chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Muscle fatigue, Pain
Clinical narrative: body aches; muscle fatigue; brain fog; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 04Mar2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 56-year-old male patient received BNT162b2 (BNT162B2), in 2021 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: PAIN (non-serious), outcome "unknown", described as "body aches"; MUSCLE FATIGUE (non-serious), outcome "unknown"; BRAIN FOG (non-serious), outcome "unknown".  Additional information: The patient reported in 2021 a whole slew of things like 13 or 15 days of adverse effects, that included muscle fatigue, brain fog, and body aches, he did not recall any reference number and since he unfortunately suffered from brain fog and if they ask him what he did 8 minutes ago he did not remember much, less about 4 years ago.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Fall
Clinical narrative: fell down on the front porch floor because I was so dizzy from being sick/ fell down because I was so freakin weak. I couldn't even get off the floor; COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-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. The patient's relevant medical history included: "Covid", start date: Aug2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer shots for covid (Dose number unknown (had all the shots and all the boosters)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "COVID"; FALL (hospitalization, medically significant) with onset 2025, outcome "recovered", described as "fell down on the front porch floor because I was so dizzy from being sick/ fell down because I was so freakin weak. I couldn't even get off the floor". The patient was hospitalized for fall (discharge date: 03Mar2025). The event "fell down on the front porch floor because i was so dizzy from being sick/ fell down because i was so freakin weak. i couldn't even get off the floor" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19, fall. Clinical course: the patient came back from (withheld) and got sick, he ended up going to urgent care the next day, they prescribed Paxlovid. "I was dying". They put him in the hospital for a few days, he came home yesterday evening (03Mar2025), he started taking Paxlovid this morning (04Mar2025). He went to get the prescription yesterday, and when he was told how much it was, he was so sick  just said he need something, and he was really sick, and when he got home, he got out truck and fell down on the front porch floor because he was so dizzy from being sick, he fell down because he was so freakin weak, couldn't even get off the floor...he was not a small weak guy, and it just knocked the crap out of him, and they had to take him by ambulance to the emergency room, and once they got the IV in him and got him straightened out, he was able to come back to normal. And they gave him a different type of drug, but it's compatible with Paxlovid, and he had a prescription at home, he hadn't opened it.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: fell down on the front porch floor because I was so dizzy from being sick/ fell down because I was so freakin weak. I couldn't even get off the floor; COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-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. The patient's relevant medical history included: "Covid", start date: Aug2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer shots for covid (Dose number unknown (had all the shots and all the boosters)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "COVID"; FALL (hospitalization, medically significant) with onset 2025, outcome "recovered", described as "fell down on the front porch floor because I was so dizzy from being sick/ fell down because I was so freakin weak. I couldn't even get off the floor". The patient was hospitalized for fall (discharge date: 03Mar2025). The event "fell down on the front porch floor because i was so dizzy from being sick/ fell down because i was so freakin weak. i couldn't even get off the floor" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19, fall. Clinical course: the patient came back from (withheld) and got sick, he ended up going to urgent care the next day, they prescribed Paxlovid. "I was dying". They put him in the hospital for a few days, he came home yesterday evening (03Mar2025), he started taking Paxlovid this morning (04Mar2025). He went to get the prescription yesterday, and when he was told how much it was, he was so sick  just said he need something, and he was really sick, and when he got home, he got out truck and fell down on the front porch floor because he was so dizzy from being sick, he fell down because he was so freakin weak, couldn't even get off the floor...he was not a small weak guy, and it just knocked the crap out of him, and they had to take him by ambulance to the emergency room, and once they got the IV in him and got him straightened out, he was able to come back to normal. And they gave him a different type of drug, but it's compatible with Paxlovid, and he had a prescription at home, he hadn't opened it.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pulmonary embolism
Clinical narrative: pulmonary embolism (PE); she was accidentally given 2 doses; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization), 2 months after the suspect product(s) administration, outcome "unknown", described as "pulmonary embolism (PE)"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "she was accidentally given 2 doses". A patient had an adverse event to the BNT162b2 omicron (kp.2) immunization (she was accidentally given 2 doses by the pharmacist and subsequently (2 months later) developed PE/hospitalization.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID yesterday; diagnosed with COVID yesterday; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 72-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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Mar2025, outcome "unknown" and all described as "diagnosed with COVID yesterday". The patient stated that he was up to date on his shots and everything. So, he didn't know how this happened. They all went on a road trip, his whole family and they all came down with Covid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: have COVID; have COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "can't see" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 6, single; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 7, single; Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have COVID". The patient had COVID. She was too sick and all by herself. When offered an online enrollment, she stated that "when you get old, you can't see". She can't even spell her name anymore when she's sick. The patient has never been this sick in her life and she had eight COVID shots. Her neighbor had to go to pick up her stuff. She couldn't go as she was too sick.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunology test
Clinical narrative: I've got COVID also.; I've got COVID also.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "all kinds of heart problems" (unspecified if ongoing), notes: and this is not doing my constitution a bit of good. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, in Sep2024 as dose number unknown, single; RSV VACCINE taken for immunisation, in Sep2024 as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "not recovered" and all described as "I've got COVID also.". The patient underwent the following laboratory tests and procedures: Immunology test: better immuned. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: HPV9, HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: HCP reported an adult patient missed their 3rd scheduled dose of GARDASIL9. HCP stated the 2nd dose was received over a year ago.  Specific date of administration was not provided. Patient demographics were not provided. No additional information was; No additional AE; This spontaneous report was received from a Nurse regarding an Adult patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection. On an unknown date in 2024 (also reported as over a year ago), the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection; both doses were administered as prophylaxis (exact dose, route of administration, anatomical site of injection, lot number and expiration date were not reported for any of the mentioned vaccines). On an unknown date, the patient missed their 3rd schedule dose of the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) vaccine (Inappropriate schedule of product administration).  No additional adverse event was reported for the patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I've got COVID also. I just don't have it as severe as my wife has got it.; I've got COVID also. I just don't have it as severe as my wife has got it.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "had an attack", start date: 23Sep2024 (unspecified if ongoing), notes: in the hospital on23Sep of this year; "passed out", start date: 23Sep2024 (unspecified if ongoing), notes: in the hospital; "wasn't breathing", start date: 23Sep2024 (unspecified if ongoing), notes: in the hospital; "blood pressure was down", start date: 23Sep2024 (unspecified if ongoing), notes: down to 51; "autoimmune disorder" (ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, start date: Sep2024, stop date: Sep2024; RSV VACCINE taken for immunisation, start date: Sep2024, stop date: Sep2024. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "not recovered" and all described as "I've got COVID also. I just don't have it as severe as my wife has got it.". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient received a second dose of Prevnar 20, when not indicated. Patient already received Prevnar 20 in July 2024, but it was not recorded in the immunization state registry.  Patient stated experiencing redness, swelling, and warmth at vaccination site. Patient states arm is sore and experienced fatigue the following day.
Age: 80.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Pt received a dose in 12/2023 and then a second dose on 03/05/2025
Age: 17.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Mobility decreased
Clinical narrative: Per patient, unable to lift
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Circumstance or information capable of leading to medication error, Scratch
Clinical narrative: 12 year old child here for Immunization VIS handed to patient/guardian. Hep A vaccine was administered, but before MA pulled out needle patient moved and caused the MA to scratch patient with the needle. Mother was there and witnessed, MA asked mother if it was ok to continue administering varicella and she stated that it was ok. Mother stood next to patient and provided comfort for the administration of the varicella vaccine. Patient was advised to stay in clinic 15 minutes after vaccine was administered in case of adverse reaction to vaccine.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Heart rate increased, Pallor, Pruritus, Urticaria
Clinical narrative: hive on lip, pale, feeling faint, increased heart rate, itching
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT STATES SHE HAS HAD SEVERE PAIN IN HER ARM SINCE RECEIVING THE SHOT. SHE HAS TROUBLE LIFTING HER ARM OVER HER HEAD OR REACHING ACROSS HER BODY TO BUCKLE HER SEAT BELT. SHE HAS TRIED EXERCISING IT, AND MASSAGING IT AND THE PAIN WONT GO AWAY
Age: 1.33
Sex: M
Vaccine: DTAP, FLU3, HEPA, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Wrong Vaccines (MMR and Varicella) administered. Treatment was 5mL of Ibuprofen
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: pt complaining from shoulder pain
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Dehydration, Feeling abnormal, Gait disturbance, Pyrexia
Clinical narrative: Patient woke up on Sunday morning feeling  poorly.  He was having fever, up to 102, no appetite and was having issues with walking without assistance. He was taken to the ER on Wednesday and he was given fluids due to the dehydration and the lack of appetite.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Muscle twitching
Clinical narrative: Patient having unilateral facial twitching.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Chills, Fatigue, Headache, Nausea
Clinical narrative: I started feeling very tired and developed a headache around 7 pm, and around 10 pm I developed the chills. Around 4 am I woke up feeling very feverish, nauseous, and weak. Around 7 am I took two Bayer's aspirin and symptoms improved considerably (no more chills or feeling feverish or nauseous). Symptoms disappeared by 1 pm.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: I started feeling very tired and developed a headache around 7 pm, and around 10 pm I developed the chills. Around 4 am I woke up feeling very feverish, nauseous, and weak. Around 7 am I took two Bayer's aspirin and symptoms improved considerably (no more chills or feeling feverish or nauseous). Symptoms disappeared by 1 pm.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Crying, Hypophagia, Pyrexia
Clinical narrative: 2 hrs or so after vaccines started with low grade temps, incosolable - crying fits with parents having to hold constantly and then 3+ days of poor eating
Age: 13.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Fatigue, Seizure, Vomiting
Clinical narrative: Hep A, Varicella & Tdap on 2/19/25. Brief seizure ? & vomiting & fatigue a few days later. Placed neurology referral.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injection site pain, Malaise, Muscular weakness, Pain
Clinical narrative: Pain in right upper arm, soreness & pain running down arm to elbow. Burning stinging just below the injection muscle aches still hurt. Right arm is weak, when writing it hurts, reaching for items it's painful. Right arm still sore & hurts it make me fell ill. I am experiencing chills & pain. No fever. Took Tylenol. Arm still hurt had x-ray done. No treatments.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: Pain in right upper arm, soreness & pain running down arm to elbow. Burning stinging just below the injection muscle aches still hurt. Right arm is weak, when writing it hurts, reaching for items it's painful. Right arm still sore & hurts it make me fell ill. I am experiencing chills & pain. No fever. Took Tylenol. Arm still hurt had x-ray done. No treatments.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMRV, MNQ, TDAP, UNK
Symptoms: Product storage error
Clinical narrative: No adverse effects reported. No additional AE; State and Private ProQuad were moved to the refrigirators where they remained within normal refrigerated temperature range until adminsitration.; This spontaneous report was received from nurse, regarding a 12-year-old male patient. The patient's medical history and concurrent conditions were not reported. Historical vaccines included diphtheria vaccine toxoid (+) Pertussis vaccine acellular 3-component (+) Tetanus vaccine toxoid (BOOSTRIX). Concomitant medications included sterile diluent (BAXTER STERILE DILUENT), Polio vaccine inact 3v (Vero) (IPOL), Meningococcal vaccine A/C/Y/W conj (CRM197) (MENVEO), and hepatitis b vaccine rHBsAg (yeast) (ENGERIX B) . On 13-Jan-2025, the pharmacy received a shipment of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). There was no room in the freezer to accommodate the shipment and it was assumed they could be stored in both freezer and refrigerator, they were moved to the refrigerators where they remained within normal refrigerated temperature range util administration.  Then on 06-Feb-2025, the patient was vaccinated with one of this improperly storage doses, as first dose, of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), in combination with the sterile diluent (BAXTER STERILE DILUENT), subcutaneously in the right arm as prophylaxis (lot number: Y017208, which was determined to be valid, with an expiration date on 13-Apr-2026) (product storage error). No additional adverse events were reported.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMRV, MNQ, TDAP, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported. No additional AE; State and Private ProQuad were moved to the refrigirators where they remained within normal refrigerated temperature range until adminsitration.; This spontaneous report was received from nurse, regarding a 12-year-old male patient. The patient's medical history and concurrent conditions were not reported. Historical vaccines included diphtheria vaccine toxoid (+) Pertussis vaccine acellular 3-component (+) Tetanus vaccine toxoid (BOOSTRIX). Concomitant medications included sterile diluent (BAXTER STERILE DILUENT), Polio vaccine inact 3v (Vero) (IPOL), Meningococcal vaccine A/C/Y/W conj (CRM197) (MENVEO), and hepatitis b vaccine rHBsAg (yeast) (ENGERIX B) . On 13-Jan-2025, the pharmacy received a shipment of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). There was no room in the freezer to accommodate the shipment and it was assumed they could be stored in both freezer and refrigerator, they were moved to the refrigerators where they remained within normal refrigerated temperature range util administration.  Then on 06-Feb-2025, the patient was vaccinated with one of this improperly storage doses, as first dose, of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), in combination with the sterile diluent (BAXTER STERILE DILUENT), subcutaneously in the right arm as prophylaxis (lot number: Y017208, which was determined to be valid, with an expiration date on 13-Apr-2026) (product storage error). No additional adverse events were reported.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, UNK
Symptoms: Product storage error
Clinical narrative: No additional AE; improper storage of product in use; This spontaneous report was received from a registered nurse referring to a 5-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Kinrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid), Havrix (Hepatitis a vaccine inact) . On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be stored in both the freezer and refrigerator and both state and private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration.   On 06-FEB-2025, the patient was vaccinated with the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot#: Y017208, expiration date: 13-APR-2026; strength and dose were not reported) subcutaneously in the left thigh for prophylaxis (product storage error). The dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to the client was received on 13-JAN-2025 and stored in the refrigerator until administered on 06-FEB-2025. No additional adverse event (AE) (No adverse event).  This case was one of several reports received from the same reporter with the case US-009507513-2254349.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improper storage of product in use; This spontaneous report was received from a registered nurse referring to a 5-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Kinrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid), Havrix (Hepatitis a vaccine inact) . On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be stored in both the freezer and refrigerator and both state and private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration.   On 06-FEB-2025, the patient was vaccinated with the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot#: Y017208, expiration date: 13-APR-2026; strength and dose were not reported) subcutaneously in the left thigh for prophylaxis (product storage error). The dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to the client was received on 13-JAN-2025 and stored in the refrigerator until administered on 06-FEB-2025. No additional adverse event (AE) (No adverse event).  This case was one of several reports received from the same reporter with the case US-009507513-2254349.
Age: 6.0
Sex: F
Vaccine: COVID19, IPV, MMRV, COVID19, IPV, MMRV, UNK
Symptoms: Product storage error
Clinical narrative: No additional adverse event was reported; Improper storage of product in use; This spontaneous report was received from a nurse and refers to a 6-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 09-Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y013583, expiration date: 03-Feb-2026), dose number 2, administered by Subcutaneous route in Left Thigh for prophylaxis. On 09-Jan-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), for prophylaxis (lot # and expiration date were not reported). On 09-Jan-2025, the patient started therapy with Moderna COVID-19 vaccine (Elasomeran) (lot #3044210) (Dose 1, right thigh), administered by Intramuscular route for prophylaxis (expiration date was not reported). On 09-Jan-2025, the patient started therapy with Ipol (Polio vaccine inact 3v (Vero)) (lot #W1C831M) (Dose 2, right thigh), administered by Subcutaneous route for prophylaxis (expiration date was not reported). Those product were stored in inappropriate temperature (Product storage error). No additional adverse event was reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/14/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 6.0
Sex: F
Vaccine: COVID19, IPV, MMRV, COVID19, IPV, MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event was reported; Improper storage of product in use; This spontaneous report was received from a nurse and refers to a 6-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 09-Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y013583, expiration date: 03-Feb-2026), dose number 2, administered by Subcutaneous route in Left Thigh for prophylaxis. On 09-Jan-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), for prophylaxis (lot # and expiration date were not reported). On 09-Jan-2025, the patient started therapy with Moderna COVID-19 vaccine (Elasomeran) (lot #3044210) (Dose 1, right thigh), administered by Intramuscular route for prophylaxis (expiration date was not reported). On 09-Jan-2025, the patient started therapy with Ipol (Polio vaccine inact 3v (Vero)) (lot #W1C831M) (Dose 2, right thigh), administered by Subcutaneous route for prophylaxis (expiration date was not reported). Those product were stored in inappropriate temperature (Product storage error). No additional adverse event was reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/14/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: M
Vaccine: HEP, IPV, MMRV, TDAP, HEP, IPV, TDAP, UNK, UNK
Symptoms: Product storage error
Clinical narrative: No additional adverse event was reported; Improper storage of product in use; This spontaneous report was received from a nurse and refers to a 9-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 31-Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017208, expiration date: 13-Apr-2026), dose number 1, administered by Subcutaneous route in Right Arm for prophylaxis. On 31-Jan-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) for prophylaxis. On 31-Jan-2025, the patient started therapy with Engerix b (Hepatitis b vaccine rHBsAg (yeast)) (lot #95BJ9) (Dose 1, right arm), administered by Intramuscular route (expiration date was not reported) for prophylaxis. On 31-Jan-2025, the patient started therapy with Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) (lot #CX4HL) (Dose 1, right arm), administered by Intramuscular route (expiration date was not reported) for prophylaxis. On 31-Jan-2025, the patient started therapy with Ipol (Polio vaccine inact 3v (Vero)) (lot #Y1A201M) (Dose 1, right arm), administered by Subcutaneous route (expiration date was not reported) for prophylaxis. Those vaccines underwent temperature excursion (Product storage error). No additional adverse events were reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 12/08/2015 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: M
Vaccine: HEP, IPV, MMRV, TDAP, HEP, IPV, TDAP, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event was reported; Improper storage of product in use; This spontaneous report was received from a nurse and refers to a 9-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 31-Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017208, expiration date: 13-Apr-2026), dose number 1, administered by Subcutaneous route in Right Arm for prophylaxis. On 31-Jan-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) for prophylaxis. On 31-Jan-2025, the patient started therapy with Engerix b (Hepatitis b vaccine rHBsAg (yeast)) (lot #95BJ9) (Dose 1, right arm), administered by Intramuscular route (expiration date was not reported) for prophylaxis. On 31-Jan-2025, the patient started therapy with Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) (lot #CX4HL) (Dose 1, right arm), administered by Intramuscular route (expiration date was not reported) for prophylaxis. On 31-Jan-2025, the patient started therapy with Ipol (Polio vaccine inact 3v (Vero)) (lot #Y1A201M) (Dose 1, right arm), administered by Subcutaneous route (expiration date was not reported) for prophylaxis. Those vaccines underwent temperature excursion (Product storage error). No additional adverse events were reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 12/08/2015 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Antinuclear antibody, C-reactive protein increased, Full blood count normal, Metabolic function test normal, Urticaria
Clinical narrative: pt says she started having a fever, joint pain, chills, a rash, that progressed. Her rash is worse now and she developed swelling. She had an US to on her right leg to rule out a blood clot. She was found to have a lot of inflammation within her body.  She has auto immune disease. She is being referred to a rheumatologist. She went to dermatologist Dr She has had a couple biopsy's on the rash. She is on steroids, steroid cream and anti inflammation medicine. She follow up with specialists and continue to take the prescribed medication.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Antinuclear antibody positive, Arthralgia, Biopsy skin, Blood test, Chills
Clinical narrative: pt says she started having a fever, joint pain, chills, a rash, that progressed. Her rash is worse now and she developed swelling. She had an US to on her right leg to rule out a blood clot. She was found to have a lot of inflammation within her body.  She has auto immune disease. She is being referred to a rheumatologist. She went to dermatologist Dr She has had a couple biopsy's on the rash. She is on steroids, steroid cream and anti inflammation medicine. She follow up with specialists and continue to take the prescribed medication.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Swelling, Ultrasound Doppler
Clinical narrative: pt says she started having a fever, joint pain, chills, a rash, that progressed. Her rash is worse now and she developed swelling. She had an US to on her right leg to rule out a blood clot. She was found to have a lot of inflammation within her body.  She has auto immune disease. She is being referred to a rheumatologist. She went to dermatologist Dr She has had a couple biopsy's on the rash. She is on steroids, steroid cream and anti inflammation medicine. She follow up with specialists and continue to take the prescribed medication.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Joint swelling, Pain, Rash, Urticaria
Clinical narrative: pt says she started having a fever, joint pain, chills, a rash, that progressed. Her rash is worse now and she developed swelling. She had an US to on her right leg to rule out a blood clot. She was found to have a lot of inflammation within her body.  She has auto immune disease. She is being referred to a rheumatologist. She went to dermatologist Dr She has had a couple biopsy's on the rash. She is on steroids, steroid cream and anti inflammation medicine. She follow up with specialists and continue to take the prescribed medication.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Pharmacist called to report 25 year old male was administered first dose of GARDASIL 9 in APR2023 and second dose in JUN2023 but has not yet received their third dose.; No adverse event; This spontaneous report has been received from a pharmacist concerns a 25-year-old male patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided. On an unknown date in April 2023, the patient received first dose of HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (GARDASIL 9) suspension for injection (strength, exact dose, anatomical route of administration, lot number and expiration date were not reported) and second dose in June 2023, but has not yet received their third dose (inappropriate schedule of product administration).   No additional adverse event.  Additional information is not expected.
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VFC immunization coordinator calling to report T/E for  ROTATEQ, and VAXNEUVANCE that was administered.   T/E date was on 2/18/2025 and ROTATEQ and VAXNEUVANCE were administered on 2/25/2025.  Permission was given to contact HCP by email. No addition; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 25-FEB-2025, the patient was vaccinated with the third dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) 0.5 mL Injection, administered as prophylaxis (lot number reported as Y005465, which has been verified as valid, expiration date reported and validated as 08-JAN-2027) (dose, route of administration, and anatomical site of injection were not provided); and with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral suspension, administered orally as prophylaxis (lot number reported as Y005878, which has been verified as valid, expiration date reported and validated as 28-OCT-2025) (strength and dose were not provided).  The administered doses were exposed to a temperature excursion of 32 Fahrenheit degrees (F) for 2 hours and 12 minutes (Product storage error). No additional adverse events were reported.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient did not report any adverse issues or side effects related to the administered dose; A HCP called to inquire about the validity and potency of an expired dose of PNEUMOVAX 23 (lot: W027449 expiration: 09/25/2024) that was inadvertently administered to a patient on 03/04/2025.  The patient did not report any adverse issues or side eff; This spontaneous report was received from a pharmacist and refers to a(n) 53-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 04-Mar-2025, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) injection, at a dose of 0.5 milliliters (mL), lot #W027449; which has been verified to be a valid, expiration date reported and upon internal validation established as 25-Sep-2024 (strength, dose number, route, anatomical site of administration and vaccination scheme frequency were not provided) for prophylaxis (Expired product administered). The vaccine had never been exposed to any temperature excursions. The HCP was provided with a "not supported" outcome per the Post Expiry Memo Vaccines and Biologics Administered. The patient did not report any adverse issues or side effects related to the administered (No adverse event).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I receive shingles twice, even with a shingles shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I receive shingles twice, even with a shingles shot). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2025 This case was reported by a patient via interactive digital media. The patient received shingles twice, even with a shingles shot. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; My doctor has had patients get shingles from the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My doctor has had patients get shingles from the vaccine). The outcome of the vaccination failure and shingles were not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-FEB-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his/her doctor had patients get shingles from the vaccine. The reporter stated that if you recognized a rash or spots and take care of it quickly you would not had a problem. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; generally have recurrent outbreaks every; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: generally have recurrent outbreaks every). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure and herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2025 This case was reported by a reporter via interactive digital media. The reporter reported that for what it was worth, the vaccine was worth getting. Unfortunately, despite being vaccinated, the patient generally had recurrent outbreaks every 12-18 months. But thanks to that vaccine, his/her outbreak was very small, about the size of a half dollar. The patient had learned to always have a prescription for valacyclovir on hand so the reporter could start treatment the moment it started. Still painful and not fun but resolves within a few days. The patient could not imagine how bad it would be if the patient had not been vaccinated. This case was considered as suspected vaccination failure as details time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. 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 shingles) is considered unrelated to GSK Shingles vaccine.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Underdose
Clinical narrative: NONE, LOW DOSE (HALF THE ADULT DOSE)