chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC20
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Painful arm; My arm not only still hurts but it's very itchy; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5 ml single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar (Dose number unknown), for immunization, reaction(s): "never had any issues". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Painful arm"; PRURITUS (non-serious), outcome "not recovered", described as "My arm not only still hurts but it's very itchy".  Additional information: patient stated "I have never had any kind of, other than a painful arm for a day. This was given on the 13th and my arm not only still hurts but it's very itchy, I should say, and I was wondering how do I tell, previously been able to tell the expiration date, so I know this vaccine's been out for a while. The form from the (withheld pharmacy) that I went to doesn't show, previously I have gone to (withheld pharmacy) or (withheld phramacy) in another area, and it's always had the number on it like the expiration of that and I was just wondering that if this kind of reaction a week later is normal. I have had all the different Pneumo-vaccine of Prevnar's in the past and never had any issues."  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (batch/lot number: 000), in left arm for covid-19 immunization. The reporter informed that the administration time was 01:00PM. The patient's relevant medical history included: "lung sequestration" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4, manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: rebound positive: (20Mar2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 as dose 1, single (Lot number: HG4664) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (Batch/Lot No: 051D22A, in left arm), administration date: 22Oct2022, when the patient was 55-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (Batch/Lot No: 064h21a, in left arm), administration date: 20Nov2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (Batch/Lot No: EW0175, in left arm), administration date: 27Apr2021, when the patient was 53-year-old, for Covid-19 immunization; BNT162b2 (Batch/Lot No: ER8734, in left arm), administration date: 05Apr2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset Mar2024, outcome "recovering", COVID-19 (medically significant) with onset Mar2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included Paxlovid from 13Mar2024 to 17Mar2024 (lot HK3278).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: appreciate UR vaccine/Paxlovid assistance; appreciate UR vaccine/Paxlovid assistance; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "appreciate UR vaccine/Paxlovid assistance". Therapeutic measures were taken as a result of drug ineffective, covid-19. The reported stated "TY 4 Paxlovid assistance, packaging, & design! V happy w/1st impression & dose. Blister pack = impossible to misunderstand dose. Equal tablet size 4 all 3 tablets fosters full-dose med adherence. TY also 4 dollar assistance. dollar 25 vs dollar 1400 is life-saving. Also appreciate UR vaccine-I fell behind; vaccine = peace-of-mind."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She had her vaccine in Sep and had covid in first part of Feb.; She had her vaccine in Sep and had covid in first part of Feb.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She had her vaccine in Sep and had covid in first part of Feb.". Clinical course: The caller got a notice that anyone over 65 should get another vaccine and it said that 2023-2024 saying that it was the newest one. And the caller stated that she thought there was one that came out in Dec. She had her vaccine in Sep and had covid in first part of Feb. She had been advised to wait a few months after having covid. Created Manual AE since caller stated that she had her vaccine in Sep and had covid in first part of Feb.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Patient was receiving her second dose of Gardasil 9 and had dizziness and syncope
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Injection site swelling, Injection site warmth, Memory impairment, Musculoskeletal stiffness
Clinical narrative: Arm swollen at site within 3 hours. Unaware of status from 7:30 pm until 10:30 pm when I woke up in bed. No memory of going to bed. Fever at injection site, significant neck stiffness, and headache despite Tylenol.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: patient returned to pharmacy after about 20 minutes saying she felt faint and dizzy.  We sat her down in our clinical services room and put an ice pack on the back of her neck and gave her some water.  Monitored for about 10 minutes while her husband sat with us.  She then said she felt fine and was able to stand up and go home.  Called patient later at home to verify she was feeling ok and was told she had no dizziness, just tired.
Age: 48.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administered out of the guidelines per State. Patient was under the age then recommended age. Patient did not report any adverse event to the vaccine. Patient was 48 years old when patient received the vaccine. Guidelines states that patient is under the age of 60 and should not be administered older adult RSV vaccine per CDC guidelines.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site reaction, Product administered at inappropriate site
Clinical narrative: Patient stated Vaccine site looked adnormal so she went to Urgent Care.  The PA stated vaccine was given too low in the arm
Age: 0.75
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient seen in the emergency department for seizure with fever. Patient currently admitted to the pediatric floor.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Dyskinesia, Injection site pain, Loss of consciousness, Rash erythematous, Vomiting
Clinical narrative: Patient received 3 vaccines. She received Ipol first, Priorix second and Engerix B last. On 3rd vaccine of Hep B, patient stated it hurt more than the others. She then proceeded to make sporadic movements and pass out. She slumped in chair and came to in about 1 and 1/2 minutes. We noticed a small red bump on back of neck and gave 1 dose of Benadryl 25mg by mouth as a precaution. We gave water and tried to give her sugary food which she declined. Patient did throw up. We observed her for about 20 minutes. She left chipper and laughing.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood thyroid stimulating hormone normal, Computerised tomogram heart normal, Dyspnoea, Echocardiogram normal
Clinical narrative: Atrial fibrillation with rapid ventricular response .  Woke up and had shortness of breath and palpitations.   Had single lead ECG on Watch that confined afib.   Went to MC and rvr corrected but still in atrial fibrillation confirmed on ECG.    Spontaneously resolved 30 hours later
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Fibrin D dimer normal, Full blood count normal, Metabolic function test normal, Palpitations
Clinical narrative: Atrial fibrillation with rapid ventricular response .  Woke up and had shortness of breath and palpitations.   Had single lead ECG on Watch that confined afib.   Went to MC and rvr corrected but still in atrial fibrillation confirmed on ECG.    Spontaneously resolved 30 hours later
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: Atrial fibrillation with rapid ventricular response .  Woke up and had shortness of breath and palpitations.   Had single lead ECG on Watch that confined afib.   Went to MC and rvr corrected but still in atrial fibrillation confirmed on ECG.    Spontaneously resolved 30 hours later
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Antimicrobial susceptibility test, Blister, Rash, Rash vesicular, Skin lesion
Clinical narrative: hours after vaccine administration, pt developed vesicular rash to left lateral ankle which progressed to 5 cm central lesion with scattered surrounding vesicles over the last week.  He tried hydrocortisone, OTC AF cream and neosporin with no improvement. Seen for evaluation on 3/22/24.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: 5-hydroxyindolacetic acid, Blood immunoglobulin A, Blood immunoglobulin E, Blood immunoglobulin G decreased, Blood immunoglobulin M increased
Clinical narrative: I developed red skin, vomiting, diarrhea when eating and drinking certain foods/drinks that started 8.16.2023. I had vomiting and diarrhea at the same time (multiple times). These attacks would wake me in the middle of the night. Foods that trigger are: tomatoes/spinach/preserved meats/avacados/pineapple/alcohol. I had multiple attacks of night sweats so badly I could wring sweat out of my shirts. Attacks were 8.19.23, 9.4.23, 9.27.23, 10.13.23 (almost called EMS), 10.20.23, 10.23. 23, 10.27.23, 11.10.23, 11.11.23, 11.28.23, 12.9.23, 12.13.23, 12.20.23, 12.29.23, 1.9.24, 1.22.24, 1.29.24, 2.1.24, 3.8.24.  I sought testing for Mast Cell Activation Syndrome in September. My plasma histamine was mildly elevated. Saw immunology and started many medications I've never needed before: gastrochrome 100mg/5ml, Allegra 180mg twice a day, Pepcid 20 mg twice a day, Benedryl 25-50 mg every night at bedtime and Xolair 150mg/injection-2 injections at the same time once a month.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Diarrhoea, Erythema, Hepatitis B antibody, Histamine level increased, Hyperhidrosis
Clinical narrative: I developed red skin, vomiting, diarrhea when eating and drinking certain foods/drinks that started 8.16.2023. I had vomiting and diarrhea at the same time (multiple times). These attacks would wake me in the middle of the night. Foods that trigger are: tomatoes/spinach/preserved meats/avacados/pineapple/alcohol. I had multiple attacks of night sweats so badly I could wring sweat out of my shirts. Attacks were 8.19.23, 9.4.23, 9.27.23, 10.13.23 (almost called EMS), 10.20.23, 10.23. 23, 10.27.23, 11.10.23, 11.11.23, 11.28.23, 12.9.23, 12.13.23, 12.20.23, 12.29.23, 1.9.24, 1.22.24, 1.29.24, 2.1.24, 3.8.24.  I sought testing for Mast Cell Activation Syndrome in September. My plasma histamine was mildly elevated. Saw immunology and started many medications I've never needed before: gastrochrome 100mg/5ml, Allegra 180mg twice a day, Pepcid 20 mg twice a day, Benedryl 25-50 mg every night at bedtime and Xolair 150mg/injection-2 injections at the same time once a month.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Night sweats, Sleep disorder, Tryptase, Vomiting
Clinical narrative: I developed red skin, vomiting, diarrhea when eating and drinking certain foods/drinks that started 8.16.2023. I had vomiting and diarrhea at the same time (multiple times). These attacks would wake me in the middle of the night. Foods that trigger are: tomatoes/spinach/preserved meats/avacados/pineapple/alcohol. I had multiple attacks of night sweats so badly I could wring sweat out of my shirts. Attacks were 8.19.23, 9.4.23, 9.27.23, 10.13.23 (almost called EMS), 10.20.23, 10.23. 23, 10.27.23, 11.10.23, 11.11.23, 11.28.23, 12.9.23, 12.13.23, 12.20.23, 12.29.23, 1.9.24, 1.22.24, 1.29.24, 2.1.24, 3.8.24.  I sought testing for Mast Cell Activation Syndrome in September. My plasma histamine was mildly elevated. Saw immunology and started many medications I've never needed before: gastrochrome 100mg/5ml, Allegra 180mg twice a day, Pepcid 20 mg twice a day, Benedryl 25-50 mg every night at bedtime and Xolair 150mg/injection-2 injections at the same time once a month.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Received a second dose of 2023-2024 formulation and had received primary series and bivalent in the past. Per mother, patient experienced fever for 10 days after vaccination.  Completed two dose primary series of Moderna, received 1 Pfizer bivalent, received 2 Pfizer 2023-2024
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Erythema, Herpes zoster, Hypoaesthesia
Clinical narrative: I received my Shingrix shot on Monday morning, March 11, 2024 and by the next morning I started getting a rash on same arm which continued to worsen greatly as the week went on...spreading from wrist , up entire arm, on shoulder, scapula area as well as alot of pain concentrated in my left shoulder/neck. I didn't know what was going on but the pains in my shoulder started getting excruciating. I finally sought medical attention at a local clinic and was diagnosed with Shingles. Another full week has passed and I am in a debilitated state. Constant pain in my left shoulder and arm. My left arm is losing strength and I am having trouble holding up items in that hand without extra pain and shaking in the hand. I also have some numbness in the left side of my scalp and face. I have alot of soreness and redness in the left side of my neck. I was super active, healthy and happy 2 weeks ago and since I took the Shingrix vaccine my life has essentially come to a screetching halt. I was under the impression I could not get Shingles from Shingrix but I feel certain that is exactly what happened. I am not getting better and the nerve pain is very unresponsive to any pain meds I have been prescribed including hydrocodone.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Injection site rash, Muscular weakness, Neck pain, Neuralgia, Rash
Clinical narrative: I received my Shingrix shot on Monday morning, March 11, 2024 and by the next morning I started getting a rash on same arm which continued to worsen greatly as the week went on...spreading from wrist , up entire arm, on shoulder, scapula area as well as alot of pain concentrated in my left shoulder/neck. I didn't know what was going on but the pains in my shoulder started getting excruciating. I finally sought medical attention at a local clinic and was diagnosed with Shingles. Another full week has passed and I am in a debilitated state. Constant pain in my left shoulder and arm. My left arm is losing strength and I am having trouble holding up items in that hand without extra pain and shaking in the hand. I also have some numbness in the left side of my scalp and face. I have alot of soreness and redness in the left side of my neck. I was super active, healthy and happy 2 weeks ago and since I took the Shingrix vaccine my life has essentially come to a screetching halt. I was under the impression I could not get Shingles from Shingrix but I feel certain that is exactly what happened. I am not getting better and the nerve pain is very unresponsive to any pain meds I have been prescribed including hydrocodone.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: I received my Shingrix shot on Monday morning, March 11, 2024 and by the next morning I started getting a rash on same arm which continued to worsen greatly as the week went on...spreading from wrist , up entire arm, on shoulder, scapula area as well as alot of pain concentrated in my left shoulder/neck. I didn't know what was going on but the pains in my shoulder started getting excruciating. I finally sought medical attention at a local clinic and was diagnosed with Shingles. Another full week has passed and I am in a debilitated state. Constant pain in my left shoulder and arm. My left arm is losing strength and I am having trouble holding up items in that hand without extra pain and shaking in the hand. I also have some numbness in the left side of my scalp and face. I have alot of soreness and redness in the left side of my neck. I was super active, healthy and happy 2 weeks ago and since I took the Shingrix vaccine my life has essentially come to a screetching halt. I was under the impression I could not get Shingles from Shingrix but I feel certain that is exactly what happened. I am not getting better and the nerve pain is very unresponsive to any pain meds I have been prescribed including hydrocodone.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Benign neoplasm, Blood prolactin increased, Heavy menstrual bleeding, Immediate post-injection reaction, Laboratory test
Clinical narrative: Heart palpitations right after the vaccines a this turned into SVT, heavy periods and high level of prolactin that caused a small benign tumor. Heavy breathing since vaccines.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Palpitations, Respiration abnormal, Supraventricular tachycardia
Clinical narrative: Heart palpitations right after the vaccines a this turned into SVT, heavy periods and high level of prolactin that caused a small benign tumor. Heavy breathing since vaccines.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute febrile neutrophilic dermatosis, Biopsy, Biopsy bone marrow, Blood test, Computerised tomogram
Clinical narrative: Sweets syndrom
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Ear inflammation, Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Flash fever over 102 on March 16/17 followed by dry congestion for a few days, followed a week later by runny nose, internal ear inflammation.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Streptococcus test
Clinical narrative: Flash fever over 102 on March 16/17 followed by dry congestion for a few days, followed a week later by runny nose, internal ear inflammation.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Back pain, Dizziness, Nausea, Pain
Clinical narrative: nausea, dizzy, subjective fever, back pain, abdominal pain, body ache, vaginal discharge at the end of February 2024 after her vaccination
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vaginal discharge
Clinical narrative: nausea, dizzy, subjective fever, back pain, abdominal pain, body ache, vaginal discharge at the end of February 2024 after her vaccination
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Pruritus, Temperature intolerance
Clinical narrative: Patient stopped by the pharmacy around 5:36 p.m. and informed us about an allergic reaction to a vaccine. Patient said that she received the Hepatitis B vaccine a few days ago  and patient has itching on the back of the neck and front of the chest after receiving the vaccine. It started a few hours after receiving the vaccine. That night she took Benadryl otc for 2 days and also used cortisone cream otc the next day. Those did not help.  She started calamine lotion two days ago and it helped somewhat and is still using. She says the itching is more intense when cold air hits it (AC or fan are blowing at her.) As of today, the itching is not as intense and is manageable and it does not bother her. Patient says she did not have hives, shortness of breath , swelling of the face and throat, dizziness,  or abnormal heartbeat.?She said she had other vaccines before and never had issues of itching.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: The patient received the pediatric dose instead of the adult dose. The patient received the Moderna 2023-24 (6M-11Y) vaccine at 0.25 ml IM when they were supposed the receive the adult formulation (Moderna 2023-24) at the adult dose (0.5 ml IM)
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 8-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 04-DEC-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005255: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 4-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 04-DEC-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 6-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 06-DEC-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 5-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 06-DEC-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 7-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 11-DEC-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 7-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 13-DEC-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 15-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 13-DEC-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 15.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 15-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 13-DEC-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided); and with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (rHA), lot #W031980, expiration date: 06-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 8-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 13-DEC-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 14-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 20-DEC-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 16.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 16-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 03-JAN-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided); and with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (rHA), lot #W031980, expiration date: 06-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: