chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Hand tingling in left hand. Thumb index, and middle fingers for 2 hours.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Inappropriate schedule of drug administration, Papilloma viral infection
Clinical narrative: Diagnosed with HPV strains against which was vaccinated with GARDASIL in 8/23/2008, 3/11/2008, 12/29/2007.
Age: 73.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Skin rash, rash, urticaria, pruritus and red, bumpy, itchy rash across top of chest. Triamcinolone, hydroxyzine, triamcinolone.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Product preparation error
Clinical narrative: Vaccine was administered using diluent that was not included in original packaging. Sterile diluent was used to reconstitute not diluent included and intended.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Pt had in arm after administration of PREVNAR 1/6/17. By 1/10/17 pain spread to elbow. Pt called and talked to pharmacy 1/10/17.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: On 11-15-16 approximately 10PM chills, shivering, muscle aches, nausea, fever 100 + (sick and miserable all night). Next day those symptoms gone, but very sore left arm where injected-with large red patch (approx. 4" x 6") + itching and stinging/throbbing pain. Redness faded after about 2 weeks. My arm still hurts and it is very painful to raise and use arm.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: On 11-15-16 approximately 10PM chills, shivering, muscle aches, nausea, fever 100 + (sick and miserable all night). Next day those symptoms gone, but very sore left arm where injected-with large red patch (approx. 4" x 6") + itching and stinging/throbbing pain. Redness faded after about 2 weeks. My arm still hurts and it is very painful to raise and use arm.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Has slightly raised, pink itchy area about 4 cm x 6 cm since given vax 12/12/2016. No improvement over last 5 weeks. (L) deltoid.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt had localized redness and itching at site (R) thigh. Redness about the size of a 50 cent piece.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Arthritis, Insomnia, Mobility decreased
Clinical narrative: Patient started experiencing joint pain/inflammation approximately 4 hrs after shot. It was difficult to move arm/sleep for approximately 6 days.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, swollen and painful by 3 pm 1/16. Got shot 1/15 at 1:30 pm.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: 2" by 3" swelling and pinkness in left arm 1/17/17, scattered bumps on neck, not itchy - started on 1/18/17.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Vomiting
Clinical narrative: Per patient's mother call 1-23-2017 at 0800, patient started with fever Saturday evening (1-27-17) alternating MOTRIN and TYLENOL Sunday evening 102.8 degree F at 6pm Monday 101.7 degree F at time of call 98.7 degree F. Mother reported vomiting.
Sex: F
Vaccine: FLUX
Symptoms: Bacterial test negative, Exposure during pregnancy, Influenza, Respiratory symptom, Vaccination failure
Clinical narrative: Case number PHHY2015US158967, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, VAERS reference number: 572743) website on 24 Nov 2015. This prospective pregnancy case was reported in a literature article. This report refers to an adult female pregnant patient. Past medical history and concomitant medications were not reported. Pregnancy history included gravidity 2 and parity 1. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, at least 2 weeks after the vaccination, between 23 Dec 2013 and Feb 2014, when the patient was 21 weeks pregnant, she developed unspecified respiratory symptoms and was later diagnosed as influenza (vaccination failure). She was first seen as an outpatient but later required hospitalization. It was stated that, no microbiologic evidence of a bacterial co-infection was identified. It was not reported if the patient received any treatment. The patient was discharged home on an unknown date. The outcome of the events and pregnancy was reported as unknown. Causality of the events was not reported. No other information was available.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Case number PHHY2015US158304 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting system (VAERS reference number: 579015) on 24 Nov 2015. This report refers to a 59 year old female patient. Her medical history included weight loss. Her current conditions included increased blood pressure, low thyroid and high cholesterol. Her concomitant medications included atenolol, levothyroxine, lisinopril, Baby aspirin and unspecified cholesterol medication. In May 2014, she started BREO ELLIPTA powder at a dose of 1 puff once daily via inhalation for the treatment of emphysema and shortness of breath. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in Oct 2014. In Oct 2014, after receiving BREO ELLIPTA and influenza vaccine, an unknown time later the patient experienced lack of drug effect. It was reported that in Mar 2015, she came down with flu. BREO ELLIPTA was continued without change. The outcome of flu was reported as complete recovery. The events were reported as non-serious, but the events, influenza and vaccination failure were upgraded as medically significant based on the information available in the source document. The reporter considered flu to be unrelated to BREO ELLIPTA. It was unknown if the reporter considered flu to be related to influenza vaccine. No further information was provided.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Case number PHHY2015US156630 is an initial spontaneous report received from a pharmacist via Vaccine Adverse Events Reporting System (VAERS reference number: 586023) on 24 Nov 2015. This report refers to a patient whose identifiers were not reported. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. She also concomitantly received ZOSTAVAX (batch number: not reported) subcutaneously on an unknown date. On an unknown date after vaccination, the patient experienced Bell's palsy. The outcome of the event was unknown. The events were reported as non-serious, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2015US152463, is an initial spontaneous report received from a health care professional via health authority (regulatory reference number: 594197) on 16 Nov 2015. This report refers to a 60 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (batch/lot number: 15753P) intramuscular in left arm along with ZOSTAVAX (other manufacturer, batch/lot number: L006392) subcutaneously in left arm both given on 06 Sep 2015. On 07 Sep 2015, the patient experienced hard like a lump at site of injection, redness, sore, and warm to touch, no fever. The patient took one ALEVE 200 mg. (Recommended cold compress but patient has not had a chance to do that yet). The outcome of the events  were not reported. The seriousness of events was reported as non-serious and causality was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Malaise, Nasal congestion, Pain
Clinical narrative: Case number PHHY2015US152438, is an initial spontaneous report received from a health care professional via health authority (regulatory reference number: 594499) on 16 Nov 2015. This report refers to a 32-year-old female patient. Medical history was not reported. Concomitant medications included ZOLOFT, MOBIC, NEURONTIN and lidocaine patch (manufacturer unknown). The patient vaccinated with FLUVIRIN (batch number: 157404) intramuscular in left arm on 06 Sep 2015 at 5:10 PM. On 08 Sep 2015, at around 3 PM the patient became sick with flu-like symptoms (nasal/chest congestion, cough, body aching, tiredness) she also went to emergency room. The outcome of the events was unknown. The seriousness of events was reported as non serious and causality was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Case number PHHY2015US152438, is an initial spontaneous report received from a health care professional via health authority (regulatory reference number: 594499) on 16 Nov 2015. This report refers to a 32-year-old female patient. Medical history was not reported. Concomitant medications included ZOLOFT, MOBIC, NEURONTIN and lidocaine patch (manufacturer unknown). The patient vaccinated with FLUVIRIN (batch number: 157404) intramuscular in left arm on 06 Sep 2015 at 5:10 PM. On 08 Sep 2015, at around 3 PM the patient became sick with flu-like symptoms (nasal/chest congestion, cough, body aching, tiredness) she also went to emergency room. The outcome of the events was unknown. The seriousness of events was reported as non serious and causality was not reported.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion
Clinical narrative: Case number PHHY2015US152286, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 594575) website on 16 Nov 2015. This report refers to 74 year old female patient. Past medical history was not reported. The patient had no use of blood thinner. Concomitant vaccine included administration of PREVNAR 13 (other manufacturer, and batch number: L77779) in the right arm. The patient was vaccinated with FLUVIRIN (batch number: 1514801) in the left arm on 27 Aug 2015. On 30 Aug 2015, the patient experienced large bruising area about 4 x 5 inches and below by 4 inches on the left arm. Outcome of the event was reported as complete recovery. Event was reported as non serious and causality was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Case number PHHY2015US153121, is an initial spontaneous report received from a health care professional via a health authority (regulatory reference number: 594621) on 16 Nov 2015. This report refers to a 36-year-old female patient. Past medical history and concomitant medication was not reported. The patient received FLUVIRIN (batch/lot number: 173537) in left arm on 08 Sep 2015. On the same day after vaccination, the patient developed pain, swelling, pruritus and erythema that began 1 to 2 hours after receiving flu shot on 08 Sep 2015. Presented 09 Sep 2015 for treatment. The patient visited to emergency room. Denies home care. The outcome of the event was unknown. The seriousness of the events were reported as non serious and causality was not reported.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: Case number PHHY2015US153145, is an initial spontaneous report received from a health care professional via a health authority (regulatory reference number: 595255) on 16 Nov 2015. This report refers to a 51 years old male patient. Past medical history and concomitant medication were not reported. The patient received FLUVIRIN (batch number: 15733P) in left arm 08 Sep 2015. On 08 Sep 2015, the patient developed diarrhea, respiratory tract congestion, headache, and pyrexia. These events were progressively got worse and felt better on Saturday (12 Sep 2015). The outcome of the events were reported as complete recovery on an unknown date. The seriousness of the events were reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Erythema, Skin warm
Clinical narrative: Case number PHHY2015US164960, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 595332) website on 14 Dec 2015. This report refers to a 54 years old female patient. Medical history was not reported. Concomitant medications included omeprazole (manufacture unknown), lisinopril (manufacture unknown), estradiol (manufacture unknown), metformin (manufacture unknown), levothyroxine (manufacture unknown), simvastatin (manufacture unknown), and fluticasone (manufacture unknown). The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly in the left arm on 10 Sep 2015. On the same day after vaccination, patient had approximately 2 inch red circle, warm to touch that lasted about 3 days. The patient reported that, there was a spike in blood sugars (190-210) over normal blood sugar (100-130) for approximately 3 days returned to normal since then. The patient reported having had similar reactions in past but this years was more pronounced and lasted longer. Seriousness of the events was reported as non-serious. Outcome of the events was reported as completely recovery on an unknown date and causality of the events was not reported.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Dizziness, Nausea, Neck pain, Pain in jaw
Clinical narrative: Case number PHHY2015US164781, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 595371) website on 14 Dec 2015. This report refers to a 58 years old male patient. Past medical history and current condition included as diabetes and heart condition. Concomitant medications was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) into right arm, intramuscularly on 02 Sep 2015. On the same day after vaccination, the patient experienced nauseous, light headed, jaw pain, neck and back pain. It was stated that, blood pressure taken in office (Left) arm manually as 118/82 (unit was not given), pulse rate up 87 (unit was not given) and glucose taken by PT/meter as 118. The nurse believed that, patient was having a cardiac and/or diabetic episode. The patient was visited to the emergency room. The outcome of the events was not reported. The seriousness of the event was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US165413 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 595520) website on 14 Dec 2015. This report refers to a 38 year old female patient. Medical history and concomitant medications were not reported. Current illness was reported as none. The patient was vaccinated with FLUVIRIN (batch number: 15753P) intramuscularly into right arm on 15 Sep 2015. It was reported that 45 minutes post injection the patient was feeling unwell and it progressed to nausea, vomiting, diarrhea, aches and fever of 102 (units not specified). Also, it was mentioned that the patient reported similar symptoms (nausea/vomiting) 4-5 days prior to immunization. The outcome of the events was not reported. The events were reported to be non-serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US165413 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 595520) website on 14 Dec 2015. This report refers to a 38 year old female patient. Medical history and concomitant medications were not reported. Current illness was reported as none. The patient was vaccinated with FLUVIRIN (batch number: 15753P) intramuscularly into right arm on 15 Sep 2015. It was reported that 45 minutes post injection the patient was feeling unwell and it progressed to nausea, vomiting, diarrhea, aches and fever of 102 (units not specified). Also, it was mentioned that the patient reported similar symptoms (nausea/vomiting) 4-5 days prior to immunization. The outcome of the events was not reported. The events were reported to be non-serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Case number PHHY2015US164785 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 596154) website on 14 Dec 2015. This report refers to a 31 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15723P) into right arm on 15 Sep 2015. On 16 Sep 2015, the patient developed nausea, vomiting, headache, redness and swelling at injection site. She was treated with TORADOL and ZOFRAN and also had CBC lab test. The outcome of the events was reported as unknown. The events were reported to be non-serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US164785 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 596154) website on 14 Dec 2015. This report refers to a 31 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15723P) into right arm on 15 Sep 2015. On 16 Sep 2015, the patient developed nausea, vomiting, headache, redness and swelling at injection site. She was treated with TORADOL and ZOFRAN and also had CBC lab test. The outcome of the events was reported as unknown. The events were reported to be non-serious and causality was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Case number PHHY2015US164919, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 596177) on 14 Dec 2015. This report refers to a 55 year old female patient. Historical condition included shingles 3 months prior. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157102) intramuscularly in right arm and ZOSTAVAX (other manufacturer, batch number: L002424) subcutaneously in left arm, both on 07 Sep 2015. On 17 Sep 2015, the patient developed small shingles rash on her back. The patient went to a physician and was given VALTREX as treatment medication. Outcome of the event was not reported. Event was reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Case number PHHY2015US164793 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 596186) website on 14 Dec 2015. This report refers to a 29 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157102) intramuscularly into left arm on 12 Sep 2015. On 13 Sep 2015, the patient developed 0.25 inch blister filled with fluid at the injection site. It was reported that she did not experience fever, itching or redness at injection site. The outcome of the event was reported as complete recovery. The event was reported to be non-serious and causality was not reported.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Anxiety, Cough, Disorientation, Malaise
Clinical narrative: Case number PHHY2015US154276, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596188) website on 24 Nov 2015. This report refers to a 36 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2014. On the same day, three hours following vaccination, the patient experienced coughing, wheezing, and then became disoriented, felt doom. The patient was sent to emergency room and she was treated for anaphylaxis. Patient stated that, this reaction has not felt well after eating eggs. The patient received corrective treatment with oral dose with BENADRYL. The outcome of the events was reported as unknown. The seriousness and causality of the events were not reported. The seriousness assessment of anaphylactic reaction, cough, wheezing and disorientation was upgraded based on information available in source documents.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Case number PHHY2015US154276, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596188) website on 24 Nov 2015. This report refers to a 36 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2014. On the same day, three hours following vaccination, the patient experienced coughing, wheezing, and then became disoriented, felt doom. The patient was sent to emergency room and she was treated for anaphylaxis. Patient stated that, this reaction has not felt well after eating eggs. The patient received corrective treatment with oral dose with BENADRYL. The outcome of the events was reported as unknown. The seriousness and causality of the events were not reported. The seriousness assessment of anaphylactic reaction, cough, wheezing and disorientation was upgraded based on information available in source documents.
Age: 67.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash generalised
Clinical narrative: Case number PHHY2015US164874, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 596648) website on 14 Dec 2015. This report refers to a 67 years old female patient. Historical conditions included pain, hypothyroidism and hyperlipidemia. Current condition included diabetes. The concomitant medication include metformin (manufacture unknown), Oxycodone/Acetaminophen, atorvastatin (manufacture unknown), glimepiride (manufacture unknown), levothyroxine (manufacture unknown), montelukast (manufacture unknown), amitriptyline (manufacture unknown), omeprazole (manufacture unknown), topiramate (manufacture unknown). The patient was vaccinated with FLUCELVAX (batch/lot number: 173989) at a dose of 1 DF intramuscularly in right arm deltoid on 11 Sep 2015. On the same day after vaccination, the patient reported to have itchy red raised patches began to appear around the injection site in the evening. During the next 10 days, the rash spread to her back, neck, scalp, buttock region, and both arms, legs and feet. Patient had been self-treating with oral BENADRYL and topical hydrocortisone. The outcome of the events was unknown. Seriousness of the events was reported as non-serious and causality of the events was not reported. The seriousness assessment of event rash generalised was upgraded as medical significant based on information available in source document.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Case number PHHY2015US156577, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 596663) website on 24 Nov 2015. This report refers to a 56 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in Aug 2014 (approximately). In Dec 2014 the patient developed flu. It was reported that the patient received flu vaccines for the past several years but never got the flu for the past 5 years. The outcome, seriousness criteria and causality of the event was not reported. Seriousness assessment of "flu" and "vaccination failure" was upgraded based on information in the source document. Further the patient was vaccinated with FLUVIRIN (batch number: not reported) on 22 Aug 2015. On 07 Sep 2015 the patient developed flu (see case: PHHY2015US156581).
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHHY2015US162909, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 596956) website on 24 Nov 2015. This report refers to a 62 year old male patient. Past medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514601) in the left arm on 18 Sep 2015. The patient reported that he was already received flu vaccine (manufacturer unknown) on an unknown date in the same season. No adverse event was reported following this administration error.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Malaise, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Case number PHHY2015US166401, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 596993) website on 14 Dec 2015. This report refers to a 49 years old female patient. Historical condition was not reported. Current conditions included allergies to DILAUDID, codeine, ZOLOFT, NSAIDS, and hypertension. Concomitant medications included metoprolol (manufacture unknown) and MS CONTIN. The patient was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly into left arm on 21 Sep 2015. On same day after vaccination, the patient experienced left arm itching, 36 hours post vaccination left arm had 13 cm x 14 cm raised red area with warmth, left arm tightness and swelling, soreness, intermittent fever and general malaise. The patient's left wrist showed positive pulse and normal sensation to touch. The outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported. Seriousness assessment of the events "vaccination site erythema" was upgraded based on information available in the source document.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Pyrexia, Skin tightness, Skin warm
Clinical narrative: Case number PHHY2015US166401, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 596993) website on 14 Dec 2015. This report refers to a 49 years old female patient. Historical condition was not reported. Current conditions included allergies to DILAUDID, codeine, ZOLOFT, NSAIDS, and hypertension. Concomitant medications included metoprolol (manufacture unknown) and MS CONTIN. The patient was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly into left arm on 21 Sep 2015. On same day after vaccination, the patient experienced left arm itching, 36 hours post vaccination left arm had 13 cm x 14 cm raised red area with warmth, left arm tightness and swelling, soreness, intermittent fever and general malaise. The patient's left wrist showed positive pulse and normal sensation to touch. The outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported. Seriousness assessment of the events "vaccination site erythema" was upgraded based on information available in the source document.
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Abasia, Fatigue, Pain, Vomiting
Clinical narrative: Case number PHHY2015US164837 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 597024) on 14 Dec 2015. This report refers to a 76 year old male patient. He had no medical history, current condition or concomitant medications. The patient was vaccinated with FLUVIRIN (batch number: 15753P) and PREVNAR 13 (other manufacturer, batch number: L99262); both vaccines administered intramuscularly in the left arm on 17 Sep 2015. On the same day after vaccination, he was tired and had vomiting and aches. He was unable to walk and was bedridden. He took TYLENOL. He was asked to go to urgent care. No laboratory tests were done. He became better next day. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Dizziness, Erythema, Hypersensitivity, Nausea
Clinical narrative: Case number PHHY2015US157032, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 597099) website on 24 Nov 2015. This report refers to a 58 years old female patient. Past medical history included as hypertension and cancer-in remission. Concomitant medication included as Lisinopril (manufacturer unknown), glipizide (manufacturer unknown) and atorvastatin (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into arm on 22 Sep 2015. The patient also received PREVNAR 13 into arm on an unknown date. On the same day after vaccination, the patient experienced red, swollen arm, lightheaded, nausea, elevated temperature (100 percentage). Follow-up physician appointment on 23 Sep 2015, physician thought it was an allergic reaction. The patient said that, it looked like cellulitis. She requested antibiotics, but request was denied. It was stated that, arm is still red and very swollen- it is now 2 days later. The outcome of the events was not reported. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Seriousness of the event allergic reaction was upgraded based on the information available in the source document.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: Case number PHHY2015US157032, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 597099) website on 24 Nov 2015. This report refers to a 58 years old female patient. Past medical history included as hypertension and cancer-in remission. Concomitant medication included as Lisinopril (manufacturer unknown), glipizide (manufacturer unknown) and atorvastatin (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into arm on 22 Sep 2015. The patient also received PREVNAR 13 into arm on an unknown date. On the same day after vaccination, the patient experienced red, swollen arm, lightheaded, nausea, elevated temperature (100 percentage). Follow-up physician appointment on 23 Sep 2015, physician thought it was an allergic reaction. The patient said that, it looked like cellulitis. She requested antibiotics, but request was denied. It was stated that, arm is still red and very swollen- it is now 2 days later. The outcome of the events was not reported. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Seriousness of the event allergic reaction was upgraded based on the information available in the source document.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Neuralgia
Clinical narrative: Case number PHHY2015US155027 is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 597307) website on 24 Nov 2015. This report refers to a 37 years old female patient. Historical condition included herniated cervical discs. Concurrent condition included neurological pain. Concomitant medications included ADDERALL, SEASONIQUE, WELLBUTRIN, CLARITIN, gabapentin, hydrocodone and B complex. The patient was vaccinated with FLUVIRIN (batch number: 15277) intramuscularly into left arm on 24 Sep 2015. On the same day after vaccination the patient presented with extreme flare of neurological pain in her right arm and hand. Outcome of the event was unknown. The case was assessed as non-serious. It was reported that the patient had never experienced this level of pain before, which led her to believe it may had been triggered by the flu vaccine. Following an internal review on 04 Dec 2015, of the data received on 24 Nov 2015, it was found that the event "condition aggravated" was wrongly coded instead of "concomitant disease aggravated". Hence the event was recoded.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Case number PHHY2015US152157 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597486) website on 24 Nov 2015. This report refers to a 60 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516201) intramuscularly into left arm along with ZOSTAVAX (batch number: L002422, other manufacturer) subcutaneously into left arm on 21 Sep 2015. After vaccination the patient developed bruise on shoulder where flu vaccine was administered and a bump on the back of the arm where the shingles vaccine was administered. Outcome of the event was not recovered. Seriousness and causality of the events were not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Palpitations, Tremor
Clinical narrative: Case number PHHY2015US164847, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 597613) website on 14 Dec 2015. This report refers to a 40 years female patient. Historical condition was not reported. Current condition included allergic to penicillin. Concomitant medication was not reported. The patient vaccinated with FLUVIRIN (batch number: 1516201) intramuscularly in right arm on 26 Sep 2015. On the same day after vaccination, patient experienced feeling dizzy with palpitations. Her hands were shaking, and she felt like her blood pressure was decreasing. The patient went to emergency room. The outcome of the events was unknown. Seriousness of the events was reported as non serious and causality was not reported.
Age: 1.0
Sex: M
Vaccine: FLUX, MEA, VARCEL
Symptoms: Erythema, Hypersensitivity, Swelling face
Clinical narrative: Case number PHHY2015US156180, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597732) website on 24 Nov 2015. This report refers to a 01 years old male patient. Past medical history and concomitant medications were not reported. The patient had no allergies prior to the vaccine. The patient was vaccinated with first dose of seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in right leg, first dose of measles vaccine (manufacturer unknown and batch number: not reported) intramuscularly in left leg, first dose of varicella vaccine (manufacturer unknown and batch number: not reported) intramuscularly in left leg on 24 Sep 2015. On the same day 15 minutes after vaccination, the patient experienced mild swelling in the face, red in the face, ears, stomach and diaper area. The patient was treated with MOTRIN and LEMONADE. It was reported that within 2 hours the allergic reaction went down. Outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality of the events was not reported. Seriousness assessment of the event was upgraded based on information available in the source document.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Neurological examination normal, Peripheral coldness, Vomiting
Clinical narrative: Case number PHHY2015US161899, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 597831) website on 24 Nov 2015. This report refers to a 41-year-old female patient. Historical condition was not reported. Vaccination history included no previous influenza vaccine although tolerated other vaccines. The patient had no current illness, current condition included very mild shrimp/shellfish allergy and no egg allergy. Concomitant medication included Multi Vitamin. The patient was vaccinated with FLUVIRIN (batch number: 173253) intramuscularly into right arm on 29 Sep 2015. On same day after vaccination, the patient experienced nausea with vomiting, weakness, cold feeling in arms. The neurological examination was normal. The patient had no visible skin reaction, no wheezing and no specific treatment. The patient visited to emergency room. The outcome of the events was not reported. Seriousness of the events was reported as non serious and causality not reported.
Sex: F
Vaccine: FLU3
Symptoms: Mouth ulceration, Oral pruritus, Pruritus, Rash
Clinical narrative: Case number PHHY2015US156663, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 597934) website on 24 Nov 2015. This report refers to a 71-year-old female patient. The patient was allergic to amoxicillin. Concomitant medication was not reported. The patient had received flu vaccine (manufacturer and batch number: not reported) in prior years with no allergic reactions. The patient denies any egg allergy. The patient was vaccinated with FLUVIRIN (batch number: 1515101) intramuscularly into the right arm on 23 Sep 2015. On the same day after vaccination in the evening the patient developed itching on face and mouth. On 24 Sep 2015, the patient developed rash and mouth ulcers. The patient did not experience any skin reaction near the injection site. Also the patient stated that she eat out at a restaurant immediately following vaccination at the pharmacy and it was possible that the symptoms she was experiencing were a result of some food type allergy although she was not aware of any food allergies at this time. The patient was currently managing symptoms with over the counter BENADRYL and was instructed to contact her primary care physician if symptoms worsen or do not resolve for further treatment. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dizziness, Eye discharge, Musculoskeletal pain, Neck pain
Clinical narrative: Case number PHHY2015US158614, is an initial spontaneous report received from Vaccine Adverse Event Reporting System, (VAERS reference number: 597935) website on 24 Nov 2015. This report refers to a 44 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in left arm intramuscularly on 28 Sep 2015. On the same day after vaccination, the patient started with cough which increased in frequency, felt that throat opening was tightening, aches in shoulders and neck. She went to bed by 8:30 PM. The patient got up during the night with very red, oozing eyes and swollen pockets on her face. No cough or throat tightness in the morning was reported but eyes were still red, face was still swollen. The patient was dizzy during the day. All the events were completely recovered on 29 Sep 2015 by evening except some aches in shoulders and neck. Seriousness of the events were reported as non-serious and causality was not reported. Seriousness assessment of the events throat tightness, cough, swelling face, eye discharge and ocular hyperemia was upgraded based on the information available in source document.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Ocular hyperaemia, Swelling face, Throat tightness
Clinical narrative: Case number PHHY2015US158614, is an initial spontaneous report received from Vaccine Adverse Event Reporting System, (VAERS reference number: 597935) website on 24 Nov 2015. This report refers to a 44 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in left arm intramuscularly on 28 Sep 2015. On the same day after vaccination, the patient started with cough which increased in frequency, felt that throat opening was tightening, aches in shoulders and neck. She went to bed by 8:30 PM. The patient got up during the night with very red, oozing eyes and swollen pockets on her face. No cough or throat tightness in the morning was reported but eyes were still red, face was still swollen. The patient was dizzy during the day. All the events were completely recovered on 29 Sep 2015 by evening except some aches in shoulders and neck. Seriousness of the events were reported as non-serious and causality was not reported. Seriousness assessment of the events throat tightness, cough, swelling face, eye discharge and ocular hyperemia was upgraded based on the information available in source document.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face, Swollen tongue, Throat irritation, Urticaria
Clinical narrative: Case number PHHY2015US156407, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598275) website on 24 Nov 2015. This report refers to a 19-year-old female patient. Current condition included Crohn's disease. The patient was allergic to prednisone. Concomitant drugs included PROZAC, REMICADE, PRILOSEC and ZOFRAN. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) via intradermal route in the right arm on 01 Oct 2015. On the same date, after vaccination the patient experienced hives, face swelling, tongue swelling and itchy throat. The outcome of the events reported as recovered. The events reported as non-serious. Seriousness assessment of the events upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Joint range of motion decreased, Muscle tightness
Clinical narrative: Case number PHHY2015US164304 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 598337) on 14 Dec 2015. This report refers to an 81 year old female patient. Her medical history included chronic pneumonia (she was currently stable). She had no current illness. Her concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515201) intramuscularly in the left arm on 28 Sep 2015. On 02 Oct 2015, she experienced muscle tightness, limited range of motion and difficulty in sleeping. The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Lacrimation increased, Oropharyngeal pain, Pain
Clinical narrative: Case number PHHY2015US155739, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598465) on 24 Nov 2015. This report refers to a 29 years old female patient. Historical condition was not reported. Past medication included LEVAQUIN (manufacture unknown). Current condition included dust mites. Concomitant medications included ZOLOFT, VELIVET. The patient vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number and expiry date: not reported) intramuscularly in the left arm on 23 Sep 2015. On the same day after vaccination, the patient developed sore throat, cough, watery eyes, body aches, sinus congestion, sinus pressure, fatigue. The patient was treated with azelastine nasal spray (manufacture unknown), NASACORT, ALLEGRA, BENADRYL with no improvement of symptoms. On 03 Oct 2015, patient started MEDROL pack. The symptoms were improving as of 03 Oct 2015. Outcome of the events (sinus congestion, sinus pressure, sore throat and cough) were reported as condition improving. Outcome of the events watery eyes, body ache and fatigue were not reported. The seriousness was assessed as non serious and causality was not reported. Seriousness of the events sinus congestion, sinus pressure, sore throat, keep lacrimation and cough was upgraded based on the available information in the source document.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Paranasal sinus discomfort, Sinus congestion
Clinical narrative: Case number PHHY2015US155739, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598465) on 24 Nov 2015. This report refers to a 29 years old female patient. Historical condition was not reported. Past medication included LEVAQUIN (manufacture unknown). Current condition included dust mites. Concomitant medications included ZOLOFT, VELIVET. The patient vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number and expiry date: not reported) intramuscularly in the left arm on 23 Sep 2015. On the same day after vaccination, the patient developed sore throat, cough, watery eyes, body aches, sinus congestion, sinus pressure, fatigue. The patient was treated with azelastine nasal spray (manufacture unknown), NASACORT, ALLEGRA, BENADRYL with no improvement of symptoms. On 03 Oct 2015, patient started MEDROL pack. The symptoms were improving as of 03 Oct 2015. Outcome of the events (sinus congestion, sinus pressure, sore throat and cough) were reported as condition improving. Outcome of the events watery eyes, body ache and fatigue were not reported. The seriousness was assessed as non serious and causality was not reported. Seriousness of the events sinus congestion, sinus pressure, sore throat, keep lacrimation and cough was upgraded based on the available information in the source document.
Age: 50.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Case number PHHY2015US165434 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 599688) on 14 Dec 2015. This report refers to a 50 year old female patient. Her medical history included acne and her current conditions included hypertension. Her concomitant medications were EXFORGE, BYSTOLIC and spironolactone. The patient was vaccinated with FLUCELVAX (batch number: 174268) intramuscularly in the right arm on 05 Oct 2015. On the same day after vaccination, the patient had facial and anterior chest rash with itching and redness. No laboratory tests were performed. The patient was treated with BENADRYL and head mild relief. She improved 10% from the previous day and had less itching. The final outcome of itching was reported as condition improving and that of other events was unknown. The events were reported as non-serious, but were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Depressed level of consciousness, Nausea, Pyrexia
Clinical narrative: Case number PHHY2015US165458 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 600711) on 14 Dec 2015. This report refers to a 63 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157621) intramuscularly in the left arm on 02 Oct 2015. On 05 Oct 2015, she had symptoms of chills, fever, nausea and temporary loss of mental alertness. She called doctor and felt better later. The final outcome of events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.