chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Impaired work ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2014US171313 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 546553) website on 29 Dec 2014. This report refers to a 50 year old female patient. Her past medical history and concomitant medications were not reported. On 21 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 145303) intramuscularly into her right deltoid. On 22 Sep 2014, she had extreme soreness that began at the site of injection then extended down to her arm to her wrist, over her shoulder, down her back and along her ribcage. She was in terrible pain and could not reach her arm up over her head. It was not getting better even though she took some naproxen to help with the inflammation. The patient was interfering with her working at her job. The final outcome of the events was condition unchanged. The events were reported as non serious but and causality of the events was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Case number PHHY2014US171313 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 546553) website on 29 Dec 2014. This report refers to a 50 year old female patient. Her past medical history and concomitant medications were not reported. On 21 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 145303) intramuscularly into her right deltoid. On 22 Sep 2014, she had extreme soreness that began at the site of injection then extended down to her arm to her wrist, over her shoulder, down her back and along her ribcage. She was in terrible pain and could not reach her arm up over her head. It was not getting better even though she took some naproxen to help with the inflammation. The patient was interfering with her working at her job. The final outcome of the events was condition unchanged. The events were reported as non serious but and causality of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling of body temperature change, Myalgia
Clinical narrative: Case number PHHY2014US171640 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 546636) on 29 Dec 2014. This report refers to a 62 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145902) and PNEUMOVAX (other manufacturer, batch number: K007822); both vaccines administered in the left arm on 26 Sep 2014. On 26 Sep 2014, he experienced fatigue, soreness in joints and muscles of entire body, dizziness for more than 3 days, shaking and he was feeling hot and cold. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Case number PHHY2014US171640 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 546636) on 29 Dec 2014. This report refers to a 62 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145902) and PNEUMOVAX (other manufacturer, batch number: K007822); both vaccines administered in the left arm on 26 Sep 2014. On 26 Sep 2014, he experienced fatigue, soreness in joints and muscles of entire body, dizziness for more than 3 days, shaking and he was feeling hot and cold. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fatigue, Hypersomnia, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US171660, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 546991) website received on 29 Dec 2014. This report refers to a 68-year-old female patient. Past medical history included elevated cholesterol, hypothyroidism and osteoporosis. The patient was allergic to LEVAQUIN and latex. This polymedicated patient was vaccinated with FLUVIRIN (batch number: not reported) along with PNEUMOVAX (batch number: not reported) on 06 Oct 2014. On the same day within 15 minutes after vaccination, the patient felt light-headed and a little sick. Within two hours, she could barely lift arm; had pain and swelling at the injection site and the sick feeling continued in the evening. The patient slept for 10 hours something she never does. On 07 Oct 2014, the patient felt very lethargic and slept again for 5 hours in the afternoon. On 08 Oct 2014, the patient felt somewhat better in her arm but was still totally exhausted. The final outcome of the events was not recovered. The events were reported as non-serious. Causality was not reported.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lethargy, Malaise, Mobility decreased
Clinical narrative: Case number PHHY2014US171660, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 546991) website received on 29 Dec 2014. This report refers to a 68-year-old female patient. Past medical history included elevated cholesterol, hypothyroidism and osteoporosis. The patient was allergic to LEVAQUIN and latex. This polymedicated patient was vaccinated with FLUVIRIN (batch number: not reported) along with PNEUMOVAX (batch number: not reported) on 06 Oct 2014. On the same day within 15 minutes after vaccination, the patient felt light-headed and a little sick. Within two hours, she could barely lift arm; had pain and swelling at the injection site and the sick feeling continued in the evening. The patient slept for 10 hours something she never does. On 07 Oct 2014, the patient felt very lethargic and slept again for 5 hours in the afternoon. On 08 Oct 2014, the patient felt somewhat better in her arm but was still totally exhausted. The final outcome of the events was not recovered. The events were reported as non-serious. Causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness postural
Clinical narrative: Case number PHHY2015US171603, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547324) website on 29 Dec 2014. This report refers to a 53 year old female patient. Medical history and concomitant medication was not reported. On 18 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1412301) intramuscular into right arm. On 19 Sep 2014, she experienced dizziness upon rising from bed that continued entire day and worsened on 20 Sep 2014. She went to urgent care. Lab data reported blood work and computerized tomogram (CAT) scan was negative. Outcome of the event was condition unchanged as of 09 Oct 2014. Causality assessment was not reported. Event was reported as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Case number PHHY2014US171605, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547330) website on 29 DEC 2014. This report refers to a 53 year old female patient. Historical drug included Cipro. Medical history and concomitant medication was not reported. On 06 OCT 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412701) intramuscularly into left arm. On 07 OCT 2014, she experienced swelling in arms and bruising. She went to emergency room. Final outcome of the events was unknown as of 09 OCT 2014. Causality assessment was not reported. Event was reported as non-serious.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache, Malaise, Pain in extremity
Clinical narrative: Case number PHHY2014uS171592, is an initial spontaneous report received from the vaccine adverse events reporting system VAERS reference number: 547414) on 29 Dec 2014. This report refers to a 31 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 146303) intramuscularly in right arm on 09 Oct 2014. On same day post vaccination she experienced abdominal discomfort, headache, malaise and pain in arm. The outcome of the event was not reported. The events were reported as non-serious and causality of the event was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Inflammation
Clinical narrative: Case number PHHY2014US171508, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547438) website on 29 Dec 2014. This report refers to a 67-year-old female patient. Concomitant drug included herbal CA (unspecified). She was vaccinated with FLUVIRIN (batch number: 66521011710) intramuscularly on 07 Sep 2014. On 11 Sep 2014, she experienced fatigue. On an unknown date, few days after vaccination she had severe joint pain. On 30 Sep 2014, the doctor prescribed naproxen 500 mg for pain and inflammation. It showed no result and hence she went to the doctor on 08 Oct 2014 and her blood was drawn and she received a steroid shot. The event joint pain ended with the steroid shot. The outcome of the events inflammation, pain and fatigue were not reported. The events reported as non-serious. The causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Lymphadenopathy
Clinical narrative: Case number PHHY2014US171673, is an initial spontaneous report received from the vaccines adverse events reporting system (VAERS reference number: 547522) on 29 Dec 2014. This report refers to a 37 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in left arm on 09 Oct 201. On 11 Oct 2014, she presented with swollen glands in left side of neck and sore collarbone. The outcome of the events was reported as unknown. The events were reported as non-serious and causality of the events was not reported.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2014US171675, is an initial spontaneous report received from the vaccines adverse events reporting system (VAERS reference number: 547545) on 29 Dec 2014. This report refers to a 40 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 14584P) intramuscularly in right arm on 03 Dec 2014. On same day after vaccination, he experienced pain in arm, shoulder and back. The outcome of the event was reported as unknown. The events were reported as non-serious and causality of the events was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dry skin, Erythema, Pruritus, Rash, Skin exfoliation
Clinical narrative: Case number PHHY2014US171540, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547582) website on 29 Dec 2014. This report refers to a 54-year-old female patient. Current condition included hypoglycemia. She was vaccinated with FLUVIRIN (batch number: 1411201) in the right arm intramuscularly on 04 Sep 2014. On an unknown date, approximately 4 days after vaccination she experienced neck rash, itchy and red face, skin peeling and very dry. The patient visited the emergency room. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US171564, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547583) website on 29 Dec 2014. This report refers to a 58-year-old female patient. Concomitant drug included Aspirin. She was vaccinated with FLUVIRIN (batch number: 1412601) in the right arm intramuscularly on 19 Sep 2014. On the same date, 30 seconds after vaccination her arm bruised (11 inch diameter) and swelled (1/2 inch raised) at injection site. Approximately 4 hours later, the patient returned and some swelling had gone down and stated that it was sore at the injection site but had no other problems. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Case number PHHY2014US171616, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547618) website on 29 Dec 2014. This report refers to a 77-year-old female patient. Her current condition included sore arm. Concomitant drugs included alprazolam and STOVITE ONE. She was vaccinated with FLUVIRIN (batch number: 145684) in the right arm on 18 Sep 2014. On 19 Sep 2014, she experienced soreness and bruising at right upper arm (site of injection). The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Amniocentesis normal, Exposure during pregnancy, Pain in extremity, Premature labour, Ultrasound antenatal screen normal
Clinical narrative: Case number PHHY2014US159783, is an initial spontaneous report received from a nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 547664) website on 28 Nov 2014. This report refers to a 29-year-old female pregnant patient. The patient obstetric history included previous full-term pregnancies with outcomes of two normal live births. There was no maternal and paternal history which would impact the outcome of the current pregnancy. The patient was not using contraception and the type of conception was normal. Concomitant medication included RHO (D) immune globulin, thyroxine sodium, metoclopramide hydrochloride and iron salt. Ultrasound examination on 28 Jun 2013, 16 Aug 2013 and 04 Sep 2013, revealed there was no evidence of defect from prenatal testing and amniocentesis in 2013 (dates unspecified) were normal. She was vaccinated with FLUVIRIN (batch number: 1308101) along with KINRIX (batch number: Y3EM3) during the third trimester of pregnancy on 22 Nov 2013. On the same day after vaccination, the patient experienced sore arm and increased fetal movement. Increased fetal movement stopped on 23 Nov 2013. It was reported that patient had preterm labor one week after the vaccination, approximately on 29 Nov 2013 and the patient never had this problem with any other pregnancies. The gestational age at the time of vaccination was 30 weeks. The date of last menstrual period was not reported. The estimated date of delivery was 26 Jan 2014. The patient delivered. The outcome of the pregnancy was live birth with no apparent congenital anomaly. The patient experience was related to erroneous/accidental administration of KINRIX when she should have received BOOSTRIX (wrong vaccine administered). The nurse reported that the patient had received the suspect products previously and then clarified by stating that the patient should have already received booster shot before. The nurse stated that the events were not life-threatening, did not involve severe or permanent disability, hospitalization, congenital anomaly and did not jeopardize the patient or require intervention. The final outcome of the events was complete recovery. The nurse considered the events to be non serious. Causality was not reported.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Vomiting
Clinical narrative: Case number PHHY2014US171646, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547681) website on 29 Dec 2014. This report refers to a 07-year-old female patient. Current conditions included asthma, tooth infection and had a head cold for 5 days. Concomitant drugs included 80 mg QVAR inhaler 2 pumps two times a day and amoxicillin. She was vaccinated with FLUVIRIN (batch number: not reported) in the left arm intramuscularly on 12 Oct 2014. On the same date, after vaccination she experienced upset stomach and vomiting for 6 hours. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Hypoaesthesia, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Case number PHHY2014US171606 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 547719) on 29 Dec 2014. This report refers to a 42 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly in the left arm on 03 Oct 2014. On 04 Oct 2014, she experienced numbness in left arm, minimum movement of arm, weak muscle and pain in left arm. She went to emergency room and saw physician thrice for pain. It was reported that shot was given high on arm which caused inflammation in joint area. The events outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2014US171695 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 547898) on 29 Dec 2014. This report refers to a 66 years old female patient. Her current conditions included chronic pain, anxiety and allergy to acetylsalicylic acid (ASA), codeine and penicillin. Her concomitant medications were NORCO 5/325, levothyroxine 125mcg, Albuterol 0.083%, XOPENEX HFA, fluoxetine 40mg, LUNESTA 3mg, folic acid 1mg, cyclobenzaprine 10mg, alprazolam 0.5mg; trazodone 50mg, hydromorphone 8mg, clonazepam 1mg, estradiol 0.5 ml; hydroxyzine 25mg and Pan. She was vaccinated with FLUVIRIN (batch number: 146502) intramuscularly in right arm and PNEUMOVAX (other manufacturer, batch number: K010522) intramuscularly in the left arm; both vaccines administered on 09 Oct 2014. The next day after vaccination, she presented with swelling and redness on the underside of arm that vaccine was given. There was no reaction at the vaccination site. She was treated with diphenhydramine and ice. Symptoms subsided, but did not completely go away at the date of reporting. The events outcome was reported as condition improving. The events were reported as non-serious. The causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Case number PHHY2014US171496 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 547902) on 29 Dec 2014. This report refers to a 55 years old female patient. She had no known allergies and her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 146304) intramuscularly in the left arm on 10 Oct 2014. On 10 Oct 2014, within 15 minutes of vaccination she experienced immediate muscle soreness mid back. Within 5 hours of vaccination, she had muscle weakness. Muscle weakness was noted for 4 hours and muscle soreness lasted over 12 hours. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Case number PHHY2014US171610 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 547932) on 29 Dec 2014. This report refers to a 55 years old male patient. His current condition included penicillin allergy. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145305) and PNEUMOVAX (other manufacturer, batch number: J014401); both vaccines administered intramuscularly in the left arm on 25 Sep 2014. On the same date, he experienced stiffness in arm, fatigue and he had swelling in bicep area. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Malaise, Pain, Sinus congestion
Clinical narrative: Case number PHHY2015US018538, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 548067) website on 03 Feb 2015. This report refers to a 38-year-old male patient. Medical history and concomitant medications were not reported. On 09 Oct 2014, he was vaccinated with FLUVIRIN (batch number: 1412001), intramuscularly in the left arm. Following the vaccination, on 11 Oct 2014, he experienced body aches, sinus congestion, headache, cough and general malaise. The final outcome of the events was unknown. The seriousness of the events was reported as non-serious. The causality of the event was not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: Case number PHHY2014US159552, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548313) website on 28 Nov 2014. This report refers to a 30 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1413201) intramuscular into left arm on 02 Oct 2014. Within 20-30 minutes after vaccination she felt lightheaded and fainted hitting her head on the floor. When pharmacist arrived she was conscious, alert and aware. Blood pressure (110/80) and blood glucose was normal, no sign of allergic reaction. Emergency team was called and arrived. Events were reported as non-serious. Outcome of the events was completely recovered. Causality assessment was not reported.
Age: 51.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Musculoskeletal discomfort
Clinical narrative: Case number PHHY2014US171649, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549545) website on 29 Dec 2014. This report refers to a 51 year old female patient. Current condition included codeine allergy, thyroid disease and gastro intestinal problems. On 10 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1413301) and BOOSTRIX (batch number: TA279, other manufacturer) both intramuscular. On an unspecified date post vaccination she developed discomfort in left shoulder almost immediately that got worse over the next few days. She went to doctor on 16 Sep 2014, and received oral steroids (unknown) that helped some but pain had continued even with steroid injection and physical therapy. Final outcome of the events was condition unchanged. Causality assessment was not reported. Events were reported an non-serious.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Case number PHHY2014US159561, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549598) website on 28 Nov 2014. This report refers to an 18 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVITIN (batch number: 145404) intramuscular into left arm on 11 Oct 2014. Within5 to 10 minutes after vaccination she experienced lightheaded and dizzy. She fell to floor passed out less than 1 minute. Her pulse was checked (result not reported) and called the emergency team. Patient felt better after some time and refused transport to hospital. Events were reported as non-serious. Outcome of the events was completely recovered. Causality assessment was not reported.
Age: 31.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US170849 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549605) on 29 Dec 2014. This report refers to a 31 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 160234) and HAVRIX (batch number: 59D74); both vaccines administered intramuscularly in the arm on 11 Oct 2014. It was reported that incorrect dose was administered to the patient. The event was reported as non-serious. No adverse events were reported following the maladministration.
Age: 34.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US170846 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549608) on 29 Dec 2014. This report refers to a 34 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 160234) and ENGERIX B (other manufacturer, batch number: N45BR); both vaccines administered on 11 Oct 2014. It was reported that incorrect dose was administered to the patient. The event was reported as non-serious. No adverse events were reported following the maladministration.
Age: 21.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US170809, is an initial spontaneous report received from the vaccines adverse events reporting system (VAERS reference number: 549611) on 29 Dec 2014. This report refers to a 21 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 100234) on 11 Oct 2014. He was also vaccinated with HAVRIX (batch number: 59D74) and ENGERIX (batch number: N45BR) on 11 Oct 2014. No adverse events reported after the maladministration (inappropriate dose of vaccine administered).
Age: 22.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US170962, is an initial spontaneous report received from the vaccines adverse events reporting system (VAERS reference number: 549612) on 29 Dec 2014. This report refers to a 22 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 160234) intramuscularly in arm on 11 Oct 2014. He was also vaccinated with HAVRIX (batch number: 59D74) intramuscularly in arm on 11 Oct 2014. No adverse events reported after the maladministration (inappropriate dose of vaccine administered).
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US170859, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549614) website on 29 Dec 2014. This report refers to a 24-year-old male patient. Historical conditions were not reported. The patient was vaccinated with incorrect dose of FLUVIRIN (batch number: 160234), along with HAVRIX (batch number: 59D74) on 11 Oct 2014. No adverse event was reporting following the maladministration.
Age: 45.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US170873, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549615) website on 29 Dec 2014. This report refers to a 45-year-old female patient. Historical conditions were not reported. The patient was vaccinated with incorrect dose of FLUVIRIN (batch number: 160234), along with ENGERIX-B (batch number: N45BR) on 11 Oct 2014. No adverse event was reported following the maladministration.
Age: 22.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US170876, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549616) website on 29 Dec 2014. This report refers to a 22-year-old male patient. Historical conditions were not reported. The patient was vaccinated with incorrect dose of FLUVIRIN (batch number: 160234), along with ENGERIX-B (batch number: N45BR) on 11 Oct 2014. No adverse event was reported following the maladministration (inappropriate dose of vaccine administered).
Age: 26.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US170877, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549617) on 29 Dec 2014. This report refers to a 26 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 160234), HAVRIX (other manufacturer, batch number: 59D74) and ENGERIX-B (other manufacturer, batch number: N45BR); all vaccines administered intramuscularly in the arm on 11 Oct 2014. It was reported that incorrect dose was administered to the patient. The event was reported as non-serious. No adverse events were reported following the maladministration.
Age: 23.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US170878, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549618) on 29 Dec 2014. This report refers to a 23 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 160234), HAVRIX (other manufacturer, batch number: 59D74) and ENGERIX-B (other manufacturer, batch number: N45BR) on 11 Oct 2014. It was reported that incorrect dose was administered to the patient. The event was reported as non-serious. No adverse events were reported following the maladministration.
Age: 18.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US170879, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549620) on 29 Dec 2014. This report refers to an 18 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 160234) and ENGERIX-B (other manufacturer, batch number: N45BR) on 11 Oct 2014. It was reported that incorrect dose was administered to the patient. The event was reported as non-serious. No adverse events were reported following the maladministration.
Age: 47.0
Sex: M
Vaccine: FLU3, HEP, PPV
Symptoms: Asthenia, Hyperglycaemia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Case number PHHY2014US171494, is an initial spontaneous report received form the Vaccine Adverse Event Reporting System (VAERS reference number: 550128) website on 29 Dec 2014. This report refers to a 47 year old male patient. Medical history and concomitant medication was not reported. On 25 Sep 2014, he was vaccinated with FLUVIRIN (batch number: 1413401) intramuscular. On the same date he also received PNEUMOVAX (batch number K001504, other manufacturer) and ENGERIX-B (batch number: EA3Z2, other manufacturer) both intramuscular. On 27 Sep 2014, he developed hyperglycemia, paresthesia and weakness. Final outcome of the events was unknown. Causality assessment was not reported. Event was reported as non-serious.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site oedema, Pruritus, Swelling
Clinical narrative: Case number PHHY2014US171493, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550435) website on 29 Dec 2014. This report refers to a 41 year old female patient. Medical history and concomitant medication was not reported. On 03 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 161281) into left arm. On the same date post vaccination she developed redness and edema to injection site. At 6 PM she also complained of itching to skin, small red raised areas to arm, shoulder, back and chest. Treatment medication included BENADRYL 25 mg oral. Final outcome of the events was recovered. Causality assessment was not reported. Events was reported as non-serious.
Age: 24.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2014US171327 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 550538) website on 29 Dec 2014. This report refers to a 24 year old male patient. His past medical history and concomitant medications were not reported. On 11 Oct 2014, he was vaccinated with FLUVIRIN (batch number: 160234) at an incorrect dose. He was concomitantly vaccinated with HAVRIX (other manufacturer, batch number: 69D74) and with ENGERIX B (other manufacturer, batch number: N45BR). No adverse events were reported following the medication error.
Age: 20.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2015US171328 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 550547) website on 29 Dec 2014. This report refers to a 20 year old male patient. His past medical history and concomitant medications were not reported. On 11 Oct 2014, he was vaccinated with FLUVIRIN (batch number: 160234) at an incorrect dose. He was concomitantly vaccinated with ENGERIX B (other manufacturer, batch number: N45BR). No adverse events were reported following this medication error.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Musculoskeletal discomfort
Clinical narrative: Case number PHHY2014US171492, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550608) website on 29 Dec 2014. This report refers to a 25 year old female patient. Medical history and concomitant medication was not reported. On 13 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1411301) intramuscular into left arm. On the same date post vaccination she reported possible swelling and discomfort in neck approximately 5 min after immunization. Blood pressure and pulse was normal. She was medicated with 20 mL of Q-DRYL 12.5 mg/5mL. and observed the patient for more than 30 minutes and no change in vitals. Final outcome of the event was recovered. Causality assessment was not reported. Event was reported as non-serious.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Case number PHHY2014US171491, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550613) website on 29 Dec 2014. This report refers to a 59 year old female patient. Medical history and concomitant medication was not reported. On 10 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 146401) intramuscular in to left arm. On an unknown date post vaccination she complained of cramping and muscle spasm in left arm requiring doctor visit. She went to the emergency room. Final outcome of the event was recovered. Causality assessment was not reported. Event was reported as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Musculoskeletal stiffness, Swelling
Clinical narrative: Case number PHHY20114US171490, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550631) website on 29 Dec 2014. This report refers to a 52 year old female patient. Medical history and concomitant medication was not reported. On 30 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 145202) intramuscular into left arm. On the same day she also received PNEUMOVAX (batch number: K006681, other manufacturer) subcutaneous into left arm. On 01 Oct 2014, her arm was stiff and could not move arm and also developed redness size bigger than softball and area was raised. Patient was asked to take BENADRYL TYLENOL or MOTRIN. Final outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Epistaxis, Headache, Oropharyngeal pain, Pain
Clinical narrative: Case number PHHY2014US171635, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550678) website on 29 Dec 2014. This report refers to a 62-year-old female patient. Medical history included gastrooesophageal reflux disease and rhinitis allergic. Concomitant medications included omeprazole. She was vaccinated with FLUVIRIN (batch number: 1411601) intramuscularly into the right arm on 03 Oct 2014. On 06 Oct 2014, the patient experienced Headache (again on 07 Oct 2014 and 08 Oct 2014 with more intensity). On 09 Oct 2014, the patient experienced chills, bloody nose and at 09:00 PM the patient had full body ache and sore throat. On 10 Oct 2014, the patient experienced chest congestion. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Case number PHHY2014US171635, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550678) website on 29 Dec 2014. This report refers to a 62-year-old female patient. Medical history included gastrooesophageal reflux disease and rhinitis allergic. Concomitant medications included omeprazole. She was vaccinated with FLUVIRIN (batch number: 1411601) intramuscularly into the right arm on 03 Oct 2014. On 06 Oct 2014, the patient experienced Headache (again on 07 Oct 2014 and 08 Oct 2014 with more intensity). On 09 Oct 2014, the patient experienced chills, bloody nose and at 09:00 PM the patient had full body ache and sore throat. On 10 Oct 2014, the patient experienced chest congestion. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site oedema, Musculoskeletal stiffness, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2014US163900 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 550692) website on 28 Nov 2014. This report refers to a 73 year old female patient. Her past medical history was not reported and concomitant medications included sumatriptan and torsemide. On 25 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1411101) intramuscularly into her left arm and with PNEUMOVAX (other manufacturer, batch number: K004281) intramuscularly into her right arm. On 26 Sep 2014, she noticed that her arm in which she was vaccinated with PNEUMOVAX was hot and red. It looked like there was fluid build up between the injection site of PNEUMOVAX and her elbow. Her right arm was stiff and sore. She was treated with BENADRYL and with cold compress. The outcome of the events was complete recovery. The events were reported as non serious and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020345 is an initial spontaneous report received from a pharmacist on 07 Oct 2014 with a follow-up received on 14 Oct 2014, and with a follow up report received from pharmacist on 08 Dec 2014 and follow up report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 561313) website on 30 Mar 2015. This report refers to a 63-year-old female patient. Her medical history was not reported. Concomitant medication included CRESTOR for cholesterol, Baby aspirin, calcium and multivitamin. She was vaccinated with FLUVIRIN (batch number: 146401) intramuscularly at a dose of 0.5 ml into left deltoid at 2:50 pm on 06 Oct 2014. It was reported that before vaccination, the FLUVIRIN prefilled syringe reached 355.54 degree Fahrenheit for 1.5 hours. It was further reported that the total excursion was 1.5 hours and the vaccine was administered within that total duration. No adverse event was reported following this administration error. Follow-up received on 14 Oct 2014: Narrative updated with total excursion time and vaccination time (total excursion was 1.5 hours and the vaccine was administered within that total duration). Follow up report received from pharmacist on 08 Dec 2014. Updated patient height and weight and vaccination site. Non significant follow up report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 561313) website on 30 Mar 2015: No new medically significant information was added. VAERS ID was updated.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2013US022427 is an initial spontaneous report from nurse received on 23 Oct 2013 with a follow up received from nurse on 06 Dec 2013. This case refers to a female patient of an unknown age. The pregnant patient received a shot of FLUVIRIN (batch number: not reported) on 10 Oct 2013. No adverse event was reported following this vaccine exposure during pregnancy. Follow up received from nurse on 06 Dec 2013. It was confirmed that patient didn't receive second FLUVIRIN injection as initially reported. Follow up information received 17 Feb 2015: Multiple attempts were made to obtain outcome of event without success. This case is considered lost to follow up. Non significant follow up report received on 01 Apr 2015. No new medically significant information was updated. Non significant follow up report received via Vaccine Adverse Event Reporting System (VAERS reference number: 561718) website on 12 May 2015: Vaers ID updated.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blepharospasm, Disorientation, Disturbance in attention, Dry mouth
Clinical narrative: Case number PHEH2014US022638, an initial spontaneous report received from a healthcare professional (clinical director) on 07 Nov 2014, with a follow up report received from a physician on 19 Jan 2015. This report refers to a 44 years old male patient. His medical history was not reported. Concomitant medication included SYNTHROID via oral route at a daily dose of 137 mcg for the treatment of hypothyroidism. The patient received FLUVIRIN in the past on unknown dates which were well tolerated. He was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly at a dose of 0.5 ml in left deltoid on 07 Oct 2014. It was reported that 1 hour after the shot, he started to feel off and then started to feel numbness at the vaccination site on left arm. He started to feel worse over the next few weeks so much that he would have to consciously think about propping his arm up when at the computer. On an unknown date, his leg started going numb. At about 2 and half weeks, he noticed a large red hematoma about 3 inches at the vaccination site. He also experienced queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and,  arm bruise over injection site. On 31 Oct 2014, no focal neurological issue was noticed and bruising at injection site was fine by that day. At 3.5 weeks, he had sort of balance issues, kind of dizzy and off. He got better, but still had sensations in his arm and leg. He went to doctor, had all blood work which was negative. He did not undergo scans yet. The outcome of queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and, arm bruise over injection site was reported as complete recovery. Queasy sensation and unsteady feeling was resolved by Nov 2014. Outcome of sensations in arm and leg was reported as condition unchanged and that of other events was reported as condition improving. Events were reported as non-serious. Causality was not reported. Follow up report received from a physician on 19 Jan 2015: Updated patient demographics, vaccination history, concomitant medication, vaccination details, new events (queasy sensation, left leg and arm weakness, less attentive and arm bruise over injection site), outcome and seriousness.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Feeling hot, Flushing, Frequent bowel movements, Head discomfort
Clinical narrative: Case number PHEH2014US022638, an initial spontaneous report received from a healthcare professional (clinical director) on 07 Nov 2014, with a follow up report received from a physician on 19 Jan 2015. This report refers to a 44 years old male patient. His medical history was not reported. Concomitant medication included SYNTHROID via oral route at a daily dose of 137 mcg for the treatment of hypothyroidism. The patient received FLUVIRIN in the past on unknown dates which were well tolerated. He was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly at a dose of 0.5 ml in left deltoid on 07 Oct 2014. It was reported that 1 hour after the shot, he started to feel off and then started to feel numbness at the vaccination site on left arm. He started to feel worse over the next few weeks so much that he would have to consciously think about propping his arm up when at the computer. On an unknown date, his leg started going numb. At about 2 and half weeks, he noticed a large red hematoma about 3 inches at the vaccination site. He also experienced queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and,  arm bruise over injection site. On 31 Oct 2014, no focal neurological issue was noticed and bruising at injection site was fine by that day. At 3.5 weeks, he had sort of balance issues, kind of dizzy and off. He got better, but still had sensations in his arm and leg. He went to doctor, had all blood work which was negative. He did not undergo scans yet. The outcome of queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and, arm bruise over injection site was reported as complete recovery. Queasy sensation and unsteady feeling was resolved by Nov 2014. Outcome of sensations in arm and leg was reported as condition unchanged and that of other events was reported as condition improving. Events were reported as non-serious. Causality was not reported. Follow up report received from a physician on 19 Jan 2015: Updated patient demographics, vaccination history, concomitant medication, vaccination details, new events (queasy sensation, left leg and arm weakness, less attentive and arm bruise over injection site), outcome and seriousness.