chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 20-APR-2015, the patient was vaccinated with one dose of PROQUAD (Merck) that had been improperly stored (subcutaneous, lot # K025760, expiry: 08-JUN-2016, dose not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information hs been requested.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Chills, Headache, Influenza virus test negative, Injection site erythema, Injection site induration
Clinical narrative: Child complains of injection site pain, redness, swelling, and heat. Also complains of fever, headache, chills, and nausea. Inspection of injection site reveals a one centimeter blister over the injection site with redness and induration spreading another centimeter out from the blister. Patient was treated with Cetirizine and Amoxicillin-potassium clavulanate.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth, Nausea
Clinical narrative: Child complains of injection site pain, redness, swelling, and heat. Also complains of fever, headache, chills, and nausea. Inspection of injection site reveals a one centimeter blister over the injection site with redness and induration spreading another centimeter out from the blister. Patient was treated with Cetirizine and Amoxicillin-potassium clavulanate.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Child complains of injection site pain, redness, swelling, and heat. Also complains of fever, headache, chills, and nausea. Inspection of injection site reveals a one centimeter blister over the injection site with redness and induration spreading another centimeter out from the blister. Patient was treated with Cetirizine and Amoxicillin-potassium clavulanate.
Age: 1.97
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid to axilla became extremely edematous, red, hot, hard to touch per grandmother's report.  Entire arm swelled to twice its normal size.  Client seen in ER. Given Prednisone and started on antibiotic per grandmother.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Fever, lethargy, loss of appetite, large (6+ inches in circumference)swollen area on arm at injection site, accompanied by swelling, heat, pain and inability to move arm.  Area was very hard, and hot to the touch.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth, Lethargy, Pyrexia
Clinical narrative: Fever, lethargy, loss of appetite, large (6+ inches in circumference)swollen area on arm at injection site, accompanied by swelling, heat, pain and inability to move arm.  Area was very hard, and hot to the touch.
Age: 19.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cold sweat, Pallor, Syncope
Clinical narrative: Patient became pale and clammy, then fainted.  Nurse and assistants lowered patient onto floor and elevated feet, applied cold cloth to forehead and back of neck, directed fan towards patient.  Nurse monitored blood pressure and pulse every 5 minutes.  Patient fully recovered within 20 minutes.  Patient's father drove patient home.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a consumer regarding a male patient of unknown age. No concurrent condition and historical medication was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date, the patient experienced mild tingling in his arm. The outcome of mild tingling in his arm was unknown. No product quality was involved. Causality between mild tingling in his arm and zoster vaccine live was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients unknown age and gender. On an unknown date the patients were vaccinated with first dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. On an unknown date the patients returned to the office over 1 year later after receiving the first dose of the GARDASIL (inappropriate schedule of drug administration). No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood potassium abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 60 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-APR-2015 the patient was vaccinated with ZOSTAVAX lot # K018171, expiry date: 23-OCT-2015 (route of administration was not reported). The pharmacist reported that the patient came by the pharmacy on unknown date (reported as "recently") and reported that his potassium levels have been altered since an unspecified date following the vaccination. Unspecified potassium level test was performed and no treatment was given to the patient for the event. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. 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 registered nurse referring to unspecified number of patients of unknown ages and genders. On an unknown date, the unspecified number of patients received an improperly stored dose of MMR II (dose, lot #, expiration date, therapy date and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Patient states that by evening, injection site was swollen and red about size of half dollar. Felt very tired the day following the injection day.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient states injection site became hot, red, swollen area with bruising 3-inches long.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 04-May-2015, the patient was vaccinated with one dose of (Merck) PROQUAD that had been improperly stored (subcutaneous, lot # K025760, expiry: 08-JUN-2016, dose not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient states injection site was sore, swollen and hot for 2-3 days.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Rash pruritic
Clinical narrative: Patient contacted pharmacy on 5/15/15 and stated he had 4-inch diameter warm, itchy rash at injection site. As of 5/21/15 symptoms have resolved.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified adult patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 20-MAY-2015 the adult patient was inadvertently administered a dose of PROQUAD (Merck) (lot number, expiration date, dose strength, route unspecified) (Drug administered to patient of inappropriate age). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Agitation, Decreased appetite, Dizziness, Fatigue, Somnolence
Clinical narrative: Fatigue, dizziness, agitation, groggy "foggy" feeling with loss of appetite for 3 days after MENACTRA vaccine. No dyspnea, rashes or Guillain Barre.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Local reaction of redness itching and swelling. Mom took to ER and received steroid shot.  Mom insisted a VAERS be submitted.
Age: 1.52
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Seizure
Clinical narrative: Woke up having seizure, lasted at least one minute. Temp was 103 and was afebrile before bed and had a dose of Tylenol at about 9 pm before bed. Went to ER for evaluation.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test, Cardiac stress test, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Pain in arms, wrists, neck, shoulder, back right side of jaw.  Sparks of electrical current down arms and tingling of finger tips, lightheadedness, shortness of breath, chest tightness.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Electrocardiogram, Nerve conduction studies, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Pain in arms, wrists, neck, shoulder, back right side of jaw.  Sparks of electrical current down arms and tingling of finger tips, lightheadedness, shortness of breath, chest tightness.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: X-ray
Clinical narrative: Pain in arms, wrists, neck, shoulder, back right side of jaw.  Sparks of electrical current down arms and tingling of finger tips, lightheadedness, shortness of breath, chest tightness.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Back pain, Blood test, Cardiac stress test, Chest discomfort
Clinical narrative: Pain in arms, wrists, neck, shoulder, back right side of jaw.  Sparks of electrical current down arms and tingling of finger tips, lightheadedness, shortness of breath, chest tightness.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Musculoskeletal pain, Neck pain
Clinical narrative: Pain in arms, wrists, neck, shoulder, back right side of jaw.  Sparks of electrical current down arms and tingling of finger tips, lightheadedness, shortness of breath, chest tightness.
Age: 48.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging, Pain in extremity, Pain in jaw, Paraesthesia
Clinical narrative: Pain in arms, wrists, neck, shoulder, back right side of jaw.  Sparks of electrical current down arms and tingling of finger tips, lightheadedness, shortness of breath, chest tightness.
Age: 63.0
Sex: M
Vaccine: MEN
Symptoms: Dry mouth, Pain, Pain in extremity, Rash
Clinical narrative: Got vaccine 5/18. Pain started 5/20-waist to thigh severe pain. Rash started 5/21 on thigh leg/thigh pain. BP-159/91-hurts to touch, dry mouth.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 04-MAY-2015, the patient was vaccinated with one dose of PROQUAD (Merck) that had been improperly stored (subcutaneous, lot # K025760, expiry: 08-JUN-2016, dose not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner regarding a patient of unknown demographics. No concurrent condition was reported. On an unknown date in July 2011, patient was vaccinated with the first dose of GARDASIL and in November 2011, second dose was vaccinated. On 22-APR-2015, the patient was in the clinic intending to get vaccinated with the third dose of GARDASIL, (inappropriate schedule of drug administration) intramuscular. No adverse event was reported. No product quality complaint was involved. the outcome of the event was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth to touch.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: Information has been received from a 78 years old male patient referring to himself. On an unknown date in October 2014, the patient was vaccinated with ZOSTAVAX in the right arm (lot #, strength, dose and route were not reported) at a pharmacy to prevent shingles. On 10-MAY-2015 the patient developed red rash on the side of chest cavity around to his back. He went to his dermatologist who confirmed for this that he had an outbreak of shingles. The patient was treated with valacyclovir, 1 gram, 3 times a day for 10 days. The outcome of herpes zoster was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-APR-2015, the patient was inadvertently vaccinated with a dose of (Merck) PROQUAD (dose, route, lot number and expiration date not reported) and a dose of (Merck) VARIVAX (dose, route, lot number and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR
Symptoms: Influenza virus test negative, Injection site erythema, Injection site induration, Irritability, Local reaction
Clinical narrative: Local reaction - quarter sized patch - erythematous with induration to (L) thigh. Fever Tmax 104. Fussiness.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Local reaction - quarter sized patch - erythematous with induration to (L) thigh. Fever Tmax 104. Fussiness.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Neck pain
Clinical narrative: C/O pain that originates from Tdap injection site radiates up (R) side of neck to base of occiput and down radial aspect of forearm to hand. No weakness or paresthesias. No fever joint pain or rash. No redness, warmth or swelling.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic
Clinical narrative: Vaccine administered 5/13/15-reported itchy, sore rash on lower abdomen (5/15/15 received call from pt's granddaughter 9:25 am) ("Rash" looks like a large bug bite, (round) and greater than size of quarter. Very itchy.
Age: 66.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Body temperature increased, Hyperhidrosis, Vomiting
Clinical narrative: Onset of severe vomiting on Friday night (a day after immunization), every hour almost with dripping sweats and elevated temperature.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site pain, Injection site reaction, Rash macular
Clinical narrative: (R) arm-pain and blotchy redness (deltoid area). Recommended ice application, oral diphenhydramine 25mg and Ibuprofen (OTC). If not better by 10/30/14 (AM) see doctor.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Abasia, Guillain-Barre syndrome
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of Guillain Barre syndrome in a 63-year-old male patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. In 2015, unknown after receiving BOOSTRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant) and unable to walk (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome and unable to walk were not recovered/not resolved. It was unknown if the reporter considered the Guillain Barre syndrome and unable to walk to be related to BOOSTRIX. Additional information was provided: The caller is a resident of another country, while on vacation, her husband received BOOSTRIX vaccine. He went back home and he could not walk and developed Guillain Barre Syndrome. At the time of reporting, he was still in the hospital. The caller did not have time to answer the rest of the questions.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date since 23-APR-2015, the patients were vaccinated with an unspecified number of improperly stored doses of PNEUMOVAX 23 (lot # K008927, expiration date: 17-MAR-2016) (dose and route were not reported). No concomitant therapies were provided. No adverse effects were reported. This is one of several reports from the same source. 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 registered nurse referring to unspecified number of patients of unknown ages and gender. On an unknown date, the unspecified number of patients received an improperly stored dose of PNEUMOVAX 23 (dose, lot #, expiration date and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 83 year old male patient. The patient had no medical history or concurrent conditions. On 05-MAY-2015, the patient was vaccinated with the dose of ZOSTAVAX injection (doses not reported), subcutaneous, lot # K008883, expiration date 20-SEP-2015. The patient had no concomitant medication. On 05-MAY-2015, 5-10 minutes after administration of ZOSTAVAX the patient experienced varicella-like rash, which manifested as blisters, appeared at the injection site while the patient was still at the pharmacy. No lab diagnostics studies were performed and no treatment was given for the event. The outcome of varicella-like rash, which manifested as blisters, appeared at the injection site, and the causality between adverse event and ZOSTAVAX were not reported. The patient sought medical attention as the reaction occurred at the pharmacy. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (strength 2.5 mcg/0.5 ml) (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. There was no product quality issue reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and genders. On an unknown date, the unspecified number of patients received an improperly stored dose of GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. Information about patient's medical histories were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (doses, frequency, routes of administration and lot # were not specified). Concomitant medication was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Rash, Surgery
Clinical narrative: This spontaneous report as received from a physician's assistant via a company representative refers to patient of unknown age who might be a female. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. On an unspecified date in May 2015 ("reported as" "within the last month"), the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot number were not provided). Immediately after the administration of ZOSTAVAX the patient experienced a really bad rash that made the patient end in surgery. The patient's surgeon stated that while the patient was "opened out" it was determined that the rash was actually shingles of a wild type of zoster and not caused by the vaccine. The specific method by which the determination was made was unspecified. It was also reported that the patient sought for medical attention and that was treated with an unspecified antiviral therapy. At the time of this report, the outcome of herpes zoster was unknown. Upon internal review the event herpes zoster was considered medically significant. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Headache, Neuralgia, Skin lesion
Clinical narrative: Patient states day after vaccination noticed pain on right cheek and side of head.  Patent went on vacation where condition worsened.  Lesions developed and patient went to hospital for treatment.  No info on treatment received.  On 4/24/15 upon arriving home, patient sought medical care at an urgent care facility.  I was told Dr. prescribed Bactrim and Valtrex. On 4/27/2015 Patient was seen by her family care Dr.  Dr. prescribed Lyrica for nerve pain.  On 5/22/2015 I contacted Merck and reported reaction.  Case # 1-13874749883.
Age: 1.03
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness to (R) leg at injection site which worries mom so she brought to doctor.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient came into pharmacy 2 days after the injection on 5/17/15 and was concerned about itching and redness at the injection site.  Pharmacist recc antihistamine and topical corticosteroid.  Patient used recommended products.  I spoke to patient on 5/20/15 to follow-up since I was out of office when she initially came in, and she said that the redness kept spreading up/down upper arm and was the worse on 5/16/15.  She kept using OTC products with relief.  She said it was most red in the center with lightening color as it moved outward, the outermost ring being light pink.  She said there was no blistering, no breaks in the skin, and no signs of infection.  No fever and no swelling at any other site in the body.  When I spoke to her on the phone on 5/20/15 she said the itching and redness was improving and she still did not feel it was infection related.
Age: 59.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Lymph node pain
Clinical narrative: The evening after the vaccine patient noted swelling in a red band around the upper rt arm, painful to the touch.  3 days later patient returned to clinic for blood work.  RN noted red rash on the upper right inside of the arm with 3 finger width projections down the arm.  Provider palpated the arm, patient noted tenderness in the area of the lymph at the rt axial.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Rash generalised
Clinical narrative: Full body rash with injection site reaction.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Injection site oedema, Injection site rash, Injection site warmth, Periorbital oedema
Clinical narrative: Full body rash with injection site reaction.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Full body rash with injection site reaction.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Right arm is red, slight swollen and itchy. Patient has FROM to arm, no other concerns. Mom to apply ice pack and Benadryl OTC prn. Call back if worsens or no improvement by 24hrs.
Age: 1.18
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Extra dose administered
Clinical narrative: State Immunization Registry was not updated by staff after MMR #1 and Pentacel #2 were given on April 17, 2015 - patient returned to the office today for immunization update and both MMR and Pentacel were given based off of the un-updated IR listing.
Age: 0.53
Sex: M
Vaccine: DTAP, DTAPH, RVX
Symptoms: Crying, Erythema, Hypophagia, Insomnia, Irritability
Clinical narrative: Non-stop crying, fever, red skin, won't sleep, won't eat as much, fussiness.
Age: 0.53
Sex: M
Vaccine: DTAP, DTAPH, RVX
Symptoms: Pyrexia
Clinical narrative: Non-stop crying, fever, red skin, won't sleep, won't eat as much, fussiness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient said fever started and arm is swollen and red.
Age: 11.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Dizziness, Fatigue, Nausea, Syncope
Clinical narrative: About 5 minutes after receiving the Td and Menactra upon leaving the exam room he fainted, but then was slow to recover. After about 15 minutes with some nausea initially was able to take fluids then after about 45 minutes wanted to go home and was improved. Family noted he was very tired at home, then slept > 16 hours solidly, was up for a short time, and drank very little fluids, was dizzy again slept more and then stated to feel slightly better.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Skin exfoliation, Swelling
Clinical narrative: Swelling, redness, blister popped and skin peeled.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) leg swelling and redness at injection site. Mom concerned enough to bring patient back to doctor.
Age: 2.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Abscess limb, Cellulitis, Rash
Clinical narrative: Developed cellulitis on lower legs after each administration of the Hepatitis A vaccine. Vaccine given on 10/28/14-rash developed on 11/4/14 on left shin was cellulitis. 5/5/15 Hepatitis A #2 dose given. Rash lower legs developed 5/15/15/cellulitis.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema abnormal, Diet refusal, Faeces discoloured, Intussusception, Melaena
Clinical narrative: Vomiting x 5, wouldn't nurse, black, tarry stool-all since 1230 AM on 5/18/15. Referred to ER at 315 when mom called office.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urinary system X-ray, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Vomiting x 5, wouldn't nurse, black, tarry stool-all since 1230 AM on 5/18/15. Referred to ER at 315 when mom called office.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Blepharospasm, Dysgeusia, Headache, Lacrimation increased, Paraesthesia oral
Clinical narrative: Patient received 3 dose of pre-exposure rabies vaccine. No previous reaction reported by patient with first two. About 1.5 hr later pt. called back reporting vomiting x 1, headache, bad/metallic taste in mouth, eyes twitching and watery, tongue feeling tingling. Seen PA and told to take 2 BENADRYL, PEPCID and go home to rest.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Patient received 3 dose of pre-exposure rabies vaccine. No previous reaction reported by patient with first two. About 1.5 hr later pt. called back reporting vomiting x 1, headache, bad/metallic taste in mouth, eyes twitching and watery, tongue feeling tingling. Seen PA and told to take 2 BENADRYL, PEPCID and go home to rest.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Rt deltoid is swollen, hot to touch.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling. Severe itching.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dizziness
Clinical narrative: 3:40 PM Tdap was given pt felt weak and lightheaded pt was placed on bed to lie down. Vital signs stable. 3:45 PM pt given 5.5 oz orange juice-pt lying down. Mother in room. 3:55 PM pt lying down on bed-feels fine vital signs stable. 4:05 PM pt was placed in chair-feels fine-vital signs stable. 4:16 PM pt walked out with mother. Pt felt fine.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Dyspnoea, Nausea, Pharyngeal oedema, Vomiting
Clinical narrative: Vaccines given at 11 AM with no immediate adverse reaction. Pt reported being asymptomatic for next seven hours. She then awakened from a nap at approx. 6 pm with shortness of breath, sensation of throat swelling, nausea/vomiting. Treated in ER with BENADRYL and steroid injection, released.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Dysphonia, Erythema, Fatigue, Headache, Influenza like illness
Clinical narrative: Borders 4" W x 2.5" long. Headache (felt like I had the flu), fever. Vaccine site reaction-extremely painful, warm to touch. Fatigue. Hoarseness of voice, swelling, redness.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Swelling, Vaccination site pain, Vaccination site warmth
Clinical narrative: Borders 4" W x 2.5" long. Headache (felt like I had the flu), fever. Vaccine site reaction-extremely painful, warm to touch. Fatigue. Hoarseness of voice, swelling, redness.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure immeasurable, Feeling hot, Hyperhidrosis, Nausea, Pallor
Clinical narrative: 1 minute (approx) after injection client stated she felt nauseous. Brought trash can to her. Says she is hot, got cool cloth and applied to forehead. Client drew arms to chest and started slumping in chair. Help summoned. Client pale and diaphoretic. Thready pulse, unable to get B/P reading. Ammonia inhalant under nose; client stirred a bit. Helped to floor to lie down. HR 72, 80/52 B/P. Dr. assessed client, monitored till recovered.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pulse abnormal
Clinical narrative: 1 minute (approx) after injection client stated she felt nauseous. Brought trash can to her. Says she is hot, got cool cloth and applied to forehead. Client drew arms to chest and started slumping in chair. Help summoned. Client pale and diaphoretic. Thready pulse, unable to get B/P reading. Ammonia inhalant under nose; client stirred a bit. Helped to floor to lie down. HR 72, 80/52 B/P. Dr. assessed client, monitored till recovered.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Condition aggravated, Diarrhoea, Fatigue, Injection site pain
Clinical narrative: Severe pain at injection site shortly after given. 2 days later fatigue, malaise. 3 days later (5/14/15) flare of abdominal pain and diarrhea (dx Irritable Bowel Syndrome).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Irritable bowel syndrome, Malaise
Clinical narrative: Severe pain at injection site shortly after given. 2 days later fatigue, malaise. 3 days later (5/14/15) flare of abdominal pain and diarrhea (dx Irritable Bowel Syndrome).
Age: 49.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Viral titre increased
Clinical narrative: 5/22/15 left arm above elbow with raised area 4 inches length by 3 inch width. In center of raised area is redness 1 1/2 inch by 1 inch. Areas are WTT.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Lt shoulder was swollen, red, painful 4 in by 2 in.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria, Wheezing
Clinical narrative: -Urticaria hours after vaccines DECADRON and BENADRYL - Then 2 days later urticaria and wheezing seen again in ER Prednisone, ZYRTEC, ZANTAC and Albuterol.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever, nausea, pain, swollen arm.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Large redness, swelling, itching to left arm (TDAP) and mild redness/swelling to right arm (MENVEO).
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Eye pain, Headache, Hyperhidrosis, Nausea
Clinical narrative: 2 hours after vaccination noticed severe nausea, no vomiting, chills, sweats, shakes that evening with headache and red achy eyes - sx resolved w/in 12 hours.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Ocular hyperaemia, Tremor
Clinical narrative: 2 hours after vaccination noticed severe nausea, no vomiting, chills, sweats, shakes that evening with headache and red achy eyes - sx resolved w/in 12 hours.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood alkaline phosphatase increased, Dyspnoea, Electromyogram normal, Fluid retention
Clinical narrative: See initial office note, attached (10/17/2014). Progressive neurologic sx also including paresthesia and head bobbing/tremor. EE presents for evaluation of reaction to influenza vaccination. EE received IIV at 0800 on Wednesday 10/15/2014. Since receiving the vaccine EE has developed pain in her large joints (knees, hips, shoulders), some generalized swelling, fluid retention, and difficulty breathing/SOB with some increased wheezing. EE is well know to this author from another matter. EE is highly sensitive to sulphites and other sulfur compounds. EE has no swelling of the lips, tongue or throat at this time. EE's sx have been slowly progressive since receiving the vaccine.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Head titubation, Neurological symptom, Paraesthesia, Red blood cell sedimentation rate increased, Swelling
Clinical narrative: See initial office note, attached (10/17/2014). Progressive neurologic sx also including paresthesia and head bobbing/tremor. EE presents for evaluation of reaction to influenza vaccination. EE received IIV at 0800 on Wednesday 10/15/2014. Since receiving the vaccine EE has developed pain in her large joints (knees, hips, shoulders), some generalized swelling, fluid retention, and difficulty breathing/SOB with some increased wheezing. EE is well know to this author from another matter. EE is highly sensitive to sulphites and other sulfur compounds. EE has no swelling of the lips, tongue or throat at this time. EE's sx have been slowly progressive since receiving the vaccine.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication, Wheezing
Clinical narrative: See initial office note, attached (10/17/2014). Progressive neurologic sx also including paresthesia and head bobbing/tremor. EE presents for evaluation of reaction to influenza vaccination. EE received IIV at 0800 on Wednesday 10/15/2014. Since receiving the vaccine EE has developed pain in her large joints (knees, hips, shoulders), some generalized swelling, fluid retention, and difficulty breathing/SOB with some increased wheezing. EE is well know to this author from another matter. EE is highly sensitive to sulphites and other sulfur compounds. EE has no swelling of the lips, tongue or throat at this time. EE's sx have been slowly progressive since receiving the vaccine.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Urticaria
Clinical narrative: PREVNAR 13 given 4/24/15. Shortly thereafter patient developed urticaria with significant arm pain 10/10. Urticaria resolved after 24 hrs, continues to have arm pain 4/10 no other symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant, via company representative, refers to a female patient of unknown age. Pertinent medical history, concurrent conditions, drug reactions or allergies were unspecified. On an unknown date, approximately in October 2014 (about 6 months ago), the patient was vaccinated with a dose of ZOSTAVAX, 1 dose, 1 time (dose, dose number, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies were unspecified. On approximately 21-APR-2015 (reported as: "about one week ago", "about 6 months after vaccine"), the patient experienced shingles (herpes zoster). The patient sought medical attention by visiting reporter's office and was treated with an unspecified pain medication. It was unspecified if laboratory test was performed. The outcome of herpes zoster was unknown. The relatedness between herpes zoster and ZOSTAVAX was not reported. Additional information is not expected because the reporter refused additional contact.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 6 month old male patient. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an expired dose of ROTATEQ lot # K008139, expiration date 18-MAY-2015, dose three, oral. No adverse effects reported. No co-suspect and concomitant therapies were reported. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Injection site pain
Clinical narrative: Ache at site. Chills at bed time o/a 11:00 PM same day.  All symptoms gone by next morning.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Borrelia test negative, Complex regional pain syndrome, Deep brain stimulation, Dystonia
Clinical narrative: After the 3rd vaccine was given on 8/13/2009 patient complained of not feeling well. Is extremely fatigued. Then in March of 2010 she started having episodes of extreme all over body pain so bad we took her to the ER twice.  An MRI in April 2010 showed nothing. Patient then started a neck tic in June 2010. August 15, 2010 @ 2:30am patient started having seizure like episodes and weak legs to the point she can't walk very far and needs a wheel chair. She was diagnosed with Tourettes, dystonia, fibromyalgia and RSD. June 16 2013 patient had to undergo deep brain stimulation but she still suffers with bad dystonia and chronic pain and still uses a wheelchair.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Fibromyalgia, Gait disturbance, Malaise, Muscular weakness
Clinical narrative: After the 3rd vaccine was given on 8/13/2009 patient complained of not feeling well. Is extremely fatigued. Then in March of 2010 she started having episodes of extreme all over body pain so bad we took her to the ER twice.  An MRI in April 2010 showed nothing. Patient then started a neck tic in June 2010. August 15, 2010 @ 2:30am patient started having seizure like episodes and weak legs to the point she can't walk very far and needs a wheel chair. She was diagnosed with Tourettes, dystonia, fibromyalgia and RSD. June 16 2013 patient had to undergo deep brain stimulation but she still suffers with bad dystonia and chronic pain and still uses a wheelchair.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Pain, Seizure like phenomena, Tic, Tourette's disorder
Clinical narrative: After the 3rd vaccine was given on 8/13/2009 patient complained of not feeling well. Is extremely fatigued. Then in March of 2010 she started having episodes of extreme all over body pain so bad we took her to the ER twice.  An MRI in April 2010 showed nothing. Patient then started a neck tic in June 2010. August 15, 2010 @ 2:30am patient started having seizure like episodes and weak legs to the point she can't walk very far and needs a wheel chair. She was diagnosed with Tourettes, dystonia, fibromyalgia and RSD. June 16 2013 patient had to undergo deep brain stimulation but she still suffers with bad dystonia and chronic pain and still uses a wheelchair.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Wheelchair user
Clinical narrative: After the 3rd vaccine was given on 8/13/2009 patient complained of not feeling well. Is extremely fatigued. Then in March of 2010 she started having episodes of extreme all over body pain so bad we took her to the ER twice.  An MRI in April 2010 showed nothing. Patient then started a neck tic in June 2010. August 15, 2010 @ 2:30am patient started having seizure like episodes and weak legs to the point she can't walk very far and needs a wheel chair. She was diagnosed with Tourettes, dystonia, fibromyalgia and RSD. June 16 2013 patient had to undergo deep brain stimulation but she still suffers with bad dystonia and chronic pain and still uses a wheelchair.
Age: 0.42
Sex: M
Vaccine: DTAP
Symptoms: Insomnia, Pain, Screaming
Clinical narrative: Screaming for hours on end. A pain scream. Straightening out his leg like he is in agony. Not eating nearly as much. Can't sleep because of pain.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Nausea, Peripheral swelling, Sleep disorder
Clinical narrative: Moderate Pain at injection site, Chills, Sleep issues, Nausea, Arm very swollen.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram head normal, Generalised tonic-clonic seizure
Clinical narrative: 2-3 minute generalized tonic clonic seizure that self-resolved. At ED at 5:00PM, had 1 minute generalized tonic clonic seizure that self-resolved.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Intense itching and redness at site of shot.  Covered with Cortisone 10.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature fluctuation, Body temperature increased, Choking, Cough, Crying
Clinical narrative: Rectal temperature of 100.4°F, beginning near 7 PM, peaking to high of 101.8°F, shortly after midnight. Steady reading until 6 AM, when temp. began decline to 100.0°F; fluctuating up/down couple degrees throughout 5/23/2015. Also, moderate diarrhea, with severe gastrointestinal cramping/gas, which caused  severe painful crying/screaming until he would just pass out, too overwhelmed. Quite lethargic, to point of appearing spaced out/lost; not seeming to recognize anything, just screaming. Body aches, had to keep soft pillow between he and I, to lessen contact pressure. Stuffy nose, cough that caused choking, breathing difficulty.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Dyspnoea, Feeling abnormal, Flatulence, Gastrointestinal pain
Clinical narrative: Rectal temperature of 100.4°F, beginning near 7 PM, peaking to high of 101.8°F, shortly after midnight. Steady reading until 6 AM, when temp. began decline to 100.0°F; fluctuating up/down couple degrees throughout 5/23/2015. Also, moderate diarrhea, with severe gastrointestinal cramping/gas, which caused  severe painful crying/screaming until he would just pass out, too overwhelmed. Quite lethargic, to point of appearing spaced out/lost; not seeming to recognize anything, just screaming. Body aches, had to keep soft pillow between he and I, to lessen contact pressure. Stuffy nose, cough that caused choking, breathing difficulty.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Loss of consciousness, Nasal congestion, Pain, Screaming
Clinical narrative: Rectal temperature of 100.4°F, beginning near 7 PM, peaking to high of 101.8°F, shortly after midnight. Steady reading until 6 AM, when temp. began decline to 100.0°F; fluctuating up/down couple degrees throughout 5/23/2015. Also, moderate diarrhea, with severe gastrointestinal cramping/gas, which caused  severe painful crying/screaming until he would just pass out, too overwhelmed. Quite lethargic, to point of appearing spaced out/lost; not seeming to recognize anything, just screaming. Body aches, had to keep soft pillow between he and I, to lessen contact pressure. Stuffy nose, cough that caused choking, breathing difficulty.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on an unknown date, the patients were vaccinated with improperly stored of VAQTA (product lot#, expiry date not reported). No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on an unknown date, the patients were vaccinated with improperly stored doses of COMVAX (product lot#, expiry date not reported). No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on an unknown date, the patients vaccinated with improperly stored doses of RECOMBIVAX HB (product lot#, expiry date not reported). No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. 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 healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (product lot#, expiration date not reported). No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the 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 was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (product lot#, expiry date not reported). No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.