chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Chest X-ray normal, Computerised tomogram normal, Cough
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old male patient. On an unknown date in April 2014 the patient was vaccinated with ZOSTAVAX (route, dose, lot number unknown). On an unknown date in 2014 the patient experienced rash on trunk as well as respiratory symptoms such as dry cough and fever. On an unknown date in 2014 Chest x-ray and Cat scan were performed and results were negative. On an unknown date physician prescribed MEDROL (dose, frequency and manufacturer unknown) dose pak and patient symptoms began to resolve. After the tapering of the MEDROL dose pak (as per the Physician orders) the patient began to experience rash, respiratory symptoms and fever. Physician reported that upon second dosing regimen of the MEDROL (dose, frequency and manufacturer unknown) dose pak, patient symptoms reoccurred as patient began to wean off the MEDROL pak. Physician reported that during this time frame patient had laboratory work ordered and the CMP came back showing an increase in liver function test (AST, ALT), the CBC were normal. On an unknown date the patient was prescribed DAPSONE (100 mg, frequency and manufacturer unknown) and two weeks into therapy spiked a fever and DAPSONE was discontinued. Physician reported that although rash has completely healed, patient is currently suffering from a 101 F (reported as 101F) temperature. VZV ID packet not offered as patient's rash is completely healed. Physician considered the events to be serious due to disability. The outcome of rash on trunk was reported as recovered/resolved. The outcome of other events was reported as not recovered/not resolved. It was reported that the patient had sought medical attention. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Full blood count normal, Pyrexia, Rash, Respiratory disorder
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old male patient. On an unknown date in April 2014 the patient was vaccinated with ZOSTAVAX (route, dose, lot number unknown). On an unknown date in 2014 the patient experienced rash on trunk as well as respiratory symptoms such as dry cough and fever. On an unknown date in 2014 Chest x-ray and Cat scan were performed and results were negative. On an unknown date physician prescribed MEDROL (dose, frequency and manufacturer unknown) dose pak and patient symptoms began to resolve. After the tapering of the MEDROL dose pak (as per the Physician orders) the patient began to experience rash, respiratory symptoms and fever. Physician reported that upon second dosing regimen of the MEDROL (dose, frequency and manufacturer unknown) dose pak, patient symptoms reoccurred as patient began to wean off the MEDROL pak. Physician reported that during this time frame patient had laboratory work ordered and the CMP came back showing an increase in liver function test (AST, ALT), the CBC were normal. On an unknown date the patient was prescribed DAPSONE (100 mg, frequency and manufacturer unknown) and two weeks into therapy spiked a fever and DAPSONE was discontinued. Physician reported that although rash has completely healed, patient is currently suffering from a 101 F (reported as 101F) temperature. VZV ID packet not offered as patient's rash is completely healed. Physician considered the events to be serious due to disability. The outcome of rash on trunk was reported as recovered/resolved. The outcome of other events was reported as not recovered/not resolved. It was reported that the patient had sought medical attention. Additional information has been requested.
Sex: M
Vaccine: MMR, MMR
Symptoms: Joint swelling, Local swelling, Neck pain, Pyrexia, Streptococcus test negative
Clinical narrative: This spontaneous report was received from a nurse via Company Representative and refers to a male patient between the ages of 2 and 3 years of age. On an unknown date, the patient was vaccinated with the first dose of M-M-R II (dose, route and lot number not reported). On an unknown date, the patient experienced swelling around his jaw. The outcome of swelling around his jaw was unknown. Additional information has been requested.
Sex: M
Vaccine: MMR, MMR
Symptoms: Swelling face
Clinical narrative: This spontaneous report was received from a nurse via Company Representative and refers to a male patient between the ages of 2 and 3 years of age. On an unknown date, the patient was vaccinated with the first dose of M-M-R II (dose, route and lot number not reported). On an unknown date, the patient experienced swelling around his jaw. The outcome of swelling around his jaw was unknown. Additional information has been requested.
Sex: M
Vaccine: MMR, MMR
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from a nurse via Company Representative and refers to a male patient between the ages of 2 and 3 years of age. On an unknown date, the patient was vaccinated with the first dose of M-M-R II (dose, route and lot number not reported). On an unknown date, the patient experienced swelling around his jaw. The outcome of swelling around his jaw was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Blood test, Erythema, Fatigue, Headache, Loss of consciousness
Clinical narrative: Last Gardasil vaccination was given in 07/2012.  She has been experiencing symptom since 12/2012.  Symptoms have been headaches, joint pain, lethargy, and ill feeling per mom.  Was also diagnosed with hypothyroidism around this same time.  Mom says thyroid levels are back to normal however, patient is still experiencing symptoms.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Malaise, Migraine
Clinical narrative: Last Gardasil vaccination was given in 07/2012.  She has been experiencing symptom since 12/2012.  Symptoms have been headaches, joint pain, lethargy, and ill feeling per mom.  Was also diagnosed with hypothyroidism around this same time.  Mom says thyroid levels are back to normal however, patient is still experiencing symptoms.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Arthralgia, Blood thyroid stimulating hormone, Epstein-Barr virus test, Full blood count, Headache
Clinical narrative: Last Gardasil vaccination was given in 07/2012.  She has been experiencing symptom since 12/2012.  Symptoms have been headaches, joint pain, lethargy, and ill feeling per mom.  Was also diagnosed with hypothyroidism around this same time.  Mom says thyroid levels are back to normal however, patient is still experiencing symptoms.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Hypothyroidism, Laboratory test, Lethargy, Malaise, Red blood cell sedimentation rate
Clinical narrative: Last Gardasil vaccination was given in 07/2012.  She has been experiencing symptom since 12/2012.  Symptoms have been headaches, joint pain, lethargy, and ill feeling per mom.  Was also diagnosed with hypothyroidism around this same time.  Mom says thyroid levels are back to normal however, patient is still experiencing symptoms.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Thyroid function test, Urine analysis
Clinical narrative: Last Gardasil vaccination was given in 07/2012.  She has been experiencing symptom since 12/2012.  Symptoms have been headaches, joint pain, lethargy, and ill feeling per mom.  Was also diagnosed with hypothyroidism around this same time.  Mom says thyroid levels are back to normal however, patient is still experiencing symptoms.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial case received on 08 May 2014 from a healthcare professional (nurse) and involves a case of vaccination given by wrong route. A 16 year old was vaccinated subcutaneously with MENACTRA Lot number U4556AA into the right upper arm on 06 May 2014. On the same day the patient experienced redness, warmth and pain at the injection site. The patient's concomitant medications and medical history were not reported. The patient was seen at the reporter's office on 08 May 2014 and had a 3.5 cm area of redness, warmth, tenderness around the injection site of the right arm. The healthcare provider evaluated it as "allergic reaction vs. cellulitis" and treated the patient with Ibuprofen and BENADRYL. Later that evening the patient also started taking Cephalexin since she still had warmth, redness and pain at the site following use of Ibuprofen and BENADRYL. On 09 May 2014, the patient called the office to report that the symptoms were getting worse and she was also experiencing numbness down the entire arm. The patient was to be seen again on 09 May 2014. Laboratory tests were not reported. The patient outcome was reported as unknown. Documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Hypersensitivity, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Initial case received on 08 May 2014 from a healthcare professional (nurse) and involves a case of vaccination given by wrong route. A 16 year old was vaccinated subcutaneously with MENACTRA Lot number U4556AA into the right upper arm on 06 May 2014. On the same day the patient experienced redness, warmth and pain at the injection site. The patient's concomitant medications and medical history were not reported. The patient was seen at the reporter's office on 08 May 2014 and had a 3.5 cm area of redness, warmth, tenderness around the injection site of the right arm. The healthcare provider evaluated it as "allergic reaction vs. cellulitis" and treated the patient with Ibuprofen and BENADRYL. Later that evening the patient also started taking Cephalexin since she still had warmth, redness and pain at the site following use of Ibuprofen and BENADRYL. On 09 May 2014, the patient called the office to report that the symptoms were getting worse and she was also experiencing numbness down the entire arm. The patient was to be seen again on 09 May 2014. Laboratory tests were not reported. The patient outcome was reported as unknown. Documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site warmth
Clinical narrative: Initial case received on 08 May 2014 from a healthcare professional (nurse) and involves a case of vaccination given by wrong route. A 16 year old was vaccinated subcutaneously with MENACTRA Lot number U4556AA into the right upper arm on 06 May 2014. On the same day the patient experienced redness, warmth and pain at the injection site. The patient's concomitant medications and medical history were not reported. The patient was seen at the reporter's office on 08 May 2014 and had a 3.5 cm area of redness, warmth, tenderness around the injection site of the right arm. The healthcare provider evaluated it as "allergic reaction vs. cellulitis" and treated the patient with Ibuprofen and BENADRYL. Later that evening the patient also started taking Cephalexin since she still had warmth, redness and pain at the site following use of Ibuprofen and BENADRYL. On 09 May 2014, the patient called the office to report that the symptoms were getting worse and she was also experiencing numbness down the entire arm. The patient was to be seen again on 09 May 2014. Laboratory tests were not reported. The patient outcome was reported as unknown. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Dizziness, Malaise, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to approximately 11 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL, (lot# J002441, expiry July 2014 (year also reported as 2214) intramuscularly. On 08-AUG-2013 the patient experienced vomiting, malaise and dizziness. The patient was given the drug and instructed to wait in the room for 15 minutes and stay seated. Mother tried to take the child without waiting. Patient got to the waiting room where he vomited 2 times and started complaining of dizziness and malaise. Patient was moved back to a room where he was monitored and released into his mothers care. The patient was not hospitalized. The event was not life threatening. The patient not died. The event still being treated was no. The events recovered on an unknown date. Reporter's causality was not provided. Additional information has been requested.
Age: 1.4
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a health care worker which is an medical assistant refers to a 16 month old patient of unknown gender. There was no pertinent medical history, concurrent conditions and drug reaction/allergies reported. It was reported that on 08-MAY-2014 a 16 month old patient was vaccinated with GARDASIL, 0.5 ml, intramuscular (lot#, dose number not provided). No concomitant medications reported. No adverse effects reported. Product quality compliant was not involved at the time of the report. Additional information has been requested.
Age: 1.4
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker which is an medical assistant refers to a 16 month old patient of unknown gender. There was no pertinent medical history, concurrent conditions and drug reaction/allergies reported. It was reported that on 08-MAY-2014 a 16 month old patient was vaccinated with GARDASIL, 0.5 ml, intramuscular (lot#, dose number not provided). No concomitant medications reported. No adverse effects reported. Product quality compliant was not involved at the time of the report. Additional information has been requested.
Age: 1.4
Sex: U
Vaccine: HPV4, HPV4, HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker which is an medical assistant refers to a 16 month old patient of unknown gender. There was no pertinent medical history, concurrent conditions and drug reaction/allergies reported. It was reported that on 08-MAY-2014 a 16 month old patient was vaccinated with GARDASIL, 0.5 ml, intramuscular (lot#, dose number not provided). No concomitant medications reported. No adverse effects reported. Product quality compliant was not involved at the time of the report. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Anxiety, Dizziness, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe radiating arm pain during injection of Hep A vaccine booster. Pain radiated through out the arm that was injected, and I felt faint after injection. Nurse mentioned that she had a hard time (had to press hard) to inject a full cc of vaccine in arm. I had to lie down for a few minutes to get my arm feel less pain. Shoulder pain started approximately one hour after I was sent home. Limited range of lifting my left arm. Pain got worse, and at 14 hours post vaccination, pain grade is 9/10 and arm cannot be lifted without severe pain. The injection point is high (1-2cm below shoulder joint). Pain keeps me from sleeping. Very anxious about current status.
Age: 25.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Severe radiating arm pain during injection of Hep A vaccine booster. Pain radiated through out the arm that was injected, and I felt faint after injection. Nurse mentioned that she had a hard time (had to press hard) to inject a full cc of vaccine in arm. I had to lie down for a few minutes to get my arm feel less pain. Shoulder pain started approximately one hour after I was sent home. Limited range of lifting my left arm. Pain got worse, and at 14 hours post vaccination, pain grade is 9/10 and arm cannot be lifted without severe pain. The injection point is high (1-2cm below shoulder joint). Pain keeps me from sleeping. Very anxious about current status.
Age: 25.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Severe radiating arm pain during injection of Hep A vaccine booster. Pain radiated through out the arm that was injected, and I felt faint after injection. Nurse mentioned that she had a hard time (had to press hard) to inject a full cc of vaccine in arm. I had to lie down for a few minutes to get my arm feel less pain. Shoulder pain started approximately one hour after I was sent home. Limited range of lifting my left arm. Pain got worse, and at 14 hours post vaccination, pain grade is 9/10 and arm cannot be lifted without severe pain. The injection point is high (1-2cm below shoulder joint). Pain keeps me from sleeping. Very anxious about current status.
Age: 25.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Pain in extremity, Presyncope
Clinical narrative: Severe radiating arm pain during injection of Hep A vaccine booster. Pain radiated through out the arm that was injected, and I felt faint after injection. Nurse mentioned that she had a hard time (had to press hard) to inject a full cc of vaccine in arm. I had to lie down for a few minutes to get my arm feel less pain. Shoulder pain started approximately one hour after I was sent home. Limited range of lifting my left arm. Pain got worse, and at 14 hours post vaccination, pain grade is 9/10 and arm cannot be lifted without severe pain. The injection point is high (1-2cm below shoulder joint). Pain keeps me from sleeping. Very anxious about current status.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Seizure like phenomena
Clinical narrative: Seizure-like activity.
Age: 1.72
Sex: F
Vaccine: DTAP, HEP, HIBV, PPV
Symptoms: Vomiting
Clinical narrative: Vomiting, lasting through most of the night. At the beginning, patient vomited every 10-20 minutes, but after a couple hours it tapered off to every 1-2 hours. I tried to keep her hydrated, but no medicine was administered.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a pediatrician via company representative refers to a patient of unknown age and gender. There was no pertinent medical history or concurrent conditions reported. On an unknown date the patient was vaccinated with GARDASIL (dose, dose number, route, lot# not reported). No concomitant medications reported. It was reported that the company representative was at health department program event and heard in agroup setting from presenter pediatrician that he administered GARDASIL to three unspecified patients on an unspecified date and all three of them fainted. The outcome of fainted was unknown. PQC was not involved. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a Pharmacist refers to approximately 75 year old female patient. The patient's current conditions included with diabetes, drug reactions to codeine and drug reactions to penicillin (unknown reactions). No pertinent medical history reported. On 27-APR-2014 the patient was vaccinated with ZOSTAVAX dose 1 (single dose), subcutaneous, lot# J014568 expire date 18-FEB-2015. Concomitant therapies included insulin. On 29-APR-2014, after administration of the ZOSTAVAX the patient developed redness, warmth and itching at the injection site. The patient came to the pharmacy on 08-MAY-2014. The pharmacist noted a 2.5 by 1.5 inch area of redness at the injection site. The patient sought medical attention (came to pharmacy). No treatment was given for an adverse event. No lab diagnostics studies performed at the time of the report. The patient's significant disability or incapacity was reported as no. There was no hospitalization and the adverse event was not life threatening. PQC was not involved at the time of the report. The outcome of warmth, itching at the injection site and redness at the injection site/2.5 by 1.5 inch area of redness at the injection site was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The nurse reported that an improperly stored VARIVAX (Merck) was administered (0.5 ml, subcutaneously, lot#, expiration date unknown) on an unspecified date. The nurse states that the vaccine reached a temperature of 39.2F for 6 hours. She also stated that there was a "possibility" that VARIVAX (Merck) reached up to 59.4F but she was unsure at the time of report. She reported that she would find out if VARIVAX (Merck) did reach to 59.4F and give the national service center a call back. There was no adverse effect reported. No further information was provided. This report is linked with MARRS# 1405USA001152 and with MARRS# 1405USA002848 via same reporter. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 18 months child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. The patient received VARIVAX (Merck) dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 21 years old female patient. On an unknown date, the patient was vaccinated with 2 doses of M-M-R II (dose, route of administration and indication were not provided). Other suspect therapy VARIVAX (Merck) 1 dose (dose, route of administration and indication were not provided) was administered on an unspecified date. No concomitants were reported. On an unknown date, the patient developed negative titres for mumps and varicella. Action taken with respect to of M-M-R II and VARIVAX (Merck) was not applicable. No product quality complaint was involved. The outcome of events was unknown. Causality was not provided. No further information provided. Additional information has been requested.
Age: 0.13
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 6 week old patient of unknown gender. On 12-MAY-2014 the patient was vaccinated with RECOMBIVAX HB injection, dose 2, dose: 0.5 ml (millitres), once, (Lot #: J009051; expiry: 26-MAR-2016) intramuscular. No concomitant medications were reported. On 12-MAY-2014, the patient had a medication error who received dose that was improperly stored. Nurse states patient receive dose of RECOMBIVAX HB (second dose in series) that was improperly stored at 0 C (celsius) for less than 72 hours. No adverse effects reported. There was no product quality complaint (PQC) involved. The outcome of received dose that was improperly stored was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Concomitant medication included "steroids". The physician mentioned that a patient received ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not reported) in approximately 2009 (on an unspecified date approximately 5 years ago) and developed the shingles on approximately 16-APR-2014 (on an unspecified date approximately 2 weeks ago). The outcome of shingles was unknown. The patient sought medical attention via visiting office. The relatedness between shingles and ZOSTAVAX was not reported. Additional information is not expected.
Age: 0.7
Sex: U
Vaccine: HEP, HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 8 months old patient of unknown gender. On 02-JAN-2014 the patient was vaccinated with the first unspecified dose of COMVAX (lot number and expiration date not reported). On 05-MAY-2014 the patient was vaccinated with a second unspecified doses of RECOMBIVAX HB (lot number and expiration date not reported) and PEDVAXHIB (lot number and expiration date not reported) at the same time (instead of COMVAX. A third dose was not administered yet. No adverse events reported. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: Seizure like phenomena
Clinical narrative: Seizure like activity began after starting immunizations, unsure of exact dates of onset.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age with no drug reactions or allergies and with no medical history provided. The reporter stated that on 17-APR-2014, the patient was inadvertently vaccinated with ROTATEQ 2 ml, oral liquid (lot# H016250), that had expired on 27-MAR-2014. There was no adverse effects reported. No concomitant medications and no diagnostic tests were mentioned. Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 months old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 17 months child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 11 months infant patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 48 hrs after injection pt had 1 1/2" x 3/4" red/hot area on Rt thigh.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 13 months old child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The nurse reported that an improperly stored M-M-R II was administered (0.5 ml, subcutaneously, lot# not reported) on an unknown date. The nurse stated that the vaccine reached a temperature of 39.2F for 6 hours. She also stated that was a "possibility" that M-M-R II reached up to 59.4F but she was unsure at the time of report. She reported that she would find out if the M-M-R II did reach to 59.4F and give the national service center a callback. There was no adverse effect reported. No further information was provided. This report is linked with MARRS# 1405USA002487 and with MARRS# 1405USA002848 via same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age with no medical history provided. The nurse reported that an improperly stored PROQUAD (Merck) was administered (0.5 ml, subcutaneously, lot#, expiration date not reported) on an unknown date. The nurse stated that all the vaccines reached a temperature of 39.2F for 6 hours. She also stated that there was a "possibility" that PROQUAD (Merck) reached up to 59.4F but she was unsure at the time of report. She reported that she would find out if PROQUAD (Merck) did reach to 59.4F and give the national service center a callback. There was no adverse effect reported. No further information was provided. This report is linked with MARRS# 1405USA001152 and with MARRS# 1405USA002847 via same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a female patient of unknown age who reported on herself. It was reported that the patient informed the physician that she had never had chickenpox but he insisted she receive the vaccine. On 27-MAR-2014 the patient was vaccinated subcutaneously with an unspecified dose ("1 single shot") of ZOSTAVAX (lot number and expiration date not reported). On 01-MAY-2014 the patient experienced chickenpox. The outcome of chickenpox was reported as not recovered. The relatedness between chickenpox and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. It was reported that the patient was administered ZOSTAVAX, single dose, subcutaneously on 22-APR-2014 and, inadvertently, was administered second dose of ZOSTAVAX on 05-MAY-2014. Sites of administrations, lot numbers and expiration dates were not provided. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 years old patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 12 months infant patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.95
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 102 began 5/9/pm and has gone up to 105.  Mother reports has only gone down to 99 during the past 5 days and has stayed elevated.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Child was ordered to receive Pediarix (Dtap+IVP+Hep B) as well as a HIB, PCV13 and rotavirus by physician. She was instead given Pediarix, PCV 13, Rotavirus and Hep B; thereby receiving two doses of Hep B at this visit rather than the HIB which was ordered. No additional treatment was needed.
Age: 1.21
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 14 months child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot oJ006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This one of several reports from the same source. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old patient. On 22-APR-2014, the patient was vaccinated with second dose of expired ROTATEQ, lot # H013539, expiry date 28-MAR-2014, dose (unknown) and route of administration (unknown). No concomitant were reported. No product quality compliant was involved. The outcome of events was unknown. No other information was reported. This report is linked to 1405USA001639 and 1405USA006753 by the same reporter link. Additional information has been requested.
Age: 0.32
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Barium double contrast, Barium enema, Haematochezia, Intussusception
Clinical narrative: Pt deve hematochezia on 5/6/14 - diagnosed with intussusception, reduced with air contrast B.E.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Patient/Employee articulates pain/tenderness in arm vaccine was administered and limited ROM.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Convulsion, Nervous system disorder, Tic
Clinical narrative: Neurological illness.  Tics, convulsions.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 9 week old patient. On 04-APR-2014, the patient was vaccinated with first dose of expired ROTATEQ, lot # H013539, expiry date 28-MAR-2014, dose (unknown) and route of administration (unknown). No concomitants were reported. No adverse effect reported. No product quality complaint was involved the outcome of events was unknown. No other information was reported. This report is linked to 1405USA006753 and 1405USA006754 by the same reporter link. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on n12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from  the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 12 months infant patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a safe visit from local health department on an unspecified date. No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscularly. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 5 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once intramuscular. The medical assistant stated there was  a  power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J006358, expiry 23-MAY-2015 ("VYC" stock), 0.5 ml once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Cough, Ear discomfort, Hyperaesthesia, Pain in jaw
Clinical narrative: Initial report received on 08 May 2014 from a consumer who is the patient. A 62 year old female patient was vaccinated intramuscularly in March 2014 with ADACEL, batch and site of administration not reported. The patient denied any illness at the time of vaccination. On an unspecified date in March 2014, three days after the vaccine, she experienced stomach pain for 3 days and a dry cough for 3 weeks that went away. She then got a "zinging feeling in her jaw", date not reported. She went to the doctor who said her parotid glands were swollen and was told that it might be lupus. She was seen by her dentist who "cleared her". She also noted a sensitivity in her ears. Concomitant medications and medical history were not reported. Laboratory tests were not reported. The patient has not recovered. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Parotid gland enlargement
Clinical narrative: Initial report received on 08 May 2014 from a consumer who is the patient. A 62 year old female patient was vaccinated intramuscularly in March 2014 with ADACEL, batch and site of administration not reported. The patient denied any illness at the time of vaccination. On an unspecified date in March 2014, three days after the vaccine, she experienced stomach pain for 3 days and a dry cough for 3 weeks that went away. She then got a "zinging feeling in her jaw", date not reported. She went to the doctor who said her parotid glands were swollen and was told that it might be lupus. She was seen by her dentist who "cleared her". She also noted a sensitivity in her ears. Concomitant medications and medical history were not reported. Laboratory tests were not reported. The patient has not recovered. Documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 5 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient ws vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Rash, Urticaria
Clinical narrative: PEDIARIX given in (L) thigh, baby developed hives on feet and redness on (L) thigh, rash diminished within 5 minutes.