chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a coworker, an adult patient of unknown age and gender. No medical history and current conditions were provided. On an unknown date the patient was vaccinated with two doses of hepatitis B vaccine (manufacturer unknown), intramuscular injection (lot number and expiration date were not provided). There was not concomitant medication reported. On an unknown date the patient was told need hepatitis B vaccine (manufacturer unknown) intradermal since he/she had two series of RECOMBIVAX HB intramuscular and the hepatitis B surface antibody was negative reported as "did not show immunity in blood work". The reporter did not assess the relatedness of B vaccine (manufacturer unknown) intramuscular injection with the hepatitis B surface antibody negative. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Rash, Skin adhesion
Clinical narrative: This spontaneous report was received from a 68 year old female consumer concerning herself, via Johnson and Johnson (30000287150), on 02-JUL-2015. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown), parenteral (anatomical location, dose number, lot number and expiration date were unspecified). On an unknown date in 2015, the patient experienced a patchy area on her arm (rash). Then, in approximately 13-MAY-2015, the patient started using Band-Aid Brand (sheer plastic extra-large), one bandage once a day, total of 6, to cover the affected area. After an unspecified duration, the patient noted the bandage adhesive was so stuck on her skin that it removed her skin and caused erythema and inflammation were the adhesive was applied. She applied hydrogen peroxide, NEOSPORIN Original Ointment and PROVODINE to treat the events. After an unspecified amount of time, the use of Band-Aid Brand was discontinued. The outcome of rash, erythema, skin adhesion and inflammation was reported as recovered/resolved on 10-JUN-2015. Additional information is not expected as no contact details were provided.
Age: 11.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Limb injury, Pruritus, Skin warm
Clinical narrative: Red raised area 3x3 in circle hot to touch and itchy mom said ice applied.
Age: 20.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Diarrhoea, Pyrexia, Rash, Vomiting
Clinical narrative: Rash, fever > 101, vomiting, diarrhea.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender who on 24-APR-2015, was vaccinated with a dose of ROTATEQ lot # K011663 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. Approximately in 2014, reported as "approximately year ago", the patient was vaccinated with her first dose of GARDASIL, one single shot, intramuscular (lot number and expiration date were not provided). No concomitant therapies were reported. The physician reported that the patient experienced Bell's palsy after being the vaccinated. The therapy with GARDASIL was discontinued. The outcome of VIIth nerve paralysis was unknown at the time of this report. The reporter did not provide a causality assessment for the event. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: This spontaneous report was received from a 67 year old no pregnant female consumer referring to herself with depression, allergy to CELEBREX and LYRICA. The patient's medical history included myalgia and hormone therapy. On 08-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # K007825: Exp 13-JAN-2016), intramuscular in the arm (dose was not provided). Concomitant therapies included an unspecified anti-depressant medication and unspecified hormone therapy medication. On 09-JUN-2015 (reported about 12 hours after getting the injection), the patient experienced injection site pain and her arm was swollen. The patient went from elbow to shoulder. (She took 3 ADVIL tablets, but that did not help relieve the pain). The patient also experience pyrexia that lasted four days. She experience chills, then hyperhidrosis during the four days. The patient had decreased appetite, dizziness, and was too fatigued to see her doctor. No treatment was given for the adverse events. No laboratory diagnostic test were performed. At the time of the report, the outcome of hyperhidrosis, fatigue, chills, pyrexia, injection site pain, peripheral swelling, pain in extremity, dizziness and decreased appetite was reported as recovering. Product quality compliance was not involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a 67 year old no pregnant female consumer referring to herself with depression, allergy to CELEBREX and LYRICA. The patient's medical history included myalgia and hormone therapy. On 08-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # K007825: Exp 13-JAN-2016), intramuscular in the arm (dose was not provided). Concomitant therapies included an unspecified anti-depressant medication and unspecified hormone therapy medication. On 09-JUN-2015 (reported about 12 hours after getting the injection), the patient experienced injection site pain and her arm was swollen. The patient went from elbow to shoulder. (She took 3 ADVIL tablets, but that did not help relieve the pain). The patient also experience pyrexia that lasted four days. She experience chills, then hyperhidrosis during the four days. The patient had decreased appetite, dizziness, and was too fatigued to see her doctor. No treatment was given for the adverse events. No laboratory diagnostic test were performed. At the time of the report, the outcome of hyperhidrosis, fatigue, chills, pyrexia, injection site pain, peripheral swelling, pain in extremity, dizziness and decreased appetite was reported as recovering. Product quality compliance was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored doses of VAQTA (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms reported. 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: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Influenza like illness, Myalgia, Restless legs syndrome
Clinical narrative: About 2 to 3 hours after vaccination, patient experienced pain in left arm at site of injection. The next day patient had muscle aches/pains, headache, fu-like symptoms. When she went to bed that night she had "restless" legs.  Pt said she took ibuprofen about every 4 hours and began to feel better. Today she feels much better but is tired and weak. No fever.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ oral (dose, dose number, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: 7x7 cm red/mild swelling/mild tender local petechiae/rash at vaccine area x 3 days.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Hot flush, Pain in extremity, Skin warm, Vomiting
Clinical narrative: Pt received PREVNAR-13 on 6/26 and in the pm, she had chills, hot flashes and threw up. Arm was very painful and warm.
Age: 0.36
Sex: F
Vaccine: RV5
Symptoms: Lip swelling
Clinical narrative: Right after dose given lower lip swelled-no other symptoms-rinsed off & observed.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Patient given PPV-23 7-14-15 (R) arm SQ developed a golf ball size redness, warm to touch. Treated with BACTRIM DS 800 mg 1 Q 12 hours.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient received HPV vaccine, then had episode of syncope 10 minutes later. Patient recovered and was able to leave 30 minutes later w/mom. Patient is "frequent fainter" per Mom.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Pain, Pyrexia
Clinical narrative: Per mother, approximately 24 hours after vaccine administration, patient developed a 104.2 fever with body aches and stomach ache. This morning, his temp was 99.9 without TYLENOL or MOTRIN.
Age: 1.05
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Hyperaesthesia, Injection site rash, Injection site reaction
Clinical narrative: Received varicella vaccine 9 days ago has a rash on right thigh size of a dime which has grown to size of quarter in two days sensitive to touch. Prescribed mupirocin topical cream for rash.
Age: 25.0
Sex: M
Vaccine: HPV4, YF
Symptoms: Breath sounds abnormal, Choking sensation, Disorientation, Dyskinesia, Feeling hot
Clinical narrative: Patient arrived at Immunizations clinic to receive vaccines. HM administered the Gardasil vaccine in his right deltoid and Yellow Fever left arm around 1458 to 1500. Seconds after receiving vaccines, Pt stated he was feeling very warm and began sweating, flush, pale, and requested water. Pt transported from chair to exam table with feet elevated. Pt drank water and stated he was feeling better and proceeded and to sit in chair after only 2-3 minutes. While monitoring Pt in chair he suddenly became non responsive to verbal command.  Skin looked pale, diaphoretic and had choking like symptoms, mouth clinched, cheeks puffy, head back with stiff neck. Also noted Pt began urinating, and jerking movement with making groggy sounds to indicate still breathing.
Age: 25.0
Sex: M
Vaccine: HPV4, YF
Symptoms: Flushing, Hyperhidrosis, Musculoskeletal stiffness, Pallor, Posture abnormal
Clinical narrative: Patient arrived at Immunizations clinic to receive vaccines. HM administered the Gardasil vaccine in his right deltoid and Yellow Fever left arm around 1458 to 1500. Seconds after receiving vaccines, Pt stated he was feeling very warm and began sweating, flush, pale, and requested water. Pt transported from chair to exam table with feet elevated. Pt drank water and stated he was feeling better and proceeded and to sit in chair after only 2-3 minutes. While monitoring Pt in chair he suddenly became non responsive to verbal command.  Skin looked pale, diaphoretic and had choking like symptoms, mouth clinched, cheeks puffy, head back with stiff neck. Also noted Pt began urinating, and jerking movement with making groggy sounds to indicate still breathing.
Age: 25.0
Sex: M
Vaccine: HPV4, YF
Symptoms: Swelling face, Thirst, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Patient arrived at Immunizations clinic to receive vaccines. HM administered the Gardasil vaccine in his right deltoid and Yellow Fever left arm around 1458 to 1500. Seconds after receiving vaccines, Pt stated he was feeling very warm and began sweating, flush, pale, and requested water. Pt transported from chair to exam table with feet elevated. Pt drank water and stated he was feeling better and proceeded and to sit in chair after only 2-3 minutes. While monitoring Pt in chair he suddenly became non responsive to verbal command.  Skin looked pale, diaphoretic and had choking like symptoms, mouth clinched, cheeks puffy, head back with stiff neck. Also noted Pt began urinating, and jerking movement with making groggy sounds to indicate still breathing.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 24 year old female patient. Medical history and concurrent conditions were not reported. The patient had received 2 doses of MMR II on unspecified dates, when she was a child. On 07-APR-2015, the patient was vaccinated with a booster dose of MMR II. Concomitant medications were not provided. The patient was seen by her healthcare provider on 22-MAY-2015 and had titers drawn which showed negative immunity for measles, mumps and rubella. The patient sought medical attention (was seen by an unspecified healthcare provider). The nurse also stated the patient was currently pregnant; she was in her early pregnancy because she had her menstrual period last month approximately on an unknown date in April 2015. The pregnancy outcome was outcome pending. No treatment was provided for the events. Action taken with the vaccine was not applicable. The outcome of antibody test negative and exposure during pregnancy was unknown. The causality was not provided for the event antibody test negative. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on neck, chest, back and groin. Mother called nurse at state health center who directed her to go to ER (child had no swelling of the face, tongue or lips, no respiratory distress). Child treated with Benadryl and oral steroid (Prelone). Spoke with mother 9:00am 7/17/15, child slept well and much improved this morning, hives clearing up, almost gone.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On unspecified dates, the patient received 2 doses of M-M-R II vial subcutaneous. Concomitant medications were not reported. On an unspecified date in April 2015, the patient had a blood titer that was negative for MMR antibodies (antibody test negative). It was unspecified if the patient sought medical attention. Action taken with the vaccine was not applicable. The outcome of antibody test negative was unknown. The causality was not reported by the reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Rash macular
Clinical narrative: (L) upper ext with 6 x 3 inches erythema macular no pustules no vesicles warm mild swelling.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received series of GARDASIL, intramuscularly (dose, frequency, lot#, expiration date and indication were not reported), that didn't confirm to the normal 0, 2 months and 6 months scheduling. No known adverse effects were 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 nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ oral liquid (strength, dose, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Injection site infection, Skin warm, Swelling
Clinical narrative: Raised hot bump with a diameter of 5 inches.  At 7am 7/16/15 diameter was 8 inches.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient called in on 7/16 to report a reaction to the Pneumovax. He says he has a 2"x5" red, raised patch in the area of the vaccination. He said it is swollen, but not painful except painful to the touch. It started the morning after vaccine administration, but has not worsened throughout the day.
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Patient returned to clinic 2 weeks post Rabavert # 2 injection with complaints of ongoing muscle pain and soreness at the site of the injection. Pain began hours after injection was given. Pain has not worsened but it has not diminished in intensity.  Patient reports that pain is localized to the site of the injection on the right arm. Pain is felt when she moves her arm or rotates her arm a certain way and occurs intermittently during certain physical activities. Patient reports that she has been self medicating with over the counter ibuprofen, taking 800 mg as needed for pain.  She reports that the ibuprofen alleviates the pain. Patient was evaluated by Dr. in office 07/16/15 at which recommendations were given and a follow-up scheduled in one week with this practice.  It was recommended by Dr. that if pain persists, that patient seek further follow-up with primary care physician.
Age: 1.52
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Dyskinesia, Eye movement disorder, Seizure
Clinical narrative: CHILD HAD SEIZURE JERKING MOVEMENT EYES ROLLED BACK LASTED FOR ABOUT 3 MINUTES NO TREATMENT DID NOT GO TO ER OR MD TILL 07/16/2015 TEMP 100.5 HAS HAD 3 SEIZURES BEFORE NOT RELATED TO VACCINE THOUGHT TO BE FEBRILE.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Seizure, Syncope, Tearfulness
Clinical narrative: Patient became unconscious shortly after the vaccines were administered. Patient fell off exam table and parent pick him up and placed him on the table. Nursing responded to exam room and found patient unconscious and incontinent of urine. Vital signs were stable. 911 was initiated and patient was taken to ED by ambulance. Patient regained consciousness prior to ambulance arrival. Patient was tearful but alert and oriented x3.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Urinary incontinence
Clinical narrative: Patient became unconscious shortly after the vaccines were administered. Patient fell off exam table and parent pick him up and placed him on the table. Nursing responded to exam room and found patient unconscious and incontinent of urine. Vital signs were stable. 911 was initiated and patient was taken to ED by ambulance. Patient regained consciousness prior to ambulance arrival. Patient was tearful but alert and oriented x3.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On an unspecified date, patients were vaccinated with improperly stored VAQTA (dose, route of administration, lot#, expiration date and indication were not reported). No adverse effects were reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from physician, via a company representative, refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with his first dose of GARDASIL, 0.5 ml, intramuscular (lot number and expiration date were not provided). No concomitant therapies were reported. According to the physician, the patient "felt faint" (dizziness) after being vaccinated with his first dose of GARDASIL, but felt fine after his second and third doses. The patient did not receive any treatment for his adverse event, however he went to the doctor for medical attention. The outcome of dizziness was reported as recovered on an unspecified date. The reporter did not provide a causality assessment for the event. 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 nurse refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 14-JUL-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (dose strength, route unspecified) lot # L006388, expiration date 25-AUG-2016. No symptoms reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1507USA007770 via same reporter link. 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 nurse refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 14-JUL-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) (dose strength, route unspecified) lot # L001332, Expiration date 13-JAN-2017. No symptoms reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1507USA007833 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with PROQUAD (Merck) (dose strength, route unspecified) lot # K003817, expiration date 14-SEP-2015 and VARIVAX (Merck) (dose strength, route unspecified) (lot K008824, expiration date 19-JUN-2016 during the same visit (overdose). No symptoms reported. The outcome of events reported was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On an unspecified date, patients were vaccinated with improperly stored GARDASIL (dose, frequency, route of administration, lot#, expiration date and indication were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of VAQTA (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports 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 nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses (RECOMBIVAX HB) (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: ANTH, TYP, YF
Symptoms: Bleeding time prolonged, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Petechiae, severe thrombocytopenia, prolonged bleeding.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: 7/7/2015 pt developed hives on left neck and shoulder and then progressed to neck/chest/arms. Attending physician prescribed topical steroid. Pt improving. Hives still noticeable 7/12/15.
Age: 53.0
Sex: U
Vaccine: HEP, PPV
Symptoms: Induration, Injection site pain, Injection site pruritus, Injection site swelling, Peripheral swelling
Clinical narrative: Vaccine PNEUMOVAX (PSV23) administered on left forearm during office visit at 11:45 AM. Pt. returned to the center at 8:30 PM with complains of swelling, burning, itchiness, tenderness in area of injection. No redness. No N/V. Arm is swollen, hard to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Pt's mother brought him in today with redness noted to his Rt leg where he received his MMRV injection on 7/14/15. Pt's mother states his leg started getting red later in the evening that same day. Pt has not been running a fever and his leg is not warm to touch at this x. Pt's mother instructed to apply cool compresses to area several x's a day and if redness starts to spread, to take pt to doctor for evaluation and treatment. Mother verbalized understanding.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cardiac function test, Chest pain, Computerised tomogram thorax, Dyspnoea, Laboratory test
Clinical narrative: Arm pain, fever, shortness of breath, chest pain and wheezing.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pulmonary function test, Pyrexia, Wheezing
Clinical narrative: Arm pain, fever, shortness of breath, chest pain and wheezing.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: MMR, VAR and KINRIX given to pt who was anxious. Within seconds broke out in hives and complete rash head to toe. Pt checked no SOB or other sx given BENADRYL 2 Tsp and within seconds rash disappearing. Called and checked on afternoon mom said rash gone site areas also fine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored ZOSTAVAX (lot #, expiration date, dose and route were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot #K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning an adult patient of an unknown age and gender who on 15-JUL-2015 was vaccinated with a dose of GARDASIL (manufacturer unknown) (lot # K006960) (dose and route not reported) that underwent a temperature excursion during 63 hours. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored MMR II (lot #, expiration date, dose and route were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.
Age: 1.13
Sex: F
Vaccine: MMR
Symptoms: Erythema, Local swelling, Urticaria
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 month old female patient with no drug reactions or allergies and with no medical history. No concomitant medications were reported. On an unspecified date in February 2015, the patient was vaccinated with a dose of MMR II, (dose, route of administration, injection site, lot number and expiration date were not reported). It was reported that after the vaccination the patient developed a 1 inch red "hive-like" bump near the injection site (on an unspecified date in February 2015). According to the reporting medical assistant, the child was observed for 20 minutes and the red bump diminished during that time, but it did not disappear completely by the time the patient left the office. The patient did not seek medical attention. No laboratory diagnostic studies were performed and no treatment was given for the event. The outcome of a 1 inch red "hive-like" bump near the injection site was reported as recovering at the time of the report. The relatedness between the event and MMR II was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via field employee refers to unspecified male patients older than 15 years of age. The nurse reported that GARDASIL 9 has been adminsitered to boys older than 15 years (lot number, dosing details unknown). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. 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 healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning an adult patient of an unknown age and gender who on 06-MAY-2015 was vaccinated with a dose of GARDASIL (manufacturer unknown) (lot # K006960) (dose and route not reported) that underwent a temperature excursion during an unknown amount of hours. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 50 year old female patient with penicillin allergy and no pertinent medical history. On 10-JUL-2015, the patient was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (lot number and expiration date not reported). There was no concomitant therapy. On 10-JUL-2015, the patient experienced a large, hard lump around the injection site after she received the vaccine shot. The patient reported the lump felt itchy and an unspecified hot sensation. There were no treatment given to the patient for the events. There were no lab diagnostics studies performed. The patient reported that the hot sensation lasted for five days and it was no longer there on 15-JUL-2015. The lump around the injection site had gone away on an unknown date in July 2015. The outcome of the lump felt itchy was reported as recovering. The patient sought medical attention (called the pharmacist). The relatedness between the events and the ZOSTAVAX was not reported. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 04-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Bronchitis, Diarrhoea, Epstein-Barr virus test, Eructation
Clinical narrative: Bronchitis, headaches, rapid heartbeat, low grade fever, tremors, anxiety attacks, exhaustion, blurred vision-night blindness, tongue sensitivity, heat intolerance, diarrhea, burping, gagging, vomiting bile, urinary incontinence, numbness in arms and legs, brain fog, hernia.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Full blood count, Glossodynia, Headache
Clinical narrative: Bronchitis, headaches, rapid heartbeat, low grade fever, tremors, anxiety attacks, exhaustion, blurred vision-night blindness, tongue sensitivity, heat intolerance, diarrhea, burping, gagging, vomiting bile, urinary incontinence, numbness in arms and legs, brain fog, hernia.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Hernia, Hypoaesthesia, Mycobacterium test, Mycobacterium tuberculosis complex test
Clinical narrative: Bronchitis, headaches, rapid heartbeat, low grade fever, tremors, anxiety attacks, exhaustion, blurred vision-night blindness, tongue sensitivity, heat intolerance, diarrhea, burping, gagging, vomiting bile, urinary incontinence, numbness in arms and legs, brain fog, hernia.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Night blindness, Nuclear magnetic resonance imaging brain, Pyrexia, Retching, Temperature intolerance
Clinical narrative: Bronchitis, headaches, rapid heartbeat, low grade fever, tremors, anxiety attacks, exhaustion, blurred vision-night blindness, tongue sensitivity, heat intolerance, diarrhea, burping, gagging, vomiting bile, urinary incontinence, numbness in arms and legs, brain fog, hernia.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Urinary incontinence, Urine analysis, Vision blurred, Vomiting
Clinical narrative: Bronchitis, headaches, rapid heartbeat, low grade fever, tremors, anxiety attacks, exhaustion, blurred vision-night blindness, tongue sensitivity, heat intolerance, diarrhea, burping, gagging, vomiting bile, urinary incontinence, numbness in arms and legs, brain fog, hernia.
Age: 1.51
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Crying, Decreased appetite, Ear infection, Irritability
Clinical narrative: 105 degree fever x3 days, very weak, loss appetite, got easily irritated, her cry changed, runny nose, rash on belly or chest, ear infection.
Age: 1.51
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rhinorrhoea
Clinical narrative: 105 degree fever x3 days, very weak, loss appetite, got easily irritated, her cry changed, runny nose, rash on belly or chest, ear infection.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient remained in immunization room for observation after shots given. When pharmacist returned pt. was slumped in chair. Pt was awake but non-responsive for approx 2 mins. EMS arrived approximately 5 mins later. Pt was responsive and cognitive by that time.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site discolouration, Injection site reaction, Rash macular, Screaming, Seizure
Clinical narrative: 20 min. following immunization while still in the office, began screaming and developed marked purplish skin of both lower extremities with red blotches and one or two very small hive like lesions which evidently has recurred 3 wks later at home. Small short term (5 second) convulsive seizure 45 min. following immunization only once.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: 20 min. following immunization while still in the office, began screaming and developed marked purplish skin of both lower extremities with red blotches and one or two very small hive like lesions which evidently has recurred 3 wks later at home. Small short term (5 second) convulsive seizure 45 min. following immunization only once.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Pain in jaw, Toothache
Clinical narrative: Four days after receiving shot my jaw and teeth and temple, mostly on the right side of my head would ache, sometimes intensely for 10-30 minutes then would completely go away for hours. This continued for about 6 weeks then the discomfort went away.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient received a duplicate PREVNAR 13. Had just received on 2/23/2015.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Angioedema, Lip swelling, Swelling face
Clinical narrative: Extreme swelling of upper lips and both cheeks. Steroid and PEPCID given. Observation for 2-4 hours in ER. Diagnose: angioedema (facial only). Steroid x7 day given with prescription for EPIPEN. 2 wks b/f edema had going down gradually.
Age: 1.08
Sex: F
Vaccine: MMR, PNC13
Symptoms: Malaise, Pyrexia, Rash, Rash erythematous, Vaccination complication
Clinical narrative: Patient received vaccine 5/19/15 the next day fever and not feeling well. 5/28 patient started with rash on back and belly. Red raised bumps with a lighter ring around each spot. 5/30 rash spread to head and face and more severe on trunk of body. Went to a urgent care. They said it was a "MMR rash" from the vaccine it will go away on its own no treatment given. They instructed mom to have provider report the reaction.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unspecified dates in 2013, the patient was vaccinated with the first and second dose of GARDASIL (dose, route, lot # and expiration date were not reported). It was reported that the patient would received the third dose of GARDASIL on 15-JUL-2015 (reported as today). There was no adverse effects reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Fainted after varicella, Tdap, HPV and meningo. Had not eaten since 8am. Vaccines given at 4pm.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Mother states child developed hives around Rt injection site, patient was itching at area. Hives resolved on own after 24 hours, no other symptoms noted by mother.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored PROQUAD (Merck) (lot #, expiration date, dose and route were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: 12 hrs after injection...unable to move arm more than 12 inches from my side.  Pain on moving arm.  Three weeks later able to move arm somewhat higher but still painful.  Pain on sleeping also.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At injection site, swollen (2x3 inch circle), red, warm to touch, purple bruise, pain.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 03-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. The patient's medical history and current conditions were  not provided. On an unknown dates, the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot #, expiration date, dose and route were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of, oral, ROTATEQ lot # K010221, K01163, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administration were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the reporting healthcare professional on 02-JUL-2015, who informed that a patient was vaccinated on 09-JUN-2015 with a dose of oral, ROTATEQ lot # K016313, expiration date not reported (administration route was not provided). According to the reporter the vaccine dose that was administered underwent a temperature excursion for 87 hours. This 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: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 06-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 (route and dose were not provided) that was exposed to temperatures outside of the recommended range during an unknown number of hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter.
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 an unknown age and gender who on 15-MAY-2015 was vaccinated with a dose of oral, ROTATEQ (lot # K016313) (expiration date, dose and route not reported) that was 12 hours in temperature excursion. No adverse effects had been observed or 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: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 08-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.