chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 14-FEB-2017 at 11:04, the patient was vaccinated with improperly stored VARIVAX injection (lot # M018436) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000473: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 15-FEB-2017 at 15:12, the patient was vaccinated with improperly stored VARIVAX injection (lot # M018436) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000448: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from certificated medical assistant referring to an adult female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-MAR-2017, the patient was vaccinated with a properly stored dose of M-M-R II, lot # L005290 with an expiration date of 17-FEB-2017 (product use issue) (strength, dose, route and anatomical location were not provided), for prophylaxis. No adverse effect and no product quality complaint were reported. Additional information is not expected because there was no consent to contact the reporter.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001065: US-009507513-1704USA001070: US-009507513-1704USA001067: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1703USA012554: US-009507513-1704USA001066.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L012479, the expiration date: 10-APR-2017, lot# M010426, the expiration date: 01-MAR-2018, Lot# M004063, the expiration date: 25-JAN-2018 and Lot# M007277, the expiration date: 09-FEB-2018 (dose and route were not provided) for prophylaxis. The nurse could not provide the lot and expiration for the properly stored sterile water diluent used to reconstitute the doses of M-M-R II) No adverse effects reported nor Product Quality Complaint involved (PQC). The call was made due to data logger with a temperature of 35°F during 45 minutes. There was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.; Sender's Comments: US-009507513-1703USA009966: US-009507513-1704USA001679: US-009507513-1704USA001680:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 lot # M029681, the expiration date: 22-JAN-2018 and Lot# M037533, the expiration date: 17-MAY-2018 (dose and route were not provided) for prophylaxis. No adverse effects reported nor Product Quality Complaint involved (PQC). The call was made due to data logger with a temperature of 35°F during 45 minutes. There was no previous temperature excursion reported.     This is one of several reports received from the same reporter.    Additional information is not expected because the reporter refused additional contact.; Sender's Comments: US-009507513-1703USA009966: US-009507513-1704USA001678: US-009507513-1704USA001680:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L029615, the expiration date: 15-MAY-2017, Lot# M012495, the expiration date: 09-OCT-2017 and Lot# M004890, the expiration date: 10-NOV-2017 (dose was not provided) for prophylaxis. No adverse effects reported nor Product Quality Complaint involved (PQC). The call was made due to data logger with a temperature of 35°F during 45 minutes. There was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact. This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ lot # L029615, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. {Additional information has been requested. / Additional information is not expected.}; Sender's Comments: US-009507513-1703USA009966: US-009507513-1704USA001678: US-009507513-1704USA001679:
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth
Clinical narrative: Patient had a topical allergic reaction around injection site and also down bicep.  Very red and warm.  No itching or pain.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Anaemia, Antinuclear antibody increased, Attention deficit/hyperactivity disorder, Cranial nerve disorder
Clinical narrative: Pt couldn't walk that night. I had to carry her around for a several days. I reported this to the doctor's office who said that they must have nicked a muscle. We had numerous problems from then on.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Language disorder, Muscle injury, Sensory processing disorder, Speech disorder
Clinical narrative: Pt couldn't walk that night. I had to carry her around for a several days. I reported this to the doctor's office who said that they must have nicked a muscle. We had numerous problems from then on.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: C/o local vaccine reaction to PCV13-Pneumococcal. Pt. c/o fever/chills 3/23 PM after receiving PCV13. She was unable to abduct Lt arm the day after receiving PCV13. Pt. took Tylenol 1 tablet for pain. Lt shoulder ROM was improved on 3/28/17 visit, but Lt deltoid swelling and erythema 2-3 inch area surrounding injection site still painful with Lt shoulder and arm movement.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: C/o local vaccine reaction to PCV13-Pneumococcal. Pt. c/o fever/chills 3/23 PM after receiving PCV13. She was unable to abduct Lt arm the day after receiving PCV13. Pt. took Tylenol 1 tablet for pain. Lt shoulder ROM was improved on 3/28/17 visit, but Lt deltoid swelling and erythema 2-3 inch area surrounding injection site still painful with Lt shoulder and arm movement.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Asthma, Attention deficit/hyperactivity disorder, Cardiac disorder, Condition aggravated, Confusional state
Clinical narrative: Asthma returned, worsening ADHD, heart condition started (I suspect the ADHD medication.)
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Intelligence test abnormal, Mental impairment, QRS axis abnormal, Staring
Clinical narrative: Asthma returned, worsening ADHD, heart condition started (I suspect the ADHD medication.)
Age: 41.0
Sex: M
Vaccine: PPV, TDAP, TYP
Symptoms: Arthralgia, Blood culture negative, Cellulitis, Headache, Injection site erythema
Clinical narrative: Patient began having fevers of 101-102 degrees on the afternoon of 3/22 after having the vaccines on 3/21 in the morning. He had generalized malaise, headaches, body/joint aches, nausea, and notices some swollen glands in his left axilla. On 3/24 he developed some redness at the site of the injections on the left arm. He presented to Urgent Care on 3/25 and was diagnosed with cellulitis vs vaccine reaction. WBC was 12.6. Treated with Keflex 500 mg qid. Redness spread so seen in ER on 3/26, WBC 9.6 that day. Bactrim added to Keflex. Fevers resolved on 3/26. After starting Bactrim patient started to feel better, redness slowly improved over the week and had resolved by 4/3. He continued to have a small lump at the site of one of the injections in the left arm with some itchiness in that area.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP, TYP
Symptoms: Injection site mass, Injection site pruritus, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Patient began having fevers of 101-102 degrees on the afternoon of 3/22 after having the vaccines on 3/21 in the morning. He had generalized malaise, headaches, body/joint aches, nausea, and notices some swollen glands in his left axilla. On 3/24 he developed some redness at the site of the injections on the left arm. He presented to Urgent Care on 3/25 and was diagnosed with cellulitis vs vaccine reaction. WBC was 12.6. Treated with Keflex 500 mg qid. Redness spread so seen in ER on 3/26, WBC 9.6 that day. Bactrim added to Keflex. Fevers resolved on 3/26. After starting Bactrim patient started to feel better, redness slowly improved over the week and had resolved by 4/3. He continued to have a small lump at the site of one of the injections in the left arm with some itchiness in that area.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP, TYP
Symptoms: Pain, Pyrexia, Vaccination complication, White blood cell count increased
Clinical narrative: Patient began having fevers of 101-102 degrees on the afternoon of 3/22 after having the vaccines on 3/21 in the morning. He had generalized malaise, headaches, body/joint aches, nausea, and notices some swollen glands in his left axilla. On 3/24 he developed some redness at the site of the injections on the left arm. He presented to Urgent Care on 3/25 and was diagnosed with cellulitis vs vaccine reaction. WBC was 12.6. Treated with Keflex 500 mg qid. Redness spread so seen in ER on 3/26, WBC 9.6 that day. Bactrim added to Keflex. Fevers resolved on 3/26. After starting Bactrim patient started to feel better, redness slowly improved over the week and had resolved by 4/3. He continued to have a small lump at the site of one of the injections in the left arm with some itchiness in that area.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Inflammation, Pain in extremity, Tenderness
Clinical narrative: Arm is sore and inflamed. Very sore to touch and appears to be infected.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pt came in to urgent care with redness swelling and rash on the left thigh, where a tdap and hep a vaccine were given at a recent well child visit.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Fatigue, Pyrexia
Clinical narrative: Upset stomach, exhaustion, leading to high temperature reading of 103.8 at highest. Still running a fever, 102 on 04/05/2017.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Attention deficit/hyperactivity disorder, Deafness, Ear discomfort, Ear infection, Epistaxis
Clinical narrative: Frequent nosebleeds, congestion, ear infection, negative pressure in ears, temporary hearing loss, chest congestion, regression of toileting abilities, symptoms of SPD, APD, ADHD, ODD began with official diagnosis to follow.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Oppositional defiant disorder, Personality disorder, Regressive behaviour, Respiratory tract congestion, Schizoid personality disorder
Clinical narrative: Frequent nosebleeds, congestion, ear infection, negative pressure in ears, temporary hearing loss, chest congestion, regression of toileting abilities, symptoms of SPD, APD, ADHD, ODD began with official diagnosis to follow.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Neck pain, LT arm with pain, swelling and redness.
Age: 10.0
Sex: F
Vaccine: HEP, IPV, TDAP
Symptoms: Injection site swelling
Clinical narrative: Marked swelling to area of injections.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling to areas of injection sites.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Areflexia, Fall, Gait disturbance, Lumbar puncture, Mobility decreased
Clinical narrative: Couldn't barely walk, fell down stairs, couldn't get up. Limbs not responding. Hosp. gave IV blood product to boost immune system.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Transfusion
Clinical narrative: Couldn't barely walk, fell down stairs, couldn't get up. Limbs not responding. Hosp. gave IV blood product to boost immune system.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin plaque
Clinical narrative: (L) anterior thigh 13 x 11 erythema and swelling. (R) lateral thigh 5 x 5 firm erythematous plaque. BENADRYL and ice f/u as needed.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Ocular hyperaemia, Urticaria, Vomiting
Clinical narrative: Vomited few mints after the vaccines was given redness of eye the mom called after 30 minutes to report for hives all over body but was breathing good. Mom gave BENADRYL, told mom to take to nearest hospital ER if diff breathing.
Age: 81.0
Sex: U
Vaccine: PNC13, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus
Clinical narrative: Had itching at (R) deltoid after vaccine. Family noticed redness a couple of days ago and getting worse. 4-5-17 - presented to office today with (R) deltoid cellulitis.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Local reaction to pneumococcal.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Vaccine not properly injected - Immediate discomfort with increasing pain and loss of range of motion in (L) arm/shoulder over next few days which had persisted with some resolution.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Wrong technique in product usage process, X-ray limb
Clinical narrative: Vaccine not properly injected - Immediate discomfort with increasing pain and loss of range of motion in (L) arm/shoulder over next few days which had persisted with some resolution.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: Patient treated with BENADRYL as needed and ice as needed. Left thigh with mild erythematous macular rash at sites of both PROQUAD and KINRIX injections.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered 1 mL of HPV instead of 0.5 mL left arm. No treatment. Hep B 1 mL was also administered in the same arm by different medical assistant.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warmth from (L) deltoid to elbow, developed chills.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of macular rash in a 20-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, 12 days after receiving BEXSERO, the patient experienced macular rash, erythematous rash, itchy rash, patchy rash and injection site pain. On an unknown date, the outcome of the macular rash, erythematous rash, itchy rash, patchy rash and injection site pain were recovered/resolved. It was unknown if the reporter considered the macular rash, erythematous rash, itchy rash, patchy rash and injection site pain to be related to BEXSERO. Additional details were reported as follows: The patient experienced a rash on his limbs and half of his waist, which was described as a fine, macular, pink rash that was hard to see. The rash was mildly itchy. The rash presented as scant patches scattered on patient's limbs and half of his waist. The patient also experienced soreness at the injection site on his arm that lasted approximately a week. There were no other adverse events reported. The patient received the vaccine somewhere other than the student health center. The patient sought treatment at the health center by Nurse Practitioner. The nurse reported it to the MD who reported it to the GlaxoSmithKline field rep. The physician reported that the rash presented for care 13 days later with a rash that was already resolving. The rash was almost completely resolved one day after it presented. The date of administration and the batch number was unknown. The patient slept on a friend's futon 2 days before the rash presented. The parts of the patient's body that were covered by clothing did not show the rash. The field representative attempted to report it to the facility yesterday but the center was closed. The nursing professional said she would report it to VAERS.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Malaise, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general malaise in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown time after receiving BEXSERO, the patient experienced general malaise and pain in arm. On an unknown date, the outcome of the general malaise and pain in arm were recovered/resolved. It was unknown if the reporter considered the general malaise and pain in arm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional called and said that the daughter of one of the practice doctors and a daughter of one of the patient of that doctor experienced pain at the injection site, soreness in injected arm and generalized malaise for 1 week following administration of BEXSERO. The healthcare professional did not have patient demographics or product information or any other information available. This case is link with the case US2017041047 (reported by same reporter).
Sex: M
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, 10 days after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were provided as follows" The age at vaccination was not reported. The speaker told the audience that his son was vaccinated with BEXSERO and 10 to 14 days later experienced pain.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Hypoaesthesia, Laboratory test
Clinical narrative: Facial drooping numbness. Dx Bells Palsy 72 hrs post Shingles vaccination.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concernig to a unspecified patient with unspecified demographics. The patient's concurrent conditions, medical history, drug reactions and/ or allergies.  On 07-MAR-2017, the patient was indavertanly administered an expired ZOSTAVAX 19400 PFU,lot # L044530/expiration date 09-FEB-2017, 0.65 ml, subcutaneous for prophylaxis. It was also reported that the vaccine was reconstituted with sterile diluent (DILUENT MRK) lot number as reported (K023742/ and expiration date 23-SEP-2017). No adverse effects were reported. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: HPVX
Symptoms: Interchange of vaccine products, Penile wart
Clinical narrative: This spontaneous report was received from a consumer, via a company representative, referring to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates the patient was vaccinated with two doses of GARDASIL (dose number, route, frequency, lot/batch numbers and expiration dates were not reported) and, when he was 25 year old, one dose of GARDASIL 9 for prophylaxis (dose number, route, frequency, lot/batch numbers and expiration dates were not reported). The patient was seen by physician, on an unspecified date, because the patient developed, on an unknown date, "a genital wart on the end of his penis" (penile wart). The outcome of penile wart was not reported. The relationship between penile wart with GARDASIL 9 and GARDASIL was not stated. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a patient of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 17-MAR-2017, the patient was vaccinated with expired dose of PNEUMOVAX23 injection, intramuscularly, lot # L017265 with expiry date on 10-FEB-2017 (dose was not reported), for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse and refers to an unspecified number of patients of unknown ages and gender. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The pharmacist reported that, on unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of PROQUAD (lot # M042499 with an expiration date in 17-APR-2018), subcutaneously, for prophylaxis (strength, dose, and frequency were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported). The vaccine data logger measured a temperature between minus 14°C to minus 10 °C for a time frame of 17 hours and 53 minutes. Additional reported excursions were of 9°C to 8°C for a time frame of 17 hours and 12 minutes. A previous temperature excursion was between minus 9°C to 8°C for 12 hours and 2 minutes. No adverse effects were reported, and there was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to and unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 for prophylaxis, reported lot # M037770 expiration date 01-JUN-2019 (dose and route were not reported). The administered doses of the vaccine experienced a temperature excursion of 0°C to 1°degrees Celsius for 4 hours 39 min. It was also reported that the vaccine experienced  previous excursions of  0°C to 1°degrees Celsius for 5 hours 23 minutes. The temperature excursions were detected by a data logger .There was no adverse effect reported.  No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012670: US-009507513-1703USA012672: US-009507513-1703USA007486:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to and unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ for prophylaxis, reported lot # M033338 expiration date 15-APR-2018(dose and route were not reported). The administered doses of the vaccine experienced a temperature excursion of 0°C to 1°degrees Celsius for 4 hours 39 min. It was also reported that the vaccine experienced  previous excursions of  0°C to 1°degrees Celsius for 5 hours 23 minutes. The temperature excursions were detected by a data logger .There was no adverse effect reported.  No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007486: US-009507513-1703USA012670: US-009507513-1703USA012671:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant via field representative and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2017, the patient was vaccinated with dose of ZOSTAVAX (expiration date: 09-FEB-2017, route, site of administration and  lot # were not reported) after the dose had expired. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No concomitant medication, patient's medical history, drug reactions or allergies were reported. On 03-MAR-2017 the patient was vaccinated with PNEUMOVAX23 (lot # K021881, route of administration, dose not reported), for prophylaxis. The nurse stated that the patient was administered an expired dose of the vaccine: expiration date 30-JUL-2016. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 15-FEB-2017 at 09:36, the patient was vaccinated with improperly stored VARIVAX injection (lot # M018436) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 16:53, the patient was vaccinated with improperly stored VARIVAX injection (lot # M018436) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000473: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704U.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 15-FEB-2017 at 13:01, the patient was vaccinated with improperly stored VARIVAX injection (lot # M018436) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704U.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 14-FEB-2017 at 09:11, the patient was vaccinated with improperly stored VARIVAX injection (lot # M031969) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a currently 1 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012554: US-009507513-1704USA001070: US-009507513-1704USA001067: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001064: US-009507513-1704USA001066:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a currently 2 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001065: US-009507513-1704USA001070: US-009507513-1704USA001067: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001064: US-009507513-1703USA012554:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001065: US-009507513-1704USA001070: US-009507513-1703USA012554: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001064: US-009507513-1704USA001066:
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a currently 9 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided.  On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001065: US-009507513-1704USA001070: US-009507513-1704USA001067: US-009507513-1703USA012554: US-009507513-1704USA001069: US-009507513-1704USA001064: US-009507513-1704USA001066: