chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Injection site pain, Injection site swelling
Clinical narrative: Woke up with large, painful swelling of outer right thigh from injection site to knee.  Child limping and complaining of pain. Right thigh measured 29.5cm and left thigh measured 27.75cm on 10/27/15.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Redness/ swollen area/knot in arm at injection site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Headache, Hypoaesthesia
Clinical narrative: Patient described having headache, numbness on forehead and burning on back of her neck stretching down left trap muscle. Sensation and numbness have diminished gradually but she says it is still present as of a week.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Patient has had pain in her shoulder area since the injection that has not gone away.  She has limited range of motion in her arm, as she cannot move it across her body hardly at all.  She has had difficulty sleeping, and has been sleeping in a chair.  On 10/26/15, she had seen her primary care doctor about it.  Patient was prescribed a Medrol Dosepak and 60 tabs of tramadol 50mg q8h prn pain.  That was the last contact we made with the patient.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient lost range of motion in left arm where vaccine was administered and is still feeling pain in said arm.
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Pt called 10/27/15 and complained of severe muscle pain. His arm could not lift. Severe GI s/e. Pain level very high.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Nausea, Palpitations, Throat tightness
Clinical narrative: "Received shot around 4 pm. Between 6-630 pm, my throat was closing up, I had chills, nausea, my heart was racing and I was light-headed. I took BENADRYL and a half-hour later, I felt better."
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Cheilitis, Rash
Clinical narrative: Upper lip rash/anterior neck rash. Treat with oral antihistamine.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Cough, Pharyngeal oedema
Clinical narrative: Transient swollen throat leading to cough. Current status: ok, wanted note did not see MD.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV4, MENB, MNQ
Symptoms: Muscle tightness, Pain, Pain in extremity
Clinical narrative: Shortly after receiving vaccines patient experienced jaw tightness predominantly on right side this decreased/resolved by 10-28-15 but then patient complained of shooting pains in left leg. Doing much better today (10-29-15).
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test normal, Pyrexia, Somnolence
Clinical narrative: Pt was given FLUZONE TIV on 10-14-15, developed fever to 103 for 1.5 days with somnolence. Excessive sleepiness has persisted x 2+ weeks now. Labs and imaging unremarkable. Continues to sleep 14-16 hours per day.
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Dizziness, Vomiting
Clinical narrative: 3:41 PM: Client reported dizziness and vomited. 3:42 PM: With assistance from client's father, client lowered to floor, feet raised, cold compress given. 3:52 PM Client had juice and reported feeling "better", client assisted to seated position in chair. 3:54 PM Client vomited again and asked to return to lying position on floor. Client reported feeling dizzy. 3:56 PM EMS called. 4:04 PM EMS arrived and assessed client. 4:13 PM EMS transported client to hospital for assessment.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash developed behind patient's neck within 24 hours of vaccination. It's possible that something else caused the reaction. Rash was red and bumpy and covered an area approximately 1 inch by 1 inch.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PAIN, REDNESS AND SWELLING AT INJECTION SITE.
Age: 66.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity
Clinical narrative: Constant pain in the right arm only relieved when arm is in movement.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling
Clinical narrative: At this time (20:45), only has upper lip swelling. I'm treating with steroids and Benadryl.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Decreased appetite, Dysgeusia, Fatigue, Headache
Clinical narrative: Commenced with a metallic taste in mouth, congestion in the back of the throat and tingling around lips/mouth. 25mg Benadryl followed by 25mg within 30 minutes to control allergic symptoms. Onset of severe chills followed almost immediately, lasting about 45 minutes. Fever of 101.  Naproxen given. Fever reduced.  Body aches, lost of appetite, headache and fatigue.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Increased upper airway secretion, Pain, Paraesthesia oral, Pyrexia
Clinical narrative: Commenced with a metallic taste in mouth, congestion in the back of the throat and tingling around lips/mouth. 25mg Benadryl followed by 25mg within 30 minutes to control allergic symptoms. Onset of severe chills followed almost immediately, lasting about 45 minutes. Fever of 101.  Naproxen given. Fever reduced.  Body aches, lost of appetite, headache and fatigue.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Raised, itchy, red area at site of injection.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Local swelling
Clinical narrative: Local swelling of roughly 1 inch in diameter immediately after the injection.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Rash
Clinical narrative: Patient has a rash on upper arm right above the elbow (cellulitis per MD) patient was put on an antibiotic to treat.
Age: 9.0
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Headache, Vomiting
Clinical narrative: Onset of severe headache followed by 1 episode of vomiting. Treated with PO fluids, Ibuprofen and rest.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Tender area, Round & swollen around injection site. Clothing bothered it and it begun to itch lasted for 3-4 days. I went back to pharmacy and RPh stated it was normal.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Arthropathy, Ehlers-Danlos syndrome, Malaise
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative concerning to a non-pregnant female patient of unknown age, who was the reporter's daughter. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On an unspecified date approximately in 2010 (reported as 5 years ago), the patient was vaccinated with GARDASIL intramuscular injection (strength, dose, route of administration, lot number and expiration date were not provided). The patient's mother reported that, in 2010 on the next day of the vaccination, the patient began to feel ill (malaise), developed migraines and began to have pain in her joints. After these symptoms occurred, the patient was admitted multiple times to the hospital on unspecified dates. Subsequently on an unknown date, the patient was diagnosed with Ehlers-Danlos Syndrome by an unspecified physician. Actually, the patient had been experiencing joint deterioration that, according to the reporter "has made it so, that the patient can no longer enjoy running". It was also reported that on an also unspecified date, a genetic test was also performed (results not provided). Finally, it was reported that the last time that the patient was discharged from the hospital was approximately on 13-OCT-2015 (reported as 2 weeks ago). No product quality complaints were reported. At the time of this report, the outcome of Ehlers-Danlos Syndrome was considered as not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative concerning to a non-pregnant female patient of unknown age, who was the reporter's daughter. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On an unspecified date approximately in 2010 (reported as 5 years ago), the patient was vaccinated with GARDASIL intramuscular injection (strength, dose, route of administration, lot number and expiration date were not provided). The patient's mother reported that, in 2010 on the next day of the vaccination, the patient began to feel ill (malaise), developed migraines and began to have pain in her joints. After these symptoms occurred, the patient was admitted multiple times to the hospital on unspecified dates. Subsequently on an unknown date, the patient was diagnosed with Ehlers-Danlos Syndrome by an unspecified physician. Actually, the patient had been experiencing joint deterioration that, according to the reporter "has made it so, that the patient can no longer enjoy running". It was also reported that on an also unspecified date, a genetic test was also performed (results not provided). Finally, it was reported that the last time that the patient was discharged from the hospital was approximately on 13-OCT-2015 (reported as 2 weeks ago). No product quality complaints were reported. At the time of this report, the outcome of Ehlers-Danlos Syndrome was considered as not recovered. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red, warm, and mildly tender. Redness extends from top shoulder to below elbow. Swelling noted as well.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Skin warm, Urticaria
Clinical narrative: Patient received FLUVIRIN MDV on 10/21/15. She called on 10/28/15 reporting hives, redness, and warmth in left arm on the day of immunization. Those symptoms subsided, then on 10/27/15 redness and rash on right hand appeared. That also subsided.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: Arm slightly red. About 2-3 inches wide and about 7 inches long: warm to touch. Slight bump where injection occurred. Does not hurt.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Momentary numbness of hand/left arm/left cheek. Dizziness. Both passed after 1-2 minutes. Took pt's BP=164/104. Pt stopped atenolol 2 wks earlier AMA. Asked pt to sit some more to retake BP. 5 min later he said he was ok. Referred to MD for BP check and advised to restart B.P. med.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt. got her flu injectable vaccine in RUE on 10/27/15 and presented back to clinic with a 3 3/4 inch diameter sore of erythema, swelling. TDP = heat to RUE. Rx BENADRY and cool compress.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema
Clinical narrative: Develop localized erythema on day of vaccination. Increased size and was taken to the ED on the following day. Given KEFLEX without response. Switched to clindamycin in 24 hours later with improvement in redness of the cellulitis.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral nerve infection
Clinical narrative: Patient stated that when she received her vaccine she experienced pain in her arm and was still experiencing this pain days later. She went to ER and doctor told her the vaccine "infected her nerve."
Age: 1.11
Sex: F
Vaccine: FLU3, HEPA, MMRV
Symptoms: Macule, Rash generalised
Clinical narrative: Pr had a generalized rash over the trunk of the body, pink, pinpoint macules with no crusting or drainage. Afebrile. Resolved <4 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea
Clinical narrative: Patient seen by PCP 10/28/15 and informed MD 2 day after receiving PCV13 she became short of breath.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with an improperly stored GARDASIL 9 (dose and route of administration were not provided: lot # L013429 and expiration date on 21-JUL-2017). No adverse effects were reported. No product quality compliant (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Information has been received from a pharmacist via a field representative to a 66 year old female patient. On 09-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX, lot # L012039, expiration date unknown (dose, dose #, route and application site were not reported). On 09-OCT-2015, "shortly after", the patient experienced "a rash that was raised and red" at the injection  following administration of ZOSTAVAX. Patient went to unspecified clinic where she was prescribed antibiotic cephalexin, and the rash went away after a few days. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 22-OCT-2015, the patient was vaccinated orally with a first, 2 ml doe of ROTATEQ (lot number reported as L008518 and expiration date 15-DEC-2016) at a little over six months of age. Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, concomitant medications, drug reactions or allergies provided. On 17-SEP-2015, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (strength reported as 0.5 (units not provided) (lot# K004148, expiration date 10-MAY-2016, dose, anatomical location and route of administration were not reported) and a dose of PREVANR 13 (lot# J67645, expiration date 03-MAR-2016, dose, anatomical location and route of administration were not reported). No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with either the second or third dose of GARDASIL after a longer than recommended interval, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Rash vesicular, Scab, Skin lesion
Clinical narrative: Information has been received from a licensed nurse practitioner referring to a 61 yeas old female patient with coronary artery disease, hypertension and hypothyroidism. The patient had unspecified reactions to azithromycin, benztropine mesylate (manufacturer unknown) dexamethazone, dolasetron mesylate, meperidine hydrochloride, phenothiazines, quinolone, sumatriptan, VIOXX. The patient had unspecified severe reaction to COMPAZINE, penicillin and hydrocodone caused the patient rash. SULA caused the patient a rash and facial swelling. On 25-SEP-2015 the patient was vaccinated with ZOSTAVAX (lot # L012476, expiration date 10-JUL-2016, dose and route were not reported. Concomitant therapies included aspirin (manufacturer unknown), calcium (unspecified) with vitamin d-3 (unspecified), levothyroxine sodium (manufacturer unknown) , lisinopril (manufacturer unknown) and simvastatin (manufacturer unknown). On 08-OCT-2015, the patient experienced rash and excruciating pain. On 10-OCT-2015 (reported as after two days), the pain was resolved. On 13-oCT-2015 the patient visited a physician and it was noted that the patient had multiple group lesions on the upper left back to midline and a vesicular   rash that was scabbing over. No treatment was given for the events and no lab diagnostics studies were performed. The outcome of vesicular rash and skin lesion was reported as recovering. The causality was not reported. This is one of the several reports from the same reporter concerning the same patient. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a licensed nurse practitioner referring to a 61 yeas old female patient with coronary artery disease, hypertension and hypothyroidism. The patient had unspecified reactions to azithromycin, benztropine mesylate (manufacturer unknown) dexamethazone, dolasetron mesylate, meperidine hydrochloride, phenothiazines, quinolone, sumatriptan, VIOXX. The patient had unspecified severe reaction to COMPAZINE, penicillin and hydrocodone caused the patient rash. SULA caused the patient a rash and facial swelling. On 25-SEP-2015 the patient was vaccinated with ZOSTAVAX (lot # L012476, expiration date 10-JUL-2016, dose and route were not reported. Concomitant therapies included aspirin (manufacturer unknown), calcium (unspecified) with vitamin d-3 (unspecified), levothyroxine sodium (manufacturer unknown) , lisinopril (manufacturer unknown) and simvastatin (manufacturer unknown). On 08-OCT-2015, the patient experienced rash and excruciating pain. On 10-OCT-2015 (reported as after two days), the pain was resolved. On 13-oCT-2015 the patient visited a physician and it was noted that the patient had multiple group lesions on the upper left back to midline and a vesicular   rash that was scabbing over. No treatment was given for the events and no lab diagnostics studies were performed. The outcome of vesicular rash and skin lesion was reported as recovering. The causality was not reported. This is one of the several reports from the same reporter concerning the same patient. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. Approximately in 2015, reported as within last month, the patients were vaccinated subcutaneously with doses of (Oka/Merck) VARIVAX injection (lot # L010148, L023592, L015046; dose and expiry dates were not reported). It was reported that a total number of 3 doses was administered. There were no concomitant therapies reported. Approximately in 2015, the patients returned to the clinic with "similar unspecified complaints", which were then confirmed to be cellulitis.  All of the patients received treatment with unspecified oral antibiotics. IT was reported that all of the vaccines were stored properly and prepared properly before the injections were given to the patients. There was no product quality complaint involved. The outcome of the event was not reported. The relatedness between (Oka/Merck) VARIVAX and the event was not provided.  This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant) refers to multiple unspecified patients of unknown age and gender. Medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # K026246, exp: 28-JAN-2017 and lot # L013429, exp: 21-JUL-2017 (dose, frequency and route of administration not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. No additional information available. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to two patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) injection (lot# L006389 and L021599; dose, route of administration and expiry dates were not reported). It was reported that a total number of 2 doses was administered. There were no concomitant therapies reported. On unknown dates, the patients returned to the clinic with "similar unspecified complaints", which were then confirmed to be cellulitis. All of the patients received treatment with unspecified oral antibiotics. The outcome of the event was not reported. The relatedness between PROQUAD and the event was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a female patient (unspecified age). On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (dose, dose #, lot # , route and application site were not reported). On an unknown date in October ("in the last week") the patient came into the pharmacy to report that she developed "a rash that was raised and red" at the injection site following administration of ZOSTAVAX. It was unknown if the patient received any treatment. The outcome of the event was unknown. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (Lot # reported as 1008354, expiry date: 11-SEP-2016). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a provider office representative via a company representative refers to a 20 year old female patient. The reporter stated that the patient was "perfectly healthy", no information regarding her medical history was provided. In approximately August 2015 (reported as "about a month ago"), the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly (dose, anatomical location, lot # and expiration date were not reported). Concomitant therapies were not reported. On an unknown date, approximately in 2015, the patient experienced severe injection site pain and she returned to the reporter's office on an unspecified date (reported as 'recently"). There was no swelling or bruising just pain. The outcome of severe injection site pain was reported as not recovered. The relatedness between GARDASIL 9 and the adverse event was not reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a 74 year old female patient. On 18-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX, lot # L012039, expiration date unknown (dose, dose #, route and application site were not reported). On an unknown date the patient called the pharmacy to report that she developed "a rash that was raised and red" at the injection site following administration of ZOSTAVAX. It was unknown if the patient received any treatment. The outcome of the event was unknown. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored doses of GARDASIL lot # K023432, expiration date 18-JUN-2016, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # reported as 1012038, expiry date 17-APR-2017) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports 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 certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (Lot # K021933, expiry date: 10-NOV-2016) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports 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 certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # K014040, expiry date: 22-JUL-2016) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports 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 certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot # K015944, expiry date: 23-SEP-2016). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple, unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored doses of GARDASIL lot # reported as L011846, expiration date 16-JUN-2017, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple, unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored doses of ROTATEQ lot # K017576, expiration date 12-JUN-2016, orally (dose, dose # and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple, unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored doses of M-M-R II lot # K011188, expiration date 12-AUG-2016 (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 27-OCT-2015, the patient was vaccinated with an dose of expired PNEUMOVAX 23 lot# K004542 with expiration date 19-AUG-2015 (dose, dose number and route were not reported) (expired product administered). No adverse symptoms were reported. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a physician via Pfizer referring to a 56 year old male patient with allergic to insulin beef, mycins, MMR II vaccine (captured in case# 1510USA008402), REGLAN, KEFLEX, TIAZAC and DARVOCET-N 100. The patient was a former smoker and did not drink alcohol. He quit smoking in 2013. On an unknown date the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (dose, route, lot# and expired date were unknown). No concomitant therapy was reported. On an unknown date the patient experienced allergy to the vaccine. The outcome of the event was unknown. 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 and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant medications were not reported. On unspecified dates,  unspecified patients were administered with an improperly stored RECOMBIVAX HB (dose and route of administration were not provided; lot #J012520 and expiration date on 30-JAN-2016). 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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (lot # J010668, expiration date 28-APR-2016, dose and frequency were unknown) intramuscularly. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 26-OCT-2015 the patient was vaccinated with one expired dose of GARDASIL (lot #H021346, expiration 01-OCT-2015, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 15 year old male patient. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with GARDASIL 9, (subcutaneous, dose not provided) for HPV prevention. No concomitant therapy was not reported. The patient experienced syncope after vaccination. The outcome of syncope was reported as recovering. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 56.0
Sex: M
Vaccine: MMR
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a physician via Pfizer referring to a 56 year old male patient with allergic to insulin beef, mycins, zoster vaccine (captured in case# 1510USA014354), REGLAN, KEFLEX, TIAZAC and DARVOCET-N 100. The patient was a former smoker and did not drink alcohol. He quit smoking in 2013. On an unknown date the patient was vaccinated with a dose of M-M-R II (dose, route, lot# and expired date were unknown). No concomitant therapy was reported. On an unknown date the patient experienced allergy to the vaccine. The outcome of the event was unknown. 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 certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot # K021486, expiry date: 03-NOV-2016). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports 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 unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored doses of ROTATEQ lot # K014826, expiration date 28-MAY-2016, orally (dose and dose # were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of male patients over the age of 15 years. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (dose, frequency, route of administration, lot # and expiration date were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with an improperly stored VAQTA (dose and route of administration were not provided; lot # was reported as L001068 with expiration date on 02-NOV-2017). 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 as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot # reported as 1013824, expiry date: 21-APR-2017) (incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with an improperly stored ROTATEQ (orally; dose was not provided; lot # reported as L008054 and expiration date on 30-NOV-2016). 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.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Injection site warmth
Clinical narrative: Patient had come in on 10/25/15 to report redness, warmth and inflammation on the upper arm in which vaccine was given. Redness, rash was persisting. Patient had reported event to her doctor.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Hypotonia, Pallor, Presyncope, Somnolence
Clinical narrative: Within 5-10 min after Hep A immunization given, child became pale and limp. She continued looking very pale and sleepy - although would open her eyes to verbal stimulation or tactile stimulation this went on for 3-4 min. Heart rate regular but could slow intermittently. Mom then passed out and child seemed to wake up and become concerned. Color regained. Heart rate regular. Suspect vasovagal reaction.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: 20 y/o AD female who developed a rash on 16 Oct 2015 (8 days post-receipt of SPV on 8 Oct 2015). Sought evaluation in ER. Itching and burning associated with rash. Initially thought to be autoinoculation and treated with ATARAX and ZYRTEC and placed on quarters. Followed up again on 20 Oct with rash spreading and itching more. On 21 Oct after the rash spread, covering her lower extremities and upper body. Also, SPV site with increased redness (erythematous border surrounding site about 3" in diameter) -> ER. Evaluation in ER, including consult with Dermatology, concluded rash was EM. Patient treated with SARNA menthol/Camphor topical lotion 2-3 times/day; Doxepin 25 mg at bedtime; Ranitidine 150 mg twice daily; Cetirizine 10 mg each morning. 23 Oct, rash resolving on arms and torso and itching decreased with medications. No significant change with rash on back and legs. No pain. No lesions in mouth. No systemic symptoms. 29 Oct, at follow up, reports itching now mild and rash continues to improve.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash macular
Clinical narrative: Patient got red blotches on his face. The patient was given 3ml of BENADRYL, he stayed happy and playful. The patient drank a bottle of formula and the redness resolved in 30-40 minutes. 10/26/15 stayed with mom and patient 45 min till symptoms resolved. Verified w/ mom on 10/27/15.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Pt received IM shot in right upper arm on 10/24/15 by intern. Pt. came to my counter today and showed me the arm. The lower (not upper muscle area) inside of arm was very red and quite swollen. It was even warm to the touch. She said it was not itchy. Recommended pt to see MD to examine arm.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Hallucination, Insomnia, Nasal congestion, Throat irritation
Clinical narrative: Patient states 4 hours after receiving vaccine he started having hallucinations, throat itching, loss of sleep, and nose clogged. Symptoms lasted for 3 days. Patient denied receiving any treatment. Patient reported symptoms when came in for 2nd dose of GARDASIL. Pt did not receive second dose of GARDASIL.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Blister, Cellulitis, Swelling
Clinical narrative: 48 hours post injection large swelling with cutaneous blisters. Treated for cellulitis.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Pt c/o chills, fever, joint aches/pains starting around 5 PM each day since getting ZOSTAVAX. "Hurts all over like the flu" temperature as high as 101.5. This AM 99.6 feels ok during the day. Injection site good per patient. He called Dr this AM-waiting for return call. Office suggested he take buffered ASA.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Contusion, Malaise, Pyrexia, Rash pruritic
Clinical narrative: Over the weekend had low grade fever and chills. On Monday developed bruising and rash that is itchy. Has malaise for several days.
Sex: U
Vaccine: PPV
Symptoms: Drug ineffective
Clinical narrative: This initial spontaneous report was received from a healthcare professional as part of a marketing research program conducted by HRA, referring to an unknown number of young children of unknown ages and genders. The patient's concurrent conditions, concomitant medication or medical history were not provided. The reporter stated that on unspecified dates the patient were vaccinated with PNEUMOVAX 23 injection (dose, route, lot# and expiration dates were not provided) but according to what he/she heard about the new "ACIP" recommendation regarding pneumococcal vaccines, it did not work and did not provide long-term protection. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oral mucosal blistering, Vaginal mucosal blistering
Clinical narrative: Blisters on mouth (2/23/15). Blisters in vaginal area (10/29/15).
Age: 25.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a 25 year old patient of unknown gender. The patient's medical history was not reported. On 27-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously, lot # L012039, expiration date reported as 07-JUL-2016 (site of administration was not reported) instead of intended VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: This spontaneous report was received from a 68 year old female patient, who was reporting on herself. The patient's pertinent medical history included high blood pressure and insomnia. She was allergic to codeine and penicillin. On 21-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, lot# and expiration date were not reported). The patient's concomitant medications included unspecified blood pressure medication. On 21-OCT-2015, after receiving ZOSTAVAX, the patient experienced swelling at the injection site and bumpy rash. The patient sought medical attention, she talked with pharmacist. No treatment was given to the patient for the events and no lab diagnostic studies were performed. The outcomes of the events were reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a currently 57 years old female subject (who is the physician also) regarding herself who was enrolled in a clinical trial for VARIVAX (Merck). The subject's concurrent conditions, relevant medical history and concomitant medications were not reported. On an unknown date in 1990 (reported as 25 years ago), the subject was vaccinated with VARIVAX (Merck) (dose and route unspecified) as part of a clinical trial. The subject could not remember if she received total of two or three doses of VARIVAX (Merck) in the clinical trial. On an unknown date, the subject's titer was drawn and she could remember being told that she did not develop good immunity to varicella after completing VARIVAX (Merck) doses (antibody test negative). Since vaccination was so long ago, the subject could not remember what the exact titer level was but she stated she did not seroconvert after receiving VARIVAX (Merck) doses from clinical trial. No treatment was rendered for the event and no product quality complaint was filed. The outcome of the event was unknown. The causal relationship of the event with study therapy and study procedure was not reported. 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 unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K020216, expiration date 17-SEP-2016, lot # K026666, expiration date 22-OCT-2016, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. 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 unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # K020214, expiration date 25-MAR-2016, orally (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot # reported as 1021215, expiry date: 10-JUN-2017) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in October 2015, the patient was vaccinated with VARIVAX (Merck) lot# L013827 exp. 21-APR-2017 (dose was not reported). The patient received a dose of VARIVAX (Merck) that was stored improperly. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter did not wish to be contacted.