chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Rash generalised
Clinical narrative: Initial report received on 07 October 2011 from a healthcare professional. This case involves 1 of a cluster of 2 patients with the same reporter, same vaccine FLUZONE and same lot number UH477AB. Information regarding the other patient is captured in case number 2011-09783. A female patient with NKA (No known allergies) had received an intramuscular injection of FLUZONE on 05 October 2011 and within approximately 6 hours later complained of chills and also noticed a rash on her torso which subsequently spread to her neck, arms, back and thigh requiring evaluated by her physician. Per the reporter, more information will be provided on follow-up. At the time of this report, the patient had not recovered. Follow-up information was received on 09 January 2012 from a health care professional. The patient was a 47-year-old female. The patient had received the injection in the left deltoid. The patient was seen at a doctor's office on 07 October 2011. The patient had no illness at the time of vaccination and took no concomitant medications. The patient's outcome was reported as recovered. Follow-up information was received on 23 February 2012 from a health care professional. The patient had no adverse events after previous flu shots. The patient's outcome remained recovered. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Vision blurred, Vomiting
Clinical narrative: Initial report was received from a health care professional on 14 October 2011. A 64-year-old patient had received an intramuscular injection of FLUZONE, lot number UH467AB (site of administration not reported) on 13 October 2011 at 5:00PM and later after the vaccination at 9:00pm, the patient developed shivering, teeth chattering, headache, blurry vision, and vomited twice. The symptoms lasted about 2 hours. No further informational was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Initial report was received from health professional on 06 October 2011. A 25-year-old female patient had received a FLUZONE intramuscular injection in left deltoid, lot number UH454AA on 19 September 2011. On the same day, shortly after the injection the patient experienced numbness, stiffness and pain at the left deltoid. Her symptoms worsened during the night; however her symptoms has not improved or worsened since the injection was given. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site nodule
Clinical narrative: Vaccination site nodule. Allergic reaction. Vaccination site erythema.
Age: 45.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: This case is one of a cluster of three patients who experienced adverse events following administration of ADACEL (lot number U4090BA and sanofi pasteur Ltd. lot number C3961) and FLUZONE, lot number UH463AA. The events for the other patients were captured in case 2011-10184 and 2011-10242. Initial report was received on 14 October 2011 from a healthcare provider. A 45-year-old male patient (date of birth not reported) had received on 29 September 2011 an intramuscular injection of FLUZONE and ADACEL. On 10 October 2011, the patient experienced decreased range of motion and pain down his arm. The patient was prescribed ice, heat, ibuprofen and TYLENOL. The patient was evaluated by the reporter and not the physician. No further informational was available at the time of the report. The patient's outcome was reported as resolving. Documents held by sender: none.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Headache, Insomnia, Vomiting
Clinical narrative: Initial report received on 05 October 2011 from a company representative and a healthcare professional. A 63-year-old male patient with no concurrent illnesses, but allergy to cobalt had received an intramuscular left arm injection of FLUZONE (lot number UH469AB) on 04 October 2011 at 16:00 pm and 2 hours later the patient complained of headache, weakness, insomnia and vomiting. Concomitant medications included oxycodone, OXYCONTIN, and a "H2O" pill (indications not provided). It was not reported whether the patient required any treatments. The patient had received a FLUZONE vaccination last year. He had not experienced any adverse events with prior vaccinations. At the time of this report the patient had not recovered. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This case involved a cluster of two female patients. This case involves one female patient and the other patient was captured in case 2011-08783. Follow-up information was received from a healthcare professional on 28 November 2011. The patient outcome was reported as recovered (date not reported). Follow-up information was received from a health care professional on 27 December 2011. The patient recovered four hours after time of injection per the reporter. Follow-up information was received from a health care professional on 17 February 2012. The patient received the injection intramuscularly. The patient's outcome remained recovered. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Follow-up information was received from a healthcare professional on 28 November 2011. Medical history included asthma, allergies to penicillin, nonsteroidal anti-inflammatory drugs (NSAIDS) and IV REGLAN. The patient did not experience vaccination site pain. The numbness was specific to the left arm and hand only. On 19 September 2011, two hours post injection the symptoms subsided. The outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Tenderness
Clinical narrative: Initial report received from a health care professional on 21 September 2011. A 40-year-old female patient received an intramuscular left deltoid injection of ADACEL, sanofi pasteur Ltd. lot number C3961 and sanofi pasteur Inc. lot number U4090BA, and an intramuscular right injection of FLUZONE, sanofi pasteur lot number UH454AA, on 18 September 2011. The patient had no illness at the time of vaccination and no other vaccines within 4 weeks of the ADACEL and FLUZONE. The patient's medical history and concomitant medications were not reported. Two days later on 20 September 2011, the patient developed tenderness under both arms. The reporter stated that no masses were felt under the arms. The outcome was reported as recovered. Follow-up information was received from a healthcare professional on 16 January 2012. The patient applied hot compress and the pain subsided. No further issues and no physician were consulted. The patient outcome was reported as recovered/resolved. Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Grip strength decreased, Muscle tightness, Muscular weakness, Oropharyngeal pain
Clinical narrative: Initial report received from a health care professional on 22 September 2011. A 37-year-old male patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur lot number UH453AC, on 19 September 2011. The patient had a history of Grave's disease. His concomitant medication was reported as TAPIZOLE 5 milligrams (mg) twice a day (bid). On 20 September 2011, the patient developed aching all over weakness in arms with difficulty in making a first and weakness in both legs. The patient felt worse in the morning (AM) with some improvement during the day. The patient also had a sore throat and reported that his left calf muscle felt like a rock. He was afebrile. The patient described the soreness as feeling like arthritis. The outcome was reported as not recovered. Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Initial report received from a health care professional on 22 September 2011. A 37-year-old male patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur lot number UH453AC, on 19 September 2011. The patient had a history of Grave's disease. His concomitant medication was reported as TAPIZOLE 5 milligrams (mg) twice a day (bid). On 20 September 2011, the patient developed aching all over weakness in arms with difficulty in making a first and weakness in both legs. The patient felt worse in the morning (AM) with some improvement during the day. The patient also had a sore throat and reported that his left calf muscle felt like a rock. He was afebrile. The patient described the soreness as feeling like arthritis. The outcome was reported as not recovered. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Initial report was received from a patient on 21 September 2011. A 69-year-old female patient had received an intramuscular FLUZONE HIGH-DOSE in left deltoid (lot number not reported) on 19 September 2011. On the same day of the injection, the patient developed swelling in her left upper arm, redness covering one in a half inches around the injection site, warm to touch, very tired, achy all over, hard time lifting arm and doesn't feel like herself. The patient has reported the events to her physician. No further information was available at the time of the report. The patient outcome was not recovered/not resolved. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pain
Clinical narrative: Initial report was received from a patient on 21 September 2011. A 69-year-old female patient had received an intramuscular FLUZONE HIGH-DOSE in left deltoid (lot number not reported) on 19 September 2011. On the same day of the injection, the patient developed swelling in her left upper arm, redness covering one in a half inches around the injection site, warm to touch, very tired, achy all over, hard time lifting arm and doesn't feel like herself. The patient has reported the events to her physician. No further information was available at the time of the report. The patient outcome was not recovered/not resolved. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: FLU3, UNK
Symptoms: Crying, Irritability, Mood altered, Pyrexia
Clinical narrative: Initial report received from a non-healthcare professional (patient's parent) on 27 August 2012. A 2-month-old male patient, whose had no medical history and concomitant medications were not reported, received first dose of FLUZONE 0.5ml (lot number: unknown, route and site of vaccination not reported) on an 23 August 2012. The patient had also received another vaccine on the same day (lot number, manufacturer, route and site of vaccination not reported). The patient was suffering with Nasal and sinus congestion with green nasal exudate at the time of vaccination. It was reported that the 2-month-old was given FLUZONE that was meant for reporter's 4-year-old son. On 25 August 2012, after 48 hours of vaccination, the patient developed low grade fever 98.9 F. The patient was also moody and irritable and was crying at times. Laboratory investigations were not reported. The patient was administered TYLENOL as the corrective medication. The patient had recovered from the events on an unspecified date. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Pityriasis, Rash
Clinical narrative: Initial report was received from a consumer on 03 January 2012. A 19-year-old female patient had received an Intramuscular (IM) injection of FLUZONE; lot number UH454AA in left deltoid on 02 January 2012. On 03 January 2012, the patient developed a rash on her chest and stomach. The patient was diagnosed by her physician with pityriasis. The patient corrective treatment was not reported. No further informational was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: None.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Injection site discharge, Purulent discharge, Rhinorrhoea
Clinical narrative: Initial report was received from a patient on 29 September 2011. An 85-year-old female patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE (lot number not reported) in left deltoid on 27 September 2011. On the same day of the injection, the patient developed chills, headache and runny nose, no vomiting and no diarrhea. The patient also stated that she had yellow pus draining from the injection site but it was a very small amount. No further information was available at the time of the report. The patient outcome was reported as all symptoms resolved. Documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Malaise, Musculoskeletal pain, Neck pain
Clinical narrative: Initial report was received from a patient on 20 September 2011. A 77-year-old female patient (date of birth not reported) had received a FLUZONE HIGH-DOSE (lot number, route and site of administration not reported). In September 2011, following vaccination the patient developed fever, chills, vomiting, chest congestion, unable to swallow, neck pain, arm soreness and shoulder blade pain; stated she has been feeling sick since last "Thursday". However, she had contact her healthcare provider but had declined to see her "today". The patient stated that she is allergic to latex and should have not received the vaccine shot since it "contain latex". The patient had several regular flu vaccines. No further information was available at the time of the report. The patient outcome was not recovered/not resolved.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: Initial report was received from a patient on 20 September 2011. A 77-year-old female patient (date of birth not reported) had received a FLUZONE HIGH-DOSE (lot number, route and site of administration not reported). In September 2011, following vaccination the patient developed fever, chills, vomiting, chest congestion, unable to swallow, neck pain, arm soreness and shoulder blade pain; stated she has been feeling sick since last "Thursday". However, she had contact her healthcare provider but had declined to see her "today". The patient stated that she is allergic to latex and should have not received the vaccine shot since it "contain latex". The patient had several regular flu vaccines. No further information was available at the time of the report. The patient outcome was not recovered/not resolved.
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Anger, Confusional state, Headache, Myalgia, Nausea
Clinical narrative: Initial report was received from a lay press report on 07 November 2011. Verbatim from report: "Ordinary flu vaccine has always worked out for a 77-year-old was perplexed on a recent Monday when her clinic gave her high-dose version without asking first. Confusion turned to anger that night as she lay in bed at her home. Her muscles ached, her head pounded and her stomach churned. "I've had the flu shot before and never had a problem", she said. "Why was this different?" She was back to full strength the following Friday. But she wonders if she would have taken the high-dose version if her clinic had offered her a choice. The outcome was not reported. Documents held by sender: none.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Vaccination complication
Clinical narrative: Initial report was from a health care professional on 26 September 2011. A 72 year-old male patient with no reported past medical history had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of later, experienced a high fever of 103 and chills. The patient was hospitalized overnight and was told it was a "reaction from the flu vaccine". No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 24 October 2011. The patient had received the FLUZONE HIGH-DOSE, lot number UH457AA on 22 September 2011. He was admitted to the hospital and kept overnight. The patient was reported to have died on 22 September 2011 but was also reported to have recovered. No further information was available at the time of the report. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Diarrhoea, Headache, Injection site pain, Pain
Clinical narrative: This case is one of a cluster of two patients who experienced adverse events following administration of FLUZONE, lot number UH476AB. The events for the other patient were captured in case 2011-09914. Initial report was received on 12 October 2011 from a patient. A 57-year-old female patient had received on 08 October 2011 an intramuscular injection in right deltoid of FLUZONE. On 11 October 2011, the patient experienced clammy feeling, generalized body aches, diarrhea, vomiting profusely and very sore on right deltoid and complained of headache. She reported that when her symptoms occurred, they came on suddenly and progressed quickly. The patient has been feeling a little better. No further informational was available at the time of the report. The patient's outcome was reported as not recovered/not resolved. Follow-up information was received from a healthcare professional on 30 January 2012. Verbatim: "Upon future exploration we found that other people we know (work with/associate) were hit with the same symptoms in the month before and since October they did not have a flu shot, so we tend to believe that our illness was not related to the shot, but the intestinal bug that has been prevalent. Ours just coincidentally occurred following the flu shot". The patient outcome was reported as recovered/resolved on 13 November 2011. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This case is one of a cluster of two patients who experienced adverse events following administration of FLUZONE, lot number UH476AB. The events for the other patient were captured in case 2011-09914. Initial report was received on 12 October 2011 from a patient. A 57-year-old female patient had received on 08 October 2011 an intramuscular injection in right deltoid of FLUZONE. On 11 October 2011, the patient experienced clammy feeling, generalized body aches, diarrhea, vomiting profusely and very sore on right deltoid and complained of headache. She reported that when her symptoms occurred, they came on suddenly and progressed quickly. The patient has been feeling a little better. No further informational was available at the time of the report. The patient's outcome was reported as not recovered/not resolved. Follow-up information was received from a healthcare professional on 30 January 2012. Verbatim: "Upon future exploration we found that other people we know (work with/associate) were hit with the same symptoms in the month before and since October they did not have a flu shot, so we tend to believe that our illness was not related to the shot, but the intestinal bug that has been prevalent. Ours just coincidentally occurred following the flu shot". The patient outcome was reported as recovered/resolved on 13 November 2011. Documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Fatigue, Feeling abnormal, Hypoaesthesia
Clinical narrative: Initial report received on 20 October 2011 from a consumer via the company's web site. This case is not medically confirmed. A male patient (date of birth not provided) had received a dose of FLUZONE HIGH-DOSE (lot number not reported) on 19 October 2011 at 2pm and around 6pm that evening the patient experienced fatigue. He took a 20 minute nap, woke up with chills, numbness in the fingers and toes, and a slight ache. He was up until around 8pm and then went to bed. He awoke around 3am the next morning in a cold sweat and then all the symptoms subsided. He felt a little out of sorts on 20 October 2011, but not too bad. In the past he has only experienced arm soreness at the site with other shots and no ill effects. Recovery status was not reported for the out of sorts feeling. Follow-up information was received from a consumer, who was also the patient, on 16 March 2012. The patient received the injection on 19 November 2011 at about 2:00PM. The patient had no illness at the time of vaccination, no adverse events to prior vaccinations and received no other vaccinations within four weeks of FLUZONE. The patient's concomitant medications included warfarin, DIGOXIN and TOPROL. The patient's outcome was recovered. Documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Initial report received on 20 October 2011 from a consumer via the company's web site. This case is not medically confirmed. A male patient (date of birth not provided) had received a dose of FLUZONE HIGH-DOSE (lot number not reported) on 19 October 2011 at 2pm and around 6pm that evening the patient experienced fatigue. He took a 20 minute nap, woke up with chills, numbness in the fingers and toes, and a slight ache. He was up until around 8pm and then went to bed. He awoke around 3am the next morning in a cold sweat and then all the symptoms subsided. He felt a little out of sorts on 20 October 2011, but not too bad. In the past he has only experienced arm soreness at the site with other shots and no ill effects. Recovery status was not reported for the out of sorts feeling. Follow-up information was received from a consumer, who was also the patient, on 16 March 2012. The patient received the injection on 19 November 2011 at about 2:00PM. The patient had no illness at the time of vaccination, no adverse events to prior vaccinations and received no other vaccinations within four weeks of FLUZONE. The patient's concomitant medications included warfarin, DIGOXIN and TOPROL. The patient's outcome was recovered. Documents held by sender: None.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Initial report received from the patient on 05 June 2012. A 76-years-old female patient, whose medical history included hypertension and thyroid and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (batch number not reported) on left deltoid, on 04 October 2011. On 04 October 2011, 1 hour after vaccination the patient had pain at the left deltoid. Pain had persisted and was moving up the arm and into the neck and the right arm was affected. Pain was persistent. Patient had physical therapy for 1 month with little change. Patient will be seeing an orthopedic MD. The event was not recovered at the time of reporting. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Initial report received from a healthcare professional on 20 August 2012. An elderly female patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed redness 4" below the vaccination site just above the elbow. Corrective treatment and laboratory investigations were not reported. As of 20 August 2012, the outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Aphagia, Arthralgia, Malaise, Vomiting
Clinical narrative: Initial report received from a non health care professional on 04 September 2012. A female patient of unknown age whose medical history and concomitant medications were not reported, had received FLUZONE HIGH DOSE vaccine (Lot number, dose, dose number, route and site of administration not reported) on an unknown date. It was reported that the patient was home sick for 8 days after receiving FLUZONE HIGH DOSE vaccination and had strange combination of symptoms including not being able to eat for 5 days, throwing up and joint pain. Details of corrective treatment and lab investigations were not reported. At the time of this report, the patient's outcome was not reported. Documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal dreams, Asthenia, Chills, Headache, Hyperhidrosis
Clinical narrative: Initial report was received from a patient on 20 September 2011. A 66-year-old male patient had received FLUZONE HIGH-DOSE in left deltoid (lot number and route of administration not reported) on 06 September 2011. On the same day, six hours after the injection the consumer developed chills lasting 30 minutes. He then experienced disruptive sleep, sweating, felt feverish, fever like dreams lasting ten hours. For the next eight hours he felt weak along with a headache. The patient had a prior flu vaccine thirty years ago. No further information was available at the time of the report. The patient outcome was recovered/resolved. Follow-up information was received from a healthcare professional on 28 November 2011. The patient reported that he does not know the lot number and no further additional information to provide. Documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Initial report was received from a patient on 20 September 2011. A 66-year-old male patient had received FLUZONE HIGH-DOSE in left deltoid (lot number and route of administration not reported) on 06 September 2011. On the same day, six hours after the injection the consumer developed chills lasting 30 minutes. He then experienced disruptive sleep, sweating, felt feverish, fever like dreams lasting ten hours. For the next eight hours he felt weak along with a headache. The patient had a prior flu vaccine thirty years ago. No further information was available at the time of the report. The patient outcome was recovered/resolved. Follow-up information was received from a healthcare professional on 28 November 2011. The patient reported that he does not know the lot number and no further additional information to provide. Documents held by sender: none.
Age: 40.0
Sex: U
Vaccine: FLU3
Symptoms: Feeling abnormal
Clinical narrative: Case of misuse received on 08 October 2011 from a consumer. A 40-year-old patient had received on an unspecified date an injection of FLUZONE HIGH DOSE (batch number, number in series, route and site of administration not reported). No concomitant therapy was reported. On an unspecified date, the patient felt slightly "out of it", more than in previous years when the patient received the regular strength version of the vaccine. No corrective therapy was reported. The final outcome was not reported. Follow-up information was received from a consumer on 19 December 2011, who is also the patient. Verbatim: "Regarding this report I later spoke to the doctor's staff by phone regarding my concern of having wrongly received the High Dose Flu vaccine and they said they checked with the nurse who then said the High Dose vaccine was not mistakenly given to me. I don't know if they were trying to cover their tracks following a mistake or if perhaps the nurse was confused when she gave me the vaccine. Therefore, I don't know if I still need to fill out this form or not as it's not 100% clear which vaccine was actually given to me". Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Initial report received on 14 October 2011 from the patient. A female patient with no concurrent illnesses, and no known allergies had received a first left arm dose of FLUZONE HIGH-DOSE (lot number unknown) on an unknown date and after vaccination developed itchy hives over her trunk that lasted 1 week to 10 days. The symptoms resolved without medical treatment. It was noted the patient was taking concomitant medications that included ZOCOR, "ALTASE", ASA, LANTUS, and HUMALOG. Indications for medications were not reported. The reporter did not want to provide any further contact information for follow-up. No further information is expected. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Initial report was received on 31 October 2011 from a consumer who is also the patient's wife. A 67 year-old male patient had received "on Saturday afternoon at 2p.m." FLUZONE HIGH-DOSE (lot number, route, site and exact date of administration not reported) and a "few hours later", began feeling ill, progressed to being ice cold, aching, very nauseous and had a low grade fever. According to the reporter, the patient only had the low grade fever for a short time and "felt better" on Sunday, but was "still not up to par". No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dysphonia, Fatigue, Headache
Clinical narrative: Initial report was received from a patient on 11 November 2011. A 77-year-old female patient had received an intramuscular (IM) injection of FLUZONE HIGH-DOSE (lot number not reported) in left deltoid on 09 November 2011. On the same day of the injection, the patient developed body ache, felt itchy, head buzzing, felt exhausted and unable to sleep. The patient course of treatment was two tablets of TYLENOL, two tablets of MOTRIN and FLEXERIL and was able to fall back asleep. On 10 November 2011, the patient "felt like she was hit by a truck", body aches, headache, weakness, throat raspy and chills. No further informational was available at the time of the report. The patient outcome was reported as not recovered/not resolved but has improved. Follow-up information was received from a consumer who is also the patient. The patient had no illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain, Pruritus
Clinical narrative: Initial report was received from a patient on 11 November 2011. A 77-year-old female patient had received an intramuscular (IM) injection of FLUZONE HIGH-DOSE (lot number not reported) in left deltoid on 09 November 2011. On the same day of the injection, the patient developed body ache, felt itchy, head buzzing, felt exhausted and unable to sleep. The patient course of treatment was two tablets of TYLENOL, two tablets of MOTRIN and FLEXERIL and was able to fall back asleep. On 10 November 2011, the patient "felt like she was hit by a truck", body aches, headache, weakness, throat raspy and chills. No further informational was available at the time of the report. The patient outcome was reported as not recovered/not resolved but has improved. Follow-up information was received from a consumer who is also the patient. The patient had no illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Activities of daily living impaired, Chills, Malaise, Pyrexia
Clinical narrative: Initial report was received from a patient on 05 December 2011. A 78-year-old female patient had received and intramuscular (IM) injection of FLUZONE HIGH-DOSE (lot number not reported) in left deltoid "one month ago" 2011. On an unspecified date, the patient developed fever, chills and an upset stomach after the vaccine. No further informational was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information was received from a consumer on 26 January 2012, who is also the patient. She reported that her symptoms appeared four hours after the vaccine. She was ill for three days and could not go to work after receiving the vaccination. The patient never had any effects from previous vaccinations; always got the normal dose. The patient husband took the normal dose with no adverse effects. The patient  outcome was reported as recovered/resolved "three days later". Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hot flush, Injection site pain, Injection site swelling, Injection site warmth, Lacrimation increased
Clinical narrative: Initial report was received from a customer service representative on 12 October 2011. A 57-year-old female patient had received a FLUZONE injection in left deltoid, lot number UH463AB on 12 October 2011. On the same day, three minutes after the injection the patient experienced pain at the injection site. Three hours later, she developed watering eyes, hot flashes, nausea, swelling and warmth at the injection site. No further informational was available at the time of the report. The patient outcome reported as not recovered/not resolved. Documents held by sender: none
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Initial report was received from a customer service representative on 12 October 2011. A 57-year-old female patient had received a FLUZONE injection in left deltoid, lot number UH463AB on 12 October 2011. On the same day, three minutes after the injection the patient experienced pain at the injection site. Three hours later, she developed watering eyes, hot flashes, nausea, swelling and warmth at the injection site. No further informational was available at the time of the report. The patient outcome reported as not recovered/not resolved. Documents held by sender: none
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: This case is one of a cluster of two patients who experienced adverse events following administration of FLUZONE, lot number UH476AB. The events for the other patient were captured in case 2011-09913. Initial report was received on 12 October 2011 from a patient. A 58-year-old male patient had received on 08 October 2011 an intramuscular injection in left deltoid of FLUZONE. On 11 October 2011, the patient experienced fever, diarrhea, generalized body aches and pains which came on sudden. No further information was available at the time of the report. The patient's outcome was reported as unknown. Follow-up information was received from a healthcare professional on 30 January 2012. Verbatim: "Upon future exploration we found that other people we know (work with/associate) were hit with the same symptoms in the month before and since October they did not have a flu shot, so we tend to believe that our illness was not related to the shot, but the intestinal bug that has been prevalent. Ours just coincidentally occurred following the flu shot". The patient outcome was reported as recovered/resolved on 13 November 2011. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Erythematous rash - Itchy.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injection site nodule, Injection site pain
Clinical narrative: Initial report received from Non-Health Care Professional on 24 April 2012. A 42-year-old female patient, whose medical history and concomitant medications were not reported, had received dose of FLUZONE HD vaccine (lot number and site of administration- not reported) in December 2011. The patient reported that she had a knot in her arm where the injection was given, the arm was still sore (soreness had been got worse and down below to the elbow). The patient also had continuous cough. The physician suggested that the events were related to the flu shot. The outcome of the events was reported as not recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Burning sensation, Dizziness, Fatigue
Clinical narrative: Initial report received from Non-Health Care Professional on 06 April 2012. Local reference number: 12-0219. A female patient, whose medical history included undiagnosed episode of suddenly experiencing weakness, exhaustion, fever, swollen and burning feet, woke up with sweats and dizziness in 2009 and concomitant medications were not reported, had received dose of FLUZONE HD vaccine (lot number- MP081AA (invalid lot) and site of administration- not reported) on 08 October 2011. It was reported that, the patient was sick for 2 days with elevated temperature, wiped out and had flu symptoms. The symptom of weakness, exhaustion, fever, swollen and burning feet, woke up with sweats and dizziness reoccurred in February 2012. The outcome of events was reported as not recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Influenza, Malaise, Oedema peripheral, Pyrexia
Clinical narrative: Initial report received from Non-Health Care Professional on 06 April 2012. Local reference number: 12-0219. A female patient, whose medical history included undiagnosed episode of suddenly experiencing weakness, exhaustion, fever, swollen and burning feet, woke up with sweats and dizziness in 2009 and concomitant medications were not reported, had received dose of FLUZONE HD vaccine (lot number- MP081AA (invalid lot) and site of administration- not reported) on 08 October 2011. It was reported that, the patient was sick for 2 days with elevated temperature, wiped out and had flu symptoms. The symptom of weakness, exhaustion, fever, swollen and burning feet, woke up with sweats and dizziness reoccurred in February 2012. The outcome of events was reported as not recovered. Documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Incorrect dose administered, Myalgia, Nausea
Clinical narrative: Initial report was received from a lay press report on 16 November 2011. Verbatim from report: "Ordinary flu vaccine has always worked out for a 77-year-old was perplexed on a recent Monday when her clinic gave her a high-dose version without asking first. Confusion turned to anger that night as she lay in bed at her home. Her muscles ached, her head pounded and her stomach churned. "I've had the flu shot before and never had a problem", she said. "Why was this different?" She was back to full strength the following Friday. But she wonders if she would have taken the high-dose version if her clinic had offered her a choice. The outcome was not reported. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site swelling, Injection site warmth, Neck pain, Pain in extremity
Clinical narrative: Initial report was received from a patient on 26 October 2011. A 31-year-old female patient had received a FLUZONE injection in deltoid, lot number U3719AA on October 2010. In October 2010, the patient developed constant pain in her arm and up her neck at times, swelling and hot at injection site. She also experienced limited range of motion. No further informational was available at the time of the report. The patient outcome was reported as resolved/recovered. Follow-up information was received from a consumer on 30 January 2012, who is also the patient. The patient concomitant medications included fluticasone and PREVIFEM. No further information provided. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Ear congestion, Nasal congestion, Respiratory tract congestion
Clinical narrative: Initial report was received from a patient on 28 October 2011. A male patient (date of birth and age not reported) had received a FLUZONE injection ( lot number, route, site of administration not reported). On an unspecified date, the patient experienced chest, ear and nasal congestion and sore joints. The patient declined to provide contact and vaccination information. No further informational was available at the time of the report. The patient treatment and outcome were not reported. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial report was received on 17 July 2012 from a consumer. A male patient (date of birth not reported) had received FLUZONE, lot number UH476AC (route and site of administration not reported) on 10 October 2011 (also reported as date of loss) and an unspecified amount of time later the patient presented a claim (adverse event NOS). No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Nodule, Pain, Pyrexia, Swelling
Clinical narrative: Initial report received from a non-health care professional on 14 September 2012. This is a cluster report for 10 patients. Ten patients with no reported medical history and concomitant medications had received FLUZONE on an unspecified date (batch number UH745AC) (route and anatomical site of administration not reported). It was reported that 45 patients were immunized from the above lot number and about 10 patients complained of "1/2 dollar size knots on their arm", fever, redness, swelling and achy feeling on an unspecified date. Laboratory investigations and corrective treatment was not reported. The overall outcome was not reported. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Myalgia, Pain
Clinical narrative: Initial report was received from a patient on 02 November 2011. A 63-year-old female patient had received an injection of FLUZONE (lot number, route and site of administration was not reported) on 31 October 2011. On the same day following vaccination, the patient experienced severe muscle spasms and aches and pains "muscle aches". The patient corrected treatment was BENADRYL. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information was received from a consumer on 20 January 2012, who is also the patient. She reported that the reaction she had experienced lasted 2 days; however she continued taking BENADRYL and was fine after that. The patient was unable to obtain information on the lot number. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Full blood count, Hypersomnia, Pyrexia, Vomiting
Clinical narrative: Fever, emesis, sleeping.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a medical assistant refers to two patients of unknown age. The patients were vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) in August 2011. The medical assistant reported that the patients came back on 06-NOV-2012 and received their second dose of GARDASIL (lot #, dose and route not reported). The medical assistant was wondering if the patients would have to start the series over. No other co-suspects were reported. No concomitant medications were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Emotional distress, Pyrexia, Rash, Urticaria
Clinical narrative: This spontaneous report as received from a mother consumer refers to a 9 years old female patient who on an unspecified date, was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient's mother reported that the patient had been sick for the last six months with frequent fevers, rash and hive after receiving an unspecified amount of GARDASIL doses. The patient's mother also reported that it had ruined her daughter's life as she was emotionally scarred. No treatments information was reported. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events was unknown for GARDASIL. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Culture, Maternal exposure during pregnancy, Ultrasound scan, Urine analysis, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to a female patient of unknown age. The reporter stated that his wife went into the office to get a flu shot (unspecified) and inadvertently was given a first dose of 0.5 ml intramuscular GARDASIL (lot#1291AA) on 19-OCT-2012. The patient was 35 weeks pregnant. The LMP was approximately on 24-FEB-2012 and EDD was not provided. She went back to the office of the health care professional (HCP) to have a sonogram performed, she was also given a urine test and a vaginal and rectal swab (results not provided). No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first and second dose of GARDASIL (lot number not provided) intramuscularly on 17-SEP-2012 and 15-OCT-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Chest pain, Fatigue, Headache, Laboratory test
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 years old female patient. No medical history of concomitant conditions were reported. It was reported that the patient had no known allergies. The nurse reported that the patient received the first dose of GARDASIL on 12-JUN-2012 (lot number reported as 1016Z with an expiration date of 22-NOV-2012). The second dose was received on 17-AUG-2012 (lot number reported as 1016Z with an expiration date of 22-NOV-2012). The route of administration and anatomical location were not reported. No co-suspects or concomitant medications were reported. The patient developed fatigue with whole body pain, but mostly abdominal and back pain on 24-SEP-2012. About a week later the patient experienced a headache with worsening of the pain (whole body pain but mostly abdominal and back pain) and a burning sensation (discomfort) in the chest. Fatigue was reported as a significant disability or incapacity because the patient was unable to attend school for the last month due to fatigue. The patient was evaluated for a urinary tract infection and Rocky Mountain Spotted Fever. No results were provided. The patient had an emergency room visit in the first week of October which was pain related. No treatment information was provided and the patient did not recover from the events. The reporter relatedness for fatigue, burning sensation (discomfort) in the chest, headache, whole body pain but mostly abdominal and back pain is unknown for GARDASIL. No further information was provided. Additional information has been requested.