (over). The reporter consented to follow up.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical Assistant called and relayed she is reporting a temperature excursion which occurred on December 30, 2022.  Caller relayed she is calling due to VFC inspection which noted temperature excursion and confirmed no expired vaccines were administe; This spontaneous report was received from a medical assistant and refers to a unknown patients.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W003118, expiration date: 13-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided); and  hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #U033519, expiration date: 10-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). Those vaccines underwent temperature excursion on 30-DEC-2022 in 35.1 Farenheit for 31 minutes 30 seconds, with no previous excursion (Product storage error). No additional adverse event was reported.  Follow up information has been received from a Medical Assistant on 09-FEB-2024.   It was reported that 3-year-old female patient with no illness at the time of vaccination, no preexisting conditions and no concomitant medications was vaccinated on 28-JUN-2023 with an incorrect storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) and incorrect storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot # U023829, expiration date 30-JUL-2023; route for both vaccines were not reported, but the medical assistant stated generally they give vaccines in the legs. This incorrect storage was due to clinical practice error and the temperature excursion occurred because of a reading from a digital data logger. The patient did not experience any adverse events after receiving vaccines involved in a temperature excursion. Also, the patient did no required prescription drug treatments.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid due to patient's identifiers.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2402USA003950: US-009507513-2402USA003951: US-009507513-2402USA003949:
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hepatitis B, Pediatric/Adolescent Dosage 09/13/03 06/14/03 12/16/02; Hepatitis B, Pediatric/Adolescent Dosage 09/13/03 06/14/03 12/16/02; This spontaneous report has been received from an physician via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (# 2312USA001546), concerning a 6-month-old female.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-DEC-2002, the patient vas vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, (dosage regimen, lot #, expiry date, route of administration, and indication were not provided). On 14-JUN-2003, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, (dosage regimen, lot #, expiry date, route of administration, and indication were not provided) (Inappropriate schedule of product administration). On 13-SEP-2003, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, (dosage regimen, lot #, expiry date, route of administration, and indication were not provided) (Inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2312USA001546: US-009507513-2402USA000207:Original Case : 2402USA000204 US-009507513-2402USA000208:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Varicella (Chicken Pox) Immunization 06/28/11 12/13/03; This spontaneous report has been received from a physician via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (MARRS #2312USA001546), regarding an 8-year-old female.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-DEC-2003, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) injection, (dosage regimen, lot #, expiry date, route of administration, and indication were not provided). On 28-JUN-2011, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) injection, (dosage regimen, lot #, expiry date, route of administration, and indication were not provided) (Inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2402USA000204:Original Case : 2402USA000204 US-009507513-2402USA000208: US-009507513-2312USA001546:
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hib - Haemophilus Influenza B Vaccine 06/14/03 04/12/03 02/01/03; This spontaneous report has been received from a physician via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (2312USA001546), regarding a 6-month-old female.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-FEB-2003, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, (dosage regimen, lot #, expiry date, route of administration, and indication were not provided). On 12-APR-2003, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, (dosage regimen, lot #, expiry date, route of administration, and indication were not provided). On 14-JUN-2003, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, (dosage regimen, lot #, expiry date, route of administration, and indication were not provided) (Inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2402USA000207: US-009507513-2402USA000204: US-009507513-2312USA001546:
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Joint noise
Clinical narrative: severe shoulder pain; "clicking" in her shoulder; This spontaneous report was received from a physician referring to a 10-year-old female patient, who was an athlete. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 18-JUL-2023, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 18-JAN-2024, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On 07-FEB-2024, the patient began having severe shoulder pain and presented to the physician's office. There was a "clicking" in her shoulder (not specified which side of shoulder was affected). The outcome of the events above was unknown. The action taken with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) regarding the events above was unknown. The reporting physician did not believe the events above were related to the patient receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) but stated that the patient's family thought it might be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).   Lot# is being requested and will be submitted if received.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Alopecia, Alopecia areata, Alopecia totalis, Fungal infection, Madarosis
Clinical narrative: Autonomic, autoimmune, and neurological injuries; Autoimmune, autonomic, and neurological injuries; Autoimmune, autonomic, and neurological injuries; Alopecia areata totalis; Fungal infection / hair loss; Alopecia areata of the scalp / circular areas of hair loss and sparse eyebrows /  lose hair on his eyelids / lost 50% of the total hair on his scalp / alopecia areata totalis; This initial spontaneous report was received from a lawyer and the consumer regarding a case in litigation and refers to a currently adult male patient (pt) of unspecified age. The pt's medical history was not reported. His concurrent conditions included hypoglicemia and asthma, for which he received medical treatment and was being monitored.   On 16-MAY-2016, when the pt was 12 years old, he was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, lot number, expiration date, route of administration, and anatomical location were not provided) administered as prophylaxis.   On 20-JUN-2016, at physician's office visit (POV) the pt presented with complaints of hair loss, he was diagnosed with fungal infection and was prescribed medication to treat. As pt's condition worsened, he was seen by another physician and was diagnosed with alopecia areata of the scalp (Alopecia areata). His hair loss worsened, and on 23-AUG-2016, he returned to physician's office; there it was noted alopecia in his scalp, along with circular areas of hair loss and sparse eyebrows, and lose hair on his eyelids. On 28-SEP-2016, at POV, it was noted that there was no hair re-growth in areas of prior hair loss, and the pt had lost 50% of the total hair on his scalp. On 16-NOV-2016, at POV, the pt's condition had progressed to the point that he was diagnosed with alopecia areata totalis (Alopecia totalis). He also claimed suffered serious and debilitating injuries, including but not limited to autonomic, autoimmune, and neurological injuries (Autoimmune disorder) (Nervous system disorder) (Autonomic nervous system imbalance) and resulting sequalae as a result of receiving the vaccine. Based upon his chronic and severe post-Gardasil symptoms, the pt had been diagnosed with various medical conditions, including but not limited to, alopecia areata totalis; and as a result of his post-Gardasil symptoms, pt had been unable to engage in normal activities that a normal young person would enjoy. The pt had suffered and continued to suffer severe and permanent physical injuries and associated symptomatology and had suffered severe and permanent emotional injuries, including pain and suffering. The outcome of all the events was considered as not recovered.  The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and all the aforementioned events was reported as related and were also considered as disability events.  Upon internal review, the autoimmune disorder was considered as a medically significant event.
Age: 0.5
Sex: M
Vaccine: HEP, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical Assistant called and relayed she is reporting a temperature excursion which occurred on December 30, 2022.  Caller relayed she is calling due to VFC inspection which noted temperature excursion and confirmed no expired vaccines were administe; This spontaneous report was received from a Medical Assistant and refers to a 6-month-old male patient. The patient did not have illness at the time of vaccination, no preexisting conditions, and no concomitant medications.       On 01-AUG-2023, the patient was vaccinated with an incorrect storage dose of  hepatitis b vaccine (recombinant) (RECOMBIVAX HB), lot # U033519, expiration date 10-FEB-2024, and incorrect storage dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (dose, lot # and expiration date were not reported) both vaccines were administered for prophylaxis; route for both vaccines were not reported, but the medical assistant stated generally they give vaccines in the legs. The vaccines reached a low temperature of 35.1F for 31 minutes and 30 seconds (product storage error). This incorrect storage was due to clinical practice error and the temperature excursion occurred because of a reading from a digital data logger. The patient did not experience any adverse events after receiving vaccines involved in a temperature excursion (no adverse event). Also, the patient did no required prescription drug treatments.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2401USA006504: US-009507513-2402USA003950: US-009507513-2402USA003951:
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient received first dose with Heplisav-B, and second dose with Engerix.; Initial report received on 13-Dec-2023  A pharmacist in the reported that a 22-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received a dose of ENGERIX..  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 08-Oct-2023, the patient received the first dose of HEPLISAV-B (lot # 943191, expiration date 21-Feb-2026, and NDC # 43528-003-05) in the left arm (route not specified) from a pharmacist.   On 02-Dec-2023, 35 days after having been vaccinated with HEPLISAV-B, the patient received a dose of ENGERIX (no details provided). No adverse reactions were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered intramuscularly into the right deltoid an expired dose of the Adacel prefilled syringe today, with no reported adverse event; Initial information received on 08-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 30 years old male patient who was inadvertently administered intramuscularly into the right deltoid an expired dose of the Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] prefilled syringe today, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Feb-2024, the patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: U7283AA) (Expiry date: 02-Feb-2024) via intramuscular route in the right deltoid for immunization.  On 08-Feb-2024, the patient was inadvertently administered intramuscularly into the right deltoid an expired dose of the Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] prefilled syringe today, with no reported adverse event (expired product administered) (latency: same day).  It was reported, Medical assistant says that expired ADACEL was administered to a patient. She would like to get information on next steps. This situation is pre-assessed as a medication error/an inappropriate use due to the inadvertent administration of an expired Adacel dose. The patient was inadvertently administered intramuscularly into the right deltoid an expired dose of the Adacel prefilled syringe today, 08 Feb 2024. The Adacel syringe had expired 6 days ago, on 02 Feb 2024. No concomitant vaccines were administered. The treating physician, contact information same as for the reporter.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles symptoms appeared on 02/10/2024, diagnosed by Urgent Care, Valacyclovir prescribed
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was Boostrix instead of Daptacel; 16 months infant recived Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 25A2F, expiry date 19-JAN-2026) for prophylaxis.   On 02-FEB-2024, the patient received Boostrix. On 02-FEB-2024, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: patient was Boostrix instead of Daptacel) and inappropriate age at vaccine administration (Verbatim: 16 months infant recived Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-FEB-2024 The nurse reported a 16 month old female patient was ordered to receive Daptacel, however they were administered Boostrix instead which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. The case is linked with US2024017843, same reporter.; Sender's Comments:  US-GSK-US2024017843:2 of 2 patient (Different patient/ same product)
Age: 0.5
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration; A HCP called to report a TE for PEDVAX HIB and ROTATEQ in which the vaccines had also been administered to a patient on 12/11/2023.; This spontaneous report has been received from a medical assistant and refers to a 6-month-old patient of unknown gender.  The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 04-DEC-2023, b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccines experienced a temperature excursion of 54.3 degrees Fahrenheit (F), within a 9-hour, 32-minute timeframe. On 05-DEC-2023, excursion was of 57.7 F for 15 hours and 30 minutes. On 06-DEC-2023, excursion was at a 50.2 F temperature for 5 hours and 43 minutes, on 07-DEC-2023, 30.6 F for 1 hour and 55 minutes and at a 52. 7 F temperature for 11 hours and 3 minutes. On 11-DEC-2023, the vaccines suffered a temperature excursion again at a 48.4 F temperature for 1 hour and 47 minutes. Later on that same date, the patient was vaccinated with both haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, at a dose of 0.5 milliliter (mL) (lot number X003664 has been determined to be valid for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date reported and validated as 10-NOV-2025); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number 1965644 has been determined to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and validated as 02-OCT-2024). Both vaccines were administered as prophylaxis after they had experienced a temperature excursion (product storage error) (strength, vaccination scheme, anatomical sites of administration and routed of administration were not provided). The patient did not report any adverse issues or side effects caused by the administration.; Sender's Comments:  US-009507513-2401USA015432: US-009507513-2401USA015454: US-009507513-2401USA015463: