chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 07-APR-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare student referring to a 58 year old patient of unknown gender. Information regarding the medical history and concurrent conditions was not reported. On an unknown date the patient was vaccinated with first dose of ZOSTAVAX (dose, strength, lot # and route were not reported). On 20-JUL-2015 the patient was vaccinated with second dose of ZOSTAVAX (dose, strength and route were not reported, lot # L006382 expiry date: 25-MAY-2016) (extra dose administered). No adverse effect was reported. This case is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 31-MAR-2015, the patient was vaccinated with an improperly stored dose of VAQTA (Lot No. K001792 Expiration date: 22-OCT-2015) (dose, route, and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Injection site red, swollen, itching, arm sore to touch 4 days after injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site pain, Injection site pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with asthma, depression, nasal congestion, and penicillins unspecified; sulfonamides-unspecified allergy. On 07-JUL-2015 the patient was vaccinated with ZOSTAVAX (lot # K016320, exp. date: 24-DEC-2015) 0.65 ml subcutaneous injection. Concomitant therapies included escitalopram, pravastatin and methylphenidate. On 09-JUL-2015, the patient experienced a mild reaction of five to six red-colored welts (urticaria), around injection site was itchy (injection site pruritus) and painful (injection site pain), but not terribly painful, after receiving ZOSTAVAX. The injection site had been weepy earlier but was no longer weepy. The patient sought medical attention and saw the pharmacist.  There was no intervention to prevent serious criteria. The events were not cancer,overdose, life threatening or caused significant disability or incapacity, hospitalization or prolongation. No PQC was involved. The outcome of the events urticaria,  injection site pruritus and injection site pain and the relatedness with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 05-JUN-2015, the patient was inadvertently administered with improperly stored MMR II vaccine, lot # K002528, expire date: 18-Feb-2016, (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Oropharyngeal pain, Palatal oedema, Purulence
Clinical narrative: Reports developing a sore throat last night. Noticed pus pockets this morning; reports gargling with peroxide. Redness and pain around area of flu shot injection on LUE and edema and white patches on his uvula yesterday; localized redness noted to (L) bicep, no redness, swelling, nor white patches noted in throat/uvula. Diphenhydramine 25 mg once.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 06-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. The patient's medical history was not reported. On 14-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # reported as K026247, expiration date reported as 29-JAN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 5 year old patient with unknown gender. No pertinent medical history was reported. On 16-JUL-2015, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route and lot# were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Neck pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: 2nd dose-rash, mild fever, pain arms, legs, neck. Joint pain. Same effects after 1st dose was administered history of Lyme Disease.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness & swelling in entire upper arm area. Presented at pharmacy 6 days after receiving vaccine.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Erythema, redness, swelling, tenderness left deltoid area centered more around the Meningococcal B vaccine than the HPV 4 vaccine injection site, with fever, malaise. 100.8 degree F temperature.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Scab, Varicella post vaccine
Clinical narrative: 7/22/15 "suspect chicken pox after varicella vaccine administered 7/15/15." "Patient looks well-ok to return to day care. 24 hours after rash has scabbed over" "or to get 2nd vaccine in future as per CDC."
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Headache, Injection site erythema, Injection site pain, Pain
Clinical narrative: 7-16-15 (L) delt. redness and pain. 7-17-15 (5 AM) H/A-vomiting-fever-body aches. She had wellness visit 7/16-no other recent illness.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: 7-16-15 (L) delt. redness and pain. 7-17-15 (5 AM) H/A-vomiting-fever-body aches. She had wellness visit 7/16-no other recent illness.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2 inch red indurated area right upper back arm. where Varicella vaccine given 2 days ago. No c/o, does not itch. Did not notice the area, mother pointed out to her it was red.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient reported to clinic at work place 6/18/15 stating pain in arm where injection took place (6/10/15), said pain was getting worse, was not seen/evaluated by anyone in clinic, advised to follow up w/ MD.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Tongue pruritus
Clinical narrative: Patient received vaccine. About 10 minutes later reported feeling of an "itchy tongue". There was no visible swelling, not erythema or other evidence of allergic reaction. Gave patient 25mg of BENADRYL and monitored for 30 additional minutes. Patient followed up with her primary care physician.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain, Pain in extremity, Swelling
Clinical narrative: Patient reported to clinic at work place 6/18/15, decreased range of motion, swelling, pain that has increased since day of injection (6/10/15), pain is constant/sharp/burning, pain moving down inner arm toward elbow.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: Pt. described rash (extremely itchy) on lower extremities 1-2 wks after MMR vaccine. No other symptoms.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Fever, swelling, redness, stinging down my arm, itching.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: Pt-received a VARIVAX booster-sq-left arm 3-5 minutes later she fainted-hit back of hand on floor. She was with her mom and sister. 911-called-they checked her out-Parents decided not to go to hospital via ambulance-Pt was up walking-no pain-no numbness-just light headed.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia
Clinical narrative: Before she left my office right after vaccine administration she noticed "numbness" of her "butt". Later that same evening she noticed numbness of the bottoms of her feet.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth (6 cm diameter) to (L) deltoid at injection site.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored VAQTA (lot #, expiry date was not reported). No adverse event was reported. The outcome of the events were not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician and refers to a 2-year-old male patient. No information about patient's concomitant medication, pertinent medical history, drug reactions or allergies was provided. On 13-JUL-2015, the patient indicated for a dose of hepatitis A vaccine, but inadvertently received a dose of GARDASIL intramuscularly (dose, lot# and expiration date not reported). No adverse experience was reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant of unknown age regarding herself (female). The concurrent condition, medical history and concomitant medication was not reported. On 15-JUL-2009, the patient was vaccinated with the first dose of hepatitis b virus vaccine (manufacturer GlaxoSmithKline). On 25-AUG-2009, the patient received the second dose of RECOMBIVAX HB 5/0.5 microgram/ml (route and lot details unavailable). The patient reported that she would like to receive a third dose of RECOMBIVAX HB now. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of VAQTA (Lot No. K001792 Expiration date: 22-OCT-2015) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, on 02-JUL-2015, concerning a patient of an unknown age and gender. On 14-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a female patient of unknown age. No medical history reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (intramuscular injection) (dose not provided). No concomitant therapy reported. On an unknown date, the patient passed out in the office moments after receiving the first dose of GARDASIL. She rested in the physician's office until she was strong enough to go home. She continued to feel tired and worn down for close to 24 hours. The patient called the physician's office but no medications were given to treat the events. PQC was not involved. The outcome of the event passed out was unknown. Additional information is not expected as the physician could not be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 21-APR-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 29-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # K010579 with expiration date 12-FEB-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medical history, drug reactions and allergies reported. On unknown date, the patient were vaccinated with improperly stored PEDVAX HIB (lot#, expiration date, dose, frequency, indication, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 07-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that  underwent 46 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of an unknown age and gender. No medical history and concurrent conditions reported. On 16-JUN-2015, the patient was inadvertently administered with improperly stored, MMR II vaccine, lot # K002528, Expired date 18-FEB-2016, therapy type not provided, (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 11-JUN-2015, the patient was inadvertently administered with improperly stored, MMR II vaccine, lot # K002528, expire date, 18-FEB-2016, therapy type not provided, (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients (age and gender were not reported). Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored doses of ROTATEQ (lot # K009753, expiration date 28-APR-2016) route default as oral (dose, strength and frequency were not reported). There was no concomitant medication reported. The reporter stated that no adverse experiences were reported. Additional information is not expected.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare student referring to a 53 year old patient of unknown gender. Information regarding the medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with first dose of (Oka/Merck) ZOSTAVAX (dose, strength, lot # and route were not reported). ON 20-JUL-2015 the patient was vaccinated with the second dose of (Oka/Merck) ZOSTAVAX (dose, strength and route were not reported, lot # L006382 expiry date: 25-MAY-2016) (extra dose administered). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old female patient. The nurse reports that she received a voice mail from a patient's mother. The patient had no known drug allergies or reactions, there was no patient medical history. On 21-JUL-2015, the patient was vaccinated with a dose of PROQUAD (dose was not reported) lot # K009890, expiration date 11-JAN-2016, subcutaneous. Secondary suspects and concomitant therapies were not reported. Approximately in July 2015, the patient experienced fever (unspecified temperature). There was no lab diagnostics studies performed. The outcome of fever was reported as not recovered. The relatedness between fever and PROQUAD (Merck) was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a female patient of unknown age. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. In 2013 (exact date not reported), the patient was vaccinated with the first dose of GARDASIL (dose, lot#, expiration date, route of administration and indication were not reported). On 20-JUL-2015 (reported as "today"), the patient was in the office to receive her second dose of GARDASIL. No adverse effects were reported. It was reported that therapy with GARDASIL was not discontinued. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K003420 with expiration date 06-MAR-2016; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored ROTATEQ (lot #, expiry date was not reported). No adverse event was reported. The outcome of the events were not reported. This is  one of the several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a 60 year old female patient. No concurrent or historical conditions were reported. On 14-JUL-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # L000453, expiration date 06-JAN-2017), strength reported as "1350 U", subcutaneously in the left arm, instead of ZOSTAVAX. The patient stated that the error was not a result of medication confusion. The patient was indicated to received ZOSTAVAX. The patient had not experienced any adverse effects. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin M decreased, Rash
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. No information on patient's concurrent conditions and medical history was provided. On 17-JAN-2001, the patient was vaccinated with dose of (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not reported). ON about 13-JUL-2015, the patient broke out in a rash on an  unspecified area of the body. On 15-JUL-2015, blood titer was drawn which revealed an immunoglobulin G (IgG) level of greater than 4000 (units not provided) and an immunoglobulin M (IgM) level of less than 0.91 (units not provided). The outcome of events was reported as not recovered/not resolved. The relatedness between the events and the vaccination with (Oka/Merck) VARIVAX was not provided. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 10-JUL-2015, the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (lot # J008441, expiry date 09-JUL-2015, strength reported as 1350 U)(dose and route of administration unspecified). There were no concomitant therapies reported. The patient did not report any adverse experience. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Injection site discolouration, Injection site induration, Injection site mass, Injection site pustule, Injection site reaction
Clinical narrative: This spontaneous report was received from a nurse and refers to an approximately 10 months old female patient. No medical history, concurrent conditions and concomitant therapies were reported. On an unknown date in 2014, the patient was vaccinated with the first dose of LIQUID PEDVAXHIB dose 0.5 ml, intramuscularly for baby vaccination (lot #, expiration date and anatomical location were not reported), on 16-SEP-2014, the patient was vaccinated with the second dose of LIQUID PEDVAXHIB dose 0.5 ml, intramuscularly for baby vaccination (lot #, expiration date and anatomical location were not reported) LIQUID PEDVAXHIB dose 0.5 ml, intramuscularly for baby vaccination (lot #, expiration date and anatomical location were not reported) and on 22-APR-2015, the patient was vaccinated with third dose of LIQUID PEDVAXHIB lot # reported as K015465, expiration date 07-SEP-2017, dose 0.5 ml, intramuscularly in thigh for baby vaccination. The patient received an unspecified second vaccine in alternate thigh at the time of third dose of LIQUID PEDVAXHIB. On 21-JUL-2015, the patient was seen in office for check up. Patient's mother reported to the nurse that approximately in May 2015 (reported as "one month later, after the third dose"), a pustule developed at injection site, like a skin abscess. The patient's mother applied warm compresses to the site and site healed over time. The nurse stated, that the last LIQUID PEDVAXHIB injection site was dark purple and had a 1 cm lump which was firm, palpable, not tender. There was no fever or rash. The outcome of the events was reported as recovering. The relatedness between the events and LIQUID PEDVAXHIB was not reported. Lot number K015465 has been verified to be a not valid lot number for LIQUID PEDVAXHIB. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Subcutaneous abscess
Clinical narrative: This spontaneous report was received from a nurse and refers to an approximately 10 months old female patient. No medical history, concurrent conditions and concomitant therapies were reported. On an unknown date in 2014, the patient was vaccinated with the first dose of LIQUID PEDVAXHIB dose 0.5 ml, intramuscularly for baby vaccination (lot #, expiration date and anatomical location were not reported), on 16-SEP-2014, the patient was vaccinated with the second dose of LIQUID PEDVAXHIB dose 0.5 ml, intramuscularly for baby vaccination (lot #, expiration date and anatomical location were not reported) LIQUID PEDVAXHIB dose 0.5 ml, intramuscularly for baby vaccination (lot #, expiration date and anatomical location were not reported) and on 22-APR-2015, the patient was vaccinated with third dose of LIQUID PEDVAXHIB lot # reported as K015465, expiration date 07-SEP-2017, dose 0.5 ml, intramuscularly in thigh for baby vaccination. The patient received an unspecified second vaccine in alternate thigh at the time of third dose of LIQUID PEDVAXHIB. On 21-JUL-2015, the patient was seen in office for check up. Patient's mother reported to the nurse that approximately in May 2015 (reported as "one month later, after the third dose"), a pustule developed at injection site, like a skin abscess. The patient's mother applied warm compresses to the site and site healed over time. The nurse stated, that the last LIQUID PEDVAXHIB injection site was dark purple and had a 1 cm lump which was firm, palpable, not tender. There was no fever or rash. The outcome of the events was reported as recovering. The relatedness between the events and LIQUID PEDVAXHIB was not reported. Lot number K015465 has been verified to be a not valid lot number for LIQUID PEDVAXHIB. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse via a field representative referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 22-JUL-2015 the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX instead of a dose of ZOSTAVAX (dose, dose number, lot #, route and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 22-JUL-2015 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L001332, expiration date 13-JAN-2017, route not reported) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a clinical medical assistant referring to a 29 day old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 22-JUL-2015 the patient was accidentally vaccinated with a dose of PEDVAXHIB (dose and lot# were not reported) instead of an unspecified Hepatitis B vaccine (wrong drug administered). No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 4 year old patient. On an unknown date between 16-JUL-2015 and 23-JUL-2015 the patient was vaccinated with PROQUAD (Merck), dose 1 (lot number unknown), 0.5 ml once intramuscularly (Inappropriate schedule of drug administration, incorrect route of drug administration). No adverse effects reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (lot # K009482, expiry date 06-MAR-2017 and lot # K011325, expiry date 08-APR-2017; strength, dose, frequency, route of administration were not reported), which were exposed to temperature outside of the recommended range. There were no concomitant therapies reported. No adverse effects were reported. Follow up information has been received on 15-JUL-2015. Patient's demographics has been updated. The patient was vaccinated on 25-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Body temperature increased, Malaise, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 61 year old female patient with cardiac issues, high cholesterol and unspecified gastrointestinal issues. The patient did not have drug reactions/allergies. On 13-JUL-2015 the patient was vaccinated with (Oka/Merck) ZOSTAVAX, (lot # was reported as L015416, expire date 03-JUL-2016, dose, dose # and strength not provided), subdermal) in the left arm for vaccination. The patient took several unspecified concomitant medications. On 16-JUL-2015 the patient felt sick, achey and feverish and had abdominal cramping. On 19-JUL-2015 the patient began vomiting. No lab diagnostics studies were performed. The reporter stated that the patient came into the pharmacy on 22-JUL-2015 and reported that her symptoms had resolved although she was still a bit achey. The outcome of felt sick and feverish abdominal cramping and vomiting was reported as recovered/resolved on an unspecified date in July 2015. The outcome of felt achey was reported as recovering/resolving. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Information has been received from a pharmacist referring to a 61 year old female patient with cardiac issues, high cholesterol and unspecified gastrointestinal issues. The patient did not have drug reactions/allergies. On 13-JUL-2015 the patient was vaccinated with (Oka/Merck) ZOSTAVAX, (lot # was reported as L015416, expire date 03-JUL-2016, dose, dose # and strength not provided), subdermal) in the left arm for vaccination. The patient took several unspecified concomitant medications. On 16-JUL-2015 the patient felt sick, achey and feverish and had abdominal cramping. On 19-JUL-2015 the patient began vomiting. No lab diagnostics studies were performed. The reporter stated that the patient came into the pharmacy on 22-JUL-2015 and reported that her symptoms had resolved although she was still a bit achey. The outcome of felt sick and feverish abdominal cramping and vomiting was reported as recovered/resolved on an unspecified date in July 2015. The outcome of felt achey was reported as recovering/resolving. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, Pyrexia
Clinical narrative: This spontaneous report was received from a physician regarding a 4 year old patient of unknown gender. There was no information about concurrent condition and historical medication. In approximately 2012, at 15 months, the patient was vaccinated with the first dose of M-M-R II (lot number, expiration date, dose, anatomical location, albumin status and route were unspecified without incident. On 08-JUN-2015 the patient was vaccinated, for the second time, with an improperly stored dose of M-M-R II lot # K014833, Expiration Date  14-SEP-2016 (dose, anatomical location, albumin status and route were unknown). No concomitant medication was reported. On an unknown date in 2015 the patient experienced fever (pyrexia). The outcome of the event was unknown. The relatedness between the fever and M-M-R II was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to three patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the three patients were vaccinated with improperly stored doses of PROQUAD (lot # L003222 with expiration date 30-JUL-2016; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored RECOMBIVAX HB (lot #, expiry date was not reported). No adverse event was reported. The outcome of the events were not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report has been received from a 64 year old female consumer, who was reporting on herself. The patient's concurrent conditions included headaches and AUGMENTIN allergy, which manifested as hives. There was no concomitant medication. On 16-JUL-2015, the patient was vaccinated with a dose of (Oka/Merck) ZOSTAVAX injection (dose, route of administration, lot # and expiry date were not reported). On the next day (17-JUL-2015) the patient experienced erythema. Each day the redness "was becoming larger" but the patient was not experiencing any pain. No treatment was given an no lab diagnostic studies were performed. The patient did not seek medical attention. The outcome of erythema was not recovered. The relatedness between the event and (Oka/Merck) ZOSTAVAX was not reported.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report has been received from a 64 year old female consumer, who was reporting on herself. The patient's concurrent conditions included headaches and AUGMENTIN allergy, which manifested as hives. There was no concomitant medication. On 16-JUL-2015, the patient was vaccinated with a dose of (Oka/Merck) ZOSTAVAX injection (dose, route of administration, lot # and expiry date were not reported). On the next day (17-JUL-2015) the patient experienced erythema. Each day the redness "was becoming larger" but the patient was not experiencing any pain. No treatment was given an no lab diagnostic studies were performed. The patient did not seek medical attention. The outcome of erythema was not recovered. The relatedness between the event and (Oka/Merck) ZOSTAVAX was not reported.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUL-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX, lot # L002869, expiration date: 27-JAN-2017, (dose, route of administration and injection site were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. The pertinent medical history and concomitant medication was not reported. Since an unknown date in 2015 (reported as since 10-JUN-2015) the patients were vaccinated with unspecified number of improperly stored doses of RECOMBIVAX HB (lot: K007263 and Expiry: 09-JUN-2016; Lot: L013377 and Expiry: 29-OCT-2016; Lot: L016959 and Expiry: 12-MAR-2018) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow-up information has been received from a Medical Assistant refers to a patient of unknown age and gender, medical history and concurrent conditions were not reported, who on 01-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 (route and dose were not provided) that was exposed to temperatures outside of the recommended range during an unknown number of hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. The pertinent medical history and concomitant medication was not reported. Since an unknown date in 2015 (reported as since 10-JUN-2015) the patients were vaccinated with unspecified number of improperly stored doses of VAQTA (lot: L014068 and Expiry: 02-NOV-2017) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-JUN-2015, the patient was vaccinated subcutaneously with an expired 0.5 ml dose of M-M-R II (therapy type: rHA) (batch # J006139; lot # 1684AA; expiry date: 17-APR-2015). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. On an unknown date, the patient was vaccinated with a dose of improperly stored M-M-R II (dose, frequency and lot # were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported by M-M-R II. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow-up information has been received from a Medical Assistant refers to a patient of unknown age and gender, medical history and concurrent conditions were not reported, who on 30-APR-2015 was vaccinated with a dose of GARDASIL lot # K006960 (route and dose were not provided) that was exposed to temperatures outside of the recommended range during 24 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Reporter information and Product tab were updated.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. In October 2012, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route of administration, lot# and expiry date were not reported). The reporter stated that the patient showed in the office on 17-JUL-2015 to receive her second dose of GARDASIL (strength, dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality issue involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 07-MAY-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 46 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. The pertinent medical history and concomitant medication was not reported. Since an unknown date in 2015 (reported as since 10-JUN-2015) the patients were vaccinated with unspecified number of improperly stored doses of ROTATEQ (lot # K023537 and Expiry: 22-JUN-2016); Lot: K019372 and Expiry: 16-JUL-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about concomitant medications and pertinent medical history reported. On 16-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose, route, site, lot# and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, on 02-JUL-2015, concerning a patient of an unknown age and gender. On 13-MAY-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient. The concurrent condition, medical history and concomitant medication was not reported. On 21-JUL-2015 the patient was inadvertently vaccinated with M-M-R II, 0.5 ml, subcutaneously and PROQUAD (Merck) (dose, route and lot details unavailable). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 09-JUL-2015, the patient was vaccinated with improperly stored VAQTA (lot # reported as 1013324 with expiration date 24-APR-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 18-JUL-2014, the patient was vaccinated with the first dose of an improperly stored GARDASIL (Lot No. J010668 Expiration date: 29-APR-2016) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. Thi sis one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender. On 04-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration  were not reported) that underwent 46 hours temperature excursion. No adverse effects had been observed or reported. This is one several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender. On 28-APR-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration  were not reported) that underwent 46 hours temperature excursion. No adverse effects had been observed or reported. This is one several reports from the same reporter. Additional information has been requested.