chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 64 years old male patient. The patient had no pertinent medical history and no known drug allergies. The patient had no concomitant medication. On 06-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml once, lot # unknown) subcutaneously. On 07-AUG-2016, the patient developed an itching, painful, raised rash, and redness and warmth around the injection site in an area of "3 inches by 2 inches." Pharmacist described the rash as "hives, severe dermatitis, raised area like it was going to start weeping or form blisters." The redness had spread from the patient's shoulder to her elbow, a defined region of light red all the way around the tricep area. No treatment was given for the adverse events. The patient had no recovered from the events. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. The patients' pertinent medication, drug reactions/allergies and concomitant medication were not reported. From 01-AUG-2016 to 09-AUG-2016, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L032182 with expiration date 25-AUG-2017; dose, dose number and route were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 11-AUG-2016 the patient was vaccinated with a dose of PROQUAD (lot # M006104 and expiration date: 01-AUG-2017) subcutaneous instead of VARIVAX. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Haemophilia, Injection site erythema, Injection site swelling
Clinical narrative: Vaccines given 8-9-16 Mom called 8-11-16 because the area vaccines were given was red and raised. Patient had Hemophilia so all vaccines are given subq.  CRNP told to give BENADRYL and call back in 3 hours. Mom called back said spots are less red but same size. Told to monitor and bring in if needed.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Erythema, Induration, Local swelling, Pain, Skin warm
Clinical narrative: Pt. noted reddened, swollen, indurated area, painful and warm to touch when waking this morning.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: PATIENT CALLED PHARMACY TO REPORT THAT SHE HAS HAD A FLARE UP OF SHINGLES POST VACCINE. HAS HAD SHINGLES IN THE PAST.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Syncope
Clinical narrative: Pt fainted after receiving vaccinations.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L039093, expiration date 06-OCT-2017; lot # L046885, expiration date 23-NOV-2017; lot # M006729, expiration date 08-FEB-2018; dose and route were unknown). The vaccines were stored under 5.1 F for 15 minutes. There was no previous temperature excursion. It was called because of a data logger. No adverse effects were reported. No PQC was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to patient of unknown age and gender. No information about patient's medical history, concurrent conditions and concomitant medications. On an unknown date the patient was vaccinated with 3rd dose GARDASIL 9 (dose, route, lot# and expiry date not provided). The patient received the 3rd dose too early as the time frame between the 1st and 3rd dose was less than 6 months; this was outside the recommendations per the GARDASIL 9 prescribing information. No adverse effects reported. No further information provided. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse via sales representative on 13 October 2015. This case involves a female patient (age unknown) who was vaccinated with a dose of FLU VACCINE (batch number, expiry date and site of administration, route and dose series were not reported) on 09 October 2015. Medical history and concomitant medications were not reported. On an unspecified date, few days following the vaccination, patient experienced chills and high fever over the weekend. Patient's laboratory investigations and corrective treatments were not reported. The outcome of the events was not reported. Follow-up information received from a nurse on 20 November 2015. This case involves a 45 years old patient who was vaccinated with 0.5 ml of Flu vaccine (batch number: UI441AC) intramuscularly in the right deltoid on an unknown date. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions and any other vaccinations within 4 weeks of vaccinations reported as no. On an unknown date, the patient was recovered from the events (Duration: 2 days). List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Blood test, Nausea, Oropharyngeal pain, Rash erythematous
Clinical narrative: Initial unsolicited report received from a nurse on 08 August 2016. This case involves a 17-year-old female patient who was vaccinated with a dose of MENACTRA intramuscularly (batch number: U5410AA, expiry date: 21 Sep 2017) (dose, dose in series not reported) in right deltoid on 28 July 2016. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions are reported as none. Concomitant medications were not reported. On 04 Aug 2016, seven days following the vaccination, the patient experienced widespread rash over her body. On an unspecified date, following vaccination, rash was initially red but has now changed to purple in some areas, rash is raised and itchy, hives are of various sizes, sore throat, joint pain, and nausea. Patient required ER/doctor visit. Blood test had been done by patient. Other relevant diagnostic tests/laboratory data was reported as none. Patient had been treated with Benadryl. The patient was recovering from events pain and itch. The patient was not recovered from other events. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Initial unsolicited report received from a nurse on 08 August 2016. This case involves a 17-year-old female patient who was vaccinated with a dose of MENACTRA intramuscularly (batch number: U5410AA, expiry date: 21 Sep 2017) (dose, dose in series not reported) in right deltoid on 28 July 2016. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions are reported as none. Concomitant medications were not reported. On 04 Aug 2016, seven days following the vaccination, the patient experienced widespread rash over her body. On an unspecified date, following vaccination, rash was initially red but has now changed to purple in some areas, rash is raised and itchy, hives are of various sizes, sore throat, joint pain, and nausea. Patient required ER/doctor visit. Blood test had been done by patient. Other relevant diagnostic tests/laboratory data was reported as none. Patient had been treated with Benadryl. The patient was recovering from events pain and itch. The patient was not recovered from other events. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, X-ray limb normal
Clinical narrative: Initial unsolicited report received from a nurse on 09-Aug-2016. This case involves a 54 year old female patient who was vaccinated with a dose of ADACEL via intra muscular route in the right deltoid (batch number: UI558AA, expiry date: 10-Apr-2018; unknown dose in series and batch number) on 08-Jul-2016. Patient denied any pre-existing physician diagnosed allergies, birth defects, medical conditions etc. Concomitant medication was unknown. On 09-Jul-2016, one day following the vaccination, the patient had persistent pain at injection site with limited ROM and certain movements trigger the pain and Reporter stated patient has also complained of a burning sensation at the injection site without redness or swelling. Patient was evaluated by the physician on an unknown date. The patient required ER/doctor visit. Laboratory data included X-ray of right arm (reported as negative). The patient received corrective treatment with Baclofen 10mg every 8 hrs as needed, Ibuprofen 600 mg and Tylenol 1000 mg both every 6 hours as needed. Application of ice to the upper R arm and rest was also reported. The outcome of events was unknown. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient had rash on his hands, feet, knees, and elbows. Dermatologist stated "multiple polymorphous and target-like erythematous patches and plaques distributed on the leg, hand, arm and feet."
Age: 1.03
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Product reconstitution issue
Clinical narrative: Client received only the DTaP and IPV component of the Pentacel. Wasn't reconstituted with the HIB component.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Papule, Rash, Rash erythematous, Rash pruritic
Clinical narrative: 3am-pinpoint to slightly larger papules, reddened, itchy rash developed to back of thighs, progressing to back of calves, later to anticubital. Rash resolves with Benadryl/topical hydrocortisone, but returns randomly somewhere on an extremity only 4-6hrs later. No rash on face or torso.  No other symptoms. Referred to physician.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-AUG-2016, the patient was administered PROQUAD, subcutaneously, lot # L016394, expiry date 08-NOV-2016 (strength, dose and site of administration were not reported). The vaccine was reconstituted with an expired sterile diluent (manufacturer unknown), lot # L010589, expiry date 15-MAY-2016. Additional information has been requested.
Sex: M
Vaccine: HPV4, MENB
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a male patient of unknown age. Medical histories, drug reactions and allergies were unknown. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number and expiry unknown) 1 shot(DF), intramuscular route. Concomitant therapies included TRUMENBA. On an unknown date the patient experienced red swollen skin all down his arm like cellulitis. The patient sought medical attention and contacted the physician. The outcome of the event was reported as recovered. The causality of the reported event was not reported. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Eye movement disorder, Fatigue, Headache, Migraine
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 12 year old female patient with attention deficit/hyperactivity disorder.  On 10-JUN-2016, the patient was vaccinated with GARDASIL intramuscular (lot #, expiration date, dose and site of administration were not reported). Concomitant medication included "VYVANCE". On 16-JUN-2016, the patient experienced bad headaches, fatigue, nausea and migraines. In approximately 2016, the patient did  not want to eat anything and her eyes rolled to the back of her head. The patient had an office visit. No treatment was given and no lab diagnostics studies were performed.  The outcome of all events was reported as not recovered/not resolved. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 12 year old female patient with attention deficit/hyperactivity disorder.  On 10-JUN-2016, the patient was vaccinated with GARDASIL intramuscular (lot #, expiration date, dose and site of administration were not reported). Concomitant medication included "VYVANCE". On 16-JUN-2016, the patient experienced bad headaches, fatigue, nausea and migraines. In approximately 2016, the patient did  not want to eat anything and her eyes rolled to the back of her head. The patient had an office visit. No treatment was given and no lab diagnostics studies were performed.  The outcome of all events was reported as not recovered/not resolved. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Hypertension, Nausea, Pyrexia, Tachycardia, Vomiting
Clinical narrative: Fever, nausea, vomiting, hypertension and tachycardia.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot# L035276, expiration date 09-JUN-2017, dose, anatomical location were not reported) oral route of administration. 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: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not reported, lot # L045954 with expiration date: 17-NOV-2017). Concomitant therapy was not reported. No adverse effects were reported. Administered vaccines experienced the temperature excursion of 24.8 degrees Fahrenheit for 13 days 4 hours 45 minutes on an unknown date. Data logger was involved. 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 medical assistant (who was also a nurse) and refers to 2 patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L040458, expiration date 04-FEB-2018 (dose, route of administration and anatomical location were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure; fever. Rushed to ER. Series of test performed. No infection found. Diagnosis was febrile seizure caused by fever spike from vaccinations.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Injection site pain
Clinical narrative: Soreness in arm / shoulder (where shot administered), Bad headache around ~2:30. Shivers ~1 AM.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site discharge, Injection site induration, Injection site scab, Injection site swelling
Clinical narrative: Shot site became hard, swollen and broke out to a blister, weeping now scabbed over. Some fatigue noted.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site vesicles
Clinical narrative: Shot site became hard, swollen and broke out to a blister, weeping now scabbed over. Some fatigue noted.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Child fainted.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Gait disturbance, Herpes zoster, Pain, Walking aid user
Clinical narrative: Red sores first a few than massive. Doctor issued presc. I presently being treated by my doc. Still in pain been on meds for 2 1/2 month. Have difficulty in walking am using cane to prevent a fall.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Blister, Erythema, Herpes zoster, Pain
Clinical narrative: Red sores first a few than massive. Doctor issued presc. I presently being treated by my doc. Still in pain been on meds for 2 1/2 month. Have difficulty in walking am using cane to prevent a fall.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin discolouration, Skin ulcer, Walking aid user, Wound secretion
Clinical narrative: Red sores first a few than massive. Doctor issued presc. I presently being treated by my doc. Still in pain been on meds for 2 1/2 month. Have difficulty in walking am using cane to prevent a fall.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Drooling, Fall, Seizure
Clinical narrative: Information has been received from a company representative and the patient's older sister referring to a 12 years old female patient. the patient had no previous history of seizures. the patient's concurrent condition and concomitant therapy were unknown. In the morning of 11-AUG-2016, the patient was vaccinated with GARDASIL 9 (dose, dose number, lot #, expiration date and route not reported) in her left arm. The patient also received another unspecified vaccination. On 11-AUG-2016 around 13:15, the company representative witnessed the adverse event. the patient fell and started seizing. There were no adults around so the representative put the patient on her side and turned the patient's head. the patient's whole body was seizing and she was drooling. 911 was called. the patient began recovering before the medics arrived. The patient was able to communicate and breath normally. When medics arrived, they put the patient in the "squad". It was unknown where they took the patient, what treatments the patient might have been given or if she fully recovered. It was unknown if the laboratory test was performed. the causality between GARDASIL 9 and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient's were vaccinated with improperly stored doses of ROTATEQ, lot # L038534, expiration date: 19-AUG-2017, orally, (dose was not reported). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Dysplasia, Human papilloma virus test negative, Incomplete course of vaccination, Product quality issue
Clinical narrative: Information has been received from a physician via a field representative referring to a currently 27 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL intramuscularly (dose and lot # were not reported). In August 2006 (reported as ten years ago), the patient did complete the 3 series of GARDASIL. On an unknown date the patient experienced dysplasia and Cervical intraepithelial neoplasia III (CIN3). The patient sought unspecified medical attention. An unspecified treatment was given for the event. The human papillomavirus (HPV) DNA test was performed on an unknown date and showed HPV negative. The outcome of the event was reported as recovered on an unknown date. The causality was not reported. Product quality complaint (PQC) was involved in the case. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-JUL-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dosage not reported) via subcutaneous. No adverse effects were reported. As of 19-JUL-2016, the cumulative/total excursion time: 23 hours and 10 minutes, highest temperature reached 8.2F. No Product Quality Complaint (PQC) was involved. This is one of several cases received from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site reaction, Pain
Clinical narrative: Noticed a quarter sized lump at GARDASIL injection site approximately 3 weeks after vaccine was given. Noticed pain to touch and move arm approximately around 08/12/2016. Lump is not getting smaller. There is an indentation in the skin at injection site. Pain is continuing to get worse.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Cerebrovascular accident
Clinical narrative: Patient reported stroke like symptoms. Now sees a neurologist for further care. We were made aware on 07/31/2016.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Chest discomfort, Chills, Dizziness, Headache
Clinical narrative: 15-20 minutes after Bexsero vaccination and lasting for 10 minutes, student develop nausea, headache, chills, dizziness and fingernails turned blue. Associated some chest tightness. Student notified academic advisor who called 911. On ER arrival, Temp 100.6, labs WNL, IV fluids. Complete symptom resolution within 2 hours.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nail discolouration, Nausea
Clinical narrative: 15-20 minutes after Bexsero vaccination and lasting for 10 minutes, student develop nausea, headache, chills, dizziness and fingernails turned blue. Associated some chest tightness. Student notified academic advisor who called 911. On ER arrival, Temp 100.6, labs WNL, IV fluids. Complete symptom resolution within 2 hours.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Decreased appetite, Fatigue, Gait disturbance, Headache
Clinical narrative: Began with a rash on right arm.  By the following day, my entire body seized with severe muscle pain which extended throughout my entire body but concentrated mainly in my legs and eyes.  I was also nauseous and had loss of appetite. On 13 August, my muscle pain became worse and walking became problematic.  I developed a 102 fever, had severe chills and by noon became extremely fatigued to the point of feeling lethargic.  My body also felt numb. On 14 August the symptoms had progressed to the point where I had to make an emergency visit to my doctor.  My eye muscles were intensely painful and I could hardly move them and I developed an additional headache.  The rash also began to spread to my left arm. At the time of this reporting, 16 August, I cannot contain the rash which is still continuing to spread up and down both of my arms, am nauseous and still experiencing slight muscle pain especially in my calves and eyes.  I also have not been able to eat in nearly 5 days and have experienced weight loss.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Hypophagia, Lethargy, Myalgia, Nausea
Clinical narrative: Began with a rash on right arm.  By the following day, my entire body seized with severe muscle pain which extended throughout my entire body but concentrated mainly in my legs and eyes.  I was also nauseous and had loss of appetite. On 13 August, my muscle pain became worse and walking became problematic.  I developed a 102 fever, had severe chills and by noon became extremely fatigued to the point of feeling lethargic.  My body also felt numb. On 14 August the symptoms had progressed to the point where I had to make an emergency visit to my doctor.  My eye muscles were intensely painful and I could hardly move them and I developed an additional headache.  The rash also began to spread to my left arm. At the time of this reporting, 16 August, I cannot contain the rash which is still continuing to spread up and down both of my arms, am nauseous and still experiencing slight muscle pain especially in my calves and eyes.  I also have not been able to eat in nearly 5 days and have experienced weight loss.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Seizure, Weight decreased
Clinical narrative: Began with a rash on right arm.  By the following day, my entire body seized with severe muscle pain which extended throughout my entire body but concentrated mainly in my legs and eyes.  I was also nauseous and had loss of appetite. On 13 August, my muscle pain became worse and walking became problematic.  I developed a 102 fever, had severe chills and by noon became extremely fatigued to the point of feeling lethargic.  My body also felt numb. On 14 August the symptoms had progressed to the point where I had to make an emergency visit to my doctor.  My eye muscles were intensely painful and I could hardly move them and I developed an additional headache.  The rash also began to spread to my left arm. At the time of this reporting, 16 August, I cannot contain the rash which is still continuing to spread up and down both of my arms, am nauseous and still experiencing slight muscle pain especially in my calves and eyes.  I also have not been able to eat in nearly 5 days and have experienced weight loss.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Heart rate decreased, Hypotension, Loss of consciousness, Nausea
Clinical narrative: Patient stated she felt like she was going to pass out after vaccine administration. She started to look pale.  I supported her and talked to her.  She passed out for a few moments. I had a fellow team member call 911.   She did shake/tremble a couple times as well. Her mother was present. She came to after a few moments and told us that she was nauseous and dizzy.  I sent someone to get a blanket so we could lay her on the floor. I also took her blood pressure.  Her blood pressure and pulse were low.  As we went to lay her on the floor, paramedics arrived.  She was talking to the paramedics. They lifted her out of the chair onto their bed.  The entire event lasted approx 10-15 minutes. I did not administer any medications - only took blood pressure and pulse.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pallor, Tremor
Clinical narrative: Patient stated she felt like she was going to pass out after vaccine administration. She started to look pale.  I supported her and talked to her.  She passed out for a few moments. I had a fellow team member call 911.   She did shake/tremble a couple times as well. Her mother was present. She came to after a few moments and told us that she was nauseous and dizzy.  I sent someone to get a blanket so we could lay her on the floor. I also took her blood pressure.  Her blood pressure and pulse were low.  As we went to lay her on the floor, paramedics arrived.  She was talking to the paramedics. They lifted her out of the chair onto their bed.  The entire event lasted approx 10-15 minutes. I did not administer any medications - only took blood pressure and pulse.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Contraindication to vaccination, Neutropenia, Neutrophil count decreased, Polymerase chain reaction positive, Scab
Clinical narrative: This spontaneous report was received from an assistant director of a laboratory and refers to a 5 year old female patient. The patient was enrolled in the Varicella Zoster Virus (VZV) Identification Program (VZVIP) to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The patient was immunocompromised (not further specified). On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, anatomical location, lot # and expiration date were not provided). On approximately 01-AUG-2016, the patient was admitted to the hospital for an unspecified reason. One lesion was noted on her arm. New lesions developed and started spreading. A sample was obtained from a lesion and polymerase chain reaction (PCR) testing was found to be VZV positive  and the patient was diagnosed with chickenpox. The samples was submitted for strain identification to VZVIP on 11-AUG-2016. New samples were not submitted as the patient's varicella were lesions crusted and the patient was "quite neutropenic" at this time (exact date was not provided). At the time of the report, the patient was still hospitalized. The outcome of the events was not reported. The relatedness between the events and VARIVAX was not reported. Upon internal review, the event of "quite neutropenic" was considered as  medically significant. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: This spontaneous report was received from an assistant director of a laboratory and refers to a 5 year old female patient. The patient was enrolled in the Varicella Zoster Virus (VZV) Identification Program (VZVIP) to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The patient was immunocompromised (not further specified). On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, anatomical location, lot # and expiration date were not provided). On approximately 01-AUG-2016, the patient was admitted to the hospital for an unspecified reason. One lesion was noted on her arm. New lesions developed and started spreading. A sample was obtained from a lesion and polymerase chain reaction (PCR) testing was found to be VZV positive  and the patient was diagnosed with chickenpox. The samples was submitted for strain identification to VZVIP on 11-AUG-2016. New samples were not submitted as the patient's varicella were lesions crusted and the patient was "quite neutropenic" at this time (exact date was not provided). At the time of the report, the patient was still hospitalized. The outcome of the events was not reported. The relatedness between the events and VARIVAX was not reported. Upon internal review, the event of "quite neutropenic" was considered as  medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with PEDVAXHIB injection, lot number M007762, expiration date 07-DEC-2018 (dose, route and anatomical location of administration were not reported), which were improperly stored at 60 F for 1 hour and 30 minutes. There was no previous temperature excursion. Digital data logger and product quality complaint were not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions and concomitant therapies were reported. On 02-AUG-2016, the patient was vaccinated with ZOSTAVAX. Route, dose, dose number, lot # and anatomical location were not provided. On an unspecified date in August 2016, after getting ZOSTAVAX injection, the patient experienced influenza like illness (reported as "flu like symptoms such as chills and headaches"). It was not a product quality complaint involved. The outcome of influenza like illness was reported as not recovered. The causality assessment between ZOSTAVAX and influenza like illness was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 08-AUG-2016, the patient was subcutaneously vaccinated with expired dose of ZOSTAVAX (dose was not reported, lot # L003218 expiration date: 30-APR-2016). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: Information has been received from a Nurse Practitioner (also reported as physician), concerning an adolescent female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown date, the patient was vaccinated with an unspecified dose of GARDASIL, via intramuscular route, (strength, dose, anatomical location, lot number and expiration date were not reported). No concomitant medications were provided. On unknown date, the patient began having seizures; she sought medical attention (unspecified) and was hospitalized on unknown dates. It was reported that the physician placed her on an unspecified medication. Then, the physician took her off the unspecified medication and she began to have seizures again, so she was placed back on the unspecified medication. It was unknown whether laboratory diagnostics studies were performed. At the time of reporting, the outcome of seizure was unknown. No product quality complaint was involved. The relatedness between the seizures and therapy with GARDASIL was not reported. Upon internal review, seizure was determined to be medically significant. 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 concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with ROTATEQ oral liquid, orally, lot number L027076, expiration date 25-MAY-2017 (dose was not reported), which were improperly stored at 60 F for 1 hour and 30 minutes. There was no previous temperature excursion. Digital data logger and product quality complaint were not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient was administered a dose of PROQUAD (rHA, lot # M004889, expiration date 25-JUL-2017, intramuscular; dose was unknown). This was outside the recommendations per the PROQUAD prescribing information. No adverse effects was reported. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with GARDASIL 9 injection, lot number M011117, expiration date 07-DEC-2017 (dose, route and anatomical location of administration were not reported), which were improperly stored at 60 F for 1 hour and 30 minutes. There was no previous temperature excursion. Digital data logger and product quality complaint were not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-JUL-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect 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: This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 15-JUL-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dosage not reported) via subcutaneous (as per prescribing information recommendation). No adverse effects were reported. As of 19-JUL-2016, the cumulative/total excursion time: 23 hours and 10 minutes, highest temperature reached: 8.2F. No Product Quality Complaint (PQC) was involved. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unknown patients of unknown age. On an multiple unknown dates, these patients were vaccinated with RECOMBIVAX HB (lot # M000442, Exp: 31-MAR-2018; lot # M010671, Exp:02-JUN-2018). It was called because of a Digital Data Logger. These vaccines were stored under 1.2 degree Celsius for one hour. There was no temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dosage not reported) via subcutaneous (as per prescribing information recommendation). No adverse effects were reported. As of 19-JUL-2016, the cumulative/total excursion time: 23 hours and 10 minutes, highest temperature reached: 8.2F. No Product Quality Complaint (PQC) was involved. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unknown patients of unknown age. On an multiple unknown dates, these patients were vaccinated with GARDASIL (lot # K010215, Exp: 05-MAY-2017). It was called because of Digital Data Logger. These vaccines were stored under 1.2 degree Celsius for one hour. There was no temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown date, the patients were vaccinated with an improperly stored doses of M-M-R II recombinant human albumin status (lot# L030162, expiration date 11-AUG-2017; lot# L005290 expiration date 17-FEB-2017; dose, anatomical location and route of administration were not reported). No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-AUG-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, lot # K010465, expiry date 23-MAR-2016 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Hepatitis B antibody negative, Incorrect route of drug administration, Measles antibody positive, Mumps antibody test positive, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to a currently 21 years old female patient. Pertinent medical history included leukemia but the patient was currently in remission. Drug reactions/allergies and concomitant medications were reported as none. Physician reporting that a patient received 3 doses of RECOMBIVAX HB, 5/0.5 mcrg/ml, vaccination, but currently has negative antibody titers. Doses were administered on 18-OCT-1994, 27-DEC-1994 and 14-NOV-1995. Each dose was given 0.5 ml intramuscularly. The physician also said that the patient received 2 doses of M-M-R II and the patient currently has antibody titers for measles and mumps. However, the patient currently did not have antibody titers for rubella (rubella titer was negative). M-M-R II was administered on-29-APR-1996 and 30-AUG-1999. Each dose was given 0.5 ml intramuscularly. Confirmed that doses of M-M-R II were given intramuscularly. No treatment was given for the adverse events. The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2016 (dose and route of administration were not reported). There was no adverse effect 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: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Limb discomfort, Skin induration, Skin warm
Clinical narrative: Mild to moderate discomfort with movement of arm. Mild warmth to area. SQ induration and firmness of tissue. Interventions: heat / Massage.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Swollen raised area, reddened size 2x2 inches.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength and dose were unspecified). There were no concomitant medications provided. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain, Diarrhoea, Feeling hot, Pharyngitis, Pyrexia
Clinical narrative: Fever, diarrhea, acute pharyngitis, abdominal pain, vomiting. ZOFRAN was given on 8-12-16 for vomiting. She presented with fever. It is described as felt hot. The symptom is sudden in onset. The symptom started 1 days ago. The temperature is 103 degrees (maximum temperature) and 99 degrees (minimum temperature). Disease exposure includes no sick contacts. Important triggers include activity pt got MVC4 vac done on 8-11-2016 in left arm.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Fever, diarrhea, acute pharyngitis, abdominal pain, vomiting. ZOFRAN was given on 8-12-16 for vomiting. She presented with fever. It is described as felt hot. The symptom is sudden in onset. The symptom started 1 days ago. The temperature is 103 degrees (maximum temperature) and 99 degrees (minimum temperature). Disease exposure includes no sick contacts. Important triggers include activity pt got MVC4 vac done on 8-11-2016 in left arm.