chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Menstrual period, which had been regular at 29-30 days for 4.5 years, arrived 17 days early following this 3rd (booster) dose of Covid-19 Vaccine.   A second event occurred 6 weeks later, on 1/14/22.    I began having mild balance and coordination deficits, along with severe vision dysfunction.    My vision became blurry and diplopic or double vision, as I was seeing 2 images when looking with both eyes.    After assessment by optometrist, who diagnosed CN4 Palsy, a brain MRI presented with multiple active lesions in multiple areas of the brain, ultimately leading to Diagnosis of Multiple Sclerosis.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: none
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: On August 10, 2023 Medical gave Pedvax Hib to a 4 year old patient instead of giving Proquad.  No signs or symptoms were reported. Parents were called and advised to bring patient in for
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Injection site pain, Mobility decreased, Sleep disorder
Clinical narrative: Severe pain where I got the shot for weeks. Thenboth hamstrings tighened to where I couldn't straighten my legs fully and it was difficult to walk. Shoulder pain restricted the use of right arm. Hard to sleep. Dr. prescribed Naprozen for 5-days and it did nothing to help. The Dr. proscribed Prednisone, 20mg a day for 5-days, which relieved the pain and hamstring problem within 36-hours. 3-days after the Predisone ended, the problems returned. Tried Prenisone again for 5-days and it relieved problems but hey returned after stoppig the drug. Now on Prednisone for 3rd time, but the 5mg dose doesn't work. Still in severe pain and can hardly use arm.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Tendon disorder
Clinical narrative: Severe pain where I got the shot for weeks. Thenboth hamstrings tighened to where I couldn't straighten my legs fully and it was difficult to walk. Shoulder pain restricted the use of right arm. Hard to sleep. Dr. prescribed Naprozen for 5-days and it did nothing to help. The Dr. proscribed Prednisone, 20mg a day for 5-days, which relieved the pain and hamstring problem within 36-hours. 3-days after the Predisone ended, the problems returned. Tried Prenisone again for 5-days and it relieved problems but hey returned after stoppig the drug. Now on Prednisone for 3rd time, but the 5mg dose doesn't work. Still in severe pain and can hardly use arm.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine on 02/15/2023 with vaccine that expired on 02/10/2023 by former employee.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pruritus, Pyrexia
Clinical narrative: VESICULAR - NON PRURITIC ERUPTIONS ON BILATERAL LOWER EXTREMITIES, UPPER RIGHT EXTREMITY AND FACE. CHILD FEBRILE. NO OTHER ADVERSE REACTIONS.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 50.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Fatigue, Pain, Pyrexia, Skin exfoliation
Clinical narrative: Within 24 hours pt had fatigue, fever, body aches, within 3 days cutaneous skin started sloughing on LUE then whole BSA face, arms, neck, upper, lower extremities and trunk. NO mucous involvement, no oral, vaginal, rectal involvement. No abd pain, n/v. No cough or respiratory problems. No difficulty swallowing
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event occurred.  The HIB vaccine was administered 2 days after the expiration date.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Erythema, Headache
Clinical narrative: Severe sleepiness to the point of sleep paralysis continuing for about 24 hours from onset at 10 hours after vaccine.  Nausea, diarrhea, dizziness, lack of appetite, headache, swollen Left arm (size of grapefruit, hot hard, itchy, red) from hour 10 thru bedtime on day 2.  Swollen arm symptoms and diarrhea continuing thru day 3 and 4.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Induration, Nausea, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Severe sleepiness to the point of sleep paralysis continuing for about 24 hours from onset at 10 hours after vaccine.  Nausea, diarrhea, dizziness, lack of appetite, headache, swollen Left arm (size of grapefruit, hot hard, itchy, red) from hour 10 thru bedtime on day 2.  Swollen arm symptoms and diarrhea continuing thru day 3 and 4.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Sleep paralysis, Somnolence
Clinical narrative: Severe sleepiness to the point of sleep paralysis continuing for about 24 hours from onset at 10 hours after vaccine.  Nausea, diarrhea, dizziness, lack of appetite, headache, swollen Left arm (size of grapefruit, hot hard, itchy, red) from hour 10 thru bedtime on day 2.  Swollen arm symptoms and diarrhea continuing thru day 3 and 4.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 on August 14, 2023,  patient expired on August 20, 2023.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Back pain, Fall, Pain, Pain in extremity
Clinical narrative: PATIENT FELL SEVERE ARM SORE RADIATING UP THE ARM AND ACROSS BACK AND DOWN THE LOWER BACK
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Patient received vaccines and after leaving the room and going to checkout area patient syncope (pale and felt like fainting). Kept patient sitting down on the floor, gave patient water, took pulse ox, other staff went to get provider from a patient room and checked out patient. Waited till patient felt better about (10-15mins) to get up and sit down in the waiting room, gave patient electrolytes, MA staff waited with patient in the waiting room about another 10mins till skin color came back and felt better to leave.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Loss of consciousness, Tremor, Urinary incontinence
Clinical narrative: A few minutes after receiving vaccine per the guardian the patient experienced loss of consciousness, light shaking, and urinated. Patient regained consciousness quickly and the paramedics were called and she received medical attention. Paramedics assisted patient to hospital for further assessments.
Age: 31.0
Sex: F
Vaccine: COVID19, HEP
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness, Vomiting
Clinical narrative: Dizziness, vomiting, tiredness, flu-like illness, headache
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Patient presented to clinic with urticaria noted to scalp, bilateral cheeks, left jaw line, right ear, bilateral arms/legs and buttock.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site mass
Clinical narrative: Noticed a lump at pt vaccine site
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Full blood count, Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On August 19 at 11:00 a.m., pain began in the site where the vaccine was administered. After an hour the site of the arm was completely swollen, hot to the touch, and the child could not tolerate the pain, at 6:00 a.m. PM was admitted to the hospital through the emergency room, because his arm measured 5 cm more than normal, he also had his arm immobilized from pain and high fever (38.4)
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test, Liver function test, Pyrexia, Ultrasound scan
Clinical narrative: On August 19 at 11:00 a.m., pain began in the site where the vaccine was administered. After an hour the site of the arm was completely swollen, hot to the touch, and the child could not tolerate the pain, at 6:00 a.m. PM was admitted to the hospital through the emergency room, because his arm measured 5 cm more than normal, he also had his arm immobilized from pain and high fever (38.4)
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Occupational exposure to product
Clinical narrative: HCP called to report that some of the MMR II vaccine got into her eye ( HCP is the affected person) after administration to a patient/ A few drops from the hub is what entered her eye.; HCP states that after flushing her eyes she started to get a headache; This spontaneous report has been received from a health care professional (HCP), regarding to herself, a 66-years-old female patient. The patient's pertinent medical history, previous drug reactions and concomitant medications were not reported. Allergies included to amoxicillin.   On 26-JUL-2023, the HCP administered the patient the entire deliverable dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection, at a dose of 0.5 milliliters as prophylaxis (lot number: X002294, which was determined to be invalid by the validation lot team) (strength, scheme, route and anatomical location of administration were not reported).  After administration, some drops from the hub of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II vaccine got into the HCP's eyes (Occupational exposure to product). HCP states that after flushing her eyes she started to get a headache.   Reporter notes she has no complaints about the quality of the product as she was calling to make sure she did everything she needed to do after exposure. The outcome of the events was reported as recovering.   The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and headache was not reported
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from an other and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in May 2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #W001518, expiration date: 13-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). Those vaccines underwent temperature excursion in 58.65 Farenheit (F) (47 Farenheit to 77 Farenheit) for 25 hours 45 minutes (Product storage error). No additional adverse events were reported.  This is non-valid case due to lack of multiple patients identifiers.  Follow-up was received on on 17-AUG-2023: The patient identifiers was updated such as name and date of birth. On 12-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: It was MMRV by Merck Lot # T027114 exp. 02/07/2022 that was given 02/08/2022 to one of my grandchildren; This spontaneous report was received from a consumer and refers to a child patient (also reported as grandchildren) of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-FEB-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, valid lot #T027114, expiration date: 07-FEB-2022, administered for prophylaxis (dose, frequency, strength, anatomical location, and route of administration were not provided) (Expired product administered).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE; HCP reported that an unknown adult patient was administered the PROQUAD and VARIVAX vaccines concomitantly.; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.       On 12-AUG-2023 the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) on that same day (accidental overdose and no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HBP calling to report the administration of an expired dose of PNEUMOVAX 23 SYRINGE to a patient on 08/15/2023.  No symptoms reported and no further details provided.  No other AE and no PQC; This spontaneous report was received from Other Health Professional and refers to a patient of an unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U027357, expiration date: 25-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided). On that day, the patient was administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). No symptoms were reported and no further details provided. No other adverse events (AE) and no product quality complaint (PQC) were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: a dose of MMRII that was administered post expiry. HCP states the MMRII expired on 04AUG2023, and was administered 11AUG2023. HCP states the patient reports no side effects; HCP states the patient reports no side effects; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender.  On 11-AUG-2023 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status: rHA (recombinant Human albumin), lot# U024229, expiry date: 04-AUG-2023 for prophylaxis (dose and route of administration were not provided) that was administered post expiry date (expired product administered). No side effects were reported by the patient. The product never experienced any temperature excursions.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Nurse reported VAQTA was administered after improper storage; unknown of VAQTA was prefilled syringe or vial, however it is known that it was a pediatric dose administered. The operator of the device was a healthcare professional. Requested follow up; This spontaneous report was received from a registered nurse (RN) referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 28-JUL-2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), 1st dose (pediatric) for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number X003791 with an expiration date of 01-JUN-2024). The administered dose of the vaccine experienced a temperature excursion of 51 degrees Fahrenheit for 1 hour. There were no previous temperature excursions. It was not reported if this information was recorded by a data logger or not.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 16-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 6-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection,  lot #W001518, expiration date: 13-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection,  lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from Other and refers to a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided).This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 14.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: No additional AE; Inappropriate schedule of vaccine administered; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 14-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #W001518, expiration date: 13-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Inappropriate schedule of product administration). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 5-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from Other and refers to a 7-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from Other and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #W001518, expiration date: 13-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received and refers to a 5-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 14-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 1-year-old patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 7-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided).This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 1-year-old patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 11-year-old patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 7.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 7-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 7.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 7-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #W001518, expiration date: 13-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided).This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 14-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Age: 14.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 14-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #W001518, expiration date: 13-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; Medical Tech calls to report vaccine given during an excursion.  No PQC. No further AE  TE Case02454494; This spontaneous report was received from pharmacy technician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, one time, lot #w024333, expiration date: 01-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine was administered during an excursion (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; Medical Tech calls to report vaccine given during an excursion.  No PQC. No further AE  TE Case02454494; This spontaneous report was received from Consumer and refers to a. patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-AUG-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, one time, lot #w024333, expiration date: 01-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 15-AUG-2023, Medical Tech called to report vaccine given during an excursion. No PQC. No further AE. TE Case02454494.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; Medical Tech calls to report vaccine given during an excursion.  No PQC. No further AE; This spontaneous report has been received from a medical tech and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 15-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, once time (valid lot number W024333 [expiration date 01-AUG-2024]) (dose, dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion (product storage error).   No further adverse events (AEs) details.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2308USA007438:
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reported AE of expired VARIVAX that was inadvertently administered to a patient. No known temperature excursions. No symptoms reported. Obtained consent to contact HCP. No additional AE/PQC.; No additional AE/; This spontaneous report has been received from a nurse and refers to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 18-AUG-2023, the patient was vaccinated an expired vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (valid lot number U025202 [expiration date 13-AUG-2023]) (dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis (expired product administered) concomitantly with sterile diluent. No known temperature excursions. No symptoms reported.  No additional adverse event (AE).