chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates between 07-JUN-2016 and 08-DEC-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L043213 with expiry date on 28-AUG-2017, lot # L019297 with expiry date on 18-AUG-2017 and lot # L020015 with expiry date on 16-AUG-2017; dose and route of administration were not reported) for prophylaxis. On 07-JUN-2016, doses of GARDASIL 9 underwent a temperature excursion of minimum 25 degrees Fahrenheit for 12 hours prior to being administered. There were no known adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010752: US-009507513-1612USA010753: US-009507513-1612USA010751.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 13-NOV-2016 to 16-DEC-2016, the patients were vaccinated with improperly stored doses of VARIVAX, subcutaneous, lot# M000756 with expiry: 06-JAN-2018 and lot# L042267 with expiry: 27-OCT-2017, for prophylaxis. The vaccine lot#s had temperature excursion of 22.53 degree Fahrenheit for 7 hours 36 minutes. It had no previous temperature excursion. The call was because of data logger. This is one of two cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA009714:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of VAQTA injection, (lot # M036459; expiration date: 18-JUN-2018), (route of administration, strength and dose were not reported) for prophylaxis. The temperature excursion with VAQTA was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010295: US-009507513-1612USA010293:US-009507513-1612USA010294: US-009507513-1612USA003446: US-009507513-1612USA010292:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of RECOMBIVAX HB injection, (lot # M033334; expiration date: 11-AUG-2018), (lot # reported as M034894; expiration date: 11-NOV-2018), (route of administration, strength and dose were not reported) for prophylaxis. The temperature excursion with RECOMBIVAX HB was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010295: US-009507513-1612USA010293: US-009507513-1612USA010294: US-009507513-1612USA010291: US-009507513-1612USA003446:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates between 07-JUN-2016 and 08-DEC-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L048236 with expiry date on 31-MAR-2018, lot # L039660 with expiry date on 04-FEB-2018 and lot # L040458 with expiry date on 04-FEB-2018; dose and route of administration were not reported) for prophylaxis. On 07-JUN-2016, administered doses of RECOMBIVAX HB underwent a temperature excursion of minimum 25 degrees Fahrenheit for 12 hours prior to being administered. There were no known adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010752: US-009507513-1612USA010753: US-009507513-1612USA004642.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates between 07-JUN-2016 and 08-DEC-2016, the patients were orally administered the improperly stored doses of ROTATEQ (lot # L039638 with expiry date on 23-AUG-2017, lot # L037574 with expiry date on 01-JUL-2017 and lot # L039297 with expiry date on 19-JUN-2017; dose was not reported) for prophylaxis. On 07-JUN-2016, doses of ROTATEQ underwent a temperature excursion of minimum 25 degrees Fahrenheit for 12 hours prior to being administered. There were no known adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004642: US-009507513-1612USA010753: US-009507513-1612USA010751.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates between 07-JUN-2016 and 08-DEC-2016, the patients were vaccinated with improperly stored doses of VAQTA (lot # M009377 with expiry date on 17-JUN-2017 and lot # M011116 with expiry date on 17-JUN-2017; dose and route of administration were not reported) for prophylaxis. On 07-JUN-2016, doses of VAQTA underwent a temperature excursion of minimum 25 degrees Fahrenheit for 12 hours prior to being administered. There were no known adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010752: US-009507513-1612USA004642: US-009507513-1612USA010751:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored GARDASIL 9 lot# M036059, expiry date: 03-JUN-2019 for prophylaxis (dosing details not reported). Temperature was reported as 51.6 F and time frame was 2 hours 20 minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored M-M-R II, lot# M014902, expiry date: 22-MAR-2018 for prophylaxis (dosing details were not reported). Temperature was reported as 51.6 F and time frame was 2 hours 20 minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports due to the same reporter. 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 regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored RECOMBIVAX HB lot# M026309, expiry date: 11-NOV-2018 for prophylaxis (dosing details were not reported). Temperature was reported as 51.6 F and time frame was 2 hours 20 minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports due to 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 regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored ROTATEQ lot# M031807, expiry date: 02-APR-2018 for prophylaxis (dosing details not reported). Temperature was reported as 51.6 F and time frame was 2 hours 20 minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved.  This is one of the several reports due to the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored PNEUMOVAX 23 lot# M042785, and expiry date: 17-JUN-2018 for prophylaxis (dosing details were not reported). Temperature was reported as 51.6 F and time frame was 2 hours 20 minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Injection site redness,erythema,and pruritus, induration of the area, about  one inch on the upper part of the lesion. Treatment: Cephalexin 500mg course given for 7 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, redness, and swelling.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site mass, Lymphadenopathy, Mobility decreased, Pain in extremity
Clinical narrative: Sunday Afternoon/Evening: Patient developed a fever and chills, which subsided after 1 day. Monday: Patient developed soreness in arm and was unable to lift arm. Tuesday: Patient started to feel a little better but still had arm soreness. Patient currently has golf-ball sized lump at the injection site and swollen glands in neck on the same side of the body as the injection.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Sunday Afternoon/Evening: Patient developed a fever and chills, which subsided after 1 day. Monday: Patient developed soreness in arm and was unable to lift arm. Tuesday: Patient started to feel a little better but still had arm soreness. Patient currently has golf-ball sized lump at the injection site and swollen glands in neck on the same side of the body as the injection.
Age: 79.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Sleep disorder
Clinical narrative: Patient states she has had redness and some swelling at the injection site since she got the vaccine.  She also stated she is having extreme joint pain that is waking her up at night.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Right thigh, 5 inch by 4 inch red inflamed reaction hot to the touch.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: High fever, chills, rigor, severe headache, profuse sweating, joint, muscle pain.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever, chills, rigor, severe headache, profuse sweating, joint, muscle pain.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: High fever, chills, rigor, profuse sweating, joint and muscle pain, severe headache.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: High fever, chills, rigor, profuse sweating, joint and muscle pain, severe headache.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Swelling, soreness, redness at injection site. Progressed to pain and difficulty raising arm. Spiked fevers in excess of 101 degrees within 24 hours. Symptoms progressed to swollen painful lymph nodes throughout the body, swollen hands, increased erythema at injection site 6"x8", raised, hot to touch, painful, stiffness of shoulder and elbow joints on side of injection. Was seen by primary physician, prescribed Prednisone and antibiotics.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth, Joint stiffness, Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling, soreness, redness at injection site. Progressed to pain and difficulty raising arm. Spiked fevers in excess of 101 degrees within 24 hours. Symptoms progressed to swollen painful lymph nodes throughout the body, swollen hands, increased erythema at injection site 6"x8", raised, hot to touch, painful, stiffness of shoulder and elbow joints on side of injection. Was seen by primary physician, prescribed Prednisone and antibiotics.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Swelling, soreness, redness at injection site. Progressed to pain and difficulty raising arm. Spiked fevers in excess of 101 degrees within 24 hours. Symptoms progressed to swollen painful lymph nodes throughout the body, swollen hands, increased erythema at injection site 6"x8", raised, hot to touch, painful, stiffness of shoulder and elbow joints on side of injection. Was seen by primary physician, prescribed Prednisone and antibiotics.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUC4, MMRV
Symptoms: Injection site haematoma, Injection site rash
Clinical narrative: Rash, hematoma on right thigh at area of injection. Left thigh which also received vaccination had no reaction.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Varicella vaccine was given intramuscular.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Acute respiratory distress syndrome, Death, Endotracheal intubation, Enterovirus test positive, Extracorporeal membrane oxygenation
Clinical narrative: Had URI, fever, developed respiratory distress, intubated in ER, ARDS ECMO, coded x2 died 12/18/2016.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Human metapneumovirus test positive, Pyrexia, Respiratory distress, Upper respiratory tract infection
Clinical narrative: Had URI, fever, developed respiratory distress, intubated in ER, ARDS ECMO, coded x2 died 12/18/2016.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Disturbance in attention, Dizziness, Muscle spasms, Myalgia
Clinical narrative: Extreme dizziness, lightheadedness, lack of concentration, muscle aches/ spasms. Muscle aches /spasms lasted for 6 days.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Abdominal pain upper, Dizziness, Emotional distress, Influenza like illness
Clinical narrative: Flu like symptoms, nausea, dizziness, losing control, intestinal distress, congestion.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Respiratory tract congestion
Clinical narrative: Flu like symptoms, nausea, dizziness, losing control, intestinal distress, congestion.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Asthenia, Cold sweat, Dizziness, Influenza like illness
Clinical narrative: Flu like symptoms, intestinal distress, feeling of light headed, dizziness, cold sweat, weakness.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Alopecia, Aphthous ulcer, Cardiac murmur, Enamel anomaly
Clinical narrative: I received first HPV vaccine 2/2/16 & second HPV vaccine 7/6/6/2016. A couple months following I noticed these symptoms: severe persistent headaches, extreme fatigue, abdominal pain, food intolerance, sore throat in the mornings, multiple canker sores@ one time, hair loss/bald spot, yeast infections, change in menstrual cycle, heart murmur, teeth enamel missing.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Food intolerance, Fungal infection, Headache, Laboratory test
Clinical narrative: I received first HPV vaccine 2/2/16 & second HPV vaccine 7/6/6/2016. A couple months following I noticed these symptoms: severe persistent headaches, extreme fatigue, abdominal pain, food intolerance, sore throat in the mornings, multiple canker sores@ one time, hair loss/bald spot, yeast infections, change in menstrual cycle, heart murmur, teeth enamel missing.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Menstrual disorder, Oropharyngeal pain
Clinical narrative: I received first HPV vaccine 2/2/16 & second HPV vaccine 7/6/6/2016. A couple months following I noticed these symptoms: severe persistent headaches, extreme fatigue, abdominal pain, food intolerance, sore throat in the mornings, multiple canker sores@ one time, hair loss/bald spot, yeast infections, change in menstrual cycle, heart murmur, teeth enamel missing.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Irritability, Pyrexia
Clinical narrative: Mother states that when dressing child this am, she noted redness to thighs bilaterally. Assessed in clinic @ 3:15 with fever (102.6 Tympanic) and fussiness.  Ibuprofen adm. with good results. Improvement of all symptoms on 12/15/16 per Mother.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath, tightness in chest.  Patient treated himself with Benadryl and inhaled albuterol.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Febrile convulsion
Clinical narrative: Complex febrile seizure.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased, Throat irritation, Tongue pruritus
Clinical narrative: Pt complained of itchy throat and tongue, light headed, dizzy, increased heart rate.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Pt presented with sore throat, fever, and rash.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Left arm-swelling, redness and itching throughout arm. Came in two days later to show me-a few hives still, red circle where vaccine was and swollen arm. This is her second dose of TWINRIX.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, HEPA
Symptoms: Biopsy, Myofascitis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of macrophagic myofasciitis in a patient who received HAVRIX. Co-suspect products included INFANRIX and PEDIARIX. On an unknown date, the patient received HAVRIX at an unknown dose, INFANRIX at an unknown doses and PEDIARIX at an unknown dose. On an unknown date, several years after receiving HAVRIX, INFANRIX and PEDIARIX, the patient experienced macrophagic myofasciitis. On an unknown date, the outcome of the macrophagic myofasciitis was unknown. It was unknown if the reporter considered the macrophagic myofasciitis to be related to HAVRIX, INFANRIX and PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received about 15 vaccines in the year 2012 to 2014, three of them were GlaxoSmithKline vaccines (HAVRIX, INFANRIX and PEDIARIX). Currently in 2016, this patient got a biopsy done and the patient had macrophagic myofasciitis. The physician (neurologist) refused to provide further details as they were still gathering more information.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Influenza vaccine unspecified. Co-suspect products included Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine unspecified at an unknown dose and Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, several months after receiving Influenza vaccine unspecified and less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine unspecified and Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not provided. This case was previously reported to doctor. A GSK employee was notified by a physician that his wife received an unknown manufacturer's influenza vaccine for the 2013-2014 season and for the 2014-2015 season and came down with the flu. The physician did not wish to provide further information or address. This case was considered as suspected vaccination failure since the exact time to onset and laboratory confirmation of influenza was not provided.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Skin lesion
Clinical narrative: Signs: mild bump like lesion.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEP, MMRV
Symptoms: Laboratory test, Pyrexia, Vomiting
Clinical narrative: Injection sites-no reaction. On 12/19/16 at 1030 pt came into clinic with parents and cousin of father. Parents relayed high fever started 12/16/16, vomited 12/17/and 12/18, checked pt's temp at 1035 101.2F temporal parents wondering if illness from vaccines received 12/15/16. I saw pt's arms-no site reaction. Recommended parents take to a walk in or ER.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Raised hives on left arm and left leg. Left arm is where shot given. Started in evening the day of vaccination-itching and hives woke up with symptoms.
Age: 35.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: A pink circle with a diameter of approx. 8 centimeters with a more red area in the center that had a diameter of about 3 centimeters. There was itching and it was warm to touch.
Age: 11.0
Sex: M
Vaccine: HPV9, IPV, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives/itching at 3:30pm. Prednisone 30mg and Cetirizine 10mg orally by PA-C with additional tablets of both to be taken for the next 3 days.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm is red and swollen. Dr. gave cephalexin and prednisolone.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Right upper extremity pain, erythema, warmth and pruritus.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Shoulder and arm pain (L) cannot abduct nor externally rotate left shoulder. No swelling, erythema or warmth.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Increased erythema, induration and tenderness (R) deltoid (site of injection).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Left deltoid swelling.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: Red, raised, fevered area that is painful to touch and child states that sometimes it itches.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Electroencephalogram, Seizure
Clinical narrative: Prolonged seizure lasting 15-18 minutes.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Counted months from previous DTaP incorrectly and gave 4th DTaP too soon. Patient follows own schedule.
Age: 15.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient's mother called in and stated that the area around the injection site is hot, red, itchy, and the size (circumference) of a baseball.
Age: 1.17
Sex: M
Vaccine: FLU4, HEPA, PNC13
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 64.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt. had a red, swollen, itchy, and hot to the touch area about 2 inches long around injection site.
Sex: F
Vaccine: HEP, FLUX
Symptoms: Herpes zoster, Seroconversion test negative
Clinical narrative: Case number PHHY2016US116247, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 636041) website on 23 Aug 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date (reported as in 1986). After vaccination, the patient developed rash on an unspecified area of body, high temperature, nausea and vomiting which lasted for an unspecified amount of time. The outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: HEP, FLUX
Symptoms: Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Case number PHHY2016US116247, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 636041) website on 23 Aug 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date (reported as in 1986). After vaccination, the patient developed rash on an unspecified area of body, high temperature, nausea and vomiting which lasted for an unspecified amount of time. The outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Condition aggravated, Rash
Clinical narrative: Case number PHHY2016US116611 is an initial spontaneous report received from a health care professional (pharmacist) via Vaccine Adverse Events Reporting System (VAERS reference number: 637815) on 23 Aug 2016. This report refers to a 78 year old female patient. Pre-existing condition included rash. The patient did not have any drug allergies. Her concomitant medication included monoclonal antibodies. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on an unknown date (a couple of weeks ago). The patient's co-suspect included KYETRUDA (pembrolizumab) (previously proposed name was lambrolizumab) at a dose of 2 mg/kg for the treatment of stage 1V melanoma intravenously in the right arm on an unknown date. On an unknown date, the patient experienced rash on her upper right arm. The pharmacist reported that one week after the first dose of pembrolizumab, the patient returned to her physician because of the event. No treatment was given. The patient returned to her physician's office on 18 Nov 2015 to receive her second dose of pembrolizumab. Prior to the infusion, it was noted by the physician that the rash looked worse, however, the pembrolizumab was still administered. The patient would be treated with hydrocortisone cream and diphenhydramine. The pharmacist reported that the patient's rash was pre-existing condition which periodically appears and then disappears. The pharmacist further explained that prior starting pembrolizumab therapy, the patient always had a rash that came and went on her arm. On the day when the first dose of pembrolizumab was scheduled, she did not have a rash. The first dose of pembrolizumab was administered and at an unspecified time, the rash re-appeared on her arm and it currently seemed to be getting worse. The event was reported as non-serious. The pharmacist did not believe that the rash was from the flu shot because the vaccine was administered in the left arm and the rash was in the right arm. The pharmacist stated that the right arm was where the patient got her KEYTRUDA and hence it might have caused the rash or the right might be due to patient's disease state of melanoma. The pharmacist last spoke to the patient on 28 Nov 2015 and the rash did not get worse further. No further information was provided.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Rash
Clinical narrative: Case number PHHY2016US116611 is an initial spontaneous report received from a health care professional (pharmacist) via Vaccine Adverse Events Reporting System (VAERS reference number: 637815) on 23 Aug 2016. This report refers to a 78 year old female patient. Pre-existing condition included rash. The patient did not have any drug allergies. Her concomitant medication included monoclonal antibodies. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on an unknown date (a couple of weeks ago). The patient's co-suspect included KYETRUDA (pembrolizumab) (previously proposed name was lambrolizumab) at a dose of 2 mg/kg for the treatment of stage 1V melanoma intravenously in the right arm on an unknown date. On an unknown date, the patient experienced rash on her upper right arm. The pharmacist reported that one week after the first dose of pembrolizumab, the patient returned to her physician because of the event. No treatment was given. The patient returned to her physician's office on 18 Nov 2015 to receive her second dose of pembrolizumab. Prior to the infusion, it was noted by the physician that the rash looked worse, however, the pembrolizumab was still administered. The patient would be treated with hydrocortisone cream and diphenhydramine. The pharmacist reported that the patient's rash was pre-existing condition which periodically appears and then disappears. The pharmacist further explained that prior starting pembrolizumab therapy, the patient always had a rash that came and went on her arm. On the day when the first dose of pembrolizumab was scheduled, she did not have a rash. The first dose of pembrolizumab was administered and at an unspecified time, the rash re-appeared on her arm and it currently seemed to be getting worse. The event was reported as non-serious. The pharmacist did not believe that the rash was from the flu shot because the vaccine was administered in the left arm and the rash was in the right arm. The pharmacist stated that the right arm was where the patient got her KEYTRUDA and hence it might have caused the rash or the right might be due to patient's disease state of melanoma. The pharmacist last spoke to the patient on 28 Nov 2015 and the rash did not get worse further. No further information was provided.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2016US116000 is an initial spontaneous report received from a health care professional via Vaccine Adverse Events Reporting System (VAERS reference number: 637946) on 23 Aug 2016. This report refers to an elderly male patient in his seventies. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and PNEUMOVAX 23 (other manufacturer, batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced redness and swelling at injection site. It was reported that events occurred 6 days after administration of PNEUMOVAX and the flu vaccine was administered within the last few weeks. The outcome of the events was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Pain, Throat irritation
Clinical narrative: Case PHHY2016US116017 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 637947) on 23 Aug 2016. This report refers to a female patient whose age was not reported. Her medical history included pregnancy. Her current condition included allergy to betaine and concomitant medications were immunoglobulin human normal, citalopram, acetaminophen, diphenhydramine, EPIPN JR, levothyroxine, FIBER-LAX, biotin, multivitamins, iron with vitamin C, amoxicillin, cyanocobalamin, tramadol and calcium D. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced pain, cough and throat irritation. The outcome of the events was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, VARCEL, FLUX, VARZOS
Symptoms: Erythema
Clinical narrative: Case  number PHHY2016US116051 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 6379710) website on 23 Aug 2016. This report refers to 69 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with influenza virus vaccine (unknown seasonal or pandemic, manufacturer: unknown, batch number: not reported) and ZOSTAVAX on an unknown date. On an unknown date, the patient experienced redness of the arm. The outcome of the event was reported as unknown. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Sex: M
Vaccine: PPV, FLUX
Symptoms: Chills, Diarrhoea, Dizziness, Malaise, Nausea
Clinical narrative: Case number PHHY216US115830 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 639345) website on 23 Aug 2016. This report refers to  male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine (Unknown seasonal or pandemic, manufacturer unknown, batch number: not reported) on an unknown date. On an unknown date, the patient had muscle aches/pain. The outcome, seriousness and causality of event was not reported.
Sex: M
Vaccine: PPV, FLUX
Symptoms: Syncope, Vomiting
Clinical narrative: Case number PHHY216US115830 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 639345) website on 23 Aug 2016. This report refers to  male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine (Unknown seasonal or pandemic, manufacturer unknown, batch number: not reported) on an unknown date. On an unknown date, the patient had muscle aches/pain. The outcome, seriousness and causality of event was not reported.
Sex: M
Vaccine: PPV, FLUX
Symptoms: Myalgia
Clinical narrative: Case number PHHY216US115830 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 639345) website on 23 Aug 2016. This report refers to  male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine (Unknown seasonal or pandemic, manufacturer unknown, batch number: not reported) on an unknown date. On an unknown date, the patient had muscle aches/pain. The outcome, seriousness and causality of event was not reported.
Sex: F
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX, DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX
Symptoms: Blister, Erythema, Rash, Skin disorder, Skin exfoliation
Clinical narrative: Case number PHHY2016US116487 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 639846) website on 23 AUG 2016. This report refers to 0.7 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine seasonal influenza virus vaccine (Manufacturer unknown, batch number: not reported) and DTAP (Manufacturer unknown, batch number: not reported) Haemophilus B conjugate vaccine (Manufacturer unknown, batch number: not reported), Hepatitis B vaccine (Manufacturer unknown, batch number: not reported), Pneumococcal vaccine (Manufacturer unknown, batch number: not reported). Poliovirus vaccine inactivated (Manufacturer unknown, batch number: not reported) and Rotavirus (manufacturer unknown, batch number not reported) on 08 Jan2013. On the same day, the patient experienced severe rash, skin issue, redness, blister and pealing. On an unknown date, the patient visited emergency room. The outcome of events was reported as condition unchanged. The seriousness of the events was reported as non serious. Causality of events was not reported.
Sex: F
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX, DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX
Symptoms: Blister, Blood pressure decreased, Erythema, Rash, Skin exfoliation
Clinical narrative: Case number PHHY2016US116487 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 639846) website on 23 AUG 2016. This report refers to 0.7 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine seasonal influenza virus vaccine (Manufacturer unknown, batch number: not reported) and DTAP (Manufacturer unknown, batch number: not reported) Haemophilus B conjugate vaccine (Manufacturer unknown, batch number: not reported), Hepatitis B vaccine (Manufacturer unknown, batch number: not reported), Pneumococcal vaccine (Manufacturer unknown, batch number: not reported). Poliovirus vaccine inactivated (Manufacturer unknown, batch number: not reported) and Rotavirus (manufacturer unknown, batch number not reported) on 08 Jan2013. On the same day, the patient experienced severe rash, skin issue, redness, blister and pealing. On an unknown date, the patient visited emergency room. The outcome of events was reported as condition unchanged. The seriousness of the events was reported as non serious. Causality of events was not reported.
Sex: F
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX, DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX
Symptoms: Skin reaction
Clinical narrative: Case number PHHY2016US116487 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 639846) website on 23 AUG 2016. This report refers to 0.7 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine seasonal influenza virus vaccine (Manufacturer unknown, batch number: not reported) and DTAP (Manufacturer unknown, batch number: not reported) Haemophilus B conjugate vaccine (Manufacturer unknown, batch number: not reported), Hepatitis B vaccine (Manufacturer unknown, batch number: not reported), Pneumococcal vaccine (Manufacturer unknown, batch number: not reported). Poliovirus vaccine inactivated (Manufacturer unknown, batch number: not reported) and Rotavirus (manufacturer unknown, batch number not reported) on 08 Jan2013. On the same day, the patient experienced severe rash, skin issue, redness, blister and pealing. On an unknown date, the patient visited emergency room. The outcome of events was reported as condition unchanged. The seriousness of the events was reported as non serious. Causality of events was not reported.
Sex: F
Vaccine: FLU3, FLUX, UNK
Symptoms: Arthralgia, Burning sensation, Drug administered at inappropriate site, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Case PHHY2016US116657 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 639956) website on 23 Aug 2016. This report refers to 75 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine seasonal influenza virus vaccine (manufacturer: unknown, batch number: not reported) into arm (unspecified) on 12 Oct 2015. On the same day, after second vaccine the patient experienced vaccine felt like boiling water had been poured on shoulder. The vaccine was given up on top of shoulder bones. The patient had aching followed immediately. Next two days she could not lift arm. Since, that time patient had aching in shoulder, arm, muscles, wrist, thumb, hip joints, ankle and joints in feet. The patient had never these before. The outcome of events was reported as condition unchanged. The seriousness of events was non serious. The causality of events was not reported.
Sex: F
Vaccine: FLU3, FLUX, UNK
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Case PHHY2016US116657 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 639956) website on 23 Aug 2016. This report refers to 75 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine seasonal influenza virus vaccine (manufacturer: unknown, batch number: not reported) into arm (unspecified) on 12 Oct 2015. On the same day, after second vaccine the patient experienced vaccine felt like boiling water had been poured on shoulder. The vaccine was given up on top of shoulder bones. The patient had aching followed immediately. Next two days she could not lift arm. Since, that time patient had aching in shoulder, arm, muscles, wrist, thumb, hip joints, ankle and joints in feet. The patient had never these before. The outcome of events was reported as condition unchanged. The seriousness of events was non serious. The causality of events was not reported.
Sex: F
Vaccine: FLU3, FLUX, UNK
Symptoms: Arthralgia, Fine motor skill dysfunction, Pain, Pain in extremity
Clinical narrative: Case PHHY2016US116657 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 639956) website on 23 Aug 2016. This report refers to 75 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine seasonal influenza virus vaccine (manufacturer: unknown, batch number: not reported) into arm (unspecified) on 12 Oct 2015. On the same day, after second vaccine the patient experienced vaccine felt like boiling water had been poured on shoulder. The vaccine was given up on top of shoulder bones. The patient had aching followed immediately. Next two days she could not lift arm. Since, that time patient had aching in shoulder, arm, muscles, wrist, thumb, hip joints, ankle and joints in feet. The patient had never these before. The outcome of events was reported as condition unchanged. The seriousness of events was non serious. The causality of events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache
Clinical narrative: Case PHHY2016US116667 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 640121) website on 23 Aug 2016. This report refers to 44 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine seasonal influenza virus vaccine (manufacturer: unknown, batch number: not reported) on Jan 2016. On the same day, the patient experienced headache. The outcome of the event was reported as completely recovered. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Sex: F
Vaccine: FLUX, PPV, FLUX
Symptoms: Pain in extremity, Pruritus, Swelling
Clinical narrative: Case PHHY2016US116681 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 640156) website on 23 Aug 2016. This report refers to 72 year old female patient. The patient medical history included she received Influenza virus vaccine at the age of 13, 17 year old. The patient current condition included diabetes, she has no any current illness at the time of vaccination. Concomitant medication included SYNTHROID, JANUMET; Baby Aspirin; Vitamin C; Simvastatin. The patient was vaccinated with Influenza virus vaccine seasonal influenza vaccine (manufacturer: unknown, batch number: not reported) on 19 Jun 2016. On the same day, after the injection the patient experienced itching and then as time progressed she had a lot of pain and swelling. She had experienced much more swelling and pain down to her elbow. On an unknown date the patient had visited emergency rom. The outcome of event was reported as completely recovery. The seriousness of the event was reported as non serious. The causality of the event was not reported.