chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Photophobia, Tic
Clinical narrative: Almost immmediately after the vaccine was administered, started experiencing involuntary vocal and motor tics, at first small but has steadily grown and become quite severe over the past couple of months. Tics seem to be triggered by sources of bright light and only disappear after prolonged absence of light.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tic
Clinical narrative: Almost immmediately after the vaccine was administered, started experiencing involuntary vocal and motor tics, at first small but has steadily grown and become quite severe over the past couple of months. Tics seem to be triggered by sources of bright light and only disappear after prolonged absence of light.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: Fatigue setting in around 3 hours after vaccination, slept for an hour  Fever overnight (noticed at 3:00am), treated with 400mg ibuprofen  Mood pain in injection side, started around 4pm
Age: 36.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Fibrin D dimer, Full blood count, Head injury
Clinical narrative: Syncope unwittnessed with injury (laceration to head). Second episode of syncope in the presence of EMS requiring emergency care.
Age: 36.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Metabolic function test, Skin laceration, Syncope, Troponin
Clinical narrative: Syncope unwittnessed with injury (laceration to head). Second episode of syncope in the presence of EMS requiring emergency care.
Age: 36.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Head injury, Syncope
Clinical narrative: Syncope unwittnessed with injury (laceration to head). Second episode of syncope in the presence of EMS requiring emergency care.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tachycardia
Clinical narrative: Tachycardia even with Metoprolol. Baseline heart rate is 60 BPM.  Now 90 BPM
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Periorbital pain, Tenderness
Clinical narrative: Developed pain under the eyes, in the site where dermal filler had previously been injected. Painful to the touch. No swelling or redness observed. No treatment seeked up to the moment of reporting.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Fever for 3 days ranging as high has 101.9, extremely muscle pain in hips, legs,  and feet. Chili?s and neck pain.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever for 3 days ranging as high has 101.9, extremely muscle pain in hips, legs,  and feet. Chili?s and neck pain.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain
Clinical narrative: Pain in arm, nausea, headache,  dizzy, fatigue, body aches
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Pain in arm, nausea, headache,  dizzy, fatigue, body aches
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: all over strong body aches, strong headache, fever @5 am= 100.8, mild intermittent nausea, chills,severe arm soreness at injection site...
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: all over strong body aches, strong headache, fever @5 am= 100.8, mild intermittent nausea, chills,severe arm soreness at injection site...
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 40.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: Severe headache,  abdominal pain and chills, vomiting, diarrhea, and fever (101.7)?temp taken after 800mg ibuprofen
Age: 40.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Vomiting
Clinical narrative: Severe headache,  abdominal pain and chills, vomiting, diarrhea, and fever (101.7)?temp taken after 800mg ibuprofen
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Axillary mass, Axillary pain, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: pain/bubble under armpit of left arm-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: Patient is reporting pain, tenderness, and raised bubble type reaction under armpit of left arm that began 1 day after injection.  There is also a tennis ball sized swollen area on side of chest close to armpit area that began 2 days after injection.  Patient notified his PCP and will monitor for development or resolution of symptoms.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lethargy, Lymphadenopathy
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: pain/bubble under armpit of left arm-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: Patient is reporting pain, tenderness, and raised bubble type reaction under armpit of left arm that began 1 day after injection.  There is also a tennis ball sized swollen area on side of chest close to armpit area that began 2 days after injection.  Patient notified his PCP and will monitor for development or resolution of symptoms.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Additional Details: Pt. described botches on forearms. her Hands were swollen. Her arms and hands were painful and itchy. She took Zyrtec and APAP> Symptoms subsided but not fully resolved the day after the immunization.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Additional Details: Pt. described botches on forearms. her Hands were swollen. Her arms and hands were painful and itchy. She took Zyrtec and APAP> Symptoms subsided but not fully resolved the day after the immunization.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: Fatigue, Weakness, Fever, swollen lymph nodes (swollen in neck), Nausea, Body Aches, Chills, Sweating, body always felt hot and over heated , headache Used Motrin and Tylenol to help the symptoms
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: Fatigue, Weakness, Fever, swollen lymph nodes (swollen in neck), Nausea, Body Aches, Chills, Sweating, body always felt hot and over heated , headache Used Motrin and Tylenol to help the symptoms
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Audiogram normal, Balance disorder, Ear infection viral
Clinical narrative: I developed severe viral infection left ear only resulting in about 80% loss of balance per testing in left ear only. No hearing loss but ENT said will be permanent.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Musculoskeletal chest pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Excruciating back pain from ribs to should, pain around front ribs, fever. Taking Tylenol every 8 hours. 4 days with no improvement. Remains ingoing
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abnormal dreams, Anxiety, Headache, Pain, Pyrexia
Clinical narrative: First the usual head ache, fever and achy body.  I also had disturbing dreams for 2 nights and woke up with intense anxiety the morning after, and some the second morning.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: The ringing in ear enhanced a little bit/it had intensified after receiving the 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (The ringing in ear enhanced a little bit/it had intensified after receiving the 2nd booster) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 017E21A, 013M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced TINNITUS (The ringing in ear enhanced a little bit/it had intensified after receiving the 2nd booster). At the time of the report, TINNITUS (The ringing in ear enhanced a little bit/it had intensified after receiving the 2nd booster) had not resolved.            No concomitant medications were reported. Patient did not had COVID positive test or diagnosis. Patient had no other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient told that the tinnitus has continued, in fact gotten worsened.Patient was very sure that the booster dose have some link with tinnitus. No treatment information was provided.   This case was linked to MOD-2022-645094 (Patient Link).
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Eye pain, Fatigue, Headache
Clinical narrative: Joint pain, headache, eye ache, fatigue.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient asked to receive the Moderna Bivalent booster (all 3 previous shots were for pfizer).  It wasn't noted until after the fact that he was 17-1/2 years old instead of the current recommended 18 years of age for this vaccine.  No adverse events noted.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Swelling of entire arm, rash on entire arm, fever (105),
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Significant bruising at the very injection site (onset within 2-hours), which could have been the administration of the injection.  Three days post injection, there developed redness, swelling, and inflammation (hot to the touch) ~2-inches below the injection site. These symptoms have been persistent to-date, with intermittent and very slight itchiness.  Symptoms have not been alarming or persistent to the point of requiring medical attention.  Also to note (which may or may not be related), I have experienced migraine headaches daily beginning with Wednesday, September 14, inclusive of today, September 17, for which I have taken Zomig doses (2.5mg once daily).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Migraine
Clinical narrative: Significant bruising at the very injection site (onset within 2-hours), which could have been the administration of the injection.  Three days post injection, there developed redness, swelling, and inflammation (hot to the touch) ~2-inches below the injection site. These symptoms have been persistent to-date, with intermittent and very slight itchiness.  Symptoms have not been alarming or persistent to the point of requiring medical attention.  Also to note (which may or may not be related), I have experienced migraine headaches daily beginning with Wednesday, September 14, inclusive of today, September 17, for which I have taken Zomig doses (2.5mg once daily).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Hyperhidrosis, Malaise, Myalgia
Clinical narrative: sweating, headache, malaise, muscle aches lasting a little over 24 hours
Age: 26.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site discolouration, Injection site swelling, Keloid scar
Clinical narrative: Permanent, raised, discolored keloid scar formed at site of the intradermal injection and has not went away .
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: All heart rate monitoring is from my smart watch which I wore for the duration of the event.  I had a fever since 7:30pm and was trying to sleep. ~10:35 pm I had been sleeping lightly for a couple of hours, but woke up and my heart rate was ~125bpm while laying down. My temperature was 100.8F. I needed to get some water, so I got up slowly and went to get some from my kitchen, only a few steps away from my bed. I began to feel slightly nauseous, so I looked at my watch to see my heart rate. It was 152 bpm. I went to lie back down. I had to get up several more times in the night and my heart rate always jumped to the upper 140s. I felt like I needed to go to the hospital but chose not to due to cost concerns.  I took 500mg of acetaminophen and was able to sleep for a few more hours. The next morning my heart rate was not jumping up as high when I stood up, although by that time I had begun taking acetaminophen every 6 hours which was helping with the fever. I still was unable to do my daily activities and kept movement to a minimum for the next 24 hours.
Age: 52.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Migraine
Clinical narrative: migraines
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: Fever over 102,  severe migraine, malaise, nausea, full body pains
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Limb discomfort
Clinical narrative: little of discomfort in her left arm during 1 day after the vaccine was given; bivalent booster administered instead of 1st dose of primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of LIMB DISCOMFORT (little of discomfort in her left arm during 1 day after the vaccine was given) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (bivalent booster administered instead of 1st dose of primary series) in a 52-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     The patient had never been diagnosed with/ tested positive for COVID-19. Patient had no acute and chronic illness at the time of vaccination. No AE cause patient to seek medical care.  Concurrent medical conditions included Penicillin allergy. Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (AFLURIA) for an unknown indication.    On 06-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 06-Sep-2022, the patient experienced LIMB DISCOMFORT (little of discomfort in her left arm during 1 day after the vaccine was given) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (bivalent booster administered instead of 1st dose of primary series). On 06-Sep-2022, LIMB DISCOMFORT (little of discomfort in her left arm during 1 day after the vaccine was given) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (bivalent booster administered instead of 1st dose of primary series) outcome was unknown.        The action taken with mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Arm pain, swelling and redness from injection spot to the elbow. Arm feels very hot compared to the other area. This is my 5 covid shot and had no problems with previous injections. It has been 6 days since injection and the arm still feels hot and redness is still present to lesser extend. The swelling has also decreased.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient was fine for the day and evening of the vaccine. The next morning when she woke up, her arm below the injection site had a rash about 2 inches x 4 inches but was not itching. Two days post vaccine, the area is itching and getting larger. Patient will be following up with her medical doctor.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Pain
Clinical narrative: Severe headache, body aches for a total of 1 week
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy, Ultrasound scan
Clinical narrative: Within approximately 2-3 weeks of the booster on October 15, 2021, I noticed an inflamed lymph node in my neck on the left side. I would describe it as 'slightly' inflamed. I could easily notice it when comparing it to the right side of my neck, which was normal in appearance. The inflammation has diminished I'd say 60%, but it is still there as of this writing on September 17, 2022.  It does not cause me discomfort, and I have had both an ultrasound and a CT scan to rule out any other conditions.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: appeared the day after vaccination. on injection arm near injection site, not on, is red and hot to touch
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Feeling abnormal, Headache, Hyperaesthesia, Injection site pain
Clinical narrative: High fever (100.6) , intense headache, my entire body ached (including the injection site), my skin hurt when touched, cough, itching of extremities.  I felt terrible and still don't feel 100%.  I can't imagine receiving this shot in conjunction with a flu shot.  NOT a good idea.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: High fever (100.6) , intense headache, my entire body ached (including the injection site), my skin hurt when touched, cough, itching of extremities.  I felt terrible and still don't feel 100%.  I can't imagine receiving this shot in conjunction with a flu shot.  NOT a good idea.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Muscular weakness, Myalgia
Clinical narrative: General muscle soreness and weakness.
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Wrong technique in product usage process
Clinical narrative: Did not get wheal with administration, repeated dose on same arm.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The individual was given a Pfizer Bivalent Booster instead of a Pfizer 5-11 yo Booster.  When I called the parent to inform her, the child had not had any adverse side effects as of 9/17/22 @ 1045am.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood urine present, Choking, Computerised tomogram, Death
Clinical narrative: Shortness of breath, hard to breathe, chocking, inability to swallow, incontinence, blood clot, blood in urine, and death
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Electrocardiogram, Haemorrhage, Incontinence
Clinical narrative: Shortness of breath, hard to breathe, chocking, inability to swallow, incontinence, blood clot, blood in urine, and death
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Swallow study, Thrombosis
Clinical narrative: Shortness of breath, hard to breathe, chocking, inability to swallow, incontinence, blood clot, blood in urine, and death
Sex: F
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Medication error, No adverse event, Product storage error
Clinical narrative: No additional AE details; 1 lot of VARIVAX was administered after non-supported excursion; This spontaneous report has been received from an office manager, regarding an unspecified number of patients of unknown gender and age. Information regarding the patients' historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   On 19-JUL-2022, the varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U008181, expiration date: 16-JUN-2022 experienced 08-FEB-2023) was administered after non-supported excursion (product storage error). Temperature excursion of 10.2 Celsius degrees (C) for 182 hour. No additional adverse events (AE) reported (no adverse event).  This case was classified as non-valid due to the lack of patient's identifiers.  Follow-up was received from the office manager on 09-SEP-2022. It was updated, that not properly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered to 4-year old female patient, and her sister. There was reported, that temperatures were misread and misrecorded, and that is why the medication error occurred. It was confirmed, that no adverse reactions were reported. This is one from two reports from the same reporter.; Sender's Comments:  US-009507513-2209USA004279:
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details provided.; expired dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant condition and drug reactions/allergies were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On 28-JUL-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (0.5 mL, lot # U002532, expiration date: 24-JUL-2022; strength, route and anatomical location was not provided) for prophylaxis (expired product administered). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had no temperature excursions through date of administration. There was no additional adverse event reported (no adverse event).  This report was considered as non-valid due to the lack of patient's identifiers.  Follow-up information was received from the medical assistant on 12-SEP-2022. Concomitant medication diphtheria vaccine toxoid, pertussis vaccine acellular 1-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (DTAP IPV SZCZEPIONKA) was added. Information about the patient's gender and age had been updated, it was referring to a 5-years-old male patient. Additionally, patient demographics had been added, and the anatomical location was updated to right vastus lateralis.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; The pharmacist reported that one patient received improperly stored vaccine.; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-AUG-2022, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W005208, expiration date: 14-FEB-2024, administered as prophylaxis (strength, and route of administration were not provided) (Improper storage of product in use). The reporter stated that the vaccine was stored at a temperature of 77 Fahrenheit degrees for 36 hours and that there was no previous temperature excursions.  No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Temperature -14°C up to-10°C (-14.04C) of VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On 20-JUL-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #T032315, expiration date: 22-SEP-2022, administered for prophylaxis (strength and route of administration were not provided) (product storage error). The vaccine underwent temperature excursion of was -14 Celsius degree (C) up to-10 C (-14.04 C) for 40 minutes. There was no previous temperature excursion. No additional adverse event details were provided (no adverse event).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006350: US-009507513-2208USA006425:
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller is an office manager reporting that an improperly stored dose of M-M-R II and VAQTA were administered to the patient on 26MAY2022 after experiencing a temperautre excursion. No additional AE reported.; Caller is an office manager reporting that an improperly stored dose of M-M-R II and VAQTA were administered to the patient on 26MAY2022 after experiencing a temperautre excursion. No additional AE reported.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On 26-MAY-2022, improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number: U033212 expiration date was reported as 28-OCT-2022, but upon internal validation established as 07-NOV-2022; strength, dose, route of administration, and anatomical location were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (rHA) (M-M-R II) subcutaneous injection (lot #T033814, expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not reported) were administered to the patient for prophylaxis after a temperature excursion of 54.5 fahrenheit (F) for 11 hours (product storage error). There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA006520: US-009507513-2208USA006720: US-009507513-2208USA006693: US-009507513-2208USA006700:
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: the patient stated that the first dose he received on 7/15/2022 was administered via intramuscular route; sore arm; This spontaneous report was received from a pharmacist and referred to an unknown age male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On 15-JUL-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U033046, expiration date: 21-OCT-2023, administered intramuscularly for prophylaxis (strength was not provided) (incorrect route of product administration). The patient reported having a "sore arm" following initial dose (unknown date in 2022). It was unknown if the patient sought a medical attention, received the treatment, or performed any lab diagnostics/studies. The therapy was not discontinued. On 17-AUG-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) administered subcutaneously for prophylaxis (strength, dose, lot#, expire date was not provided). On 01-SEP-2022 an inbound telephone call, it was confirmed the patient received vaccine at a pharmacy. The outcome of sore arm was not reported. The causal relationship between sore arm and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose, Product quality issue
Clinical narrative: no adverse reaction/no addtional AES; double dose of varicella given through concomitant administration of PROQUAD and VARIVAX to 1 year old patient.; This spontaneous report was received from a registered nurse, referring to a 1-year-old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.      On 19-AUG-2022, double dose of varicella was given through concomitant administration of varicella virus vaccine live (oka/merck) (VARIVAX) (0.5ml/once, strength, route, lot# and expiration date were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5ml/once, strength, route, lot# and expiration date were unknown) to the patient for prophylaxis (overdose). This was patient's first dose and that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was injected into left arm and varicella virus vaccine live (oka/merck) (VARIVAX) was injected into right arm. No adverse reactions and product quality compliant were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; administration of improperly stored vaccine/ (-14C) for 30 Minutes; This spontaneous report was received from a nurse navigator/registered nurse referring to a 4-year-old patient (a private doctor) of unknown gender. The patient's pertinent medical history, concomitant condition, drug reactions/allergies and concomitant medication were not reported.  On 19-AUG-2022, the patient was vaccinated with one improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (lot # U031564, expiration date: 06-APR-2023; dose details, strength was not provided) Intramuscularly in the left deltoid for prophylaxis. The vaccines underwent temperature excursion of minus 14 degrees Celsius (C) for 13 mintes (product storage error). The previous temperature excursion was not reported. The vaccine was discarded and only given to this one patient post temperature excursion. The patient did not take any medications. The patient did not have any other vaccinations within 4 weeks prior to this one. The health care provider office was a combination of a private practice and a public health clinic. No other adverse event (AE) was reported (no adverse event).
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Malaise, Pain in extremity
Clinical narrative: feeling sick to her stomach this morning; arm hurt all night long; This spontaneous report was received from a consumer concerning herself, a 68-year-old female patient. The patient had a pneumonia vaccine one year ago (did not know what it was) but had no side effects from the vaccine. The patient had no medical history. The concurrent condition included seasonal allergy. The concomitant therapy included allergy pill (unsure the name).  On 18-AUG-2022, the patient received a pneumonia shot (pneumonia vaccine) with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prevent pneumonia (dose, strength, lot #, expiry date, and route of administration were not provided) at her doctor's office. The doctor would not tell her what it was just said it was a pneumonia shot and she was supposed to get it.   The patient stated that her arm hurt all night long (pain in extremity) on 18-AUG-2022. On 19-AUG-2022, the patient was pretty sick this morning. The patient felt sick to her stomach this morning (abdominal discomfort), and her arm still hurts this morning. The patient was not sure if the nurse did not know what she was doing or if the vaccine was too close together but she never had a reaction before. The patient did give permission to contact her healthcare provider. At the time of this reported, the patient had not recovered from pain in extremity and abdominal discomfort. The patient had no treatment for events.  The causal relationship between pain in extremity, abdominal discomfort and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE for this patient.; patient received PROQUAD after a temperature excursion/Temperature 11.5F, Time frame 13 hours; This spontaneous report has been received from a health care worker referring to a male patient with unknown age.   The patient's pertinent concurrent conditions, medical history, drug reactions or allergies and concomitants therapies were not reported.  On 18-AUG-2022, the patient was vaccinated with an improper storage vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, (strength, dose, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided), lot number U022729 has been verified to be a valid lot number with expiration date on 16-JAN-2023, administered as prophylaxis. The administered dose of the vaccine underwent temperature excursions from 11.5 Fahrenheit (F) for 13 hours. There was no previous temperature excursion reported. No other adverse event (AE) was reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2208USA008545:02230187 US-009507513-2208USA009042: US-009507513-2208USA008719: US-009507513-2208USA008698: US-009507513-2208USA009322: US-009507513-2208USA008698:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller is a nurse who reports that PROQUAD and VARIVAX may have been given after a temperature excursion that occurred in April 2022. Vaccines were then sent back so she does not have time/temperature data and does not know whether any vac; This spontaneous report was received from a nurse and refers to an unknown number of patients of an unknown age and gender.  The patient's medical history, concurrent conditions. concomitant therapies and previous drugs reactions or allergies were not reported.  On an unknown date in 2022, the patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot #W004694, expiration date: 08-AUG-2023, and lot # U019289 expiration date 15-DEC-2022 (vaccination scheme, dose description and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) lot #U030162, expiration date: 28-SEP-2023, administered for prophylaxis (vaccination scheme, dose description and route of administration were not provided) following a temperature excursion that occurred on an unknown date in April 2022 (product storage error), it was mentioned that there was not previous temperature excursion. No additional adverse event was reported.  This is a non-valid case due ot lack o f patient's identifiers.  Follow-up information has been received from a registered nurse on 07-SEP-2022 and patients' identifiers have been provided. The patient was a 4-year-old female. On 11-FEB-2022, the freezer temperature on the temperature tracker was noted to be out of range and on 21-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U019289 subcutaneously in the left thigh for prophylaxis. There were no previous doses reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA003332: US-009507513-2209USA003333: US-009507513-2209USA003334: US-009507513-2209USA003333: US-009507513-2209USA003332:
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; a patient was administered PROQUAD that experienced a temperature excursion.; This spontaneous report has been received from a non health care professional and refers to a unknown patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 23-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) subcutaneous injection,  as prophylaxis ( lot #W017567 confirmed to be valid, expiration date reported and stablished as 29-NOV-2023 ) (strength, dose, vaccination scheme, route of administration and anatomical location were not provided) following a temperature excursion of 3.6 degrees Celsius for 3 hours 7 minutes, it was stated that no previous temperature excursions occurred. No additional adverse event was reported.  This case was considered as non-valid due to lack of patients identifiers.  Follow-up information has been received from  a registered nurse on 15-SEP-2022, regarding a now reported as a 4-year-old male patient. His concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (GSK).  It was updated that this was the second dose (also reported as: "previous doses: 1") of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was administered subcutaneously.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; a dose of MMRII which expired on 18Aug2022 was given; This spontaneous report was received from a register nurse referring to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 23-AUG-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) virus vaccine live (rHA) subcutaneous injection, 0.5 milliliter/ once, lot #T027935, expiration date: 18-AUG-2022, administered for prophylaxis (strength and route of administration were not provided) (expired product administered) with sterile diluent (MERCK STERILE DILUENT) (lot #T003595, expiration date: 03-NOV-2022). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had no history of temperature excursions. No other adverse event was reported (no adverse event).
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: 'tested positive for HPV; This spontaneous report was received from a register pharmacist referring to a 23-year-old female patient. Pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  In approximately 2010 (at around 11 years of age on unknown), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) administered as routine vaccinations for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided).  On an unknow date in August 2022 (a few weeks ago), the patient was tested positive for human papillomavirus (HPV) confirmed by PAP smear. The patient was 'hysterical'. The present status was not recovered (considered the outcome was not recovered). The causality was not reported.
Age: 4.0
Sex: F
Vaccine: MMRV, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptomatic AEs reported; Inbound call from HCP reporting a patient received a 3rd dose of PROQUAD inadvertently on 08/23/2022 after the second dose was administered. on 12/01/2021. No symptomatic AEs reported. No additional AE details or PQC.; This spontaneous report was received from a Nurse referring to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX).     On 01-DEC-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported).     On 23-AUG-2022, the patient received inadvertently a third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL, by subcutaneous route, in the left thigh, lot # W007745 with expiration date on 04-SEP-2023, after the second dose (extra dose administered). Patient was doing fine and there was no side effects (no adverse event). The error was caught the same vaccination day and was informed to the provider, office manager, pharmaceutical companies and patient's mother. Vaccines were not updated into the local immunization information system.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional Adverse Events reported; MMR II was administered to a patient today 8/25/2022. Product expired 8/18/2022.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 25-AUG-2022, the patient received an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA) (M-M-R II) administered as prophylaxis, lot number T027935 with expiration date 18-AUG-2022 (dose frequency and route of administration were not reported) (Expired product administered), diluted in sterile diluent. The product and the sterile diluent were stored according to prescribing information through the date of administration. No additional adverse event reported (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE were reported; Medical assistant called to report that today on 8/25/2022, a patient was given MMR II via intramuscular route.; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug allergies, and reactions were not provided.   On 25-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) for prophylaxis, intramuscularly (incorrect route of product administration) (lot number W011885 has been verified to be valid; expiration date reported and established as 04-SEP-2023) (dosage, vaccination scheme, and anatomical site of injection were not provided). No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: Pharmacist reports an inadvertent concomitant administration of VARIVAX and PROQUAD to a 1 year old patient on 25AUG2022. No additional AE reported. No PQC reported.; Pharmacist reports an inadvertent concomitant administration of VARIVAX and PROQUAD to a 1 year old patient on 25AUG2022. No additional AE reported. No PQC reported.; This spontaneous report was received from a pharmacist concerning a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 25-AUG-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (strength and route of administration were not reported), lot number W016357, expiration date 16-NOV-2023, administered for prophylaxis, and inadvertently concomitantly the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength and route of administration were not reported) lot number U028165, expiration date 09-SEP-2023, administered for prophylaxis (accidental overdose). No additional adverse events were reported (no adverse event).