chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
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 medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (concentration, dose, dose number, route, lot number and expiration date were not provided). Concomitant medication information was not provided. On an unknown date, the patient developed shingles after receiving ZOSTAVAX injection. No product quality complaint (PQC) was involved. At the time of the report, the outcome of herpes zoster was unknown. The primary reporter did not provide the causal relationship between ZOSTAVAX and herpes zoster. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain, Paraesthesia, Pyrexia
Clinical narrative: Severe H/A, Severe tingling of all extremities, Severe body aches, fever -Mother reported S/S to office 7-22-2016.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified pharmacy technician, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 23-JUN-2016, the patient was vaccinated with expired M-M-R II, lot # K005175, expiration date 30-APR-2016 (dose, dose number, route, and anatomical location were unknown by the reporter). No adverse effects reported. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: ANTH, JEVX, TYP
Symptoms: Back pain, Dyspnoea, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Felt SOB, felt cold and sweaty. Headache. Backache, generalized muscle soreness. Redness, tenderness warmth at injection site (L) deltoid.
Age: 40.0
Sex: M
Vaccine: ANTH, JEVX, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: Felt SOB, felt cold and sweaty. Headache. Backache, generalized muscle soreness. Redness, tenderness warmth at injection site (L) deltoid.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Cold sweat, Fall, Skin warm, Unresponsive to stimuli
Clinical narrative: Pt received HPV vaccine in (R) deltoid. Approximately 5 minutes later slipped from chair to floor after freely conversing with nurse and mother. Pt came to rest on (L) side with eyes closed and no response to calling of name. Aroused shortly with touch to face and asked, "What happened?" Slowly assisted to sitting position. Back slightly damp to touch. Assisted to recliner and feet elevated. Once talking freely, given water and peanut butter crackers (pt had not eaten). Skin warm and dry. BP 104-64. Pt discharged home in care of mother. Walking without difficulty. Gait stable and straight. Conversing freely with mother.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4X4 cm area of redness with swelling (R) arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Tenderness
Clinical narrative: Red area, tender to touch, hardening around injection site.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, TDAP
Symptoms: Chest pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Received TDaP, HPV and TRUEMBA. Day after injections, shivering, no fever, c/o pin and needles, headache, chest hurts, exhausted, pain at inj site. Felt somewhat better after MOTRIN.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, TDAP
Symptoms: Paraesthesia
Clinical narrative: Received TDaP, HPV and TRUEMBA. Day after injections, shivering, no fever, c/o pin and needles, headache, chest hurts, exhausted, pain at inj site. Felt somewhat better after MOTRIN.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration and erythema on right lateral deltoid measuring 15cm x 8cm.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Induration, Mass, Pain, Tenderness, Ultrasound scan
Clinical narrative: Pain; hard lump; continued tenderness to touch w/radiating pain-lump and tender to touch/radiating pain continued 1 mo. No real treatment done at this time. Seen for evaluation today.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, swollen (R) shoulder.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Left biceps area with significant erythema. Minimal induration minimal tenderness to palpation. Slight warmth to touch.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Urticaria, Wheezing
Clinical narrative: Hives on forehead, wheezing, the area where PCV13 was given had some hives. Pt was given 0.01 of epinephrine on (L) thigh immediately and responded. Pt was kept under observation for another hour. Vial signs normal, Pt stable. No signs of distress. Pt sent home.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain
Clinical narrative: Nerve pain in right abdominal quadrant similar to pain experienced when she was diagnose with shingles in May 2014. Treatment: Acyclovir 400 mg 2 tabs five times daily x 7 days, NEURONTIN 100 mg twice daily as needed for pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Apathy, Asthenia, Pyrexia, Skin warm, Urticaria
Clinical narrative: Back of (R) arm hot to touch , fever of 104.5 degrees (temporal scan thermometer). Decreased energy and motivation. DX started 06/25/2016 at 10:00, hives all over body and fever started a few hours after mother first noticed. Mother gave ibuprofen and BENADRYL, monitored at home. Took 4 days for symptoms to resolve.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the 3rd dose of GARDASIL 9 (dose, route of administration and lot number were not reported). On an unknown date, after vaccination with GARDASIL 9 the patient fainted, fell off the table and bumped her head. Additionally, she lost consciousness for 30 seconds. Then the patient was advised to go to the emergency room (ER). It was reported that the patient received an unspecified treatment for the adverse events and she sought medical attention. At the time of the report, the outcome of loss of consciousness was recovered. The outcome of fainted, fell and bumped her head was unknown. The reporter did not provide causality assessment for the events. Follow up information was received from the physician (pediatrician) on 15-JUL-2016. Along with already reported events, on an unknown date, the patient experienced also loss of sight (LOS) for 20-30 seconds, loss of bladder control, headache and was unable to stand. It was reported that she was laid flat for a few minutes and monitored for about 45 minutes. Then, the patient was brought to the ER for further monitoring. In the ER, there were following tests performed: computerised tomogram (CT) of head, electrocardiogram (EKG/ECG) and influenza test. All tests' results were normal. Tilt table test was not conducted. The patient did not receive any treatment. There were no overt causes of orthostatic symptoms or tachycardia. Since the patient was unable to stand, it was not reported if her heart rate increased when moving from a supine to standing position. The outcome of the LOS was reported as recovered. The outcome of the other events was not reported. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of loss of consciousness and loss of sight were considered to be medically significant. Additional information is not expected as all relevant information has been received. Laboratory tests, events and narrative were updated.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Blindness, Computerised tomogram head normal, Dysstasia, Electrocardiogram normal, Fall
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the 3rd dose of GARDASIL 9 (dose, route of administration and lot number were not reported). On an unknown date, after vaccination with GARDASIL 9 the patient fainted, fell off the table and bumped her head. Additionally, she lost consciousness for 30 seconds. Then the patient was advised to go to the emergency room (ER). It was reported that the patient received an unspecified treatment for the adverse events and she sought medical attention. At the time of the report, the outcome of loss of consciousness was recovered. The outcome of fainted, fell and bumped her head was unknown. The reporter did not provide causality assessment for the events. Follow up information was received from the physician (pediatrician) on 15-JUL-2016. Along with already reported events, on an unknown date, the patient experienced also loss of sight (LOS) for 20-30 seconds, loss of bladder control, headache and was unable to stand. It was reported that she was laid flat for a few minutes and monitored for about 45 minutes. Then, the patient was brought to the ER for further monitoring. In the ER, there were following tests performed: computerised tomogram (CT) of head, electrocardiogram (EKG/ECG) and influenza test. All tests' results were normal. Tilt table test was not conducted. The patient did not receive any treatment. There were no overt causes of orthostatic symptoms or tachycardia. Since the patient was unable to stand, it was not reported if her heart rate increased when moving from a supine to standing position. The outcome of the LOS was reported as recovered. The outcome of the other events was not reported. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of loss of consciousness and loss of sight were considered to be medically significant. Additional information is not expected as all relevant information has been received. Laboratory tests, events and narrative were updated.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Head injury, Headache, Influenza virus test negative, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the 3rd dose of GARDASIL 9 (dose, route of administration and lot number were not reported). On an unknown date, after vaccination with GARDASIL 9 the patient fainted, fell off the table and bumped her head. Additionally, she lost consciousness for 30 seconds. Then the patient was advised to go to the emergency room (ER). It was reported that the patient received an unspecified treatment for the adverse events and she sought medical attention. At the time of the report, the outcome of loss of consciousness was recovered. The outcome of fainted, fell and bumped her head was unknown. The reporter did not provide causality assessment for the events. Follow up information was received from the physician (pediatrician) on 15-JUL-2016. Along with already reported events, on an unknown date, the patient experienced also loss of sight (LOS) for 20-30 seconds, loss of bladder control, headache and was unable to stand. It was reported that she was laid flat for a few minutes and monitored for about 45 minutes. Then, the patient was brought to the ER for further monitoring. In the ER, there were following tests performed: computerised tomogram (CT) of head, electrocardiogram (EKG/ECG) and influenza test. All tests' results were normal. Tilt table test was not conducted. The patient did not receive any treatment. There were no overt causes of orthostatic symptoms or tachycardia. Since the patient was unable to stand, it was not reported if her heart rate increased when moving from a supine to standing position. The outcome of the LOS was reported as recovered. The outcome of the other events was not reported. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of loss of consciousness and loss of sight were considered to be medically significant. Additional information is not expected as all relevant information has been received. Laboratory tests, events and narrative were updated.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Tachycardia, Urinary incontinence
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the 3rd dose of GARDASIL 9 (dose, route of administration and lot number were not reported). On an unknown date, after vaccination with GARDASIL 9 the patient fainted, fell off the table and bumped her head. Additionally, she lost consciousness for 30 seconds. Then the patient was advised to go to the emergency room (ER). It was reported that the patient received an unspecified treatment for the adverse events and she sought medical attention. At the time of the report, the outcome of loss of consciousness was recovered. The outcome of fainted, fell and bumped her head was unknown. The reporter did not provide causality assessment for the events. Follow up information was received from the physician (pediatrician) on 15-JUL-2016. Along with already reported events, on an unknown date, the patient experienced also loss of sight (LOS) for 20-30 seconds, loss of bladder control, headache and was unable to stand. It was reported that she was laid flat for a few minutes and monitored for about 45 minutes. Then, the patient was brought to the ER for further monitoring. In the ER, there were following tests performed: computerised tomogram (CT) of head, electrocardiogram (EKG/ECG) and influenza test. All tests' results were normal. Tilt table test was not conducted. The patient did not receive any treatment. There were no overt causes of orthostatic symptoms or tachycardia. Since the patient was unable to stand, it was not reported if her heart rate increased when moving from a supine to standing position. The outcome of the LOS was reported as recovered. The outcome of the other events was not reported. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of loss of consciousness and loss of sight were considered to be medically significant. Additional information is not expected as all relevant information has been received. Laboratory tests, events and narrative were updated.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal pain, Night sweats, Pain
Clinical narrative: Severe shoulder pain. Inability to rotate shoulder without pain. Upper arm and hand swelling. Numbness from shoulder to fingertips. Extreme pain at site of injection. Night sweats.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Severe shoulder pain. Inability to rotate shoulder without pain. Upper arm and hand swelling. Numbness from shoulder to fingertips. Extreme pain at site of injection. Night sweats.
Age: 1.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PPV, VARCEL
Symptoms: Discomfort, Lethargy, Musculoskeletal stiffness, Pyrexia, Rash morbilliform
Clinical narrative: Fever onset, general discomfort on first two days. Third day, woke up with high grade fever and was stiff and shaking (possible seizure) and lethargic. Fourth day woke up with a rash that resembled measles and a high grade fever. All fevers came down with medication.
Age: 1.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PPV, VARCEL
Symptoms: Tremor
Clinical narrative: Fever onset, general discomfort on first two days. Third day, woke up with high grade fever and was stiff and shaking (possible seizure) and lethargic. Fourth day woke up with a rash that resembled measles and a high grade fever. All fevers came down with medication.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt began experiencing redness near injection site and pruritis; applied hydrocortisone to relieve itching; pt states that it is getting better.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Pt stated he got light headed after shot was administered. Blood pressure was normal.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia
Clinical narrative: Patient called 2 days after vaccine to report he had been having severe new onset joint pain in his hip since he received the vaccine.  I recommended icing the joint and taking aleve OTC 2 tablets every 12 hours for pain.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Exposure during pregnancy, Injected limb mobility decreased, Joint stiffness, Pain
Clinical narrative: Tdap vaccine was given less than a finger's width below the joint space.  Have had decreased PROM/AROM especially with L shoulder ABD, flexion, and internal rotation.  Unable to sleep on left or right side.  Constant aching w/ pain worse at night due to increased joint stiffness.  Have been to orthopedist and PT.  Have received joint mobs, PROM, and dry needling.  Tdap vaccine received because I am 7 months pregnant.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: Tdap vaccine was given less than a finger's width below the joint space.  Have had decreased PROM/AROM especially with L shoulder ABD, flexion, and internal rotation.  Unable to sleep on left or right side.  Constant aching w/ pain worse at night due to increased joint stiffness.  Have been to orthopedist and PT.  Have received joint mobs, PROM, and dry needling.  Tdap vaccine received because I am 7 months pregnant.
Age: 0.2
Sex: M
Vaccine: HIBV, IPV, PPV, RVX
Symptoms: Decreased appetite, Insomnia, Musculoskeletal stiffness, Screaming
Clinical narrative: Screaming non stop, lack of eating, stiffening his body while screaming and grabbing at his face and pulling, and lack of sleeping.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Abnormal behaviour, Fear, Reflexes abnormal, Screaming
Clinical narrative: Following the vaccinations, my baby had severely worsened Moro reflex, especially when she was flat on her back (diaper changes, etc). She would display the Moro reflex 10-20 times in a row in rapid succession then scream, terrified. I'm pretty sure this was not a seizure, since it would stop after I picked her up. She was afebrile at the time. She kicked her toys without difficulty, so it was not from her legs hurting. She was not herself at all for several days after the vaccine. The heightened Moro reflex eventually dissipated and went back to normal after about 4-5 days. I read about this happening to other babies after vaccines on internet forums, but my doctor had never heard of this reaction.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Tenderness, Urticaria
Clinical narrative: Reported as red, itchy, hard welp bigger than half dollar.  Arm tenderness.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood iron, Borrelia test, Dizziness postural, Laboratory test, Pain in extremity
Clinical narrative: Symptoms: Extreme Leg Pain, heart palpitation, dizzy when standing.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Palpitations, Thyroid function test
Clinical narrative: Symptoms: Extreme Leg Pain, heart palpitation, dizzy when standing.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness postural, Pain, Pyrexia, Vomiting
Clinical narrative: Fever of 101.5 F for 2.5 days so far. Chills, vomiting, aches and pains.  Dizziness when standing.
Sex: F
Vaccine: HPV9
Symptoms: Crohn's disease, Inflammatory bowel disease
Clinical narrative: This spontaneous report concerning a currently 10 years old female patient was received from a nurse practitioner. No concurrent conditions and medical history were provided. On an unknown date in January 2016, reported as approximately six months ago, the patient was vaccinated with the first dose of GARDASIL 9, one dose (lot number and expiration date were not provided), by intramuscular route. There were no concomitant medications reported. On an unknown date in 2016, the patient experienced Crohn's disease. The reporter stated that, since the patient's first dose of GARDASIL 9, she was started a treatment with REMICADE for her Crohn's disease and she was responded well to it. No product quality complain was involved. At the time of reporting, the outcome of the event of inflammatory bowel disease was unknown. The causality between the event of inflammatory bowel disease and GARDASIL 9 was not assessed. Upon internal review, the event of inflammatory bowel disease was considered medically significant. 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 certified medical assistant and refers to an unspecified numbr of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (lot # M004116, expiration date on 12-OCT-2017 (strength, dose number, route and anatomical location were not reported). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 31.5 degrees Fahrenheit for 125 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M002061, expiration date: 12-JAN-2018 and lot# M006724, expiration date: 08-FEB-2018) (dose, route of administration and injection site were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. 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 referring to an unspecified number of patients of unknown age and gender. Information regarding medical history or concurrent conditions were not reported. On unknown dates, the patients were vaccinated with 17 improperly stored doses of PROQUAD (which had the lot number reported as M004894, expiration date 26-JUL-2017) (dose, route and anatomical site of vaccination were not informed). Information regarding concomitant medication was not provided. No adverse effects were reported. And there was not product quality complaint involved. This is one of two cases from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were unspecified. The reporter stated that, on 26-APR-2016, the patient was inadvertently vaccinated with a dose of VARIVAX (dose, strength, vaccination site, route unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected since these was no consent to contact the reporter.
Age: 6.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Drug administration error, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 6 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was inadvertently vaccinated with VARIVAX injection, subcutaneously, lot # L049532, expiry date 08-DEC-2017 (dose and anatomical location were not specified) and ZOSTAVAX 19400 plaque-forming unit (PFU) injection, lot # L037790, expiry date 30-DEC-2016 (dose, route of administration and anatomical location were not provided), at the same office visit. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown multiple dates, the patient were vaccinated with improperly stored dose of PNEUMOVAX 23 (lot # L024132, expiry date: 21-JAN-2017, dose and route were not reported). The doses were stored under temperature of 60 F for 3 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of the 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: This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L02946, expiration date: 06-AUG-2016) (dose, route of administration and injection site were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one the two 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 health care worker via company representative. Information regarding patient's medical history and concomitant medication were not reported. On an unknown date the multiple unspecified patients were vaccinated intramuscularly with improperly stored RECOMBIVAX HB (lot # L040458, expiration date 04-FEB-2018) 10/1.0 mcrg/ml. No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 year old patient of unknown gender. The patient's pertinent medical history and concomitant medications were not reported. On 18-JUL-2016, the patient was inadvertently vaccinated with expired dose of VARIVAX (lot # K007975, expiry date 03-JUN-2016, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in (also reported as "on 21-SEP-2016"), the patient was vaccinated an improperly stored dose of VARIVAX injection, lot # K016132, expiry date 21-SEP-2016 (dose, route of administration an anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. 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 was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose, lot #, expiry date, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. 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 was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-JUN-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection (dose, lot # expiry date, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not 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: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown multiple dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L015460, expiry date: 20-JUL-2017 and lot # reported as M013653, expiry date: 26-MAY-2017, dose and route were not reported). The doses were stored under temperature of 60 F for 3 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a nurse via field representative and referred to a female patient of unknown race who was 23 years old at the time of the report. On an unknown dates, the patient received the first two doses of GARDASIL (lot #, expiration date, strength, dose and frequency were not reported). The patient did not intend to finish the series as on an unspecified date she performed pap smear test which was HPV positive. The patient sought medical attention but no treatment was given for adverse event. Therapy with GARDASIL reported as discontinued. The outcome of human papilloma virus test positive was reported as recovering/resolving at the time of the report. Relatedness between the event and therapy with GARDASIL was not reported. 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 Certified Medical Assistant (CMA) refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with improperly stored ROTAREQ orally (dose, frequency and lot # were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from  the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, frequency, route and lot # were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose, frequency, route and lot # were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, frequency, route and lot # were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 28-JUN-2016, the patient was inadvertently administered with M-M-R II, subcutaneously (dose, frequency and lot information were unspecified for both vaccines) that were improperly stored (incorrect product storage). No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-JUL-2016, the patient was inadvertently administered with VARIVAX, at an unspecified dose subcutaneously (lot information were unspecified) that was improperly stored. No adverse effect reported. The outcome of the event was unknown. This is one the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and referred to a patient of unknown age, race and sex. On 18-JUL-2016, the patient was inadvertently administered an expired dose of VARIVAX, (lot # K009759, expiration date: 09-JUL-2016) subcutaneous. No adverse effect was reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Viral test negative
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 25 year old female patient. Information on the concurrent condition, pertinent medical history and drug allergies were not reported. On an unknown date in 1994, the patient was vaccinated with VARIVAX (lot, expiry date, dose number, dose units, route and anatomical location were not reported) 1 dose. Other suspect therapies included M-M-R II vaccinated with 2 doses, one on an unknown date in 1994 and another on an unknown date in 2001. Concomitant medication were not reported. On an unknown date, patient presented to the pharmacy with "low serologic testing" (test results unspecified and unavailable), requesting to be re-vaccinated. The patient had been vaccinated in her native country (country unspecified). The outcome of viral test negative was unknown. No adverse effects reported. There were no Product Quality Complaint (PQC) involved. Relatedness of the event viral test negative with suspect therapies was not reported. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 07-JUL-2016, the patient was inadvertently administered with VARIVAX and M-M-R II, subcutaneously (dose, frequency and lot information were unspecified for both vaccines) that were improperly stored (incorrect product storage). No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as "office manager") and referred to a patient of unknown age, race and gender. On 13-JUl-2016 the patient was inadvertently administered a dose of ROTATEQ (lot # K022990), orally which expired on 26-JUN-2016. This was supported as per stability memo. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician 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 vaccinated with unspecified number of doses of improperly stored ROTATEQ lot# reported as L035637 with expiration date: 09-JUN-2017, orally (dose was not reported). No adverse effects were 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 as received from a healthcare professional refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of ROTATEQ oral injection (lot #, expiry date, strength and dose were unspecified). The administered vaccine underwent the temperature excursion at 34.5 degrees Fahrenheit for 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same 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 healthcare professional refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot #, expiry date, strength, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 34.5 degrees Fahrenheit for 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 03-NOV-2015 the patient was vaccinated with GARDASIL 9 (lot#, expiry date, dose and route of administrations not reported). On 04-JAN-2016, the patient was vaccinated with GARDASIL (lot#, expiry date, dose and route of administrations not reported). On 07-JUN-2016, the patient was vaccinated with GARDASIL 9 (lot#, expiry date, dose and route of administrations not reported). No adverse symptoms were reported. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse refers to a patient of unknown age. On 19-JUL-2016, the patient was inadvertently vaccinated with a dose expired ZOSTAVAX, lot # L001203, expiry date 07-JUL-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to two patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L029469, expiration date: 06-AUG-2017; dose and route not provided). No adverse effect was reported. Additional information has been requested.
Age: 1.17
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-JUN-2016, the patient was inadvertently administered with M-M-R II, subcutaneously (dose, frequency and lot information were unspecified) that were improperly stored (incorrect product storage). No adverse effect reported. The outcome of the events was unknown. This is one of the 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 physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 08-JAN-2016, the patients were vaccinated with improperly stored dosed of RECOMBIVAX HB intramuscularly (dose, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1 degrees Celsius for 220 hours. Time frame/date of excursion: from 08-JAN-2016 to 24-MAY-2016. 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: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions concomitant therapies or medical histories provided. On unknown dates since 08-JAN-2016, the patients were vaccinated with improperly stored doses of VAQTA intramuscularly (dose, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -1 degrees Celsius for 220 hours. Time frame/date of excursion: from 08-JAN-2016 to 24-MAY-2016. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-JUL-2016, the patient was inadvertently administered with two doses of PROQUAD, subcutaneously (dose, frequency and lot information were unspecified) that was improperly stored (incorrect product storage), (overdose), (medication error). No adverse effected reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 08-JAN-2016, the patients were vaccinated with improperly stored doses of GARDASIL intramuscularly (dose, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1 degrees Celsius for 220 hours. Time frame/date of excursion: from 08-JAN-2016 to 24-MAY-2016. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
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 and gender. Tnhe patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored VARIVAX (lot # L045956 with expiration date: 17-NOV-2017, dose and route of administration were not reported). NO adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of  several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 2 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 14-JUL-2016, the patients were administered subcutaneously with a 0.5 ml dose of VARIVAX (lot # reported as L050561, expiration date: 14-DEC-2017) during the temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-JUL-2016, the patient was vaccinated  with ZOSTAVAX 19400 PFU, 0.65 milliliter (ml), once, subcutaneously. Concomitant medications were not reported. On 07-JUL-2016, the patient experienced swelling and redness that localized at injection site. The patient sought medical attention and was seen in the pharmacy. NO treatment was given to the adverse events. The outcome of swelling and redness that localized at injection site was unknown. Product quality complaint (PAC) was not filed. Causality assessment was not provided. Additional information has been requested.