chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Acne
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 13 year old male patient with no pertinent medical history and no drug reactions or allergies. On an unknown dates, the patient was vaccinated with the first and second dose of GARDASIL injection (dose, route of administration, anatomical location and interval were not reported). Approximately in September 2014 (reported as "completed his GARDASIL series 1 year ago"), he was vaccinated with the third dose of GARDASIL injection (dose, route of administration, anatomical location and interval were not reported). There were no concomitant medications. Approximately in December 2014 (reported as "3 to 4 months after completion of their third and final dose of the vaccine"), the patient developed severe acne on his face and back. He was treated with ACCUTANE. It was reported, that the patient sought medical attention - office visit. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and GARDASIL was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB 5 micrograms/0.5 mL (dose, frequency and route were not reported) lot # L010595 with an expiry of 12-NOV-2016. No concomitant medications were reported. No adverse effects were reported. This healthcare worker also inquired about the stability of M-M-R II, however, M-M-R II did not undergo a temperature excursion and is not included in this adverse event (AE). There was no product quality complaint involved. This is one of the several reports received from 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 and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 16-NOV-2006, the patient received the first dose in the series of three of GARDASIL (dose, route of administration, lot # and expiration date were not provided). On 06-MAR-2007, the patient received the second dose in the series of three of GARDASIL (dose, route of administration, lot # and expiration date were not provided). On 18-MAY-2007, the patient received the third dose in the series of three of GARDASIL (dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product label confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to 10 unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 24-SEP-2015 and on 25-SEP-2015, the patients were each inadvertently administered a dose of PNEUMOVAX 23 (dose and route of administration were not reported) instead of an intended dose of FLUVIRIN. An unspecified number of these doses were administered on 24-SEP-2015 and an unspecified number of these doses were administered on 25-SEP-2015. Each of these 10 doses of PNEUMOVAX 23 were from 1 of 3 different lot numbers (lot number K021030 and expiration date 22-JUN-2016; lot number L010598 and expiration date 06-AUG-2016; lot number L003227 and expiration date 13-OCT-2016). It was unspecified how many or which of the 10 unspecified patients were administered doses from each of the 3 lot numbers. All 10 unspecified patients had each received either one or two doses of PNEUMOVAX 23 previously (dose, route of administration, lot number, expiration date and dates of administration were not reported). It was stated that these 10 unintended doses of PNEUMOVAX 23 were administered by a different nurse who, due to her inexperience, confused PNEUMOVAX 23 for FLUVIRIN since both vaccines and the same labeled dosage of 0.5 ml and had been stored in the same location. No adverse effect was reported for any of the 10 unspecified patients. Additional information is not expected as the reporter did not wish further contact.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer (the mother) refers to her approximately 14-year-old non-pregnant daughter with no pertinent medical history and no drug reactions or allergies. On unknown dates, the patient was vaccinated with the first and the second dose of GARDASIL injection (dose, route of administration, anatomical location and interval were not reported). Approximately in September 2011 (reported as "finished GARDASIL series 4 years ago"), the patient was vaccinated with the third dose of GARDASIL injection (dose, route of administration, anatomical location and interval were not reported). There were no concomitant medications. Approximately in December 2011 (reported as "3 to 4 months after completion of their third and final dose of the vaccine"), the patient developed severe acne on her face and back. She was treated for this event with over the counter treatment methods. It was reported, that the patient sought medical attention - office visit. The outcome of the event was reported as recovered/resolved. The relatedness between the event and GARDASIL was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored VAQTA 25/0.5 (units not provided) (dose, frequency and route were not reported) lot # L023966 with an expiry of 15-MAR-2017. No concomitant medications were reported. No adverse effects were reported. This healthcare worker also inquired about the stability of M-M-R II, however, M-M-R II did not undergo a temperature excursion and is not included int his adverse event (AE). There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL (strength, dose, frequency, lot # and route were not reported). No concomitant medications were reported. No adverse effects were reported. This healthcare worker was inquired about the stability of M-M-R II, however, M-M-R II did not undergo a temperature excursion and is not included in this adverse event (AE). There was no product quality complaint involved. This is one of the several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of adult patients of unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The pharmacist reported that on unknown dates, each adult patient who came to the pharmacy for the PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) and one dose of PREVNAR 13 (dose, route of administration, lot # and expiration date were not reported) separated by one year. It was unspecified in what order these vaccines were administered. No adverse events symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (strength, dose, frequency and route were not reported) lot # L008574 with an expiry of 22-NOV-2016. No concomitant medications were reported. No adverse effects were reported. This healthcare worker also inquired about the stability of M-M-R II, however, M-M-R II did not undergo a temperature excursion and is not included in this adverse event (AE). There was no product quality complaint involved. This is one of the several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not provided. In July 2015, unspecified number of patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ, oral, lot # K016261 expiration date 23-JUN-2016 and lot # K016263 and expiration date 26-JUN-2016 (doses were not provided). There was no concomitant medication reported. The reporter referred that the vaccines were administrated by an unspecified physician and no adverse experiences had been reported. This is one of several reports received from the same reporter. Follow up information has been received on 25-SEP-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified patients of unknown age and gender In September 2015 (reported as between 10-SEP-2015 and 18-SEP 2015), the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 08-JUL-2015). No adverse effect reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Information has been received from a consumer referring to his wife, a 40 year old female patient with lupus and allergy to gabapentin and compazine. The patient has a history of migraine headaches. On 19-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported, 0.65 ml/one time injection, subcutaneously in the back of the left arm) (recommended by her rheumatologist, which was other than indicated in the Prescribing Information (off label use). There was no concomitant medication. On 20-SEP-2015 the patient experienced headaches for three days following the injection of ZOSTAVAX and was treated with TYLENOL. An unspecified number of days after receiving the ZOSTAVAX vaccine injection, inui September 2015 the patient noticed a series of bumps on the right side of her body near her hip and on her right forearm. No lab diagnostics studies were performed. The patient did not seek medical attention for the adverse events of ZOSTAVAX, but would contact her healthcare professional (HCP). Outcome of the event "headaches" was reported as recovered on 22-SEP-2015 (estimated per three days duration). Outcome of the event "bumps on the right side of her body near her hip and on her right forearm" was reported as not recovered. Outcome of the event "off label use" was unknown. The causality was not provided. 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 licensed practical nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# J006245, expiry date: 03-FEB-2016 and lot# K008334, expiry date: 09-JUN-2016), dose, route, frequency unspecified (Incorrect storage of drug). Other suspect and concomitant therapies were not reported. No adverse symptoms reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient has been in pain every since the shot.  He alleges that the shot was given too high.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Severe arm pain and muscle weakness.
Age: 21.0
Sex: F
Vaccine: FLUX, HEP, HPVX, FLU3, HEP, HPV9
Symptoms: Arthralgia, Dizziness, Immediate post-injection reaction, Pain, Syncope
Clinical narrative: Injection felt solid going into my arm. Pretty intense pain was immediate and came with the needle not the serum its self. Within 3 seconds of injection I started to feel faint. Seeing the room darken with colored spots and slight loss of hearing had to lay on the floor of the hospital until the symptoms passed probably around 10 minutes. Continuous pain in the joint now for over 24 hours and has not diminished. Little to no Muscle pain associated with the shot.
Age: 21.0
Sex: F
Vaccine: FLUX, HEP, HPVX, FLU3, HEP, HPV9
Symptoms: Visual impairment
Clinical narrative: Injection felt solid going into my arm. Pretty intense pain was immediate and came with the needle not the serum its self. Within 3 seconds of injection I started to feel faint. Seeing the room darken with colored spots and slight loss of hearing had to lay on the floor of the hospital until the symptoms passed probably around 10 minutes. Continuous pain in the joint now for over 24 hours and has not diminished. Little to no Muscle pain associated with the shot.
Age: 21.0
Sex: F
Vaccine: FLUX, HEP, HPVX, FLU3, HEP, HPV9
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: Injection felt solid going into my arm. Pretty intense pain was immediate and came with the needle not the serum its self. Within 3 seconds of injection I started to feel faint. Seeing the room darken with colored spots and slight loss of hearing had to lay on the floor of the hospital until the symptoms passed probably around 10 minutes. Continuous pain in the joint now for over 24 hours and has not diminished. Little to no Muscle pain associated with the shot.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Heart rate increased, Injection site pain, Nausea
Clinical narrative: Headache and nausea started around 2:00 PM on 10/2/15 through today. Fast heart rate around 6:15 PM on 10/02/15. Pain in right shoulder started around 2:00PM on 10/2/15 through today.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain, Pruritus, X-ray
Clinical narrative: Arm was achy right away and then just never went away. Went through physical therapy to try and relieve pain and improve range of motion when lifting arm with no real relief. 11 months later they finally ordered at MRI to see what is happening.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Pain and redness at injection site and feeling of tiredness. Patient presented back to pharmacy at 10:00AM on 10/03/2015. Patient taking anti-inflammatory. Instructed to apply cold pack or ice to area of inflammation and continue taking anti-inflammatory. Instructed patient to follow up with primary care doctor if no change by Monday and to call 911 if shortness of breath or mouth or tongue swelling occur.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Large patch of red bumps, pain, soreness close to injection site.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain in extremity
Clinical narrative: Headache, vomiting, diarrhea, fever, chills, extreme tiredness, sore arm.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache, vomiting, diarrhea, fever, chills, extreme tiredness, sore arm.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test normal, Headache, VIIth nerve paralysis
Clinical narrative: Severe headache. While brushing teeth day before notice had problem rinse. But quickly noticed that I could not se the left side of face. Tried to whistle and smile was only on one side. Thought I had a mild stroke. Went immediately for medical help.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Hyperaesthesia, Nausea
Clinical narrative: Extreme fatigue at first, then fever, chills, body aches, skin sensitivity, headache, some nausea. Lasted about 40 hours.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Extreme fatigue at first, then fever, chills, body aches, skin sensitivity, headache, some nausea. Lasted about 40 hours.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal disorder, Myalgia
Clinical narrative: Patient reports her muscle was very sore.  So sore she couldn't use her arm for two days.  She says it is improving every day.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Haematochezia, Pain
Clinical narrative: Sore arm, achy all over, fatigue, weakness, no energy, lack of appetite, most lasted about three weeks, I thought I had the flu.  Then I got the diarrhea for about four days with blood in my stool.  I thought it was something I ate.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Sore arm, achy all over, fatigue, weakness, no energy, lack of appetite, most lasted about three weeks, I thought I had the flu.  Then I got the diarrhea for about four days with blood in my stool.  I thought it was something I ate.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pruritus, Pruritus, Swelling, Urticaria
Clinical narrative: My elbows started itching then hives covered my body very quickly.  Swollen red hives all over.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Eyelid oedema, Pharyngeal oedema, Streptococcus test negative, Swelling face
Clinical narrative: Swelling of right side of face. Right eye swollen shut. Throat swelling. Difficulty breathing.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Arm was very painful right after adminstration. Pain went down the arm. Could not lift arm up.  Soreness and range of motion has improved, but 3 months after injection he still does not have full range of motion and arm is still mildly sore.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Head discomfort, Headache
Clinical narrative: Headache and weakness started within an hour. By midnight I had the chills and was shaking so bad it felt like a seizure, pressure in head increased, nausea and vomiting, very achy joints. Took Tylenol.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: Headache and weakness started within an hour. By midnight I had the chills and was shaking so bad it felt like a seizure, pressure in head increased, nausea and vomiting, very achy joints. Took Tylenol.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Eye irritation, Eye pruritus, Eye swelling, Headache
Clinical narrative: Patient reports that about an hour and a half after receiving his flu vaccination, he started to develop a headache and bilateral eye itching, swelling, burning and redness. Patient also states that he started to have itching and redness on his neck. Patient denied any respiratory symptoms. Patient's first set of vitals was obtained at approximately 08:45; his BP was 132/80 and HR was 79 BPM. Per doctor's orders, 50 mg/ML of Diphenhydramine (Lot # 4296463, Exp: Oct 2016) was administered IM in the R arm at 0900 to the patient. Vital signs were re-assessed at 09:14; BP was 118/78, HR was 75 BPM and 02 was 96%. Patient was taken to the urgent care per doctor's recommendation at approximately 09:30 for further follow-up.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pruritus
Clinical narrative: Patient reports that about an hour and a half after receiving his flu vaccination, he started to develop a headache and bilateral eye itching, swelling, burning and redness. Patient also states that he started to have itching and redness on his neck. Patient denied any respiratory symptoms. Patient's first set of vitals was obtained at approximately 08:45; his BP was 132/80 and HR was 79 BPM. Per doctor's orders, 50 mg/ML of Diphenhydramine (Lot # 4296463, Exp: Oct 2016) was administered IM in the R arm at 0900 to the patient. Vital signs were re-assessed at 09:14; BP was 118/78, HR was 75 BPM and 02 was 96%. Patient was taken to the urgent care per doctor's recommendation at approximately 09:30 for further follow-up.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness below area of injection.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Local swelling
Clinical narrative: Donor stated she woke up this AM (10/03/15) with some pain and puffiness in the armpit of arm that received vaccine. She denied other s/s and said "pain not that bad."
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dehydration, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Light-headed, loss of color and strength, loss of consciousness on two back to back occasions.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Light-headed, loss of color and strength, loss of consciousness on two back to back occasions.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Syncope about 5 minutes after vaccination. Patient regained consciousness in a few seconds and appeared to be fine. EMS was called, evaluated patient, mother declined transport to hospital.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: 1. The injection point was like a bee sting 2. The area from the point of injection towards the bicep of the left arm was red with size of a grapefruit. 3. The area was extremely warm to touch. 4. Developed a fever. 5. Felt fluish and fatigued. 6. Had diarrhea on Friday 10/2/2015. 7. On Friday fever went away but still felt sluggish. 8. The red area on my left arm was still sore, red like a rash and size of a grapefuit. Felt hot to touch and was still sore at point of injection similar to a bee sting. Saturday 10/3/2015. 9. Fever is gone, diarrhea is gone, fatigue feeling is gone. However, the area on the left arm is still extremely warm to touch and sore and still reddish and the size of grapefruit.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site warmth, Pyrexia, Sluggishness
Clinical narrative: 1. The injection point was like a bee sting 2. The area from the point of injection towards the bicep of the left arm was red with size of a grapefruit. 3. The area was extremely warm to touch. 4. Developed a fever. 5. Felt fluish and fatigued. 6. Had diarrhea on Friday 10/2/2015. 7. On Friday fever went away but still felt sluggish. 8. The red area on my left arm was still sore, red like a rash and size of a grapefuit. Felt hot to touch and was still sore at point of injection similar to a bee sting. Saturday 10/3/2015. 9. Fever is gone, diarrhea is gone, fatigue feeling is gone. However, the area on the left arm is still extremely warm to touch and sore and still reddish and the size of grapefruit.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Rash generalised
Clinical narrative: Body rash, muscle ache, fever.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness and swelling, "hot and itching about 4 inches" no treatment by patient, receding by 4 days, self-limiting.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Several hours after the vaccine was administered, patient experienced hives all over his torso. Reaction was mild and self-limiting. Patient was monitored during first 15 minutes after vaccine administration, but no signs/symptoms of allergic reaction occurred during that time. No other adverse effects occurred besides the hives. Patient had received flu vaccine in the past, but it was several years ago. No previous reactions to the flu vaccine or any other vaccines.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Pain in extremity, Pyrexia
Clinical narrative: Weakness, fever, sore arm.
Age: 43.0
Sex: F
Vaccine: FLU4, HEP, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: SEVERE SWELLING, WARMTH, AND PAIN IN LEFT ARM. WENT TO EMERGENCY ROOM TWICE AND THEN WAS ADMITTED FOR TREATMENT.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Lacrimation increased, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, cough, watery eyes, body aches, sinus congestion, sinus pressure, fatigue. Treated with Azelastine nasal spray, Nasacort, Allegra, Benadryl with no improvement of symptoms. 10/3/2015 started Medrol pack. Symptoms improving as of 10/3/2015.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Paranasal sinus discomfort, Sinus congestion
Clinical narrative: Sore throat, cough, watery eyes, body aches, sinus congestion, sinus pressure, fatigue. Treated with Azelastine nasal spray, Nasacort, Allegra, Benadryl with no improvement of symptoms. 10/3/2015 started Medrol pack. Symptoms improving as of 10/3/2015.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: While RN administered flu vaccine, syringe malfunctioned and only ejected half the dose.  A second half dose had to be administed via a second pre-filled syringe.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Herpes zoster, Laboratory test, Rash
Clinical narrative: Herpes Zoster Rash.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Pollakiuria
Clinical narrative: Extreme pain in joints (all) and all over muscle soreness. Started at 10:30pm on 9/27/15 and lasted until 3am on 9/28/15 teeth chattering, chills, sweating, urinating profusely.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Hyperaesthesia, Increased tendency to bruise
Clinical narrative: Pt received two vaccines on 9/24/15. The 2nd vaccine caused mild raised bruising within seconds of admin. Pt reported easy bruising and previous sensitivity. Pt's health was good upon leaving the site.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Within a few hrs of immunization on 9/30, pt's arm began to itch. Became swollen and red. Next day-sought treatment. MD Rx'd hydroxyzine HCL. Also SMX/TMP on 10/2.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: On the vaccinated arm, between the elbow and deltoid-patient experienced a large red, warm to touch area followed by a bruise for over 1 week.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients' medical history was not reported. In approximately 2015 (reported as since 11-AUG-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K020181, expiration date reported as 24-JUN-2016 (dose, route and site of administration were not reported) which were exposed to the temperatures outside of the recommended range. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients' medical history was not reported. In approximately 2015 (reported as since 01-JUL-2015), the patients were vaccinated with doses of GARDASIL lot # K004215, expiration date 05-MAY-2017; K004205, expiration date 12-JAN-2017; lot # K006960, expiration date 19-FEB-2017 (dose, route and site of administration were not reported) which were exposed to the temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients' medical history was not reported. In approximately 2015 (reported as since 01-JUL-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010323, expiration date 10-MAY-2016 (dose, route and site of administration were not reported) which were exposed to the temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Itching, swelling, redness and hives at injection site.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Chest pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, chest pains.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Headache, Influenza A virus test, Influenza B virus test
Clinical narrative: Fever, chills, nausea, headache, neck and back pain, muscle aches.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Neck pain, Pyrexia
Clinical narrative: Fever, chills, nausea, headache, neck and back pain, muscle aches.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Dysmenorrhoea, Headache, Nasopharyngitis, Nausea, Seizure
Clinical narrative: First time seizure lasting 15 seconds, unusually intense menstrual cramps, new nausea 20 minutes prior to seizure, headache, 'head cold' type symptoms several days prior to seizure.
Age: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Lip swelling, Peripheral swelling
Clinical narrative: Arm swelled up. Later on patient reported lip swelling and went to ER.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: Initially injectable solution "wouldn't go in" as it was being administered, then it did and there was a lot of pain at the site. Site noted to be posterior on the left shoulder and  too high up on the arm, above the deltoid.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient reports starting Friday 10/2/15 he experienced facial redness, rash, and itching on forehead, nose, and cheeks. Slightly improved today Sunday 10/4/15, wife reports they used coconut oil and Neosporin at home to soothe and treat.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Carpal tunnel syndrome, Chest X-ray normal, Electromyogram abnormal, Feeling abnormal, Malaise
Clinical narrative: Low grade fever and malaise lasting for 20 days. Following recovery from fever, paresthesias (extremities and oral), "brain fog", muscle weakness continue to present date.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Paraesthesia oral, Pyrexia
Clinical narrative: Low grade fever and malaise lasting for 20 days. Following recovery from fever, paresthesias (extremities and oral), "brain fog", muscle weakness continue to present date.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Vitamin D deficiency
Clinical narrative: Low grade fever and malaise lasting for 20 days. Following recovery from fever, paresthesias (extremities and oral), "brain fog", muscle weakness continue to present date.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Skin burning sensation
Clinical narrative: Burning Skin Sensation started in lower back and moved up to shoulders and lower neck area both sides plus mild headache.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Insomnia, Mobility decreased, Muscular weakness, Pain
Clinical narrative: Just a few hours after receiving the flu shot in my left arm, it began to ache. I noticed by that evening it was very sore from the shoulder all the way down to the elbow. It became difficult for me to cross my arm across to the right side of my body and raise it above my head. When I did try to move my arm in this way, a sharp pain ran from my shoulder to my elbow. It has gotten worse since that initial day and I am now plagued with sharp pains, muscle weakness, tingling in my fingers and a throbbing pain all day, everyday. It also aches all night! I have difficulty sleeping because my left arm hurts to sleep on and hurts terribly to move! It has been 3 weeks now and I have seen a chiropractor twice thinking that might ease the pain. I have also tried sleeping with a heating pad on my shoulder (on the injection site) but that seems to make it worse. I am finding no relief at this point! I have a doctor appointment on Monday, October 5, 2015 to see if they can help me or have any suggestions/solutions.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Just a few hours after receiving the flu shot in my left arm, it began to ache. I noticed by that evening it was very sore from the shoulder all the way down to the elbow. It became difficult for me to cross my arm across to the right side of my body and raise it above my head. When I did try to move my arm in this way, a sharp pain ran from my shoulder to my elbow. It has gotten worse since that initial day and I am now plagued with sharp pains, muscle weakness, tingling in my fingers and a throbbing pain all day, everyday. It also aches all night! I have difficulty sleeping because my left arm hurts to sleep on and hurts terribly to move! It has been 3 weeks now and I have seen a chiropractor twice thinking that might ease the pain. I have also tried sleeping with a heating pad on my shoulder (on the injection site) but that seems to make it worse. I am finding no relief at this point! I have a doctor appointment on Monday, October 5, 2015 to see if they can help me or have any suggestions/solutions.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: Patient bled immediately from vaccine, and a hard bump/bruise appeared within seconds of vaccine administration on the patient's upper arm/deltoid region. Patient reported sore arm the following morning, as well as a sore neck, which she was positive occurred before the vaccination.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain, soreness, and stiffness in upper right arm.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest X-ray, Dyspnoea, Injection site pain, Injection site paraesthesia
Clinical narrative: Shooting pain/tingling in right arm where shot was given. Trouble breathing. Went to ER and given breathing treatment.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test
Clinical narrative: Shooting pain/tingling in right arm where shot was given. Trouble breathing. Went to ER and given breathing treatment.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity, Peripheral swelling
Clinical narrative: Arm got gradually more sore and upper arm swelled and was bruised.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient presents to pharmacy with complaint of rash where Prevnar 13 immunization was administered. Rash is not itchy, but is red and warm to the touch. Rash is approximately palm-sized. I advise the patient to take Benadryl tablets to help stop the allergic reaction and to seek immediate medical attention if she experiences trouble breathing or facial swelling.
Age: 51.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Local swelling, Rash, Rash vesicular, Skin irritation, Swelling
Clinical narrative: Patient first report rash and noticed area swollen. Then patient reported to physician on 10/1/2015 with Shingles like rash near area of injection and noticeable swelling and irritation.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient complained of localized itching and swelling at subcutaneous site of immunization.  Patient denied any generalized symptoms or dyspnea.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt has redness, swelling, and mild tenderness at injection site. Asked if painful. Pt stated no, just tender.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Back pain, Hyperhidrosis, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Had severe upper back pain on left side. Was not even able to turn other side during sleep or not even able to walk still. Took Tylenol, kept ice, put ice patch but pain still keeps persisting. Didn't have any back pain before the flu shot. Next day morning around 6 am had a vomiting sensation with so much sweat and throat was also not good. But I had so much pain in my upper left hand when flu shot was being given and may be it trigerred an upper back pain on left side.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain in extremity, Vomiting
Clinical narrative: Had severe upper back pain on left side. Was not even able to turn other side during sleep or not even able to walk still. Took Tylenol, kept ice, put ice patch but pain still keeps persisting. Didn't have any back pain before the flu shot. Next day morning around 6 am had a vomiting sensation with so much sweat and throat was also not good. But I had so much pain in my upper left hand when flu shot was being given and may be it trigerred an upper back pain on left side.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Haematoma, Injection site erythema, Injection site warmth, Mass, Tenderness
Clinical narrative: Warmth and redness at injection site. Deep tender lumps noted in muscles at follow-up visit on 9/23/15, felt to be hematoma in/near muscles. No treatment required. No signs of secondary infection.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm red, swollen and warm to the touch extending out from vaccination site.
Age: 48.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Fever, chills, achiness for 3 days followed by rash for 3 days.
Age: 0.52
Sex: M
Vaccine: IPV
Symptoms: Abnormal behaviour, Emotional distress, Irritability, Pyrexia
Clinical narrative: Fever 103 and above for 3 days. Patient was inconsolable and severely cranky, fussy, and not himself until fever broke.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Insomnia, Pain
Clinical narrative: Generalized body aches, trouble sleeping, stomach ache.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Abnormal behaviour, Dyspnoea, Encephalitis, Fall, Feeding disorder
Clinical narrative: My son had his well child check up on September 30th 2015. He passed with flying colors and before his shots he was his happy healthy self. After the appointment, he fell asleep on the way home. We only live 5 minutes away. I laid him down in his crib and he slept for about 4 hours. When he woke up I went to get him and he wasn't acting normal. He usually stands up and yells for me. This time he was just sitting there whining. I picked him up and brought him downstairs. He saw his brother and tried to walk to him. He took a step forward and fell down. He laid on his stomach until I picked him up. After that he refused to walk. He couldn't bare weight on his legs. His left leg and foot were swollen and his right leg had a red bump where his shot was given. He laid on the couch for awhile. His breathing became labored and had limp arms and legs. He kept his eyes squinted and wouldn't move off of the couch for about 2-3 hours. I gave him juice and tried to get him to eat but his food and drink would just roll out of his mouth like he couldn't chew. At this time he didn't have a fever yet. I called the ER around 8:30/9 pm. When his breathing began to concern me. I counted 45 breaths per minute. They told me to bring him in so I did immediately. When we got there a fever set in. It went from 97 to 99, up to 101. They gave him Motrin and basically told me I was over reacting even tho they saw him laying in my arms basically limp and screaming a terrible high pitched scream. I finally told the nurse I wanted him hooked up to an O2 monitor and sure enough I was right. We stayed there until they cleared us to leave. The next day I had a bad feeling because he still refused to walk. He was showing the exact symptoms as the day before. A 15 month old doesn't wake up and forget how to walk. He's been walking perfectly since he was 9 months old. I brought him in to pediatrics and he saw doctor. Doctor looked at him. Tried to get him to walk. And he decided that patient needed to be seen by another hospital. He called them and we rushed there ASAP. When we got there his temp was at about 102. He still was not bearing weight on his legs. He was in and out of it and not really responsive. The ER then sent us to have an MRI and spinal tap. They admitted us and we ended up staying there from October 1st to 3rd. They ruled out all life threatening diseases but did tell me that he had cerebritis. Which is inflammation of the brain and spine. But it was only acute or minor. Making them think it was a virus. But online - it shows that the shots he got show adverse side effects 4 hours after injection. Just like my child. One doctor told me it probably was from the vaccines. More agreed. We had so many tests and my baby was so miserable. Fevers reaching 103. He began walking again on his own again shortly after but his fever is still here. This has been the scariest time of our lives.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Feeling abnormal, Gait disturbance, Hyporesponsive to stimuli, Hypotonia, Inflammation
Clinical narrative: My son had his well child check up on September 30th 2015. He passed with flying colors and before his shots he was his happy healthy self. After the appointment, he fell asleep on the way home. We only live 5 minutes away. I laid him down in his crib and he slept for about 4 hours. When he woke up I went to get him and he wasn't acting normal. He usually stands up and yells for me. This time he was just sitting there whining. I picked him up and brought him downstairs. He saw his brother and tried to walk to him. He took a step forward and fell down. He laid on his stomach until I picked him up. After that he refused to walk. He couldn't bare weight on his legs. His left leg and foot were swollen and his right leg had a red bump where his shot was given. He laid on the couch for awhile. His breathing became labored and had limp arms and legs. He kept his eyes squinted and wouldn't move off of the couch for about 2-3 hours. I gave him juice and tried to get him to eat but his food and drink would just roll out of his mouth like he couldn't chew. At this time he didn't have a fever yet. I called the ER around 8:30/9 pm. When his breathing began to concern me. I counted 45 breaths per minute. They told me to bring him in so I did immediately. When we got there a fever set in. It went from 97 to 99, up to 101. They gave him Motrin and basically told me I was over reacting even tho they saw him laying in my arms basically limp and screaming a terrible high pitched scream. I finally told the nurse I wanted him hooked up to an O2 monitor and sure enough I was right. We stayed there until they cleared us to leave. The next day I had a bad feeling because he still refused to walk. He was showing the exact symptoms as the day before. A 15 month old doesn't wake up and forget how to walk. He's been walking perfectly since he was 9 months old. I brought him in to pediatrics and he saw doctor. Doctor looked at him. Tried to get him to walk. And he decided that patient needed to be seen by another hospital. He called them and we rushed there ASAP. When we got there his temp was at about 102. He still was not bearing weight on his legs. He was in and out of it and not really responsive. The ER then sent us to have an MRI and spinal tap. They admitted us and we ended up staying there from October 1st to 3rd. They ruled out all life threatening diseases but did tell me that he had cerebritis. Which is inflammation of the brain and spine. But it was only acute or minor. Making them think it was a virus. But online - it shows that the shots he got show adverse side effects 4 hours after injection. Just like my child. One doctor told me it probably was from the vaccines. More agreed. We had so many tests and my baby was so miserable. Fevers reaching 103. He began walking again on his own again shortly after but his fever is still here. This has been the scariest time of our lives.