chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Urinary incontinence
Clinical narrative: Patient was given shots with no problem. She was a little nervous but did not cry after injections. She sat up and mom noticed she was not alert, she asked her what was wrong and she didn't respond. Patient was limp and was laid down. Immediately she starting urinating. Eyes were open but fixed. Patient was not responding. Her rt leg was twitching during the event. Event lasted less than 1 minute. After regaining consciousness she responded to basic questions but remained pale. She laid down for 10-15 minutes then someone carried her to the bathroom. After coming back patient looked drowsy and felt like she had to vomit. She again turned very pale. Mom held her over the garbage can but did not vomit. Patient complained of just wanting to go to sleep. Also said she felt dizzy after the shots but was not dizzy anymore. EMS called.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: AS SOON AS CHILD GOT HOME HAD SLT HA, THEN SPIKED A FEVER OF 101 PROCESSED BY GENERALIZED BODY ACHES ON EVENING OF 08/23/2016 BODY ACHES CONTINUED NEXT DAY BUT FEVER RESOLVED. KEPT HOME FROM SCHOOL. 08/25/16 SLT BODY ACHES REMAIN, FEVER RESOLVED CHILD BACK TO SCHOOL TODAY.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Eye movement disorder, Pallor
Clinical narrative: Routine shots for tots clinic held on site, administered Tdap, Menactra, and Hepatitis A vaccine per VFC guidelines and ACIP recommendations without any problems. Patient standing after receiving immunizations and within 10 minutes noticed pallor color to face and eyes rolling to back of head. Assisted patient to floor, lying flat with knees bent, cool compress to forehead and back of neck. Vital signs: BP 100/70 Pulse 74 Resp. 22 Patient alert and orientated x3. After 15 minutes, assisted to sitting position in chair. Vital signs: BP 98/68 Resp. 22 Pulse 74 Patient offered no complaints. Skin dry, pink, and warm. Patient escorted to car and released in c/o of guardian. Advised to take child to get something to eat. Aware report will be submitted.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 08-AUG-2016, the patient inadvertently received an expired dose of ZOSTAVAX (lot# J011211, expiration date: 31-JUL-2014 (also reported as 31-JUN-2014), dose and route unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of unspecified patients of unknown age and gender. Information regarding pertinent medication, drug reactions/allergies and concomitant medication were not reported. On unknown dates starting on or after 21-JUL-2016, the patients were administered improperly stored doses of VARIVAX lot # L039092 with expiration date 06-OCT-2017 (dose and route were not reported). The temperature excursion was 10.89 Fahrenheit and time frame was 12 hours. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster disseminated, Rash, Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist that refers to a 79 year old male patient. The patient had no allergies, concurrent conditions or medical history reported. On 21-MAR-2011, the patient was vaccinated with ZOSTAVAX, (route of administration, strength lot number and expiration date were not reported). Information about concomitant therapy was not provided. On approximately March 2011, the patient experienced herpes zoster disseminated reported as "since receiving ZOSTAVAX, the patient had experienced multiple shingles outbreaks, and he was in the middle of an outbreak now" (unspecified dates). It was also reported that "the patient was currently in a lot of discomfort and had a rash on parts of his throat and different parts of his body". When asked if the patient received treatment for the event, the reported stated "he had acyclovir, assuming his physician prescribed it for him". No laboratory tests were performed, and on an unspecified date the patient sought medical attention. When asked for the present status event, the reporter stated "the patient had a current case shingles". The outcome of herpes zoster disseminated and discomfort were not resolved. The relationship between the vaccine and the events was unknown. Upon internal review, Herpes Zoster disseminated was determined to be medically significant. Additional information is not expected because the primary reporter didn't want to be contacted.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Herpes zoster disseminated, Rash
Clinical narrative: This spontaneous report was received from a pharmacist that refers to a 79 year old male patient. The patient had no allergies, concurrent conditions or medical history reported. On 21-MAR-2011, the patient was vaccinated with ZOSTAVAX, (route of administration, strength lot number and expiration date were not reported). Information about concomitant therapy was not provided. On approximately March 2011, the patient experienced herpes zoster disseminated reported as "since receiving ZOSTAVAX, the patient had experienced multiple shingles outbreaks, and he was in the middle of an outbreak now" (unspecified dates). It was also reported that "the patient was currently in a lot of discomfort and had a rash on parts of his throat and different parts of his body". When asked if the patient received treatment for the event, the reported stated "he had acyclovir, assuming his physician prescribed it for him". No laboratory tests were performed, and on an unspecified date the patient sought medical attention. When asked for the present status event, the reporter stated "the patient had a current case shingles". The outcome of herpes zoster disseminated and discomfort were not resolved. The relationship between the vaccine and the events was unknown. Upon internal review, Herpes Zoster disseminated was determined to be medically significant. Additional information is not expected because the primary reporter didn't want to be contacted.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster disseminated, Rash, Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist that refers to a 79 year old male patient. The patient had no allergies, concurrent conditions or medical history reported. On 21-MAR-2011, the patient was vaccinated with ZOSTAVAX, (route of administration, strength lot number and expiration date were not reported). Information about concomitant therapy was not provided. On approximately March 2011, the patient experienced herpes zoster disseminated reported as "since receiving ZOSTAVAX, the patient had experienced multiple shingles outbreaks, and he was in the middle of an outbreak now" (unspecified dates). It was also reported that "the patient was currently in a lot of discomfort and had a rash on parts of his throat and different parts of his body" (Herpes Zoster disseminated). When asked if the patient received treatment for the event, the reported stated "he had acyclovir, assuming his physician prescribed it for him". No laboratory tests were performed, and on an unspecified date the patient sought medical attention. When asked for the present status of the event, the reporter stated "the patient had a current case shingles". The outcome of herpes zoster disseminated and discomfort were not resolved. The relationship between the vaccine and the events was unknown. Upon internal review, Herpes Zoster disseminated was determined to be medically significant. Additional information is not expected because the primary reporter didn't want to be contacted.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Herpes zoster disseminated, Rash
Clinical narrative: This spontaneous report was received from a pharmacist that refers to a 79 year old male patient. The patient had no allergies, concurrent conditions or medical history reported. On 21-MAR-2011, the patient was vaccinated with ZOSTAVAX, (route of administration, strength lot number and expiration date were not reported). Information about concomitant therapy was not provided. On approximately March 2011, the patient experienced herpes zoster disseminated reported as "since receiving ZOSTAVAX, the patient had experienced multiple shingles outbreaks, and he was in the middle of an outbreak now" (unspecified dates). It was also reported that "the patient was currently in a lot of discomfort and had a rash on parts of his throat and different parts of his body" (Herpes Zoster disseminated). When asked if the patient received treatment for the event, the reported stated "he had acyclovir, assuming his physician prescribed it for him". No laboratory tests were performed, and on an unspecified date the patient sought medical attention. When asked for the present status of the event, the reporter stated "the patient had a current case shingles". The outcome of herpes zoster disseminated and discomfort were not resolved. The relationship between the vaccine and the events was unknown. Upon internal review, Herpes Zoster disseminated was determined to be medically significant. Additional information is not expected because the primary reporter didn't want to be contacted.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 11 year old male patient with no pertinent medical history. The patient's concurrent conditions were not reported. On 22-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot # M005714, expiration date: 03-OCT-2017) intramuscularly. Concomitant therapies included MENACTRA and ADACEL. On 22-AUG-2016, the patient experienced syncope and fainted, had fallen and hit his head. Patient sought medical attention. He was hospitalized on the same date. The therapy with GARDASIL 9 was discontinued, also on 22-AUG-2016. The outcome of reported events was unknown at the date of this report. The causality assessment was not provided. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Decreased appetite, Hypersomnia, Induration, Injection site erythema, Lethargy
Clinical narrative: Woke early, then fell asleep again once up for the day (unusual). Didn't eat anything that day aside from nonstop breastfeeding (very unusual). Fell asleep again 2 hours before scheduled nap time (unusual). Very red injection site. Instead of one red spot on that leg, there were two. Slowly began forming two giant lumps under skin. They are swollen and hard to the touch. I emailed his doctor and received no response. Lethargic, crabby, loss of appetite, fever of 101.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Local swelling, Pyrexia, Skin mass
Clinical narrative: Woke early, then fell asleep again once up for the day (unusual). Didn't eat anything that day aside from nonstop breastfeeding (very unusual). Fell asleep again 2 hours before scheduled nap time (unusual). Very red injection site. Instead of one red spot on that leg, there were two. Slowly began forming two giant lumps under skin. They are swollen and hard to the touch. I emailed his doctor and received no response. Lethargic, crabby, loss of appetite, fever of 101.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest X-ray, Chest discomfort, Dry mouth, Electrocardiogram
Clinical narrative: Patient claims that around 6:30 she expereinced a dry mouth and her "throat felt funny".  By 7:30, she started to feel chest tightness, so she had someone drive her to the emergency room.  She was seen around 10pm, given an EKG, chest X ray and "gave blood samples to rule out a heart attack".  She was prescribed prednisone, famotidine and zyrtec for a suspected allergic reaction to her flu shot and instructed by the ER doctor to not get a flu shot in the future.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Throat irritation
Clinical narrative: Patient claims that around 6:30 she expereinced a dry mouth and her "throat felt funny".  By 7:30, she started to feel chest tightness, so she had someone drive her to the emergency room.  She was seen around 10pm, given an EKG, chest X ray and "gave blood samples to rule out a heart attack".  She was prescribed prednisone, famotidine and zyrtec for a suspected allergic reaction to her flu shot and instructed by the ER doctor to not get a flu shot in the future.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: Erythematous Rash developed on 8/19/16 on upper arm. Covered proximal body parts and spread to bilateral extremities.
Sex: F
Vaccine: MEA
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a Registered Nurse refer to a currently (at the time of reporting) 56 years old non pregnant female patient. The patient's concurrent conditions, medical history and concomitant therapy was not reported. On an unknown date, the patient was vaccinated with ATTENUVAX (dose, route of administration, lot# and expiry date were not reported). The patient required evidence of immunity for Measles, Mumps and Rubella for school. The reporter believed that the patient received the vaccine as a child but immunization records were not able to be located. Titers were drawn at an unspecified time (reported as recently) and the patient showed negative for immunity to measles only. On 02-AUG-2016, the patient was vaccinated with M-M-R II. The outcome of the event was unknown, however the patient was doing fine. The relatedness between the event and ATTENUVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A report has been received from a Health Professional concerning a 16 year old Male patient, who received Nasal FLUMIST Quadrivalent (Intranasal), 0.2 milliliters, unknown for influenza. FLUMIST Quadrivalent started on 04-JAN-2016. Nurse reported patient received FLUMIST on 4-JAN-2015 then the Flu Shot on 7-JAN-2015.  FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of received FLUMIST on 4-JAN-2015 Then The Flu Shot on 7-JAN2015 was unknown. Report provided no information about the lot and how FLUMIST was administered. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered, Product quality issue
Clinical narrative: The report concerning a Male subject, who had been receiving FLUMIST, 0.2 Millilitres, Unknown. FLUMIST started on an unknown date. It was reported that administration of expired dose and product quality complaint. The outcome of the event of ADMINISTRATION OF EXPIRED DOSE and PRODUCT QUALITY COMPLAINT is unknown. An investigation is not required for a medication error unless it is a confirmed combined complaint. The report was considered to be non-serious by the company physician. Follow-up of insignificant information received by AstraZeneca/Medimmune 18-Mar-2016 from a Health Professional: PQC investigation summary report received.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT 0.2 milliliters. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated patient was administered expired dose which started on 13-Jan-2016. The outcome of the event of expired dose is unknown. The reporter's description of the event(s) was as follows: No pertinent medical history for any of the 3 children. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a child, subject of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 Millilitres. FLUMIST quadrivalent (intranasal) started on an unknown date for INFLUENZA. The reporter stated patient administered expired dose which started on 13-Jan-2016. The outcome of the event of EXPIRED DOSE is unknown. The reporter's description of the event(s) was as follows: No pertinent medical history for any of the 3 children. The report was considered to be non-serious.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients (ages and gender were not indicated). The pertinent medical history of patient and their concurrent conditions were not provided. It was reported that on an unknown date multiple unspecified patients were administered improperly stored doses of M-M-R II lot # L039613, expiration date 08-OCT-2017 (concentration, dosage and therapy route were not provided). There were no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 88 F for 735 hours and 15 minutes. There was no data logger or previous exposures. No product quality complaint (PQC) was involved. This is one of five reports from the same source (MARRS # 1608USA009575, 1608USA010370, 1608USA010371, 1608USA010372). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Broke out with a rash that progressed to Torso/Neck and on Head.  Was given (by her PPO) Triamcinolone injection, Rx for Zyrtec and Benadryl.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: FEVER; HEADACHES; CHILLS; WEAKNESS.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information about patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB, lot # L048236, expiry date: 31-MAR-2018 (dose and route not reported). No adverse effect 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: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 25-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M014544, expiration date on 27-NOV-2017), orally, which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: FLUN4
Symptoms: Seizure
Clinical narrative: A spontaneous report received from a consumer concerning a 4 years old child. No information was provided regarding medical history and concomitant medications and concurrent disease of the patient. Patient was prescribed FLUMIST QUADRIVALENT (Intranasal), 0.2 millilitres on 15-Jan-2016. Patient had a seizure and was hospitalized after receiving FLUMIST on 15-Jan-2016. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of seizure was unknown. The company physician assessed the event of seizure to be serious with the seriousness criteria of hospitalization.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reaction/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # L027634, expiry date: 21-JAN-2017) (incorrect product storage). No adverse effect were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (strength unspecified) (lot# L040181 with expiration date: 18-AUG-2017), route unspecified. The suspect product was exposed to 50.2F for 36 minutes detected by a data logger. No adverse effects reported. No product quality complaints involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Therapy non-responder
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. In approximately 2011 (reported as approximately 5 years ago), 2014 (reported as approximately 2 years ago) and 2015 (reported as approximately 1 year ago), the patient was vaccinated with the first, second and third dose of M-M-R II respectively (lot #, expiration date, exact doses and route of administration were not reported). On an unknown date, the patient failed to seroconvert for measles after at least 3 vaccinations with M-M-R II. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a nurse via company representative concerning unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PEDVAXHIB. The reporter stated the patients had not followed the recommended schedule and may have possibly administered at extended intervals (inappropriate schedule of drug administration). No adverse effect reported. 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 regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored GARDASIL 9 Lot# L038917 with expiry date: 20-FEB-2018, L000610 with expiry date: 31-JAN-2017 and M013636 with expiry date: 15-FEB-2018 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 F with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (strength unspecified) (lot# M010440 with expiration date: 09-DEC-2018 and lot# M020102 with expiration date: 18-MAR-2019), route unspecified. The suspect product was exposed to 50.2F for 36 minutes detected by a data logger. No adverse effects reported. No product quality complaints involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX (strength unspecified) (lot# M023379 with expiration date: 11-MAY-2018 and lot# M017290 with expiration date: 07-APR-2018), route unspecified. The suspect product was exposed to 8.6F for 44 minutes detected by a data logger. No adverse effects reported. No product quality complaints involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered medical assistant referring to a 30 months old (reported as two and 1/2 years old) patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 11-MAY-2015, the patient was vaccinated with the first dose of VAQTA (lot #, expiration date and dose were not reported, intramuscular). On 10-FEB-2016, the patient was vaccinated with the second dose of VAQTA (lot #, expiration date and dose were not reported, intramuscular). On 10-AUG-2016 (also reported as "today"), the patient was inadvertently vaccinated with the third dose of VAQTA (lot # M002268 with expiration date 20-SEP-2017, dose unknown, intramuscular) (extra dose administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # L040422 with expiration date 15-OCT-2017, dose and route were not reported). No adverse effect was 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 as received from a physician assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # M004508, expiry date: 29-JUN-2017 (dosing details were not reported). It was reported that the vaccines were exposed to the temperature of 34.7 F during a timeframe of 2 hours. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Areflexia, Bladder dysfunction, C-reactive protein increased, Electromyogram abnormal, Gait disturbance
Clinical narrative: A spontaneous report had been received from a pharmacist concerning a 5 years old male patient. Patient had upper respiratory tract infection three weeks before he developed Guillain Barre Syndrome. On 29-Oct-2015, patient received FLUMIST QUADRIVALENT (intranasal) annually. On 12-Jan-2016 (after ten weeks), patient was diagnosed with GBS. Sign and symptoms of GBS were of leg weakness, loss of deep tendon reflexes in lower limbs, bladder dysfunction and positive Romberg. Patient had treatment of two day course of intravenous Immunoglobulin of total dose of 2g/kg. Patient had respiratory infection several weeks before GBS development after FLUMIST administration. Electromyography (EMG) and nerve conduction study showed distal latency of all motor nerves were prolonged. C-reactive protein was increased. Patient had recovered from the event of GBS with sequelae of gait instability and extremity weakness. Patient was current in rehab. Reporter considered the event of Guillain Barre Syndrome to be serious with seriousness criteria of hospitalization and important medical event.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Nerve conduction studies abnormal, Respiratory tract infection
Clinical narrative: A spontaneous report had been received from a pharmacist concerning a 5 years old male patient. Patient had upper respiratory tract infection three weeks before he developed Guillain Barre Syndrome. On 29-Oct-2015, patient received FLUMIST QUADRIVALENT (intranasal) annually. On 12-Jan-2016 (after ten weeks), patient was diagnosed with GBS. Sign and symptoms of GBS were of leg weakness, loss of deep tendon reflexes in lower limbs, bladder dysfunction and positive Romberg. Patient had treatment of two day course of intravenous Immunoglobulin of total dose of 2g/kg. Patient had respiratory infection several weeks before GBS development after FLUMIST administration. Electromyography (EMG) and nerve conduction study showed distal latency of all motor nerves were prolonged. C-reactive protein was increased. Patient had recovered from the event of GBS with sequelae of gait instability and extremity weakness. Patient was current in rehab. Reporter considered the event of Guillain Barre Syndrome to be serious with seriousness criteria of hospitalization and important medical event.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Romberg test positive
Clinical narrative: A spontaneous report had been received from a pharmacist concerning a 5 years old male patient. Patient had upper respiratory tract infection three weeks before he developed Guillain Barre Syndrome. On 29-Oct-2015, patient received FLUMIST QUADRIVALENT (intranasal) annually. On 12-Jan-2016 (after ten weeks), patient was diagnosed with GBS. Sign and symptoms of GBS were of leg weakness, loss of deep tendon reflexes in lower limbs, bladder dysfunction and positive Romberg. Patient had treatment of two day course of intravenous Immunoglobulin of total dose of 2g/kg. Patient had respiratory infection several weeks before GBS development after FLUMIST administration. Electromyography (EMG) and nerve conduction study showed distal latency of all motor nerves were prolonged. C-reactive protein was increased. Patient had recovered from the event of GBS with sequelae of gait instability and extremity weakness. Patient was current in rehab. Reporter considered the event of Guillain Barre Syndrome to be serious with seriousness criteria of hospitalization and important medical event.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to 21 unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On multiple unspecified dates, 21 patients were vaccinated with improperly stored GARDASIL 9 lot # M004508, expiry date:03-OCT-2017 (dosing details were not reported. It was reported that the vaccines were exposed to the temperature of 34.7 F during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of 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 multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored M-M-R II (strength and therapy type unspecified) (lot# L049316 with expiration date: 03-DEC-2017 and lot# M010426 with expiratory date: 01-MAR-2018), route unspecified. The suspect product was exposed to 50.2F for 36 minutes, detected by a data logger. No adverse effects reported. No product quality complaints involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose unknown, lot # L048849, expiration date: 04-FEB-2018, lot # M008551, expiration date: 02-JUN-2018, lot # M000442, expiration date: 31-MAR-2018). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose unknown, lot # L026602 with expiration date: 19-OCT-2017, lot # M007764 with expiration date: 30-JAN-2018. No adverse effect was reported. Lot verification has been received on 17-AUG-2016, lot number M007764 is not valid for GARDASIL 9. 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 certified medical assistant and refers to multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored ROTATEQ lot# L046318 with expiration date: 28-SEP-2017, orally (dose was not reported). Administered doses of ROTATEQ underwent temperature excursions at 31 Fahrenheit degrees, for 189 hours (7 days and 21 hours) (2 cycles). There was no previous temperature excursion. Data logger was not involved. 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: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On an unknown date the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 injection (lot# L012042, expired on 18-NOV-2016) once intramuscularly (dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, 4 doses of improperly stored PROQUAD (lot# M006102, expiration date 01-AUG-2017, recombinant human albumin (rHA), dose and route unknown) was administered to the unspecified patients. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive, Malaise
Clinical narrative: A report has been received from a Medical rep concerning a female patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. On 15-Oct-2015, patient received nasal FLUMIST (intranasal) for flu vaccination. Reporter stated that patient tested positive for flu type A on 04-Jan-2016, and was ill for 4 days. The outcome of flu was unknown. Company physician considered flu to be non serious.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored M-M-R II lot# K018990 with expiry date: 15-OCT-2016, L015280 with expiry date: 30-APR-2017, L047134 with expiry date 24-NOV-2017 and L012482 with expiry date: 10-APR-2017 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 F with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 12 month old Female patient, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 11-Feb-2016. Reporter stated that administration to a 12 month old girl FLUMIST was the booster dose received 2 month after the first dose of TIV was given to this healthy girl. The outcome of the event of administration to a child younger than 2 years is unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between administration to a child younger than 2 years and FLUMIST QUADRIVALENT.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored PNEUMOVAX 23 lot# M005286 with expiry date: 08-OCT-2017 and Lot# M018766 with expiry date: 15-OCT-2017 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 F with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 01-AUG-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M014544 with expiration date 27-NOV-2017) orally, which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. 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 referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 20-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical locations and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has bee requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored ROTATEQ lot # L035508 with expiry date: 12-JUL-2017, M019691 with Expiry date: 02-NOV-2017 and M014318 with Expiry date: 30-SEP-2017 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 29-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M004883, expiration date on 02-OCT-2017) orally, which was exposed to a temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. 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 was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored VAQTA lot# K012457 with expiry date: 04-JUN-2017 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 F with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L024998, expiry date: 06-OCT-2016) (incorrect product storage). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza A virus test positive, Seizure
Clinical narrative: A report has been received from a health professional, concerning a patient of unknown age and gender. No concomitant medication was provided. The patient's concurrent disease included epilepsy. On an unknown date, the patient received FLUMIST QUADRIVALENT (intranasal). The patient experienced seizure which required hospitalization. In the hospital the H3 strain was isolated. The outcome of the event of seizure was unknown. The company physician considered the event of seizure as serious due to hospitalization. The reporter and the company physician considered that there was no causal relationship between seizure and FLUMIST QUADRIVALENT.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood glucose decreased, Hypoglycaemia, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unspecified date about 1 week ago (approximately in Jul-2016), the patient was vaccinated with first dose of GARDASIL (strength, dosing details, anatomical location, lot# and expiration date were unknown). The reporting physician stated that within 10 minutes, while the patient was still in the office, the patient developed weakness and syncope that has been steadily improving but has not yet resolved. On an unspecified date (approximately in Jul-2016) after receiving GARDASIL the patient developed hypoglycemia with blood sugar levels in the 40's (unit unspecified). The reporting physician stated that the patient's condition is causing her to miss time at work. Patient is being treated through her primary care physician and that her primary care physician has performed multiple unspecified tests to determine the cause of the patient's problems. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. On an unknown date in 2016, the patient was vaccinated with a dose of 0.5 ml expired PNEUMOVAX 23 (lot# not reported with expiration date 06-JUL-2016) subcutaneous. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Pharmacist (who was informed by another unknown patient) referring to a patient of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On an unknown date, at the same office visit the patient was vaccinated with 2 doses of M-M-R II (Lot #, expiration date, strength, dose and route were not provided) (overdose). No adverse event was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Extra dose administered
Clinical narrative: MENVEO given in error 8/24/16. Patient had been given MENVEO 9/24/15. Patient has received 1 MENVEO at age 12 instead of age 16. Parent was made aware. Dr. is aware and spoke with patient's mother.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV, PNC13, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus, Pyrexia, Rash
Clinical narrative: 8-16-16 vaccines given. 8-17-16 child c/o itching. Mom notes redness and rash from neck to waist that later spreads to entire body. No redness or swelling at injection sites. Fever of 102. Swelling in arm pits and pelvic area. Taken to ER. Given ATARAX 10 mg/5 ml 4 ml Q 6 hours x 5 days. Mom notes improvement the evening of 8-17-16 after medication was started.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV, PNC13, VARCEL
Symptoms: Rash generalised, Swelling
Clinical narrative: 8-16-16 vaccines given. 8-17-16 child c/o itching. Mom notes redness and rash from neck to waist that later spreads to entire body. No redness or swelling at injection sites. Fever of 102. Swelling in arm pits and pelvic area. Taken to ER. Given ATARAX 10 mg/5 ml 4 ml Q 6 hours x 5 days. Mom notes improvement the evening of 8-17-16 after medication was started.