chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Information has been received from a physician assistant and a nurse referring to an 28 year old male patient. Patient had a history of a reaction of nausea and vomiting to VICODIN. On 29-JAN-2015 the patient was vaccinated with his first dose of M-M-R II injection, 0.5ml, lot # J008534, expiration date 12-JUL-2015, subcutaneously in the right deltoid. This was the patient's first vaccine in entire life. Concomitant therapies included RITALIN. The physician assistant reported that on 11-FEB-2015, the patient experienced a rash which began on his face described as little, red areas which were individual fine papules and small lesions, looked more like a vial rash and discoloration of skin. And the rash did not itch and rash was also on the patient's torso, front, back and upper arms and very slightly on legs on this day. The patient had a sore throat for a couple of weeks since an unspecified date and a fever for 24 hours since an unspecified date before the rash appeared. The patient was treating himself with ibuprofen for his fever. The patient sought medical attention at student health center on 11-FEB-2015. The outcome of the events was not reported. The causality was not reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: TDAP, YF
Symptoms: Back pain, Insomnia, Muscle spasms
Clinical narrative: This case was reported by a consumer and described the occurrence of spasms in a 50-year-old male patient who received DTPa vaccine. Co-suspect products included Hepatitis B vaccine, Meningococcal vaccine, Poliovirus vaccine, Yellow Fever, Typhoid, MALARONE tablet for malaria prophylaxis and CIPRO unknown for an unknown indication. The patient's past medical history included hypertension. Concurrent medical conditions included arthritis. Concomitant products included hydrochlorothiazide (HCTZ). On 8th July 2009, the patient received DTPa vaccine. On 2nd July 2009, the patient received Hepatitis B vaccine, Meningococcal vaccine and Poliovirus vaccine. On 8th July 2009, the patient started Yellow Fever at an unknown dose and frequency. On 2nd July 2009, the patient started Typhoid at an unknown dose and frequency. On 28th August 2009, the patient started MALARONE (oral) 1 tablet once daily (1 tablet daily). On an unknown date, the patient started CIPRO at an unknown dose and frequency. On 30th August 2009, 53 days after receiving DTPa vaccine, 59 days after receiving Hepatitis B vaccine and 2 days after starting MALARONE and CIPRO, the patient experienced spasms, back pain and insomnia. The action taken with MALARONE was discontinued (Dechallenge was positive). Rechallenge with MALARONE was negative. On an unknown date, the outcome of the spasms, back pain and insomnia were recovering/resolving. It was unknown if the reporter considered the spasms, back pain and insomnia to be related to DTPa vaccine, Hepatitis B vaccine, MALARONE and CIPRO. A male patient who was 50 years of age at time of event. reports back pain and back spasms while taking MALARONE. The patient described these symptoms as wave-like. He also had trouble sleeping due to the back pain. The onset of symptoms began two days into therapy. The patient was seen by a physician who ordered the MALARONE to be discontinued. Total days on therapy were five days. The symptoms began to improve 2 days after discontinuation. The patient did report that he has some back pain to date, but he attributes this to arthritis. The dosing of MALARONE was the started dosing strength. CIPRO was given with the MALARONE as a precautionary prophylaxis for going to teach in another country. I asked if he is relating his current back pain to MALARONE and he said no.
Age: 1.38
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness left upper thigh injection site. No fever.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Induration, Local swelling, Nausea, Paraesthesia
Clinical narrative: Local swelling and induration with some tingling down (R) arm within (6) several hours of vaccination. Onset nausea and vomiting with diarrhea also last evening (3/4/15).
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Local swelling and induration with some tingling down (R) arm within (6) several hours of vaccination. Onset nausea and vomiting with diarrhea also last evening (3/4/15).
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. On an unknown date, the patient "experienced a cold" and had been breaking out in fever blisters which popped up one after another since an unspecified date and sought medical attention when spoke with the pharmacist and did not received a treatment. The outcome of experienced a cold and fever blisters was reported as not recovered at the time of the report. Relatedness between the therapy with NUVARING and the events: experienced a cold and fever blisters was not reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Headache (severe), chills, emesis.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient had a runny nose and body aches. Her arm was hot to the touch at the injection site and visibly swollen and red. She also stated that it was itchy and her arm was painful.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: Patient had a runny nose and body aches. Her arm was hot to the touch at the injection site and visibly swollen and red. She also stated that it was itchy and her arm was painful.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and mild numbness in left hand, lightheaded.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: 8 pm - arm pain 3/4/15. 3/5/15 Cant move arm well - started fever up to 101.8 at 9:00 pm arm red raised rash. 3/6/15 100 degree temp in a.m. 99 degrees PM. Arm sore. 3/7/15 fever gone.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Head injury, Suture insertion, Syncope
Clinical narrative: Fainted and had head injury which required stitches at urgent care.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Rashes/itching - all over body 5 days after vaccine given SOLU-MEDROL shot one time and BENADRYL pill as needed.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling down entire left arm.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Cold sweat, Feeling hot, Headache, Pain, Pyrexia
Clinical narrative: I had hot and cold sweats. I had body pain all over. It have me a fever and a constant headache.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Feeling cold, Paraesthesia
Clinical narrative: Experienced coldness and tingling after receiving vaccine. Loss of strength in left hand. Tingle feeling began at elbow and continued for 30 min.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt. received vaccine on Thursday, came down with fever Friday-Sund. 101 degrees-103.6 degrees-called pharmacy Mond. 3/16/15.
Age: 1.33
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blister, Rash, Varicella post vaccine
Clinical narrative: Pt. came in for office visit with complaint of a rash, patient had vesicles on skin and was diagnosed with vaccine induced varicella.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Clostridium difficile infection, Diarrhoea
Clinical narrative: Progressive diarrhea leading to C. diff.
Age: 16.0
Sex: F
Vaccine: HPV4, MMR, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Morning after vaccine developed itching, redness, swelling (R) shoulder at injection site. No fevers. Resolving with ice and ibuprofen. Red area measures 6 cm
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to multiple unspecified patients of unkonwn age and gender. On an unknown date, the patients were vaccinated with improperly stored VAQTA Lot # J000366, expiration date 22-AUG-2015, Lot # K000943, expiration date 24-SEP-2016 and Lot #J011757, expiration date 15-JAN-2016 (reported as 13-JAN-2016) (dose and route were not reported). No adverse effects reported. No quality product complaint (PQC) was reported. This is one of several report received from the same report. Additional information has been medical.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness and swelling of upper left thigh following vaccination. Symptoms started the morning after. F/U with Dr. on 3/16, given BENADRYL liquid and Fluocinolone Acetonide topical oil.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles five days after ZOSTAVAX injection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Injection site rash, Respiratory tract congestion
Clinical narrative: Patient complains of rash at site. Used ice and lotion. Also had cough and congestion.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain, swelling redness and heat from elbow to axilla, unable to move LUE.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Injection site pain, swelling redness and heat from elbow to axilla, unable to move LUE.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Client presented with raised, reddened area to (L) arm at varicella vaccination site. Site to (L) arm was approximately 2 1/4" x 1", erythematous and patient reported "itchy".
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. On an unknown date a patient was vaccinated with M-M-R II (route, dosage, dose number and lot number unknown). The nurse reported that doses of M-M-R II, which were exposed to temperatures outside of the recommended storage range, have been administered to unspecified patients on unspecified dates since 05-FEB-2015. No adverse experience has been reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Lt arm red, raised, hot to touch area approx 1 1/2 in x 2 in on left posterior of arm. Cellulitis per Dr.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers 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 unspecified number of patients were vaccinated with doses of VARIVAX (Merck), (dose, frequency, route, anatomical location, lot number and expiration ate were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Redness! Major swelling, rash, fatigue, pain in arm and shoulders, itching, sharp pains, light sensitivity - all symptoms have lasted over a week.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Pruritus, Rash, Swelling
Clinical narrative: Redness! Major swelling, rash, fatigue, pain in arm and shoulders, itching, sharp pains, light sensitivity - all symptoms have lasted over a week.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Head discomfort, Malaise, Nausea, Syncope
Clinical narrative: Nausea, diarrhea, fainting (pt fainted). "Not well" for 2-3 days real heavy headed. Around 6 hours post shot went to bed 5-6 hrs earlier than normal.
Age: 101.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 101 year old female patient. The patient was vaccinated with PNEUMOVAX23 nine years ago, in approximately March 2006. The last month, in February 2015 the patient experienced pneumonia. The pharmacist asked if the patient should received PREVNAR 13. The outcome of pneumonia was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from an office manager via field employee referring to a 68 year old female patient. On an unknown date in October 2010, the patient received her first shot of ZOSTAVAX (lot#, expiration date, dose, route unspecified). On 02-MAR-2015 the patient was vaccinated with the second dose of ZOSTAVAX (lot #, expiration date, dose unspecified, route was reported as injection). The second dose of ZOSTAVAX was given in error by an unspecified clinician when the patient was supposed to receive a different unspecified vaccine on that date instead (wrong vaccine administered). Product confusion was not reported by the reporter. No adverse effects were reported. The patient had not sought medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: Administered 3/07/2015. Came by store on 3.08.15 evening and presented with a quarter size red area with inflammation surrounding. Pt. instructed to take ZYRTEC and apply 1% hydrocortisone. As of Wed 3.11.15 symptom subsided and totally by Sat. 3.14.15.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Skin discolouration, Swelling
Clinical narrative: Per patient complaint of bruises with black marks, and swelling 10/10/2014 PM, on 10/11/2014 per pt. took "old clindamycin found at home".
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Body temperature increased, Injection site cellulitis, White blood cell count increased
Clinical narrative: Case number PHHY2015US017382, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552119) website on 03 Feb 2015 with a follow up information received from quality assurance department (QA reference number: 352156) on 16 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 352156) on 12 Mar 2015. This report refers to a 51-year-old male patient. Concomitant medications included losartan 25 mg once daily and NORCO as required for leg pain. He was vaccinated with FLUVIRIN (batch number: 145404), along with PNEUMOVAX (batch number: K008976) into the right arm intramuscularly on 15 Oct 2014. On 16 Oct 2014, the patient experienced cellulitis at, around, above and below injection site. The patient had a body temperature of 103 degrees. The patient was hospitalized. The patient underwent blood work during the hospitalization: white blood cells were 17,000. The patient was treated with intravenous Vancomycin and ZOSYN. The patient was hospitalized for four days. Further, the patient was given doxycycline and cefdinir per oral 10-day course at the time discharge from the hospital. After seven days, the patient underwent blood culture twice and the result was negative. The events were reported as serious (life threatening and hospitalization). The final outcome of the events was recovered. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145404) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up information received from quality assurance department on 16 Feb 2015: QA number updated. Follow-up information received from the Quality Assurance Department (reference number: 352156) on 12 Mar 2015: Updated FLUVIRIN batch review report.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site infection
Clinical narrative: Case number PHHY2015US018032, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552568) website on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 352159) on 16 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 352159) on 12 Mar 2015. This report refers to a 60-year-old female patient. Historical conditions and current illness were none. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145305) into the left arm, along with ZOSTAVAX (batch number: U008883) into the left arm on 04 Nov 2014. On 06 Nov 2014, the patient developed infection at the injection site of ZOSTAVAX. The patient went to the emergency room. The final outcome of the event was recovered. The event was reported as non-serious. The event 'infection at injection site from ZOSTAVAX' was internally upgraded as medically significant based on the information available in the source document. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145305) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 352159) on 16 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 352159) on 12 Mar 2015: Updated FLUVIRIN batch review report.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Pruritic rash, systemic, worse in antecubital fossae.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash, systemic, worse in antecubital fossae.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Raised, red, itchy rash at injection site.
Age: 22.0
Sex: M
Vaccine: JEV1, SMALL, JEV1, SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: Auto-inoculation of upper right arm adjacent to original site of vaccine placement.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abasia, Arthralgia, Pyrexia, Vomiting
Clinical narrative: 3/5- fever T 100.7, vomiting x 2. + intermittent bilateral knee pain in popliteal fossa. 3/9 AM pt refused to walk due to pain, Tylenol used. Pt is OK in PM. No further pain since 3/14/15.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Lung adenocarcinoma
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old female patient with hypertension. In September 2014, the patient was vaccinated with ZOSTAVAX (dose, strength and lot# were not reported, subcutaneous). Recently (in approximately March 2015), the patient was diagnosed by an unspecified physician with adenocarcinoma of the lung. There was no treatment given for the event. The adenocarcinoma of the lung was reported as not recovered. Causality between the event and ZOSTAVAX was not reported. Upon internal review, lung adenocarcinoma was determined to be medical significant. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: RN administered Boostrix Tdap Vaccine  Lot: 7535X Exp. 02/15/2015 on 03/12/2015. Vaccine was administered after expiration date. No signs or symptoms noted, Patient was made aware, and was revaccinated on 03/16/2015 with Tdap vaccine with Lot: 65030AA and Exp. 05/01/2017 by BSN RN.
Age: 41.0
Sex: F
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Expired product administered
Clinical narrative: RN administered Tdap Vaccination Boostrix with Lot #:7535X and Expiration date of 2/15/2015. RN administered vaccine after vaccine expiration date. RN notified patient and patient was revaccinated on 03/16/2015 with Tdap vaccine Lot #: U5030AA and Exp.: 05/01/2017 by RN.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Nausea, Pain in extremity, Vomiting
Clinical narrative: Extremely pain arm about an hour after receiving injection; shoulder joint begin to ache and then the rest of his joints ached painfully the rest of the night.  Severe nausea during the night; vomited once.
Age: 64.0
Sex: M
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Expired product administered, Immunisation
Clinical narrative: RN administered Tdap vaccination Boostrix with Lot#: 7535X and Expiration date of 2/15/2015.  RN administered vaccine after vaccine expiration date.  RN notified patient and revaccinated on 3/16/15 with Tdap vaccine Lot #: U5030AA and Expiration date: 05/01/2017 by RN.
Age: 3.0
Sex: F
Vaccine: HEP, HIBV, PNC
Symptoms: Cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea, Vomiting
Clinical narrative: Cough, runny nose, congestion 4 am on Sunday night vomiting twice and fever 103.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Severe pain in upper arm persisting for 3 months.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Pain, Tenderness
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. A 91-year-old female patient of an unspecified age and ethnicity received PREVNAR 13 0.5 ml, single via an unspecified route of administration on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. Two days after injection the patient experienced cellulitis, pain, tenderness, all on an unspecified date with outcome of unknown.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Hypersensitivity, Rash, Rash erythematous, Urticaria
Clinical narrative: Red rash on trunk and extremities.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Pruritus, Rash erythematous, Swelling
Clinical narrative: Initially some itching and swelling on the 15th wasn't really concerned. Today Tuesday 03/17/15 woke up with a raised red rash about an inch wide and 2 to 3 inches long coming down from injection site on left arm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Eye movement disorder, Febrile convulsion, Irritability, Muscle twitching, Pyrexia
Clinical narrative: Saturday, 3/7. child had a fever (really hot) at 1:30 Am. Given ibuprofen and slept in a diaper. Child was crabby around noon. Mom thought teeth were bothering her so gave a dose of ibuprofen. Child was fine until 6:30-7 pm. Child felt warm but was not given anything. Played in the pool until child stared off and then eyes rolled back and child started twitching. Ambulance called and temp was 103.1. From motel to hospital child came around. Mom said seizure was about 1-3 minutes. Temp at ER was 100.9 rectally. ER gave ibuprofen. Parents were told child had a febrile seizure. Child has been fine since episode.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Skin warm, Staring
Clinical narrative: Saturday, 3/7. child had a fever (really hot) at 1:30 Am. Given ibuprofen and slept in a diaper. Child was crabby around noon. Mom thought teeth were bothering her so gave a dose of ibuprofen. Child was fine until 6:30-7 pm. Child felt warm but was not given anything. Played in the pool until child stared off and then eyes rolled back and child started twitching. Ambulance called and temp was 103.1. From motel to hospital child came around. Mom said seizure was about 1-3 minutes. Temp at ER was 100.9 rectally. ER gave ibuprofen. Parents were told child had a febrile seizure. Child has been fine since episode.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm, White blood cell count increased
Clinical narrative: LUE cellulitis s/p PNEUMOVAX injection 3/11/15 at health center. ED 3/13/15 for redness, warmth, swelling from shoulder to below elbow. Given TORADOL and IV ANCEF. D/C 3/15 from hospital and seen in f/u at health center 3/17/15.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Patient states began having a dry cough on 3/9/15. She went to her private physician who gave her a cough medicine with codeine.  On 3/10/15, she began having hives (welp-like and patchy), headaches, fatigue, diarrhea, joint pain, hip pain, and sweating. She went to the ER on the evening of 3/10/15.  She was told at the ER that it was not an allergic reaction to the cough medicine but they didn't know what was wrong. They gave her a Medrol Dose pack.  Her symptoms persist and she is going to see the doctor today due to persistent rash and fatigue.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Hyperhidrosis, Rash, Urticaria
Clinical narrative: Patient states began having a dry cough on 3/9/15. She went to her private physician who gave her a cough medicine with codeine.  On 3/10/15, she began having hives (welp-like and patchy), headaches, fatigue, diarrhea, joint pain, hip pain, and sweating. She went to the ER on the evening of 3/10/15.  She was told at the ER that it was not an allergic reaction to the cough medicine but they didn't know what was wrong. They gave her a Medrol Dose pack.  Her symptoms persist and she is going to see the doctor today due to persistent rash and fatigue.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: At first there was shooting pain when arm was raised, slowly over next 2 months, the shooting pain has gradually stopped, but ROM is much less. I can raise arm straight up- only goes about 45 degrees, and can not hold it out to side more than about 45 degrees.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Paraesthesia
Clinical narrative: When receiving immunization felt a jolt down my arms and out my finger tips as is an electrical shock.  By that evening I had lost almost all range of motion in my left arm.  The loss of motion continues one and a half months later although not always as extreme.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: Patient has a bruise at injection site, and also her arm was red and itchy for most her upper arm. She followed up with MD 3/16/15 at her normal check up and he told her that he would give her antibiotics if it appeared to be not getting better. Today 3/17/15 I was notified and she was prescribed doxycycline.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abdominal discomfort, Alanine aminotransferase increased, Analgesic drug level decreased, Analgesic drug level therapeutic, Antinuclear antibody negative
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Aspartate aminotransferase increased, Autoantibody negative, Hepatitis A virus test, Hepatitis B test negative, Hepatitis C test negative
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hepatitis viral test negative, International normalised ratio increased, Nausea, Vomiting
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase increased, Anion gap decreased, Antinuclear antibody, Aspartate aminotransferase increased
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Atrial fibrillation, Basophil count decreased, Basophil percentage, Bilirubin conjugated normal, Blood albumin decreased
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood bilirubin unconjugated normal, Blood calcium decreased, Blood chloride decreased
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium decreased, Blood sodium decreased, Blood urea decreased
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Carbon dioxide normal, Cardiovascular examination abnormal, Chest X-ray normal, Clostridium test negative, Cough
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Diarrhoea, Dysuria, Eosinophil count decreased, Eosinophil percentage increased, Glomerular filtration rate
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Haematocrit normal, Haemoglobin normal, Hepatitis, Hepatitis A virus test, Hepatitis B surface antigen negative
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hepatitis B virus test, Hepatitis C test negative, Hepatitis acute, Hyponatraemia, International normalised ratio increased
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Liver function test abnormal, Lymphocyte count decreased, Lymphocyte percentage decreased, Malaise, Mean cell haemoglobin concentration normal
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume normal, Monocyte count increased, Monocyte percentage increased
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nausea, Neutrophil count normal, Neutrophil percentage increased, Palpitations, Platelet count decreased
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Protein total decreased, Red blood cell count decreased, Red cell distribution width increased, Specialist consultation, Ultrasound abdomen normal
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Urinary tract infection, Urological examination abnormal, Vomiting, White blood cell count normal
Clinical narrative: Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives all over body that lasted for several days no other symptoms.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Pain, Pyrexia
Clinical narrative: FEVER OF 100 FOR 24 HOURS BODY ACHES AND DISCOMFORT.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: Patient presented to ER with course of shingles.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR, PNC13, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: During charting, it was found out that Tdap was given instead of the ordered DTaP. Tdap was given to 2 year old instead of DTaP. It was the patient's 4th dose. According to immunize.org, Tdap given to a child younger than 7 years as either dose 4 or 5 can be counted as valid for DTaP dose 4 or 5. Patient will come in for last dose of DTaP between age 4-5 years.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Mononucleosis heterophile test positive, Oropharyngeal pain, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: FEVER, SORE THROAT, VOMITING.
Sex: F
Vaccine: HEP
Symptoms: Blood bilirubin, Gastrooesophageal reflux disease, Jaundice, Lethargy
Clinical narrative: Became lethargic, GERD, and developed jaundice. Jaundice lasted total of twelve weeks. Exculsively breast fed. Is now Five months of age and still has episodes of GERD.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Full blood count, Platelet count decreased, Platelet transfusion
Clinical narrative: During annual physical-was given PREVNAR 13 injection for first time. Had blood drawn; CBC indicated platelet count 15 (15,000). Dr repeated blood test, 13,000...hospitalized, a few hours later 3,000; given platelet infusion.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Abdominal pain, Abnormal behaviour, Febrile convulsion, Mononucleosis heterophile test negative, Pyrexia
Clinical narrative: Fever, febrile seizure, abdominal pains, change in behavior; tested negative for mono, no treatment.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Mobility decreased, Pain in extremity
Clinical narrative: As of now, experiencing flu-like bodyache, aching throughout the injected arm and limitation of arm movement.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Gastroenteritis Escherichia coli, Gastroenteritis norovirus, Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Information has been received from a nurse via a company representative referring to a 12 month old male patient. Information about concurrent conditions and medical history were not provided. On 17-DEC-2014 the patient was vaccinated with M-M-R II, VAQTA, VARIVAX (Merck) and PREVNAR (lot#, dose, dose#, route and vaccination site was not provided for all these vaccines). On 07-JAN-2015 the patient experienced Idiopathic thrombocytopenic purpura (ITP), Norovirus, and enteropathogenic Escherichia coli (EPEC) Diarrhea. The patient was admitted to a Hospital from 07-JAN-2015 to 09-JAN-2015. Upon admittance to the hospital an unspecified blood platelet test revealed that the patient had a low blood platelet count (unspecified date in January 2015). The outcome of all the events was reported as recovered on an unspecified date in 2015. Upon internal review, the event idiopathic thrombocytopenic purpura (ITP) was considered to be serious due to medically significant. Additional information has been requested.
Sex: U
Vaccine: FLU3, HEP
Symptoms: No adverse event, Product packaging confusion
Clinical narrative: This spontaneous report was received from a nurse and it concerns a potential product confusion. The reporter stated that she has heard of many healthcare providers almost mistaking RECOMBIVAX HB pre-filled syringes with FLUZONE for patient younger than 3 years of age as the products look very similar. The reporter was not aware of any instances in which the wrong product was administered to a patient as a result of this confusion. No adverse effects were reported. This is one of the two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from health care professional regarding patients of unknown demographics. There was no information regarding concurrent conditions and historical medication. On an unknown date, patients received improperly stored ROTATEQ (dose strength and route was unknown). No adverse effect was reported. No concomitant medication was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Rash
Clinical narrative: Rash on face and under eyes (cheek area) noted 2 days after vaccines were given. 3/9/14 seen by PCP, no treatment, rash was gone.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pt. complained of left deltoid pain and decrease range of motion after flu vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Eating disorder, Tremor
Clinical narrative: Crying since visit 5 hours ago. Shaking and tremors of arms/legs since appox 2 1/2 hours ago. Not eating well since vaccine. Did start to breast feed better tonight at office.
Age: 64.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Electromyogram, Injection site pain, X-ray limb normal
Clinical narrative: Persistent soreness at injection site outer deltoid area to just above elbow. Aches, esp at night.
Age: 64.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Electromyogram normal, Joint range of motion decreased, Limb deformity, Pain in extremity, Periarthritis
Clinical narrative: Persistent soreness at injection site outer deltoid area to just above elbow. Aches, esp at night.
Age: 64.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Peripheral swelling, X-ray limb normal
Clinical narrative: Persistent soreness at injection site outer deltoid area to just above elbow. Aches, esp at night.
Age: 32.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Dysphagia, Rash macular
Clinical narrative: 210 PM-Received flu shot. 240pm-Returns to clinic stating her neck feels blotchy with difficulty swallowing. No redness or blotching noted. 3:20P Examined by MD. No medication given. Observed for 40 mins and then discharged. Patient states she feels better.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Erythema, Injection site rash, Papule, Rash generalised, Rash macular
Clinical narrative: Rash appeared at site of injection of left thigh. Skin pink. Numerous raised papules with pink blotchiness. Physician immediately notified.  Rash spreading onto abdomen, back, arms. Gave 1/2 tsp BENADRYL 12.5mg/5mL and 3/4 tsp TYLENOL 160mg/5mL. Child observed for 30 min s/p reaction with significant improvement. No swelling noted. No resp distress.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions or medical history were not reported. On an unknown date, one dose of ROTATEQ oral suspension, which was exposed to temperatures outside of the recommended range, was administered to an unspecified patient (route defaulted to oral by Merck, dose, anatomical location, lot number and expiration date not reported). No adverse experience had been observed or reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a health care worker and refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On an unknown date in June 2014, the patient was vaccinated with the first dose of VAQTA and on an unknown date in September 2014, the patient was vaccinated with the second dose of VAQTA (lot number and expiry date were not reported) intramuscularly (the second doses was administered in less than the recommended interval). There were no concomitant medications reported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.