chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mite allergy, Respiratory tract congestion, SARS-CoV-2 test positive, Tinnitus
Clinical narrative: 2/5/23   I did not sleep all night. I became very congested and had trouble breathing. The next morning, I took an at home COVID test which was positive.  I went to pharmacy and had a positive test. I was unable to see a doctor. I called my PCP and was prescribed an antibiotic, not sure of name, and prednisone. I took the prednisone for 2 days and was unable to urinate, so I stopped it.  I finished the antibiotic. I was told not to take a decongestant because of my Losartan. I called my PCP back and told them I was miserable with congestion. I was told I could take one dose here and there of Alka Seltzer Cold. It ran its course. I was very tired, which remained.  I started feeling tinnitus in my ear. I went back to my PCP and had ear wax removed. The tinnitus continued.  The Allergist approved blood test to see what I was allergic to.  The bloodwork revealed I was allergic to dust mites which I am taking allergy shots for.  I saw an ENT doctor on 3/10/23 who prescribed two weeks of antibiotic because I had an infection in my nose.  I saw a different ENT doctor last week and had a hearing test and was told I had hearing loss.  I have a CT of my sinuses is scheduled next week.
Age: 1.42
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: The patient was given a higher dose of the vaccine than needed.  The patient was then observed by the nurse for over an hour. The doc of day went in and assessed the patient. The manager was informed and spoke with the family. Called the on-call pediatrician for advice on what to do next and informed family of his recommendations.  Nurse followed up with family on 04/17/23 to which the dad stated that the patient was doing fine.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a second dose of Moderna Bivalent covid-19 vaccine. Standing orders from the state have not been issued hence the need for this to be reported as it was given out of the recommendations by the state.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Hypertension
Clinical narrative: I went to my doctor for a routine exam, they noticed my blood pressure was high. She checked it at the end of the exam, it was still high, she prescribed me medication to help bring it down. We have been watching my blood pressure and I have been following up with her every month and my blood pressure is currently back to normal.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Ascites, Coronary artery disease, Essential hypertension, Obstructive sleep apnoea syndrome
Clinical narrative: G47.33 OBSTRUCTIVE SLEEP APNEA 4/5/2022 ASCITES I20.8 STABLE ANGINA 2/11/2022 ASCITES G47.33 OBSTRUCTIVE SLEEP APNEA 4/5/2022 ESSENTIAL HTN I20.8 STABLE ANGINA 2/11/2022 ESSENTIAL HTN G47.33 OBSTRUCTIVE SLEEP APNEA 4/5/2022 CAD WO ANGINA, MULTIPLE VESSEL I20.8 STABLE ANGINA 2/11/2022 CAD WO ANGINA, MULTIPLE VESSEL G47.33 OBSTRUCTIVE SLEEP APNEA 4/5/2022 HX OF ACUTE KIDNEY INJURY I20.8 STABLE ANGINA 2/11/2022 HX OF ACUTE KIDNEY INJURY
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered a second dose of Moderna Bivalent covid-19 vaccine. Standing orders from the state have not been issued hence the need for this to be reported as it was given out of the recommendations by the state.  No adverse reactions noted during the observation period.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: On April 22, 2023, about 10am, I, RPH, administered a Pfizer monovalent Covid Vaccine (NDC: 59267102504) to the patient. I had not worked since April 18th, 2023. I did not realize that the guidelines had changed on April 19th, 2023. The patient had never received a Covid vaccine so I administered based on the old guidelines, believing they were the most current.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pelvic fracture
Clinical narrative: I95.9 HYPOTENSION 5/17/2021 RIGHT PUBIS UNSPECIFIED TYPE FX, INIT
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Hypotension
Clinical narrative: I95.9 HYPOTENSION 2/3/2021 COVID-19 PNEUMONIA
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Impaired work ability, Vertigo, Vertigo positional
Clinical narrative: The first bout of Vertigo happened as I lay down to bed that evening.  This continued the next day as soon as I tried to sit up.  I tried to get up and failed.  Vertigo lasted all day and I was unable to perform my job.  Vertigo continued into the next day, but it was not as severe.  Went into doctor?s office.  Doctor performed a physical exam.   Diagnosed Vertigo based on observations.  Doctor recommended  Cawthorne Exercises and proscribed Meclizine as needed.  No vertigo since the doctor?s visit on 3/29.
Age: 78.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: COVID-19, Fatigue, Myalgia, SARS-CoV-2 test positive
Clinical narrative: On 2/8/2023, I began to feel very tired and have muscle aches. The symptoms worsened throughout the day, so I decided to go to the doctor on 2/9/2023. I underwent a PCR test and got a positive result. The doctor prescribed me Paxlovid, which I began taking that afternoon. I began to feel better pretty quickly. I isolated for either ten days or two weeks. I never developed any other symptoms besides the muscle aches and fatigue, and I had those only maybe two or three days. After I recovered, I felt fine and didn't have any residual symptoms. In fact, after the first two or three days, I felt well enough to go outside and walk for exercise.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Hearing has been impacted. Enconutering a constant woshing whistling  sound.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus that became distracting after contracting covid in late August 2022
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Back pain, Brain fog, COVID-19, Cough
Clinical narrative: In October in 2022 I noticed I had a rash on my breastbone.  It was raised, red, itchy bumps.  It appears different on my chest than on my face.  On my face it looks more like acne with white heads and would become dry and scaly.  It started to appear on my face in February 2023.  It got worse as I got emotionally stressed.  I finally went to the doctor in April 2023 and diagnosed with dandruff on chest and face in addition to rosacea on my face.  I received prescriptions for Doxycycline, face wash, Sodium Fulsacetamide Wash, Ketoconazole cream for my face.  I began noticing symptoms for COVID-19 on February 4, 2023, and tested positive on the 6th. My symptoms were severe fatigue, joint pain, back pain, coughing and a runny nose.  The symptoms progressed within 36 hours, and I had a bad cough and sore throat.  I had a telehealth appointment and was prescribed Paxlovid.  I felt better within the first day.  I just remained fatigued and had brain fog for about another week.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dandruff, Dry skin, Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: In October in 2022 I noticed I had a rash on my breastbone.  It was raised, red, itchy bumps.  It appears different on my chest than on my face.  On my face it looks more like acne with white heads and would become dry and scaly.  It started to appear on my face in February 2023.  It got worse as I got emotionally stressed.  I finally went to the doctor in April 2023 and diagnosed with dandruff on chest and face in addition to rosacea on my face.  I received prescriptions for Doxycycline, face wash, Sodium Fulsacetamide Wash, Ketoconazole cream for my face.  I began noticing symptoms for COVID-19 on February 4, 2023, and tested positive on the 6th. My symptoms were severe fatigue, joint pain, back pain, coughing and a runny nose.  The symptoms progressed within 36 hours, and I had a bad cough and sore throat.  I had a telehealth appointment and was prescribed Paxlovid.  I felt better within the first day.  I just remained fatigued and had brain fog for about another week.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Rhinorrhoea
Clinical narrative: In October in 2022 I noticed I had a rash on my breastbone.  It was raised, red, itchy bumps.  It appears different on my chest than on my face.  On my face it looks more like acne with white heads and would become dry and scaly.  It started to appear on my face in February 2023.  It got worse as I got emotionally stressed.  I finally went to the doctor in April 2023 and diagnosed with dandruff on chest and face in addition to rosacea on my face.  I received prescriptions for Doxycycline, face wash, Sodium Fulsacetamide Wash, Ketoconazole cream for my face.  I began noticing symptoms for COVID-19 on February 4, 2023, and tested positive on the 6th. My symptoms were severe fatigue, joint pain, back pain, coughing and a runny nose.  The symptoms progressed within 36 hours, and I had a bad cough and sore throat.  I had a telehealth appointment and was prescribed Paxlovid.  I felt better within the first day.  I just remained fatigued and had brain fog for about another week.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rosacea, SARS-CoV-2 test positive, Skin exfoliation, Stress
Clinical narrative: In October in 2022 I noticed I had a rash on my breastbone.  It was raised, red, itchy bumps.  It appears different on my chest than on my face.  On my face it looks more like acne with white heads and would become dry and scaly.  It started to appear on my face in February 2023.  It got worse as I got emotionally stressed.  I finally went to the doctor in April 2023 and diagnosed with dandruff on chest and face in addition to rosacea on my face.  I received prescriptions for Doxycycline, face wash, Sodium Fulsacetamide Wash, Ketoconazole cream for my face.  I began noticing symptoms for COVID-19 on February 4, 2023, and tested positive on the 6th. My symptoms were severe fatigue, joint pain, back pain, coughing and a runny nose.  The symptoms progressed within 36 hours, and I had a bad cough and sore throat.  I had a telehealth appointment and was prescribed Paxlovid.  I felt better within the first day.  I just remained fatigued and had brain fog for about another week.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Laboratory test abnormal, Neuropathy peripheral
Clinical narrative: I had losing sensation in the fingertips, they feel numb a lot, I have also lost sensation in my toes. I had test run to find that I had peripheral neuropathy in my hands, arms, legs, feet. I am not taking medication for this at this time. I am not experiencing pain, burning sensation.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test normal, Gastric ulcer, Gastric ulcer surgery, Magnetic resonance imaging normal
Clinical narrative: 3/18/23 -  I had an ulcer in my stomach.  I had to have surgery on 3/20/23. I had x-ray, blood tests, MRI and they were all normal.  I had a patch placed.  I was placed on several medications, Omeprazole, Tamulosin and Eliquis.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: 3/18/23 -  I had an ulcer in my stomach.  I had to have surgery on 3/20/23. I had x-ray, blood tests, MRI and they were all normal.  I had a patch placed.  I was placed on several medications, Omeprazole, Tamulosin and Eliquis.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient received Proquad dose, when only needed MMR.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, VARCEL, DTPPVHBHPB, PNC13, RV5, VARCEL
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client at clinic accompanied by mother and father for 2 month immunizations. Client properly identified by name and DOB. Client properly screened for allergies (food/medication) and medical conditions. Explained to mother and father what vaccines are to be received. Nurse began by first  administering Rotavirus vaccine via oral administration. No adverse reaction. Patient tolerated Rotavirus vaccine well. Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well. Nurse then proceeded to administer PCV vaccine intramuscular to left vastus lateralis. No adverse reaction noted. Patient tolerated  PCV vaccine well. Nurse then administered Varicella vaccine subcutaneously on left arm. No adverse reaction noted. Patient tolerated Varicella vaccine well. Nurse advised mother and father of possible side effects of vaccines and what precautions to take if necessary. Mother, father and patient were then escorted back to main lobby to await finalization of paperwork. Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made. LVN was notified, as was Nurse Supervisor. The mother and father were called back in to discuss the medication error and its possible side effects. Nurse and RN viewed all three injection sites and determined they were within normal limits. Patient was observed for 30 minutes with no adverse reaction noted. Mother and father were encouraged to inquire any questions they have before departing.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, VARCEL, DTPPVHBHPB, PNC13, RV5, VARCEL
Symptoms: Medication error, No adverse event, Product administration error
Clinical narrative: Client at clinic accompanied by mother and father for 2 month immunizations. Client properly identified by name and DOB. Client properly screened for allergies (food/medication) and medical conditions. Explained to mother and father what vaccines are to be received. Nurse began by first  administering Rotavirus vaccine via oral administration. No adverse reaction. Patient tolerated Rotavirus vaccine well. Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well. Nurse then proceeded to administer PCV vaccine intramuscular to left vastus lateralis. No adverse reaction noted. Patient tolerated  PCV vaccine well. Nurse then administered Varicella vaccine subcutaneously on left arm. No adverse reaction noted. Patient tolerated Varicella vaccine well. Nurse advised mother and father of possible side effects of vaccines and what precautions to take if necessary. Mother, father and patient were then escorted back to main lobby to await finalization of paperwork. Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made. LVN was notified, as was Nurse Supervisor. The mother and father were called back in to discuss the medication error and its possible side effects. Nurse and RN viewed all three injection sites and determined they were within normal limits. Patient was observed for 30 minutes with no adverse reaction noted. Mother and father were encouraged to inquire any questions they have before departing.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Tinnitus
Clinical narrative: Constant ringing and hearing loss in left ear that continues to get worse.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Immunisation reaction, Injection site pain, Muscle swelling
Clinical narrative: Patient was given a 3rd dose of Shingrix.. Patient return to Clinic three days after injection complaining of reaction. SHe had a 3-4 inch raised area over her deltoid muscle region. Did complain of pain at the injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other AEs/PQCs; VARIVAX was administered after temperature excursion.; This spontaneous report was received from a licensed vocational nurse (LVN) 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 an unknown date, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dosage form, administered for prophylaxis lot# W022605, expiration date: 17-JUL-2024 (strength and route of administration were not provided) after temperature excursion of -13.5 degree Celsius for 5 minutes (product storage error ). There was no previous temperature excursion. No other adverse events reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Off label use
Clinical narrative: A doctor in (name unknown) recommended the male patient have the HPV vaccine for his throat cancer.; No Additional AE reported; This spontaneous report was received from a physician via company representative referred to a male patient in his 60s. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant therapies were unknown.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, anatomical location and route of administration were unknown) for throat cancer which was advised by a specialist (off label use).  It was reported that the patient had a dental practice office next door to the physician's practice. The patient had retired from his dental practice and moved out of the area. No Additional adverse event was reported (no adverse event).
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: HCP listed below who reported a 4 y/o female was administered a dose of PROQUAD that was reconstituted with an expired diluent; HCP listed below who reported a 4 y/o female was administered a dose of PROQUAD that was reconstituted with an expired diluent; No additional AE  reported; This spontaneous report was received from a pharmacist referring to a 4-year-old female patient. Information regarding the patient's medical history, concomitant medications, drug allergies or reactions were not provided.   On unspecified date, the patient was vaccinated at a pediatric clinic with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported/unknown by the reporter) which was not expired; nonetheless, the vaccine was diluted with an expired diluent, lot #T018038(expiration date 22-DEC-2022) (expired product administered and product preparation issue).  No further adverse events were reported (No adverse events).  This was one of several reports from the same reporter.; Sender's Comments:  US-009507513-2304USA002815:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Physician called to report administered expired PROQUAD AE. PROQUAD expiration was 04/03/2023 and it was administered 04/07/2023; This spontaneous report was received from physician referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 07-APR-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (therapy type: recombinant human albumin (rHA)), lot #U039260, expiration date: 03-APR-2023, administered for prophylaxis (strength, route of administration, vaccination scheme frequency, anatomical location, dose, lot number and expiration date were not reported) (Expired product administered). No additional adverse event (AE) was reported (no adverse event).
Age: 77.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; TE with PNEUMOVAX 23 PFS; This spontaneous report was received from a consumer and refers to a 77-year-old patient of unknown gender.. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 03-MAR-2023, the patient was vaccinated  with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #W027449, expiration date: 25-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F). The excursion was discovered upon looking at the data logs. Data logger recorded a 46.7F on 03-MAR-2023 and did not record again until logging a 43F temperature on 06-MAR-2023 (product storage error). No additional adverse event (AE).  This is one of 9 reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002750: US-009507513-2304USA002667: US-009507513-2304USA002694: US-009507513-2304USA002746:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report a TE for GARDASIL 9, product administered after the excursion.; No additional AEs. No PQCs.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drugs reactions or allergies, and concomitant medications were not reported.   On 05-APR-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot number: W010661, expiration date reported as 19-OCT-2024), administered for prophylaxis (strength, dose, and route of administration were not provided) after it was exposure to a temperature excursion (product storage error). The temperature excursion was of 61.7 Fahrenheit degrees for 4 hours 39 minutes. It was reported that there was not a previous temperature exclusion. No additional adverse event was reported.
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: The caller was patient's mother. The caller stated that her son received the MMR II vaccine 16FEB2023 and now has a rash  all over his face , arms, legs, and lower back.; The caller was patient's mother. The caller stated that her son received the MMR II vaccine 16FEB2023 and now has a rash  all over his face , arms, legs, and lower back.; This spontaneous report has been received from a consumer concerning her son of a 13-month-old male patient. His concurrent conditions, medical history, and concomitant therapies were not reported.   On 16-FEB-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection 0.5 ml (strength, dose, route of administration were not provided; lot# U006485 and expiration date) for prophylaxis.   On 13-MAR-2023, the patient had a rash all over his face, arms, legs, and lower back, and the provider stated it looked like Rubella rash. Besides, the provider thought it was from the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine. The provider did not know how long it would take the rash to go away. At the time of this report, the outcome of the events was not reported. The action taken regarding the events with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not applicable.   The causality between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was related.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional information or AE's reported; one expired dose of PNEUMOVAX 23 (syringes) was administered to a patient on 3/23/23 and vaccine expired on 1/28/23.; This spontaneous report was received from a nurse and referred to a 66-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 23-MAR-2023, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 ml injection, 1 quantity, lot #U026796, expiration date: 28-JAN-2023, administered intramuscularly for prophylaxis (expired product administered). There was no previous temperature excursion reported. No additional adverse event (AE) was reported.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Product use issue
Clinical narrative: Product use in unapproved indication; Product use in unapproved population; Literature Report:    Information has been received from the authors of a published literature article, titled as stated above, regarding a 58-year-old male post Left Ventricular Assist Device (LVAD) with hoarseness post implant related to intubation injury. He received a heart transplant in February 2022, with persisting hoarseness 3 months after surgery. A laryngoscopy was done which noted bulky papilloma with central vascularization on medial surface of bilateral arytenoids, left vocal fold, and vallecula. Ear Nose & Throat (ENT) recommended that the patient be given the HPV vaccine (manufacturer unknown) to prevent recurrence and regrowth (Product use in unapproved indication, Product use issue)  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: MMR
Symptoms: Product use issue
Clinical narrative: patient with CID vaccinated with MMR;   Information has been received from the authors of a published literature article, titled as stated above, regarding a 12-year-old female patient.  The patient's concurrent conditions included hypogammaglobulinaemia, T-,B-cell  lymphopenia, and combined immunodeficiency (CID). The patient's medical history included recurrent herpes simplex virus (HSV) gingivostomatitis, bacterial pneumonia, and cutaneous abscesses. Concomitant therapies were not reported.  On an unknown date, the CID patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (route, dosage information and lot number were not provided) (product use in unapproved population).  A copy of the published article is attached as further documentation of the patient's experience
Age: 0.92
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer called for a temperature excursion of VARIVAX was administered; This spontaneous report was received from a medical assistant referring to a unknown number of patients of unknown age and gender. The patients' medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019628, expiration date 19-DEC-2023 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  No information about the temperature excursion was provided.  Follow up information has been received on 10-MAR-2023.  varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot numberW018828 expiration date 14-JUN-2024), and  Lot number W006412 expiration date 23-FEB-2024) (dose and route of administration) for prophylaxis (product storage error), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019627, expiration date 19-DEC-2023)  (product storage error).  Follow up information has been received on 18-APR-2023.  It referred to a 11 months old female patient. On 20-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W006412, expiration date 23-FEB-2024, intramuscular in the right thigh) for prophylaxis (product storage error). Temperature excursion occurred as result of reading from digital data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report was received from a medical assistant referring to a unknown number of patients of unknown age and gender. The patients' medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019628, expiration date 19-DEC-2023 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  No information about the temperature excursion was provided.  Follow up information has been received on 10-MAR-2023.  varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot numberW018828 expiration date 14-JUN-2024), and  Lot number W006412 expiration date 23-FEB-2024) (dose and route of administration) for prophylaxis (product storage error), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019627, expiration date 19-DEC-2023)  (product storage error).    This is a non-valid case due to the lack of patient identifiers.  Follow up information has been received from an other healthcare professional on 18-APR-2023. The reporter specified the patient's information. Therefore, this valid case was split from original case 2303USA002114. This spontaneous report was regarding a 12-month-old male patient. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported. On 02-DEC-2022. the vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W018828, expiration date 14-JUN-2024) underwent temperature excursion for 30 min. The digital data logger was involved in recording excursion details. On 29-DEC-2022, the patient was vaccinated with the improperly stored vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W018828, expiration date 14-JUN-2024, strength and dose were not reported) intramuscularly (IM) at right thigh for prophylaxis at private doctor's office/hospital (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114: US-009507513-2304USA007837:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion and administered to patient; This spontaneous report was received from a medical assistant referring to a 12-month-old male patient. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 07-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# W006412, expiration date upon internal review was established as 23-FEB-2024, dose and strength were not reported) intramuscularly in right thigh for prophylaxis at a private doctor's office/hospital, after a temperature excursion. Total time in the range of -14 degree Celsius to -10 degree Celsius was 1 hour. Total combined excursion time was 1 hour (product storage error). This adverse event was previously reported to manufacturer. No additional adverse events were provided (no adverse event).  This is one of several reports reported by the same reporter.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling.; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-FEB-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, lot# W019627 and expiration date was estimated to 19-DEC-2023 (strength and exact dose were not provided) administered intramuscularly for prophylaxis.  Reporter called for a temperature excursion and reported measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) that had undergone temperature excursion was administered to patient (product storage error). No additional adverse event (AE) was reported.  Lot number [W019627] has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD)   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:
Sex: F
Vaccine: VARCEL
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored vaccine was administered to patients; This spontaneous report was received from an other health care professional referring to 13-month-old female patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 23-FEB-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) injection (VARIVAX) (intramuscularly in right thigh, lot #W006412, expiration date 23-FEB-2024, exact dose and dose number were not provided) for prophylaxis.  On 20-JAN-2023, the suspect vaccine experienced a temperature excursion from -14 to -10 degrees Celsius for 1 hour (product storage error). There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). It was indicated that medication error could occur during storage in clinical practice. Adverse event had been reported previously to manufacturer. The patient was vaccinated at private doctor's office/hospital. Temperature excursion occurred as a result of a reading from a Data Logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114: US-009507513-2304USA007723: US-009507513-2304USA007731: US-009507513-2304USA007733: US-009507513-2304USA007842:
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; Subcutaneous vaccine administered intramuscularly (IM) in the right thigh; temperature excursion; This spontaneous report was received from a medical assistant concerning to a 13-month-old male patient. His medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date in January 2023, several vaccines which included a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number W006412 (expiration date: 23-FEB-2024) went trough a temperature excursion (about 1 hour at -14 degrees Celsius to -10 degrees Celsius) (Product storage error) and on 22-FEB-2023, the patient was vaccinated at a private doctor's office with this dose, intramuscularly as prophylaxis (strength, was not provided) (Subcutaneous injection formulation administered by other route).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007733: US-009507513-2304USA007731: US-009507513-2304USA007759: US-009507513-2304USA007810: US-009507513-2304USA007822: US-009507513-2304USA007828: US-009507513-2304USA007837: US-009507513-2304USA007842: US-009507513-2304USA007844: US-009507513-2304USA007848: US-009507513-2304USA007857: US-009507513-2304USA007860: US-009507513-2304USA007866: US-009507513-2304USA007869: US-009507513-2304USA007881: US-009507513-2304USA007884: US-009507513-2304USA007886: US-009507513-2304USA007889: US-009507513-2304USA007891: US-009507513-2304USA007902: US-009507513-2304USA007907: US-009507513-2304USA007927: US-009507513-2304USA007942: US-009507513-2304USA007988: US-009507513-2304USA008013: US-009507513-2304USA008017:
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excusion; This spontaneous report has been received from a medical assistant, concerning a 14-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 30-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, right thigh, intramuscular (valid lot number W006412 [expiration date 23-FEB-2024 obtained per internal validation]) (dose, vaccination scheme, anatomical location, and frequency were not provided) for prophylaxis, after a temperature excursion. Total time in the range of -14 degrees Celsius (C) to -10 degrees C: 120 hours. Total time in the range of 9 degrees C to 25 degrees C: 20 minutes. Total combined excursion time: 120 hours, 20 minutes, 0 seconds (product storage error).   No additional adverse events were provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:origical case US-009507513-2304USA007931:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE; HBP calling to request information regarding revaccination of a 3 year old child that received 2 doses of VAQTA that were given less than 6 months apart. The interval between the first and second dose was 5 months and 25 days. Doses were given outsid; This spontaneous report was received from Pharmacist and refers to a 3-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 20-APR-2023, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 20-APR-2023, HBP called to request information regarding revaccination of a 3 year old child that received 2 doses of hepatitis a vaccine, inactivated (VAQTA) that were given less than 6 months apart. The interval between the first and second dose was 5 months and 25 days. Doses were given outside the recommended intervals drom the hepatitis a vaccine, inactivated (VAQTA) PI (Inappropriate schedule of vaccine adminsitered). No additional AE/PQC reported.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No Additional AE; Pharmacist called to report that PRIORIX sterile water/diluent was used to reconstitute MMRII and administered; This spontaneous report was received from a pharmacist and refers to a 3-year-old male patient. No information on patient medical history, current conditions and concomitant medications was provided.    On 18-APR-2023 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # U039549 and exp. Date 14-DEC-2023 for prophylaxis (exact dose and route of administration were not provided).  Other suspect therapies included water for injection (STERILE WATER) which was used to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (product preparation error and no adverse event).; Sender's Comments:  US-009507513-2304USA008628:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: completion of a GARDASIL 9 series for a 36 year old whose last dose was on 03/2022; No additional AE details or PQC.; This spontaneous report was received from a medical assistant and refers to a 36-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in March 2022, the patient was vaccinated with the first dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, lot #, expiry date, and route of administration were not provided) as prophylaxis. The reporter informed that the patient would complete the vaccination scheme in more than a year (Inappropriate schedule of product administration). No adverse event was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Vaccination failure
Clinical narrative: Leg has lost nerve feeling; I have terrible pain, ruining my life!; Both shots, now terrible case of Shingles/suspected vaccination failure; Terrible case on left leg, groin and buttock; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 81-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. In APR-2023, several months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Both shots, now terrible case of Shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Terrible case on left leg, groin and buttock). On an unknown date, the patient experienced nerve damage (Verbatim: Leg has lost nerve feeling) and pain (Verbatim: I have terrible pain, ruining my life!). The outcome of the vaccination failure was unknown and the outcome of the shingles, nerve damage and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, nerve damage and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 18-Apr-2023 The patient never before had shingles was suggested to him or her to have the new Shingles vaccine because of his or her age and immune deficiency.  The patient had both shots within the past couple of months and had contracted a terrible case of shingles last week on my left leg. groin and buttock, the left leg had lost nerve feeling and had terrible pain. The physician said that he had never seen anything like this before and said this would probably last for 2 to 3 months, ruining the patient's life. The reporter did not want a phone call and just want to know that the vaccine did not work. The reporter denied to follow-up. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: About 5 patients miss the 2nd dose due to COVID-19 pandemic; This non-serious case was reported by a other health professional via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date 1st dose of Shingrix received.).   On an unknown date, the patients did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: About 5 patients miss the 2nd dose due to COVID-19 pandemic). The outcome of the social problem was unknown.   Additional Information: GSK Receipt date 14-APR-2023 The pharmacy technician stated that the pharmacy had several patients received there first dose of Shingrix and then miss the 2 to 6 month dosing window for the second dose, due to COVID-19 pandemic. At the time of reporting the reporter known about 5 patients that they know of so far. The reporter did not had any of the patient dosing information. The reporter did consent to follow up via fax, phone or mail.; Sender's Comments:  US-GSK-US2023055332:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Received unstable vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 65-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 05-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: Received unstable vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-APR-2023 The patient who received unstable shingles vaccines after a temperature excursion. The reporter stated that all the vaccines were administered, lot numbers, administration dates and patient involved. The reporter provided the consent for a follow up via email by safety team. The patient who received unstable shingles vaccines after a temperature excursion, which led to incorrect storage of vaccine. This was 1 of 3linked  cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 52-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 06-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-APR-2023 The patient who received unstable shingles vaccines after a temperature excursion. The reporter stated that all the vaccines were administered, lot numbers, administration dates and patient involved. The reporter provided the consent for a follow up via email by safety team. The patient who received unstable shingles vaccines after a temperature excursion, which led to incorrect storage of vaccine. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 54-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 09-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patient, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter