chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Case number PHHY2016US181039 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 653299) website on 21 Dec 2016. This report refers to 55 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168702) intramuscular into right arm and ZOSTAVAX (batch number: M027117, other manufacturer) subcutaneously into left arm on 12 Sep 2016. On 14 Sep 2016 patient developed rash and itching on arm where vaccine was administered. The outcome of the events was reported as unknown. The seriousness of the events was non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Induration, Pain
Clinical narrative: Case number PHHY2016US181472, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 653420) website on 21 Dec 2016. This report refers to a 62 years old female patient. Past medical history included migraine, brain bleed and vaccination with pneumococcal vaccine (reported as at the age of 40 years) and experienced redness and pain. Current conditions included hypertension (HTN). Concomitant medications were included NORVASC, potassium and almotriptan. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) in left arm on 13 Sep 2016. On the same day after vaccination, the patient experienced pain, redness and induration approximately 1 inch adjacent to injection site, for 24 hrs. The patient was treated with loratadine (10 mg QD) and topical hydrocortisone cream. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 77.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2016US181257, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 653645) website on 21 Dec 2016. This report refers to a 77 years old female patient. Past medical history was not reported. Current conditions included as chronic obstructive pulmonary disease (COPD) and multiple sclerosis (MS). Concomitant medications was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 165803) into right arm intramuscularly on 13 Sep 2016. On 14 Sep 2016, the patient experienced redness and pain at site of injection - also redness and pain approximately 02 inches from site of injection. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 33.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Case number PHHY2016US182348, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 653754) website on 21 Dec 2016. This report refers to a 33 years old female patient. Past medical history was not reported. Concomitant medications included VIIBRYD, tramadol and lamotrigine. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185284) into right arm on 23 Aug 2016. The patient was also vaccinated with ADACEL (other manufacturer, batch number: U5315AA) into left arm on 23 Aug 2016. After vaccination on 30 Aug 2016, the patient experienced worsening pain which was not improving and was like punched in the arm. It was also reported that the arm pain and weakness was continued without improvement for more than 2 weeks. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non-serious and causality was not reported.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: Case number PHHY2016US181477, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 653924) website on 21 Dec 2016. This report refers to a 64-years-old male patient. Past medical history was not reported. Concomitant mediation included AMBIEN, XANAX and PERCOCET. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) intramuscular in left arm on 24 Aug 2016. On an unspecified date after vaccination the patient experienced that the injection site on his left arm was still hurt especially when he raised his arm to take his shirt off. The patient received treatment with ice, ICY HOT and MOTRIN. On 17 Sep 2016 the patient went to pharmacy. At the time the patient presented arm there was no swelling, bruising or infection. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Induration, Pain, Pruritus, Swelling
Clinical narrative: Case number PHHY2016US181996, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 654306) website on 21 Dec 2016. This report refers to a 46 years old female patient. Past medical history was not reported. Current conditions included as cholesterol and blood pressure. Concomitant medications included as BENADRYL, lisinopril and unspecified cholesterol medication. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 185286) Into left arm, intramuscularly on 09 Sep 2016. On the same day after vaccination, the patient experienced swelling, itchy, hard, sore and swollen. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Case number PHHY2016US182234 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 654315) website on 21 Dec 2016. This report refers to 26 year old female patient. Historical condition included thyroid; cholesterol; hydrops (details not reported) and migraines. Concomitant medication included HCTZ and Propranolol. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185286) into right arm on 09 Sep 2016. On the same day, 3:00 PM 1 hour after injection the patient had swollen red painful, warm, 3 cm. The patient was treated with steroids and antihistamine. The outcome of the events was condition unchanged. The seriousness and causality of the events was not reported.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Rash macular
Clinical narrative: Case number PHHY2016US181823, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 654384) website on 21 Dec 2016. This report refers to a 52-years-old male patient. Past medical history and concomitant were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168605) intramuscularly in right arm on 20 Sep 2016. On the same day after vaccination at 13:50, the patient experienced feeling itchy on her arm and had some red blotches on her neck and shoulders hence she came back down to vaccine rooms. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site swelling
Clinical narrative: Case number PHHY2016US181052, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 654407) on 21 Dec 2016. This report refers to a 62 years old female patient. Historical condition was not reported. Current condition included latex allergy and no known drug allergy. Concomitant medication included Clobetasol 0.05% cream. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168605) intramuscularly and ZOSTAVAX ((other manufacturer), batch number: M015925) subcutaneously, both into left arm on 18 Sep 2016. On 20 Sep 2016 after vaccination, the patient experienced itchiness, redness, swelling, hard bulky 2.5 inch rectangular area around site of vaccination. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 54.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Injection site erythema, Pyrexia
Clinical narrative: Case number PHHY2016US181506, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 655336) on 21 Dec 2016. This report refers to a 54 years old male patient. Historical conditions included acid reflux. Current condition included atrial fibrillation and hypertension. Concomitant medication included LIPITOR, Metoprolol, PROTONIX, irbesartan, cyclobenzaprine, fish oil and Aspirin. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185887) and PNEUMOVAX (other manufacturer), batch number: L01225) intramuscularly into left arm on 20 Sep 2016. On 21 Sep 2016 after vaccination, the patient experienced vaccination site pain, redness and fever. It was reported that, the patient was requiring MEDROL dosepak and BENADRYL. The laboratory data revealed, influenza nasal swab test which found to be negative for both A and B. The patient went to emergency room on an unknown date. The outcome of the events was reported as complete recovery on 25 Sep 2016 without the use of antibiotics. The seriousness of the events was reported as non serious and causality was not reported.
Age: 54.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2016US181506, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 655336) on 21 Dec 2016. This report refers to a 54 years old male patient. Historical conditions included acid reflux. Current condition included atrial fibrillation and hypertension. Concomitant medication included LIPITOR, Metoprolol, PROTONIX, irbesartan, cyclobenzaprine, fish oil and Aspirin. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185887) and PNEUMOVAX (other manufacturer), batch number: L01225) intramuscularly into left arm on 20 Sep 2016. On 21 Sep 2016 after vaccination, the patient experienced vaccination site pain, redness and fever. It was reported that, the patient was requiring MEDROL dosepak and BENADRYL. The laboratory data revealed, influenza nasal swab test which found to be negative for both A and B. The patient went to emergency room on an unknown date. The outcome of the events was reported as complete recovery on 25 Sep 2016 without the use of antibiotics. The seriousness of the events was reported as non serious and causality was not reported.
Age: 32.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2016US182010, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655742) website on 21 Dec 2016. This report refers to a 32-years-old male patient. Past medical history included felt like there was wax built up in both ear and left knee injury. Current condition included trouble breathing, asthma and seasonal allergies. Concomitant medications included albuterol, BREO ELLIPTA and NASACORT allergy 24 HR. The patient was vaccinated with FLUVIRIN (batch number: 168804) intramuscularly in right arm on 21 Sep 2016. The patient was also vaccinated with PNEUMOVAX (batch number L017406) intramuscularly in left arm on 21 Sep 2016). On 24 Sep 2016 after vaccination, the patient experienced tenderness at pneumonia injection site, flu-like symptoms, upper arm where pneumonia shot was given was painful, red, swollen and skin was a little hard and redness was about the diameter of a baseball and fever was not reported. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Case number PHHY2016US181850, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system website (VAERS 656022) on 21 Dec 2016. This report refers to a 19-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (lot number: 168802) into left arm intramuscularly on 27 Sep 2016. On 28 Sep 2016, the patient developed headache. The outcome of the event headache was reported as condition unchanged. Seriousness of the event headache was considered as non-serious. The causality of the event headache was not reported.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site swelling
Clinical narrative: Case number PHHY2016US182263 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 656172) website on 21 Dec 2016. This report refers to 8 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 186111) intramuscular into left arm on 28 Sep 2016. On the same day, patient had swollen arm around injection site from shoulder down to elbow. Patient went to doctor/emergency room (date not reported). The patient got steroid shot. The outcome of the event was complete recovery. The seriousness and causality of the event was not reported.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Case number PHHY2016US179460, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656513) on 21 Dec 2016. This report refers to a 16 years old female patient. Medical history was not reported. No current illness and concomitant medication at the time of vaccination. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168605) intramuscularly into right arm on 01 Oct 2016. On same day after vaccination, the patient experienced rash on upper torso, neck, face and scalp. The patient did not have any difficulty breathing. The patient was told to take BENADRYL (which was placed on the shelves) and the patient was asked to visit an urgent care for immediate evaluation. The outcome of the event was reported as unknown. The seriousness of the event was reported as non serious and causality was not reported.
Age: 31.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Case number PHHY2016US181796, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System website (VAERS: 656530) website on 21 Dec 2016. This report refers to a 31-year-old male patient. Historical condition was not reported. Current conditions included allergies to penicillins and allergy to cephalosporins. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186685) and PNEUMOVAX (batch number: M024673) into left arm intramuscularly on 28 Sep 2016. On 01 Oct 2016 the patient experienced swelling and redness advanced quickly. The patient reported to a doctor and treated with doxycycline. Seriousness of the events was reported as non serious. Outcome of the events was unknown. Causality of the events was not reported.
Age: 85.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Erythema
Clinical narrative: Case number PHHY2016US180111, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656534) on 21 Dec 2016. This report refers to a an 85 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168805) intramuscularly into left arm on 21 Sep 2016. The patient was vaccinated with PREVENAR 13 (manufacturer unknown, batch number: N16562) intramuscularly into right arm on 21 Sep 2016. It was reported that the patient visited physician on 25 Sep 2016, because the arm of the patient turned red to the elbow. The physician prescribed antibiotics and anti-inflammatory medications for the treatment. The outcome of the event erythema was not reported. The seriousness of the event was reported as non-serious and causality was not reported.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Case number PHHY2016US182305, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 656762) website on 21 Dec 2016. This report refers to a 45 years old female patient. Past medical history was not reported. Current condition included as bronchitis 02 weeks before. Procedure included as steroid shot 02 weeks prior. Concomitant medication included as ELAVIL. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185888) into left arm, intramuscularly on 27 Sept 2016. On 28 Sep 2016, the patient experienced felt dizzy and lightheaded the morning after injection which worsened for few hours then began to less in intensity. It was reported that, symptoms had gradually reduced since 28 Sep 2016 and currently feels symptoms very slightly. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Case number PHHY2016US182351, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656763) on 21 Dec 2016. This report refers to a 34 years old female patient. Medical history was not reported. Vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) when the patient was 30 years old and experienced redness and swelling (see case: PHHY2016US182377). Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185888) intramuscularly in to left arm on 27 Sep 2016. On 28 Sep 2016 after vaccination, while working the patient smelled strange smell then began to get headache, dizzy, nauseated and then vomited (occurrence 5), continued to feel very tired, no appetite, achy, slight headache and nasal drainage. It was reported that, no cause for odor was found in her work environment. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Parosmia, Rhinorrhoea, Vomiting
Clinical narrative: Case number PHHY2016US182351, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656763) on 21 Dec 2016. This report refers to a 34 years old female patient. Medical history was not reported. Vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) when the patient was 30 years old and experienced redness and swelling (see case: PHHY2016US182377). Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185888) intramuscularly in to left arm on 27 Sep 2016. On 28 Sep 2016 after vaccination, while working the patient smelled strange smell then began to get headache, dizzy, nauseated and then vomited (occurrence 5), continued to feel very tired, no appetite, achy, slight headache and nasal drainage. It was reported that, no cause for odor was found in her work environment. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 54.0
Sex: F
Vaccine: FLUC4, PPV, TD
Symptoms: Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Case number PHHY2016US181446, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656864) on 21 Dec 2016. This report refers to a 54 years old female patient. Historic condition was not reported. Current conditions included diabetes. It was also reported that the patient had no history of drug allergies. Concomitant medication included glimepiride, atorvastatin, levothyroxine and Losartan/HCT. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168605) into left arm, PNEUMOVAX (manufacturer unknown, batch number: M022086) into left arm and TENIVAC (manufacturer unknown, batch number: U5525AA) into right arm intramuscularly on 30 Sep-2016. On the same day after vaccination, the patient experienced fever, headache, injection site pain and redness which started the night of vaccination. It was reported that the patient took CLARITIN and MOTRIN. The outcome of the events was reported as unknown. The seriousness of the events was reported as non-serious and causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2016US180234, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 657429) on 21 Dec 2016. This report refers to a 53 years old female patient. Medical history was reported as fusion in the neck. Concomitant medications included oxycodone and diazepam. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1619601) into left arm and PNEUMOVAX (batch number: I013428) into right arm, both intramuscularly on 29 Sep 2016. On 04 Oct 2016 after vaccination, the patient experienced severe pain in the right arm and it was reported that, the event was considered due to the PNEUMOVAX vaccine. The patient received steroid shot in the arm and MEDROL dose pack. The patient went to emergency room on an unknown date. The outcome was reported as unknown. The seriousness was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLUC4
Symptoms: Feeling cold, Hyperhidrosis, Nausea
Clinical narrative: Case number PHHY2016US182257 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 657455) website on 21 Dec 2016. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185285) intramuscular left arm on 21 Sep 2016. On the same day, the patient experienced nausea, coolness, sweating. The patient had BENADRYL given per protocol, re-evaluated 45 minutes later and was feeling better. The outcome of the events was reported complete recovery. The seriousness and causality of the events was not reported.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Dysgeusia
Clinical narrative: Case number PHHY2016US182319, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS: 657477) website on 21 Dec 2016. This report refers to a 55-year-old male patient. Medical history was not reported. Concomitant medication included DUAVEE. The patient was vaccinated with 7th dose of FLUCELVAX QUADRIVALENT (lot number: 1619801) into left arm intramuscular on 29 Sep 2016. On the same day after vaccination the patient experienced metallic taste in mouth within 20 minutes of vaccine and persisting 5 plus days at this point. Outcome of the event was condition unchanged. Seriousness of the event was reported as non serious. Causality was not reported.
Age: 18.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain, Pyrexia
Clinical narrative: Case number PHHY2016US182230, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 657789) website on 21 Dec 2016. This report refers to an 18 years old male patient. Past medical history was not reported. Concomitant medication included ZYRTEC for seasonal allergies. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1620301) intramuscularly into left arm on 04 Oct 2016. On the same day after vaccination, the patient experienced fever and body temperature 100.6 (normal range and units not reported) and achiness. The patient was administered with altering ibuprofen and TYLENOL every 3 hours. It was reported that the symptoms lasted for 36 hours. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non-serious and causality was not reported.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHHY2016US174231, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 657809) website on 21 Nov 2016. This report refers to a 47 years old female patient. Past medical history included allergy to penicillin, sulfa and antibiotics. Concomitant medications included IVIG (immunoglobulin intravenous). The patient was vaccinated with FLUCELVAX (manufacturer unknown and batch number: 185325A) intramuscularly on 04 Oct 2016. On 06 Oct 2016, the patient experienced large erythema at the site of the injection. She stated that, it was itchy and hot. She denied any fever, chills or shortness of breath (SOB). The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Palpitations, Pruritus, Swollen tongue
Clinical narrative: Case number PHHY2016US179157 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 657963) on 21 Dec 2016. This report refers to a 48 year old female patient. Medical history was not reported. Current condition included latex allergy. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186111) intramuscularly on 04 Oct 2016. Few hours (early afternoon) after vaccination, the patient experienced tongue swelling, heart racing and itchiness on top of the head. She reported to her physician and was seen in emergency room. She was treated with BENADRYL and "home steroids", both to consider BD. It was reported that there was no latex in the cap on packaging and Band-Aid (gauze post vax) or gloves were not used. Also, the hands were sanitized with 65% alcohol. The outcome of the events was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Case number PHHY2016US182349, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 657967) on 21 Dec 2016. This report refers to a 55 years old female patient. Historical conditions included gastroesophageal reflux disease (GERD), insomnia, depression and migraines. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1619401) intramuscularly in to left arm and ZOSTAVAX ((other manufacturer), batch number: M024698) subcutaneously into right arm on 04 Oct 2016. On 05 Oct 2016 after vaccination, the patient developed large red spot where the vaccine had been given, spot was dark red, had defined borders that did not look like a normal rash, the patient stated that it was very itchy and the patient went to the store on 07 Oct 2016. The patient went to the emergency room on an unknown date. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Case number PHHY2016US182314, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 657981) website on 21 Dec 2016. This report refers to a 53 years old female patient. Past medical history was not reported. Current condition included as allergic to sulfa which caused eye swelling. Historical medication included as cannot tolerate azithromycin. Concomitant medication included as only vitamins (per patient). It was reported that, at the time of immunization, patient stated that she did not had any medication allergies. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168702) into right arm, intramuscularly on 04 Oct 2016. On the same day after vaccination, the patient experienced some numbness at the location of vaccination in the deltoid muscle, numbness or feeling funny extends to the back of her scapula when she was driving. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2016US181782 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 658064) website on 21 Dec 2016. This report refers to 59 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 166704) intramuscular into left arm on 17 Sep 2016. On 08 Oct 2016, patient states that they were now 3 week out from vaccine administration and still experiencing injection site pain (left arm). Patient reports pain was evident at rest throughout the day but did not change when they rotate arm. Patient denies any bruising. Patient had tried oral NSAIDS with moderate relief. Patient was recommended to see primary care physician for examination. It was states they will seek medical attention if pain continues to persist an additional week. The outcome of the event was reported as unknown. The seriousness and causality of the event was not reported.
Age: 79.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Case number PHHY2016US0182231, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 658195) website on 21 Dec 2016. This report refers to a 79-years-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1618401) intramuscularly in left arm on 21 Sep 2016. The patient also vaccinated with PREVNAR 13 (batch number: N05076) intramuscularly in right arm on 21 Sep 2016. On 29 Sep 2016 after vaccination the patient experienced redness, swelling and heat. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Erythema, Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2016US182229, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 658218) website on 21 Dec 2016. This report refers to a 64-years-old female patient. Past medical history was not reported. Current condition included chronic lymphocytic leukemia (CLL). Concomitant medications included WELLBUTRIN, levothyroxine, trazodone, meloxicam, lovastatin, Lisinopril, hydrochlorothiazide and Metoprolol. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) intramuscularly in left arm on 06 Oct 2016. The patient was also vaccinated with PNEUMOVAX (batch number: not reported) intramuscularly in left arm on 06 Oct 2016. On the same day after vaccination the patient experienced chills, fever, pain around injection site and red swollen upper arm with raised welts. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US182229, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 658218) website on 21 Dec 2016. This report refers to a 64-years-old female patient. Past medical history was not reported. Current condition included chronic lymphocytic leukemia (CLL). Concomitant medications included WELLBUTRIN, levothyroxine, trazodone, meloxicam, lovastatin, Lisinopril, hydrochlorothiazide and Metoprolol. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) intramuscularly in left arm on 06 Oct 2016. The patient was also vaccinated with PNEUMOVAX (batch number: not reported) intramuscularly in left arm on 06 Oct 2016. On the same day after vaccination the patient experienced chills, fever, pain around injection site and red swollen upper arm with raised welts. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site reaction, Rash macular, Urticaria
Clinical narrative: Case number PHHY2016US179651 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 658669) website on 21 Dec 2016. This report refers to 33 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185887) intramuscular into arm (unspecified) on 08 Oct 2016. On 09 Oct 2016 the patient woke up at 3:00 AM and noticed hives on face, neck, chest and bilateral arms. She also had a big red splotchy area at injection site. The outcome of the events was reported as complete recovered. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Headache, Pyrexia
Clinical narrative: Case number PHHY2016US180328, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 659403) website on 21 Dec 2016. This report refers to a 26 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185325A) into left arm, intramuscularly on 10 Oct 2016. On 11 Oct 2016, the patient experienced mild headache and fever which has lasted longer than typical for a vaccine (going on 4 days now). The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Decreased appetite, Dizziness, Heart rate increased, Nausea
Clinical narrative: Case number PHHY2017US027580 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 659458) website on 21 Feb 2017. This report refers to a 64 year old female patient. Prior vaccination history included vaccination with seasonal influenza virus vaccine (manufacturer unknown) on an unknown date when the patient was 49 years old and experienced extreme headache (see case: PHHY2017US027618). Historical condition was not reported. Current conditions included outer ear pain/swelling, allergy to sulfa drugs, high blood pressure (controlled with medications), anxiety/depression (controlled with medications), hypothyroid (control with medications), sleep aid and arthritis strength. Concomitant medications included SYNTHROID, buproprion, PAXIL, BENICAR, daily vitamins, CALM'S FORTE and TYLENOL arthritis strength. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) intramuscularly into the right arm on 05 Oct 2016. On the same day after vaccination, patient developed heart beating fast, no appetite, lightheaded and queasiness. On 06 Oct 2016 at 08:00 hours the patient was very lightheaded, dizzy, nauseated and felt like might faint when standing. It was reported that these events lasted all day into evening and when the patient awoke next morning, it was all gone (complete recovery). The lab data of the patient was reported as none. The final outcome of the events was reported as complete recovery on 07 Oct 2016. The events were assessed as non serious by the reporter and causality was not reported.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Case number PHHY2017US029241, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 659742) on 21 Feb 2017. This report refers to a 48 years old female patient. Medical history was not reported. Concomitant medications included Vit D and fish oil (reported as she did not remember to take like she should). Patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185284) intramuscularly on 23 Sep 2016. On 26 Sep 2016, the patient developed muscle ache and spasms varies in intensity and duration. The outcome of the events were reported as condition unchanged. Seriousness of the events were reported as non-serious. The causality of the events were not reported.
Sex: U
Vaccine: FLUX, HPV9
Symptoms: Injection site discharge
Clinical narrative: Case number PHHY2017US022504, is an initial spontaneous report received from a nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 659825) website on 23 Jan 2017. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 21 Sep 2016. The patient also vaccination with GARDASIL 9 vaccine (other manufacture, batch number: L043214 and expiry date: 30 Aug 2017) intramuscularly on 21 Sep 2016. On an unknown date after vaccination, the patient experienced injection site was wet and looked like it oozed out. No adverse effect was reported. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHHY2017US031862 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS reference number: 659867) website on 21 Feb 2017. This report refers to 7 year old female patient. Medical history and concomitant medication was reported as none. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186685) intramuscular into left arm on 15 Oct 2016. On 17 Oct 2016, the patient experienced redness, warm to touch, itchy site of injection. Patient visited emergency room/doctor (date not reported). The outcome of the events was complete recovery on an unknown date, seriousness of the events was non serious and causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Case number PHHY2016US179657, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 659917) website on 21 Dec 2016. This report refers to a 48-year-old female patient. Past medical history was not reported. Current condition included multiple sclerosis and aortic valve dosimetry. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185887) intramuscularly in left arm on 26 Sep 2016. On the same day after vaccination, the patient experienced slight rash on neck and upper chest area and both arms. The outcome of the event was complete recovery on an unspecified date. The seriousness and causality of the event rash were not reported.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2016US180091, is an initial spontaneous report received from Vaccine Adverse Events System (VAERS reference number: 659929) on 21 Dec 2016. This report refers to a 39 years old female patient. Medical history was not reported. Concomitant medications included NORCO, ULTRAM, VALIUM, CYMBALTA and PRILOSEC. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185284) into left arm on 22 Aug 2016. It was reported that the patient visited to the pharmacy complaining of arm soreness on 22 Aug 2016. It was also reported that the patient received LEVAQUIN 3 days later. The outcome of the event pain in extremity was reported as unknown. The seriousness of the event was reported as non-serious and causality was not reported.
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Local reaction, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Case number PHHY2017US031737 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 660089) website on 21 Feb 2017. This report refers to a 09 year old female patient. Historical condition was not reported. Current condition included penicillin allergy and current illness was reported none. Concomitant medications were reported as none. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186685) into left arm on 18 Oct 2016. On the same day after vaccination patient experienced large local reaction on left arm, which was hot, red, swollen and tender. It was also reported that patient had cough with no wheezing. Following the events patient visited emergency room on an unknown date. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Case number PHHY2017US031739, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 660091) website on 21 Feb 2017. This report refers to a 53 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185325A) into left arm on 26 Sep 2016. On 29 Sep 2016 (02 days after vaccination), the patient experienced 18 hours of severe limiting dizziness which gradually resolved over a period of approximately 4 to 5 days. The outcome of the event was reported as complete recovery on an unknown date. The seriousness and causality of the event were not reported.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash pruritic, Swelling
Clinical narrative: Cash number PHHY2017US031865 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 660554) website on 21 Feb 2017. This report refers to a 37 year old female patient. Historical condition was not reported. Past medication included sulfa. Current illness were reported as none. Concomitant medications included LO LOESTRIN 24 FE. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) intramuscularly into right arm on 26 Sep 2016. On the same day after vaccination, patient experienced a raised and itchy rash on left leg, above and the interior side of knee. It was reported that the area of rash was approximately 4 x 3 inches. Following the events patient visited emergency care. On 27 Sep 2016, the patient visited with primary care physician and was advised over the counter antihistamine and topical Cortison cream. The patient was said to outline rash area with a pen or marker and watch for growth or more adverse reaction and return to physician for more follow up. It was reported that the rash lessened on an unknown date (reported as over next week). The final outcome of the events was reported as condition improving (lessened over next week). The seriousness of the events was reported as non serious and causality was not reported.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Swelling
Clinical narrative: Case number PHHY2017US033210, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 660572) website on 21 Feb 2017. This report refers to a 65 years old male patient. Past medical history included as abnormal stress test. Current conditions included as hypertension, coronary artery disease (CAD), mixed hyperlipidemia and scleroderma. Concomitant medications included as naproxen, omeprazole, gabapentin, Glucosamine, penicillamine and zinc-pumpkin seed oil. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1619221) into left arm, intramuscularly on 14 Oct 2016. On 18 Oct 2016, the patient experienced red raised area of skin on back of neck and top of head. The patient visited emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Oral discomfort, Pruritus, Urticaria
Clinical narrative: Case number PHHY2017US033486 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 660821) website on 21 Feb 2017. This report refers to 44 year old male patient. Medical history was reported as none, concomitant medication was SYMBICORT 160 inhaler and Albuterol and Finasteride 1 mg (these listed in history or medication unaware if patient was continuous on these meds at present). The patient was vaccinated with four dose of FLUCELVAX QUADRIVALENT (batch number: 185327) intramuscular into left arm on 06 Oct 2016. On the same day, patient felt itchy and developed hives around 7 PM and took one ZYRTEC oral when he felt that his mouth felt weird. Patient reported he called doctor and prescribed with prednisone unknown dose for 5 days and was fine now. The outcome of the events was complete recovery on an unknown date, seriousness of the events was non serious and causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2017US032916, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 660833) on 21 Feb 2017. This report refers to a 75 years old female patient. Historical condition was not reported. Current conditions included elevated cholesterol and hypertension. Concomitant medication included cholesterol (manufacturer unknown). The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185285) into the right arm and PREVNAR 13 (other manufacturer) (batch number: N16561) on 11 Oct 2016 into the left arm. On 12 Oct 2016, the patient developed redness, swelling, pain, itching at site date after injection and which were slowly subsided. The patient fully recovered from these events on an unknown date. Seriousness of the events were reported as non-serious. The causality of the events were not reported.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2017US018042, is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 660997) website on 23 Jan 2017. This report refers to a 09 years old female patient. Past medical history was not reported. Current condition included seasonal and environmental allergies. The concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly in left arm on 17 Oct 2016. On 18 Oct 2016 after vaccination the patient experienced redness at injection site on while showering and reported to parent at 8pm. Site was reported to be red, swollen and warm to touch. The patient was taken to pediatric urgent care and treated with cephalexin (manufacture unknown) TID for 07 days. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.