chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Phantom limb syndrome
Clinical narrative: I am an above knee amputee. I lost my left leg to osteosarcoma 37 years ago. Since my amputation I have infrequently experienced moderate phantom limb pain (2-3 times per year). Usually it lasts a few hours (usually at night) and then resolves. 8 hours after I received my Shingrix shot, the most unrelenting phantom pain I've ever had started. Every 1-2 minutes i would have episodes of intense pain. This lasted 18 hours until a doctor prescribed Percocet. I have taken 3 Percocet tablets in the last 24 hours (the last was 10 hours ago) and I believe the pain has generally resolved, although I still have twinges.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Administration site rash, Administration site swelling, Injection site erythema
Clinical narrative: A small area couple inches below the administration site has a rash, pink and a little swollen
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: PATIENT WAS ADMINISTERED PREVNAR -13 AT THE PHARMACY ABOUT 8.30PM. PATIENT DAUGHTER CAME BACK TO PHARMACY THE FOLLOWING DAY TO INFORM ME THAT PATIENT  EXPERIENCED HEADACHE, EXTEREM FATIGUE , FEVER, RASH AND SHORTNESS OF BREATH AT ABOUT MIDNIGHT THURSDAY 06/11/2020 AND TO TAKEN TO THE ER.  UPON CONTACTING ER STAFF I WAS INFORMED THAT FATIMAH WAS DIAGOINSED WITH SERUM SICKNESS. SHE WAS PRESCRIBED TYLENOL AND IBUPROFEN AND SENT HOME.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Serum sickness
Clinical narrative: PATIENT WAS ADMINISTERED PREVNAR -13 AT THE PHARMACY ABOUT 8.30PM. PATIENT DAUGHTER CAME BACK TO PHARMACY THE FOLLOWING DAY TO INFORM ME THAT PATIENT  EXPERIENCED HEADACHE, EXTEREM FATIGUE , FEVER, RASH AND SHORTNESS OF BREATH AT ABOUT MIDNIGHT THURSDAY 06/11/2020 AND TO TAKEN TO THE ER.  UPON CONTACTING ER STAFF I WAS INFORMED THAT FATIMAH WAS DIAGOINSED WITH SERUM SICKNESS. SHE WAS PRESCRIBED TYLENOL AND IBUPROFEN AND SENT HOME.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Myalgia, Swelling, Tenderness
Clinical narrative: Chills, muscle aches, localized swelling/redness/tenderness
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Arthritis, Bone pain, Formication, Impaired work ability
Clinical narrative: Initially shoulder was sore and painful to touch. That pain went away. Developed trouble with range of motion. Shoulder joint cricks during movement and patient has trouble when reaching out. Described as permanently changed joint in shoulder. When lying down, being completely still can fill movement like something is going on in there. It is like something ate away at joint, muscle, or bursa, not sure what it is called. It is just not the same as it was before. Grew to get worse, but is stable where it is currently.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Injection site pain, Joint range of motion decreased, Movement disorder, Musculoskeletal discomfort
Clinical narrative: Initially shoulder was sore and painful to touch. That pain went away. Developed trouble with range of motion. Shoulder joint cricks during movement and patient has trouble when reaching out. Described as permanently changed joint in shoulder. When lying down, being completely still can fill movement like something is going on in there. It is like something ate away at joint, muscle, or bursa, not sure what it is called. It is just not the same as it was before. Grew to get worse, but is stable where it is currently.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Shoulder injury related to vaccine administration
Clinical narrative: Initially shoulder was sore and painful to touch. That pain went away. Developed trouble with range of motion. Shoulder joint cricks during movement and patient has trouble when reaching out. Described as permanently changed joint in shoulder. When lying down, being completely still can fill movement like something is going on in there. It is like something ate away at joint, muscle, or bursa, not sure what it is called. It is just not the same as it was before. Grew to get worse, but is stable where it is currently.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint noise, Joint range of motion decreased, Musculoskeletal discomfort, Musculoskeletal pain, Tenderness
Clinical narrative: Initially shoulder was sore and painful to touch. That pain went away. Developed trouble with range of motion. Shoulder joint cricks during movement and patient has trouble when reaching out. Described as permanently changed joint in shoulder. When lying down, being completely still can fill movement like something is going on in there. It is like something ate away at joint, muscle, or bursa, not sure what it is called. It is just not the same as it was before. Grew to get worse, but is stable where it is currently.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Pt having swollen area around site, low grade fever, nausea for 48 hours post vaccine.
Age: 0.25
Sex: M
Vaccine: PNC13, RV1
Symptoms: Abdominal pain, Diarrhoea, Eating disorder
Clinical narrative: Extreme belly pain, difficulty eating, it?s been 23 days of diarrhea at this point and it has not yet stopped.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Presyncope
Clinical narrative: Patient had a vasovagal event.  Patient was cared for, BP checked and sent home once stable.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Presyncope
Clinical narrative: Vasovagal, patient was attended to, BP checked patient was released once stable
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Insomnia, Pyrexia
Clinical narrative: Significant stimulant effect starting about two hours after the injection and lasting about 24 hours --  preventing any sleep throughout the night.  Fever up to 100.4, chills, and fatigue, starting about 24 hours after injection and lasting for about 12 hours.  Lingering fatigue lasting for three days after the injection.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Condition aggravated, Haemophilia
Clinical narrative: Hemophilia; missed second scheduled dose supposed to get at age 4 months due to fell off the grid, looking to get dose at 6 months; This is a spontaneous report from a contactable Other Health Professional reported on behalf of Nurse Practitioner via a Pfizer-sponsored program. A 4 months old male patient received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, batch/lot AL8456, Expiration Date: 31Jul2021), intramuscularly in left thigh on 11Feb2020 at the age of 10 weeks old at 0.5 mL, single for Routine vaccination and had no adverse reaction to first dose (as reported). Patient kind of fell off the grid and missed second scheduled dose he was supposed to get at age 4 months, looking to get dose at 6 months. Patient also had lab work prescribed at age 2 months which was not done. Patient was diagnosed with Hemophilia on 07Apr2020, but unknown onset date, or if patient developed hemophilia before or after first dose of Prevnar 13; but it was reported the patient's mom had Hemophilia. The patient's concomitant medications were not reported.  The outcome of hemophilia was not recovered.  Relatedness of drug to Hemophilia: Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Unrelated.; Sender's Comments: Hemophilia is unrelated to PREVNAR 13 use being a congenital coagulation disorder.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: decrease in serotypes 1 and 4; patient received 5 doses of PREVNAR 13; This is a spontaneous report from a contactable physician. A 9-year old patient of unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on Jul2014 (had 5 doses) at a single dose for immunization. The patient's medical history included previous infections. Concomitant medications were not reported. The patient experienced decrease in serotypes 1 and 4 on an unspecified date. He tested 9-year old's antibody response for pneumococcal 13-val conj vac (dipht crm197 protein) at the request of the mother, as child is doing fine now but has had some history of previous infections. Vaccine administered in Jul2014, had 5 doses of pneumococcal 13-val conj vac (dipht crm197 protein). Antibody test in May2020 showed titers: Serotype 1 to be 1.1 and Serotype 4 to be 1.2, lab suggested that antibody should be at least 1.3 to be more effective. Antibody response when previously tested in May2017 titers for Serotype 1 was 1.5 and for Serotype 4 was 1.6. After revaccination in 2014, Serotype 1 went up to 12.6, now back down to 1.1. Serotype 4 went up to 9.2, now down to 1.2. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This is spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced vaccination site pain. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Headache, Immunisation reaction, Induration, Malaise
Clinical narrative: Pt. had a delayed immunization reaction to Kinrix administered 6/10/2020. Pt developed complaint of headache & general malaise, with a large local area of redness & induration measuring 13.5x11cm
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; Unspecified number of patients have recieved improperly stored ROTATEQ on unspecified dates; This spontaneous report was received from a nurse, referring to a 12 weeks old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 26-NOV-2019, the patient was vaccinated with the improperly stored only dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number S004251 with expiration date: 22-SEP-2020; dose, strength and route of administration were unknown) for prophylaxis (product storage error). No symptoms reported. It was reported that the patient was not administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on 28-MAY-2019.  Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion of 46.9 degrees Fahrenheit (F) for 55 minutes. Data logger was involved. The previous temperature excursion was 34.9 F for 25 minutes and 48.6 F for 25 minutes.  This is 1 of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA007560: US-009507513-1911USA004865: US-009507513-2005USA007562:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: due to a temperature excursion; the labeled expiration date was short dated to 1/30/2020; No adverse effects reported; a dose of Varivax was administered after the labeled expiration date; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 17-FEB-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number S002396 was verified to be a valid lot number, expiration date reported as 31-JAN-2021, but upon internal validation established as 23-JAN-2021 (dose and route of administration were not provided) for prophylaxis.  It was reported that the labeled expiration date was short dated to 20-JAN-2020 due to a temperature excursion. The patient did not experience any additional adverse effects.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009697: US-009507513-2005USA009697:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 21-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA004887: US-009507513-2006USA004888: US-009507513-2006USA004889: US-009507513-2006USA004890: US-009507513-2006USA004891: US-009507513-2006USA004892: US-009507513-2006USA004893: US-009507513-2006USA004894: US-009507513-2006USA004895: US-009507513-2006USA004896: US-009507513-2006USA004897: US-009507513-2006USA004898: US-009507513-2006USA004899: US-009507513-2006USA004901: US-009507513-2006USA004902: US-009507513-2006USA004900:
Sex: U
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event.; Inadvertent administration of PROQUAD and MMR II to the patient; This spontaneous report has been received from a medical assistant referring to a 13-month-old patient, of unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 08-MAY-2020, the patient started to received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, administered subcutaneously (SC) lot # S029456, and expiration date 19-SEP-2021 (strength, dose, frequency and indication were not reported); and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection SC, lot # S022917, expiration 19-JAN-2021 (strength, dose, frequency and indication were not reported). Both vaccines were inadvertently administered to the patient (inappropriate schedule of product administration) on that date for prophylaxis. In addition, an sterile diluent (MERCK STERILE DILUENT) was also administered (dose, route of administration were not reported, lot number and expiration date were unknown by the reporter). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a pharmacist at the pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 18-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) is an invalid lot number, expiry date reported as 11-FEB-2021 (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 2 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 20-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 20-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 with an expiry date of (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 22-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 5 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 25-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 3 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 27-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 3 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 03-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 3 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 06-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 06-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 3 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 09-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 11-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 2 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 12-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 13 months old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 13-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 13-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 20-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 03-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 06-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 24-JAN-2020, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 23-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 28-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-009507513:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 26-SEP-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 04-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 08-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 15-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 13-SEP-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 11-NOV-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010: