chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Case number PHHY2014US048255, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520021) web site on 14 Apr 2014. This report refers to a 45-year-old female patient. She had no known drug allergies. This poly medicated patient was vaccinated with FLUVIRIN (batch number: 1308001) intramuscularly in the left deltoid on 07 Nov 2013. On 23 Nov 2013, she experienced knot and warm to touch feeling on injection site and her left arm pain radiated to upper and lower arm. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2014US048393 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 520027) web site on 14 Apr 2014. This report refers to a 66 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 009031A) intramuscularly in the right arm on 08 Jan 2014. On 12 Jan 2014, approximately 4 days after vaccination, he experienced rash in chest. It was reported that the rash spread to upper arms and low back. The event outcome was reported as complete recovery. The events were reported non serious. The causality was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Rash
Clinical narrative: Case number PHHY2014US048711 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520074) website on 14 Apr 2014. This report refers to a 61 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13391P) intramuscularly into his right arm on 16 Dec 2013. On 24 Dec 2013, he had a rash that showed up a week after the vaccination. He also complained of some numbness on his arm. The outcome of the events was unknown. The events were assessed as non-serious and the causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site rash, Paraesthesia
Clinical narrative: Case number PHHY2014US048711 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520074) website on 14 Apr 2014. This report refers to a 61 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13391P) intramuscularly into his right arm on 16 Dec 2013. On 24 Dec 2013, he had a rash that showed up a week after the vaccination. He also complained of some numbness on his arm. The outcome of the events was unknown. The events were assessed as non-serious and the causality of the events was not reported.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2014US046589, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520099) website on 14 Apr 2014. This report refers to a 05-year-old female patient. Her concurrent condition included mild cough. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm on 20 Jan 2014. On the same date, after vaccination she experienced rash over front and back of body. The final outcome of the event reported as not recovered. The event was reported as non-serious; however the case was internally upgraded as medically significant by the MAH. The causality of the event was not reported.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2014US048202, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520208) website on 14 Apr 2014. This report refers to a 25-year-old female patient. Her medical history included food allergy to nuts and shellfish. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 13404P) on 20 Nov 2013. She experienced high fever with body temperature 103 degree Fahrenheit for two days post vaccination. The outcome of the event was recovered. Seriousness and causality assessment was not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Case number PHHY2014US046514 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 520228) website on 14 Apr 2014> This report refers to a 40-year-old female patient. She tore a bicep muscle approximately 3 months ago. She was vaccinated with FLUVIRIN (batch number: 1309701) into left arm on 08 Jan 2014. On an unknown date post vaccination, she experienced injection site redness, bruising, warm to touch and muscle soreness. These events were reported as non-serious; however the case was internally upgraded as medically significant by the MAH. Outcome of the events was unknown. Causality of the events was not reported.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: Case number PHHY2014US048254 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520590) web site on 14 Apr 2014. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 134728) intramuscularly into left arm and ZOSTAVAX (other manufacturer and batch number: J0084373) subcutaneously into right arm both on an unknown date. Post vaccination, she had injection site reaction that became rash and grew larger over 2 days. She was instructed to go to physician to double check and she did. The event was reported as non-serious. Outcome of the event was reported as recovered. Causality of the event was not reported.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2014US048663 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520658) web site on 14 Apr 2014. This report refers to a 10 year old male patient. His medical history included asthma and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309801) in the left arm on 20 Jan 2014. On the same day after vaccination, he experienced injection site pain. The outcome of the event was not reported. The seriousness of the event was reported as non-serious. The causality of the event was not reported. No additional information was available.
Age: 28.0
Sex: M
Vaccine: FLUC3
Symptoms: Pain, Pain in extremity
Clinical narrative: Case number PHHY2014US048681 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 520707) on 14 Apr 2014. This report refers to 28 year old male patient. His medical history included sinus infection. His concomitant medications included hydrocodone/APAP 5/325. He was vaccinated with FLUVIRIN (batch number: 13403P) intramuscularly in right arm on 23 Jan 2014. On 23 Jan 2014 his arm was sore and it hurt to  lift above shoulder. The outcome was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US048694, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520840) website on 14 Apr 2014. This report refers to a 32-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309801) along with PNEUMOVAX (batch number: J007786) in the right arm on 23 Oct 2013. On 26 Oct 2013, she experienced redness, warmth and swelling at injection site. She was given antibiotics and sent home from urgent care. The outcome of the events were not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Case number PHHY2014US0487373, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520845) website on 14 Apr 2014. This report refers to a 67-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309101) intramuscularly in the right arm on 14 Oct 2013. On 08 Nov 2013, she experienced swollen lymph nodes under arms. The patient visited the emergency room. She was prescribed with doxycycline and naproxen. The outcome of the event was unknown. The seriousness and causality of the event were not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pruritus, Urticaria
Clinical narrative: Case number PHHY2014US048781, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520856) website on 14 Apr 2014. This report refers to a 32-year-old female patient. Her vaccination history included Seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date and she became very ill (see case: PHHY2014US048788). She was vaccinated with FLUVIRIN (batch number: 1309801) intramuscularly in the right arm on 10 Jan 2014. On the same date, after vaccination she experienced a hives type rash, had itching, aches and headache. She received BENADRYL as treatment drug. It was reported that on 14 Jan 2014, she did not take the BENADRYL and the event hives returned back. The patient visited the emergency room. The final outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity
Clinical narrative: Case number PHHY2014US048811, is an initial spontaneous report received from the Vaccine Adverse Event Reporting system (VAERS reference number: 520860) website on 14 Apr 2014. This report refers to a 34-year-old male patient. He was vaccinated with LUVIRIN (batch number: 520860) in the left arm on 10 Jan 2014. On 11 Jan 2014, he experienced joint pain in left shoulder, pain in arm (severe pain) and also had numbness in arm and waist. The patient visited the emergency room. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Rash macular
Clinical narrative: Case number PHHY2014US047049, is an initial spontaneous report received from the Vaccine Adverse Event Reporting system (VAERS reference number: 520887) website on 14 Apr 2014. This report refers to a 46-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 13465P) intramuscularly into left arm on 25 Jan 2014. On 27 Jan 2014, he developed face flash and red blotchy skin. The outcome of the events was unknown and causality assessment was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the MAH.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Case number PHHY2014US048832, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520894) website on 14 Apr 2014. This report refers to a 55-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1307701) intramuscularly in the arm on 20 Sep 2013. On the same date, after vaccination she experienced muscle pain at site of injection. The patient visited the emergency room.  The event was ongoing from 4 months. It was reported that the patient needed therapy. The seriousness and causality of the event were not reported.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Headache, Hyperhidrosis, Malaise
Clinical narrative: Case number PHHY2014US048851, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520901) website on 14 Apr 2014. This report refers to a 65-year-old male patient. She was vaccinated with FLUVIRIN (batch number: 13097) along with PNEUMOVAX (batch number: J005068), both intramuscularly in the right arm on 12 Nov 2013. On an unknown date, 24 hours after vaccination the patient became severely sick with excessive sweating, headache and weakness. It was reported that the patient almost required a hospital visit but the events resolved after 3 days. The seriousness and causality of the events were not reported.
Age: 44.0
Sex: M
Vaccine: FLU3, IPV
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2014US048806, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAER reference number: 520996) website on 14 Apr 2014. This report refers to a 44-year-old male patient. Past medical history included allergy to dust; grass; ragweed; mold; pollen; iodine; shellfish and penicillin. Concomitant medications included ALLEGRA. He was vaccinated with FLUVIRIN (batch number: 13424P), along with IMOVAX (batch number: J1745) intramuscularly on 15 Jan 2014. On the same day after vaccination, he experienced burning and soreness at injection site. The final outcome of the event was condition unchanged. The reporter assessed the event as non-serious and causality was not provided.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2014US048938, initial spontaneous report received form the Vaccine Adverse Event Reporting System (VAERS reference number: 521185) website on 14 Apr 2014. This report refers to a 52-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13475P) intramuscularly into left arm on 12 Nov 2013. On 14 Nov 2013, he experienced pain in the left arm and was unable to lift the left arm above shoulder level without pain. The final outcome of the events was condition unchanged. The reporter assessed the events as non-serious and causality was not provided.
Age: 8.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2014US049000 is an initial spontaneous report received form the vaccine adverse event reporting system (VAERS reference number: 521214) web site on 14 Apr 2014. This report refers to a 08 Year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 13454P) via intramuscular route into right arm along with HAVRIX (batch number: 494G5) via intramuscular route into left arm on 16 Jan 2014. On 17 Jan 2014, she experienced quarter sized red area at injection site (right deltoid). The outcome of the event was reported as complete recovery. The events were reported as non-serious. However, causality was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Case number PHHY2014US04950 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 521425) web site on 14 Apr 2014. This report refers to a 44 year old female patient. Her current condition included hypertension and her concomitant medication included enalapril and hydrochlorothiazide. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13385P) via intramuscular route into left arm on 20 Jan 2014. On 23 Jan 2014 in the night, she noticed itchy red hives at injection site. The final outcome of the events was reported complete recovery. The events were reported as non-serious. However, the causality was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: Case number PHHY2014US048764, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521446) website on 14 APR 2014. This report refers to a 29 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 131001) into her right arm on 10 JAN 2014. On 11 JAN 2014, she had pain at the vaccination site radiating down from upper to lower forearm with tingling in right fourth and fifth digits. The outcome of the events was condition unchanged. The events were assessed as non-serious and the causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2014US048803, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521475) website on 14 APR 2014. This report refers to a 62 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 010021A) intramuscularly on 29 JAN 2014. On 30 JAN 2014, she had a raised red bump at injection site. The injection site was sore and itchy. The outcome of the events was condition unchanged. The events were assessed as non-serious and the causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2014US048864, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521486) website on 14 APR 2014. This report refers to a 21 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 3010301) intramuscularly into her left arm on 17 JAN 2014. On the same day, after the vaccination, she went back to the clinic complaining of hives and itching on bilateral lower legs. The outcome of the events was reported as condition unchanged. The events were assessed as non-serious and the causality of the events was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Headache, Malaise, Pain in extremity
Clinical narrative: Case number PHHY2014US048876, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521586) website on 14 APR 2014. This report refers to a 45 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13422P) into her right arm and with Pneumovax (batch number: J004196, other manufacturer) into her right arm on 24 JAN 2014, her arm was very sore for the past week since the vaccination and she was feeling very weak with headaches. She was given over the counter medications which did not help. She has never been this sick ever. The outcome of the events was not reported. The events were assessed as non-serious and the causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2014US048904 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 521741) website on 14 APR 2014. This report refers to a 64-year-old female patient. She had a medical history of paroxysmal atrial tachycardia and type 2 diabetes. Her concomitant medications included Janumet, Atenolol, Prandin, Actos, and Lipitor. She reported that she always had soreness at the injection site of flu shots which recovered after a couple of days. On 03 DEC 2013, she was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308401) intramuscularly in the left arm. On the same date, after the vaccination, she experienced vaccination site soreness which did not recover after a couple of days. She reported that it had been two months since the injection site soreness was not felt when the arm was at her side but felt when the arm was over head (backstroke-swimming), holding hair dryer, combing hair, etc. The final outcome was reported as condition unchanged. The reporter assessed the case as non serious. The causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood test, Mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHHY2014US048783 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521753) website on 14 APR 2014. This report refers to a 57 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309101) intramuscularly into her arm on 04 OCT 2013. On the same day within minutes after vaccination, she had soreness/pain at the vaccination site. Within 20 minutes, the pain extended to elbow and in less than 2  hours her entire arm was in a lot of pain. Pain continued although it was easing and she started losing mobility. Three and a half months later, her arm was still painful and mostly around vaccination site and she had loss of mobility. She went to emergency room and had visited physician. She underwent X-ray and the result was reported as negative. She had physical therapy which was stopped as per doctor's orders. Blood test ws done and the results were not reported. It was reported that the events were impacting her everyday life (activities like dressing, washing, etc). The outcome of the events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Case number PHHY2014US048783 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521753) website on 14 APR 2014. This report refers to a 57 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309101) intramuscularly into her arm on 04 OCT 2013. On the same day within minutes after vaccination, she had soreness/pain at the vaccination site. Within 20 minutes, the pain extended to elbow and in less than 2  hours her entire arm was in a lot of pain. Pain continued although it was easing and she started losing mobility. Three and a half months later, her arm was still painful and mostly around vaccination site and she had loss of mobility. She went to emergency room and had visited physician. She underwent X-ray and the result was reported as negative. She had physical therapy which was stopped as per doctor's orders. Blood test ws done and the results were not reported. It was reported that the events were impacting her everyday life (activities like dressing, washing, etc). The outcome of the events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Case number PHHY2013US048771 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521773) web site on 14 APR 2014. This report refers to a 62 years old female patient. She did not have any allergies reported before vaccination. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1343) intramuscularly in th right arm on 11 NOV 2013. On the same day after vaccination, she had pain at the vaccination site and could not raise her right arm. The events continued till 06 JAN 2014. The final outcome of the events was unknown. The events were reported non-serious. The causality was not reported.
Age: 28.0
Sex: F
Vaccine: FLU3, TYP, YF
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Case number PHHY2014US048762 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521804) web site on 14 APR 2014. This report refers to a 28 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 15405P), Typhim V1 (other manufacturer, batch number: H1482) both vaccines administered intramuscularly in the arm and YF-VAX (other manufacturer, batch number UH587AA) subcutaneously in the arm on 29 JAN 2014. On 01 FEB 2014, she experienced redness, some swelling and itching at the vaccination site of arm. The even outcome was reported as complete recovery. The events were reported non-serious. The causality was not reported.
Age: 19.0
Sex: F
Vaccine: ANTH, FLU3, SMALL, TYP
Symptoms: Maternal exposure before pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Case number PHHY2013US048723 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521812) web site on 14 APR 2014. This report refers to a 19 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 005011A), Biothrax (other manufacturer, batch number: FAV324A) and Typhim V1 (other manufacturer, batch number H13821); all three vaccines administered intramuscularly in the right arm and ACAM 2000 (other manufacturer, batch number VV04003A) administered in the left arm on 08 JAN 2014 after a negative pregnancy test. On 03 FEB 2014, she found out that she was pregnant and it was confirmed by another pregnancy test. The event was reported non serious. No adverse events were reported following the maladministration.   Follow up information received on 27 MAY 2014. Outcome of events could not be obtained because reporter was anonymous. This case is lost to follow up.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Case number PHHY2014US048726, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522206) website on 14 APR 2014. This report refers to 7-year-old male patient. His medical history included penicillin allergy. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 13462P) into right arm on 07 FEB 2014. On 08 FEB 2014, he developed redness and in pain. The outcome of the events was unknown. Seriousness and causality assessment was not reported.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Case number PHHY2014US048751, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522207) website on 14 APR 2014. This report refers to 9-year-old female patient. Her medical history included penicillin allergy. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13462P) into right arm on 07 FEB 2014. On 08 FEB 2014, she developed redness and pain. The outcome of the events was unknown. Seriousness and causality assessment was not reported.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014 US048894, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522369) website on 14 APR 2013. This report refers to 36 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number 13475P) and Pneumovax (other manufacturer, batch number: J008799) both intramuscularly one inch apart into right arm on 06 FEB 2014. Injections went well, there was no bleeding. He said later that event was red, swollen and sore went to express care three days later, swollen and red about 4 inch below injection. Treatment medication included Bactrim DS, BID. The next day he developed swelling down to elbow. He visited the emergency room and consulted infectious disease physician. On 10 FEB 2014, complete blood count (CBC) was performed but the results were not reported. The outcome of the events seriousness and causality assessment was not reported.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain, Paraesthesia
Clinical narrative: Case number PHHY2014US049403 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 522449) on 14 APR 2014. This report refers to a 42 years old male patient.  His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014. On the same day after vaccination, he experienced tingling and little pain initially. It was reported that he was having difficulty in moving the injected arm and in wearing clothes. He went to emergency room and saw an orthopedic who recommended physical therapy. The outcome was not reported. The event was reported as non-serious. The causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Case number PHHY2014US049374, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522526) website on 14 Apr 2014. This report refers to a 34-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 13461P) intramuscularly in the left arm on 13 Jan 2014. On the same date, after vaccination she felt dizzy. The patient was observed and asked to lie flat with feet elevated for about 10 minutes. Her blood pressure was reported as 113/71 and pulse was 81 bpm. The patient felt better, sat up and drank fluids. The patient was observed for another 10 minutes. Her blood pressure was checked again and reported as (118/79) and pulse as (78 bpm). The patient felt fine standing and left the pharmacy. She was advised to contact primary care provider or emergency room in the event of deteriorating condition. The final outcome of the event reported as recovered. The seriousness and causality of the event were not reported.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Case number PHHY2014US049381 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522544) web site on 14 Apr 2104. This report refers to a 63-year-old female patient. Her medical history included arthritis. She was vaccinated with FLUVIRIN (batch number: 13471P) intramuscularly in the arm along with ZOSTAVAX (batch number: J007858) subcutaneously, both on 16 Jan 2014. On the same date, after vaccination she experienced large bumpy rash at injection (1 x 3 inches) for 3 weeks and also had severe pain in the arm when patient moves the arm it still exists. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US049348, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522589) website on 14 Apr 2014. This report refers to 46 year old male patient. His medical history included hypertension. Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 13433P) intramuscularly and PNEUMOVAX (other manufacturer, batch number: J009689) subcutaneous both into arm on 11 Jan 2014. On the same date, patient developed pain, redness and swelling of injection site. Redness spread down the arm. The outcome of the events was recovered. Seriousness and causality assessment was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2014US049701, initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522590) website on 14 Apr 2014. This report refers to a 48-year-old female patient. Past medical history included multiple sclerosis. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 13433P) intramuscularly into the arm, along with PNEUMOVAX (other manufacturer, batch number: J009689) subcutaneously at unspecified site on 11 Jan 2014. On the same day after vaccination, she experienced swelling and redness around the unspecified injection site of PNEUMOVAX. The final outcome of the events was complete recovery. The reporter assessed the event as non-serious and causality was not provided.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2014US055385 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522684) web site on 06 May 2014. This report refers to a 33 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13099001) into arm on 06 Jan 2014. On 08 Jan 2014, she experienced pain at injection site and the pain radiated down the arm. The outcome and causality of the event was not reported. The events were reported as non-serious.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site rash
Clinical narrative: Case number PHHY2014US055413 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522746) web site on 06 May 2014. This report refers to a 53 year old male patient. His medical history was not reported. His concomitant medication included citalopram. He was vaccinated with FLUVIRIN (batch number: 13465P) via intramuscular route into left arm on 11 Jan 2014. On 15 Jan 2014, he developed rash at vaccination site and rash on arm (vaccinated arm). The outcome and causality of the event was not reported. The events were reported as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Case number PHHY2014US055220, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522762) website on 06 May 2014. This report refers to a 57-year-old female patient. Past medical history included hypertension and arthritis in back. Concomitant medications included lisinopril, FLEXERIL ibuprofen and Aspirin. She was vaccinated with FLUVIRIN (batch number: 1310001) into the left arm on 11 Feb 2014. On 13 Feb 2014, she experienced sore throat, headache, coughing, achy and tiredness. She never had such adverse effects previously. The final outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Case number PHHY2014US054708, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference  number: 523012) website on 06 May 2014. This report refers to a 7-year-old male patient. Past medical history included asthma, seasonal allergy and perennial allergy. Concomitant medications included Albuterol (salbutamol). He was vaccinated with FLUVIRIN (batch number: 13403P) on 08 Jan 2014. On 14 Jan 2014, he experienced hives/rash. He was admitted in the emergency department and treatment for the event was rendered with BENADRYL, PEPCID and SOLU-MEDROL. When he was discharged from the emergency department, he was prescribed BENADRYL, felodipine and prednisone. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Immediate post-injection reaction, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2014US056484, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523084) website on 06 May 2014. This report refers to a 58-year-old female patient. Her medical history included hypertension, diabetes and hypercholesterolaemia. She had no known drug allergies. Concomitant drugs included Fenofibrate, simvastatin, metformin and lisinopril/hydrochlorothiazide. She was vaccinated with FLUVIRIN (batch number: 1309701) intramuscular in the right arm on 18 Nov 2013. On the same date, she experienced tingling in wrist (right) immediately after vaccination. She experienced tingling, pain the length of right arm, right scapular pain and underarm soreness. She had no rash, redness or fever. The final outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Case number PHHY2014US055244, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523128) website on 06 May 2014. This report refers to a 53-year-old female patient. Concomitant drugs included simvastatin, hydrochlorothiazide, omeprazole, lisinopril and amlodipine. She was vaccinated with FLUVIRIN (batch number: 13452P) intramuscularly on 18 Jan 2014. On the same date, after vaccination the patient experienced pain when moving her hand (soreness). The final outcome of the event reported as not recovered. The seriousness and causality of the event were not reported.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2014US055106 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523130) website on 06 May 2014, with the following internal review of the date received on 06 May 2014. This report refers to a 74 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13391P) intramuscularly in the left arm on 28 Oct 2013. On the same day after vaccination, she experienced arm pain at injection site, which required doctor visit. The outcome of the event was not reported. The seriousness of the case was reported as non-serious. The causality of the event was not reported. Following internal review of the data received on 06 May 2014: The suspect product recoded from FLUCELVAX to FLUVIRIN.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2014US055133 is an initial spontaneous report received the Vaccine Adverse Event Reporting System (VAERS reference number: 523131) website on 06 May 2014. This report refers to a 74 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number, 13391P) intramuscularly in the left arm on 28 Oct 2013. On the same day after vaccination, he experienced arm pain at injection site, which required doctor visit. The outcome of the event was not reported. The seriousness of the case was reported as non-serious. The causality of the event was not reported.
Age: 53.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2014US055886, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523250) website on 06 May 2014. This report refers to 53 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1307801) intramuscular into left arm on 11 Feb 2014. On the same day he also received MENACTRA (batch number: U4658BB, other manufacturer) intramuscular into right arm. On 12 Feb 2014, he experienced right upper arm tender with swollen lymphatic that began hours after injection and lasted for three days. On 14 Feb 2014, he saw the primary care and complained of fever with body temperature 103 degrees Celsius. He visited the emergency room. Outcome of the events was recovered. Seriousness and causality assessment was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2014US055715 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 523278) website on 06 May 2014. This report refers to a 64-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13421P) in the left arm on 12 Oct 2013. On the same day she suffered pain from the distal portion of her deltoid area and the upper portion of her tricep of her vaccinated arm and it continued event at the time of reporting. She stated that it was painful during vaccine administration, but it improved over the past few months. However, the final outcome of the event was reported as condition unchanged. The event was reported as non-serious. The causality of the event was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US051397 is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 523296) website on 24 APR 2014. This report refers to a male patient of an unknown age. He was vaccinated with FLUVIRIN 2010/2011 (batch number: unknown) on an unknown date in 2010. On an unknown date post vaccination , he experienced arm soreness. Seriousness, outcome and causality of the event were not reported.
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Case number PHHY2014US055847 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523331) website on 06 MAY 2014. This report refers to a 47-year-old male patient. His medical history included hypertension and concomitant medications included Atenolol. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 13412P) intramuscularly in the left arm on 02 NOV 2013. On 03 NOV 2013, he had chronic sharp pain on the left arm where the shot was administered. It was reported that the pain in the vaccination site remains in arm from day after shot to the date of reporting. He went to the emergency room on 08 FEB 2014 and had evaluation. The outcome of the event was reported as condition unchanged. The event was reported as non-serious. The causality of the event was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Case number PHHY2014US055874 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523474) web sit on 06 MAY 2014. This report refers to a 29 year old female patient. Her current condition included dust and seasonal allergies and concomitant medication included Centrum and Aviane. On an unknown date, she was vaccinated with FLUVIRIN 2013/2014 (batch umber: 13465P) into left arm. On an unknown date after vaccination, she experienced injection site pain which continued for next 2 days. She had no pain for few days but the pain returned and she could not lift her arm. She also experienced pain on lifting things with arm. The pain continued or got severe. Next day she experienced burning sensation in injection site. The final outcome and causality were not reported. The events were reported as non-serious.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2014US055915 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523478) web site on 06 MAY 2014. This report refers to a 77 year old male patient. His current condition included skin cancer, diabetes, high blood pressure and allergy to Niaspan. On 23 OCT 2013, he was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309701) and Pneumovax (other manufacturer, batch number: H004080) both into left arm. On 26 OCT 2013, he experienced redness and swelling in left arm at lower elbow to wrist region. He visited a pharmacist who recommended Benadryl for the events. On 29 OCT 2013, he consulted a physician who had asked him to take Zyrtec. On an unknown date redness and swelling had decreased. The events were reported as non-serious and the causality was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Case number PHHY2014US051379, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523902) website on 24 APR 2014 and a follow up report from the VAERS received on 09 JUN 2014. This report refers to a 67-year-old female patient. Concomitant drugs included Aspirin and Vitamin D with calcium. She was vaccinated with FLUVIRIN 2013/2014 (batch number: not reported) intramuscularly in the left arm on 15 NOV 2013. On the same date, the flu injection was painful and began to be sore at once. It was reported that approximately 3 months later, in her arm where the vaccine was given was still achy, painful and sore intermittently. It was reported that her entire upper arm and shoulder were affected. The final outcome of the events were reported as not recovered. The seriousness and causality of the event were not reported.   Follow up report from the VAERS received on 09 JUN 2014. Updated the suspect vaccine from Seasonal influenza vaccine INN to FLUVIRIN 2013/2014.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2014US056071 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524010) web site on 06 MAY 2014. This report refers to a 60 year old female patient. She had no medical history or concomitant medication. She was vaccinated with FLUVIRIN 2013/2014 (batch number 13442P) intramuscularly into left arm on 27 JAN 2014. On the same day after vaccination, she could not move her arm due to shoulder pain. The outcome of the events was condition unchanged. The events were reported as non-serious and causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US055803, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524183) website on 06 MAY 2014. This report refers to a 53-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1310101) into the right arm on 08 NOV 2013. On an unknown date after vaccination, she experienced pain in right arm (vaccinated arm) and it radiates into arm. The final outcome of the event was condition unchanged. The event was reported as non-serious. Causality was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain
Clinical narrative: Case number PHHY2014US055827, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524196) website on 06 MAY 2014. This report refers to a 65-year-old male patient. Past medical history was not reported. Concomitant medications included Nifedipine and Pantoprazole. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1310101) intramuscularly into the left arm on 22 JAN 2014. On 23 JAN 2014, she experienced pain from shoulder down to elbow. She went to the emergency room and got pain medication. One month later she was still feeling pain throughout neck and from shoulder down to elbow. The final outcome of the events was condition unchanged. The events were reported as non-serious. Causality was not reported.