chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024274, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 56 year old  female patient. Medical history was not reported. Concomitant medications were none. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the right deltoid at a dose of 0.5 ml on 21 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hours and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. No further information was provided. Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024271, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 58 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 18 Nov 214. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. No further information was provided. Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024277, is an initial spontaneous report received from a nurse on 02 Dec 2014, and with a follow up report received from nurse on 21 Jan 2015. This report refers to a 52 year old female patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into left deltoid at a dose of 0.5 ml on 12 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hours and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow up report received from nurse on 21 Jan 2015. Updated site of vaccination.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024272, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from nurse on 21 Jan 2015. This report refers to a 57 years old female patient. Her medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into left deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hours and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. No further information was provided. Follow up report received from nurse on 21 Jan 2015: Updated site of vaccination and reporter comment.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Acute left shoulder/arm pain within 24 hours of the injection, pain level 9 out of 10.  Worst with movement, no swelling, ecchymosis, erythema. Pain has only slowly improved since the injection with patient using ice, heat, ibuprofen. Has not been referred to Physical Therapy.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Insomnia, Nerve conduction studies
Clinical narrative: Flu shot site was sore for about 2 days then I started feeling severe sharp pain shooting from my left shoulder to elbow. Unable to life much weight with the left arm. By October 14 pain traveled from left shoulder to left wrist was suddenly moved or when used. Unable to raise left arm or pick up her young child. Saw physician on 10-15-2015. Prescribed anti-inflammatory medications and rest. Out of work for 3 days. Symptoms persisted, and physical therapy was prescribed and received. As of January 08, pain had improved after therapy but once therapy was discontinued, the symptoms recurred, and now the pain prevents sleep. Physical therapy is to resume.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022363, is an initial spontaneous report from a medical assistant received on 05 Nov 2014, with the follow-up received on 16 Dec 2014. This report refers to a 52 years old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 29 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error. Follow-up received from medical assistant on 16 Dec 2014: Report type changed from other to spontaneous, updated patient demographics (initials, DOB, age and gender), vaccination date, dose, route and site of vaccination.
Age: 21.0
Sex: F
Vaccine: FLU3, HEPA, YF
Symptoms: Fall, Nausea
Clinical narrative: A few minutes after receiving immunizations client fell from chair onto her knees. She was assisted back into the chair. At that time she said she felt nauseous. She was assisted to the bathroom per her request. Vitals taken and were normal. Client stated she has a history of fainting and fear of needles. No visible injuries and denied pain. Followed up w/a phone call at 4:00pm. Client stated she felt fine.
Age: 46.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Blood creatine phosphokinase, Full blood count normal, Influenza virus test negative, Injection site pain, Injection site swelling
Clinical narrative: Myalgias. Pain and swelling at injection site (left arm). URI symptoms. Trial on NSAID - no help. On prednisone, ice.
Age: 46.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Metabolic function test, Myalgia, Red blood cell sedimentation rate, Upper respiratory tract infection
Clinical narrative: Myalgias. Pain and swelling at injection site (left arm). URI symptoms. Trial on NSAID - no help. On prednisone, ice.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site
Clinical narrative: Pt. was told by doctor the vaccine was given in her rotator cuff. She has had injections, oral medications, and 6 months of physical therapy.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024273, is an initial spontaneous report from  a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 57 years old female patient. Medical history and concomitant medications were not reported. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 02 Dec 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from the nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024265, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 91 year old female patient. Her medical history and concomitant medication were not reported. Her previous vaccinations (unspecified) were well tolerated. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscular in left deltoid at a dose of 0.5 ml on 14 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history and recent vaccination site.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024278, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 52 year old female patient. Medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 06 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). No further information was provided. Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case number PHEH2014US023278, is an initial spontaneous report received from a physician on 14 Nov 2014. This report refers to a male patient of unknown age. His medical history and concomitant medications were not reported. His current condition includes psychiatric disorder. He received one dose of FLUVIRIN (batch number: 1412301) intramuscularly in Oct 2014 or in Nov 2014 (reported as within the past 30 days) in their facility but the patient has reported he received more doses of influenza vaccine from other places to make his own high dose. All the doses were not administered on the same day. The patient's story was not consistent. The reporter was unable to confirm what the patient had told. The reporter was unknown whether patient really received additional doses. No adverse events reported after the maladministration (inappropriate schedule of vaccine administered).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024279, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 52 year old female patient. Medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. No further information was provided. Follow up received from nurse 21 Jan 2015: updated site of vaccination and reporter comment.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024286, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 22 Jan 2015. This report refers to a 19 years old female patient. Medical history and concomitant medications were not reported. She had tolerated vaccines (no further details provided) well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) left deltoid intramuscularly at a dose of 0.5 ml on 05 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received on 22 Jan 2015: Site of vaccination (left deltoid) and other clinical relevant information on previous vaccinations in the narrative was updated.
Age: 60.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Activities of daily living impaired, Injection site reaction, Pyrexia
Clinical narrative: Pt reports fever and injection site reaction on arm given PNEUMOVAX 23. Pain spread from deltoid muscle into bicep. Pt. lost day of work.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH20114US023192, is an initial spontaneous report from a health care professional received on 17 Nov 2014. This report refers to a 21-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: unknown) subcutaneously from a multidose vial on 13 Nov 2014. On the same day, after vaccination, the patient experienced redness and swelling at injection site. Outcome of the events was reported as unknown. Seriousness and causality of the events was not reported.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US022545 is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This report refers to a 74 year old female patient. Her medical history and concomitant medication were not reported. On 10 Nov 2014, she was vaccinated with an expired dose of FLUVIRIN (batch number: 1206901) via intramuscular route. No adverse event was reported following this administration error.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Hepatic enzyme increased, Pain in extremity
Clinical narrative: Case number PHEH2014US023179, is an initial spontaneous report from a health care professional received on 17 Nov 2014. This report refers to a 38-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412401) intramuscularly in Oct 2014. On 22 Oct 2014, approximately 10 days after vaccination, the patient experienced soreness in her arms and legs. The patient consulted her doctor who found elevated liver enzymes. The patient was feeling well at the time of this report. Final outcome of the events was reported as recovered on 02 Nov 2014. Seriousness and causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Case number PHEH2014US022554, is an initial spontaneous report from a pharmacist received on 10 Nov 2014 and with a combined follow up received from the pharmacist via quality assurance department (QA reference number: 343542) on 16 Dec 2014 and on 17 Dec 2014 respectively, with the follow-up information received from Quality Assurance Department (reference number: 343542) on 27 Feb 2015. This report refers to a 66 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145623, expiry date: 30 Apr 2015) intramuscularly in deltoid on 08 Nov 2014. It was reported that the prefilled syringe FLUVIRIN stopper jammed and the pharmacist was only able to administer 2/3rd of the dose to the patient. No adverse event reported. It was reported that there was no damage to package and was stored in the original box until the time of use. It was also reported that there was difficulty to push plunger. The complaint was raised for FLUVIRIN batch 145623 as the stopper jammed. No sample was available for analysis. No root cause was identified during the BD investigation. The most probable root cause is that the needle, not provided by Novartis, was plugged, although no sample available for analysis it is difficult to determine the exact nature of the defect. The root cause has therefore been determined as supplier/material defective due to a blocked needle. Combined follow up received from the pharmacist via quality assurance department (QA reference number: 343542) on 16 Dec 2014 and on 17 Dec 2014 respectively: Updated expired date of vaccine, site of vaccination and reporter comment in narrative. Follow-up information received from the Quality Assurance Department (reference number: 343542) on 27 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: Case number PHEH2014US022959 is an initial spontaneous report received from a physician on 12 Nov 2014. This report refers to a 43 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with a dose of FLUVIRIN (batch number: not reported) intramuscularly on an unknown date (reported as a month ago). In Oct 2014, three days after vaccination, he experienced lightheadedness, fatigue and vertigo. The outcome of the events was reported as condition unchanged. The seriousness and causality was not reported.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022576, is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This case refers to a 42 years old male patient. past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN, (batch number: 14625P), at a dose of 0.5 ml intramuscularly on 09 Nov 2014, that had been at 34 F to 39.4 F. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022580, is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This case refers to a 40 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 14625P), at a dose of 0.5 ml intramuscularly on 09 Nov 2014, that had been at 34 F to 39.4 F. No adverse event was reported following this administration error.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: Case number PHEH2014US022822 is an initial spontaneous report from the pharmacist received on 12 Nov 2014. This report refers to a 62-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 146621) intramuscularly on 12 Nov 2014. It was reported that some of the FLUVIRIN vaccine squirted out during administration as the needle was not attached properly. No adverse event reported following this medication error.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022581, is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This case refers to a 15 years old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 14625P), at a dose of 0.5 ml intramuscularly on 09 Nov 2014, that had been at 34 F to 39.4 F. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US022652, is an initial spontaneous report from a pharmacist received on 11 Nov 2014. This report refers to a 70-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412301A) intramuscularly twice in this flu season on 04 Sep 2014 and on 10 Nov 2014. No adverse event was reported following this medication error.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022750, is an initial spontaneous report from a health care professional (clinic coordinator) received on 11 Nov 2014. This report refers to a 2 years old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUVIRIN (batch number: 1413901) intramuscularly on 10 Nov 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022816, is an initial spontaneous report from a health care professional received on 13 Nov 2014. This report refers to a 69-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with prefilled syringe (PFS) FLUVIRIN (batch number: 146401) intramuscularly which was stored at 33 F for approximately 11 hours on 12 Nov 2014. No adverse event was reported.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US022766 is an initial spontaneous report received from a pharmacist on 12 Nov 2014. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported, expiry date: Mar 2014) intramuscularly on an unknown date. No adverse events were reported following the medication error.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 40-year-old male patient who received FLUARIX. In October 2015, the patient received FLUARIX. In October 2015, less than a day after receiving FLUARIX, the patient experienced injection site muscle pain and injection site discomfort. On an unknown date, the outcome of the injection site muscle pain and injection site discomfort were not recovered/not resolved. The reporter considered the injection site muscle pain and injection site discomfort to be probably related to FLUARIX. Additional details were provided as follows: This case was not previously reported to anyone. Sometime in early to mid of October 2015, the patient received the FLUARIX vaccine in his left arm at work for a routine vaccination. In October 2015, less than a day after receiving the vaccine, the patient experienced a muscular type ache in the arm at the injection site, which has continued till the time of reporting. The patient's arm hurts on moving and he had not experienced anything like this from previous flu vaccinations. In October 2015, less than a month after receiving the vaccine, the patient experienced mild discomfort until about three days before the time of reporting, when he woke up and noticed the discomfort in his arm had increased. He initially thought that he had slept on it wrong and stated that it feels like a band around his arm at the area of the injection site. However, the discomfort has continued and was only a little better at the time of reporting. The reporter wanted to be contacted as soon as possible because he was concerned that the events could progress into something worse. The patient wanted to know if the events were common to experiences for almost 3 months and inquired solution for the discomfort.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024269, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 22 Jan 2015. This report refers to a 58 years old female patient. Her medical history and concomitant medications were not reported. She had tolerated vaccines (no further details provided) well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) left deltoid intramuscularly at a dose of 0.5 ml on 06 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 22 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024270, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 58 years old female patient. Her medical history was not reported. Concomitant medications were none. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). No further information was provided. Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024276, is an initial spontaneous report received from a nurse on 02 Dec 2014, and with a follow up report received from nurse on 21 Jan 2015. This report refers to a 53 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into left deltoid at a dose of 0.5 ml on 12 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree for 1 hour and 15 minutes. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided. Follow up report received from nurse on 21 Jan 2015. Updated site of vaccination.
Age: 79.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Abasia, Chills, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Swollen and itchy fingers, achiness, chills, profuse sweating, headache, sore at shot sites, vomiting, drowsiness, collapsed, unable to walk.
Age: 79.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Pain, Peripheral swelling, Pruritus, Somnolence, Syncope
Clinical narrative: Swollen and itchy fingers, achiness, chills, profuse sweating, headache, sore at shot sites, vomiting, drowsiness, collapsed, unable to walk.
Age: 79.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Vomiting
Clinical narrative: Swollen and itchy fingers, achiness, chills, profuse sweating, headache, sore at shot sites, vomiting, drowsiness, collapsed, unable to walk.
Age: 79.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Asthenia, Peripheral swelling, Pruritus, Syncope, Vomiting
Clinical narrative: Swollen and itchy fingers, achiness, chills, profuse sweating, headache, sore at shot sites, vomiting, drowsiness, collapsed, unable to walk.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: It is unknown the exact onset of symptoms.  Patient reported pain and loss of mobility in the immunization arm, reporting she cannot lift her coffee pot.  The adverse reaction was reported as a complaint to the company hotline, not directly to the pharmacy where it was administered.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: It is unknown the exact onset of symptoms.  Patient reported pain and loss of mobility in the immunization arm, reporting she cannot lift her coffee pot.  The adverse reaction was reported as a complaint to the company hotline, not directly to the pharmacy where it was administered.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Impaired work ability, Injection site erythema, Injection site oedema
Clinical narrative: Large amount of edema, erythema around injection site for 3 days.  Required patient to be grounded from flight duties.
Age: 1.01
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Large (2 inch), hard, warm, red, knot on leg at injection site.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Nerve injury, Pain, Wrong technique in product usage process
Clinical narrative: Left arm totally disabled, unable to move in any position without severe pain, severe pain subsided after 48 hours but could not push, pull or raise arm above chest level. Pain continues to persist at various intervals and all movements are restricted. Reported history to clinic on 1/6/16. Suspect problem was improper injection procedure causing severe nerve damage, prognosis for recovery unknown at this time. PCV 13 vaccine and/or unknown allergy not suspect.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Case number PHEH2014US024249, is an initial spontaneous report received from a pharmacist on 04 Dec 2014. This report refers to a 27 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1412601) intramuscular on an unknown date. On 04 Oct 2014, 1-2 days after vaccination she experienced skin discoloration at the injection site. The patient stated that the color of the skin looked like it was bleached where the injection was given and became worse over time and the area had become bigger about the size of a dime (the area looks lighter than the rest of her skin). The pharmacist stated that she saw the patient's arm last week. The patient stated that it was about quarter size now and the patient was seen a dermatologist. Nothing was prescribed by the dermatologist and the dermatologist stated they had not seen anything like this before. Outcome of the event was unknown. Seriousness and causality assessment was not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US024187, is an initial spontaneous report from a medical assistant received on 02DEC2014. This report refers to a 30-year-old female patient. Historical conditions were not reported. No concomitant medications was reported. She was vaccinated with expired FLUVIRIN 2013/2014 (batch number: 1310201) intramuscularly on 02DEC2014. No adverse reaction was reported following the maladministration (expired vaccine used).
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024167, is an initial spontaneous report received from a nurse on 02 Dec 2014 and a combined follow up report from the nurse received on 14 Jan 2015 and on 16 Jan 2015. This report refers to a 79 years old male patient. His vaccination history included unspecified vaccine in the past and it was well tolerated. Concomitant vaccine included PNEUMOVAX23, (batch number: K007824) at a dose of 0.5 ml intramuscularly in the left deltoid on 18 Nov 2014. He was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) at a dose of 0.5 ml intramuscularly on 18 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Combined follow up report from the nurse received on 14 Jan 2015 and on 16 Jan 2015: Added vaccination history and concomitant vaccine (PNEUMOVAX).
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US023991, is an initial spontaneous report received from a health care professional on 26 Nov 2014. This report refers to a 56-year-old female patient. Medical history and concomitant medications were not reported. On 25 Nov 2014, the patient received an intramuscular dose of FLUVIRIN, (batch number: 141401) that has been stored at 26.4 F for 2.5 hours but was not frozen. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Needle issue, Syringe issue, Underdose
Clinical narrative: Case number PHEH2014US023971, is an initial spontaneous report received from a pharmacist on 01DEC2014, with a follow-up report received from the pharmacist on 17DEC2014, with a follow up report received from the pharmacist on 19JAN2015, with the follow-up information received from Quality Assurance Department (reference number: 343532) on 27FEB2015. This report refers to a 29  year old male patient. Historical condition and concomitant medication were not reported. His previous vaccinations (unspecified) were well tolerated. He was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14584P, expiration date: 30APR2015) intramuscularly in left arm on 30NOV2014 at 08:45 PM. It was reported that during administration the plunger of the FLUVIRIN pre-filled syringe (PFS) got stuck and could not be fully depressed. As a result the patient received a partial dose. No adverse event was reported following these administration errors (vaccine under dose and syringe issue). The complaint was raised for a stuck plunger for FLUVIRIN batch 14584P. No same was available for analysis. No root cause was identified during either the Catalent or BD investigation. The most probable root cause is that the needle, not provided by was plugged, although with no sample available for analysis it is difficult to determine the exact nature of the defect. THe root cause has therefore been determined as supplier/material defective due to a blocked needle. Follow up report received from the pharmacist on 17DEC2014: Updated vaccine expiration date. Follow up report received from a pharmacist on 19JAN2015: Updated vaccination details (vaccination history, site and time of vaccination). Follow-up information received from the Quality Assurance Department (reference number: 343532) on 27 FEB 2015: Updated FLUVIRIN 2014/2015 vaccine batch review report.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Case number PHEH2014US023968, is an initial spontaneous report from a pharmacist received on 26 Nov 2014. This report refers to a 15 years old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly on 24 Nov 2014. On 26 Nov 2014, 48 hours after vaccination, the patient developed flu (strain A). Outcome of the event was reported as unknown. Seriousness and causality of the event was not reported.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Rhinorrhoea, Sneezing
Clinical narrative: Case number PHEH2014US023663 is an initial spontaneous report received from a consumer on 24NOV2014. This report refers to a 72 years old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of two doses of seasonal influenza vaccine (manufacturer and batch number: not reported) which were of 2014/2015 season on unknown dates (see related case number: PHHY2014US156880). She was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: not reported) intramuscularly from a multi-dose vial on 17NOV2014. It was reported that on the same day after vaccination, she experienced cough, sneezing and runny nose. The events outcome was unknown. The seriousness and causality were not reported.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US023663 is an initial spontaneous report received from a consumer on 24NOV2014. This report refers to a 72 years old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of two doses of seasonal influenza vaccine (manufacturer and batch number: not reported) which were of 2014/2015 season on unknown dates (see related case number: PHHY2014US156880). She was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: not reported) intramuscularly from a multi-dose vial on 17NOV2014. It was reported that on the same day after vaccination, she experienced cough, sneezing and runny nose. The events outcome was unknown. The seriousness and causality were not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024280, is an initial spontaneous report received from a nurse on 02DEC2014, with a follow up received from nurse on 21JAN2015. This report refers to a 52 year old female patient. Medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 24NOV2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). No further information was provided. Follow up received from nurse on 21JAN2015: Updated site of vaccination and reporter comment.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US023654 is an initial spontaneous report from a health care professional receive don 24 Nov 2014, with a follow up received from health care professional on 05 Jan 2015. This report refers to a 67 years old male patient. His medical history and concomitant medications were not reported. The patient had tolerated the vaccines well in the past. He was vaccinated with FLUVIRIN, (batch number: 14584P) intramuscularly at a dose of 0.5 ml into the right deltoid on 24 Nov 2014 at 08:00 AM. It was reported that the vaccine administered was at 0.9 degree Celsius over the weekend. The reporter confirmed that the vaccine was not frozen. No adverse events were reported following the inadvertent administration. Follow up received from health care professional on 05 Jan 2015: updated patient demographics, dose and site of FLUVIRIN vaccine.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024284, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 37 years old female patient. Medical history and concomitant medication were not reported. Her previous vaccinations (unspecified) were well tolerated. She was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml on 01 Dec 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Case number PHEH2014US023352, is an initial spontaneous report received from a pharmacist on 19NOV2014. This report refers to a 42 year old female patient. Historical condition was not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 1412401) from a multi dose vial via intramuscular route on 19NOV2014. It was reported that during vaccination most of the liquid rolled down the patient's arm. No adverse event was reported following this administration error (vaccine under dose). No additional details were available.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024285, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 19 years old male patient. Medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. He was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 13 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US023336, is an initial spontaneous report from a pharmacist received on 19 Nov 2014. This report refers to a 64-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN, (batch number: 1414101) intramuscularly twice in this Flu season on 07 Oct 2014 and on 18 Nov 2014. No adverse event was reported following this medication error (inappropriate schedule of vaccine administered).
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024287, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 17 year old male patient. His medical history and concomitant medication were not reported. His previous vaccinations (unspecified) were well tolerated. He was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in left deltoid on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014U8024305 is an initial spontaneous report from a nurse received on 02DEC2014, with a follow up received from nurse on 19JAN2015. This report refers to a 43 year old female patient. Her medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly at a dose of 0.5 ml into the left deltoid on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49 F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degrees F for 1 hour and 15 minutes. No adverse reaction was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up received from nurse on 19JAN2015: updated site of vaccination and reporter comment.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024304 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 45 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up from a nurse received on 21JAN2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024303 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 45 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up from a nurse received on 21JAN2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024302, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 45 year old female patient. Past medical history and concomitant medication were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar2015) left deltoid intramuscularly at a dose of 0.5 ml on 05 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024288, is an initial spontaneous report received from a nurse on 02DEC2014, with a follow up received from nurse on 21JAN2015. This report refers to a 16 years old male patient. His medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. He was vaccinated with FLURVIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly into the right deltoid at a dose of 0.5 ml on 05NOV2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from nurse on 21JAN2015: updated site of vaccination and reporter comment.