chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Patient had notable swelling of the upper arm and a fever of 101 F the next morning. She felt extremely dizzy and nauseated. Told her to take BENADRYL 50mg, TYLENOL PRN, cool compresses to arm. Patient had just redness and swelling on Monday. Patient just has itching left as of 10/20/16.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient had notable swelling of the upper arm and a fever of 101 F the next morning. She felt extremely dizzy and nauseated. Told her to take BENADRYL 50mg, TYLENOL PRN, cool compresses to arm. Patient had just redness and swelling on Monday. Patient just has itching left as of 10/20/16.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain
Clinical narrative: Severe neck pain.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain
Clinical narrative: Severe neck pain.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Vaccination site swelling
Clinical narrative: 1/2 dollar sized bump at vaccine site no fever.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had pain, swelling and redness at injection site. Patient received vaccine on 10/11/16. Patient was fine when I contacted her.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Rash erythematous, Rash generalised
Clinical narrative: Patient stated that 2 hours after the immunization she broke out in a rash all over her body. The rash was large red flat rash. She also was bruised at injection site and it was also very red and hard. Pt. used cortisone and BENADRYL for the rash. On 10/18 she went to urgent care and received Prednisone 20 mg.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Swelling face
Clinical narrative: Patient's eye and face swelled shortly after vaccine administration. School nurse was informed that the child was taken to the ED at hospital. Childs face would swell gain as BENADRYL wore off.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Flu shot right arm. Might hit nerve. Numbness-on right arm, tingling, to neck. Headache, fatigue. Took Ibuprofen (3) dragging.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: 8 months after my PREVNAR 13 shot in my left arm I think the pain at the site of the injection might almost be gone. The first several months the pain was absolutely horrible and painful. It has gotten less painful (gradually) with time. I tried pain pills, ice, TENS - nothing worked.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Feeling of body temperature change, Headache, Migraine, Weight decreased
Clinical narrative: Experienced headache/migraines, lost 6 lbs in about 2 week, feels like he cannot control body temperature (hot/cold). Lasted about 3 weeks.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site at time of injection.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling in left arm.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Fatigue, Headache
Clinical narrative: For 2 days after receiving both PREVNAR 13 and FLUZONE HD pt reported having chills (but no fever) and headache and was very tired. Symptoms resolved 2 days later.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site rash
Clinical narrative: Rash on right upper arm.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Headache started 12 hours after receiving vaccination followed with fever up to 102 degrees F, chills, and vomiting. Left arm tender at injection site. Feeling well on 10/20/16 AM.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Injection site swelling, Lethargy, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat started 2 hours after receiving flu vaccination. Complaints of lethargy, stuffy nose, fatigue remaining. Slight bump at injection site was gone by 10/20/16 AM.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: Fever, headache, malaise.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Lg oval shape red warm hard area on upper LT arm. Parents used ice packs Tuesday night with some relieve.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Mother reports that child has abdominal pain and vomiting issues. She suspects that this is due to HPV vaccine. Last dose given 9/21/16.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye movement disorder, Feeling cold, Muscle twitching, Presyncope
Clinical narrative: About 7 min after the vaccination, Pt was unresponsive to mother's calls. Her eyes rolled back and she started to twitch. 911 was called. About 2 min later she was responsive but cold and dizzy. BP was normal. Mother thought it best to bring her to the ER in case. Happy, awake, alert, doing well - Near syncope.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: About 7 min after the vaccination, Pt was unresponsive to mother's calls. Her eyes rolled back and she started to twitch. 911 was called. About 2 min later she was responsive but cold and dizzy. BP was normal. Mother thought it best to bring her to the ER in case. Happy, awake, alert, doing well - Near syncope.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient past out after flu and Tdap vaccination happened 1 min. after vaccination after past out we went to pt and grab him. Few seconds later he said he is fine now. About to call 911. He refuse to call 911. Waited 1/2 hr at pharmacy ask his roommate to take him.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis, Headache, Pain
Clinical narrative: Aches, HA, dried blood in nose.
Age: 59.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Malaise, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: The day after receiving vaccines, patient developed a low-grade fever of 101 degrees and malaise. Patient experienced red, warm, swelling of right arm and was tender to touch. Patient contacted pharmacy 10/17 - was instructed to use cold pack and BENADRYL and monitor. If worsening in 24 hours or no improvement in 48 hours - instructed to see dr. Followed up on 10/20, swelling resolved, now just some soreness, No intervention needed.
Age: 59.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Tenderness
Clinical narrative: The day after receiving vaccines, patient developed a low-grade fever of 101 degrees and malaise. Patient experienced red, warm, swelling of right arm and was tender to touch. Patient contacted pharmacy 10/17 - was instructed to use cold pack and BENADRYL and monitor. If worsening in 24 hours or no improvement in 48 hours - instructed to see dr. Followed up on 10/20, swelling resolved, now just some soreness, No intervention needed.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Cellulitis
Clinical narrative: Cellulitis, increased BP 2 days after PNEUMOVAX 23 given. Pt prescribed KEFLEX 500 QID x 10 days and OTC diphenhydramine from PCP.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: 2-3 days after flu injection. Client has increased left joint pain, decreased ROM. Pain level 2/10. Pain progresses to 9/10 by 10.17.2016 with continued decreased ROM. Client is taking TYLENOL 500mg x 2 tab SIB and Tramadol 50 mg 2 tab BID for past 3 days.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Upper arm stiff and swollen all around the deltoid muscle and hot to touch and painful.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a pharmacist referring to a 79 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On 06-OCT-2016, the patient was vaccinated with ZOSTAVAX (subcutaneous; dose was unknown). On approximately 13-OCT-2016 (reported as about one week later), the patient developed a quarter size red and itchy area at the injection site where she received ZOSTAVAX. Unspecified treatments were given. No lab test was performed. The outcome of the events was reported as recovering. The causality was not provided. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist referring to a 79 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On 06-OCT-2016, the patient was vaccinated with ZOSTAVAX (subcutaneous; dose was unknown). On approximately 13-OCT-2016 (reported as about one week later), the patient developed a quarter size red and itchy area at the injection site where she received ZOSTAVAX. Unspecified treatments were given. No lab test was performed. The outcome of the events was reported as recovering. The causality was not provided. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Condition aggravated, Hypotonia, Irritability, Musculoskeletal stiffness
Clinical narrative: 3d after receiving vaccine he was sitting in chair-he fussed, nanny picked him up. His left side twisted and stiffened for approx 15 sec and then he went limp for a few seconds. Since then (48 hrs) he has low energy (but with URI).
Age: 1.33
Sex: M
Vaccine: PNC13
Symptoms: Upper respiratory tract infection
Clinical narrative: 3d after receiving vaccine he was sitting in chair-he fussed, nanny picked him up. His left side twisted and stiffened for approx 15 sec and then he went limp for a few seconds. Since then (48 hrs) he has low energy (but with URI).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Swollen, redness if you do a C with your hand it's about that size, that's what the parent stated.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: R upper arm swollen, painful, red and warm to touch. Advised OTC BENADRYL and TYLENOL PRN.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Erythema, Skin warm, Tenderness, Testicular pain, Testicular swelling
Clinical narrative: Patient's mother called a month after the event to report what happened (patient had swelling of the testicles with pain to the area; states the were tender for anything to touch them, warm to touch and red). She stated she did not want anymore HPV vaccinations for him.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Skin warm, Tenderness, Testicular swelling
Clinical narrative: Patient's mother called a month after the event to report what happened (patient had swelling of the testicles with pain to the area; states the were tender for anything to touch them, warm to touch and red). She stated she did not want anymore HPV vaccinations for him.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an Administrator, and refers to a 1 year old infant patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 01-JUN-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by 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 referring to a patient of unknown age and gender. On 29-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1152 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect 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 referring to a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1728 hours with lowest recorded temperature of 20 Fahrenheit degree. No adverse effect 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 referring to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1728 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect 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 physician refers to an unspecified number of patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose (at a temperature of 56 F for 1 hour) of ROTATEQ lot # M025568 (expiry date: 07-NOV-2017) (dosage not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of 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 was received from a physician refers to an unspecified number of patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose (at a temperature of 10 F for 1 hour) of PROQUAD, therapy type: rHA, lot # M029595 (expiry date: 10-DEC-2017) (dosage not reported). No adverse effects reported. No Product Quality Complaint (PQC) was 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: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old female patient. The patient had no pertinent medical history, drug reactions/ allergies and concomitant medications. On 12-OCT-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU, 0.65 ml, once, subcutaneously, (lot # and expiry date not reported). Subsequently, on the same day, the patient experienced redness and swelling at the injection site. Therefore, the patient sought medical attention - seen in the pharmacy. However, no treatment was given for the events and no lab diagnostics were performed. At the time of report, the patient was recovering from the events. No product quality complaint (PQC) involved and no further information provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown demographics. On 23-SEP-2016, the patients were vaccinated with am improperly stored doses of GARDASIL 9 lot # M009378 and expiration date: 23-APR-2018, (strength, dosage and route unspecified). The vaccine was exposed to temperature of 34.6F for the timeframe of 7 hours. The call was because of a data logger. No previous temperature excursion involved. No adverse effect reported. No product quality complaint involved. No further details provided. 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 referring to a patient of unknown age and gender. On 11-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5 ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time for the first time was 9120 hours with lowest recorded temperature of 27 Fahrenheit degree. The total cumulative excursion time for the second time was 3468 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown demographics. On 27-SEP-2016, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # M009378 and expiration date: 23-APR-2018, (strength, dosage and route unspecified). The vaccine was exposed to temperature of 34.6F for the timeframe of 7 hours. The call was because of a data logger. No previous temperature excursion involved. No adverse effect reported. No product quality complaint involved. No further details provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 18-AUG-2016, the patient was vaccinated with improperly stored VARIVAX (0.5 ml, once, lot # M006157, expiration date 05-FEB-2018) subcutaneously. The vaccine had been stored under an unspecified temperature from 11-JUL-2016 to 20-SEP-2016. There was no digital data logger involved or prior excursions. No adverse effects were 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 referring to patient of unknown age and gender. On 26-JUN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 360 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown demographics. On 28-SEP-2016, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # M009378 and expiration date: 23-APR-2018, (strength, dosage and route unspecified). The vaccine was exposed to temperature of 34.6F for the timeframe of 7 hours. The call was because of a data logger. No previous temperature excursion involved. No adverse effect reported. No product quality complaint involved. No further details provided. 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 referring to a patient of unknown age and gender. On 19-AUG-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1656 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several 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 refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient were vaccinated with improperly stored PROQUAD which had lot # M015698 with expiry: 26-SEP-2017 and lot # L051102 with expiry: 17-JUN-2017 (dosing details not reported). No adverse effects reported and no further information reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown demographics. On 30-SEP-2016, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # M009378 and expiration date: 23-APR-2018, (strength, dosage and route unspecified). The vaccine was exposed to temperature of 34.6F for the timeframe of 7 hours. The call was because of a data logger. No previous temperature excursion involved. No adverse effect reported. No product quality complaint involved. No further details provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown demographics. On 29-SEP-2016, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # M009378 and expiration date: 23-APR-2018, (strength, dosage and route unspecified). The vaccine was exposed to temperature of 34.6F for the timeframe of 7 hours. The call was because of a data logger. No previous temperature excursion involved. No adverse effect reported. No product quality complaint involved. No further details provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 10-OCT-2016, the patient was vaccinated with expired dose of (wistar ra 27-3) M-M-R II (lot # K015375, expiration date: 18-SEP-2016, dose and route of administration were not provided). The patient has not reported and adverse experience. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose (at a temperature of 56 F for 1 hour) of PEDVAXHIB (lot # M025193 (expiry date: 21-MAR-2019) (dosage not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning unspecified patients. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates these patients were administered improperly stored VAQTA (lot # M022531, expired date 23-FEB-2018) (dose and frequency were unknown). The VAQTA was stored at 46.8 F for 4 hours 30 minutes. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an 18 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUL-2016, the patient was vaccinated with a pediatric dose of VAQTA, strength: 25/ 0.5 (units not provided), lot # M002268 with expiry: 20-SEP-2017, intramuscularly. Then, on 29-SEP-2016, the patient received in error an adult dose of VAQTA, strength: 50/ 1.0 U/ml, lot # M031695 with expiry: 26-MAY-2017, intramuscularly. The patient had not reported an adverse experienced. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates these patients were administered improperly stored PEDVAXHIB lot # M001813, expired date 14-OCT-2018 (dose and frequency were unknown). The PEDVAXHIB was stored at 46.8 F for 4 hours and 30 minutes. No adverse effects provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a IR Administrator of The Pediatric Group, and refers to a 4 years old infant patient of unknown gender. No medical history, concurrent condition and concomitant medication were reported. On 20-MAY-2016, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # L048468 (strength, dosing detail, anatomical location were unknown). All the (Oka/Merck) VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Administrator, and refers to a 12 months old infant patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by 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 assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates these patients were administered improperly stored RECOMBIVAX HB (lot # M010212, expired date 21-JAN-2019) (dose and frequency were unknown). The RECOMBIVAX HB was stored at 46.8 F for 4 hours 30 minutes. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Amenorrhoea, Ovarian failure, Premature menopause
Clinical narrative: Information has been received from a physician via a company representative referring to an article. The company representative could not confirm whether any patient was mentioned in the article. Therefore medical history, current conditions and concomitant therapies were reported. On an unknown date, the patient or patients were vaccinated with a dose of an unidentified Merck HPV vaccine (trade name and lot number were not provided). On an unknown date, the patient or patients, experienced ovarian failure, amenorrhoea and premature menopause. The outcome of ovarian failure, amenorrhoea and premature menopause was unknown. No product quality complaint (PQC) was involved. The relationship between ovarian failure, amenorrhea, premature menopause and therapy with the unidentified Merck HPV vaccine administered was unknown at the time of the report. Upon internal review ovarian failure was considered serious as medically significant. Additional information is not expected because the reporter refused to be contacted.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a nurse via a company representative concerning to a 64 year old patient (gender not reported). In September 2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). In September 2014, the patient was diagnosed with shingles of an unspecified eye. The patient was treated with an unspecified antiviral for the shingles and the patient recovered on an unknown date. On 23-SEP-2016, the patient was diagnosed with shingles that was located on the "back of the patient's right shoulder, neck, hairline, and across her face". The patient was treated with an unspecified antiviral and recovered on an unknown date. No hospitalization nor cancer were reported. No product quality complaint was involved. The relationship between shingles and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a Nurse Practitioner, via company representative, referring to a 18 year old pregnant female patient. The patient's medical history included asthma. Concurrent conditions and concomitant medication were not provided. On 05-OCT-2016, the patient inadvertently received a dose of GARDASIL 9 injection, 0.5ml, lot # M009378, expiration date 23-APR-2018, 0.5 ml, intramuscularly, instead of Tdap. Nurse practitioner stated no adverse effects were reported. The patient became pregnant with last menstrual period (LMP) of 21-MAR-2016 and estimated date of delivery (EDD) of 26-DEC-2016. Initial exposure to GARDASIL 9 was at 28 week(s) and two days. The pregnancy outcome was pending. There was no product quality complaint involved as the Nurse Practitioner stated there was no product confusion between the GARDASIL 9 and TDAP. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Rash generalised
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of generalized rash in a 18-year-old  male patient who received MENVEO. Co-suspect products included Hepatitis A vaccine. Previously administered products included DTAP with an associated reaction of adverse reaction (received on an unknown date, at an age of 15 months, see case US2016GSK154263). In September 2016, the patient received MENVEO and Hepatitis A vaccine. In September 2016, 1 day after receiving MENVEO and Hepatitis A vaccine, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved. The reporter considered the generalized rash to be almost certainly related to MENVEO and Hepatitis A vaccine. Additional details were provided as follows: This case was reported by the patient's father was also a physician. The age at vaccination was not reported. The patient experienced body rash after receiving MENVEO and Hepatitis A vaccine (unknown manufacturer). Limited details were available.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on patients' pertinent medical history, drug reactions or allergies was provided. On an unknown date, multiple unspecified patients were vaccinated with a dose of GARDASIL 9 (dose and route were not reported) (lot # L040054, expiry date 26-DEC-2017 or lot# M007764, expiry date 30-JAN-2018) that were improperly stored. Concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same reporter source. 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 patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (dose, frequency, route of administration and indication were not reported, lot # L048848 with expiration date: 09-AUG-2018). Concomitant medications were not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccination with improperly stored ZOSTAVAX lot # M026874, 19-JUL-2017, 0.65 ml, subcutaneous. No adverse effects were reported. Temperature was 8 degree centigrade for 21 days. Previous excursion was no. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency, route of administration and indication were not reported, lot # M004116, with expiration date: 12-OCT-2017). Concomitant medications were not reported. No adverse symptoms reported. This is one of several reports received 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 an other healthcare worker refers to an unspecified number of patients of unknown and gender. No information on patients' pertinent medical history, drug reactions or allergies was provided. On an unknown date, multiple unspecified patients were vaccinated with a dose of ROTATEQ (route were not reported) (lot # L027076, 25-MAY-2017) that were improperly stored. Concomitant therapies were not provided. No adverse effects were reported. This is a one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on patients' pertinent medical history, drug reactions or allergies was provided. On unknown dates, multiple unspecified patients were vaccinated with a doses of VAQTA (dose and route were not reported) (lot # M018644, expiry date 20-SEP-2017) that were improperly stored. Concomitant therapies were not provided. No adverse effects were reported. This is a one of several reports from the same reporter 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 certified medical assistant (C.M.A.) refers to a multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with a dose of improperly stored PEDVAXHIB lot # L051124 and expiration date: 14-OCT-2018; lot # M014927 and expiration date: 18-FEB-2019; (strength, dosage and route unspecified). No adverse effect reported. No product quality complaint involved. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report a received from a certified medical assistant (C.M.A.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with a doses of improperly stored VARIVAX lot # M023380 and expiration date: 11-MAY-2018; (strength, dosage and route unspecified). No adverse effect reported. No product quality complaint involved. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with a doses of improperly stored GARDASIL 9 lot # M020103 and expiration date: 15-FEB-2018; (strength, dosage and route unspecified). No adverse effect reported. No product quality complaint involved. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant from a medical assistant and refers to a 9 month old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-OCT-2016, the patient was inadvertently administered a dose of VAQTA intramuscularly, lot # M015290 with expiration date 20-SEP-2017 (dose not reported). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in Spring of 2015, the patient was vaccinated with ZOSTAVAX (frequency reported as once, dose, injection site, lot# and expiration date were not provided), subcutaneously. The patient had a hard small round lump, located at the injection site (reported as where she had the "shingles shot"). The patient sought medical attention via visiting the pharmacy on 17-OCT-2016, but the pharmacist couldn't evaluate, if the patient had this small round lump since the Spring of 2015 (when she had the ZOSTAVAX), or if she experienced it after the vaccination. No treatment was given for the adverse event. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with the improperly stored doses of GARDASIL 9 (lot # reported as M011840 with expiration date 01-FEB-2018, lot # L044475 with expiration date 12-MAY-2017; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies or concomitant therapies was not provided. On 10-OCT-2016, the patient was vaccinated with an improperly stored VARIVAX (lot# L050956 with expiry date 17-DEC-2017) first dose. The vaccine had a temperature excursion of 6.3 Fahrenheit (F) for 1 hour and 50 minutes, 6.6F for 1 hour and 40 minutes, 40.5F for 2 hours, 5.2F for 20 minutes and 6.3F for 1 hour and 50 minutes. Previous temperature excursions included 13.3F for 80 minutes, 9F for 420 minutes. The call was because of a data logger. No adverse effects reported. This sis one of the two cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and current conditions were not provided. On 21-SEP-2016, the patient was inadvertently vaccinated with a dose of expired PNEUMOVAX 23 (dose and route were unknown; lot number K019386 with expiration date 09-JUN-2016). No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Chills, Injection site rash, Pain
Clinical narrative: Rash (L) deltoid at injection site, achey all over body, chills.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician (also reported as "registered nurse (RN)") and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in July 2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date not reported). The second dose was administered on an unknown date in September 2016. On 19-OCT-2016, earlier than recommended, the patient was given the third dose of GARDASIL 9. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (vial 19400 PFU) 0.65 ml (lot#, dose number, anatomical location and route unspecified). The pharmacist reported that he was told by another pharmacist that the patient had "experienced a lump" (location unspecified) after the administration of ZOSTAVAX on an unspecified date. On an unknown date the patient experienced mass. The outcome of the event was unknown. No product quality complaints was involved. No further information was provided. Causality assessment was not provided. 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 and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug reaction or allergies not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # L002217, expiration date: 21-JAN-2017). The reporter could not specify temperature exposure or timeframe. No adverse effects were reported. Additional information is not expected as the reported did not wish to be contacted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Raised red area, taking BENADRYL.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with the improperly stored doses PEDVAXHIB (lot # M011814 with expiration date 15-OCT-2018; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding her daughter (age unspecified). The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient's vaccine schedule is "out of compliance due to getting MMR II (dose, frequency, route, lot number were not reported) and then 2 weeks later getting VARIVAX (dose, frequency, route, lot number were not reported). There were no adverse event. There was no product quality issue (PQC) involved. Additional information is not expected.