chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Urticaria
Clinical narrative: Hives and fever started approximately 2 hours following vaccination.  Patient had been experiencing cough x 2 months. CXR showed LLL infiltrate. Treated with prednisolone. Also advised mother to use Zyrtec and/or Benadryl PRN for itching. Tx pneumonia with Azithromycin and Albuterol. Vital signs stable at visit on 10/25/24.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Starting a few hours after vaccination, pt experienced fever, chills, body aches, joint pain, sweating, severe pain, pain with breathing, red/hard/painful/itchy bump at injection site. Patient reports feeling similar to when she had shingles about a year prior.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pain, Painful respiration
Clinical narrative: Starting a few hours after vaccination, pt experienced fever, chills, body aches, joint pain, sweating, severe pain, pain with breathing, red/hard/painful/itchy bump at injection site. Patient reports feeling similar to when she had shingles about a year prior.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Starting a few hours after vaccination, pt experienced fever, chills, body aches, joint pain, sweating, severe pain, pain with breathing, red/hard/painful/itchy bump at injection site. Patient reports feeling similar to when she had shingles about a year prior.
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event reported by patient during outreach. Patient informed that vaccine was administered early. It should have been administered on patient's. Patient feeling fine and did not report any untoward reaction or symptom at the time of the telephone encounter.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Symptoms: reddness, tenderness, hot to the touch, pain to touch, swollen
Age: 11.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna Covid 19 vaccine is for patients aged 12 and over.  Patient is 11 years 3 months.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Discomfort, Fine motor skill dysfunction, Lymphadenitis, Lymphadenopathy, Pain
Clinical narrative: Patient with him some mild decreased motor skill due to discomfort and pain. Vascular     and sensory exam seem to be normal. No redness or swelling at the site but     tenderness at the shoulder with mild reactive lymph node in the left supraclavicular area     and 1 or 2 in the left axillary region. Likely inflammation from IM injection. Recommend     continue with Motrin Tylenol as needed, range of motion exercises. Anticipate     improvement in the next 2 to 3 days. Return as needed for worsening symptoms     nonresolution or as needed
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Patient with him some mild decreased motor skill due to discomfort and pain. Vascular     and sensory exam seem to be normal. No redness or swelling at the site but     tenderness at the shoulder with mild reactive lymph node in the left supraclavicular area     and 1 or 2 in the left axillary region. Likely inflammation from IM injection. Recommend     continue with Motrin Tylenol as needed, range of motion exercises. Anticipate     improvement in the next 2 to 3 days. Return as needed for worsening symptoms     nonresolution or as needed
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported by patient. Patient informed that he received a 2nd RSV dose. Patient have no reported symptom doing well at the time of telephone encounter. Thank you.
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Vaccination error
Clinical narrative: Gave RSV Vaccine when it was not needed.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was brought to the Immunization Clinic's mass vaccination flu event with his family. The family was receiving the flu vaccines together and the parent was given the correct flu screening form which was pre-filled with the age-appropriate vaccine Flulaval which was to be used for 6mo-2yrs. For the mass vaccination event our team was using a color system to indicate which vaccine was appropriate for each patient on their screening form as we carry three different flu vaccines. Flulaval is indicated with a green dot, Afluria 3y+ with a blue dot, and Fluzone HD with a yellow dot. Our medical support assistant had the color chart and was given instruction prior to the event but mistakenly put a blue dot for Afluria on the patient's screening form. The vaccinator an RN reviewed the form and noted the discrepancy but did not question it and gave Afluria as she does not normally work in immunizations and figured that as the patient is 2 and close to 3 that Afluria was appropriate. The error was caught by our documenter and this nurse notified the parents by phone the following morning. The father stated over the phone that the patient seemed fine that morning and was currently at daycare during our call. Father was given precautions to watch for adverse reactions as well as a sincere apologize for the error. Staff of the event were all instructed to slow down and verify the six rights of medication administration regardless of the color system.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Mobility decreased, Muscle tightness, Myalgia, Tension
Clinical narrative: patient stated that she started to get dizzy and decided to lay down. after laying for a few minutes she states that her whole body became tense and further progressed to her muscles locking up. she states that she lay unable to move or even call for help for over an hour in immense pain because her muscle were locked up as a reaction to the shots she received earlier that day on 10/24/2024. after roughly 1 hour she states that she slowly began to gain movement back in her body and was able to get back up and move around. she states that even now a day later she is very sore and concerned about the scary reaction she experienced.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event or symptom reported by patient at the time of telephone encounter. Provided information to patient that a 2nd dose of RSV was administered for awareness. Thank you. Patient was fine and no symptoms noted.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: patient came in and requested a covid vaccination; however, patient received the flu vaccine. Patient came in today and requested the flu vaccination; however, she already received it so the covid was given today
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: fatigue, chills, upset stomach, sore throat, runny nose, muscle ache
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: fatigue, chills, upset stomach, sore throat, runny nose, muscle ache
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site warm to the touch immediately following injection (10/22) and still warm evening of 10/25. Raise red bumps appeared around the day after injection. Raised red bumps became itchy on 10/24. Raised red site is still itchy and warm to the touch on 10/25 at 5pm. The raised red bump measures 1.75" wide by 1.5" high.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Fibrin D dimer normal, Troponin normal
Clinical narrative: chest pain lasting about 48 hours
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No side effects reported; expired MMRII was inadvertently administered after its labeled expiry date; This spontaneous report was received from a pharmacist and refers to a 13-month-old patient of unknown gender.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 10-SEP-2024, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, expiration date: 25-MAY-2024, administered for prophylaxis (strength, lot #, and route of administration were not provided).  No side effects were reported.  This is one of several reports received from the same reporter.  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2409USA009168: US-009507513-2409USA009587:MSD
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; vaccines were administered after experiencing a temperature excursion; This spontaneous report was received from nurse and refers to a 15-month-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 23-JUL-2024, the patient was vaccinated with third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # Y003146 (which was internally validated), expiration date: 12-SEP-2026, intramuscularly in right thigh(strength and dose were not provided). The vaccine was improperly stored (Product storage error). Administered vaccine was exposed to the temperature excursion (temperature: 8.8 C; for 4 minutes and 45 seconds).There was no previous temperature excursion. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose
Clinical narrative: baby spit up their administered dose of ROTATEQ; baby spit up their administered dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a 9 weeks old infant patient of unknown gender. Information regarding the patient's current condition, historical condition and concomitant medication was nor provided.    On 22-OCT-2024 (the event onset date was reported as 22-OCT-2024), the patient was vaccinated with dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (2 milliliter; strength, dose number, batch/lot# and expiration date were unknown) orally for prophylaxis.         On 22-OCT-2024, the patient spit up the administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (infantile spitting up, accidental underdose). The outcome of infantile spitting up and accidental underdose was unknown. the causality between infantile spitting up and the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was unknown.     Lot# is being requested and will be submitted if received.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Anti-HBs Antibody Negative; Literature report:  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to an adult patient of unknown gender.  On an unknown date, the patient (adult at the time of vaccination) was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, units, route and anatomical locations, lot# and expiration date were not reported) for prophylaxis.  On an unknown date, the patient had negative or indeterminate serum Hepatitis B antibody (HBsAb) level.  The event of Anti-HBs antibody negative was considered to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two cases derived from the same literature article (cross referenced with MARRS#2409USA009667).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: arm was hard; Arm was red; Arm was swelling; Severe sore arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 29Y9K, expiry date 17-MAY-2026) for prophylaxis.   On 21-MAY-2024, the patient received the 1st dose of Shingrix (left deltoid). On 21-MAY-2024, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Severe sore arm). On an unknown date, the patient experienced induration (Verbatim: arm was hard), erythema of extremities (Verbatim: Arm was red) and swelling arm (Verbatim: Arm wasswelling). On 04-JUN-2024, the outcome of the pain in arm was resolved. The outcome of the induration, erythema of extremities and swelling arm were not reported.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the induration, erythema of extremities and swelling arm to be related to Shingrix.     The company considered the pain in arm to be related to Shingrix. It was unknown if the company considered the induration, erythema of extremities and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-OCT-2024 The nurse reported that a patient received Shingrix vaccine and after receiving vaccine experienced severe sore arm. The patient also experienced arm was hard, red and swollen.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia
Clinical narrative: Tingling skin; This non-serious case was reported by a other health professional and described the occurrence of tingling skin in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ZK9P4) for prophylaxis.   On 30-SEP-2024, the patient received Bexsero (intramuscular) .5 ml. On 30-SEP-2024, less than a day after receiving Bexsero, the patient experienced tingling skin (Verbatim: Tingling skin). On 01-OCT-2024, the outcome of the tingling skin was resolved (duration 1 day).   It was unknown if the reporter considered the tingling skin to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the tingling skin to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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-OCT-2024  The patient experienced tingling skin and symptoms were treated.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B pediatric dose given to adult patient; underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 52-year-old female patient who received HBV (Engerix B pediatric) (batch number 4ZN3H, expiry date 28-MAR-2025) for an unknown indication.   On 25-SEP-2024, the patient received Engerix B pediatric. On 25-SEP-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose given to adult patient) and underdose (Verbatim: underdose). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt date: 26 Sept 2024 The medical assistant called to report that a pediatric dose of Engerix-B was administered to an adult patient which led to underdose and adult use of a child product.
Age: 15.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Assistants gave the Kinrix vaccine to a 15 years old Patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Previously administered products included IPV (received 4 doses of IPV vaccine on an unknown date), Dtap (received 5 doses of Dtap vaccine on an unknown date) and Tdap (received Tdap at 11 year of age).   On 27-JUN-2024, the patient received Kinrix. On 27-JUN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Assistants gave the Kinrix vaccine to a 15 years old Patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-SEP-2024 A medical assistant reported that one of their medical assistants gave the Kinrix vaccine to a 15 years old patient, which led to inappropriate age at vaccine administration. The Kinrix vaccination intention was unclear. This case is linked with case US2024118265, reported by the same reporter; Sender's Comments:  US-GSK-US2024118265:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient had the first dose in 2023 and the 2nd dose in July 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2023).   In JUL-2024, the patient received the 2nd dose of Shingrix. In JUL-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient had the first dose in 2023 and the 2nd dose in July 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2024 The reporter reported that the patient had the first dose of Shingrix in 2023 and the 2nd dose in July 2024. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: inadvertently gave two doses of the Menveo.; Menveo administered instead of Bexsero.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo).   On 03-OCT-2024, the patient received the 2nd dose of Menveo. On an unknown date, the patient did not receive Bexsero. On 03-OCT-2024, an unknown time after receiving Menveo and not applicable after receiving Bexsero, the patient experienced accidental overdose (Verbatim: inadvertently gave two doses of the Menveo.) and wrong vaccine administered (Verbatim: Menveo administered instead of Bexsero.). The outcome of the accidental overdose and wrong vaccine administered 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: 03-OCT-2024 The pharmacist called and reported that a patient was supposed to get a dose of Menveo and a dose of Bexsero and a nurse practitioner inadvertently gave two doses of the Menveo, which led to accidental overdose and wrong vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Product storage error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 12-month-old female patient who received MMR (Priorix) (batch number LY377, expiry date 01-APR-2025) for prophylaxis.   On 20-SEP-2024, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Product storage error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter stated that they recently started using Priorix because they switched from using the MMR vaccine.  The MMR was frozen, but priorix they realized after it was too late that it was also placed in the freezer. The reporter asked, whether patient had to be reimmunized if they gave frozen Priorix. The Priorix vaccine was stored at minus 21.8 degree Celsius for 2 months and administered to a patient, which led to incorrect storage of drug. This was 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123890:same reporter US-GSK-US2024123952:same reporter
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Administration of Arexvy in pregnancy; mother received Arexvy instead of Abryso; Administration of Arexvy in pregnancy; Live birth; This non-serious retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of drug use in unapproved population in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   On an unknown date, the patient received Arexvy and Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: Administration of Arexvy in pregnancy), wrong vaccine administered (Verbatim: mother received Arexvy instead of Abryso), vaccine exposure during pregnancy (Verbatim: Administration of Arexvy in pregnancy) and live birth (Verbatim: Live birth). The outcome of the drug use in unapproved population, wrong vaccine administered, vaccine exposure during pregnancy and live birth were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Exposure (Abrysvo): To mother in third trimester Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK Receipt date : 10-OCT-2024 The patient was the new born whose mother received Arexvy instead of Abryso of Pfizer when she was between 32 to 36 weeks of gestation pregnant, which led to wrong vaccine administered and drug use in unapproved population. They were not the facility where the vaccine was administered and they did not have information about lot numbers or mother's information.  The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Intercepted product prescribing error
Clinical narrative: Inappropriate age/Is this patient eligible to receive Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 24-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient did not receive Arexvy. On 11-OCT-2024, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: Inappropriate age/Is this patient eligible to receive Arexvy). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2024 The pharmacist reported that a 24 year old patient present to his/her pharmacy today (on the day of reporting) requesting for Arexvy vaccine based on her doctor's recommendation. The reporter asked, was this patient eligible to receive Arexvy, which led to intercepted drug prescribing error.
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: only received the adjuvant; only received the adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4LJ4T, expiry date 12-OCT-2025) for prophylaxis.   On 11-OCT-2024, the patient received Arexvy. On 11-OCT-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: only received the adjuvant) and inappropriate dose of vaccine administered (Verbatim: only received the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2024 The pharmacist reported that a Arexvy vaccine was administered to two patients and after vaccination it was discover that one of them only received the adjuvant but did not know who received a complete dose and who received the adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2024125611:Duplicate case
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administration of the Shingrix adjuvant potion only; administration of the Shingrix adjuvant potion only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number AQF3R, expiry date 26-OCT-2026) for prophylaxis.   On 11-OCT-2024, the patient received the 1st dose of Shingrix. On 11-OCT-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administration of the Shingrix adjuvant potion only) and inappropriate dose of vaccine administered (Verbatim: administration of the Shingrix adjuvant potion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2024 The pharmacist reported that the administration of the Shingrix adjuvant portion only to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Bone marrow transplant, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; subsequently developed shingles; patient had received a bone marrow transplant; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17-JAN-2024, the patient received the 2nd dose of Shingrix. On 23-OCT-2023, 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: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: subsequently developed shingles) and bone marrow transplant (Verbatim: patient had received a bone marrow transplant). The outcome of the vaccination failure and shingles were unknown and the outcome of the bone marrow transplant was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and bone marrow transplant to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles and bone marrow transplant to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that a physician reached out to her regarding a patient that completed the Shingrix series, and the patient had subsequently developed shingles. At the time of reporting, the pharmacist did not have any patient specific details, and did not have dose lot number/expiration data. The pharmacist did not know when the patient developed shingles, but believed it was recently in 2024. The healthcare professional (HCP) mentioned that the patient had received a bone marrow transplant which was not stated in the original case with the 1st line agent. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding  time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers .No concomitant medications were reported. Patient stated that she had an allergic reaction after getting the covid vaccine (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainting in association with injection of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Fainting in association with injection of the vaccine) in a 21-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043333) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 5 microgram. On 18-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced SYNCOPE (Fainting in association with injection of the vaccine) (seriousness criterion medically significant). On 18-Oct-2024, SYNCOPE (Fainting in association with injection of the vaccine) had resolved.            No concomitant medications were reported. The patient had fainting in association with injection of the vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: breaking out in chronic hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA CHRONIC (breaking out in chronic hives) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA CHRONIC (breaking out in chronic hives) (seriousness criterion medically significant). At the time of the report, URTICARIA CHRONIC (breaking out in chronic hives) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-775775 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775775:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: has pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (has pain in the arm) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Belly ache. Previously administered products included for Belly ache: dicyclomine. Past adverse reactions to the above products included No adverse effect with dicyclomine.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 21-Oct-2024, the patient experienced PAIN IN EXTREMITY (has pain in the arm). At the time of the report, PAIN IN EXTREMITY (has pain in the arm) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: Device malfunction; Liquid squirted out; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: DEVICE MALFUNCTION (non-serious), outcome "unknown"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "Liquid squirted out".  Additional information: a caller wanted to report a product quality complaint, a device malfunction, it's for ABRYSVO, the active vial presentation. So, when they wanted to administer it, pushed it down, the liquid squirted out. Confirmed that it was not administered to any patient.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Overdose, Product preparation error, Pyrexia
Clinical narrative: a dose of COVID-19 6mos-4year old and it was not diluted when given to a patient; a dose of COVID-19 6mos-4year old and it was not diluted when given to a patient; fever; supersick; This is a spontaneous report received from a Nurse from medical information team, Program ID.  A 2-year-old male patient received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), on 17Oct2024 as dose 1, single (Lot number: LN7305) at the age of 2 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset Oct2024, outcome "not recovered", described as "fever"; ILLNESS (non-serious) with onset Oct2024, outcome "not recovered", described as "supersick"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 17Oct2024, outcome "unknown" and all described as "a dose of COVID-19 6mos-4year old and it was not diluted when given to a patient". Therapeutic measures were taken as a result of pyrexia, illness which included TYLENOL.  Additional information: The patient had no prior vaccination within 4 weeks. The nurse needed some clarity on the situation a dose of COVID-19 6mos-4year old and it was not diluted when given to a patient. The nurse wanted to know if there was an adverse effect. HCP advised that on 17Oct2024, a 2 year old, male patient was given a dose of the Pfizer BioNTech Covid-19 vaccine for 6 months to 4 years which is undiluted. HCP also advised that this is the patient's 4th dose and the 1st Pfizer. She mentioned patient was running a fever and was supersick.
Sex: F
Vaccine: RSV
Symptoms: Exposure via skin contact, Occupational exposure to product, Syringe issue
Clinical narrative: while in process of mixing medication, top of syringe cracked/inverted solution to pull up syringe, medication fell into her hands; while in process of mixing medication, top of syringe cracked/inverted solution to pull up syringe, medication fell into her hands; while in process of mixing medication, top of syringe cracked/inverted solution to pull up syringe, medication fell into her hands; while in process of mixing medication, top of syringe cracked/inverted solution to pull up syringe, medication fell into her hands; This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: KC7884, Expiration Date: Oct2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), SYRINGE ISSUE (non-serious), DEVICE LEAKAGE (non-serious) and all described as "while in process of mixing medication, top of syringe cracked/inverted solution to pull up syringe, medication fell into her hands".  Additional information: The pharmacist was asking to get replacement. The pharmacist clarified, has all of the components for Abrysvo, was all connected. It was just the stopper that broke off, when trying to invert it. There was nothing on the adapter itself, threw the outside part away. It was on the 4th step, reconstitution, did not realize there was information on all these pieces. The sample of the product available to be returned, if requested was Yes.  Causality for "while in process of mixing medication, top of syringe cracked/inverted solution to pull up syringe, medication fell into her hands" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: body aches; Fever; chills; vomiting; nausea; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Oct2024 at 02:30 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs allergy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 14Oct2024 as dose number unknown, single. Past drug history included: Metronidazole, reaction(s): "Allergy". The following information was reported: PYREXIA (non-serious) with onset 22Oct2024, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 22Oct2024, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 22Oct2024, outcome "recovering"; NAUSEA (non-serious) with onset 22Oct2024, outcome "recovering"; VOMITING (non-serious) with onset 22Oct2024, outcome "recovering". Therapeutic measures were not taken as a result of pain, pyrexia, chills, vomiting, nausea.  Additional information: The patient had not received any other vaccines on the same date as the vaccine(s) for which they are reporting. The patient was not taking any other medications within 2 weeks of the event starting. The vaccine batch/lot not available/provided to reporter at the time of report completion.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Hypertonic bladder
Clinical narrative: Overactive Badder lasting two weeks beginning three days after shot; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Oct2024 at 02:30 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 04Oct2024 as dose 1, single), in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERTONIC BLADDER (non-serious) with onset 07Oct2024, outcome "recovered" (Oct2024), described as "Overactive Badder lasting two weeks beginning three days after shot". Therapeutic measures were not taken as a result of hypertonic bladder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the vaccines which were reported. The patient was not taking any other medications within 2 weeks of the event starting. It was reported that overactive bladder lasting two weeks beginning three days after shot, no prior bladder issues, no history of UTIs. It was reported that the patient not had known allergies.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Brain fog, Headache, Nausea
Clinical narrative: brain fog; nausea; headache; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Oct2024 at 14:15 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 22Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMICTAL; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: BRAIN FOG (non-serious) with onset 23Oct2024 at 10:00, outcome "not recovered"; HEADACHE (non-serious) with onset 23Oct2024 at 10:00, outcome "not recovered"; NAUSEA (non-serious) with onset 23Oct2024 at 10:00, outcome "not recovered". Therapeutic measures were not taken as a result of brain fog, nausea, headache.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the Pfizer vaccine. The patient didn't take any other medications within 2 weeks of the event starting. Patient was not hospitalized due to the events.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site haemorrhage
Clinical narrative: Bleeding at the injection site; unfortunately it was either vaccine. The pharmacy documented both as being in the right deltoid, however the injection that bled was in the left deltoid.; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Oct2024 at 16:30 as dose 1, single (Lot number: LN0588) at the age of 49 years, in left deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 22Oct2024 as dose number unknown, single (Lot number: 2724L), in left deltoid for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious) with onset 22Oct2024 at 16:30, outcome "recovered" (Oct2024), described as "Bleeding at the injection site; unfortunately it was either vaccine. The pharmacy documented both as being in the right deltoid, however the injection that bled was in the left deltoid.". Therapeutic measures were not taken as a result of vaccination site haemorrhage.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the vaccine(s) for which was reported. Patient was taking any other medications within 2 weeks of the event starting.  No follow-up attempts are possible.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, COVID-19, Drug ineffective, Illness, Weight
Clinical narrative: after getting vaccine, ended up making sick and got Covid; after getting vaccine, ended up making sick and got Covid; sick; This is a spontaneous report received from an Other HCP, Program ID.  A 60-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Jan2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 59 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Thyroid problems" (unspecified if ongoing); "UTI" (unspecified if ongoing), notes: Has been suffering from a UTI for longest time, may be E. coli. Concomitant medication(s) included: SYNTHROID oral taken for thyroid disorder (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "after getting vaccine, ended up making sick and got Covid"; ILLNESS (non-serious), outcome "unknown", described as "sick". The patient underwent the following laboratory tests and procedures: Body height: 5 feet 3 inches or 5 feet 4 inches; Weight: Over 180 something pounds. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Caller stated caller got the shot, the COVID vaccine, at (Withheld) along with caller's son. However, after getting the vaccine it ended up making caller and caller's son sick and they got Covid. When caller came back to the pharmacy to get the administration sheet, caller checked the name of the person who administered the vaccine, and the person is not of caller's knowing. Caller stated it is like the person is not anyone from the pharmacy (Withheld).; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug effective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202400286566 same reporter, similar events, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Glaucoma
Clinical narrative: glaucoma; wiped out/Fatigue; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-016122 (Biontech).  A 79-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT) at 300 mg (300mg, every other week), subcutaneous for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GLAUCOMA (medically significant), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "wiped out/Fatigue". The clinical course was reported as follows: Patient had glaucoma and wiped out after getting dupilumab via dupilumab single dose pre-filled pen injection and a covid-19 vaccine 24 hours prior to the dupilumab injection. The patient reported being treated for glaucoma and was seeing his eye doctor every 4 months instead of every 6 months. The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of glaucoma.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  BNT162b2 omicron (kp.2) is under agreement with BIONTECH SE.