chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Took to urgent care on 2/6. Was vomiting. Falling asleep and had fever of 103.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness from right upper mid arm to right forearm. Patient stated feeling hot and pain/soreness at the injection site (Rt. triceps area).
Age: 6.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site induration
Clinical narrative: Injection site oozing and surrounding area by injection is red and hard.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Rash
Clinical narrative: Rash.
Age: 60.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given the wrong vaccine.  Patient was to receive Tdap and was given Dtap instead.
Age: 1.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13, MMRV
Symptoms: Rash
Clinical narrative: Patient developed rash.
Age: 1.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13, MMRV
Symptoms: Pyrexia, Rash, Rash morbilliform
Clinical narrative: Patient developed rash.
Age: 45.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Facial numbness which became facial paralysis or Bells Palsy.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site movement impairment, Injection site pain, X-ray limb
Clinical narrative: Left shoulder pain started immediately. Pain decreased ROM still 3 wks later.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: ADACEL C4712AA Exp. 3/22/17. 1 week after injection pt states arm was itchy, red, swollen, arm erythematous, Nontender -> 2/16/15 ice and ALEVE as needed.
Age: 0.54
Sex: M
Vaccine: DTAP, FLU4, HEP, HIBV, PNC13, RV5
Symptoms: Injection site reaction, Skin mass
Clinical narrative: Subcutaneous nodule on right thigh.
Age: 68.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster, Injection site rash, Rash
Clinical narrative: Rash spots on left shoulder/back. Diagnosed as shingles per Dr. on 2/10/15.
Age: 22.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Back pain, Fatigue, Headache, Influenza virus test negative
Clinical narrative: Sore throat, back ache, stomach ache, headache, nausea, vomiting, fatigue. Treatment: Toradol, IV fluids, labwork.
Age: 22.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Oropharyngeal pain, Streptococcus test negative, Vomiting
Clinical narrative: Sore throat, back ache, stomach ache, headache, nausea, vomiting, fatigue. Treatment: Toradol, IV fluids, labwork.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle tightness, Pain in extremity
Clinical narrative: LEFT ARM HURTS AT THE SITE AND BELOW DOWN TO FOREARM - ACHING AND SORE TYPE PAIN AND THE MUSCLES FEEL TIGHT BELOW THE INJECTION SITE - WOKE UP AND HAD A HARD TIME MOVING ARM - TOOK ADVIL AND IT DIDN'T HELP SO SHE CAME BACK TO THE CLINIC.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Eye pain, Ulcerative keratitis
Clinical narrative: Vaccine was taken for shingles prevention - Zostavax. Pain in right eye. Dr on 2/20/15 diagnoses as corneal ulcer.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Agitation, Crying, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: VERY SWOLLEN LEFT UPPER LEG THAT WAS RED AND WARM TO THE TOUCH. PREVNAR VACCINE GIVEN IN UPPER LEG AND ACT HIB GIVEN IN LOWER LEG. LOWER NEEDLE POKE WAS NOT SWOLLEN OR RED. PATIENT WAS ALSO VERY AGITATED MOM STATES HE CRIED FOR PAST 2 HOURS.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Dyspnoea
Clinical narrative: Chills 3 hours after injection, 5 hours injection sob and pain in chest. Patient went to ER for observation. They were not sure if these symptoms were due to Zostavax.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, Injection site erythema, Injection site warmth
Clinical narrative: PT WAS GIVEN AN EXTRA DOSE OF KINRIX IN HER RT ARM. MOM CALLED TO REPORT THAT CHILD HAS A REDDENED AREA 4IN BY 2IN THAT WAS HOT TO TOUCH.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Activated partial thromboplastin time normal, Contusion, Differential white blood cell count normal, Full blood count normal, Haematocrit normal
Clinical narrative: Petechaie and bruising of left cheek, around eye and left ear, + swelling of left cheek, some petechaie and bruising around right eye and cheek but much less than left. Vaccine injection sites have no swelling or bruising. Pt is happy and in no acute distress.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Haemoglobin normal, Petechiae, Platelet count normal, Prothrombin time normal, Swelling face
Clinical narrative: Petechaie and bruising of left cheek, around eye and left ear, + swelling of left cheek, some petechaie and bruising around right eye and cheek but much less than left. Vaccine injection sites have no swelling or bruising. Pt is happy and in no acute distress.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: White blood cell count normal
Clinical narrative: Petechaie and bruising of left cheek, around eye and left ear, + swelling of left cheek, some petechaie and bruising around right eye and cheek but much less than left. Vaccine injection sites have no swelling or bruising. Pt is happy and in no acute distress.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Ultrasound Doppler, Vaccination site reaction, X-ray limb
Clinical narrative: WOKE UP WITH SHOOTING AND THROBBING PAIN IN ARM WHERE VACCINE WAS ADMINISTERED.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Immune system disorder, Respiratory syncytial virus infection
Clinical narrative: My daughter was hospitalized with a temp of 106.8 for RSV.  The Dr said RSV rarely hospitalizes children and asked if she'd had any shots recently.  I had told him about her flu shot and he explained it had weakened her immune system allowing the RSV to get so bad as to need hospitalization.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This literature marketed report as received from a physician refers to 5 patients of unknown demography. The patient's current condition included STAT3 deficient hyper IgE syndrome. On an unknown date, the 5 patients were vaccinated with PNEUMOVAX 23. On an unknown date, the 5 patients were hospitalized for IV antibiotics. The outcome of the event was unknown. The reporter assessed the causality of the event to be related to the suspect therapy. This case is linked to case # 1502USA008319 and case # 1502USA008276 (same literature link). Additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This literature marketed report as received from a physician refers to 2 patients of unknown demography. The patient's current condition included STAT3 deficient hyper IgE syndrome. On an unknown date, the 2 patients were vaccinated with PNEUMOVAX 23. On an unknown date, the 2 patients experienced pneumonia and were hospitalized within 24 hours. The outcome of the event was unknown. The reporter assessed the causality of the event to be related to the suspect therapy. The event pneumonia was considered as serious due to hospitalization. This case is linked to case # 1502USA008319 and case # 1502USA008320 (same literature link). Additional information is expected.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Basophil percentage decreased, Haematocrit normal, Haemoglobin normal, Hypotonia, Listless
Clinical narrative: About 3 1/2 hrs after receiving vaccines, pt had an episode of projectile vomiting, became pale, limp and listless. Lasted about 10 minutes, until paramedics arrived.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Lymphocyte percentage increased, Metabolic function test normal, Neutrophil percentage decreased, Pallor, Platelet count normal
Clinical narrative: About 3 1/2 hrs after receiving vaccines, pt had an episode of projectile vomiting, became pale, limp and listless. Lasted about 10 minutes, until paramedics arrived.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting projectile, White blood cell count increased
Clinical narrative: About 3 1/2 hrs after receiving vaccines, pt had an episode of projectile vomiting, became pale, limp and listless. Lasted about 10 minutes, until paramedics arrived.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Arteriosclerosis coronary artery, Autonomic neuropathy, Demyelination, VIIth nerve paralysis
Clinical narrative: Facial paralysis/Bells palsy. Acute autonomic neuropathy. ASHD (arteriosclerotic heart disease). Demyelinating nervous system disease or syndrome.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Aura
Clinical narrative: This case was reported by a pharmacist and described the occurrence of aura in 41-year-old female subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). Concurrent medical conditions included seizure disorder. On 31 August 2014, the subject received a dose of FLUARIX QUADRIVALENT (administration site and route unknown). On 1 September 2014, less than one day after vaccination with FLUARIX QUADRIVALENT, the subject experienced 5 auras. At the time of reporting, the event was resolved.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm pain at injection site in a 39-year-old female subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 22 August 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown route, unknown arm and batch number). On 23 August 2014, 1 day after vaccination with FLUARIX QUADRIVALENT, the subject experienced arm pain and small blisters, both at injection site. At the time of reporting, the events were unresolved.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Circumstance or information capable of leading to medication error, Cough, Incorrect dose administered
Clinical narrative: This spontaneous report was received from a nurse refers to a 6 month old male patient. No pertinent medical history was reported. On 15-OCT-2014, the patient started therapy with ROTATEQ VIAL (lot # K008139 and expiration date 15-APR-2016) dose 1, oral for routine vaccination. On 17-FEB-2015, the patient was vaccinated with dose 3, 2 ml, oral. On 17-FEB-2015, the patient coughed either during or after administration of his third 2 ml ROTATEQ, oral and as a result, a drop of rotavirus vaccine, inadvertently entered the eye of another nurse (refer MARRS # 1502USA009155). It was not clarified whether this may had resulted in a partial dose of ROTATEQ. Treatment was not given to the patient. Patient sought medical attention, still in office when event occurred. No Product Quality Complaint (PQC) was involved. Action taken with the therapy of ROTATEQ. On 17-FEB-2015, the outcome of events was reported as recovered/resolved. Causality was not assessed by the reporter. This is one of two reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose decreased, Disorientation, Dystonia, Electroencephalogram, Extremity contracture
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a 16 year old female patient with allergy to latex. No medical history was reported. On 12-FEB-2015, the patient was vaccinated with a first dose of GARDASIL (lot # K007264, expiration date not provided), intramuscularly, dose was not reported. No concomitant medication was reported. On 12-FEB-2015, after first injection of GARDASIL, the patient, experienced syncope (reported as 'cynope'), clinching arms, nausea, dystonia, hypertensive crises, became disoriented, had 15 minute lack of awareness, tachycardia, hyperventilating, panic attack, and low blood sugar of 25 (units not provided). The patient was given sugar and oxygen while in physician's office. The patient was then transported to hospital emergency via ambulance. The patient was hospitalized for two days (from 12-FEB-2015 until 14-FEB-2015). While in hospital, the patient had magnetic resonance imaging (MRI) and 24 hour electroencephalography (EEG), and was treated with BENADRYL. The outcome of all events was not reported. Relatedness between the events and GARDASIL was not provided. Upon internal review, hypertensive crisis was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypertensive crisis, Hyperventilation, Nausea, Nuclear magnetic resonance imaging, Panic attack
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a 16 year old female patient with allergy to latex. No medical history was reported. On 12-FEB-2015, the patient was vaccinated with a first dose of GARDASIL (lot # K007264, expiration date not provided), intramuscularly, dose was not reported. No concomitant medication was reported. On 12-FEB-2015, after first injection of GARDASIL, the patient, experienced syncope (reported as 'cynope'), clinching arms, nausea, dystonia, hypertensive crises, became disoriented, had 15 minute lack of awareness, tachycardia, hyperventilating, panic attack, and low blood sugar of 25 (units not provided). The patient was given sugar and oxygen while in physician's office. The patient was then transported to hospital emergency via ambulance. The patient was hospitalized for two days (from 12-FEB-2015 until 14-FEB-2015). While in hospital, the patient had magnetic resonance imaging (MRI) and 24 hour electroencephalography (EEG), and was treated with BENADRYL. The outcome of all events was not reported. Relatedness between the events and GARDASIL was not provided. Upon internal review, hypertensive crisis was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tachycardia
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a 16 year old female patient with allergy to latex. No medical history was reported. On 12-FEB-2015, the patient was vaccinated with a first dose of GARDASIL (lot # K007264, expiration date not provided), intramuscularly, dose was not reported. No concomitant medication was reported. On 12-FEB-2015, after first injection of GARDASIL, the patient, experienced syncope (reported as 'cynope'), clinching arms, nausea, dystonia, hypertensive crises, became disoriented, had 15 minute lack of awareness, tachycardia, hyperventilating, panic attack, and low blood sugar of 25 (units not provided). The patient was given sugar and oxygen while in physician's office. The patient was then transported to hospital emergency via ambulance. The patient was hospitalized for two days (from 12-FEB-2015 until 14-FEB-2015). While in hospital, the patient had magnetic resonance imaging (MRI) and 24 hour electroencephalography (EEG), and was treated with BENADRYL. The outcome of all events was not reported. Relatedness between the events and GARDASIL was not provided. Upon internal review, hypertensive crisis was considered to be medically significant. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Malaise, Pneumonia, Pyrexia
Clinical narrative: 2 days after injection I became ill. High temp. up to 103, (flu shot was 10/13/14). On 10/22/14 I went to Dr. She didn't let me go home, took me to Emergency. They put me in hospital for 3 days. Said I had pneumonia or bronchitis.
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 unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, between later December 2014 and early January 2015, the patients were vaccinated with improperly stored ROTATEQ oral. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 2 days after vaccine-red, hot, itching and painful site of 10cm circumference. 1 week later, still the same, to (L) deltoid area. Antihistmaine increased.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: On 2-19-15 at 4:25 p.m. pt presented with bilateral arm swelling, redness, and warmth. Hard to touch. Dimensions: (L) arm 10x9 inches (R) arm 5x6 inches. Per provider, tx with ice and Children's ibuprofen and RTC if worsens.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64-year-old male patient. The patient's medical history and concurrent conditions were not reported. The patient had no known allergies. On 01-FEB-2015, the patient was subcutaneously vaccinated with ZOSTAVAX (0.65 ml, lot # K012921, exp. date-November 2015; anatomical location was not reported) for shingles prevention. Concomitant therapies included budesonide, SYMBICORT, FLONASE, XANAX, SPIRONOLACTONE and CELEBREX. On the night of 17-FEB-2015, the patient could not sleep. On 18-FEB-2015, he visited his physician and was diagnosed with shingles in his ear. The patient sought medical attention and was prescribed VALTREX as a treatment for the event. The outcome of the events was reported as not recovered. The relatedness between vaccination with ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster oticus, Insomnia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64-year-old male patient. The patient's medical history and concurrent conditions were not reported. The patient had no known allergies. On 01-FEB-2015, the patient was subcutaneously vaccinated with ZOSTAVAX (0.65 ml, lot # K012921, exp. date-November 2015; anatomical location was not reported) for shingles prevention. Concomitant therapies included budesonide, SYMBICORT, FLONASE, XANAX, SPIRONOLACTONE and CELEBREX. On the night of 17-FEB-2015, the patient could not sleep. On 18-FEB-2015, he visited his physician and was diagnosed with shingles in his ear. The patient sought medical attention and was prescribed VALTREX as a treatment for the event. The outcome of the events was reported as not recovered. The relatedness between vaccination with ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 16 mos old child, received her HIB and MMR on the Rt thigh, developed red, hard swelling one week after the date of injections. Subsided gradually on its own. She had HIB before with no reactions.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture throat, Ear pruritus, Headache, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: This spontaneous report was received from a 55 year old female patient (who was also a lab technician) referring herself. The patient's pertinent medical history included leg cramps, bacterial meningitis in 2009, degenerative disease, arthritis, herniated disc, nerve damage in right leg, gastrooesophageal reflux disease, hyperlipidemia, hepatitis C and the patient was allergic to BIAXIN (had swelling of tongue and lips), COMPAZINE (had unspecified reaction) and also experienced hallucinations with unspecified narcotics. On 30-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were not reported). Concomitant therapies included PROAIR, KLONOPIN 9as needed), budesonide, SYMBICORT (reported as the patient had not used for approximately the past 7 days because she ran out of medicine), lorazepam 9as needed), DEXILANT and LINZESS. On 02-FEB-2015, patient noticed that the gland on the right side of her neck was swollen, her throat was also hurting when swallowing. The patient looked in to her throat using a mirror and saw that her tonsils were covered in white patches and had some bleeding. The patient did not sought medical attention. The patient was treated by gargling with peroxide and placing a heating pad on the neck. No lab tests were performed. On 03-FEB-2015 (reported ad this morning), the appearance of tonsils was improved. On 03-FEB-2015 (reported as starting today), the patient experienced headache and itching of her right ear. The outcome of gland on the right side of her neck was swollen, itching of her right ear, headache, tonsils were covered in white patches and had some bleeding and her throat was also hurting when swallowing was reported as not recovered/not resolved. The causality of the events was not reported. No product complaint was reported for ZOSTAVAX. The specimen was obtained on 03-FEB-2015 and the source of specimen was throat swab. The patient did not had any recent Varicella Zoster Virus (VZV) exposure to chicken pox or shingles. This case is linked to the case 1502USA009294 via same reporter link. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Tonsillar disorder, Tonsillar haemorrhage
Clinical narrative: This spontaneous report was received from a 55 year old female patient (who was also a lab technician) referring herself. The patient's pertinent medical history included leg cramps, bacterial meningitis in 2009, degenerative disease, arthritis, herniated disc, nerve damage in right leg, gastrooesophageal reflux disease, hyperlipidemia, hepatitis C and the patient was allergic to BIAXIN (had swelling of tongue and lips), COMPAZINE (had unspecified reaction) and also experienced hallucinations with unspecified narcotics. On 30-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were not reported). Concomitant therapies included PROAIR, KLONOPIN 9as needed), budesonide, SYMBICORT (reported as the patient had not used for approximately the past 7 days because she ran out of medicine), lorazepam 9as needed), DEXILANT and LINZESS. On 02-FEB-2015, patient noticed that the gland on the right side of her neck was swollen, her throat was also hurting when swallowing. The patient looked in to her throat using a mirror and saw that her tonsils were covered in white patches and had some bleeding. The patient did not sought medical attention. The patient was treated by gargling with peroxide and placing a heating pad on the neck. No lab tests were performed. On 03-FEB-2015 (reported ad this morning), the appearance of tonsils was improved. On 03-FEB-2015 (reported as starting today), the patient experienced headache and itching of her right ear. The outcome of gland on the right side of her neck was swollen, itching of her right ear, headache, tonsils were covered in white patches and had some bleeding and her throat was also hurting when swallowing was reported as not recovered/not resolved. The causality of the events was not reported. No product complaint was reported for ZOSTAVAX. The specimen was obtained on 03-FEB-2015 and the source of specimen was throat swab. The patient did not had any recent Varicella Zoster Virus (VZV) exposure to chicken pox or shingles. This case is linked to the case 1502USA009294 via same reporter link. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Erythema of eyelid, VIth nerve paralysis
Clinical narrative: 1 day after receiving the MMR she developed redness around the (L) eye and it deviated medially. She was diagnosed by ophthalmology as a 6th nerve palsy. 4d later developed diarrhea.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: 1100 2-19-15 Pt need PNEUMOVAX 23 IM (R) deltoid. 1500 2-19-15 SN rec'd call from pt stating her arm hurt; SN stated the vac usually hurts. 0810 2-10-15 tc from Pt c/o severe pain SN made appt. that day RT clinic w/Dr.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction
Clinical narrative: Localized redness 12 x 12 cm. No warmth/tenderness/hives/SOB. Dx: localized reaction to shot.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This literature marketed report as received from a physician refers to 7 patients of unknown demography. The patient's current condition included STAT3 deficient hyper IgE syndrome. On an unknown date, the 7 patients were vaccinated with PNEUMOVAX 23. On an unknown date, 7 patients experienced large local cellulitis-like reactions. The outcome of the event was unknown. The reporter assessed the causality of the event to be related to the suspect therapy. A copy of the published article is attached as further documentation of the patient's experience. This case is linked to MARRS case # 1502USA008276 and case # 1502USA008320 linked from the same literature. Additional information is expected.
Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Middle insomnia, Mobility decreased, Pain in extremity, X-ray
Clinical narrative: Patient stated her arm is in severe pain, she can't rotate it or lift her arm. She would get awaken at night due to the pain, and takes about 4 tablets of OTC ADVIL everyday for the pain.
Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Bone marrow oedema, Erythema, Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Patient stated her arm is in severe pain, she can't rotate it or lift her arm. She would get awaken at night due to the pain, and takes about 4 tablets of OTC ADVIL everyday for the pain.
Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Irritability, Joint effusion, Joint instability, Joint range of motion decreased
Clinical narrative: Patient stated her arm is in severe pain, she can't rotate it or lift her arm. She would get awaken at night due to the pain, and takes about 4 tablets of OTC ADVIL everyday for the pain.
Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Local reaction, Localised infection, Middle insomnia, Mobility decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient stated her arm is in severe pain, she can't rotate it or lift her arm. She would get awaken at night due to the pain, and takes about 4 tablets of OTC ADVIL everyday for the pain.
Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Osteoarthritis, Pain in extremity, Peripheral swelling, Synovitis, Tenderness
Clinical narrative: Patient stated her arm is in severe pain, she can't rotate it or lift her arm. She would get awaken at night due to the pain, and takes about 4 tablets of OTC ADVIL everyday for the pain.
Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Tendon disorder, Tendon rupture, X-ray limb abnormal
Clinical narrative: Patient stated her arm is in severe pain, she can't rotate it or lift her arm. She would get awaken at night due to the pain, and takes about 4 tablets of OTC ADVIL everyday for the pain.
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pruritus, Skin discolouration, Skin warm, Swelling
Clinical narrative: Raised, reddened, itchy, hot to touch. Left two marks.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender who on 04-FEB-2015 was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # J011338, expiration date 19-DEC-2014). No adverse experienced reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Medical history and concurrent condition were not reported. On 06-JUN-2014 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml dose, intramuscularly. On 30-JUL-2014 was vaccinated with the second dose, 0.5 ml dose, intramuscularly, the third dose was given on 08-DEC-2014 and the patient received a fourth dose of GARDASIL 0.5 ml dose, intramuscularly. No symptoms reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope, Rash, Vomiting
Clinical narrative: This spontaneous report as received from a physician via a company representative refer to a 14 year old female patient. The patient's relevant medical history was not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (route, dose, lot# and expiration date were not reported). Information about concomitant medication was not reported. On an unknown date, after receiving the first dose of GARDASIL, the patient developed an unspecified rash in an unspecified location. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (route, dose, lot# and expiration date were not reported) and after the second vaccination, on an unknown date, the patient experienced dizziness, vomiting and "near syncope" stated. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 18-FEB-2015 the patient received an expired dose of GARDASIL (lot # 0754AE, expiration date: 17-JAN-2015) .5 ml, intramuscular. No adverse effect was reported. No product quality complaint (PQC) was reported. Reporting pharmacist considered the event to be not related to GARDASIL. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 50 year old patient (gender unknown). On 11-FEB-2015 the patient was vaccinated in error with a pediatric dose of VAQTA 25/0.5 (units not provided (lot # and route were not provided). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEP, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever. Grandparents reported rash on baby's trunk started from today, can not think of any new food/clothes/detergent/bed sheets etc. Baby does not seem itching, no fever/chills, no cough, is active, eating well.
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 unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, between late December 2014 and early January 2015, the patients were vaccinated with improperly stored VAQTA. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, between late December 2014 and early January 2015, the patients were vaccinated with improperly stored GARDASIL. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Irritability
Clinical narrative: Vaccinated 2/03/15 - pt was cranky and then rash appeared 2/13/15. Rash (B) legs (+) itching. No real zoster rash but raised and red. BENADRYL and oatmeal bath.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pruritus, Rash, Skin warm
Clinical narrative: Patient came in and showed her arm. Received ZOSTAVAX on Friday and on Monday complained of rash going down arm, itching, redness, bruising and warm.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Malaise, Nausea
Clinical narrative: Patient experienced nausea, diarrhea and malaise after second dose.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Patient only took first dose on 2/13/15. Vomited on 2/15/15 dose 2 not taken.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 30-JAN-2015 the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (dose, dose number, route, lot/batch number, expiration date were not reported) (reported as that underwent temperature excursions). No adverse event was reported. No product quality complaint (PQC) involved. The outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the third dose in RECOMBIVAX HB (lot#, dose and route not reported) series which was improperly stored. No adverse events were reported. This is one of several reports (triplets patients, MARRS# 1502USA004588, 1502USA009115 and 1502USA009116) received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions and medical history were not provided. On an unknown date the patient was vaccinated with a dose of improperly stored  ZOSTAVAX (lot # k018175, expiration date 10-JAN-2016, dose, frequency and route not reported). No adverse effects reported. The outcome of the event was not reported. Additional information is not expected as there was no consent for follow up contact.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Rash "morbilliform" on face, chest abd, back and extremities x2 days "No itch, no pain, no change in diet, no fever. Received vaccines 10 days prior expected course.
Age: 32.0
Sex: M
Vaccine: MENB
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: During vaccination, complained of left arm pain. After 45 min left arm pain continued with numbness in 3 middle fingers. Today feels reduced numbness and still pain in left arm, can't lift > 90 degrees.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot#, dose and route not reported) series which was improperly stored. No adverse events were reported. This is one of several reports (triplets patients, MARRS# 1502USA004588, 1502USA009115 and 1502USA009116) received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician via a company representative referring to a 21 year old female patient. The patient had no medical history or drug reactions/allergies. On 30-SEP-2014 the patient was vaccinated with the first dose of GARDASIL (injection, strength: 120 (unit not reported), lot # J015378, expire date 09-APR-2016, dose, frequency and route were not reported). There was no concomitant therapy. The patient became pregnant with conception date of 30-OCT-2014. The date of last menstrual period (LMP) was 16-OCT-2014 and estimated due date (EDD) was 23-JUL-2015. The pregnancy outcome was pending. Therapy with GARDASIL was discontinued. No lab diagnostics studies were performed. No treatment was given for the event. The patient sought medical attention via seeing the doctor. The outcome the event was reported as not recovered/not resolved. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. There was no pertinent medical history, concomitant medications and drug reaction/allergies reported. On an unspecified dates, the patient was vaccinated with two doses series of adult formulation of RECOMBIVAX HB (strength: 10 microgram, dose: 1 ml, route intramuscular, lot number and expiration date were not reported) outside the recommended schedule in RECOMBIVAX HB prescribing information. There was no adverse effects reported. Additional information has ben requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. In 2013 the patient was vaccinated with the first dose of GARDASIL. On 05-FEB-2015, the patient would receive the second dose of the vaccine which was considered as inappropriate schedule of drug administration. No adverse effects reported. Additional information is not expected as we are not allowed to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified amount of patients of unknown age and gender. On an unknown date, an unspecified amount of dose of (Oka/Merck) VARIVAX (0.5 ml, subcutaneous, lot number unknown) that underwent a temperature excursion were administered to an unspecified amount of patients. No adverse effect reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse concerning a 23 year old female patient. On 07-FEB-2015 the patient was vaccinated in error with a pediatric dose of VAQTA 25/0.5 (units not provided) (lot # and route were not provided). no adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Malaise, Nausea, Oral administration complication, Vomiting
Clinical narrative: Patient took first dose, after 3.5 hours felt ill and vomited the capsule intact, second dose was taken and experienced nausea, diarrhea and malaise.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Myalgia, Rash
Clinical narrative: Rash on inside of arm and stomach, muscle soreness, headache x1-2 days. Resolved by day 3.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Infection, International normalised ratio increased, Pruritus, Swelling
Clinical narrative: Cellulitis infection/swelling, itching.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Case number PHHY2013US056699, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486982) website on 05 Jun 2013. This report refers to a 12-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: 912022) intramuscularly in the left arm on 08 Mar 2013. On 14 Mar 2013, six days after vaccination, she experienced 4-cm of cutaneous urticarial reaction. The event outcome was reported as condition unchanged as on 14 Mar 2013. the seriousness and causality of the event was not reported.
Age: 31.0
Sex: M
Vaccine: JEVX
Symptoms: Back pain, Dysstasia, Gait disturbance, Pain
Clinical narrative: 4/10 lower back pain that made standing/walking in an upright position difficult.  Pain lasted approximately 30 hours.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: After 7 days she started running a fever. Around 101-102 at night. It lasted for three days. At 14 days past vaccine, another three days of fevers and she started complaining of her legs hurting. It has now been 28 days and she is still complaining of leg pain.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient began experiencing severe limb pain for about 6-8 weeks which was accompanied by weakness which continued to develop over the next few months. Once the pain disappeared, she was left with nerve damage and extreme weakness. She was diagnosed with either Guillain Barre Syndrome or it's more severe counterpart of CIDP. She underwent a spinal tap and multiple 8 hour IVIG treatments at the hospital. She is still currently undergoing neurology appointments, physical therapy and continued treatment. Symptoms originally started about 2 weeks after the vaccine and have continued over the last 6 months.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Lumbar puncture, Muscular weakness, Nerve injury, Neurological examination, Pain in extremity
Clinical narrative: Patient began experiencing severe limb pain for about 6-8 weeks which was accompanied by weakness which continued to develop over the next few months. Once the pain disappeared, she was left with nerve damage and extreme weakness. She was diagnosed with either Guillain Barre Syndrome or it's more severe counterpart of CIDP. She underwent a spinal tap and multiple 8 hour IVIG treatments at the hospital. She is still currently undergoing neurology appointments, physical therapy and continued treatment. Symptoms originally started about 2 weeks after the vaccine and have continued over the last 6 months.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain, swelling, redness, fever in arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Red spot a little larger than a quarter at site of injection, hot to touch, painful and itchy.
Age: 0.75
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Anger, Crying, Decreased appetite, Irritability, Lethargy
Clinical narrative: My baby had the the polio, Hib and DTaP vaccines when he was 4 months and was not normal until the 6th day. At 9 mos was his next vaccines and he received the same as 4 mos. He was very lethargic only awake a total of 4 hrs during the day, did not want to nurse or eat, when awake he just cried and fussed and never wanted to be snuggled, very angry never smiled. This now went on for a total of 9 days and the 10th day he seemed to be somewhat normal. Clapping hands and smiling. My other children never were like this and it was kind of scary waiting for him to return to normal or if would ever. I also wonder if the next time he will be worse since each time he gets worse.
Age: 33.0
Sex: M
Vaccine: MMR, MNQ, TDAP
Symptoms: Contraindication to vaccination
Clinical narrative: MMR Vaccine administer to patient receiving Humira.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Confusional state, Convulsion, Dysarthria, Electroencephalogram
Clinical narrative: Walking around, stumbling, mumbling, banging his head on a cabinet, falling over, eyes moving all over, slurred speak and then confusion. It lasted about 15 minutes and was considered a seizure in January 2014 following an ER visit due to a seizure.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Epilepsy, Eye movement disorder, Fall, Gait disturbance, Head banging
Clinical narrative: Walking around, stumbling, mumbling, banging his head on a cabinet, falling over, eyes moving all over, slurred speak and then confusion. It lasted about 15 minutes and was considered a seizure in January 2014 following an ER visit due to a seizure.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Laboratory test, Nuclear magnetic resonance imaging, Speech disorder
Clinical narrative: Walking around, stumbling, mumbling, banging his head on a cabinet, falling over, eyes moving all over, slurred speak and then confusion. It lasted about 15 minutes and was considered a seizure in January 2014 following an ER visit due to a seizure.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: The patient developed a rash across her right abdomen, side, and around her back. She went to the dr after coming to show us at the pharmacy on 2/18/15 to confirm our diagnosis of shingles and receive treatment. I spoke with her as a follow-up on 2/21/15. She is in terrible pain and wishes she didn't get the vaccine.
Age: 59.0
Sex: M
Vaccine: FLUC3, PPV, FLU3, PPV
Symptoms: Dizziness, Fatigue, Injection site rash, Rash, Urinary incontinence
Clinical narrative: Patient said he developed a rash on his left shoulder and arm that he treated with hydrocortisone cream OTC. Also he felt tired and dizzy for 7 to 10 days after getting the shots, lost control of his bladder and peed himself during that time.
Age: 59.0
Sex: M
Vaccine: FLUC3, PPV, FLU3, PPV
Symptoms: Dizziness, Injection site rash, Urinary incontinence
Clinical narrative: Patient said he developed a rash on his left shoulder and arm that he treated with hydrocortisone cream OTC. Also he felt tired and dizzy for 7 to 10 days after getting the shots, lost control of his bladder and peed himself during that time.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown demographics. On an unspecified date the patient was administered with expired PROQUAD (Merck), .5 ml, once, subcutaneous. No adverse events were reported. Outcome of the event was unknown. No product quality complaint (PQC) was involved. The reporter considered event to be not related to PROQUAD (Merck). Additional information has been requested. This is one of several reports received from the same reporter.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Pain
Clinical narrative: Pain after vaccination; arm red around vaccine admin site. itchy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Tonsillar hypertrophy
Clinical narrative: Fever one day after vaccine for few days. Swollen tonsils for few days. Rash on both sides of neck starting 1 day after vaccine and spreading for 2 weeks after vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Area of redness with induration at site of injection, fever. Treated with cephalexin for presumed cellulitis.