chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Neck pain, Pain, Vaccination site swelling
Clinical narrative: Case number PHHY2014US094553 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 517063) website on 24 Jul 2014. This report refers to 37-year-old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) for the past 10 years. She was vaccinated with FLUVIRIN (batch number: 13443P) intramuscularly in the left arm on 15 Dec 2013. It was reported that it hurt more than normal immediately after she received the shot. Soreness in the site became so bad that she could not shower, dress, drive or move it without extreme shooting pains down her arm. The pain radiated to her back and neck. She took ibuprofen and used heat on it with no relief. She had a red sore bump at vaccination site and the top of her shoulder. The patient reported that the pharmacist did not give the shot where she was supposed to 2 days later the events became worse. The patient called pharmacist and she was asked to take pain medications and go to doctor if the events did not stop. She went to family physician who prescribed her physical therapy and anti-inflammatory drugs. It was very painful and she had very limited use of her arm. The final outcome of the event was reported as condition unchanged. The events were reported as non-serious. The causality of the event was not reported.
Age: 46.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2014US094023 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 517094) website on 24 Jul 2014. This report refers to a 46-year-old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. The patient was vacationed with FLUVIRIN (batch number: 1310101 intramuscularly in the left arm on 12 Nov 2013. On 12 Nov 2013 after vaccination, the patient had big area above vaccination site which was red and painful. Redness resolved in 2 days and pain persisted. It was reported that any movement that involved the left arm was painful. The final outcome of the event was reported as condition unchanged. The events were reported as non-serious. The causality of the event was not reported.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2014US093789 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517193) on 24 Jul 2014. This report refers to a 4 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13415P) in left arm on 19 Dec 2013. It was reported that 2 hours after vaccination she experienced fever with body temperature of 102.6 degree F (39.2 degree C). She was treated with TYLENOL and body temperature decreased to 101.7 degree F (38.7 degree C) within an hour. By 9.00 PM. temperature returned to normal. The outcome of the event was reported as complete recovery. The event was reported as non-serious. The causality of the event was not reported.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pyrexia
Clinical narrative: Case number PHHY2014US093650 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517455) website on 24 Jul 2014. This report refers to a 31-year-old female patient. Past medical history and concomitant medications were not provided. She was vaccinated with FLUVIRIN (batch number: 13472P) intramuscularly into right arm on 17 Dec 2013. On the same day, immediately after vaccination, she experienced fever with body temperature of 100 to 103 degrees Celsius. The event was reported as non-serious. Outcome of the event was reported as unknown. Causality of the event was not reported.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2014US093655 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517499) website on 24 Jul 2014. This report refers to a 35-year-old female patient. Past medical history and concomitant medications were not provided. She received FLUVIRIN (batch number: 1310101) intramuscularly into left arm on 26 Nov 2013. She was pregnant at the time of vaccination. No adverse reaction was reported after vaccination.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2014US093656 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517517) website on 24 Jul 2014. This report refers to a 60-year-old female patient. Past medical history and concomitant medications were not provided. She received FLUVIRIN (batch number: 1345 (as reported)) intramuscularly into left arm on 12 Nov 2013. On an unknown date, post vaccination, she experienced hand numbness, neck, shoulder and arm pain for 2 days. She denied shortness of breath. These events were reported as non-serious. Outcome of the events was reported as recovered. Causality of the events was not reported.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2014US093657 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517558) website on 24 Jul 2014. This report refers to a female patient of an unknown age. Her concurrent conditions included high blood pressure, diabetes and cholesterol. She received FLUVIRIN (batch number: 13392P) intramuscularly on 21 Dec 2013. On the same day, she was also vaccinated with ZOSTAVAX (other manufacturer and batch number: H018798) subcutaneously. On 23 Dec 2013, two days after vaccinations, she started feeling itchiness, pain, redness and swelling at the injection site. These events were reported as non-serious. Outcome of the events was unknown. Causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2014US093658 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517580) website on 24 Jul 2014. This report refers to a 62-year-female patient. Past medical history and concomitant medications were not provided. She received FLUVIRIN (batch number: 13471P) intramuscularly on 10 Dec 2013. On 12 Dec 2013, two days after vaccination, she experienced redness 1 cm above injection site. She had a visit to emergency room due to this event. The event was reported as non-serious. Outcome of the event was reported as recovered. Causality of the event was not reported.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Case number PHHY2014US094054, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517648) website on 24 Jul 2014. This report refers to a 56-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 13455P) in the left arm on 05 Dec 2013. On an unknown date, after vaccination he experienced soreness on upper arm (left). The patient had soreness in arm and lifting the arm was painful. The patient was advised to recheck and schedule appointment with his MD to check if this could be related to immunization. The outcome of the events was unknown. The events reported as non-serious.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Eye pain, Vomiting
Clinical narrative: Case number PHHY2014US094838 is an initial spontaneous report from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number; 517713) website on 24 Jul 2014. This report refers to a 81-year-old female patient. Her medical history included high blood pressure. She was vaccinated with FLUVIRIN (batch number: 1307901) intramuscularly in the left arm on 12 Dec 2013. On the same date, after vaccination she experienced eye pain and redness on one side of face. She began vomiting and was getting weak. The reporter called paramedics and sent her to the ER. The final outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Rhinorrhoea
Clinical narrative: Case number PHHY2014US094420, is an initial spontaneous report from a consumer (patient) via Vaccine adverse event reporting website (VAERS id: 517747) received on 24 Jul 2014. This report refers to a 44 year old male patient. His medical history reported that he was allergic to ampicillin. He had no previous illness. Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 13373P) intramuscular into left arm on 28 Sep 2013. The patient reported that the day after vaccination on 29 Sep 2013, he developed runny nose, coughing and headache. The events were ongoing until 20 Dec 2013. He had no fever and nothing requiring a visit to MD, but believes it was directly related to the vaccine. The final outcome of the events was unknown. Seriousness was not reported.
Age: 46.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Chest discomfort, Injection site pain, Lethargy, Limb discomfort, Neck pain
Clinical narrative: Case number PHHY2014US095150, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517818) website on 24 Jul 2014. This report refers to a 46-year-old female patient. Past medical history and concomitant medication were not provided. She was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly on right arm on 13 Nov 2013. On the same day, she was also vaccinated with INFANRIX (other manufacturer and batch number: 3T549) intramuscularly into left arm. On the same day, post vaccination, she felt a pain in her left arm at site of injection which traveled up to her neck. She stated that she still continues to have this pain at times. She stated that her injection felt very heavy and lethargic for days after the injection. She had tightness in the same side in her chest and felt that the pain was radiating down her left arm as well. She did not feel any of this until she was given the injection. She intends to make a doctor visit. The events were reported as non-serious. Outcome and causality of the events was not reported.
Age: 46.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US095150, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517818) website on 24 Jul 2014. This report refers to a 46-year-old female patient. Past medical history and concomitant medication were not provided. She was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly on right arm on 13 Nov 2013. On the same day, she was also vaccinated with INFANRIX (other manufacturer and batch number: 3T549) intramuscularly into left arm. On the same day, post vaccination, she felt a pain in her left arm at site of injection which traveled up to her neck. She stated that she still continues to have this pain at times. She stated that her injection felt very heavy and lethargic for days after the injection. She had tightness in the same side in her chest and felt that the pain was radiating down her left arm as well. She did not feel any of this until she was given the injection. She intends to make a doctor visit. The events were reported as non-serious. Outcome and causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Case number# PHHY2014US093870, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517853) website on 24 Jul 2014. This report refers to a 64-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1209701) intramuscularly on 31 Oct 2013. On 01 Nov 2013, she experienced itching around the vaccination site area. The outcome of the event was unknown. The event was reported as non-serious. Causality was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Decreased appetite, Dizziness, Headache
Clinical narrative: Case number PHHY2014US094548, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517857) website on 24 Jul 2014. This report refers to a 58-year-old male patient. Past medical history included brain aneurysm. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1310101) intramuscularly into left arm on 25 Dec 2013. On 26 Dec 22013, he developed a swollen ball (soft ball size) to the bottom tricep area of the arm,pain in elbow, stiffness of the arm, stomach upset, headache, dizziness, sweating, loss of appetite, fever and itching. He was referred to emergency room and was on his way to urgent care. The outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Musculoskeletal stiffness, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Case number PHHY2014US094548, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517857) website on 24 Jul 2014. This report refers to a 58-year-old male patient. Past medical history included brain aneurysm. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1310101) intramuscularly into left arm on 25 Dec 2013. On 26 Dec 22013, he developed a swollen ball (soft ball size) to the bottom tricep area of the arm,pain in elbow, stiffness of the arm, stomach upset, headache, dizziness, sweating, loss of appetite, fever and itching. He was referred to emergency room and was on his way to urgent care. The outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Case number# PHHY2014US093960, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517864) website on 24 Jul 2014. This report refers to a 29-year-old female patient. Past medical history included sulfa allergy. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 13464P) intramuscularly into left arm on 22 Dec 2013. On 23 Dec 2013, she experienced widespread rash and itching around injection site. The events were not terribly troublesome. Treatment for the events was rendered with cortisone. The outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Cough
Clinical narrative: Case number# PHHY2014US094435, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517995) website on 24 Jul 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 10 Oct 2013. On 24 Oct 2013, he experienced cough. The outcome of the event was condition unchanged. The event was reported as non-serious. Causality was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US048468 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519321) web site on 14 Apr 2014. This report refers to a 55 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 13475P) intramuscularly into arm on 22 Nov 2013. On the same day after vaccination, her "arm was still hurting". The outcome and causality of the events were not reported. The event was reported as non-serious.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy, Nausea, Pain
Clinical narrative: Case number is initial received from a pharmacist on 15 Jan 2014. This report refers to a 16-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1310301; expiry date: not reported) intramuscularly to left arm on 13 Jan 2014. On 15 Jan 2014 the patient presented with nausea, pain and swollen lymph nodes in armpit of his left arm. Outcome of the events, seriousness and causality were not reported.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US071057, is an initial spontaneous report from a physician via sales representative from Vaccine adverse event reporting website (VAERS id: 519975) received on 09 Jun 2014. This report refers to a 39 year old male patient. His medical history included diabetes mellitus. Concomitant medication was not reported. On 25 Nov 2013, he was vaccinated with FLUVIRIN (batch number: 13453P) and PNEUMOVAX 23 (batch number: J004332) both intramuscular into right arm. On an unknown date post vaccination the patient developed pain, swelling, and erythema at the injection site. The patient was seen in an unspecified emergency room on an unspecified date and received an unspecified antibiotic. On an unknown date, the patient was recovered from the adverse events. The events were reported as non-serious. Causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Rash
Clinical narrative: Case number PHEH2013US026649 is an initial spontaneous report received from a pharmacist on 31 Dec 2013. This report refers to a 61-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13391P) intramuscularly on 16 Dec 2013. One week after vaccination, on 24 Dec 2013, he experienced numbness and tingling in his left arm up to his neck and a rash in his left deltoid area. The pharmacist reported that the symptoms began on 24 Dec 2013 and that it was reported on 31 Dec 2013. The outcome of the event was unknown. The seriousness and causality was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site rash, Paraesthesia
Clinical narrative: Case number PHEH2013US026649 is an initial spontaneous report received from a pharmacist on 31 Dec 2013. This report refers to a 61-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13391P) intramuscularly on 16 Dec 2013. One week after vaccination, on 24 Dec 2013, he experienced numbness and tingling in his left arm up to his neck and a rash in his left deltoid area. The pharmacist reported that the symptoms began on 24 Dec 2013 and that it was reported on 31 Dec 2013. The outcome of the event was unknown. The seriousness and causality was not reported.
Age: 27.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Culture throat, Fatigue, Headache, Mononucleosis heterophile test negative, Oropharyngeal pain
Clinical narrative: Case number PHHY2014US056494 is an initial spontaneous report received from the Vaccine Adverse Event Reporting system (VAERS reference number: 524343) website on 06 May 2014. This report refers to a 27-year-old female patient. She did not have a medical history. her current condition included mild sore throat without fever. Her concomitant medications included MONONESSA and Acyclovir. On 19 Feb 2014, she was vaccinated with FLUVIRIN (batch number: 1310001) along with he sixth dose BOOSTRIX (batch number: N3BE2) intramuscularly in the right arm. On the same day, she was also vaccinated with the first dose of HAVRIX (batch number: 9E2GN) intramuscularly in the left arm. Following the vaccinations, on 20 Feb 2014, she experienced headache, sore throat, fever, fatigue and vomited once. Due to the events she had also visited the emergency room. She underwent mononucleosis heterophile test and streptococcus test which gave negative results. She had a white blood cell count of 10.6. Her throat culture test report pending. The final outcome of the events was unknown. The causality of the events was not reported. The events were reported as non-serious.
Age: 27.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Pyrexia, Streptococcus test negative, Vomiting, White blood cell count increased
Clinical narrative: Case number PHHY2014US056494 is an initial spontaneous report received from the Vaccine Adverse Event Reporting system (VAERS reference number: 524343) website on 06 May 2014. This report refers to a 27-year-old female patient. She did not have a medical history. her current condition included mild sore throat without fever. Her concomitant medications included MONONESSA and Acyclovir. On 19 Feb 2014, she was vaccinated with FLUVIRIN (batch number: 1310001) along with he sixth dose BOOSTRIX (batch number: N3BE2) intramuscularly in the right arm. On the same day, she was also vaccinated with the first dose of HAVRIX (batch number: 9E2GN) intramuscularly in the left arm. Following the vaccinations, on 20 Feb 2014, she experienced headache, sore throat, fever, fatigue and vomited once. Due to the events she had also visited the emergency room. She underwent mononucleosis heterophile test and streptococcus test which gave negative results. She had a white blood cell count of 10.6. Her throat culture test report pending. The final outcome of the events was unknown. The causality of the events was not reported. The events were reported as non-serious.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Case number PHHY2014US056643 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 525286) web site on 06 May 2014. This report refers to an 82 year old male patient. He had no medical history or concomitant medication. He was vaccinated with FLUVIRIN (batch number: 13425P) intramuscularly into right arm on 30 Oct 2013. On 31 Oct 2013, he experienced rash on and off at injection site. The outcome of the event was reported as complete recovery. The event was assessed as non-serious and causality was not reported.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Headache
Clinical narrative: Case number PHHY2014US056651 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 525404) web site on 06 May 2014. This report refers to a 53 year old male patient. His current conditions included high blood pressure, high cholesterol, mild inflammation and heart problem. He was vaccinated with FLUVIRIN (batch number: 1310101) into left arm on 25 Jan 2014. On the same day after one hour of vaccination, he experienced headache and little chest pain. He was taken to emergency room for medical support were blood pressure test was performed (no data given). The outcome of the event was reported as complete recovery. The event was assessed as non-serious and causality was not reported.
Age: 18.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Case number PHHY2014US072158, is an initial spontaneous report from a nurse via Vaccine Adverse Event Reporting website (VAERS ID: 525462) received on 09 Jun 2014. This report refers to an 18 year old female patient. Medical history was not reported. Concomitant medications included Albuterol. On 12 Jan 2012, the patient was vaccinated with the first dose of GARDASIL, (batch number: 669795/1317AA, expiry date: 13 Oct 2013). On 12 Mar 2012, the patient received the second dose of GARDASIL, (batch number: 671006/1291AA, expiry date: 12 Apr 2014). She was also vaccinated with HAVRIX, (batch number: unknown, other manufacturer) and FLUVIRIN, (batch number: unknown) on 12 Jan 2012. The nurse reported that the patient was spotting monthly since Nov 2011 and on an unspecified date about 3 weeks ago (approximately on 28 Mar 2012), the normal monthly spotting did not occur. Subsequently, the patient was found to be pregnant. Ultrasound and fetal heart sounds were performed on an unknown date (approximately in 2012). Her last menstrual period was approximately on 16 Nov 2011. She was presently 22 weeks pregnant and her estimated delivery date was on 22 Aug 2012. The patient sought unspecified medical attention. Information was received on 27 Feb 2014. Telephone attempts to obtain follow-up information on 25 Feb 2014 and on 27 Feb 2014 were unsuccessful. Information was received on 04 Mar 2014. The pregnancy outcome was reported as normal infant with no congenital anomaly. Seriousness and causality assessment was not reported. No more details provided.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Case number PHHY2014US056550, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 525489) website on 06 May 2014. This report refers to 54 year old male patient. His medical history was not reported. Concomitant medication included DIOVAN. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscular into right arm on 11 Dec 2013. On 12 Dec 2013, he experienced shoulder joint pain. Outcome of the event was condition unchanged. Seriousness and causality assessment was not reported.
Age: 33.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Headache
Clinical narrative: Case number PHHY2014US056638 is an initial spontaneous report received from a nurse via Vaccine Adverse Event Reporting System (VAERS, reference number: 525847) website on 06 May 2014. This report refers to a 33-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 13411P) intramuscularly into left arm on 14 Mar 2014. On the same day, she was also vaccinated with MMR II (other manufacturer and batch number: J003787) subcutaneously into right arm and VARIVAX (other manufacturer and batch number: J007350) subcutaneously into left arm. On the same day, post vaccination, she experienced mild headache. No shortness of breath, rashes and tingling sensation were reported as per nurse. She was advised to wait for another 30 minutes for further symptoms of adverse reactions. No other adverse reactions were noted and she was discharged home. Advised patient if there were any other symptoms such shortness of breath, tingling sensations, rashes, severe headache to proceed to emergency. The event was reported as non-serious. Outcome of the event was reported as recovered.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2014US071833 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 526145) web site on 09 Jun 2014. This report refers to a 59-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly into left arm on 16 Oct 2013. On the same day after vaccination, she experienced itching, swelling and redness at injection site. The outcome for itching at injection site was complete recovery and for redness at injection site was condition improving. Outcome for swelling at injection site was not reported. Event was reported as non serious and causality was not reported.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Case number PHHY2014US071253 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 527404) website on 09 Jun 2014. This report refers to a 57-year-old male patient. He had no known allergies. His concurrent conditions included gastritis and aches. He was vaccinated with FLUVIRIN (batch number: 008011A) intramuscularly into right arm on 27 Mar 2014. On the same day, he was also vaccinated with ADACEL (other manufacturer, and batch number: UA4837AA) intramuscularly into left arm. On 28 Mar 2014, one day after vaccinations, he experienced local reactions described as mild swelling and pain at deltoid area and was treated with ibuprofen and bacitracin. The events were reported as non-serious. Outcome of the events was reported as recovered. Causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2014US071190, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 527813) website on 09 Jun 2014. This report refers to a 29-year-old female patient. Past medical history included tenderness at site of injection. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 13464P) intramuscularly into the arm on 22 Feb 2014. On the same day after vaccination, she experienced pain at site of injection. Also she had pain lifting her arm, feels pain on her fingertips and tingle on her fingertips. The outcome of the events was condition unchanged. The events were reported as non-serious. Causality was not reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2014US081746 is an initial spontaneous report received from vaccine adverse event reporting system web site (VAERS reference number: 530731) on 01 Jul 2014. This report refers to a 37 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly into her left arm on 29 Sep 2013. On 30 Sep 2013, she had soreness at the injection site and then pain down her arm. She had difficulty twisting or lifting her arm. After a few months, the pain had moved to back of her neck and shoulder area. She was not seen by a physician. The outcome of the events was condition unchanged. The events were reported as non-serious and the causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain
Clinical narrative: Case number PHHY2014US099635, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 531233) website on 08 Aug 2014. This report refers to a 60 year old female patient. Her current conditions included diabetes and her past medical history included heart disease. her concomitant medications were not reported. On 13 Dec 2013, she was vaccinated with FLUVIRIN (batch number: 1309501) intramuscularly into her left deltoid. On 19 may 2014, the patient stated to the reporter that she developed a lump on her arm at the vaccination site. The lump was palpable about 2 mm in size and was only visible when the patient flexed the arm muscle. The lump was painful at time and interfered in her range of motion. When the reporter touched the lump, the patient did not show any signs of pain. The outcome of the events was unknown. The events were assessed as non serious and the causality of the events was not reported.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac discomfort, Pruritus
Clinical narrative: Case number PHHY2014US099419, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAER reference number: 531408) website on 08 Aug 2014. This report refers to a 79-year-old female patient. past medical history included high cholesterol and thyroid. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: not reported) on 01 Oct 2013. On the same day a few hours after vaccination, she felt like some electrical things going on within her heart and the next morning it happened again but not after that. She does not know if she was allergic to latex or rubber. She itches when she takes her tube socks off. She was getting the flu shot for over 50 years without side effects. The final outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the MAH. Causality was not reported.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2014US100404, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 532559) website on 08 Aug 2014. This case refers to a 77-year-old female patient. Her concurrent condition included severe arthritis. She was vaccinated with FLUVIRIN (batch number: 138001) on 01 Oct 2013. On 04 Oct 2013, three days after vaccination, she experienced fever of 100.3 degrees Fahrenheit for about four days. She also experienced severe shoulder pain (both shoulders), headache, chills, weakness and pain in leg. She had seen doctor due to these events. Events began to recover after two weeks. These events were reported as non-serious. Final outcome of the events was reported as recovered. Causality of the events was not reported.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site discharge, Injection site rash, Injection site scab
Clinical narrative: Case number PHHY2014US100155, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 533931) website on 08 Aug 2014. This report refers to a 60-year-old male patient. Her historical drug included sulfa antibiotics. On 19 Sep 2013, he was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly in the left arm along with ZOSTAVAX (batch number: J002240) subcutaneously in the left arm. On 01 Apr 2014, approximately 6 months after vaccinations he noticed a nickle-sized rash to the left arm where injection was given, this rash grew and became weepy. it was now crusting over. The patient visited the emergency room. The outcome of the events reported as not recovered. The events reported as non-serious. The causality of the events reported as suspected with ZOSTAVAX injection. The causality of the events with regard to FLUVIRIN injection was not reported.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Case number PHHY2014US110217, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 536128) website on 27 Aug 2014. This report refers to a 31 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 13461P) intramuscular into right arm on 12 Dec 2013. On 13 Dec 2013, he experienced shoulder pain. he was using cortisone shots for the event. He went to the emergency room. The physician claimed that the event was due to the flu vaccine. The outcome of the event was condition unchanged as on 03 Jul 2014. Seriousness and causality assessment was not reported.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Muscle spasms
Clinical narrative: Case number PHHY2014US135585, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 537518) website on 10 OCT 2014. This report refers to a 68-year-old male patient. Concurrent conditions included high blood pressure, cholesterol, gout and diabetes. Concomitant medications included carvedilol, amlodipine and atorvastatin. The patient sibling was vaccinated with H1N1 influenza vaccine (manufacturer and batch number: not reported) and experienced anaphylaxis (see case: PHHY2014US135587). the patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410901) into the right arm along with Pneumovax (batch number: K004280) into the left arm intramuscularly on 23 JUL 2014. On the same day after vaccination, he had neck spasms which progressed to lower back spasms with blood pressure elevating to 190/90. After approximately 10 minutes of resting, spasms ceased and blood pressure decreased to 160s. He was monitored and at 8:00 PM the patient stated that he had no symptoms and the blood pressure had returned to 120s as tested on home blood pressure monitor. The final outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the MAH. Causality was not reported.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, TDAP, VARZOS
Symptoms: Blister, Erythema, Local swelling, Pruritus
Clinical narrative: Case number PHHY2014US137605, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 538077) website on 10 OCT 2014. This report refers to a 72-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001) into the right arm intramuscularly along with Pneumovax (batch number: J010654) intramuscularly into the right arm, Boostrix (batch number: 4JL44) intramuscularly into the left arm and Zostavax (batch number: J008436) subcutaneously into the left arm on 28 JUL 2014. On the same day after vaccination, he experienced localized swelling on his right arm that was very red and itching. On 29 JUL 2014, one day after receiving the vaccination, he developed blisters in the right arm. He was instructed to use cold compress, Benadryl 25 mg, and Tylenol 500 mg. He was also instructed to see a physician but he refused. The final outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal pain upper, Chills, Erythema, Headache, Muscle spasms
Clinical narrative: Case number PHHY2014US137656, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 538442) website on 10 OCT 2014. This report refers to a 38-year-old female patient. Historical conditions were not reported. Current illness was none. Concomitant medications included Zofran and Percocet. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) into the right arm intramuscularly along with Pneumovax (batch number: J00507) intramuscularly into the right arm on 24 JUL 2014. On the same day after vaccination, within 15 to 30 minutes she was throwing up. In the night ambulance was called to take her to emergency room. She was nauseous, had stomach pain, headache, muscle cramps, chills and arm tingling. She came to pharmacy on 27 JUL 2014 at about 5:30 PM and her arm was still visibly red and swollen. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Paraesthesia, Peripheral swelling, Vomiting
Clinical narrative: Case number PHHY2014US137656, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 538442) website on 10 OCT 2014. This report refers to a 38-year-old female patient. Historical conditions were not reported. Current illness was none. Concomitant medications included Zofran and Percocet. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) into the right arm intramuscularly along with Pneumovax (batch number: J00507) intramuscularly into the right arm on 24 JUL 2014. On the same day after vaccination, within 15 to 30 minutes she was throwing up. In the night ambulance was called to take her to emergency room. She was nauseous, had stomach pain, headache, muscle cramps, chills and arm tingling. She came to pharmacy on 27 JUL 2014 at about 5:30 PM and her arm was still visibly red and swollen. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Breast tenderness, Chills, Fatigue, Hyperaesthesia, Induration
Clinical narrative: Case number PHHY2014US138031 is an initial spontaneous report received from a health care professional via vaccine Adverse Event Reporting System (VAERS ID: 539474) on 10 OCT 2014. This report refers to a 58-year-old female patient. Her past medical history or concomitant medications were not reported. On 04 AUG 2014, she was vaccinated with FLUVRIN 2014/2015 (batch number: 145001) intramuscularly into her left arm and with Zostavax (other manufacturer, batch number K000995) subcutaneously into her right arm. On the same day after the vaccinations, her breast area was tender. Her arm at the site of injection was very tender and was on fire which began as a round hard spot and became a large hard sot. The reaction spread to arm pit areas. The patient felt sluggish and tired. Her skin was sensitive to touch around injection area. She also had chills. She visited the emergency room on an unspecified date. The outcome of the events was unknown. The events were reported as non-serious and causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Sluggishness
Clinical narrative: Case number PHHY2014US138031 is an initial spontaneous report received from a health care professional via vaccine Adverse Event Reporting System (VAERS ID: 539474) on 10 OCT 2014. This report refers to a 58-year-old female patient. Her past medical history or concomitant medications were not reported. On 04 AUG 2014, she was vaccinated with FLUVRIN 2014/2015 (batch number: 145001) intramuscularly into her left arm and with Zostavax (other manufacturer, batch number K000995) subcutaneously into her right arm. On the same day after the vaccinations, her breast area was tender. Her arm at the site of injection was very tender and was on fire which began as a round hard spot and became a large hard sot. The reaction spread to arm pit areas. The patient felt sluggish and tired. Her skin was sensitive to touch around injection area. She also had chills. She visited the emergency room on an unspecified date. The outcome of the events was unknown. The events were reported as non-serious and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Case number PHHY2014US138042 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS ID: 539532) on 10 OCT 2014. This report refers to a female patient of an unspecified age. Her past medical history and concomitant medications were not reported. On 07 AUG 204, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 145203) intramuscularly into her arm. On 08 AUG 2014, her arm was swollen and she was unable to lift her arm up. The patient completely recovered from swollen arm on an unspecified date and from unable to lift her arm after five days on onset. The events were reported as non serious and the causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Skin disorder
Clinical narrative: Case number PHHY2014US136248 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 539780) website on 10 OCT 2014. This report refers to a 65-year-old female patient. Her medical history included blood transfusion. Concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145001B) intramuscularly along with Zostavax (batch number: K000325, other manufacturer) subcutaneously, both into left arm on 11 AUG 2014. On 12 AUG 2014, within 24 hours after vaccinations, she experienced quarter-sized tough area on the skin at the injection site. Within 48 hours the area became large, red, and inflamed. It was reported that the events resolved on its own with Benadryl. Outcome of the events was reported as recovered. These events were reported as non-serious. Causality of the events was not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Case number PPHEH2014US018809, is an initial spontaneous report from a pharmacist received on 18 SEP 2014 with a follow up report received from the pharmacist on 20 OCT 2014. This report refers to a 40 year old female patient. Past medical history and concomitant medications were not reported. Past vaccination included administration of Afluria (other manufacturer, batch number: unknown) into left arm and experienced swollen lymph nodes on left side (reported as last year) and vaccination with influenza vaccine (unknown manufacturer, batch number: not reported) on an unspecified date. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145603) at a dose of 0.5 ml intramuscularly into right deltoid on 15 SEP 2014, at 11:00 AM. On the same day, at about 9:00 PM, she had swollen lymph nodes on right side and pain in the right side. The patient completely recovered from the events. Seriousness and causality of the event were not reported.  Follow up report was received from the pharmacist on 20 OCT 2014. Updated vaccine history (influenza vaccine), dose, anatomical site of vaccination, date and time of the FLUVIRIN 2014/2015 administration, outcome of the event and time of onset of the event. Added new event pain in right side.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Blood pressure decreased, Chronic fatigue syndrome, Dizziness, Heart rate increased
Clinical narrative: Case number PHHY2014US170414, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547879) website on 29 Dec 2014, with the follow up information received from Quality Assurance Department on 12 Jan 2015. This report refers to an 11 year old female patient. Her medical history was not reported. Concomitant medication included amoxicillin. On 25 Sep 2013, she was vaccinated with MENVEO (batch number: unknown) into arm. On the same day she also received GARDASIL (batch number: J002641, other manufacturer) and BOOSTRIX (batch number: N4352, other manufacturer) both into arm. On 01 Nov 2013, she developed postural orthostatic tachycardia syndrome (POTS) treated with salt tabs and FLORINEF, syncope, chronic fatigue syndrome, migraines treated with doxepin, ferritin deficiency treated with iron supplement, vitamin D deficiency treated with vitamin D supplement, insomnia, abdominal pain, nausea and dizziness. Lab data reported as tilt table test patient fainted on minute 13 of tilt when blood pressure was at 39/36, pulse went to a high of 152; ferritin in blood was 8 and Vitamin D 17. She went to the emergency room. Outcome of the events was condition unchanged. Events were reported as serious (permanent disability). Causality assessment was not reported. Upon on FU from QA department, it stated that, the reported batch number: U4511AA for MENVEO is invalid. Therefore, no investigation will be performed for unknown batch number. Follow up information received from Quality Assurance Department on 12 Jan 2015: Upon on FU from QA department, it stated that, the reported batch number: U4511AA for MENVEO is invalid. Therefore, no investigation will be performed for unknown batch number.