chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited case received from a consumer (patient parent) on 24 Apr 2017. This case involves 14-year-old male patient who was vaccinated with first dose of MENACTRA (Batch number was unknown, expiry date and dose was not reported) via intramuscularly in left arm on 03 Apr 2017. The patient illness at the time of vaccination was not reported (reported as parent denied), the patient was allergic to peanuts, tree nuts, and it was also reported as the patient had hay fever. Concomitant medications were not reported. On 04 Apr 2017, one day following the vaccination, the patient developed a fever of (103-100.5) which has lasted 3 weeks, also experienced nausea, dizziness, and Local site reaction of redness and swelling. On 05 Apr 2017, the patient was evaluated by a physician. Other relevant lab tests were not reported. The patient took CEFTIN as a corrective treatment and which the patient did not tolerate. On an unknown date, the patient recovered from the events fever, Local site reaction of redness and swelling (reported as Local reaction resolved on its own), and the outcome of other events were unknown. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Acupuncture, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome, Tendon rupture
Clinical narrative: Initial unsolicited report received from a Consumer on 27 April 2017. This case involves a 72-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date not reported) by intramuscularly in right deltoid on 05 November 2016. Patient's ongoing illness, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were reported as unknown. On an unknown date, few days following the vaccination, the patient had soreness in the arm and two days later she had accupuncture for the sore arm. On an unknown date, following the vaccination, the patient had an MRI and X-ray, and was found to have a torn rotator cuff and perforated tendon. The patient required ER visit. Other laboratory investigations were not reported. The corrective treatment was not reported. The patient was not recovered from the events. Upon medical review, the case was considered as serious due to important medical event. List of documents held by sender: none.; Sender's Comments: Sanofi company comment dated 03-May-2017: A 72 year old female patient experienced Rotator cuff tear, Tendon rupture and pain in arm few days after vaccination with FLUZONE HD. Time to onset is compatible and all events are unlisted. Patient's medical history, work style, any history of bone spur, concurrent conditions and concomitant medications were not reported. Based upon available information the role of the vaccine cannot be assessed.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb abnormal
Clinical narrative: Initial unsolicited report received from a Consumer on 27 April 2017. This case involves a 72-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date not reported) by intramuscularly in right deltoid on 05 November 2016. Patient's ongoing illness, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were reported as unknown. On an unknown date, few days following the vaccination, the patient had soreness in the arm and two days later she had accupuncture for the sore arm. On an unknown date, following the vaccination, the patient had an MRI and X-ray, and was found to have a torn rotator cuff and perforated tendon. The patient required ER visit. Other laboratory investigations were not reported. The corrective treatment was not reported. The patient was not recovered from the events. Upon medical review, the case was considered as serious due to important medical event. List of documents held by sender: none.; Sender's Comments: Sanofi company comment dated 03-May-2017: A 72 year old female patient experienced Rotator cuff tear, Tendon rupture and pain in arm few days after vaccination with FLUZONE HD. Time to onset is compatible and all events are unlisted. Patient's medical history, work style, any history of bone spur, concurrent conditions and concomitant medications were not reported. Based upon available information the role of the vaccine cannot be assessed.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Peripheral swelling, Skin warm
Clinical narrative: THIS IS THE SECOND DOSE, THE PATIENT REFERS THAT SHE HAD ALMOST THE SAME REACTION FOR THE FIRST DOSIS BUT DID NOT SAY ANYTHING. SHE REFERS THAT SHE THE LEFT ARM BECAME HOT TO THE TOUCH AND SWOLLEN, IT STARTED OUT AS A BUMP AND THEN THE CELULITIS WAS FORMED, IT LASTED 3 WEEKS AND SHE VISITED THE EMERGENCY ROOM AND WAS GIVEN ANTIBIOTICS, SHE REFERS THAT SHE DID NOT REPORT THE REACTION BECAUSE SHE THOUGHT THAT IT WAS NORMAL. SHE DID NOT HAVE FEVER OR RASH AND DID NOT APPLY AND COMPRESSES ON HER ARM.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Eye movement disorder, Malaise, Musculoskeletal stiffness
Clinical narrative: PER MOM PT 10 MINUTES AFTER LEAVING CLINIC TN THE CAR, BEGAN NOT FEELIING WELL HER EYES ROLLED BACK AND BECAME STIFF, UNSURE IF SHE HAD ANY CONVULSIONS ALSO UNDURE OF HOW LONG THE EPISODE LASTED.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: PER MOM PT 10 MINUTES AFTER LEAVING CLINIC TN THE CAR, BEGAN NOT FEELIING WELL HER EYES ROLLED BACK AND BECAME STIFF, UNSURE IF SHE HAD ANY CONVULSIONS ALSO UNDURE OF HOW LONG THE EPISODE LASTED.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dizziness, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Dizzy, diaphoretic, fainted, unresponsive for approximately 1-2min, woke up was coherent, BP 103/68, patient was stable and able to go home.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 25-APR-2017 from a medical assistant who was reporting on a 6 month old male patient. No medical history or concomitant medications were reported. On 25-APR-2017, the patient was administered a dose of M-M-R II (lot M032153, expired 22-APR-2017, dose and injection site not reported) for prophylaxis. No adverse effects were reported. No other information was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Emotional distress, Facial paralysis, Fatigue, Headache
Clinical narrative: Information was received on 03-MAY-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-SEP-2014 the patient received the ZOSTAVAX(lot number and expiration not reported) subcutaneous for its intended purpose of the prevention of shingles. On 20-MAR-2015, the patient went to a physician for complaints of fatigue, dizziness, body aches, and headaches. The patient was diagnosed with Bell's palsy. The patient's condition developed into paralysis on the right side of her face and ringing in her ear. It was reported that the patient's injuries were caused by the ZOSTAVAX. The patient was never told, and never had any reason to believe, that her injuries were related in any way to the ZOSTAVAX vaccine until recently. The patient suffered nerve damage and continues to suffer from Bell's palsy. As a direct and proximate result of the ZOSTAVAX vaccine the patient's symptoms have resulted in physical limitations not present prior to her use of the ZOSTAVAX vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the patient's use of ZOSTAVAX, the patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of her use of ZOSTAVAX vaccine. Bell's Palsy/paralysis on the right side of her face was considered to be medically significant. Bell's Palsy/paralysis on the right side of her face, ringing in her ear, fatigue, dizziness, body aches, headaches and nerve damage were considered to be disabling.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injury, Nerve injury, Pain, Physical disability, Quality of life decreased
Clinical narrative: Information was received on 03-MAY-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-SEP-2014 the patient received the ZOSTAVAX(lot number and expiration not reported) subcutaneous for its intended purpose of the prevention of shingles. On 20-MAR-2015, the patient went to a physician for complaints of fatigue, dizziness, body aches, and headaches. The patient was diagnosed with Bell's palsy. The patient's condition developed into paralysis on the right side of her face and ringing in her ear. It was reported that the patient's injuries were caused by the ZOSTAVAX. The patient was never told, and never had any reason to believe, that her injuries were related in any way to the ZOSTAVAX vaccine until recently. The patient suffered nerve damage and continues to suffer from Bell's palsy. As a direct and proximate result of the ZOSTAVAX vaccine the patient's symptoms have resulted in physical limitations not present prior to her use of the ZOSTAVAX vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the patient's use of ZOSTAVAX, the patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of her use of ZOSTAVAX vaccine. Bell's Palsy/paralysis on the right side of her face was considered to be medically significant. Bell's Palsy/paralysis on the right side of her face, ringing in her ear, fatigue, dizziness, body aches, headaches and nerve damage were considered to be disabling.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Information was received on 03-MAY-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-SEP-2014 the patient received the ZOSTAVAX(lot number and expiration not reported) subcutaneous for its intended purpose of the prevention of shingles. On 20-MAR-2015, the patient went to a physician for complaints of fatigue, dizziness, body aches, and headaches. The patient was diagnosed with Bell's palsy. The patient's condition developed into paralysis on the right side of her face and ringing in her ear. It was reported that the patient's injuries were caused by the ZOSTAVAX. The patient was never told, and never had any reason to believe, that her injuries were related in any way to the ZOSTAVAX vaccine until recently. The patient suffered nerve damage and continues to suffer from Bell's palsy. As a direct and proximate result of the ZOSTAVAX vaccine the patient's symptoms have resulted in physical limitations not present prior to her use of the ZOSTAVAX vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the patient's use of ZOSTAVAX, the patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of her use of ZOSTAVAX vaccine. Bell's Palsy/paralysis on the right side of her face was considered to be medically significant. Bell's Palsy/paralysis on the right side of her face, ringing in her ear, fatigue, dizziness, body aches, headaches and nerve damage were considered to be disabling.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 03-MAY-2017, the patient was vaccinated with an improperly stored dose with PROQUAD lot # M043308, expiration date: 24-APR-2018,  as prophylaxis (Strength. dose and route were not reported), which experienced a temperature excursion of 15 Fahrenheit degrees for 3 hours and 30 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. The patient's concomitant therapies included sterile diluent (manufacturer unknown). Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 27 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M022400, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Anal incontinence, Back pain, Borrelia test negative, CSF protein increased, CSF white blood cell count negative
Clinical narrative: 5/6 Admit to hosp. 5/7 Dx made GBS. Sx started on 5/3/17 with upper back pain and bilat feet and hand paresthesias and episodic bowel incontinence. By 5/5 she was having difficulty walking.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Gait disturbance, Guillain-Barre syndrome, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia
Clinical narrative: 5/6 Admit to hosp. 5/7 Dx made GBS. Sx started on 5/3/17 with upper back pain and bilat feet and hand paresthesias and episodic bowel incontinence. By 5/5 she was having difficulty walking.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-05-05.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-05-06.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization NEC, init on 2017-05-02.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Genital rash, Pyrexia, Rash
Clinical narrative: Fever, rash on scrotum, trunk and left buttocks.
Age: 21.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Dizziness, Nausea, Headache.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: Per Dr - MA called me, c/o reaction after vaccine, has some tiny hives on face- itchy , no distress. Benadryl given, 7 ml, reassessed , better , hives fading , not itchy. So2 100 %.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, warm lump at injection site as described by wife.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 03-NOV-2016, the patient was vaccinated with GARDASIL (route, dose, dose number, frequency, lot # and expiration date were unknown) for prophylaxis. Subsequently, on 14-APR-2017 after the dose of GARDASIL the pharmacist reported that the patient went into the pharmacy  to received a dose of GARDASIL 9 (route, dose, dose number, frequency, lot # and expiration date were unknown) for prophylaxis. No adverse effect were reported. This is one of two cases from  the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA002180:
Sex: M
Vaccine: MMR
Symptoms: Antibody test abnormal, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and referred to a male patient of an unknown age. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient had an antibody testing performed and the results were inconclusive (Antibody test abnormal). No adverse effects were reported. At the time of this report, the outcome of antibody test abnormal was unknown. There was no product quality complaint (PQC) involved. The causality assessment between antibody test abnormal and M-M-R II was unknown. Additional information is not expected as there was no contact consent granted.
Sex: F
Vaccine: HPV9
Symptoms: Injection site haematoma
Clinical narrative: This information has been received from a physician, via a company representative, concerning a 18 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 01-APR-2017, the patient was vaccinated the first dose of GARDASIL 9 (dose, lot number, expiration date and anatomical localization were not reported), administered intramuscularly for prophylaxis. On 01-APR-2017, the patient experienced a haematoma at the injection site after administration of her first dose of GARDASIL 9. The patient called the office, 2 weeks later, to inform that the haematoma developed a few hours after the injection. The outcome of injection site haematoma and the causal relationship between GARDASIL 9 and the event were unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 03-NOV-2016, the patient was vaccinated with GARDASIL (route, dose, dose number, frequency, lot # and expiration date were unknown) for prophylaxis. Subsequently, on 14-APR-2017 after the dose of GARDASIL the pharmacist reported that the patient went into the pharmacy  to received a dose of GARDASIL 9 (route, dose, dose number, frequency, lot # and expiration date were unknown) for prophylaxis. No adverse effect were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA007031:
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blindness, Fall, Head injury
Clinical narrative: Patient was given a GARDASIL L deltoid, MENACTRA (L) deltoid, and TDAP in (R) deltoid all IM. Patient was talking to me and his mom. I walked from the table to the counter - to put needles in sharp - patient then states he couldn't see and then fell backwards, hit head on wall. Dr. assisted me to get patient straightened out on bed. We both stayed till he was good to walk out without dizziness - I walked patient and mom to truck. Dr. assessed patient before leaving.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Discomfort, Injection site erythema, Injection site warmth, Tenderness
Clinical narrative: 3 days post vaccine mom reports warm pink area at inject site palm sized. C/O tenderness to axilla. No fever. F/U 4 days post vaccine-marked decreased in size and discomfort.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Erythema, Urticaria
Clinical narrative: C/O left arm redness, burning, and whelp next day after shot given. Reports going to walk in clinic and prescribed cream 2 weeks after symptoms started. Reports site where Zoster vaccine given.
Age: 30.0
Sex: F
Vaccine: FLUC4, HEP, PPV, TYP
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient given Hepatitis B IM upper (L) deltoid on 4/7/17. She stated at time of administration vaccine hurt slightly more than all other vaccines given. TYPHIM VI (L) lower deltoid, FLUCELVAX (R) deltoid IM, PNEUMOVAX 23 SQ (R) arm. After 3 day (R) arm stopped hurting, (L) upper arm still continues to be slightly painful like with abduction of arm and external rotation, presented on 5/5/17. No numbness.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, IPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted. Patient was inadvertently vaccinated with both PEDIARIX and IPOL.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Mother of pt. noticed on 5/14/17 a large redness area where vaccine was TDaP was administrated. She also noticed a small one where Varicella was given. Mother states daughter complains of itchiness on the area. Today provider ordered BENADRYL 125 mg oral tab/chewable. No other reaction from MMR.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash macular
Clinical narrative: Fine macular rash, low grade temp, mild irritability.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local erythema and swelling of Lt Deltoid area.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given MMRV instead of MMR. No adverse reaction noted.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Insomnia, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Day 1: Feel sick to stomach (after 2 1/2 hours) right arm swollen (whole arm) pain no sleep at night. Day 2 Left arm was red/swollen/pain/sick to stomach right arm still swollen. Day 3 right arm still swollen/pain. Day 8 feel better no more swelling no more pain back to normal.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Guillain-Barre syndrome, Hypertension, Immobile, Immunoglobulin therapy
Clinical narrative: Guillain Barre Syndrome, Quadriplegia, urinary retention, Immobility, back pain, hypertension (December 2016), Immunoglobulin (December 2016).
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Quadriplegia, Urinary retention
Clinical narrative: Guillain Barre Syndrome, Quadriplegia, urinary retention, Immobility, back pain, hypertension (December 2016), Immunoglobulin (December 2016).
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Rash, Rash pruritic
Clinical narrative: Day after receiving vaccine in (R) deltoid, pt developed itchy rash in neck area ant and post.
Age: 25.0
Sex: U
Vaccine: HEPA, MNQ, TDAP, TYP, YF
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Musculoskeletal stiffness, Myalgia
Clinical narrative: Client experienced minor chest pain, SOB, stiff neck, muscle pain 4 days after receiving TDaP, MENACTRA, YF, Hep A (HAVRIX) and TYPOHID (INJ). Went to ER, EKG was normal.
Age: 13.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Pyrexia
Clinical narrative: Fever of 102 degrees on awakening at 6 AM, temperature increased to 103 degrees at noon. 2 x 300mg aspirin caplets taken at noon. Fever reduced to 100 degrees in evening. May 8 today, fever again of 102 degrees, 2 x 300 mg aspirin caplets taken again.
Age: 13.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Body temperature increased
Clinical narrative: Fever of 102 degrees on awakening at 6 AM, temperature increased to 103 degrees at noon. 2 x 300mg aspirin caplets taken at noon. Fever reduced to 100 degrees in evening. May 8 today, fever again of 102 degrees, 2 x 300 mg aspirin caplets taken again.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered
Clinical narrative: Patient was given a HPV vaccine that expired 05/05/2017.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PT REPORTED SWELLING AND REDNESS AROUND THE INJECTION SITE ARM.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Information had been received on 01-MAY-2017 from a pharmacist who reported that a 73 year old female received properly stored ZOSTAVAX vial 19400 PFU (lot#/expiration, dosage and frequency not reported) reconstituted with properly stored sterile diluent (lot#/expiration unknown) on 27-APR-2017. Patient sought medical attention and presented at pharmacy on 01-MAY-2017 with a blister at the injection site and complained that the injection site is "itchy". Patient's present status was not recovered. VZV packet not faxed to pharmacy as no fax number was available for the pharmacy. Pharmacist disconnected before most questions asked therefore most fields were reported as not applicable. No further information provided. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This is a spontaneous report received 03-MAY-2017 from a nurse who reported on a 13-year-old male who received his first dose of GARDASIL 9 on 29-JUL-2015 (lot and expiration unknown). The reporter stated that the patient received a second dose of  GARDASIL 9 (lot M009378, exp. 23-APR-2018) on 04-AUG-2016. No side effects were reported. No treatment was given. Outcome and causality were not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Demyelination, Imaging procedure, Lumbar puncture, Muscular weakness, Nystagmus
Clinical narrative: VERTIGO, NYSTAGMUS, BILATERAL LOWER EXTREMITY WEAKNESS, AND URINARY RETENTION.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Urinary retention, Vertigo
Clinical narrative: VERTIGO, NYSTAGMUS, BILATERAL LOWER EXTREMITY WEAKNESS, AND URINARY RETENTION.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Hives, swelling, redness, and warmth at injection site on left arm.
Age: 0.17
Sex: M
Vaccine: DTPHIB, OPV
Symptoms: Death, Resuscitation, Sudden infant death syndrome
Clinical narrative: Death CPR administered and taken to the hospital.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left arm noticeable after 48 hours. Treated with cephalexin.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse referring a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On 19-APR-2017, the patient was vaccinated inadvertently with a dose of expired of M-M-R II lot # L000458 with an expiration date of 06-JAN-2017, for prophylaxis (dose and route of administration). No adverse effect reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 01-MAY-2017 from a registered nurse regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. The registered nurse reported that on unspecified dates, unspecified patients received doses of GARDASIL 9 (lot number, expiration, dose, route not reported), PNEUMOVAX23 )(lot number, expiration, dose, route not reported) and M-M-R II )(lot number, expiration, dose, route not reported) which were stored at -0.24 degrees Celsius for 124 hours. There were no previous temperature excursions. The call was made because of a data logger. The lot and expiration date for the sterile diluent used to reconstitute was unknown by the reporter. No side effects to report. No further information to report. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test negative, Arrhythmia, Insomnia, Pruritus, Rash erythematous
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 year old female patient. On 21-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L029483 exp date 06-NOV-2016) (dose not reported) subcutaneously. Concomitant therapies included CARDIZEM. The nurse reported that in April 2016, the patient experienced a rash. The patient went to the office in August 2016 with rash over her whole body. The nurse stated that it was red skin bumps with follicular appearance of trunk, back, legs and arms. The patient was advised to take NSAIDS and BENADRYL. The patient also complained of heart arrhythmias. She was referred to the cardiologist. The nurse stated that the cardiologist stopped the patient's CARDIZEM. Subsequently, the patient called back towards the end of August 2016 and she was referred to an unspecified allergist and seen by an allergist in September 2016. The allergist stated that rash came on anytime in worsening heat. "Triamcinolone helped some". The allergist ordered allergy testing and took skin samples as well. The patient was negative for food allergies. Skin test was also negative. In January 2017, the patient was seen again with complaints of itching, no relief and rash all over the body; chest and limbs were the worst. The patient was also awake at night. The patient was given prednisone (manufacturer unknown), hydroxyzine and cetirizine hydrochloride. The patient was seen again in February 2017, the itching was still present and the medicine was helping. No other changes to medication were performed. At the time of the report, the patient had not recovered from rash and itching. The outcome for heart arrhythmias and awakening at night was unknown. Upon internal review heart arrhythmias were considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash follicular, Rash generalised, Skin test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 year old female patient. On 21-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L029483 exp date 06-NOV-2016) (dose not reported) subcutaneously. Concomitant therapies included CARDIZEM. The nurse reported that in April 2016, the patient experienced a rash. The patient went to the office in August 2016 with rash over her whole body. The nurse stated that it was red skin bumps with follicular appearance of trunk, back, legs and arms. The patient was advised to take NSAIDS and BENADRYL. The patient also complained of heart arrhythmias. She was referred to the cardiologist. The nurse stated that the cardiologist stopped the patient's CARDIZEM. Subsequently, the patient called back towards the end of August 2016 and she was referred to an unspecified allergist and seen by an allergist in September 2016. The allergist stated that rash came on anytime in worsening heat. "Triamcinolone helped some". The allergist ordered allergy testing and took skin samples as well. The patient was negative for food allergies. Skin test was also negative. In January 2017, the patient was seen again with complaints of itching, no relief and rash all over the body; chest and limbs were the worst. The patient was also awake at night. The patient was given prednisone (manufacturer unknown), hydroxyzine and cetirizine hydrochloride. The patient was seen again in February 2017, the itching was still present and the medicine was helping. No other changes to medication were performed. At the time of the report, the patient had not recovered from rash and itching. The outcome for heart arrhythmias and awakening at night was unknown. Upon internal review heart arrhythmias were considered to be medically significant. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt had Redness at injections site size of 50 cent piece.  Also, itchiness, soreness and warm to touch. Doctors office recommended Benadryl and hydrocortisone cream.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13
Symptoms: Feeling cold, Injection site pain, Injection site swelling, Pallor
Clinical narrative: He has bilateral leg soreness, with the right being more sore than the left this morning but overall he is improving. Mom did report that he has a little swelling at the site on the right leg. There is no swelling on the left. Patient received his immunizations on 5/3/2017, and mom reported that night, at about 9 PM, he became really pale and cold. They provided him some blankets to warm him up. Mom stated that this episode lasted a couple of hours. He has not had a recurrent episode, and is not running any fevers.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt received his routine 4 month immunizations. Parents took him home and he slept for a few hours. After patient awoke, he was screaming in what seemed to be pain and mom noted both legs to be bright red and hot from thighs to feet. Legs appeared more swollen. Mom gave a dose of Tylenol to help patient. The baby slept through the night and did okay. The following morning when the baby woke up he had what sounds like a petechial rash on both entire legs from thigh to ankle but was behaving normally. Did not appear to be in any pain. Did have a fever to 100.7F the morning after his shots but only that once.  Rash on the legs faded over the next week.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pain, Peripheral swelling, Petechiae, Pyrexia, Rash
Clinical narrative: Pt received his routine 4 month immunizations. Parents took him home and he slept for a few hours. After patient awoke, he was screaming in what seemed to be pain and mom noted both legs to be bright red and hot from thighs to feet. Legs appeared more swollen. Mom gave a dose of Tylenol to help patient. The baby slept through the night and did okay. The following morning when the baby woke up he had what sounds like a petechial rash on both entire legs from thigh to ankle but was behaving normally. Did not appear to be in any pain. Did have a fever to 100.7F the morning after his shots but only that once.  Rash on the legs faded over the next week.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Screaming, Skin warm
Clinical narrative: Pt received his routine 4 month immunizations. Parents took him home and he slept for a few hours. After patient awoke, he was screaming in what seemed to be pain and mom noted both legs to be bright red and hot from thighs to feet. Legs appeared more swollen. Mom gave a dose of Tylenol to help patient. The baby slept through the night and did okay. The following morning when the baby woke up he had what sounds like a petechial rash on both entire legs from thigh to ankle but was behaving normally. Did not appear to be in any pain. Did have a fever to 100.7F the morning after his shots but only that once.  Rash on the legs faded over the next week.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Lip blister, Nodule, Pain
Clinical narrative: Immediately stung, felt like bees stinging arm over and over which continued that evening. then that night there was a big knot, itched really bad, and looked red. It was not hot to the touch but it was sore and itched very badly. Her lip also developed a blister. Symptoms continued Friday-sunday and then started to subside.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Immediately stung, felt like bees stinging arm over and over which continued that evening. then that night there was a big knot, itched really bad, and looked red. It was not hot to the touch but it was sore and itched very badly. Her lip also developed a blister. Symptoms continued Friday-sunday and then started to subside.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fall, Headache, Pain in extremity
Clinical narrative: Patient states she had chills, HA, sore left arm later that night. The next day, she fell after using the restroom. Couldn't get up and was down for about 3 hours, crawled to her bed.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Cyanosis, Oral mucosal eruption, Pain, Pyrexia
Clinical narrative: Rash started around mouth and face and than to the rest of his body. Next came a fever of upto 103 degrees. His lips turned blue he cried none stop. Went to primary care doctor who said he was having a reaction and took him to ER. He was examined and given fluids and sent home. Followed up with primary care following day. He maintained pain for about 2-3 weeks. Went back to the primary care doctor who did nothing. The rash subsided after 4 months.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash generalised
Clinical narrative: Rash started around mouth and face and than to the rest of his body. Next came a fever of upto 103 degrees. His lips turned blue he cried none stop. Went to primary care doctor who said he was having a reaction and took him to ER. He was examined and given fluids and sent home. Followed up with primary care following day. He maintained pain for about 2-3 weeks. Went back to the primary care doctor who did nothing. The rash subsided after 4 months.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Oral mucosal eruption, Pain, Pyrexia, Rash
Clinical narrative: Rash started around mouth spread to his legs, torso, arms; he was covered head to toe. He developed a fever of up to 103. Went to primary care who feared a reaction to MMR sent to ER. ER administered fluids and observed him and his vitals. Doctor gave Hydrocodone to stop his pain and crying which he was on for several days. After two weeks he stopped crying but Rash did not go away for 4 months.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash started around mouth spread to his legs, torso, arms; he was covered head to toe. He developed a fever of up to 103. Went to primary care who feared a reaction to MMR sent to ER. ER administered fluids and observed him and his vitals. Doctor gave Hydrocodone to stop his pain and crying which he was on for several days. After two weeks he stopped crying but Rash did not go away for 4 months.
Age: 1.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Conjunctivitis, Dyspnoea, Enterovirus test positive, Erythema, Generalised tonic-clonic seizure
Clinical narrative: Conjunctivitis wit herythema and pus (patient had similar reaction to previous Hep.B vaccine). On 05/04/2017 patient developed shortness of breath. On 05/05/17 developed tonic-clonic seizures.
Age: 1.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Human rhinovirus test positive, Purulent discharge, Respiratory viral panel
Clinical narrative: Conjunctivitis wit herythema and pus (patient had similar reaction to previous Hep.B vaccine). On 05/04/2017 patient developed shortness of breath. On 05/05/17 developed tonic-clonic seizures.
Age: 1.25
Sex: M
Vaccine: DTAP, MMRV, PNC13
Symptoms: Decreased appetite, Injection site pain, Injection site warmth, Irritability, Pyrexia
Clinical narrative: Fever 5/4/17 post immunization, fussy and decreased appetite. Left upper leg tender and warm. Treatment - increase fluids continue Children's TYLENOL and MOTRIN PRN. Call if symptoms not improved over next 24 hours.
Age: 1.25
Sex: M
Vaccine: DTAP, MMRV, PNC13
Symptoms: Vaccination complication
Clinical narrative: Fever 5/4/17 post immunization, fussy and decreased appetite. Left upper leg tender and warm. Treatment - increase fluids continue Children's TYLENOL and MOTRIN PRN. Call if symptoms not improved over next 24 hours.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella skin lesions.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Fever, redness, swelling, aches.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash started on abdomen and back on 5/7/17 then spread. Fever 102 on 5/4/17 and 5/5/17.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient came to receive PREVNAR 13 at the pharmacy on 5/2/17 and came back in today to report redness and swelling at the area of injection. She was referred to her physician for further evaluation.
Sex: F
Vaccine: HPV9
Symptoms: Carotid pulse abnormal, Computerised tomogram head normal, Disorientation, Dizziness, Dyspnoea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642094) on 02-MAY-2017. This spontaneous report refers to a 14 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 05-JUL-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L024993, via unknown route in the left arm for prophylaxis. Immediately after vaccination, patient stated that she is going to pass out. Patient was made to lie down on bed and her mother was called for help. On the same day, the patient underwent urine analysis, metabolic function test, full blood count, fibrin D dimer, electroencephalogram normal, computerised tomogram head normal, carotid pulse abnormal (strong carotid pulse) and also experienced immediate post-injection reaction, urinary incontinence, muscle rigidity, loss of consciousness for approximately 1 minute, hypopnoea, dyspnea, labored and dizziness. After regaining consciousness, the patient was disoriented, tearful and sleepy. Patient was taken to the hospital via ambulance. Lab data included CT (computerize tomogram) scan of head and EEG (electroencephalogram) and both results were normal, "U/A (urine analysis)', CMP (comprehensive metabolic panel), CBC (complete blood count), D-dimer were also conducted the results of which were unknown. The outcome of the events was reported as recovered. Causality assessment was not reported. The agency considered the case to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Electroencephalogram normal, Fibrin D dimer, Full blood count, Hypopnoea, Immediate post-injection reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642094) on 02-MAY-2017. This spontaneous report refers to a 14 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 05-JUL-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L024993, via unknown route in the left arm for prophylaxis. Immediately after vaccination, patient stated that she is going to pass out. Patient was made to lie down on bed and her mother was called for help. On the same day, the patient underwent urine analysis, metabolic function test, full blood count, fibrin D dimer, electroencephalogram normal, computerised tomogram head normal, carotid pulse abnormal (strong carotid pulse) and also experienced immediate post-injection reaction, urinary incontinence, muscle rigidity, loss of consciousness for approximately 1 minute, hypopnoea, dyspnea, labored and dizziness. After regaining consciousness, the patient was disoriented, tearful and sleepy. Patient was taken to the hospital via ambulance. Lab data included CT (computerize tomogram) scan of head and EEG (electroencephalogram) and both results were normal, "U/A (urine analysis)', CMP (comprehensive metabolic panel), CBC (complete blood count), D-dimer were also conducted the results of which were unknown. The outcome of the events was reported as recovered. Causality assessment was not reported. The agency considered the case to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.