chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHEH2014US022014, is an initial spontaneous report received from a health care professional (materials manager) on 31 Oct 2014. This report refers to a 47 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 Oct 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHEH2013US025758 is an initial spontaneous report from a pharmacist received on 12 Dec 2013. This report refers to a 61-year-old female patient. Her medical history was not reported. Concomitant medication included ZYRTEC. She was vaccinated with 0.5 ml dose of FLUVIRIN (batch number: 1309701 and expiry date: 01 May 2014) intramuscularly into left arm on 10 Dec 2013. She experienced numbness and tingling in both arms since administration of vaccine. It was reported that the left arm (site of FLUVIRIN administration) has stronger sensations of numbness and tingling than the right arm. It was also reported that the feeling comes and goes but has not ended. Seriousness and causality of the event was not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHEH2014US022016 is an initial spontaneous report received from a health care professional on 31 Oct 2014. This report refers to a 30 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 Oct 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHEH2014US022017 is an initial spontaneous report received from a health care professional on 31 OCT 2014. This report refers to a 36 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 OCT 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2013 US024509 is an initial spontaneous report from the consumer received on 19 NOV 2013. This report refers to a female patient of an unspecified age. The patient became pregnant on an unknown date and her last menstrual date was not provided. This pregnant patient received FLUVIRIN 2013/2014 (batch number: not reported) on an unknown date. No adverse event reported following the vaccination. No other information was available.     Follow up information received on 19 NOV 2013. Reporter was anonymous so this case is lost to follow up.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Case number PHEH2014US022018 is an initial spontaneous report received from a health care professional on 31 OCT 2014. This report refers to a 40 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412501) art a dose of 0.5 ml intramuscularly in the arm on 10 OCT 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case  number PHEH2013US024206 is an initial spontaneous report from the pharmacist received on 15 NOV 2013. This report refers to an elderly male patient. He received flu shots for number of years but never experienced any event before. The patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308601) intramuscularly on 02 OCT 2013. On an unknown date, after vaccination he experienced an extremely sore arm with sharp pain. The outcome reported as event lasted from past 6 weeks. No other information was available.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHEH2014US022029 is an initial spontaneous report from the nurse received on 29 OCT 2014. This report refers to a 32-year-old female patient. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411401) intramuscularly at a dose of 0.5 ml on 27 OCT 2014. On the same date, after vaccination she experienced redness and circle on the FLUVIRIN injection site and area was still red and hot to touch. The final outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: Mother case. Case number PHEH2014US022267 is an initial spontaneous report from the pharmacist received on NOV 2014. This  report refers to a 37-yaar-old female pregnant patient. This pregnant patient's last menstrual date was not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 03 OCT 2014. On the same date, after vaccination she experienced pain in the arm at the injection site which has continued for 30 days. It was reported that she was still reporting pain in her arm. The seriousness and causality of the event were not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Case number PHEH2014US022297, is an initial spontaneous report from a pharmacist received on 05 NOV 2014. This report refers to a 61-year-old female patient. Concurrent conditions included latex sensitivity/allergy. She was vaccinated with FLUVIRIN 2013/2014 (batch number: not reported) intramuscularly on an unknown date. On an unknown date after vaccination, she developed a swollen arm at the injection site. The outcome of the event was unknown. Seriousness and causality was not reported. The pharmacist reported that the patient did not receive the vaccination at pharmacy and does not have any additional data.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PH#H2013IS023985 is an initial spontaneous report from the consumer received on 12 NOV 2013. This report refers to a female patient of an unknown age. On an unknown date, she received an intramuscular dose of FLUVIRIN 2013/2014 (batch number: not reported) which was drawn from a multi dose vial. At the time of FLUVIRIN vaccination, the patient was pregnant. No adverse event reported following the vaccination.  Follow up information received on 11 AUG 2014: Multiple attempts were made to obtain outcome of event without success. This case is considered lost to follow up.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHEH2013US025261 is an initial report received from a pharmacist on 04 DEC 2013. This report refers to a female patient of an unknown age. The patient who was a nurse was vaccinated with FLUVIRIN (batch number: not reported, expiry date: not reported) by an another nurse intradermally on an unspecified date. As a result the injection site was red, itchy and raised. Onset date of the adverse event was not reported. Outcome of the events, seriousness and causality were not reported.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2013US024868, is an initial spontaneous report received from a pharmacist on 26 NOV 2013.  This report refers to a 71-year-old male patient. His medical history and concomitant  medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309201, expiration date: April 2014) at dose of 0.5 ml intramuscularly on 03 NOV 2013. On the same day after vaccination, he experienced persistent pain at the injection site. He did not seek for medical care from a health care professional at the time of reporting. The outcome of the event was condition unchanged. The seriousness and causality of the events was not reported.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2013US025834 is an initial spontaneous report received from a pharmacist on 13 DEC 2013. This report refers to a 78-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 13402P) intramuscularly on 16 SEP 2013. Later on the same day, he began to experience soreness at the injection site. Outcome of the event was reported as ongoing. Seriousness and causality of the event was not reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHEH2013US024581, is an initial spontaneous report received from a health care professional (HCP) on 19 NOV 2013. This report refers to a 46-year-old female patient. Her medical history and concomitant medications were not reported. She ws vaccinated with FLUVIRIN 2013/2014 (batch number: 1308901) at a dose of 0.5 ml into her right deltoid on 10 JUL 2013 at 5:04 PM. On the same day, after vaccination, she experienced itching, redness, soreness, swelling and induration of the injection site. On 10 SEP 2013, she completely recovered from these events. No causality and seriousness of the events was reported.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHEH2014US020802 is an initial spontaneous report received from a health care professional on 13 OCT 2014. This report refers to a female patient of an unspecified age. Her past medical history and concomitant medications were not reported. On an unspecified date, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411501) intramuscularly. On an unspecified date, after the vaccination, the patient developed  hives. She visited a physician and completely recovered from hives after two days, the seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Impaired work ability
Clinical narrative: Case number PHEH2014US020963, is an initial spontaneous report received from a pharmacist on 15 OCT 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) intramuscular on 14 OCT 2014. She experienced dizziness immediately post vaccination which progressively got worse. She was unable to work on 15 OCT 2014. Pharmacist reported that she had the most severe reactions among reported reactions. Seriousness, causality and outcome of the event were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Myalgia, Pain
Clinical narrative: Case number PHEH2014US020968 is an initial spontaneous report received from a pharmacist on 15 OCT 2014. This report refers to an adult female patient in her thirties. Her past medical history and concomitant medications were not reported. On 14 OCT 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly at a dose of 0.5 ml. On the same day, after the vaccination, she developed a headache, generalized aches, sore muscles and felt unwell like she was coming down with something. The patient had no adverse reactions in the past year. The outcome of the events was not reported. The events were reported as non serious and the causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Myalgia, Pain
Clinical narrative: Case number PHEH2014US020969 is an initial spontaneous report received from a pharmacist on 15 OCT 2014. This report refers to an adult female patient in her sixties. Her past medical history and concomitant medications were not reported. On 14 OCT 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly at a dose of 0.5 ml. On the same day, after the vaccination, she developed a headache, generalized aches, sore muscles and felt unwell like she was coming down with something. The patient had no adverse reactions the past year. The outcome of the events were not reported. The events were reported as non serious and the causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHEH2014US021088, is an initial spontaneous report from a pharmacist received on 17 Oct 2014. This report refers to a 47-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly on 06 Oct 2014. On the same day after vaccination, she experienced tingling of her entire arm including fingers. Also, she has severe soreness in the arm causing limited range of motion of the affected arm. Thi final outcome of the events was unknown. Seriousness and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2014US021116 is an initial spontaneous report received from a pharmacist on 20 Oct 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. It was reported that on an unspecified date after vaccination, she experienced an allergic reaction. The event outcome was unknown. The seriousness and causality of the event was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Case number PHEH2014US021124, is an initial spontaneous report from a health care professional received on 16 Oct 2014. This report refers to male patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date after vaccination, he experienced diarrhea. The outcome of the event diarrhea was reported as condition improved. Seriousness of the event was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Case number PHEH2014US021327, is a combined initial and follow up spontaneous report received from a consumer (patient) on 21 Oct 2014 and on 22 Oct 2014. This report refers to a male patient of unknown age. He was vaccinated with FLUVIRIN (batch number: 1411101, expiry date: Apr 2015) intramuscular into right deltoid on 17 Sep 2014. On the same day post vaccination he experienced right arm swelling of the area, itchy, redness, warmth to touch and fever. Outcome of the event, seriousness and causality assessment was not reported. No further information was provided.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during breast feeding, No adverse event
Clinical narrative: Case number PHEH2014US021401 is an initial spontaneous report received from a pharmacist on 23 Oct 2014. This report refers to a 30 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated FLUVIRIN (batch number: not reported) from multi-dose vial (MDV) intramuscularly on 22 Oct 2014. It was reported that she was breastfeeding at the time of FLUVIRIN vaccination. No adverse events were reported following the maladministration.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Case number PHEH2014US021407 is an initial spontaneous report received from a nurse on 23 Oct 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly at a dose of 0.5 ml on 02 Oct 2014. It was reported that on an unknown date after vaccination, she experienced fever, chills, muscle ache and fatigue. The events outcome was reported as complete recovery. The seriousness and causality were not reported.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Case number PHEH2014US021408 is an initial spontaneous report received from a nurse on 23 Oct 2014. This report refers to a 93 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly at a dose of 0.5 ml on 30 Sep 2014. It was reported that on an unknown date after vaccination, she experienced fever, chills, muscle ache and fatigue. The events outcome was reported as complete recovery. The seriousness and causality were not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Myalgia
Clinical narrative: Case number PHEH2014US021414 is an initial spontaneous report received from a consumer on 21 Oct 2014. This report refers to a 63 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 17 Oct 2014. It was reported that 24 hours after vaccination, she experienced lower back pain and muscle ache. The event outcome of back pain was reported as condition improving and that of muscle ache was not reported. The seriousness and causality were not reported.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Case number PHEH2014US021421 is an initial spontaneous report received from a consumer on 23 Oct 2014. This report refers to an 83 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. It was reported that she experienced redness from elbow to armpit and soreness in upper arm to shoulder. The event outcome was reported as resolved. The seriousness and causality were not reported.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy test negative, Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Case number PHEH2014US021522 is an initial spontaneous report from the nurse received on 23 Oct 2014. This report refers to a 09-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1412501) intramuscularly on 19 Oct 2014. On 20 Oct 2014, 24 hours after vaccination his injection site became red, itchy and swelling. It was reported that the patient was tested for allergic reaction to flu vaccine and it was negative, but when he received the full dose he reacted. The injection site initially looked like a bug bite, but increased to a local 2 inch rash that was discomforting to the patient at the site. The final outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Case number PHEH2014US021522 is an initial spontaneous report from the nurse received on 23 Oct 2014. This report refers to a 09-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1412501) intramuscularly on 19 Oct 2014. On 20 Oct 2014, 24 hours after vaccination his injection site became red, itchy and swelling. It was reported that the patient was tested for allergic reaction to flu vaccine and it was negative, but when he received the full dose he reacted. The injection site initially looked like a bug bite, but increased to a local 2 inch rash that was discomforting to the patient at the site. The final outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Case number PHEH2014US021662 is an initial spontaneous report received from a medical assistant on 24 Oct 2014. This report refers to a 26 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413601) multi-dose vial (MDV) intramuscularly in the deltoid on 23 Oct 2014. It was reported that on the same day evening, she experienced redness and hotness and her arm was swollen. The event outcome was reported as unknown. The seriousness and causality were not reported. Following an internal review of the data received on 24 Oct 2014, it was identified that the event verbatim "redness and hotness" were erroneously coded as erythema and skin warm and hence the events were recoded using local vaccination site terms.
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Pain, Pyrexia
Clinical narrative: Case number PHEH2014US021749, is an initial spontaneous report from a health care professional received on 27 Oct 2014. This report refers to a male patient of an unknown age. Medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1412801) intramuscularly on an unknown date. Post vaccination, the patient experienced strong reaction described as low grade fever and pain. It was reported that the patient did not go to work due to this reaction. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number of PHHY2014US021780, is an initial spontaneous report received from a health care professional on 28 Oct 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 14581P) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. On 23 Oct 2014 shortly after vaccination, she developed hives. The outcome of the event was reported as unknown. The seriousness and causality of the event was not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: Case number PHEH2013US026705 is an initial spontaneous report received from a pharmacist on 31 Dec 2013. This report refers to a 30-years-old female patient. She had a history of latex allergy. She was vaccinated with FLUVIRIN (batch number: 13424P, expiry date: 30 Apr 2014) on 31 Dec 2013. No adverse event was reported following the maladministration.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Vomiting
Clinical narrative: Case number PHEH2014US019129, is an initial spontaneous report from a health care professional received on 22 Sep 2014. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 12 Sep 2014. On 16 Sep 2014, she started sulfa medication (no details provided). On 19 Sep 2014, she experienced headache and vomiting. The outcome of the events was unknown. Seriousness and causality was not reported.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Case number PHEH2014US018323 is an initial spontaneous report received from a medical assistant on 11 Sep 2014. This report refers to a 70 year old elderly male patient. His past medical history and concomitant medications were not reported. In Oct 2013, he was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly. On the same day, after the patient went home after vaccination, he had a local reaction; the site of administration was red and swollen. The outcome of the events was not reported. The seriousness and causality of the events was not reported.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: Case number PHEH2014US000521 is an initial spontaneous report from the pharmacist received on 02 Jan 2014. This report refers to a 55-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 13402P) intramuscularly and PNEUMOVAX (batch number: not reported), both in the left arm on 29 Dec 2013. On the same date, after vaccinations his arm swollen and he had a pain with movement. The patient stated that he was in quite a bit of pain. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2014US000906 is an initial spontaneous report received from a consumer on 08 Jan 2014. This report refers to a 27 years old pregnant female patient. Her medical history and concomitant medications were not reported. She was vacconated with first dose of FLUVIRIN (batch number: 13461P) intramuscularly on 15 Nov 2013 when she was pregnant. No adverse event was reported following the maladministration. She was further vaccinated with a second dose of FLUVIRIN (batch number: 13461P) intramuscularly on 08 Jan 2014 (see related case number: PHEH2014US001495).
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2014US001401 is an initial report received from a pharmacist on 15 Jan 2014. This report refers to an adult female patient. This pregnant patient was vaccinated with FLUVIRIN (batch number: 1310101; expiry date: not reported) intramuscularly on 13 Jan 2014. No adverse event was reported followed by this vaccine exposure during pregnancy. Seriousness and causality were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2014US001694 is an initial spontaneous report received from a consumer on 22 Jan 2014. This report refers to a female patient of an unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309001, expiry date: Apr 2014) on an unknown date in 2013. On 29 Oct 2013, post vaccination, she experienced left arm pain which was persistent at the time of this report. Seriousness and causality of the event was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling, Vaccination site pain
Clinical narrative: Case number PHEH2014US001688 is an initial spontaneous report received from a consumer on 21 Jan 2014 with a follow-up received from the physician on 10 Feb 2014. This report refers to a 66-years-old female patient. Her medical history was not reported. Her concomitant medication included Chlorthalidone at 25 mg orally QD for ankle edema. She was vaccinated with FLUVIRIN (batch number: 1308201 and expiry date: Mar 2014) intramuscularly at 0.5ml to left arm on 03 Oct 2013. On an unknown date. two weeks after vaccination, she experienced raised red knot at the injection site which was almost felt like rubber. Two weeks later it was redder and the size was about 1.4 inches circumference and itching. On an unknown date she also developed swelling at the vaccine site along with erythema. She visited physician and they prescribed a steroid cream triamcinolone and Triaminicin with some mixture of cream. At the time of follow-up report in 10 Feb 2014, she still had pain, swelling and erythema at the vaccination site. Other events recovered on an unknown date of Nov 2013 or Dec 2013. Seriousness and causality of the events was not reported. Follow-up received from the physician on 10 Feb 2014: Updated patient demographic, concomitant medication, dose and expiry date of FLUVIRIN, event and outcome.
Sex: M
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Case number PHEH2014US002075 is an initial spontaneous report received from a pharmacist on 27 Jan 2014. This report refers to a male patient of an unknown age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13465P) intramuscularly on 25 Jan 2014. On 27 Jan 2014, two days after vaccination, he experienced small red blotches on his face. It was reported that around the same time of vaccination, he also started using a new hair care product. Outcome of the event was reported as condition unchanged. Seriousness and causality of the event was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHEH2014US002167 is an initial spontaneous report received from a pharmacist on 28 Jan 2014. This report refers to an adult female patient of unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309801) intramuscularly on 31 Dec 2013. On an unknown date one or two days after vaccination, she began to experience pain in left arm muscle which extended from shoulder to elbow. It was also reported that occasionally she had to pick up left arm with her right arm while sleeping. The outcome of the event was reported as condition unchanged. The causality and seriousness of the events were not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Case number PHEH2014US002524 is an initial spontaneous report received from a pharmacist on 03 Feb 2014 with a follow up information received from a pharmacist on 27 May 2014. This case was initially reported as a multiple patient case involving 2 patients, but upon follow up information the patient identifiers were reported. This report refers to an adult female patient. Past medical history included shellfish allergy and concomitant medication were not reported. She was vaccinated with an initial dose of FLUVIRIN (batch number: 13464P) intramuscularly in the left deltoid at a dose of 0.5 ml on 05 Feb 2014. It was reported that on an unknown date after vaccination, it was hurt to lift arm and it hurt to sleep on it for 5 weeks. She experienced painful and limited movement of her arm. Arm affected was the arm she received the injection in. She did not want to go to the physician. The outcome was reported as condition improving at the end of Mar 2014. The seriousness and causality of the events were not reported. Follow up information received from a pharmacist on 27 May 2014: Patient demographics (initial, date of birth, age group and gender), medical history, vaccination date, batch number, dose and site of vaccination, description on event, stop date and outcome updated.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Case number PHEH2014US002598 is am initial spontaneous report from the consumer received on 04 Feb 2014. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination she felt nauseous and light headed. The outcome of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHEH2014US004300 is an initial spontaneous report from a pharmacist received on 27 Feb 2014. This report refers to a 52-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1310101) intramuscularly into right arm on an unknown date. On 08 Nov 2013, post vaccination, she experienced pain that radiates up her arm and into her shoulder. The pharmacist states that the patient had not seen a physician and the patient still had the symptoms. Seriousness and causality of the events was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Case number PHEH2014US007744 is an initial spontaneous report received from a pharmacist on 15 Apr 2014. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with an intramuscular dose of FLUVIRIN (batch number: not reported) in the mid of Nov 2013. It was reported that after vaccination, on an unknown date in the mid of Nov 2013, she experienced vaccination site reaction which was further described as red lump about the size of a pea at the site. She saw a physician on an unknown date in Jan 2014 or Feb 2014. The event outcome was unknown. The seriousness and causality were not reported.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHEH2014US017653 is an initial spontaneous report received from a pharmacist on 29 August 2014. This report refers to a 63 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145223) intramuscularly on 25 Aug 2014. On the same day after vaccination, he experienced hives. The outcome was unknown. Seriousness and causality were not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Case number PHEH2014US018095, is an initial spontaneous report from a pharmacist received on 08 Sep 2014. This report refers to a 50-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly in arm on 03 Sep 2014. Post vaccination, she experienced pain and discomfort right away in the vaccination site and she said that the vaccination hurt. The event probably started and just continued and the pain went down her whole arm. The final outcome of the event was unknown. The seriousness and causality of the events were not reported.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cough, Fatigue, Influenza like illness, Muscle fatigue
Clinical narrative: Case number PHEH2014US018299 is an initial spontaneous report received from consumer (who is the patient) on 10 Sep 2014, with a follow up consumer on 30 Oct 2014. This report refers to a 38 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 01 Sep 2014. On the same day 04 hours after vaccination, he experienced flu like symptoms for 10 days. The symptoms were described as tiredness, weakness, tired muscle feeling, runny nose and cough. The first two days of the event were worst and after that he was a little better. The final outcome was reported as unknown. The seriousness and causality were not reported. Non-significant follow up received from consumer on 30 Oct 2014: updated nurse contact information only.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Case number PHEH2014US018299 is an initial spontaneous report received from consumer (who is the patient) on 10 Sep 2014, with a follow up consumer on 30 Oct 2014. This report refers to a 38 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 01 Sep 2014. On the same day 04 hours after vaccination, he experienced flu like symptoms for 10 days. The symptoms were described as tiredness, weakness, tired muscle feeling, runny nose and cough. The first two days of the event were worst and after that he was a little better. The final outcome was reported as unknown. The seriousness and causality were not reported. Non-significant follow up received from consumer on 30 Oct 2014: updated nurse contact information only.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHEH2014US018540, is an initial spontaneous report from a pharmacist received on 15 Sep 2014 and with a follow up information received from the pharmacist on 22 Oct 2014 and a follow up report from the physician received on 05 Nov 2014. This report refers to a 49 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into arm on 31 Aug 2014. On 01 Sep 2014, one day after vaccination, she started experiencing pain and was unable lift her arm completely. Outcome of the events was reported as ongoing at the time of this report. Seriousness and causality of the events was not reported. Reporter stated that they do not administer FLUVIRIN at their office and only administer FLUZONE. Reporter also stated that they have a patient with same identifiers but not sure whether this was that patient report. The physician stated that the vaccine was not given in their clinic and due to limited information, it was unable to determine the patient. Follow up information received from the pharmacist on 22 Oct 2014: Updated reporter comment in the narrative. Follow up report from the physician received on 05 Nov 2014: Updated physician's comments regarding the patient in the case.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Case number PHEH2014US018540, is an initial spontaneous report from a pharmacist received on 15 Sep 2014 and with a follow up information received from the pharmacist on 22 Oct 2014 and a follow up report from the physician received on 05 Nov 2014. This report refers to a 49 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into arm on 31 Aug 2014. On 01 Sep 2014, one day after vaccination, she started experiencing pain and was unable lift her arm completely. Outcome of the events was reported as ongoing at the time of this report. Seriousness and causality of the events was not reported. Reporter stated that they do not administer FLUVIRIN at their office and only administer FLUZONE. Reporter also stated that they have a patient with same identifiers but not sure whether this was that patient report. The physician stated that the vaccine was not given in their clinic and due to limited information, it was unable to determine the patient. Follow up information received from the pharmacist on 22 Oct 2014: Updated reporter comment in the narrative. Follow up report from the physician received on 05 Nov 2014: Updated physician's comments regarding the patient in the case.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Case number PHEH2014US018544, is an initial spontaneous report received from a consumer (patient) on 12 Sep 2014. This report refers to an adult female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscular on 09 Sep 2014. The patient reported that her arm swelled up the next day on 10 Sep 2014. Pharmacist told her to take ibuprofen. She still had a quarter red spot at the injection site and it was a little sore. She had a high tolerance for pain, but it was hurting a little bit. Final outcome of the events, seriousness and causality assessment was not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHEH2014US018695, is an initial spontaneous report received from a consumer on 16 Sep 2014 and with a follow up information received from the physician on 10 Nov 2014. This report refers to a 38 years old female patient. Her medical history included allergic to neomycin. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly at a dose of 0.5 ml in right deltoid on 09 Sep 2014 at 11.30 AM. On 10 Sep 2014, in morning she presented with two hives inferior to the injection site on either side lasted for 3 days. The physician reported that he had no information that the patient had reaction with vaccine. The final outcome of the event was reported as unknown. The seriousness and causality of the events were not reported. Follow up information received from the physician on 10 Nov 2014: Removed another suspect vaccine (FLUCELVAX). Updated batch number of FLUVIRIN, dose, and site of vaccination and physician comment in the narrative.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2014US018791, is an initial spontaneous report from a pharmacist received on 16 Sep 2014. This report refers to a female patient of an unknown age. Past medical history and concomitant medication was not reported. Her last menstrual date was not reported. This pregnant patient received FLUVIRIN (batch number: unknown) from a multiple dose vial intramuscularly on an unknown date. No adverse event reported following vaccination.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2014US019556 is an initial spontaneous report from the health care professional on 25 Sep 2014. This report refers to a 47-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1411101) intramuscularly on 14 Sep 2014. On 15 Sep 2014, he had fever. On 16 sep 2014, he experienced injection site reactions which were mentioned as itchy, warm to touch, arm swollen and redness. He also had diarrhea. He went to doctor on the same date and went to pharmacy to report. On 17 Sep 2014, he went to emergency room. On an unknown date, the patient recovered from the events. The seriousness and causality of the events were not reported.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Case number PHEH2014US019556 is an initial spontaneous report from the health care professional on 25 Sep 2014. This report refers to a 47-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1411101) intramuscularly on 14 Sep 2014. On 15 Sep 2014, he had fever. On 16 sep 2014, he experienced injection site reactions which were mentioned as itchy, warm to touch, arm swollen and redness. He also had diarrhea. He went to doctor on the same date and went to pharmacy to report. On 17 Sep 2014, he went to emergency room. On an unknown date, the patient recovered from the events. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Case number PHEH2014US019557 is an initial spontaneous report received from a pharmacist on 26 Sep 2014. This report refers to an adult female patient who was in her 20's. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145404) intramuscularly on an unknown date in Sep 2014 (reported as 21 Sep 2014 or 22 Sep 2014). It was reported that after vaccination, on an unknown date in Sep 2014 she experienced heat and rash at the vaccination site. The pharmacist did not know if the rash persists or it has discontinued. The event outcome was unknown. The seriousness and causality were not reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site paraesthesia
Clinical narrative: Case number PHEH2014US019589, is an initial spontaneous report from a pharmacist received on 29 Sep 2014. This report refers to a 46-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1411201) intramuscularly two weeks ago on an unknown date. On 13 Sep 2014, she experienced tingling sensation at injection site. The outcome of the event was unknown. Seriousness and causality was not reported.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site mass, Injection site pruritus, Skin warm
Clinical narrative: Case number PHEH2014US019764 is an initial spontaneous report from the consumer received on 01 Oct 2014. This report refers to a 68-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. On 21 Oct 2013, couple of hours after vaccination her injection site got itchy. At end of the day, her arm felt hot and had a large red circle. When she went to bed at night her arm from her elbow to shoulder was purple/red. She also had lump at the injection site. It was reported that the event redness went away 3 days later and event lump at injection site was still ongoing. The outcome of the remaining events was not reported. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Case number PHEH2014US019836, is an initial spontaneous report received from a consumer (health care professional) on 30 Sep 2014. This report refers to a 64 year old female patient. She was vaccinated with FLUVIRIN (batch number: 1410701) intramuscular on 29 Sep 2014. On the same she developed red blotch at injection site. Outcome of the event, seriousness and causality assessment was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Case number PHEH2014US019842, is an initial spontaneous report received from a health care professional on 30 Sep 2014.  This report refers to a 64 year old female patient. She was vaccinated with FLUVIRIN (batch number: 1410701) intramuscular on 29 Sep 2014. On the same she developed swelling at injection site and entire arm hurts. Outcome of the event, seriousness and causality assessment was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2014US019850 is an initial spontaneous report from the health care professional received on 30 Sep 2014. This report refers to a 54-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1410701) at a dose of 0.5 ml intramuscularly on 29 Sep 2014. On the same date, after vaccination she experienced swelling and tenderness at injection site. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2014US019857 is an initial spontaneous report received from a pharmacist on 01 Oct 2014. This report refers to and adult male patient who was in his 40 to 50s. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 24 Sep 2014. On 28 Sep 3014, he experienced pain and soreness in his arm. The event outcome was unknown. The seriousness and causality were not reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Case number PHEH2014US020030 is an initial spontaneous report received from a pharmacist on 02 Oct 2014. This report refers to a 46 year old female patient. Her current condition included known latex allergy. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. On 01 Oct 2014, after an unknown interval of vaccination, she experienced injection site rash and itching. Final outcome was reported as unknown. Causality and seriousness were not reported.