chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a currently 78 year-old female patient with contrast dye allergy and iodine allergy. Other medical history was not reported. On an unknown date, the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown) (Batch#, Lot#, dose and frequency not reported) also reported as an unspecified Hepatitis B vaccine. Concomitant therapies included letrozole, furosemide (manufacturer unknown), atenolol, atorvastatin, warfarin sodium (manufacturer unknown), potassium chloride (manufacturer unknown), Lactobacillus (unspecified), senna and docusate. On an unknown date the patient experienced unspecified allergy. The outcome of unspecified allergy is unknown. The relatedness between the event and suspect therapy was not reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Pain, redness about 4" in diameter, swelling in the left arm.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Insomnia, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: My left shoulder felt like I had been stabbed.  I had the worst pain in my life. I took extra pain meds that I had for my back pain, but it did not help.  That day the weather was bad with snow drifts and bad roads, so I did not want to leave my house.  Same on Sunday and the pain was worse.  After contacting my doctors office I went in to see Dr. I told her that the Med student gave me the shot way to high (I had searched the internet that weekend for proper injection sites).  I rolled up my left sleeve when he was ready to give the pneumonia shot and he said "No, you'll have to take off your shirt because I need to give the shot higher". He gave the shot at a 45-90 deg angle on the crown of the shoulder.  Now I suspect he went through the Subdeltoid Bursa muscle.   By Monday morning 01/27/2014, I could not physical lift my left arm without extreme pain.  Now, 02/28/2014 I can lift my arm, but it's very painful.  I have alot of trouble sleeping because I can't find a good position to lay without a lot of pain.
Age: 0.48
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Convulsion, Crying, Electroencephalogram normal, Gaze palsy, Nuclear magnetic resonance imaging brain normal
Clinical narrative: He received Hib and Prevnar at 10 AM.  At 1230, Mother was holding infant in arms and states that his eyes popped open and he seemed to had a fixed stare for 1 minute. Then he had "convulsing" movements of arms and legs that lasted for 35 seconds.  Eyes rolled back in his head.  Episode lasted approx 35 seconds, then he resumed a fixed stare for 1 minute.  Then he cried and appeared responsive.  No fever.  He vomited once during episode.
Age: 0.48
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Staring, Vomiting
Clinical narrative: He received Hib and Prevnar at 10 AM.  At 1230, Mother was holding infant in arms and states that his eyes popped open and he seemed to had a fixed stare for 1 minute. Then he had "convulsing" movements of arms and legs that lasted for 35 seconds.  Eyes rolled back in his head.  Episode lasted approx 35 seconds, then he resumed a fixed stare for 1 minute.  Then he cried and appeared responsive.  No fever.  He vomited once during episode.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Increased upper airway secretion, Respiratory tract infection, Rhinorrhoea, Sneezing
Clinical narrative: Severe Respiratory Infection, Cough, Phlegm, Sneezing, Rhinorrhea.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Pt developed hives within 30-60 minutes of her vaccines. She received her 3rd Pediarix, Rotateq, PCV13, Hib and her first Influenza vaccine. She still had hives when I saw her the next day.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Erythema, Nausea, Swelling face, Urticaria
Clinical narrative: Swelling/Redness to face; hives 10:00AM treated with Benadryl. Later- went to ER d/t no improvement and now N/V/D received steroid injections and Zofran per mom.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Swelling/Redness to face; hives 10:00AM treated with Benadryl. Later- went to ER d/t no improvement and now N/V/D received steroid injections and Zofran per mom.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 25 year old female patient. Patient had no pertinent medical history. On 10-FEB-2014 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. Patient did not use concomitant medications. Patient was subsequently determined to be pregnant. The patient contacted the nurse on 13-FEB-2014 to report she had a positive pregnancy test. The nurse has referred to an unspecified obstetrical practice for evaluation. No further information provided. No treatment was given for the event. Outcome of pregnancy and the LMP and EDD were not known. Outcome of the event was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: REDNESS/SWELLING AT INJECTION SITE / WHOLE UPPER ARM RADIATING TO ELBOW BY THE NEXT DAY / STIFFNESS IN NECK.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Ultrasound scan, Vomiting projectile
Clinical narrative: Projectile vomiting.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Decreased appetite, Vomiting projectile
Clinical narrative: Projectile vomiting started 2 days post vaccines. Decrease appetite.
Age: 0.21
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Vomited rotavirus (ROTATEQ) within minutes.
Age: 9.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Chest discomfort, Chest pain, Injection site pain
Clinical narrative: Patient went to primary care provider's office with c/o chest pain or discomfort and pain in her arm at site of administration. Patient received prescription for pain and was released. No other adverse effects reported, patient's symptoms abated next day.
Age: 9.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Chest discomfort, Chest pain, Drug administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Patient went to primary care provider's office with c/o chest pain or discomfort and pain in her arm at site of administration. Patient received prescription for pain and was released. No other adverse effects reported, patient's symptoms abated next day.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chills, Dysphagia, Erythema, Pruritus
Clinical narrative: 3PM on 10/22/13 pt. received HD flu shot. Within 2 hrs, she felt as though she had a lump in her throat and had diff. swallowing. At 6PM, she continued w/ lump in throat and chilling. At 8PM her hands and face were red and itched. At 815 took a shower and had hives over body. To hosp.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of foreign body, Urticaria
Clinical narrative: 3PM on 10/22/13 pt. received HD flu shot. Within 2 hrs, she felt as though she had a lump in her throat and had diff. swallowing. At 6PM, she continued w/ lump in throat and chilling. At 8PM her hands and face were red and itched. At 815 took a shower and had hives over body. To hosp.
Age: 75.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Myalgia
Clinical narrative: Hurts where shot was given. Arm hurts in muscle - after 3 mos.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Restlessness, Tremor
Clinical narrative: Arm turned red, began uncontrollable shakes, all over body. Lasted 2 hours. Restless night. Shortness of breath.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site nodule, Pain, Pruritus, Skin warm
Clinical narrative: Received flu vaccine on 2-18-14. On 2-19-14 AM knot size of nickel on (L) deltoid. After school redness came in to clinic redness 2 x 2 1/2 in. Instructed cool compress and TYLENOL for pain. Returned on 2-20-14 redness 3 x 3 1/2 in warm to touch. Will give BENADRYL for itching and changed antibiotic to BACTRIM. Area now 4 1/2 in x 4 1/2 in and 1/2 in below area has a redness 1 3/4 x 1 in.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Asthenia, Dizziness, Headache, Influenza, Malaise
Clinical narrative: Date 2-7-14. Rash - swollen. Lightheaded, weak, headache, problem lifting left arm, pain. Flu -> I called pharmacy told them the problem with Flu shot, taken BENADRYL and pain reliever, became very ill.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Pain, Rash, Swelling
Clinical narrative: Date 2-7-14. Rash - swollen. Lightheaded, weak, headache, problem lifting left arm, pain. Flu -> I called pharmacy told them the problem with Flu shot, taken BENADRYL and pain reliever, became very ill.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Decreased appetite, Erythema, Feeling hot, Pyrexia, Urticaria
Clinical narrative: Day of inj Flu and MMRV slight redness and warm. 2/20/14 symptoms worsened - guardian states pt was feverish and decreased appetite along with large welts. Appears pt was not brought into clinic until 300 pm 2/21/14.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Incorrect dose administered
Clinical narrative: None. Pt received 1 extra dose of Hep A.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Red, swollen arm from elbow to shoulder on back side of arm.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 24-FEB-2014, the patient was vaccinated with PROQUAD (Merck), subcutaneous injection, (lot # H015642, expiry date 06-JAN-2014), dose 0.5 ml, subcutaneous after the expiration date. Concomitant medication was unspecified. No adverse effects reported. No product quality complaint involved. Outcome of the events was unknown. No further information was provided. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Gastrointestinal infection, Hyperhidrosis, Pain, Poor quality sleep
Clinical narrative: Profound weakness, sweating, upper respiratory infection, gastrointestinal infection, poor sleeping, body aches throughout. Rx: fluticasone, ZYRTEC, SUDAFED, TYLENOL.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Upper respiratory tract infection
Clinical narrative: Profound weakness, sweating, upper respiratory infection, gastrointestinal infection, poor sleeping, body aches throughout. Rx: fluticasone, ZYRTEC, SUDAFED, TYLENOL.
Age: 1.04
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Antinuclear antibody positive, Full blood count normal, Gait disturbance, Injection site joint swelling, Juvenile idiopathic arthritis
Clinical narrative: Received VARIVAX, MMR, and PREVNAR in right thigh on 5/21. On 5/22, developed (R) knee swelling. Started ibuprofen, x ray and CBC were normal. Limping continued, seen by orthopedic surgery, no intervention. Swelling persisted, seem 8/2012 by rheumatology - ANA (+); diagnosed with juvenile idiopathic arthritis. Treated w/NAPROSYN.
Age: 1.04
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: X-ray normal
Clinical narrative: Received VARIVAX, MMR, and PREVNAR in right thigh on 5/21. On 5/22, developed (R) knee swelling. Started ibuprofen, x ray and CBC were normal. Limping continued, seen by orthopedic surgery, no intervention. Swelling persisted, seem 8/2012 by rheumatology - ANA (+); diagnosed with juvenile idiopathic arthritis. Treated w/NAPROSYN.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Constipation, Fatigue, Feeling abnormal, Headache
Clinical narrative: 10/1/13 AM Slight asthma attack within 10 minutes of receipt of vaccine. 10-17-13 PM feet started aching and cramping 10:20 PM lower legs starting aching and cramping. 10-25-13 AM woke up hurting all over, brain fog, headache, nausea, fatigue, constipation.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Nausea, Pain, Pain in extremity
Clinical narrative: 10/1/13 AM Slight asthma attack within 10 minutes of receipt of vaccine. 10-17-13 PM feet started aching and cramping 10:20 PM lower legs starting aching and cramping. 10-25-13 AM woke up hurting all over, brain fog, headache, nausea, fatigue, constipation.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site nodule, Local swelling
Clinical narrative: Pt's left arm swollen and had a hard knot at site of injection. Pt came in 2 days after receiving shot, his arm is still noticeably swollen, but knot went down.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Injected limb mobility decreased, Joint crepitation, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: My son has Cystic Fibrosis. He was diagnosed at the age of 15 months old. Has been seeing doctors in the Pulmonary Clinic. He does see other doctors as well. He is currently caught up on all his vaccinations. On October 7, 2013, Dr's office gave patient his first GARDASIL shot. He got the shot in his right (Delt) shoulder area. After the shot he did have arm soreness and redness over the next few days. I called the Drs office and they said that was normal. Over the next few weeks the soreness was still there, then on October 28, 2013 his right arm was locked and he could not move it up over his shoulder. Some of his symptoms were the soreness, popping of the shoulder, and him not able to have full range of motion. Then I just called Dr. Went to see him on November 1, 2013 and he had a x-ray done. Then on November 8, 2013 we had a MRI done, and then on November 12, 2013 we went back to Dr, and patient's test results. Dr said he has no shoulder, it is bone on bone. Not saying the shot cause it but, all of patient's doctors that I spoke to seemed concerned as am I. It even happened again on the 2nd shot of GARDASIL. Patient's second shot of GARDASIL was given on December 19, 2013 at Dr office. His second shot was given on his left (Delt) shoulder area. Then exactly 3 weeks after his shot was given, on January 9, 2014, he started getting the same symptoms. His shoulder was popping but was still able to use it. I called Dr office and they wanted to see him. On January 16, 2014 went back to see Dr and he did another x-ray and it showed exactly was the other x-ray showed on his other shoulder. So this is why I'am so concerned and reporting these to you. Not sure if the shots caused these but it seems so coincidental that it happened again. The timing between when he got each shot and when he had problems, then saw the doctors are 3-4 weeks. All the doctors that I spoke to about this agreed that this all seemed so coincidental and I should report these to the FDA. After talking with Dr office, I am no going to give the 3rd GARDASIL shot patient.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: X-ray limb abnormal
Clinical narrative: My son has Cystic Fibrosis. He was diagnosed at the age of 15 months old. Has been seeing doctors in the Pulmonary Clinic. He does see other doctors as well. He is currently caught up on all his vaccinations. On October 7, 2013, Dr's office gave patient his first GARDASIL shot. He got the shot in his right (Delt) shoulder area. After the shot he did have arm soreness and redness over the next few days. I called the Drs office and they said that was normal. Over the next few weeks the soreness was still there, then on October 28, 2013 his right arm was locked and he could not move it up over his shoulder. Some of his symptoms were the soreness, popping of the shoulder, and him not able to have full range of motion. Then I just called Dr. Went to see him on November 1, 2013 and he had a x-ray done. Then on November 8, 2013 we had a MRI done, and then on November 12, 2013 we went back to Dr, and patient's test results. Dr said he has no shoulder, it is bone on bone. Not saying the shot cause it but, all of patient's doctors that I spoke to seemed concerned as am I. It even happened again on the 2nd shot of GARDASIL. Patient's second shot of GARDASIL was given on December 19, 2013 at Dr office. His second shot was given on his left (Delt) shoulder area. Then exactly 3 weeks after his shot was given, on January 9, 2014, he started getting the same symptoms. His shoulder was popping but was still able to use it. I called Dr office and they wanted to see him. On January 16, 2014 went back to see Dr and he did another x-ray and it showed exactly was the other x-ray showed on his other shoulder. So this is why I'am so concerned and reporting these to you. Not sure if the shots caused these but it seems so coincidental that it happened again. The timing between when he got each shot and when he had problems, then saw the doctors are 3-4 weeks. All the doctors that I spoke to about this agreed that this all seemed so coincidental and I should report these to the FDA. After talking with Dr office, I am no going to give the 3rd GARDASIL shot patient.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Aggression, Amnesia, Blood potassium decreased, Cognitive disorder, Computerised tomogram head normal
Clinical narrative: Pt reports memory loss of events after about 30 minutes post vaccination with shingles vaccine.  Pt reports her last recollection was at the end of driveway from hospital grounds.  Patient's husband reports that his wife called him on her cell phone and said that she could not find her way home.  Pt husband reports that his wife was not cognitive enough to follow directions until they were able to find her after about 2 hours.  Patient was found on a gravel road in their home vacinity.  Husband reports that his wife complained of a "bad" headache and eye sensitivity to light.  EMS arrived and patient was taken to hospital.  Husband reported that patient was combative when EMS tried to take her in.  Labs and CT of head were taken at hospital.  Patient was kept overnight for observation.  Patient was given oral potassium for slight hypokalemia and observed overnight.  Patient reports after the vaccination and prior to time of memory loss, she denies any onset of known symptoms.  Patient's husband reports that patient has a long time history of "severe" migraine headaches.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug screen negative, Headache, Hypokalaemia, Photophobia, Troponin normal
Clinical narrative: Pt reports memory loss of events after about 30 minutes post vaccination with shingles vaccine.  Pt reports her last recollection was at the end of driveway from hospital grounds.  Patient's husband reports that his wife called him on her cell phone and said that she could not find her way home.  Pt husband reports that his wife was not cognitive enough to follow directions until they were able to find her after about 2 hours.  Patient was found on a gravel road in their home vacinity.  Husband reports that his wife complained of a "bad" headache and eye sensitivity to light.  EMS arrived and patient was taken to hospital.  Husband reported that patient was combative when EMS tried to take her in.  Labs and CT of head were taken at hospital.  Patient was kept overnight for observation.  Patient was given oral potassium for slight hypokalemia and observed overnight.  Patient reports after the vaccination and prior to time of memory loss, she denies any onset of known symptoms.  Patient's husband reports that patient has a long time history of "severe" migraine headaches.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: Pt reports memory loss of events after about 30 minutes post vaccination with shingles vaccine.  Pt reports her last recollection was at the end of driveway from hospital grounds.  Patient's husband reports that his wife called him on her cell phone and said that she could not find her way home.  Pt husband reports that his wife was not cognitive enough to follow directions until they were able to find her after about 2 hours.  Patient was found on a gravel road in their home vacinity.  Husband reports that his wife complained of a "bad" headache and eye sensitivity to light.  EMS arrived and patient was taken to hospital.  Husband reported that patient was combative when EMS tried to take her in.  Labs and CT of head were taken at hospital.  Patient was kept overnight for observation.  Patient was given oral potassium for slight hypokalemia and observed overnight.  Patient reports after the vaccination and prior to time of memory loss, she denies any onset of known symptoms.  Patient's husband reports that patient has a long time history of "severe" migraine headaches.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Acute sinusitis, Computerised tomogram head abnormal, Electrocardiogram abnormal, Grand mal convulsion, Heart rate decreased
Clinical narrative: Patient received Hep A without incident. Immediately after he received his 3rd HPV immunization, the patient began to slump over. He was caught while leaning forward and assisted to supine position. The patient began to have a brief 20 second grand mal seizure. His mother noticed he was posturing with his right arm. BP 107/54 | Pulse 54 | Resp 12 | SpO2 100%. After the seizure, he was pale and pulse was noted to be low at 45. Pulse oximeter was placed and his pulse gradually came back to baseline. He was alert and seemed oriented. Heart showed regular rate and rhythm.  Patient was transported via ambulance to the hospital for further evaulation.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Immediate post-injection reaction, Pallor, Posture abnormal, Posturing, Sinus bradycardia
Clinical narrative: Patient received Hep A without incident. Immediately after he received his 3rd HPV immunization, the patient began to slump over. He was caught while leaning forward and assisted to supine position. The patient began to have a brief 20 second grand mal seizure. His mother noticed he was posturing with his right arm. BP 107/54 | Pulse 54 | Resp 12 | SpO2 100%. After the seizure, he was pale and pulse was noted to be low at 45. Pulse oximeter was placed and his pulse gradually came back to baseline. He was alert and seemed oriented. Heart showed regular rate and rhythm.  Patient was transported via ambulance to the hospital for further evaulation.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chills, Headache, Pain
Clinical narrative: Patient received Tdap without incident. Her spouse called this am stating that she had a rough noc with a temp of 101, chills, aches, rash on cheeks, and headache.  Currently, rash and HA appears to have subsided and temp is down to 99, however she continues with aches in joints and chills. Advised that provider is not in the office until Monday.  She will continue with cool compresses behind neck and Tylenol.  He was advised to bring patient to IC/UC over the weekend PRN as there are no providers in house today.  He verbalizes understanding.  Spouse feels that she is improving and no contact to provider is needed at this time.  He would like a call back on Monday with any further instructions.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Patient received Tdap without incident. Her spouse called this am stating that she had a rough noc with a temp of 101, chills, aches, rash on cheeks, and headache.  Currently, rash and HA appears to have subsided and temp is down to 99, however she continues with aches in joints and chills. Advised that provider is not in the office until Monday.  She will continue with cool compresses behind neck and Tylenol.  He was advised to bring patient to IC/UC over the weekend PRN as there are no providers in house today.  He verbalizes understanding.  Spouse feels that she is improving and no contact to provider is needed at this time.  He would like a call back on Monday with any further instructions.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Feeling hot, Mobility decreased, Pyrexia
Clinical narrative: Redness, warmth, tender, difficulty moving arm. Today, chills and fever.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Redness, warmth, tender, difficulty moving arm. Today, chills and fever.
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered at inappropriate site, Injection site pain, Skeletal injury
Clinical narrative: Pharmacist gave a flu injection to patient and noticed it was difficult to get the needle in all the way and she winced. Realizing he had hit bone he readjusted the needle then finished injection. She complained of shoulder pain to her doctor and it was determined that the immunization went into the joint. She is continuing followup with her primary care physician.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling from left deltoid to above (L) elbow. Pt given PNEUMOVAX 23 on 2/25, symptoms started 2/26 evening.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Vaccine on 2/24/14, pt with (L) upper arm edema and pain on 2/26/14,
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Depression, Fatigue, Glucose tolerance test, Hypoglycaemia
Clinical narrative: Progressive development of incapacitating fatigue, reactive hypoglycemia, IBS, chronic pain, degenerative disc disease, depression.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Intervertebral disc degeneration, Irritable bowel syndrome, Pain
Clinical narrative: Progressive development of incapacitating fatigue, reactive hypoglycemia, IBS, chronic pain, degenerative disc disease, depression.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Small red bump started developing. Was not painful immediately.  Evening became larger.  By morning and raised and large approx 2 inches in diameter. Dr. said draw line around in sharpie and give ice and Benadryl.  Gave repeatedly at prescribed hours, got larger. Went into doctor's office and they said continue.  Gradually diasappeared over the course of the week.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation
Clinical narrative: Local inflammatory reaction on the left arm.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and slight induration at site of injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local reaction, Local swelling, Pyrexia, Skin warm
Clinical narrative: Large local reaction with redness and swelling around the deltoid. Swelling felt warm to the touch. Patients mother said that she had been treating him for a fever as well.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling on R deltoid.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Altered state of consciousness, Crying, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Heat and swelling at injection site, intense high pitched screaming, inconsolable crying, rash at injection site, change in breathing, lethargy, change in consciousness.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Lethargy, Respiration abnormal, Screaming
Clinical narrative: Heat and swelling at injection site, intense high pitched screaming, inconsolable crying, rash at injection site, change in breathing, lethargy, change in consciousness.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Periarthritis
Clinical narrative: Date and time is approximate - it was definitely before 10/23.  Pain in my upper left shoulder.  Went to Dr in November - started phys therapy and am still going.  Received one cortizone shot in January.  Diagnosed with adhesive capsulitis.  I am still in treatment.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: 110 mm warm/sts area at site of Kinrix/slightly pruritic/good gait. Ibuprofen and Benadryl 1.5 tsp. every 6 hrs. x 48, cool compress today and warm sit bath with epsom salt tomorrow.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: HD vaccine given to pt under 65 (63 years old).
Age: 24.0
Sex: M
Vaccine: HEPA
Symptoms: Local swelling, Pruritus, Urticaria
Clinical narrative: At 7pm client noticed his hands swelling at the base of his thumbs and then itching and hives on upper body including extremities; he went to the pharmacy and was recommended Benadryl; he went home and took two tabs and went to sleep; the next morning there was no evidence of above signs/symptoms and he reported feeling fine.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO ADVERSE REACTION WAS REPORTED BY PATIENT.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Leg numbness, seen in the ER.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Not a true adverse effect, except we determined that the vaccine administered to patient was indicated for patients over 65 years old and she was 63 at the time.
Age: 72.0
Sex: F
Vaccine: YF
Symptoms: CSF mononuclear cell count increased, Headache, Meningitis, Neck pain, White blood cell disorder
Clinical narrative: Meningitis presented with headache, neck pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: RAT 0.5 - 0.7 mm induration with mild erythema at injection site - Advised cool compress x 2 days and then warm soaks.
Age: 27.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Culture throat, Fatigue, Headache, Mononucleosis heterophile test negative, Oropharyngeal pain
Clinical narrative: Headache, sore throat, vomit x 1, fevers, fatigue.
Age: 27.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Pyrexia, Streptococcus test negative, Vomiting, White blood cell count increased
Clinical narrative: Headache, sore throat, vomit x 1, fevers, fatigue.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complaint of pain, redness, and swelling at the injection site and along arm (left). Pt was advised to take ibuprofen.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site erythema, Rash vesicular
Clinical narrative: Received ZOSTAVAX vaccine on February 17th, 2014 and started feeling viral illness next day. Broke out in a shingles looking rash with blisters and redness on the back of arm where injection was given. The patch is approximately 3 inches by 5 inches. Dr initiated treatment with valacyclovir 500 mg TID x 7 d.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Received ZOSTAVAX vaccine on February 17th, 2014 and started feeling viral illness next day. Broke out in a shingles looking rash with blisters and redness on the back of arm where injection was given. The patch is approximately 3 inches by 5 inches. Dr initiated treatment with valacyclovir 500 mg TID x 7 d.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: (L) shoulder, cellulitis, treated with BACTRIM DS.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling hot, Joint effusion, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Received injection 2/14/14, presented to walk in care the following day with arm pain. Stated it started 3 hrs after injection. 2/24/14 - decreased ROM, mild warmth and swelling. MRI - tear of supraspinatus tendon, large joint effusion. Referred to orthopedic surgeon.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rotator cuff syndrome, Swelling, X-ray limb
Clinical narrative: Received injection 2/14/14, presented to walk in care the following day with arm pain. Stated it started 3 hrs after injection. 2/24/14 - decreased ROM, mild warmth and swelling. MRI - tear of supraspinatus tendon, large joint effusion. Referred to orthopedic surgeon.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Joint range of motion decreased, Joint swelling, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Received injection 2/14/14, presented to walk in care the following day with arm pain. Stated it started 3 hrs after injection. 2/24/14 - decreased ROM, mild warmth and swelling. MRI - tear of supraspinatus tendon, large joint effusion. Referred to orthopedic surgeon.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Ultrasound scan
Clinical narrative: Received injection 2/14/14, presented to walk in care the following day with arm pain. Stated it started 3 hrs after injection. 2/24/14 - decreased ROM, mild warmth and swelling. MRI - tear of supraspinatus tendon, large joint effusion. Referred to orthopedic surgeon.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Pain
Clinical narrative: Redness and severe inflammation to (L) deltoid arm muscle also c/o pain.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Adverse reaction, Erythema, Pain
Clinical narrative: Patient was assessed for some redness/soreness with slight reaction at approx 1.5 cm x 1.5 cm in size on Feb. 21, 2014 at 0900 hrs. No elevation or induration noted. 2/23/14 - Reaction increased to 8.0 cm x 9.0 cm. No induration/elevation noted. TX. ice pack applied. 2/25/14 - Reaction subsided no swelling no redness.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash macular
Clinical narrative: Pt returned at 1300 today (2-27-14) with pink blanching macular rash to legs, abdomen and arms. Otherwise well appearing and afebrile. Suspect reaction to MMR vaccine. Will give 3/4 tsp BENADRYL Q6h until rash gone.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Induration, Local swelling, Skin warm
Clinical narrative: 2-28-14 patient called to say she had a bump (size of her hand) that was hard and hot. Vaccine given 2-26-14. No pain unless pressing on area. Had headache day of administration.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Cyanosis, Discomfort, Foaming at mouth, Grand mal convulsion
Clinical narrative: Fever and shaking of whole body w/staring of sight and associated foaming. Patient stopped breathing with cyanosis. Mom gave CPR and after 4-5 mins, patient turned responsive and started crying, back to baseline except for discomfort. On arrival to ER, she was crying, active, no seizure activity, with spontaneous breathing without any distress. Overall, well-looking child with fever. Then she developed a second GTC seizure that lasted for 1 min, followed by post-ictal confusion. She received 0.7 mg of ATIVAN.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Postictal state, Pyrexia, Respiratory arrest, Resuscitation, Staring
Clinical narrative: Fever and shaking of whole body w/staring of sight and associated foaming. Patient stopped breathing with cyanosis. Mom gave CPR and after 4-5 mins, patient turned responsive and started crying, back to baseline except for discomfort. On arrival to ER, she was crying, active, no seizure activity, with spontaneous breathing without any distress. Overall, well-looking child with fever. Then she developed a second GTC seizure that lasted for 1 min, followed by post-ictal confusion. She received 0.7 mg of ATIVAN.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Fever and shaking of whole body w/staring of sight and associated foaming. Patient stopped breathing with cyanosis. Mom gave CPR and after 4-5 mins, patient turned responsive and started crying, back to baseline except for discomfort. On arrival to ER, she was crying, active, no seizure activity, with spontaneous breathing without any distress. Overall, well-looking child with fever. Then she developed a second GTC seizure that lasted for 1 min, followed by post-ictal confusion. She received 0.7 mg of ATIVAN.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Injection site pain, Injection site swelling, Tenderness
Clinical narrative: 2/27 injection - c/o - swollen, sore about inject site. No fever. Today 2/27 5 cm zone of secondary indurated eg tenderness, no axillary LAN. No fevers.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Patient alerted staff of feeling over heated, sweating profusely, dizziness, and was slightly confused while talking.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Allergy to vaccine, Dysgeusia, Heart rate increased, Hypoaesthesia oral, Sluggishness
Clinical narrative: This recently retired M was referred to VHC by Rheumatologist for risk/benefit analysis after voicing concerns with past influenza vaccine. He advised in the 1982 he received a flu vaccine and within a few moments his ears began to ring, lips were numb, heart rate increased and he had a metallic taste in his mouth, and he felt very sluggish. He denied any breathing difficulty, tongue/oral swelling, no throat swelling or itching, rash, headaches, visual changes, dizziness or any other symptoms. He advised he was monitored by medical and all symptoms resolved in 30-45 minutes. These symptoms reoccurred again following an MMR vaccine 8/31/1988 and with the use of DEPOMEDROL (not related to vaccines). He advised he was evaluated by Dr who advised he was allergic to MMR. He has not received a flu shot or MMR vaccine since 1988. He denied any recurrence of symptoms since. Other vaccines received from 1995-2008 include yellow fever, typhoid (IM x2), Td, and Tdap. No reported reactions occurred with these immunizations. No medical records of events/immunizations available.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Tinnitus
Clinical narrative: This recently retired M was referred to VHC by Rheumatologist for risk/benefit analysis after voicing concerns with past influenza vaccine. He advised in the 1982 he received a flu vaccine and within a few moments his ears began to ring, lips were numb, heart rate increased and he had a metallic taste in his mouth, and he felt very sluggish. He denied any breathing difficulty, tongue/oral swelling, no throat swelling or itching, rash, headaches, visual changes, dizziness or any other symptoms. He advised he was monitored by medical and all symptoms resolved in 30-45 minutes. These symptoms reoccurred again following an MMR vaccine 8/31/1988 and with the use of DEPOMEDROL (not related to vaccines). He advised he was evaluated by Dr who advised he was allergic to MMR. He has not received a flu shot or MMR vaccine since 1988. He denied any recurrence of symptoms since. Other vaccines received from 1995-2008 include yellow fever, typhoid (IM x2), Td, and Tdap. No reported reactions occurred with these immunizations. No medical records of events/immunizations available.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Exposure during pregnancy, Human chorionic gonadotropin positive, Hypertension, Labour induction
Clinical narrative: Information has been received from a 31 year old female consumer, for GARDASIL, a Pregnancy Registry product, reporting herself with no pertinent medical history and drug reactions who was vaccinated her first dose of GARDASIL in March 2011 and her second dose of GARDASIL on 28-SEP-2011. There was no concomitant medication. On 09-NOV-2011 the patient went to the office and had a urine pregnancy test with a positive result. The patient was 5.5 weeks pregnant", the date of last menstrual period was 03-OCT-2011 and the estimated delivery date was 09-JUL-2012. No treatment was given for adverse event. It was also indicated that the patient is over 26 years old. No adverse effects were reported. The therapy was discontinued. Additional information was received from Registered Nurse regarding the 31 year old female patient. The physician was unavailable at that time. The phone call was transferred to the registered nurse who stated that the patient was induced at 36 weeks due to hypertension and anemia. The patient gave birth on 14-JUN-2012. The infant, (boy) had no congenital anomalies and birth weight was 4 pounds 10 ounces. The patient has not received any further GARDASIL vaccines. There was no information regarding the infant's pediatrician. Outcome of hypertension and anemia was unknown. Causality was not reported. Additional information is not expected. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This spontaneous report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with no pertinent medical history and no know drug allergies who on 26-MAR-2012 was vaccinated IM with a dose of GARDASIL (dose, route and lot# not reported). Other suspect therapy included ENGERIX-B. The patient's last menstrual period was note as 28-MAR-2012 in the patient's chart, but the nurse practitioner was not sure if that was correct. The patient came to the physician's office on 11-APR-2012 for a normal annual  exam. During the visit, it was discovered that she was pregnant, via urine pregnancy test. The patient was still pregnant. The estimated delivery date would be 02-JAN-2013. Follow up information has been received from a registered nurse who was able to access the clinic records for information concerning this pregnancy registry patient. The registered nurse stated that the patient had a prenatal appointment scheduled for 14-MAY-2012 and the patient never came in for the appointment. The registered nurse stated that the patient had been lost to follow up and they have no information to share. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers of 2 patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX vial (dose, route, lot and expiration date were not reported). On an unknown date, the patients developed shingles. At the time of the report outcome for shingles was unknown. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Abasia, Diarrhoea, Pyrexia, Vertigo, Vomiting projectile
Clinical narrative: Severe vertigo (was unable to walk), projectile vomiting, high fever,  severe diarrhea, possible dementia.
Age: 26.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Blood culture negative, Chest discomfort, Chills, Injection site swelling, Metabolic function test normal
Clinical narrative: Fever, chills, swelling of left arm at injection site, chest tightness, myalgias.  Fever to 102 developed 24 hours after injection and persisted for 48 hours.
Age: 26.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Myalgia, Peak expiratory flow rate decreased, Pyrexia, White blood cell count increased
Clinical narrative: Fever, chills, swelling of left arm at injection site, chest tightness, myalgias.  Fever to 102 developed 24 hours after injection and persisted for 48 hours.
Age: 43.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Asthenia, Blood glucose, Cold sweat, Cough, Disorientation
Clinical narrative: 12:30 throat got dry, scratchy and swollen.  Continued to get worse.  Dry mouth. Developed deep cough. Then eyes got red, irritated, bloodshot and vision blurred about 1-1:30 by 2pm I was dizzy, weak and disoriented. I broke out to a cold sweat, soaked through clothing.  Rescue was called and taken to ER. Also had nausea. Sweating stopped after 15 minutes. Most symptoms subsided after a few hours except nausea and throat. When returned home at 7pm slept for 12 hrs.  Woke with headache and gunky eyes and still a sore scratch throat.  Experienced nausea when eating and haven't felt well most of today, day 2.
Age: 43.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Dizziness, Dry mouth, Dry throat, Electrocardiogram, Eye discharge
Clinical narrative: 12:30 throat got dry, scratchy and swollen.  Continued to get worse.  Dry mouth. Developed deep cough. Then eyes got red, irritated, bloodshot and vision blurred about 1-1:30 by 2pm I was dizzy, weak and disoriented. I broke out to a cold sweat, soaked through clothing.  Rescue was called and taken to ER. Also had nausea. Sweating stopped after 15 minutes. Most symptoms subsided after a few hours except nausea and throat. When returned home at 7pm slept for 12 hrs.  Woke with headache and gunky eyes and still a sore scratch throat.  Experienced nausea when eating and haven't felt well most of today, day 2.
Age: 43.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Eye irritation, Headache, Malaise, Nausea, Ocular hyperaemia
Clinical narrative: 12:30 throat got dry, scratchy and swollen.  Continued to get worse.  Dry mouth. Developed deep cough. Then eyes got red, irritated, bloodshot and vision blurred about 1-1:30 by 2pm I was dizzy, weak and disoriented. I broke out to a cold sweat, soaked through clothing.  Rescue was called and taken to ER. Also had nausea. Sweating stopped after 15 minutes. Most symptoms subsided after a few hours except nausea and throat. When returned home at 7pm slept for 12 hrs.  Woke with headache and gunky eyes and still a sore scratch throat.  Experienced nausea when eating and haven't felt well most of today, day 2.
Age: 43.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Oropharyngeal pain, Pharyngeal oedema, Throat irritation, Vision blurred
Clinical narrative: 12:30 throat got dry, scratchy and swollen.  Continued to get worse.  Dry mouth. Developed deep cough. Then eyes got red, irritated, bloodshot and vision blurred about 1-1:30 by 2pm I was dizzy, weak and disoriented. I broke out to a cold sweat, soaked through clothing.  Rescue was called and taken to ER. Also had nausea. Sweating stopped after 15 minutes. Most symptoms subsided after a few hours except nausea and throat. When returned home at 7pm slept for 12 hrs.  Woke with headache and gunky eyes and still a sore scratch throat.  Experienced nausea when eating and haven't felt well most of today, day 2.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Injection site reaction, Pain, Rash erythematous
Clinical narrative: Local rash/red area 3 inch diameter around injection site. Flush to skin, painful. Showed up approximately 3 days post injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness (R) thigh with some induration.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to his currently 6 year old daughter. The patient's past medical history and past drug history was not reported. On an unknown date in 2009, the patient was vaccinated with VARIVAX (Merck) dose 1, once, when she was about 1 year old. No concomitant medication reported. This pharmacist reported that, his currently 6 year old daughter got a VARIVAX injection once in 2009 when she was about 1 year old. The pharmacist reported that about 9 weeks later in 2009 she got the second VARIVAX (Merck) vaccine. On 24-FEB-2014, the nurse accidentally read her chart wrong and she was given a third VARIVAX (Merck) injection in her arm. The reporter reported that she is acting fine tonight. It was unknown if there was any relevant laboratory data. The reporting pharmacist does not have lot number or expiration date for the VARIVAX (Merck). Additional information has been requested.