chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 66 year old female patient. Patient's concurrent condition included a convulsive disorder. Patient was allergic to iodine, shellfish, phenobarbital, DILANTIN and TEGRETOL. On 06-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 in an unspecified arm (lot # M005287, expiration date 08-OCT-2017). Concomitant therapies included atorvastatin, montelukast (manufacturer unknown) and divalproex sodium. That evening after vaccination, the patient developed pain, swelling and warmth at the injection site. The next day after vaccination the patient's symptoms became worse as the day went on, until eventually the pain became excruciating. Patient sought medical attention-she placed a call to an unspecified physician. The physician informed the patient to go to the emergency room. The patient was seen at the emergency room, was administered prednisone, BACTRIM, and BENADRYL and was released the same night without being admitted. No laboratory tests were performed. Patient went back to the physician's office on 09-MAY-2016 and at that time "she was feeling much better after 4 doses of antibiotic and 3 dose of prednisone" (hence outcome of injection site warmth and injection site swelling was considered as recovering), but was still experiencing mild pain and erythema. The medical assistant reported that they have not been in contact with the patient since then. Outcome of injection site pain and erythema at the time of report, was considered to be not recovered. Causality assessment was not known. The PNEUMOVAX 23 vaccine was administered by a new employee at the facility and this may have played a role in the reason for the reactions. The reporter requested a lot check for PNEUMOVAX 23 with lot # M005287, expiration date 08-OCT-2017. This is one of the two reports received from the same reporter (linked to 1605USA006411). Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Swelling and redness to (R) arm. Dx: cellulitis. Cephalexin 250 mg/mL 10mL po TID x 10 days.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Muscular weakness, Paraesthesia
Clinical narrative: Information has been received from a physician via a company representative referring to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date in January 2016 the patient was vaccinated with the second dose of GARDASIL 9 (dose, lot# and expiration date unknown, intramuscular) and experienced leg tingling and weakness in leg (unspecified which leg). On 12-MAY-2016 the patient was vaccinated with the third dose of GARDASIL 9 (dose, lot# and expiration date unknown, intramuscular). On the same day the patient experienced severe leg tingling and lower back pain (unspecified which leg). On 13-MAY-2016 the patient went to emergency room at hospital A. It was reported that the patient was not admitted to hospital. Outcome of the events was unknown. 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 licensed practical nurse regarding unspecified patients age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since unspecified dates starting on or after 05-MAY-2016, the patients were vaccinated with an improperly store doses of ROTATEQ (orally, dose was not reported, lot #L035508 with expiration date 12-MAY-2017 or lot# L029618 with expiration date 20-MAY-2017 or lot #L033693 with expiration date 31-MAY-2017). The temperature was 11 Fahrenheit degrees during 11 days (digital data logger). There was no previous temperature excursion. There was no adverse events reported. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Lip swelling, Pyrexia, Rash, Swelling face
Clinical narrative: Developed fever on the evening of 5/13, the following day developed facial and lip swelling which resolved the same evening, then 2 days later developed rash, rash started on face and moved down, the next day the rash covered most of her and she still continued with fevers.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Swelling, Urticaria
Clinical narrative: Developed hives that came and went. Given CLARITIN and BENADRYL with little relief. Seen in office 3 times for this and had some body swelling as well. Symptoms completely resolved approximately 5/10/16. Also had been treated with amoxicillin during this time and had several possible environmental triggers.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pharyngeal paraesthesia, Swollen tongue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of swollen tongue in a 63-year-old female patient who received BOOSTRIX (batch number TX34X, expiry date 14th May 2017). Concurrent medical conditions included food allergy (Corn allergy). On an unknown date, the patient received BOOSTRIX .5 ml. On an unknown date, less than a day after receiving BOOSTRIX, the patient experienced swollen tongue and pharyngeal paresthesia. On an unknown date, the outcome of the swollen tongue and pharyngeal paresthesia were recovered/resolved. It was unknown if the reporter considered the swollen tongue and pharyngeal paresthesia to be related to BOOSTRIX. Additional details were provided as follows: The reporter stated that, the patient experienced tongue swelling and throat tingling shortly after receiving the BOOSTRIX. The events subsided shortly after.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 16-year-old female patient who received BEXSERO. Concomitant products included Hepatitis A vaccine and MENACTRA. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain, nausea and dizziness. On an unknown date, the outcome of the injection site pain, nausea and dizziness were unknown. It was unknown if the reporter considered the injection site pain, nausea and dizziness to be related to BEXSERO. Addition details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient experienced nausea, dizziness, and left arm (injection site) pain after receiving BEXSERO vaccination. On the same day, the patient also received MENACTRA and Hepatitis A (unknown manufacturer) vaccination in right arm. The patient's date of birth, initials, date of vaccination and adverse event onset date were unknown.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, 24 hours after administration of BEXSERO, the patient experienced severe pain at the injection site and the patient had trouble in lifting her arm where he got the injection. The reporter did not have any further information. This case has been linked with US2016GSK070376 reported by same reporter.
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Feeling abnormal, Formication, Local swelling, Muscle twitching
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myoclonic jerks in a 59-year-old female patient who received Rabies vaccine. Previously administered products sulfa drugs with an associated reaction of urticarial (sulfa antibiotics caused hives). Concurrent medical conditions included arthritis. Concomitant products included CLARITIM, COREG, PREVACID and Cranberry pills. On 15th September 2015, the patient received Rabies vaccine. On an unknown date, less than a year after receiving Rabies vaccine, the patient experienced myoclonic jerks, anxiety, crawling sensation, neck swelling, neck pain, feeling abnormal and muscle twitching. Rabies vaccine was continued with no change. On an unknown date, the outcome of the myoclonic jerks, crawling sensation, neck swelling, neck pain, feeling abnormal and muscle twitching were unknown. It was unknown if the reporter considered the myoclonic jerks, anxiety, crawling sensation, neck swelling, neck pain, feeling abnormal and muscle twitching to be related to Rabies vaccine. Additional information was provided as follows: The patient was not actually bitten by a bat in her home. Her condition was getting worse. The patient was given 5 injection, but the physician was not sure what all 5 injections were and reported that she may have gotten a split dose of the RABAVERT and the HRIG with doses in both shoulders, both thighs and 1 shot in the buttocks.
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Myoclonus, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myoclonic jerks in a 59-year-old female patient who received Rabies vaccine. Previously administered products sulfa drugs with an associated reaction of urticarial (sulfa antibiotics caused hives). Concurrent medical conditions included arthritis. Concomitant products included CLARITIM, COREG, PREVACID and Cranberry pills. On 15th September 2015, the patient received Rabies vaccine. On an unknown date, less than a year after receiving Rabies vaccine, the patient experienced myoclonic jerks, anxiety, crawling sensation, neck swelling, neck pain, feeling abnormal and muscle twitching. Rabies vaccine was continued with no change. On an unknown date, the outcome of the myoclonic jerks, crawling sensation, neck swelling, neck pain, feeling abnormal and muscle twitching were unknown. It was unknown if the reporter considered the myoclonic jerks, anxiety, crawling sensation, neck swelling, neck pain, feeling abnormal and muscle twitching to be related to Rabies vaccine. Additional information was provided as follows: The patient was not actually bitten by a bat in her home. Her condition was getting worse. The patient was given 5 injection, but the physician was not sure what all 5 injections were and reported that she may have gotten a split dose of the RABAVERT and the HRIG with doses in both shoulders, both thighs and 1 shot in the buttocks.
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Injection site oedema
Clinical narrative: Patient with edema in muscle where T-dap shot administered. 3.5 cm length/3.0 cm wide.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed rash looking like hives that came and went.  Given Claritin and Benadryl with little relief.  Seen in office once with complete resolution of symptoms on approximately 5/10/16.  Also had been treated with amoxicillin during this time and had several environmental triggers.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: Patient experiences pain "inside and outside" of right arm. States she is able to move the arm. Dense redness or swelling.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient said that he arm is still hurting.  This has been going on since the vaccine was administered.  She did say that she has spoke to Dr and is going to see a Dr for other issues that it may be related to but wanted to check/verify with us.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Mom reports patient awoke with pain in right arm. Patient is having difficulty moving the right arm.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Dizziness, Injection site pain, Nausea
Clinical narrative: Nausea, vomiting, diarrhea, fever 101.4, lightheaded, body aches, chills, sore arm at injection site. Was told to take Tylenol to reduce fever and drink liquids.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, fever 101.4, lightheaded, body aches, chills, sore arm at injection site. Was told to take Tylenol to reduce fever and drink liquids.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Infection, Pain, Pruritus
Clinical narrative: PATIENT EXPERIENCED REDNESS, ITCHING, AND SOME PAIN. SHE WENT TO MD AND WAS TOLD SHE HAD INFECTION.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dyspnoea, Wheezing
Clinical narrative: After ZOSTAVAX was administered, patient experienced wheezing and difficulty breathing (approximately 15 minutes later). BENEDRYL 50 mg was given to her. Blood pressure measurements showed increase in blood pressure. Patient had rapid relief of wheezing/breathing and went home after 30 minutes.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Hyperhidrosis, Lymphadenopathy, Muscle twitching, Seizure like phenomena
Clinical narrative: At night time for the next 4 nights, my son had seizure-like activity when falling asleep and during sleep.  He would have uncontrollable twitching, sweating (no fever), and would stare off like an absence seizure; would not respond to me.  He would fuss/cry during these episodes because he wanted to fall asleep and couldn't due to his uncontrollable movement.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: At night time for the next 4 nights, my son had seizure-like activity when falling asleep and during sleep.  He would have uncontrollable twitching, sweating (no fever), and would stare off like an absence seizure; would not respond to me.  He would fuss/cry during these episodes because he wanted to fall asleep and couldn't due to his uncontrollable movement.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Pt presented to the pharmacy on 5/19/16 with a red rash about 8cm by 25cm on the left on arm. Not painful, but red, hot, and tight skin.
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, lightheaded, sweaty, nausea.
Age: 76.0
Sex: M
Vaccine: PNC
Symptoms: Injection site mass, Joint range of motion decreased, Mobility decreased
Clinical narrative: Patient stated the next day after his vaccine he could barely move his arm. His range of motion was limited. He couldn't reach the faucet on the sink to turn the water on. It was sore, but slowly got better maybe 2 weeks later. Now he approached me in the pharmacy to tell me he has a lump on that left shoulder and he thinks it's related to the vaccine. He can move his arm and doesn't have more pain than he usually does, but now he was a large lump on top.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Dyspnoea, Localised intraabdominal fluid collection, Malaise
Clinical narrative: I have COPD.  48 house after i had my PREVNAR 13 VACCINE I STARTED GETTING MORE SHORT OF BREATH, FEELING VERY UNCOMFORTABLE AND STARTED GAINING FLUID ON MY ABDOMEN.  JUST FEELING SICK ALL OVER.  I AM FEELING WORSE AFTER THE DATE OF MY VACCINE.
Age: 1.96
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Gait disturbance, Injection site swelling, Nodule
Clinical narrative: The leg where the injection was given was swollen to the size of a baseball for 1 week. He couldn't walk without dragging his leg. His leg had a huge knot for 6 weeks after the shot was given.
Age: 1.09
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Injection site reaction, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Rash (red, itchy, fine macular popular) around Hep A injection site immediately.  (6 cm diameter).
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Back pain, Headache, Muscle spasms, Pain
Clinical narrative: Lower back pain, cramping, abdominal pain, body ache, headache. Pt's mom gave her ADVIL 0630-0700 and she slept. Had MCV and HPV yesterday, went to school and was OK. In the middle of the night had HA, body aches, stomach cramps. Sweat a little while sleeping which is not abnormal per mom. Has slept most of day. HA is gone now, lower back pain now is now moved to mid-back, a bit of body aches. OK to touch chin to chest. She is getting better per mom. No fever.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Glycosylated haemoglobin increased, Injection site pain
Clinical narrative: On 5/11/16 pt. seen for laceration left thumb and received tetanus. Came back on 5/19/16 to have stitches removed and c/o (L) upper arm sore and tender to touch. No redness.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: High fever 102-103, fatigue, lightheaded and nausea with headache.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, MNQ, PNC13
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 05-MAY-2016, the patient was vaccinated with PROQUAD lot # L050909 expiry date 14-JUN-2017, (dose, route and anatomical site of injections were not reported); that was inadvertently reconstituted with MENACTRA instead of the diluent. Concomitant therapies were not provided. No adverse effects were reported. NO product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot number L036831, expiry date 24-SEP-2017; L039092, expiry date 06-OCT-2017 and L044526, expiry date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature between -26 degrees Celsius and -14 degrees Celsius, for 48 hours. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complain (PQC) was involved. 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 registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' concurrent conditions and medical conditions was not provided. On an unspecified date starting on or after 31-MAR-2016, the patients were administered an unspecified number of improperly stored doses of VAQTA, intramuscular injection, (lot # L043209, its expiration date: 17-SEP-2017; lot # M003011, its expiration date: 05-NOV-2017) (route, dose and frequency were not reported). Information regarding the patient's concomitant medication was not provided. The temperature was 33 degrees F and the time frame: 13 hours and 30 minutes. Therefore, there was not a previous temperature excursion and the call was not because of a data logger. Additionally, no adverse effects were reported. This is one of several reports from the same reporter (MARRS # 1604USA017966 and MARRS # 1605USA008486) Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' concurrent conditions and medical conditions was not provided. On an unspecified date starting on or after 31-MAR-2016, the patients were administered an unspecified number of improperly stored doses of ROTATEQ, orally liquid, (lot # L035276, its expiration date: 09-JUN-2017; lot #L037924, its expiration date: 22-JUN-2017) (route, dose and frequency were not reported). Information regarding the patient's concomitant medication was not provided. The temperature was 33 degrees F and the time frame: 13 hours and 30 minutes. Therefore, there was not a previous temperature excursion and the call was not because of a data logger. Additionally, no adverse effects were reported. This is one of several reports concerning the same reporter. (MARRS # 1605USA008485 and MARRS # 1604USA017966). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' concurrent conditions and medical conditions was not provided. On unspecified dates starting on or after 31-MAR-2016, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB, intramuscular injection, (lot #L045117, its expiration date: 06-OCT-2018; lot # M001578, its expiration date: 21-NOV-2018) (route, dose and frequency were not reported). Information regarding the patient's concomitant medication was not provided. The temperature was 33 degree F and the time frame: 13 hours and 30 minutes. Therefore, there was not a previous temperature excursion and the call was not because of a data logger. Additionally, no adverse effects were reported. This is one of several reports from the same reporter (MARRS # 1605USA008485 and MARRS # 1605USA008486). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # L021599 with expiration date of 10-DEC-2016; lot # L008353 with expiration date of 11-SEP-2016; dose and route unknown) (incorrect product storage). The vaccines were exposed at 6 Fahrenheit (F) for 24 hours. There was no previous temperature excursion. 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: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. From late February 2016 to 12-MAY-2016, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 immunization series (lot # L024993 with expiration date of 17-OCT-2017; lot # reported as L206602 with expiration date of 19-OCT-2017, which was not valid for GARDASIL 9 (dose and route unknown). The vaccines were exposed at 32 Fahrenheit (F) as lowest for 1395 hours (58 days) as worst case scenario. The temperature excursion was cumulative since late February 2016 according to manual recording system. No adverse effects were reported. 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 healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. From late February 2016 to 12-MAY-2016, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB immunization series (lot # K022265 with expiration date of 22-OCT-2016; dose and route unknown). The vaccines were exposed at 32 Fahrenheit (F) as lowest for 1395 hours (58 days) as worst care scenario. The temperature excursion was cumulative since last February 2016 per manual recording system. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates the patients were vaccinated with doses of improperly stored VARIVAX (lot # K011085) with expiration date of 08-AUG-2016; lot # L032394 with expiration date of 26-AUG-2017; dose and route unknown) (incorrect product storage). The vaccines were exposed at 6 Fahrenheit (F) for 24 hours. There was no previous temperature excursion. 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: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. In July 2015 the patient was vaccinated a booster dose of VAQTA, 4 months after the first dose of VAQTA that was administered in March 2015 (dose, route and lot# were unspecified). No adverse effect was reported. Additional information is not expected because there was no consent for contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored GARDASIL (lot #K023432 with expire date of 18-JUN-2017, dosage and route not provided). The temperature/time frame was Cumulative "-4.7 C" for 513 hours. The call was because of a "date logger". There was no previous temperature excursion. No adverse effects were 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: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age or gender. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored ROTATEQ (Lot # included: L027719 with expire date of 28-APR-2017 and L037574 with expire date of 01-JUL-2017, dosage and route not provided). The temperature/time frame was cumulative "-4.7 C" for 513 hours. It was reported because of a "date logger". There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Heart rate decreased, Immediate post-injection reaction, Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 69 years old female patient with hypertension. The patient had no drug reactions/allergies. On 12-MAY-2016 the patient was vaccinated with ZOSTAVAX (Lot# reported as L044528, expiration date 09-FEB-2017) subcutaneously. Concomitant therapies included propranolol hydrochloride (manufacturer unknown) and amlodipine. The pharmacist reported that on 12-MAY-2016 the patient experienced dizziness which persisted several hours following vaccination, a low heart rate of 50 Bpm (beats per minutes) and slight redness that localized at the injection site immediately following the administration of ZOSTAVAX. The patient sought unspecified medical attention. It was unknown if treatment was given for adverse events. Other laboratory tests were not performed. The patient was still dizzy at the time of reporting. The outcomes of heart rate decreased and injection site erythema were unknown. Reporter's causality was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified numbers of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. From late February 2016 to 12-MAY-2016, the patients were vaccinated with unspecified doses of improperly store PNEUMOVAX 23 (lot # L010598 with expiration date of 06-AUG-2016; dose and route unknown). The vaccines were exposed at 32 Fahrenheit (F) as lowest for 1395 hours (58 days) as worst case scenario. The temperature excursion was cumulative since late February 2016 per manual recording system. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. From late February 2016 to 12-MAY-2016, the patients were vaccinated with unspecified doses of improperly stored ROTATEQ immunization series (lot # L027070 with expiration date of 30-APR-2017; dose unknown) orally. The vaccines were exposed at 32 Fahrenheit (F) as lowest for 1395 hours (58 days) as worse case scenario. The temperature excursion was cumulative since late February 2016 per manual recording system. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Condition aggravated, Injection site pruritus, Injection site rash, Joint swelling
Clinical narrative: 4/01/16 Hep B vaccine administered (L) upper arm. Developed injection site rash with itching. Symptoms still present as of 5/17/16 office examination. More rheumatoid arthritis joint pain and swelling subsequently.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Rheumatoid arthritis
Clinical narrative: 4/01/16 Hep B vaccine administered (L) upper arm. Developed injection site rash with itching. Symptoms still present as of 5/17/16 office examination. More rheumatoid arthritis joint pain and swelling subsequently.
Age: 1.06
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Heart rate abnormal, Heart rate increased, Pyrexia, Tremor
Clinical narrative: 5/17/16 at 2000, fever started and it was 102.3 mom gave TYLENOL. Next morning woke up fine. Day care called mom, at 1400 of 5/18/16. They said he had fever of about 102.3 again and that his hands were very cold and his lips looked bluish in color. Mom picked him up and fever was still 102 at 1445. Mom gave TYLENOL. 1545 temp 100.1, woke up at 1900 after an hour as he was crying but very hot. Took temp it was 103 axillary then he started shaking, his whole body, lasted 30 sec. Mom gave him a dose of MOTRIN and dad took him to the ER at hosp. The ER said to overlap TYLENOL and MOTRIN as needed for fever. Parents though he was having a seizure but ER per mom basically said he was just upset. Also at 1900 when he was shaking mom said his heart was beating really hard and fast. Today, 5/19/16 seems fine per mom.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site joint movement impairment, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Case number PHHY2014US045944 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 519423) website on 14 Apr 2014. This report refers to an 11-year-old male patient. He was vaccinated with MENVEO (batch number: M13012) and ADACEL (other manufacturer, batch number: C4506AC) both intramuscularly on left arm on 08 Jan 2014. On the same day, post vaccinations, he experienced swollen arm from deltoid to elbow, redness, fever to 101.2 degrees Fahrenheit, nausea and swollen cheeks. He was also unable to move left arm for 3-4 days. The event was reported as non-serious; however the event swelling cheeks was internally upgraded as medically significant by the MAH. MAH assessed the other events as non-serious. Outcome of the events was reported as recovered. Causality of the events was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Swelling face
Clinical narrative: Case number PHHY2014US045944 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 519423) website on 14 Apr 2014. This report refers to an 11-year-old male patient. He was vaccinated with MENVEO (batch number: M13012) and ADACEL (other manufacturer, batch number: C4506AC) both intramuscularly on left arm on 08 Jan 2014. On the same day, post vaccinations, he experienced swollen arm from deltoid to elbow, redness, fever to 101.2 degrees Fahrenheit, nausea and swollen cheeks. He was also unable to move left arm for 3-4 days. The event was reported as non-serious; however the event swelling cheeks was internally upgraded as medically significant by the MAH. MAH assessed the other events as non-serious. Outcome of the events was reported as recovered. Causality of the events was not reported.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Electroencephalogram abnormal, Seizure
Clinical narrative: Case number PHHY2014US047108 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519898) website on 14 Apr 2014. This report refers to a 12 year old female patient. Her current condition included neurologic phenomenon which was initially thought to be sleep paralysis, but later it was found to be seizure activity for a few months prior, almost daily. She did not have any infectious illness. She was vaccinated with MENVEO (batch number: not reported) intramuscularly, FLUMIST (other manufacturer, batch number: not reported) and GARDASIL (other manufacturer, batch number: not reported) intramuscularly on 25 Nov 2013. On the same day after vaccination, she experienced seizure activity occurred 7 to 9 times per day. Initially seizure activity happened at least once daily after awakening, but later it became more severe and prolonged daytime event. She was taken to emergency room for medical support. She consulted a sleep specialist and a neurologist shortly after the episodes of events. On an unknown date, an EEG was performed which showed some abnormalities (unspecified). She was treated with anti-seizure medications which were helping her. The outcome of the event was reported as complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the company. The causality was not reported.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US046520 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 520272) website on 14 Apr 2014. This report refers to a 16-year-old male patient. He was vaccinated with MENVEO (batch number: M12130) intramuscularly into right arm on 13 Jan 2014. On the same day, he was also vaccinated with HAVRIX (other manufacturer and batch number: 5J5HT) intramuscularly into right arm, ENGERIX B (other manufacturer and batch number: AHBVC188AA) intramuscularly into right arm, MMR II (other manufacturer and batch number: H014648) subcutaneously into right arm, IPOL (other manufacturer and batch number: J13821) subcutaneously into left arm, BOOSTRIX (other manufacturer and batch number: 33AG5) intramuscularly into left arm and VARIVAX (other manufacturer and batch number: J006732) subcutaneously into left arm. On the same day, post vaccinations, the patient had an episode of syncope. The patient was placed on floor with legs elevated, cold compress applied to forehead and took sips of water. The patient recovered within 5 minutes. The patient remained in seat with parents beside him for 20 minutes and felt fine after that time and parents agreed to take him home. The event was reported as non-serious; however the case was internally upgraded as medically significant by the company. Causality of the event was not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Case number PHHY2014US054861 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522897) website on 06 May 2014. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13013) intramuscularly into right arm, GARDASIL (other manufacturer, batch number: J009788) intramuscularly into left arm and BOOSTRIX (other manufacturer, batch number: 9FS27) intramuscularly into left arm on 17 Feb 2014. On the same day after three minutes of vaccination, he felt lightheaded and fainted. He was under observation and after 15 minutes was fine to leave. The outcome of the events was reported as complete recovery. The event was reported as non-serious; however the case was internally upgraded as medically significant by the company.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Ear infection, Ear pain, Facial paralysis
Clinical narrative: Case number PHHY2014US055231 is an initial spontaneous report received from a nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 523711) website on 06 May 2014. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. On 16 Sep 2013, he was vaccinated with MENVEO (batch number: M12120) intramuscularly. On the same date he was also vaccinated with FLUMIST (batch number: BH2124) intranasally along with BOOSTRIX (batch number: ACS2B099CA) intramuscularly. Following the vaccination, on 01 Oct 2013, he experienced right ear pain and was diagnosed with right ear infection on the same day. Due to these events, he started taking CIPRODEX drops. On 07 Oct 2013, he experienced symptoms of Bell's palsy (right sided facial drooping) due to which he visited the emergency room on 08 Oct 2013. The physician prescribed him ZITHROMAX and prednisone. At the time of reporting, the event of patient's right sided droop had not improved. The outcome of the event of right ear infection was unknown. The reporter considered the events to be non-serious; however the case was internally upgraded as medically significant by the company. The causality of the events was not reported.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2014US054684 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 523794) website on 24 Apr 2014. This report refers to a 16-year-old female patient. She was vaccinated with MENVEO (batch number: A12009) into left arm on 25 Feb 2014. On the same day, she was also vaccinated with HAVRIX (other manufacturer and batch number: YZ2F7) into left arm, GARDASIL (other manufacturer and batch number: J012212) into right arm and VARIVAX (other manufacturer and batch number: J008026) into right arm. On the same day, post vaccinations, she experienced moderate anaphylactic reaction. The physician assessed the patient and advised her mom to give BENADRYL when home and can take asthma rescue medications if respiratory issues develop or take to emergency room immediately. The event was reported as non-serious; however the case was internally upgraded as medically significant by the company. Outcome of the event was reported as recovered. Causality of the event was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Erythema, Nausea, Swelling face, Urticaria
Clinical narrative: Case number PHHY2014US054754 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 524260) website on 06 May 2014. This report refers to an 11-year-old male patient. His concurrent conditions included asthma and allergies to all nuts, sunflower seeds, pineapples, PULMICORT and ibuprofen. Concomitant medications included SINGULAIR, Albuterol inhaler, nebulizer treatments and BENADRYL as needed. Past vaccination included Tdap and experienced swelling. He was vaccinated with MENVEO (batch number: A12104) intramuscularly into left arm on 24 Feb 2014. On the same day, he developed swelling/redness to face and hives and was treated with BENADRYL. Later he went to emergency room due to no improvement and experienced nausea, vomiting, diarrhea and received steroid injections and ZOFRAN. These events were reported as non-serious; however the case was internally upgraded as medically significant by the company. Outcome of the events was reported as unknown. Causality of the events was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Case number PHHY2014US054754 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 524260) website on 06 May 2014. This report refers to an 11-year-old male patient. His concurrent conditions included asthma and allergies to all nuts, sunflower seeds, pineapples, PULMICORT and ibuprofen. Concomitant medications included SINGULAIR, Albuterol inhaler, nebulizer treatments and BENADRYL as needed. Past vaccination included Tdap and experienced swelling. He was vaccinated with MENVEO (batch number: A12104) intramuscularly into left arm on 24 Feb 2014. On the same day, he developed swelling/redness to face and hives and was treated with BENADRYL. Later he went to emergency room due to no improvement and experienced nausea, vomiting, diarrhea and received steroid injections and ZOFRAN. These events were reported as non-serious; however the case was internally upgraded as medically significant by the company. Outcome of the events was reported as unknown. Causality of the events was not reported.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: Case number PHHY2014US071293 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524397) web site on 09 Jun 2014. This report refers to an 18-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M13017) into right arm and GARDASIL (other manufacturer, batch number: J009243) into left arm both on 22 Feb 2014. On the same day 02-minutes after vaccination, he experienced dizziness, diaphoresis, cold clammy skin and hypotension. His blood pressure was 75/38 and after 02 minutes it was 79/48. He was continuously monitored until fully recovered. The final outcome was reported as complete recovery. The event was reported as non serious; however the case was internally upgraded as medically significant by the company. The causality was not reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2014US070977 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525953) on 09 June 2014. This report refers to a 16 year old female patient. Her medical history included hyperlipidemia and obesity. Her concomitant medications were not reported. Her vaccination history included administration of MENACTRA (other manufacturer, batch number: not reported) on an unspecified date. She was vaccinated with the booster dose of MENVEO (batch number: M12100) intramuscularly in the left arm on 04 Mar 2014. It was reported that on 05 Mar 2014 she presented with rash all over body. There were no other symptoms. She called triage nurse at the medical clinic and was sent to emergency room for evaluation. The outcome of the event was not reported. The health authority reported that the event was non-serious; however company has upgraded the case internally. The causality of the event was not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Ultrasound scan normal, White blood cell count normal
Clinical narrative: Case number PHHY2014US070875, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 526459) website on 09 Jun 2014, with a follow-up information received from Quality Assurance Department (reference number: 304948) on 14 Jul 2014. This report refers to a 11-year-old male patient. His medical history included seasonal allergies and he had no known drug allergy. Concomitant drug included CLARITIN. On 07 Mar 2014, he was vaccinated with MENVEO (batch number: M13012 and expiry date: Sep 2014) intramuscularly in the left arm along with GARDASIL (other manufacturer, batch number: J012438) in the right arm and BOOSTRIX (other manufacturer, batch number: 253B4) in the left arm, both intramuscularly. On 09 Mar 2014, he experienced cellulitis with redness and swelling of left upper arm. The patient was taken to emergency room and diagnosed with cellulitis and had WBC count of 10,000 and was afebrile. He received intravenous ROCEPHIN and was kept on oral AUGMENTIN treatment. The patient underwent ultrasound of left upper arm and it ruled out abscess. The final outcome of the events reported as not recovered. The events reported as non-serious; however the case was internally upgraded as medically significant by the company. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M13012) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from Quality Assurance Department (reference number: 304948) on 10 Jun 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 304948) on 14 Jul 2014: Updated batch review report.