chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Paraesthesia, Ultrasound scan
Clinical narrative: 10/03/3016 Moderate other. Pt. states went to ER and Dr. Complaints of both arms, wrist and hands with burning and shooting pain. Has numbness and tingling both hands and left leg. Started after took vaccines. States Dr ordered amoxicillin and gabapentin 10-17-16.
Age: 85.0
Sex: M
Vaccine: FLU4
Symptoms: Insomnia, Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 85-year-old male patient who received FLUARIX QUADRIVALENT. The patient's past medical history included stroke. Concomitant products included PROSCAR, ZETIA, amlodipine, carvedilol, clopidogrel, spironolactone, valsartan, warfarin and low dose aspirin. On 6th October 2016, the patient received FLUARIX QUADRIVALENT. On 6th October 2016, 6 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced muscle pain, mobility decreased, difficulty sleeping and pins and needles. On an unknown date, the outcome of the muscle pain was recovering/resolving and the outcome of the mobility decreased was not recovered/not resolved and the outcome of the difficulty sleeping and pins and needles were unknown. The reporter considered the muscle pain, mobility decreased and difficulty sleeping to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the pins and needles to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: Approximately 6 hours after receiving FLUARIX QUADRIVALENT in his right arm, the patient experienced severe muscle pain around his collar bone going down through upper arm on the left side. The patient could not lift his left arm and was feeling like there were pins and needles in that arm. Due to pain, the patient had difficulty in sleeping that night. This was one of the 3 cases reported by same reporter.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dyspnoea, Pain, Pyrexia
Clinical narrative: Patient experienced cold sweats, body aches, fever and difficulty breathing - symptoms lasted for about 1.5 day. She didn't need any treatments and didn't go to Dr. or hospital. She's feeling ok now.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Chills, "feverish", site tenderness and swelling, general myalgias, onset 2 hrs after injection.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Receive shot Monday 9-26-2016, 12 midnight woke up with chills. Took TYLENOL. Redness on shot spot. Hard and hurt to touch.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash erythematous, Urticaria
Clinical narrative: Had shot at about 2 pm on 8/11. 12:45 am on 8/12 woke up with arm throbbing. 8/13 developed hives and red rash on torso.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Skin rash, redness in the left arm in the site of adm.
Age: 23.0
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: Chills, Headache, Mononucleosis heterophile test, Pain, Pyrexia
Clinical narrative: Received MMR, VZV, and GARDASIL 9 on Oct. 5. Next day had low grade fever and headache. 12 days later developed a rash generalized to body with chills and body aches.
Age: 23.0
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Received MMR, VZV, and GARDASIL 9 on Oct. 5. Next day had low grade fever and headache. 12 days later developed a rash generalized to body with chills and body aches.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood glucose normal, Fall, Head injury, Hypotension, Syncope
Clinical narrative: Syncope with posterior head trauma (closed) secondary fall. Low BP. Observation x 15 min, then vomiting ensued. Blood sugar 108 after juice/cookie. Obs. x 45 min, symptoms resolved.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Syncope with posterior head trauma (closed) secondary fall. Low BP. Observation x 15 min, then vomiting ensued. Blood sugar 108 after juice/cookie. Obs. x 45 min, symptoms resolved.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: At approximately 12:08 pm on 10/17/2016 patient received the MENACTRA vaccine. She was fine after shot with no complaints. While mother was paying patient became dizzy and fainted. Paramedics were called because she hit her head. Her vitals were fine and refused further medical treatment.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Woke up on 8-18-16 with fever and fussiness. Mom brought her in to Hospital urgent care, treated with TYLENOL and had physical exam and sent home.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Vaccines given 0900. Pt presented 5 hours later with warmth and erythema both thighs at sites of inj.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site discomfort, Injection site joint inflammation, Injection site pain, Injection site reaction, Loss of control of legs
Clinical narrative: Synovitis of thigh - legs shaky and giving out "L leg appears minimally tender". She is able to internally and externally rotate the hip as well as to extend and flex it although w/extension of hip and knee at same time - some discomfort present.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Tremor
Clinical narrative: Synovitis of thigh - legs shaky and giving out "L leg appears minimally tender". She is able to internally and externally rotate the hip as well as to extend and flex it although w/extension of hip and knee at same time - some discomfort present.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # L034335, expire date 18-MAY-2017; dose and route unknown). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 72 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 96 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the third time was 24 hours with the lowest recorded temperature of 30 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 27-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (strength: 0.5ml, lot # L012190, expire date 13-APR-2017; dose and route unknown). The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: This spontaneous report received from a physician via a company representative referred to a 13 year old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 05-OCT-2016, the patient received first dose of GARDASIL 9 (dose, site of administration, lot number and expiry date were not reported) intramuscularly. The patient became nauseous and light headed. She was monitored for 15 minutes and recovered. There was no treatment given for the events. The reporter did not provide the relatedness of the events with GARDASIL 9. 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 medical assistant refers to a patient of unknown gender and age. The patient's relevant medical and past drug histories and concomitant medications were unknown. On an unknown date, the patient was vaccinated with VARIVAX (lot # M008173, expiry date: 16-FEB-2018) via subcutaneous route in the back of the arm. Medical assistant reported that the vaccine underwent a temperature excursion, but the patient did not experience any adverse reactions. It is unknown if there were any relevant laboratory data. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 79 year old female patient, reporting on herself. There was no information regarding the patient's pertinent medical history. She was allergic to epinephrine. Concomitant therapies included ZIAC, CELEXA and ZOCOR. Seven years ago, approximately in 2009 the patient received one time vaccination with ZOSTAVAX in the right arm. Patient reported that on an unknown date recently, she developed shingles. Outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 16-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 23-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient. The patient did not have pertinent medical history. The patient had gluten intolerance and drug reactions to tipepidine, opioid analgesics, barbiturates, beta lactam antibiotics. On 22-SEP-2016, the patient was vaccinated with ZOSTAVAX one vial, subcutaneously (lot# and expiration date were not reported). Concomitant medications included digoxin, torsemide, sildenafil, allopurinol, sertraline, ELIQUIS, Metoprolol, TAZITA XT, potassium. On 22-SEP-2016, the patient experienced redness and intermittent "shooting pain" at the injection site. The patient informed pharmacist she had applied BENADRYL cream and an unspecified lidocaine cream to the injection site, with no improvement. No lab diagnostic studies were performed. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Anaphylactic reaction, Throat tightness
Clinical narrative: This spontaneous report as received from a nurse refers to a 67 year old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. In 2006, the patient was vaccinated with the dose of hepatitis B vaccine (recombinant) (manufacturer unknown; also reported: "cannot rule out RECOMBIVAX") (dose, route, lot # and expiration date were not reported). On an unknown date (reported as shortly after), the patient experienced an anaphylactic response of throat closing. The outcome of the adverse event was unknown. The relatedness between the adverse event and hepatitis B vaccine (recombinant) (manufacturer unknown) was not provided. Upon internal review, the adverse event of anaphylactic reaction was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 23-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-SEP-2015 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (strength: 0.5ml, lot # L006233, expire date 03-APR-2016; dose and route unknown). This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time of the first time was 272 hours with the lowest recorded temperature of 31 Fahrenheit degree. The total cumulative excursion time of the second time was 152 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the third time was 64 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the fourth time was 88 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the fifth time was 8 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. 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 nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On 15-SEP-2016, a temperature excursion during the storage of VARIVAX took place. Temperature was of -10.9 Celsius degrees for 90 minutes. Data logger was involved. There was no prior excursion. Since that date, unspecified number of patients was vaccinated with unspecified number of doses of improperly stored VARIVAX, lot # M015735, expiration date: 30-MAR-2018 (dose and route were not provided). There were no adverse events reported. There was no product quality complaint (PQC) involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On 15-SEP-2016, a temperature excursion during the storage of PROQUAD took place. Temperature was of -10.9 Celsius degrees for 90 minutes. Data logger was involved. There was no prior excursion. Since that date, unspecified number of patients was vaccinated with unspecified number of doses of improperly stored PROQUAD, lot # M014304, expiration date: 22-SEP-2017 (dose and route were not provided). There were no adverse events reported. There was no product quality complaint (PQC) involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician referring to a 14 years old male patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient inadvertently received a dose of PROQUAD injection (lot #, expiration date, dose and route were unknown), which was outside the recommendations per the prescribing information. No adverse effects 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 medical assistant via Center and refers to a patient of unknown age and gender. The patient's relevant medical and past drug histories were unknown. The patients concomitant medications were unknown. On an unknown date, the patient was vaccinated with VARIVAX, that underwent a temperature excursion, subcutaneously in the back of the arm (lot # M008173, expiration date: 16-FEB-2018, dose was not provided). The patient did not experience any adverse reactions. It was unknown, if there was any relevant laboratory data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a patient of to a 65 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details unknown). "Confirmed not GARDASIL". No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional called to see if there was any difference between FLUARIX QUADRIVALENT 2015/2016 and 2016/2017 season vaccines. The healthcare professional stated his hospital staffs were saying they were seeing more local reactions from last year. The healthcare professional stated he did not want to forward that information because the information was third hand information. No product or patient information was provided.
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a male patient who received MENVEO. On an unknown date, the patient received MENVEO. On an unknown date, less than a day after receiving MENVEO, the patient experienced injection site erythema, injection site irritation, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site irritation, injection site pain and injection site warmth were recovered/resolved. The reporter considered the injection site erythema, injection site irritation, injection site pain and injection site warmth to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the unknown male patient experienced injection arm redness, warmth, irritation and pain after receiving MENVEO vaccination. This case had been linked with US2016146452, reported by the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 10-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 840 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. The patient's pertinent medical history, drug reaction/allergies and concomitant medication were not provided. On an unknown date in June 2016, the patient was vaccinated with ZOSTAVAX (lot # M005727; expiration date, dose and route were unknown). On an unknown date in 2016, the patient experienced injection site pain and had a rash on her arm. The patient contacted the physician to seek medical attention. Unspecified antibiotics were given for treatment. The outcome of the events was reported as recovered on an unknown date in 2016. The causality was not provided. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Skin rash and urticaria pruritus. Diphenhydramine 50 mg prn, Hydrocortisone
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 10-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 840 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. this is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 02-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 1092 hours with the lowest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 09-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time was 1172 hours with the highest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the second time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the third time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative 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 a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient developed a fever after receiving PNEUMOVAX 23. The patient sought an unspecified type of medical attention. The outcome of the adverse event was unknown. The relatedness between the adverse event and PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 20-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 26-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a consumer refers to her daughter, a one year old female patient (present age of the patient reported as 4 years). The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified date of 2012 the patient was vaccinated with PEDVAXHIB (lot, expiration date and dose regimen were unknown). On unspecified date of 2012, the patient experienced high fever. The patient went to an unspecified emergency room to treat the high fever and was discharged the same day. The fever cleared up after about 3 days. The outcome of pyrexia was reported as recovered. The causality assessment was not provided by the reporter. No product quality complaint was filed. No further adverse event information was provided. Additional information is not expected because there is no correspondent details of the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The medical history included chicken pox. Drug reactions or allergies and concomitant medication were none. On 26-SEP-2016, the patient was vaccinated with ZOSTAVAX lot # M018453 28-JUN-2017. On an unknown date in 2016 the patient experienced injection site reaction a couple of days after vaccination. The injection site reaction was described as redness and pain at the injection site. On 05-OCT-2016 the patient stated that the pain radiated along the side of the same arm of the injection site to the same side of the body. On 06-OCT-2016, the outcome of the events were reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 24-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 08-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number was exposed to temperature excursion once. The total cumulative excursion time was 720 hours with the lowest recorded temperature of 27 Fahrenheit degree. The total cumulative excursion time was 720 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 02-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports 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 medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 03-OCT-2016 and on 04-OCT-2016, the patients were vaccinated with improperly stored VAQTA 25/0.5 (units not reported) (route of administration was not reported) (lot # M009377, expiry date: 17-JUN-2017). The temperature excursion was 0.7 degree of Celsius during 6 hours and 24 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manger via company representative referring to a patient of unknown age and gender. On 31-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLUX, TDAP, VARZOS
Symptoms: Glycosylated haemoglobin decreased
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old male patient. The patient's concurrent conditions included esophageal cancer and high blood pressure. On 27-SEP-2016, the patient was subcutaneously (SQ) vaccinated with a 19.400units/0.65ml dose of ZOSTAVAX lot # M026876, expiration date 26-JUL-2017 (dose and anatomical location were not reported). On the same day, the patient was vaccinated with a dose of (unspecified) TDAP (manufacturer unknown) and influenza virus vaccine (unspecified) (manufacturer unknown). Other concomitant therapy included unknown chemotherapy drug. The pharmacist reported that the patient's A1C was a little low on that day (low 500 range) per the patient's nurse. The pharmacist reported that on that day, 27-SEP-2016, he was informed that the patient had esophageal cancer and was on chemotherapy after he had given the patient the ZOSTAVAX. The pharmacist reported that he notified the patient's doctor and provided consultation to the patient, which included referring the patient to his physician if he noticed fever or fatigue. As of 27-SEP-2016, the patient received the ZOSTAVAX and the outcome of receiving the vaccine as a cancer patient who received chemotherapy was reported as unknown. The causality between the event and ZOASTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were unknown. On an unknown date more than 18 months ago, the patient was administered with ZOSTAVAX (dosing details were not provided). Pharmacist reported that since vaccination, the patient experienced shingles multiple times on unspecified dates. She reported that she was interested in Varicella-Zoster virus analysis by Polymerase chain reaction (PCR) and wanted to send viral isolates. Outcome of the event was unknown. Reporting pharmacist had not assessed the causality of the event with respect to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 10-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported. There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 840 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 13-year-old male patient who received MENVEO. Concomitant products included GARDASIL. On an unknown date, the patient received MENVEO. On an unknown date, less than a day after receiving MENVEO, the patient experienced injection site erythema, injection site irritation and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site irritation and injection site warmth were recovered/resolved. The reporter considered the injection site erythema, injection site irritation and injection site warmth to be related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient was son of nurse reporter. The patient received MENVEO on unknown arm and experienced arm redness, irritation and warmth at injection site up to 2 days after receiving vaccination. This case has been linked with case US2016146453 as reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a 60 year old female pharmacist via a company representative referring to the pharmacist herself. The patient's concurrent conditions, medical history and concomitant therapies were unknown. On 15-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot # and dose unknown, subcutaneous). On approximately 17-JUL-2016 (reported as about "2 or 3 days later"), the patient developed an "itchy raised rash" about the size of "2 half dollars" around the injection site. She treated the rash with cold compresses and also took ibuprofen for minor pain (onset date unspecified, approximately in July 2016). The patient also reported the rash and itchiness all went away 2 days later (approximately on 19-JUL-2016). No labs performed for the events. It was reported that the patient did not seek medical attention for the events. The outcome of pain was not reported. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 15-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manger via company representative referring to a patient of unknown age and gender. On 16-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.