chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Narcolepsy, Sleep study, Syncope
Clinical narrative: At first episodes of eyes closing the after that happening a few times started having episodes of collapsing.  Knees buckling and falling to ground or face on table if sitting.  ESP IF I LAUGHED.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Administration site pain, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reported to pharmacy 2 weeks post vaccine administration. Patient stated in significant pain at site of administration. Both arms hurt, but the right arm hurt significantly more than the left and had limited range of motion.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Pt stated she developed itchy red rash on right and left arm and all over her waist area.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Rash erythematous
Clinical narrative: Per pt she called her Dr since on her arm it got red & a little swollen. On her chest region were little red dots like an allergic reaction.  Pt was suggested to take Benadryl also & she said she was fine.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Abdominal distension
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's concurrent conditions included haemophilia. Patient's drug reaction/allergies or concomitant information was not reported. On an unknown date, the patient was vaccinated with ROTATEQ orally (strength, dosage schedule, lot # and expiration date were not reported). On an unknown date, the patient developed significant bloating and was admitted to a hospital for an unspecified time length. While in the hospital the patient received unspecified treatment. At the reporting time the patient's outcome of bloating was unknown, as well the causality assessment between the event and therapy with ROTATEQ. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Limb discomfort, Swelling
Clinical narrative: Redness, slight swelling, tender left upper arm. Pt described a "heaviness, like fluid accumulation" in arm day after vaccination - observation only.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Amnesia, Anxiety, Arthralgia, Asthenia, Catheter placement
Clinical narrative: Blurred vision, double vision, severe headache, nausea, loss of energy, loss of strength, tingling in arms, hands, legs, feet, numbness in arms, hands, legs, feet, joint pain, anxiety, stress, shortness of breath, chest pain, paralysis, indwelling catheter, permanent immobility, memory loss, loss of appetite, dehydration, insomnia, nightmares, pneumonia, kidney infection, bladder infection, urinary tract infection, sepsis. Time Course: 1/26/16 (onset of Guillain-Barre)-9/5/2016 (date of death). Treatment: Hospital confinement, intensive care unit, and rehabilitation centers provided testing, medications, and physical therapy.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Cystitis, Death, Decreased appetite, Dehydration
Clinical narrative: Blurred vision, double vision, severe headache, nausea, loss of energy, loss of strength, tingling in arms, hands, legs, feet, numbness in arms, hands, legs, feet, joint pain, anxiety, stress, shortness of breath, chest pain, paralysis, indwelling catheter, permanent immobility, memory loss, loss of appetite, dehydration, insomnia, nightmares, pneumonia, kidney infection, bladder infection, urinary tract infection, sepsis. Time Course: 1/26/16 (onset of Guillain-Barre)-9/5/2016 (date of death). Treatment: Hospital confinement, intensive care unit, and rehabilitation centers provided testing, medications, and physical therapy.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Diplopia, Dyspnoea, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: Blurred vision, double vision, severe headache, nausea, loss of energy, loss of strength, tingling in arms, hands, legs, feet, numbness in arms, hands, legs, feet, joint pain, anxiety, stress, shortness of breath, chest pain, paralysis, indwelling catheter, permanent immobility, memory loss, loss of appetite, dehydration, insomnia, nightmares, pneumonia, kidney infection, bladder infection, urinary tract infection, sepsis. Time Course: 1/26/16 (onset of Guillain-Barre)-9/5/2016 (date of death). Treatment: Hospital confinement, intensive care unit, and rehabilitation centers provided testing, medications, and physical therapy.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Immobile, Insomnia, Intensive care, Kidney infection, Laboratory test
Clinical narrative: Blurred vision, double vision, severe headache, nausea, loss of energy, loss of strength, tingling in arms, hands, legs, feet, numbness in arms, hands, legs, feet, joint pain, anxiety, stress, shortness of breath, chest pain, paralysis, indwelling catheter, permanent immobility, memory loss, loss of appetite, dehydration, insomnia, nightmares, pneumonia, kidney infection, bladder infection, urinary tract infection, sepsis. Time Course: 1/26/16 (onset of Guillain-Barre)-9/5/2016 (date of death). Treatment: Hospital confinement, intensive care unit, and rehabilitation centers provided testing, medications, and physical therapy.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Nightmare, Paraesthesia, Paralysis, Pneumonia
Clinical narrative: Blurred vision, double vision, severe headache, nausea, loss of energy, loss of strength, tingling in arms, hands, legs, feet, numbness in arms, hands, legs, feet, joint pain, anxiety, stress, shortness of breath, chest pain, paralysis, indwelling catheter, permanent immobility, memory loss, loss of appetite, dehydration, insomnia, nightmares, pneumonia, kidney infection, bladder infection, urinary tract infection, sepsis. Time Course: 1/26/16 (onset of Guillain-Barre)-9/5/2016 (date of death). Treatment: Hospital confinement, intensive care unit, and rehabilitation centers provided testing, medications, and physical therapy.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Sepsis, Stress, Urinary tract infection, Vision blurred
Clinical narrative: Blurred vision, double vision, severe headache, nausea, loss of energy, loss of strength, tingling in arms, hands, legs, feet, numbness in arms, hands, legs, feet, joint pain, anxiety, stress, shortness of breath, chest pain, paralysis, indwelling catheter, permanent immobility, memory loss, loss of appetite, dehydration, insomnia, nightmares, pneumonia, kidney infection, bladder infection, urinary tract infection, sepsis. Time Course: 1/26/16 (onset of Guillain-Barre)-9/5/2016 (date of death). Treatment: Hospital confinement, intensive care unit, and rehabilitation centers provided testing, medications, and physical therapy.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MENB, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, erythema, tenderness of L. deltoid 3 days after vaccine admin.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Started with redness right deltoid area 2 days ago after receiving MMRV and Flu vaccine and has increased, positive tenderness, no fever.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm red, swollen.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Flushing, Syncope
Clinical narrative: Flushing, redness, faintness, administered EPIPEN and called paramedics.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Fluid retention, Injection site induration, Tenderness
Clinical narrative: Patient's bicep is all red and tendered. There is water retention aboved the elbow. The muscle is harder at the injection site.
Age: 33.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Synovitis
Clinical narrative: On 10/21 Pt c/o pain and limited ROM to arm where Tdap was administered. Evaluated by physician who states pt has synovitis to shoulder on 10/25.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody, Computerised tomogram, Full blood count, Injection site pain, Injection site swelling
Clinical narrative: Pt C/O severe arm/shoulder pain to (L) shoulder and arm on 10/15/2016. Patient now attempted to wait pain out but continues to have pain and now swelling to (L) shoulder.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Pt C/O severe arm/shoulder pain to (L) shoulder and arm on 10/15/2016. Patient now attempted to wait pain out but continues to have pain and now swelling to (L) shoulder.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site discolouration, Pain in extremity
Clinical narrative: Arm sore several weeks after administration. Slight discoloration at administration site.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Head injury, Syncope
Clinical narrative: Approximately 12 pm the patient fainted in bathroom and hit her head. Patient received a flu vaccine at approximately 10:30 AM.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Loss of consciousness, Seizure, Tremor
Clinical narrative: Patient given FLUARIX QUADRIVALENT vaccine at approximately 930am on 10/25/16. At approximately 935am patient noted to have seizure (left arm shaking, fell to floor convulsing, then unconscious for approximately 30-40 seconds). Regained consciousness about 2 minutes after seizure starts. Paramedics transport patient to Emergency at approximately 950am. Patient denied hx of seizures.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: While in waiting area post vaccination pt developed generalized hives, lip swelling, and uncontrollable itching. Airway patent, no wheezing - BENADRYL 31.25 mg PO stat, EPI 24 mg SC to (L) left thigh given - 911 called. EMS transported pt to ER - O2 given 99% O2 sat. This was first visit with provider.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Erythema, Eyelid oedema, Headache, Pain in extremity
Clinical narrative: Arm swelled twice the size. Headache. Upset stomach. Arm was red, face was red and puffy, eyes puffy, red on arm was a square. Arm extremely painful.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Arm swelled twice the size. Headache. Upset stomach. Arm was red, face was red and puffy, eyes puffy, red on arm was a square. Arm extremely painful.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient got PNEUMOVAX 23 injection in left arm late in day on 10/24/16. Had some degree of pain, redness and swelling later that night. Went to MD's today 10/25/16. Dr, said not a major problem swelling should decrease 50% w/day. Treatment with BENADRYL and Clobetasol propionate.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warm, hard to touch, itchy upper left arm mod. eryth and swollen. Approx 8.5 X 10cm from non tender no pain.
Sex: U
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt is reporting itchiness that started 48hrs after shot and is still continuing.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Pain in extremity, Pyrexia
Clinical narrative: Arm pain and numbness with fever.
Age: 70.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site pain, Pyrexia
Clinical narrative: Severe arm pain with high injection site. Redness on arm with fever.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history included H1N1 influenza and penicillin allergy. Concomitants therapies were not reported. On an unspecified date in 2014, the patient was vaccinated with ZOSTAVAX (route, strength, dosage schedule, lot # and expiration date were not reported). On an unknown date, the patient was diagnosed with shingles in the area of her right hip. The patient was currently being treated with Acyclovir (manufacturer unknown). At the reporting time the patient's outcome of herpes zoster was reported as not recovered. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Incorrect route of drug administration, Pain, Swelling
Clinical narrative: Pt feels injection too high on arm (near shoulder joint) constant pain, redness and swelling.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain from elbows to shoulders and down back after PNEUMOVAX, EMS was called, no treatment or hospital visit was necessary.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Asthma, Chest discomfort, Condition aggravated, Diarrhoea, Nausea
Clinical narrative: Fever asthma exacerbation, chest tightness for a few days. BENADRYL helped symptoms. Developed nausea and diarrhea on 10/7/16 and BENADRYL helped.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Fever asthma exacerbation, chest tightness for a few days. BENADRYL helped symptoms. Developed nausea and diarrhea on 10/7/16 and BENADRYL helped.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Skin irritation
Clinical narrative: Area of irritation/breaking out on my forearms, bilateral.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 04-AUG-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the 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 08-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time of the first time was 104 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event 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 referring to a patient of unknown age and gender. On 07-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 01-AUG-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the 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 24-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 26-JUL-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the 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 08-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 104 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 29-JUL-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 28-JUL-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the 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 10-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was 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 was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unknown multiple dates, the patients were vaccinated with an improperly stored doses of GARDASIL lot # L040054, expiration date 26-DEC-2017 (dose and route of administration were not reported). The administered doses of vaccines were exposed to a temperature of 9 Celsius degrees, for 5 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to patient of unknown age and gender. The patient's concurrent or historical conditions were not reported. On 11-OCT-2016, the patient received a dose of M-M-R II (Lot #L043702, expiry 03-NOV-2017) that was reconstituted with improperly stored sterile diluent (lot # L001533, expiry 24-OCT-2017) (dose, route not reported). The sterile diluent temperature excursion was reported as 95 F for a duration of 9.5 hours. No previous excursions were reported. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown date in September and October 2016, patients were vaccinated with improperly stored ROTATEQ (lot # M019691 and expiration date 02-NOV-2017, orally, dose was not reported). The vaccine was exposed to temperature excursions described as: minimum temperature 47.0 (unit not provided) and maximum temperature 48.2 (unit not provided) for 48 hours and minimum temperature 32.1 (unit not provided) and maximum temperature 35.9 (unit not provided) for 80 hours. There was no previous temperature excursion. It was not because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPVX, IPV, MMR, TD
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 04-OCT-2016, the patient was vaccinated with an expired dose of M-M-R II (rHA, lot # K016153, expiration date 24-SEP-2016, dose unknown) intramuscularly. 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 a patient of unknown age and gender. On 14-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 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 event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information as received from a nurse concerning unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On an unknown date, an unspecified number of unspecified patients were administered improperly stored doses of PEDVAXHIB (lot# M007762, expiration date 07-DEC-2018; lot# M020101, expiration date 07-MAR-2019; lot# M025193, expiration date 21-MAR-2019) (strength, dose, frequency and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant drugs were not known. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosage regimen were unknown by reporter), intramuscularly. On an unknown date, the patient "passed out" at the office front desk after administration of GARDASIL 9. Paramedics were called to the office but the patient recovered without requiring treatment. no hospitalization was required. Causality assessment was not provided. 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-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 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 event 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 received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients received VAQTA (Lot number: M002268, Expiry date: 20-SEP-2017) (dose, frequency were not reported) which was improperly stored. No adverse effects reported. Causality assessment was not reported for the events. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Injection site pain
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 regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with doses of PROQUAD (lot #, expiration date, site, dose and route of administration were not reported). The nurse stated that all patients has pain at the injection site when PROQUAD was administered. The outcome of the event was unknown. The relatedness between the event and PROQUAD was not reported. This is one of two 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 received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients received ROTATEQ (Lot number: L033543, Expiry date: 30-MAY-2017) (dose, frequency were not reported) which was improperly stored. No adverse effects reported. Causality assessment was not reported for the events. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 12 year old non-pregnant female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were unknown. On an unknown date, the patient was intramuscularly vaccinated with the first dose of GARDASIL 9 (site of administration, dose, lot number and expiration date were not reported). On an unknown date, "while on" GARDASIL 9, the patient developed hives. The patient sought medical attention via a physician visit. It was unknown if any lab diagnostic studies were performed. No treatment was given for the event. Product quality complaint was not involved. The GARDASIL 9 vaccination series was not discontinued. The outcome of developing hives and the relatedness between this event and the vaccination with GARDASIL 9 were not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received on 13-OCT-2016 from a pharmacist regarding a female patient. Medical history, concurrent conditions and concomitant medications were not reported. The pharmacist reported that the patient received doses of ZOSTAVAX on the following dates: 12-MAY-2015 and 11-OCT-2016. The dose of ZOSTAVAX received on 12-MAY-2015, was administered at another location, therefore the pharmacist was unable to provide the lot number and expiration date. The dose administered on 11-OCT-2016 was lot # L046899, expiration date 23-FEB-2017. No adverse experience had been reported. No additional information was provided. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse prescriber, concerning an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown date, the patients were vaccinated with a dose of improperly storage RECOMBIVAX HB lot # L048209, expiration date 26-JUN-2017, (dosage and therapy route were not provided). Concomitant therapies were not informed. It was reported that the RECOMBIVAX HB was exposed to a temperature excursion of 33.6F for 49.5 hours. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients received RECOMBIVAX (Lot number: M022077, Expiry date: 10-MAR-2017) (dose, frequency were not reported) which was improperly stored. No adverse effects reported. Causality assessment was not reported for the events. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product lot number issue
Clinical narrative: Information has been received from a medical assistant concerning a 7 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 17-OCT-2016, the patient was vaccinated with a dose of GARDASIL 9 (expired date: 30-APR-2018) (Reporter reported GARDASIL 9 with Lot # M026306 which was not valid for GARDASIL 9. However, lot # M026306 is valid for GARDASIL) intramuscularly. The patient has not experienced an adverse effect. 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 medical assistant refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported) lot # M013636 and expiry date: 15-FEB-2018. The vaccine was exposed to a temperature frame of 34.9 Fahrenheit for 336 hours. A data logger was used to record the temperatures. No adverse effects were reported. No additional information was provided. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date in November 2015, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency and route were unknown; lot number K020187 and expiration date was not provided). The following day, the patient developed redness, swelling and tenderness from the shoulder down to the elbow. The patient sought medical attention and received a steroid injection and the patient improved within a couple days and the outcome of the events were reported as recovered. The causal relationship between ZOSTAVAX and the events was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a female patient of unknown age. There was no information regarding concomitant medication, medical history or drug reactions/allergies. On 15-FEB-2015, the patient received a first dose of GARDASIL 9 (lot #, expiration date, dose and route were not reported). On 26-AUG-2016, the patient received her second dose of GARDASIL 9 (lot #, expiration date, dose and route were not reported). On 20-OCT-2016, the patient received her third dose of GARDASIL 9 (lot # M003659, expiration date 20-SEP-2017; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not informed. It was reported that on 19-OCT-2016 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # M032651, expiration date 15-JUN-2017, administered via intramuscular route instead subcutaneous route. Concomitant therapies were not informed. The pharmacist stated that no adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia
Clinical narrative: This spontaneous report was received from a female consumer in her 60's, concerning herself. The patient's concurrent condition included economic problems. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On an unspecified date in 2016, the patient was vaccinated with ZOSTAVAX (route, dosage schedule, lot # and expiration date were not reported). On an unspecified date in 2016 (reported as "for many months"), the patient experienced chronic dysphonia. The patient's outcome for her dysphonia was unknown at the reporting time. The reporter did not provided the causality assessment between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, these patients received improperly stored VAQTA (lot# M032492, expiration date 02-MAR-2018) (lot# M036459, expiration date 18-JAN-2018) (dose and route not provided). The improperly stored VAQTA were exposed to temperatures ranging from a minimum of 31.9F and a maximum of 35.5F for a cumulative time frame of 1 hour. No previous excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. On an unknown dates, the patient were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # M002055, expiration 11-JUL-2017) and ZOSTAVAX, (lot # M015926, expiration date 28-JUN-2017). Temperature was 13.9 degrees F. Time frame was one hour. 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 a patient of unknown age and gender. On 18-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 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 event was 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: Information has been received from a medical assistant (also reported as "administrator"), concerning unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with unspecified improperly stored doses of VARIVAX (lot number M006722 with an expiration date of 08-FEB-2018, lot number M020899 with an expiration date of 27-APR-2018, lot number M023380 with an expiration date of 11-MAY-2018 and lot number reported as M027342 with an expiration date of 01-JUN-2018) (strength, dosage schedule, route and anatomical location were not reported). Concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also reported as "administrator"), concerning unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with unspecified improperly stored doses of PROQUAD (lot number reported as M006167 with an expiration date of 01-AUG-2017, lot number M021427 with an expiration date of 29-OCT-2017 and lot number reported as M031942 with an expiration date of 27-DEC-2017) (strength, dosage schedule, route and anatomical location were not reported). Concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also reported as "administrator"), concerning an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with unspecified improperly stored doses of M-M-R II (lot number L043703 with an expiration date of 03-NOV-2017, lot number M010426 with an expiration date of 01-MAR-2018, lot number M002419 with an expiration date of 12-JAN-2018 and lot number M08589 with an expiration date of 16-FEB-2018) (strength, dosage schedule, route and anatomical location were not reported). Concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, unknown number of doses of VAQTA (Lot# M022924 with expiry date: 24-JAN-2018, L015460 with expiry date: 20-JUL-2017, M015290 with expiry date: 20-SEP-2017) (dosing details were not reported) were administered to an unknown number of patients following a temperature excursion of 33 F for 23 days. No adverse effects were reported. No product quality complaint was reported. This is one of the several reports. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, unknown number of doses of GARDASIL 9 (lot# L043213 with expiry date: 28-AUG-2017, M003659 with 20-SEP-2017, M004116 with expiry date: 12-OCT-2017, M020103 with expiry date: 15-FEB-2018 and M021407 with expiry date: 30-APR-2018) (dosing details were not reported) were administered to an unknown number of patients following a temperature excursion of 33 F for 23 days. No adverse effects were reported. No product quality complaint was reported. This is one of the several reports. Additional information is not expected as there is no consent to contact the reporter.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Immediate post-injection reaction, Incorrect product storage, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient did not have any pertinent medical history, concomitant therapies or any known drug reactions or allergies. On 12-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD injection, subcutaneously (lot # M018636 with an expiration date 11-OCT-2016), albumin status rHA (dose and anatomical location were not reported). On 12-OCT-2016, reported as immediately after receiving PROQUAD, the patient experienced pain at the injection site and a "small bump" at the injection site. The nurse reported that the patient stayed in the waiting room for "a few minutes" and the pain subsided but was not resolved when the patient left the office. No treatment was given for the events and no diagnostic lab studied were performed. The outcome of the event of "small bump" at the injection site was not reported. The relatedness between the events and PROQUAD was not reported. This is one of two 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 was received from a registered nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, unknown number of doses of ROTATEQ (lot# M004885 with expiry date: 23-OCT-2017, M019708 with expiry date: 25-OCT-2017, M025563 with expiry date: 06-NOV-2017 and M004890 with expiry date: 10-NOV-2017) (dosing details were not reported) were administered to unknown number of patients following a temperature excursion of 33 F for 23 days. No adverse effects were reported. No product quality complaint was reported. This is one of the several reports. Additional information is not expected as there is no consent to contact the reporter.
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-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 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 event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, these patients received improperly stored RECOMBIVAX HB (lot# L044707, expiration date 06-OCT-2018) (dose and route not provided). The improperly stored RECOMBIVAX HB were exposed to temperatures ranging from a minimum of 31.9F and a maximum of 35.5F for a cumulative time frame of 1 hour. No previous excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.