chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Case number PHHY2017US031785, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 666033) website on 21 Feb 2017. This report refers to a 54 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619521) into left arm on 23 Oct 2016. On 30 Oct 2016, the patient cannot move arm as far as she could before and recommended ibuprofen. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Case number PHHY2017US032488 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 666101) website on 21 Feb 2017. This report refers to a female patient of unknown age. Medical history and concomitant medication was not reported, current condition reported as none. The patient was vaccinated with FLUVIRIN (batch number: 162601) intramuscular on an unknown date. On an unspecified date, patient called today and informed pharmacist that she had pain in one of her legs whenever she puts pressure on it or perform heavy duty use of that particular leg. She noticed the pain/weakness the day after vaccine administration. The outcome of the events was unknown, seriousness of the events was non serious and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Case number PHHY2017US033049 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 666287) on 21 Feb 2017. This report refers to a 31 year old female patient. She had no medical history or current illness. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 169003) intramuscularly into the left arm on 28 Sep 2016. On 29 Sep 2016, the patient developed left shoulder pain that became progressively worse and lead to impaired range of motion. The patient was treated with NSAIDS, MEDROL dose pack and physical therapy. She continued to have symptoms. It was reported that she was still under treatment at the time of reporting. The final outcome of the events was not reported. Events were reported as non-serious. The causality of the events was not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2017US033044, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 666990) website on 21 Feb 2017. This report refers to a 63 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 168805) into left arm, intramuscularly on 04 Oct 2016. On 05 Oct 2016, the patient experienced severe pain in left arm followed by inability to raise or move arm. The patient visited emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Sensory loss
Clinical narrative: Case number PHHY2017US033376, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 667086) website on 21 Feb 2017. This report refers to a 51 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 168601) intramuscularly in right arm on 04 Oct 2016. On 05 Oct 2016 after vaccination, the patient experienced weakness and loss of sensation in arm. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Malaise, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2017US033794, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 667152) website on 21 Feb 2017. This report refers to a 55-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (lot number: 1620201) into arm intramuscularly on 15 Nov 2016. 16 Nov 2016 the patient experienced arm pain, back pain, neck pain, and general malaise. Outcome of the events was condition unchanged. Seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2017US033796, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 667173) 12 Feb 2017. This report refers to a 60-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619021) into left arm intramuscular on  29 Oct 2016. On 30 Oct 2016, the patient developed "severe pain in the shoulder and in the arm where the shot was given and severe pain in the shoulder and in the arm where the shot was given. The outcome of the events musculoskeletal pain and vaccination site pain was not reported. These events musculoskeletal pain, vaccination site pain were considered non-serious by the health care professional. The causality of the events musculoskeletal pain and vaccination site pain was not reported.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Fatigue
Clinical narrative: Case number PHHY2017US033582, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 667189) website on 21 Feb 2017. This report refers to a 50 years old male patient. Past medical history was not reported. Current condition included egg Allergy and Meniere's disease. Concomitant medications included LOPRESSOR, PRILOSEC, VALTREX, simvastatin and VALIUM prn. The patient was vaccinated with FLUVIRIN (batch number: 186685) intramuscularly in left arm on 18 Oct 2016. On the same day after vaccination, the patient experienced fatigue, weakness, gastrointestinal discomfort, diarrhea for 24 hours. The outcome of the event was reported as complete recovery on an unspecified date. The seriousness and causality of the event were not reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2017US033454, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 667193) website on 21 Feb 2017. This report refers to a 46-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (lot number: 168702) into left arm intramuscularly on 27 Sep 2016. On 28 Sep 2016, the patient developed arm/shoulder pain since administration. The outcome of the events pain in extremity and musculoskeletal pain was unknown. Seriousness of the events was reported as non serious and causality was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Case number PHHY2017US033327, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667551) website on 21 Feb 2017. This report refers to a 52 years old female patient. Medical history and current illness were reported as none. Concomitant medication included vitamins (unspecified). She was vaccinated with FLUVIRIN (batch number: 168805) intramuscularly into the left arm on 28 Oct 2016. After vaccination, on the same day, she experienced swelling on left deltoid and left inner arm. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 73.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Hypersensitivity, Injection site pain, Nightmare
Clinical narrative: Case number PHHY2017US012295 is an initial spontaneous report received from pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 667590) website on 23 Jan 2017. This report refers to 73 year old female patient. Prior vaccination history included vaccination with PREVNAR 13 (manufacturer unknown, batch number: not reported) on an unknown date approximately in Nov 2015 with no reactions. The patient drug reactions, allergies and pertinent medical history was not reported. Concomitant medications were not reported. The patient was vaccinated with unspecified high dose of seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into arm on 14 Nov 2016. The patient was also vaccinated with PNEUMOVAX 23 (manufacturer unknown, batch number: M032635, expiry date: 05 May 2018) intramuscularly into the same arm on 14 Nov 2016. On the same day after vaccination, patient experienced excessive chills and tremors, and when she went to bed that night was up every two hours urinating and experienced severe nightmares what really laid her out for about two days. It was reported that, on an unknown date in Nov 2016, the patient also experienced soreness in the injection arm and a severe allergic response in her arm, which involved swelling, redness, warmth to the touch on the top of her arm, and it looked like there were worms in the top of her arm. The only treatment that was given was BENADRYL on 15 Nov 2016 (reported as last night as of this report). The patient returned to the pharmacy on 16 Nov 2016, and stated that the patient was experiencing less soreness in her arm and the swelling had gone down, but it was now also swollen underneath her arm. No laboratory diagnostic studies were performed. On 16 Nov 2016, the patient recovered from the event of laying out and the outcome of the other events was reported as recovering. The seriousness of the events were reported as non serious. The causality of the events was not reported.
Age: 73.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nocturia, Peripheral swelling, Pollakiuria, Skin warm, Swelling
Clinical narrative: Case number PHHY2017US012295 is an initial spontaneous report received from pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 667590) website on 23 Jan 2017. This report refers to 73 year old female patient. Prior vaccination history included vaccination with PREVNAR 13 (manufacturer unknown, batch number: not reported) on an unknown date approximately in Nov 2015 with no reactions. The patient drug reactions, allergies and pertinent medical history was not reported. Concomitant medications were not reported. The patient was vaccinated with unspecified high dose of seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into arm on 14 Nov 2016. The patient was also vaccinated with PNEUMOVAX 23 (manufacturer unknown, batch number: M032635, expiry date: 05 May 2018) intramuscularly into the same arm on 14 Nov 2016. On the same day after vaccination, patient experienced excessive chills and tremors, and when she went to bed that night was up every two hours urinating and experienced severe nightmares what really laid her out for about two days. It was reported that, on an unknown date in Nov 2016, the patient also experienced soreness in the injection arm and a severe allergic response in her arm, which involved swelling, redness, warmth to the touch on the top of her arm, and it looked like there were worms in the top of her arm. The only treatment that was given was BENADRYL on 15 Nov 2016 (reported as last night as of this report). The patient returned to the pharmacy on 16 Nov 2016, and stated that the patient was experiencing less soreness in her arm and the swelling had gone down, but it was now also swollen underneath her arm. No laboratory diagnostic studies were performed. On 16 Nov 2016, the patient recovered from the event of laying out and the outcome of the other events was reported as recovering. The seriousness of the events were reported as non serious. The causality of the events was not reported.
Age: 73.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Tremor
Clinical narrative: Case number PHHY2017US012295 is an initial spontaneous report received from pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 667590) website on 23 Jan 2017. This report refers to 73 year old female patient. Prior vaccination history included vaccination with PREVNAR 13 (manufacturer unknown, batch number: not reported) on an unknown date approximately in Nov 2015 with no reactions. The patient drug reactions, allergies and pertinent medical history was not reported. Concomitant medications were not reported. The patient was vaccinated with unspecified high dose of seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into arm on 14 Nov 2016. The patient was also vaccinated with PNEUMOVAX 23 (manufacturer unknown, batch number: M032635, expiry date: 05 May 2018) intramuscularly into the same arm on 14 Nov 2016. On the same day after vaccination, patient experienced excessive chills and tremors, and when she went to bed that night was up every two hours urinating and experienced severe nightmares what really laid her out for about two days. It was reported that, on an unknown date in Nov 2016, the patient also experienced soreness in the injection arm and a severe allergic response in her arm, which involved swelling, redness, warmth to the touch on the top of her arm, and it looked like there were worms in the top of her arm. The only treatment that was given was BENADRYL on 15 Nov 2016 (reported as last night as of this report). The patient returned to the pharmacy on 16 Nov 2016, and stated that the patient was experiencing less soreness in her arm and the swelling had gone down, but it was now also swollen underneath her arm. No laboratory diagnostic studies were performed. On 16 Nov 2016, the patient recovered from the event of laying out and the outcome of the other events was reported as recovering. The seriousness of the events were reported as non serious. The causality of the events was not reported.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Nodule, Pain, Pain in extremity
Clinical narrative: Case number PHHY2017US033777 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 667593) website on 21 Feb 2017. This report refers to 43 year old male patient. Medical history was reported as none, concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620401) intramuscular into left arm on 30 Sep 2016. On the same day, patient experienced pain in left arm when stretching or moving sideways, small knot when touched/rubbed. He had sore at injection site and patient called to report this on 20 Nov 2016 and had not seen his primary care physician yet. The outcome of the events was condition unchanged, seriousness of the events was non serious and causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2017US033248 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 667629) on 21 Feb 2017. This report refers to a 47 year old female patient. She had no medical history or current illness. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on 27 Oct 2016. On 28 Oct 2016, patient stated that the injection site was initially red and hot. She also noted bruising at the injection site. The outcome of the events was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2017US032977 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667853) website on 21 Feb 2017. This report refers to a 48 year old female patient. Historical condition was not reported. Current condition included allergy to penicillin and was reported that patient was not currently ill. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 168605) intramuscularly into left arm on 22 Nov 2016 around 12:30 PM. On the same day after vaccination patient experienced numbness on palm of her hand and top of forearm and pain at injection site. It was reported that the injection site was verified and was not too high, the amount of bleeding was not abnormal and patient was not dizzy nor lightheaded. Patient was given ice pack to apply at the injection site and was observed full 20 minutes and was advised to follow up with physician and notify the pharmacy if numbness persists. It was reported that the patient was phoned on 22 Nov 2016 at 3 PM to inquire if numbness continued and the patient reported that numbness had gone away but her arm was still sore as of 22 Nov 2016. The patient was advised to take TYLENOL to help with pain and to follow up with physician if numbness returns (unexpected). The final outcome of the event hypoaesthesia was reported as complete recovery on 22 Nov 2016 and for the other events was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious and causality was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2017US034296, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 668120) website on 21 Feb 2017. This report refers to a 36 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168805) intramuscularly in left arm on 25 Oct 2016. On 01 Nov 2016 after vaccination, the patient experienced arm pain and could not raise arm fully and still having problem on 23 Nov 2016 as per her husband. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Contusion, Myalgia
Clinical narrative: Case number PHHY2017US035171, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 668185) on 21 Feb 2017. This report refers to an 86-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN, lot number: 1618101 into left arm intramuscularly on 18 Oct 2016. On 19 Oct 2016, the patient arm had a bruise then she also had muscle aches and weakness. Outcome of the events was condition unchanged and seriousness was reported as non-serious. Causality was not reported.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Sensation of foreign body
Clinical narrative: Case number PHHY2017US031333 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS number: 668189) website on 21 Feb 2017. The report refers to a 53 year old male patient. The patient had no known allergy and current condition included non-ketotic hyperglycemic coma, concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1618701) intramuscular into left arm on 26 Oct 2016. On the same day, patient experienced redness and soreness at injection site. Patient indicates it felt as if the needle was still in the muscle. The outcome of the events was unknown, seriousness of the events was non serious and causality of the events was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dehydration, Dizziness, Laboratory test, Nausea
Clinical narrative: Case number PHHY2017US035253 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 668199) website on 21 Feb 2017. This report refers to 65 year old male patient. Medical history was not reported, current condition included chronic kidney disease, hypertension and bipolar disorder. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 168905) intramuscular into left arm on 01 Nov 2016. On 02 Nov 2016 (Tuesday) patient woke up Wednesday with nausea, dizziness and chills. Patient had mostly intense nausea. He was seen in emergency room (ER) for two days. He was treated with dehydrated given intravenous (IVs) and nausea medication (unspecified). The patient underwent for lab tests for chronic kidney disease and hypertension (results, values were not reported). The outcome of the events was complete recovery on an unknown date and seriousness of the events was non serious and causality of the events was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Renal function test
Clinical narrative: Case number PHHY2017US035253 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 668199) website on 21 Feb 2017. This report refers to 65 year old male patient. Medical history was not reported, current condition included chronic kidney disease, hypertension and bipolar disorder. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 168905) intramuscular into left arm on 01 Nov 2016. On 02 Nov 2016 (Tuesday) patient woke up Wednesday with nausea, dizziness and chills. Patient had mostly intense nausea. He was seen in emergency room (ER) for two days. He was treated with dehydrated given intravenous (IVs) and nausea medication (unspecified). The patient underwent for lab tests for chronic kidney disease and hypertension (results, values were not reported). The outcome of the events was complete recovery on an unknown date and seriousness of the events was non serious and causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHHY2017US034871, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668287) website on 21 Feb 2017. This report refers to a 27 years old female patient. Historical conditions included gastro esophageal reflux disease. Current condition included Still's disease. Past medications included macrolides and latex. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 168901) into the right arm on 18 Oct 2016. After vaccination, on the same day, she experienced numbness tingling in injection arm involving fingers and there was no visible injection site reaction. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Case PHEH2016US031175, is an initial spontaneous report received from nurse on 28 Nov 2016. This report refers to 62 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619101, expiry date: Apr 2017) at a dose of 0.5 ml intramuscular on 07 Oct 2016. On the same day, the patient experienced redness and hives at injection site, arm and chest following FLUVIRIN administration. Symptoms began almost immediately and they were continuing and had not resolved. The patient has no allergies or hypersensitivity to egg or other previous vaccines. The patient had not received any treatment for symptoms. The outcome of the event hives was reported as condition unchanged and for event vaccination site redness was reported as unknown. The seriousness and causality of the events was not reported. Follow up report received from a nurse on 28 Dec 2016: added outcome of event hives.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Myalgia
Clinical narrative: Case number PHHY2017US034910, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668503) website on 21 Feb 2017. This report refers to a 51 years old female patient. Medical history was not reported. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1620501) intramuscularly on 01 Nov 2016. After vaccination, on the same day, muscle pain from flu shot and she had been experiencing discomfort since after the shot. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2017US035298 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 668600) website on 21 Feb 2017. This report refers to a 65 year old female patient. Current condition included allergy to VICODIN, historical drug included Iodine; ANECTINE; NEXIUM. The patient was vaccinated with FLUVIRIN (batch number: 1619221) intramuscular into right arm on 26 Sep 2016. On 28 Sep 2016, two days after vaccination patient had pain in right arm. Patient had right arm tenderness of upper 1/3 of right lateral arm. She had pain on pressure and arm elevation. The patient was treated with ALEVE twice daily for 1 week. She had call to office it got worse. The outcome of the events was condition unchanged, seriousness of the events was non serious and causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Case number PHHY2017US034195, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 668685) on 21 Feb 2017. This report refers to a 60-year-old female patient. Medical history was not reported. Past medications included penicillin, erythromycin and cephalosporins. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (lot number: 1620601) into right arm intramuscularly on 21 Nov 2016. On 22 Oct 2016, the patient experienced large red, swollen, hot area extending down below elbow. Arose next day after vaccine administered. Symptoms remained for 4 days before severity started to decrease. Outcome of the events were condition improving. Seriousness of the events was reported as non serious. Causality was not reported.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Feeling hot
Clinical narrative: Case number PHHY2017US032730 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (Vaers number: 669117) website on 21 Feb 2017. This report refers to 54 year old male patient. Medical history was not reported, current condition included essential hypertension and diabetes mellitus; Concomitant medication included Pravastatin; amlodipine; metformin; LANTUS and HUMALOG. The patient was vaccinated with FLUVIRIN (batch number: 1620001) intramuscular into right arm and PNEUMOVAX (other manufacturer, batch number: M022086) intramuscular into left arm on 25 Nov 2016. On the same day, patient experienced heat sensation at upper back area, pain at back area. He had no hives and nor itchiness, no shortness of breath, cerebral palsy not in distress; he had drink a glass of H2O. He was monitor and seen by doctor 12.15 PM. Patient felt better 12.40 PM; asymptomatic, not in pain no more heat sensation and discharged 12:45 PM. According to patient above symptoms felt after PNEUMOVAX vaccination. The outcome of the events was complete recovery on 25 Nov 2016, seriousness of the events was non serious and causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth, Pain
Clinical narrative: Case number PHHY2017US034252, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 669552) website on 21 Feb 2017. This report refers to a 60 years old female patient. Historical condition was not reported. Current condition included drug allergies as: Sulfa had caused Steven Johnson; Penicillin had caused hives; Tetracycline had caused skin peeling; Clindamycin had caused chest pain and shortness of breath. Concomitant medication included Fish Oil. No medical conditions were reported at the time of vaccination. She was vaccinated with the first dose of FLUVIRIN (batch number: 169305) intramuscularly onto the left arm on 10 Nov 2016. After vaccination, on 13 Nov 2016, she experienced muscle ache in left upper arm, it was warm to touch at times and it was difficult to lift with arm due to increased pain. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Muscle injury, Pain, Pain in extremity
Clinical narrative: Case number PHHY2017US034258, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 670060) website on 21 Feb 2017. This report refers to a 59 years old male patient. Historical condition was not reported. Current conditions included diabetes, hypertension and hyperlipidaemia. Concomitant medications included amlodipine, Metformin ER, CRESTOR and Valsartan HCTZ. He was vaccinated with FLUVIRIN (batch number: 168705) intramuscularly into the right arm on 03 Oct 2016. After vaccination, on the same day, he experienced a dull achy pain that occasionally radiated to his elbow. He had pain daily and it had been present ever since the immunization. He sought medical treatment by his primary doctor on 01 Dec 2016. The doctor was not certain of the cause but attributed his pain to either muscle damage caused by the injection or a torn rotator cuff due to lifting weights several times weekly. It was reported that he would follow up with physical therapy and X ray if symptoms do not improve. He visited the emergency room on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. The causality of muscle damage was reported as suspected with FLUVIRIN and for pain in arm it was not reported.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Tremor
Clinical narrative: Case number PHHY2017US015983, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 670077) on 23 Jan 2017. This report refers to a 55 years old male patient. Medical history was reported as none. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619701) intramuscularly into left arm on 11 Nov 2016. On same day after vaccination, the patient experienced dizziness and shakiness. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2017US033392 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (Vaers numbers: 670152) website on 21 Feb 2017. This case refers to a 64 year old female patient. Medical history and concomitant medication was not reported, current condition was reported as none. The patient was vaccinated with FLUVIRIN (batch number: 1618621) intramuscular into left arm on 19 Nov 2016. On 20 Nov 2016, complained of pain, swelling, difficulty moving left arm and reported symptoms to pharmacy on 27 Nov 2016. Patient visited emergency room/doctor (date not reported). The outcome of the events was condition unchanged, seriousness of the events was non serious and causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Pain in extremity, Pruritus
Clinical narrative: Case number PHHY2017US034171, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 670218) on 21 Feb 2017. This report refers to a 27 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on 01 Nov 2016. On 02 Nov 2016, the patient developed giant red spot covering the entire bicep/triceps area above the elbow with severe itching, burning and pain. This stayed for 4 days. The patient had to take BENADRYL for all 4 days and it only helped a little bit. The patient fully recovered from these events on an unknown date. Seriousness of the events were reported as non-serious. The causality of the events were not reported.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Case number PHHY2017US034223, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 670373) website on 21 Feb 2017. This report refers to a 55 years old female patient. Past medical history was not reported. Current condition included as multiple sclerosis. Concomitant medications included as COPAXONE, ADVAIR PRO AIR inhaler, calcium and Vitamin D, loratadine, pseudoephedrine, oxybutynin, clonazepam, citalopram, alendronate, zolpidem and tizanidine. The patient was vaccinated with FLUVIRIN (batch number: 1620301) into left arm, intramuscularly on 05 Dec 2016. The patient also vaccinated with PNEUMOVAX vaccine (other manufacturer and batch number: M038216) into right arm, intramuscularly on 05 Dec 2016. On 06 Dec 2016, the patient experienced redness, swelling and heat in a circle about 2 into 3 inches just above elbow. Patient applied cold packs every 02 hours and taking Acetaminophen (codeine and paracetamol) as needed. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2017US033717, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 670735) website on 21 Feb 2017. This report refers to a 30 years old female patient. Historical condition was not reported. Current condition included penicillin allergy. Concomitant medications included amitriptyline hydrochloride, loratadine, gabapentin, oxycodone and naproxen. She was vaccinated with FLUVIRIN (batch number: 1620201) into the left arm on 01 Dec 2016. After vaccination, on the same day, she experienced sore arm 1 and half days then hard swollen. It was still swollen as of this report. The outcome of swollen arm was reported as condition unchanged as of this report while it was complete recovery for sore and hard arm. The seriousness and causality of the events were not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Mood altered, Paraesthesia, Paraesthesia oral
Clinical narrative: Case number PHEH2017US002351, is an initial spontaneous report received from a consumer on 19 Jan. This report refers to a 38 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUVIRIN (seasonal, batch number: 169005) at a dose of 0.5 ml, intramuscularly on 16 Sep 2016. On 25 Sep 2016, the patient experienced paresthesias in hands/feet and mouth/lips, weakness, speech impairment, vision changes, back pain and mood changes. Patient reports she was still experiencing paresthesias in hands/feet and amp, mouth/lips. Patient reports that her neurologist told her the symptoms were from her influenza vaccine. The outcome of the events was reported as unknown. The seriousness and causality of the events were not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Speech disorder, Visual impairment
Clinical narrative: Case number PHEH2017US002351, is an initial spontaneous report received from a consumer on 19 Jan. This report refers to a 38 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUVIRIN (seasonal, batch number: 169005) at a dose of 0.5 ml, intramuscularly on 16 Sep 2016. On 25 Sep 2016, the patient experienced paresthesias in hands/feet and mouth/lips, weakness, speech impairment, vision changes, back pain and mood changes. Patient reports she was still experiencing paresthesias in hands/feet and amp, mouth/lips. Patient reports that her neurologist told her the symptoms were from her influenza vaccine. The outcome of the events was reported as unknown. The seriousness and causality of the events were not reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This initial non-serious spontaneous case was received on 01-Sep-2017, reported by other non-health professional concerns a 37-year-old female patient. Patient's medical history was not reported. The patient did not receive any concomitant medications. On 30-Aug-2017, the patient received FLUVIRIN (dose: 0.5ml, batch number, expiry date was not reported, route of administration: intramuscular). On 30-Aug-2017, 2 to 4 hours, after administration of FLUVIRIN, the patient developed hives. The patient was treated with steroid shot, BENADRYL (oral tablets), prednisone (oral tablet). The outcome of the event hives was not recovered. It was reported that, the patient was planning to get admitted in hospital.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a 23 year old female patient. The patient's concurrent condition included asthma and rash caused by penicillin. Concomitant medications included unspecified birth control pill and VENTOLIN INHALER. On 11-DEC-2017, the patient was vaccinated with M-M-R II lot # M047302  and expiration date 30-NOV-2018 for prophylaxis (dose, frequency and route were not provided) which was reconstituted with an sterile diluent (manufacturer unknown). Furthermore on the same date, the patient received TUBERSOL (dose, frequency, route, lot #, expiration date and indications were not provided). On 11-DEC-2017, the patient called the physician and reported hives all over her body. The physician prescribed BENADRYL and EPSOM SALT bath. On 12-DEC-2017, the patient called back and stated that the hives was still on her face and was prescribed with CLARITIN or ZYRTEC, however the patient did not take the CLARITIN or ZYRTEC and continued taking BENADRYL; on 13-DEC-2017, the patient was seen on the physician's office and the hives were gone. The causal relationship between hives and the therapies M-M-R II and TUBERSOL was not assessed.
Age: 0.75
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner, referring to a 9 month old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On 15-DEC-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # N020352, expiration date 10-APR-2020, for prophylaxis (route of administration was not informed). No adverse effects reported.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report refers to a 66 year old male patient and was received from the patient's wife via Poison Control Center. The patient spoke on the phone briefly to give consent for physician follow up. On approximately December 2017, reported as "the week before", the patient had his knee checked by the physician, because his knee was bothering him and was swollen and painful. He was put on ALEVE for a week. Concomitant therapies included also aspirin (manufacturer unknown), atorvastatin, metoprolol succinate, pantoprazole sodium and isosorbide mononitrate. The patient's medical history included a couple of stents put in a few years ago and he was put on an unspecified blood thinner, but was no longer on it at the time of reporting (reported as "no longer on it now"). The patient's wife reported that on 04-JAN-2018, the patient was sent to the pharmacy to see if he needed a whooping cough vaccine and it was determined that he need a pneumonia vaccine. The pharmacist determined that the patient needed PNEUMOVAX 23. On 04-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 25 microgram (mcg)/ 0.5 ml, once, in his arm (route of administration, lot # and expiration date were not reported). On the same day, he received FLUZONE and BOOSTRIX. When he received the shots, he said that his arm was bleeding quite a bit when getting the shots and the blood had to be wiped away. He also found his Band-Aid was full of blood. On the same day, he started having pain and swelling in his arm. The patient's wife described the swelling as "about the size of my hand and about an inch high". On 06-JAN-2018, reported as "today", the patient started having redness down at an angle from the shoulder towards the side of the arm. There was no relevant laboratory work performed. As of the time of this report, the patient did not recover from the redness, pain and swelling. The outcome of the event of bleeding was not reported. At the time of reporting, it was unknown if the patient would receive another PNEUMOVAX 23 again. The relatedness between the events and PNEUMOVAX 23 was not assessed.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Erythema, Injection site haemorrhage, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report refers to a 66 year old male patient and was received from the patient's wife via Poison Control Center. The patient spoke on the phone briefly to give consent for physician follow up. On approximately December 2017, reported as "the week before", the patient had his knee checked by the physician, because his knee was bothering him and was swollen and painful. He was put on ALEVE for a week. Concomitant therapies included also aspirin (manufacturer unknown), atorvastatin, metoprolol succinate, pantoprazole sodium and isosorbide mononitrate. The patient's medical history included a couple of stents put in a few years ago and he was put on an unspecified blood thinner, but was no longer on it at the time of reporting (reported as "no longer on it now"). The patient's wife reported that on 04-JAN-2018, the patient was sent to the pharmacy to see if he needed a whooping cough vaccine and it was determined that he need a pneumonia vaccine. The pharmacist determined that the patient needed PNEUMOVAX 23. On 04-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 25 microgram (mcg)/ 0.5 ml, once, in his arm (route of administration, lot # and expiration date were not reported). On the same day, he received FLUZONE and BOOSTRIX. When he received the shots, he said that his arm was bleeding quite a bit when getting the shots and the blood had to be wiped away. He also found his Band-Aid was full of blood. On the same day, he started having pain and swelling in his arm. The patient's wife described the swelling as "about the size of my hand and about an inch high". On 06-JAN-2018, reported as "today", the patient started having redness down at an angle from the shoulder towards the side of the arm. There was no relevant laboratory work performed. As of the time of this report, the patient did not recover from the redness, pain and swelling. The outcome of the event of bleeding was not reported. At the time of reporting, it was unknown if the patient would receive another PNEUMOVAX 23 again. The relatedness between the events and PNEUMOVAX 23 was not assessed.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt came in on 12/28/17 at 5:50 pm to pick up other meds and indicated that he got flu shot on 8/31/17 on his Rt upper arm and still hurts and painful. He can't lift his arm above his ears. Even as of 1/11/18 at 5 pm. He is still having pain/hurting in the arm.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Headache, Injection site pain, Injection site rash, Insomnia
Clinical narrative: On the night of the injection an intense headache began that included the back of the head and the neck, the injection site became very sore to the touch, a sleepless night due to a general malaise. In the morning there was intense pain in all the joints which continued, with the headache and a flash feverish feeling. After 24 hours the symptoms were less but prohibitive. Chest congestion started. It's now been 48 hours and the headache and join pain is mostly gone but the injection site has a rash that has spread a few inches down. and there is considerable chest congestion.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: On the night of the injection an intense headache began that included the back of the head and the neck, the injection site became very sore to the touch, a sleepless night due to a general malaise. In the morning there was intense pain in all the joints which continued, with the headache and a flash feverish feeling. After 24 hours the symptoms were less but prohibitive. Chest congestion started. It's now been 48 hours and the headache and join pain is mostly gone but the injection site has a rash that has spread a few inches down. and there is considerable chest congestion.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Asthenopia, Crying, Decreased appetite, Malaise, Pyrexia
Clinical narrative: Fever spiking at 103.2 that has lasted three days and now we're on to day 4. Baby is not eating as well as normal, and he seems to be feeling very sick: clingy, tired eyes, crying randomly.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a 13 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter. On unknown dates, the patient had gotten her first two doses of GARDASIL 9 0.5 ml, for prophylaxis (strength, route, lots # and expiration dates were not reported) at a different practice. On unknown dates, each time, the patient developed a strange and bad rash. It was unknown if the patient sought medical attention, received any treatment for the condition or if any laboratory study was performed. At the reporting time, the patient had not received her third dose of GARDASIL 9 yet. The outcome of rash was unknown. The causality assessment between the event and vaccinations with GARDASIL 9 was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N021727, expiration date 06-FEB-2019, (dose, route and frequency were not reported) for prophylaxis; administered along with a properly stored sterile diluent, Lot # N016995, expiration date 08-OCT-2019 (dose, route and frequency were not reported). The improperly stored vaccine was noticed due to a data logger. It was stored between 15 Fahrenheit degrees (F) and 46 F (average of 37 F) during 24 hours; and there was a second excursion between 6 F and 14 F (average of 11 F) during 1 hour. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved.