chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: Case number PHHY2014US155007, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 542731) website on 13 Nov 2014. This report refers to a 55 year old female patient. Historical condition was not reported. Concomitant medications included Synthroid, NEXIUM, Pravachol, HYZAAR and PRISTIQ. She was vaccinated with FLUVIRIN (batch number: 145223) intramuscularly in right arm and ZOSTAVAX (other manufacturer, batch number: J012658) subcutaneously in left arm on 03 Sep 2014. ZOSTAVAX was administered at 06:15 pm. On 05 Sep 2014, the patient came to pharmacy around 4:41 pm for some other medicines when an injection site reaction described as local rash was noticed. It was determined that the local rash occurred almost 02 days following vaccination. The rash was not raised and did not feel warm to touch. She did not feel faint or lightheaded. Except from the rash, she was fine. She was advised to take BENADRYL to treat the event. No ice pack was needed as there was no swelling. Final outcome was complete recovery. Event were reported as non-serious. Causality was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: Case number PHHY2014US155063, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 542732) website on 13 Nov 2014. This report refers to a 64 year old female patient. Historical condition was not reported. Concomitant medications included FLONASE and PRILOSEC. She was vaccinated with FLUVIRIN (batch number: 145223) intramuscularly in right arm and ZOSTAVAX (batch number: J012658) subcutaneously in right arm both on 05 Sep 2014. ZOSTAVAX was administered at around 12:00 pm. On the same day, 20 minutes after vaccination, she noticed a rash around injection site. There was no swelling, bruising or warmth at injection site. The rash was about the size of a quarter. The patient did not feel faint or lightheaded. She was fine otherwise. She was advised to take BENADRYL to treat the event. She was asked to call the pharmacist in case of serious event. Final outcome was complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash, Urticaria
Clinical narrative: Case number PHHY2014US150450, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542876) website on 13 Nov 2014. This report refers to a 47 year old female patient. Historical drug included Aspirin. Concurrent condition included bronchitis. Concomitant medication included prednisone and CLARITIN. She was vaccinated with FLUVIRIN (batch number: 145005) intramuscular on 17 Aug 2014. On the same day she experienced hives, rash and itching all over the body. Outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Case number PHHY2014US154944, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542942) website on 13 NOV 2014. This report refers to a 29-year-old male patient. Medical history included adrenal disorder and anxiety. Concurrent conditions included asthma. Concomitant medications included Paxil, buspirone, Ativan and Ventolin. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145204) intramuscularly on 05 SEP 2014. On 06 SEP 2014, the patient complained of sweating and also having a fever. The felt these symptoms since the morning the day after the vaccine. The patient went to hospital ER where he left shortly after. The outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Sex: U
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US155003, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543043) website on 13 Nov 2014. This report refers to patient of unknown demographics. Historical conditions and current illness were none. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145203), along with ZOSTAVAX (batch number: K007986) on 05 Sep 2014. On the same day after vaccination, the patient developed redness, swelling, hot to touch and soreness at the site of injection. The outcome of the events was complete recovery. The events were reported as non-serious; Causality was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Case number PHHY2014US151315, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543092) website on 13 Nov 2014. This report refers to a 23-year-old female patient. Concomitant drug included Lo Loestrin Fe. She was vaccinated with FLUVIRIN (batch number: 1411001) intramuscularly on 02 Sep 2014. On 03 Sep 2014 morning, she was itchy all over (mentioned face and arms) and later in the day she developed hives on face. She had no trouble breathing/swelling of tongue/throat. She was advised to take BENADRYL and cool compresses for facial hives. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Pruritus generalised, Rash generalised
Clinical narrative: Case number PHHY2014US1553560 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 543275) on 13 Nov 2015. This report refers to a 52 year old male patient. His past medical history included acute intermittent porphyria and current conditions included seasonal allergies. His concomitant medications were not reported. On 08 Sep 2014, he was vaccinated with FLUVIRIN (batch number: 1411101) intramuscularly into his left arm. On the same day after the vaccination, he had itching at the injection site and itching all over his body. He also had rash on his body and head, and also developed a large bump at the injection site. The patient completely recovered from the events on an unspecified date. The events were reported as non serious and causality of the events was not reported.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2014US154751, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543335) website on 13 Nov 2014. This report refers to a 72-year-old female patient. On 06 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 145221) along with PNEUMOVAX (other manufacturer, batch number: J000799), both intramuscularly in the left arm. On the same date, after vaccination she experienced muscle tenderness on her upper arm and also had pain on that area followed by fever for a couple days. The outcome of the events reported as recovered. The events reported as non serious. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Case number PHHY2014US154794, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543340) website on 13 Nov 2014. This report refers to a 53-year-old female patient. On the same date, after vaccination she had pain/dull ache. The outcome of the event reported as not recovered. The event reported as non-serious. The causality of the event was not reported.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Pruritus
Clinical narrative: Case number PHHY2014US154809, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543423) website on 13 Nov 2014. This report refers to a 78-year-old male patient. Historical condition included shingles. He was vaccinated with FLUVIRIN (batch number: 1412601) intramuscularly in the left arm on 08 Sep 2014. On 10 Sep 2014, he experienced nickel-sized raised red area that itched and caused pain on left knee area. He had similar event on right side of forehead but it did not itch until a later date. It was reported that he felt the events as similar, but less severe, than a previous case of shingles (unspecified). The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Case number PHHY2014US154869, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543441) website on 13 Nov 2014. This report refers to a 67-year-old female patient. Her current conditions included gastroesophageal reflux disease and hypercholesteremia. Concomitant drugs included omeprazole 40 mg, temazepam 30 mg, OMEGA 3 (fish oil), calcium 500 mg, Vitamin C and glucosamine/chondroitin. On 12 Aug 2014, she was vaccinated with FLURIVIN (batch number: 145304) along with PNEUMOVAX (other manufacturer, batch number: J014399), both intramuscularly in the left arm. On the same date, after vaccination she experienced fever, pain, swelling and redness on injected arm. She took ibuprofen for the pain and fever. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Case number PHHY2014US151279, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543572) website on 13 Nov 2014. This report refers to a 72-year-old female patient. Historical conditions were not reported. Concomitant medication was none. She was vaccinated with FLUVIRIN (batch number: 1411001) intramuscularly on 11 Sep 2014. On the same day after vaccination, the patient arm swelled up where the shot was administered and looked like it might bruise. She was told to keep an eye on it and watch for worsening. She was asked to call her MD and use compresses and BENADRYL if needed. The outcome of the event was complete recovery. The event was reported as non-serious; Causality was not reported.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Case number PHHY2014US155046, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543574) website on 13 NOV 2014. This report refers to a 67-year-old male patient. On 05 SEP 2014, he was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) in the right arm along with PNEUMOVAX (other manufacturer, batch number: K007773) in the left arm. On the same date, after vaccinations he broke out in a rash. The patient reported about the event to pharmacy and physician. The rash was worsening. He was told to take BENADRYL, but physician prescribed hydroxyzine and Medrol. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHHY2014US155067, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543591) website on 13 Nov 2014. This report refers to a 30-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1411901) intramuscularly in the arm on 10 Sep 2014. On 12 Sep 2014, his arm in which vaccine was given became numb. The outcome of the event was unknown. The event reported as non-serious. The causality of the event was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised, Rash macular, Rash pruritic
Clinical narrative: Case number PHHY2014US151068, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543596) website on 13 Nov 2014. This report refers to a 54-year-old female patient. Historical conditions and current illness were none. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145221) intramuscularly on 08 Sep 2014. On the same day after vaccination, she developed red, splotchy rash that itched intensely and spread all over body. The reaction began about an hour after the flu shot was given. The outcome of the events was complete recovery. The events were reported as non-serious; Causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2014US155356 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 543598) website on 13 Nov 2014. This report refers to a 57 year old female patient. Her current conditions included diabetes. Her concomitant medications included pravastatin, levothyroxine, VICTOZA and metformin. Her vaccination history included a dose of pneumococcal vaccine (other manufacturer, batch number: not reported) after which she developed redness and swelling. On 10 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 145302) intramuscularly into her left arm and with PNEUMOVAX (other manufacturer, batch number: K004483) intramuscularly into her right arm. On 11 Sep 2014, she developed redness and swelling in the vaccinated arm. The outcome of the events was complete recovery. The event were reported as non serious and causality of the events was not reported.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2014US154276, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543761) website on 13 NOV 2014. This report refers to a 76-year-old female patient. Concurrent condition included type 2 diabetes. Concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: unknown) along with intramuscular dose of PNEUMOVAX (batch number: J005068, other manufacturer) in the left arm over inch apart on 08 SEP 2014. On an unknown date, after vaccinations, the patient developed redness and warmth at site. She was treated with Benadryl and ice which relieved her symptoms. Outcome of the events was reported as recovered. These events were reported as non-serious. Causality of the events was not reported.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US169402 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 543814) on 29 DEC 2014. This report refers to a 25 years old female patient. Past medical history was not reported and concomitant medications included minocycline. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145205) intramuscularly in the left arm on 14 SEP 2014. On the same day after vaccination, she experienced syncope. She went to emergency room. The outcome of the event was reported as complete recovery. The event was reported as non-serious. The causality of the event was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Case number PHHY2014US169925, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544037) website on 29 DEC 2014. This report refers to a 49-year-old female patient. The patient's current conditions included lupus, lung disease, heart disease, asthma and anemia. The patient was on several medications concomitantly (no further details provided). She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) along with PNEUMOVAX23 (batch number: K004148) intramuscularly on 16 SEP 2014. On the same day after vaccination the patient developed a swollen arm (softball size) around the injection site. She was treated at ER and then sent. The final outcome of the event was unknown. The event was reported as non-serious. Causality was not reported.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2014US169318, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544520) website on 29 DEC 2014. This report refers to a 25-year-old female patient. Concomitant drug included levetiracetam 750 mg. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly in the left arm on 18 SEP 2014. On 19 SEP 2014, she developed bumps on arms and other body. The outcome of the event was unknown. The event reported as non-serious. The causality of the event was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Miliaria, Rash erythematous, Rash macular
Clinical narrative: Case number PHHY2014US170551 is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS ID: 544832) on 29 DEC 2014. This report refers to a 64 years old female patient. Her medical history included flat red splotchy rash after taking Robitussin and guaifenesin. Her concomitant medicaitons were Anusol-HC, omeprazole, Nasonex and Valtrex. Hours prior to vaccination, she had a massage. She was vaccinated with FLURVIN 2014/2015 (batch number: 145401) intramuscularly in the right arm on 22 SEP 2014. On 22 SEP 2014, 1 hour after vaccination, she experienced flat, red, splotchy rash which looked like heat rash. Rash appeared on abdomen, under breasts to waist and it was not appearing on back. The events outcome was reported as unknown. The events were reported as non-serious. The causality of the event was not reported.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Loss of consciousness, Syncope
Clinical narrative: case number PHHY2014US169854, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 545345) website on 29 DEC 2014. This report refers to a 13-year-old male patient. Medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410901) intramuscularly into left arm on 23 SEP 2014. On the dame day, 5 minutes after the vaccination, the patient felt very dizzy, lightheaded and passed out for few minutes. No loss of consciousness was reported. The patient went to emergency where it was told that he experienced vasovagal syncope which was common in kids. Laboratory data included blood pressure 146/93 and pulse rate: 82. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Case number PHHY2014US170251 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 545737) on 29 DEC 2014. This report refers to a 32 years old male patient. His medical history was not reported and concomitant medications included fluticasone nasal spray. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413301) intramuscularly in the left arm on 09 SEP 2014. On 09 SEP 2014, he developed rash on arms and legs which were further described as red raised bumps by the staff at doctor's office. 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.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2014US163190, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546363) website on 28 NOV 2014. This report refers to a 47-year-female patient. Medical history of concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412901) intramuscularly into left arm on 20 SEP 2014. On 21 SEP 2014, she experienced red circle at site of injection which was feverish to touch. She was advised to go clinic immediately. Outcome of the events was unknown. The events were reported as non-serious. Causality of the event was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Case number PHHY2014US170144, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546429) website on 29 DEC 2014. This report refers to a 62-year-old female patient. Medical history included seizure (under control by medication). Concomitant medications included Diflucan, Phenobarb, and Vagifem. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145405) intramuscularly into right arm on 24 SEP 2014. On the dame day, she was also vaccinated with ZOSTAVAX (batch number: K003603, other manufacturer) subcutaneously into left arm. On 02 OCT 2014, she developed 10 red bumps on legs and itching. She was treated with Benadryl cream for itching. Outcome of the events was recovered. The case was assessed as non-serious. Causality of th events was not reported.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Nodule, Pruritus, Rash erythematous, Rash maculo-papular
Clinical narrative: Case number PHHY2014US170074, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546610) website on 29 DEC 2014. This report refers to a 17 year old female patient. Her medical history and concomitant medication was not reported. On 02 OCT 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1414001) IM into left arm and MENACTRA (batch number: UH325AA, other manufacturer) IM into right arm. On the same day post vaccination she developed rash with raised red maculopapules on right arm and also pruritus. Patient reported right sided chin swelling nodule inframandibular. She visited the emergency room. The events improved with Benadryl. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Seizure like phenomena, Syncope
Clinical narrative: Case number PHHY2014US170082, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546619) website on 29 DEC 2014. This report refers to a 16 year old male patient. No known pre-existing medical allergies were reported. His medical history and concomitant medication was not reported. On 04 OCT 2014, he was vaccinated with FLUVIRIN 2014/2015 (batch number: 145222) IM into left arm. On the same day post vaccination he fainted (collapsed) after complaining of feeling dizzy and went into what appeared to be a seizure of vasovagal syncope. He went to an urgent care and doctor reassured patient it was a vasovagal syncope response from being scared of vaccination. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site paraesthesia, Injection site pruritus, Injection site swelling
Clinical narrative: Case number: PHHY2014US170089, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546833) website on 29 DEC 2014. This report refers to a 54 year old female patient. Medical history and concomitant medication was not reported. Current condition included allergy to latex and milk (diary). On 01 OCT 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411001) IM into right arm. She began to experience mild-to-moderate signs of allergic reaction about 10-15 seconds post vaccination. She also experienced local swelling in deltoid region, redness, minor itching and tingling that spread up and down the right arm. Emergency squad transported patient to ER where she received Benadryl 25 mg injection and was discharged in stable condition. Outcome of the events was completely recovered. Causality assessment was not reported. Events were reported as non serious.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Case number PHHY2014US163289, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547316) website on 28 Nov 2014. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number: 1413301) intramuscularly into left arm on 04 Oct 2014. On the same day, after vaccination, the patient experienced lightheadedness, dizziness and nausea. Outcome of the events was reported as recovered. The events were reported as non-serious. Causality of the events was not reported.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Case number PHHY2014US159567, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547501) website on 28  NOV 2014. This report refers to a 33  year old male patient. Historical drugs included nonsteroidal anti-inflammatory drugs.  His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1411821) intramuscular into left arm on 11 OCT 2014. Approximately 3 minutes following vaccination patient stood up and reported feeling dizzy. The patient was reseated but again reported dizziness and fainted. He was laid down on the ground and his feet were elevated at the point he became responsive. Emergency medical team arrived and recorded his vitals. Vitals were unremarkable and within normal limits. Patient declined any additional services including transport to  hospital and was able to travel home safely without additional assistance. Events were reported as non-serious. Outcome of the events were completely recovered. Causality assessment was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash pustular, Swelling face
Clinical narrative: Case number PHHY2014US170419, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547638) website on 29 DEC 2014. This report refers to a 48 year old female patient. Medical history was not reported. Concomitant medication  included Motrin as  needed. On 10 OCT 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) IM into left arm. On 11 OCT 2014, she awoke with 3 pustules on right side of face associated with right sided facial swelling (pustules remained and the nurse questions whether bug bite or adverse reaction). She also reported that her left arm was painful, red and swollen. Outcome of the events was condition unchanged as of 13 OCT 2014. Causality assessment was not reported. Events were reported as non-serious.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2014US163899 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 548104) website on 28 Nov 2014. This report refers to a 67 year old female patient. Her past medical history and concomitant medications were not reported. On 29 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1410701) intramuscularly into her left arm. On the same day after the vaccination in the evening, she developed a rash on her face and trunk. She was treated with MEDROL and with VISTARIL for the rash. The outcome of the events was unknown. The events were reported as non serious and causality of the events was not reported.
Age: 54.0
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site hypersensitivity, Local reaction
Clinical narrative: Case number PHHY2014US170458, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548109) website on 29 DEC 2014. This report refers to a 54-year-old patient of an unknown gender. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413301) in the right arm on 01 OCT 2014. On the same day, immediately after vaccination the patient experienced local allergic reaction at site of injection. The patient was treated with 50 mg Benadryl. The outcome of the event reported as recovered. The event reported as non-serious. The causality of the event was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Case number: PHHY2014US162832 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS ID: 548140) website on 28  NOV 2014. This report refers to a 62 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412311), intramuscularly in the arm on 24 SEP 2014. It was reported that, the patient called on 25 SEP 2014 to report dizziness after flu vaccination (24 SEP 2014) that had continued off and on for almost 24  hours. She was visited to the emergency room. The outcome of the event was unknown. The event was reported as non-serious. The causality of the event was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site pain, Injection site rash, Photophobia
Clinical narrative: Case number PHHY2015US032691, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554314) website on 16 MAR 2015. This report refers to a 62 years old female patient. Concurrent condition included codeine allergy. No history of migraines. Concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 144622F) intramuscularly on 27 OCT 2014 at 09:30. On the same day, at 11:30, the patient experienced loss of bladder control, blinding headache, vomiting,  photophobia and dizziness. On 28 OCT 2014, the patient experienced diffuse painful rash at injection site. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: Case number PHHY2015US032691, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554314) website on 16 MAR 2015. This report refers to a 62 years old female patient. Concurrent condition included codeine allergy. No history of migraines. Concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 144622F) intramuscularly on 27 OCT 2014 at 09:30. On the same day, at 11:30, the patient experienced loss of bladder control, blinding headache, vomiting,  photophobia and dizziness. On 28 OCT 2014, the patient experienced diffuse painful rash at injection site. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Ear pain, Lymphadenopathy, Musculoskeletal stiffness, Pain
Clinical narrative: Case number PHHY2015US111087 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553170) website on 10 SEP 2015. This report refers to a 27 years old female patient. Medical history was not reported. Concomitant medication included microgestin. The patent was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413801) into left arm on 08 NOV 2014. On the same day after vaccination the patient had joint pain in knees and it was hurt to walk. Further the patient had throbbing ear pain. On 11 NOV 2014 the patient had a stiff neck and swollen glands. The patient consulted provided who ruled out meningitis. The patient reported no localized reaction or any previous problems with vaccines. Outcome of the events was recovered. The case was assessed as non-serious. causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Wound secretion
Clinical narrative: Case number PHHY2015US032819, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554086) website on 16 MAR 2015 and with follow up information received from the quality assurance department (reference number: 360894) on 27 MAR 2015, with the follow-up information received from Quality Assurance Department (reference number: 360894) on 23 APR 2015. This report refers to a 62-year-old female patient. Her current condition included hypertension (controlled). Concomitant medication was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 146404) intramuscularly on right arm on 12 NOV 2014. On 14 NOV 2014, the patient had an open oozing wound which was in dime size. Final outcome of the event reported as recovered. Seriousness of the event reported as non-serious. Causality of the event was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN 2014/2015 vaccine (batch number: 146404) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 360894) on 27 MAR 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 360894) on 23 APR 2045: Updated FLUVIRIN 2014/2015 vaccine batch review report.
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Nausea, Peripheral swelling, Vomiting
Clinical narrative: Case number PHHY2015US033903, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 554128) website on 16 MAR 2015. This report refers to a female patient of  unspecified age. Her medical history and concomitant medication was not reported. Vaccination history included administration of seasonal influenza  vaccine (manufacturer and batch number: not reported) and experienced events (See cases: PHHY2015US034581, PHHY2015US034583). She was vaccinated with FLUVIRIN 2014/2015 (batch number: 014031A) intramuscularly on 07 OCT 2014. ON the same day after vaccination at 05:00, she had nausea, diaphoresis, arm burning from shoulder tip to elbow. At 06:30, she continued to have the events. At 07:45, she had nausea, burning in forearm, induration of 10x12 cm from shoulder to elbow,  hot to touch, numbness and headache with no redness. On the same day, she was unable to work due to reaction. She took Benadryl 50 mg. At 21:00, she experienced still had slight nausea and arm was very painful but was able to lift arm, all joints ache and had  headache. On 08 OCT 2014 in the morning, she had slight nausea, arm was very sore, no headache and mild joint pain. The final outcome of the events was complete recovery. The events were assessed as  non-serious. The causality assessment of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Arthralgia, Burning sensation, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Case number PHHY2015US033903, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 554128) website on 16 MAR 2015. This report refers to a female patient of  unspecified age. Her medical history and concomitant medication was not reported. Vaccination history included administration of seasonal influenza  vaccine (manufacturer and batch number: not reported) and experienced events (See cases: PHHY2015US034581, PHHY2015US034583). She was vaccinated with FLUVIRIN 2014/2015 (batch number: 014031A) intramuscularly on 07 OCT 2014. ON the same day after vaccination at 05:00, she had nausea, diaphoresis, arm burning from shoulder tip to elbow. At 06:30, she continued to have the events. At 07:45, she had nausea, burning in forearm, induration of 10x12 cm from shoulder to elbow,  hot to touch, numbness and headache with no redness. On the same day, she was unable to work due to reaction. She took Benadryl 50 mg. At 21:00, she experienced still had slight nausea and arm was very painful but was able to lift arm, all joints ache and had  headache. On 08 OCT 2014 in the morning, she had slight nausea, arm was very sore, no headache and mild joint pain. The final outcome of the events was complete recovery. The events were assessed as  non-serious. The causality assessment of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Impaired work ability, Induration, Nausea, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2015US033903, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 554128) website on 16 MAR 2015. This report refers to a female patient of  unspecified age. Her medical history and concomitant medication was not reported. Vaccination history included administration of seasonal influenza  vaccine (manufacturer and batch number: not reported) and experienced events (See cases: PHHY2015US034581, PHHY2015US034583). She was vaccinated with FLUVIRIN 2014/2015 (batch number: 014031A) intramuscularly on 07 OCT 2014. ON the same day after vaccination at 05:00, she had nausea, diaphoresis, arm burning from shoulder tip to elbow. At 06:30, she continued to have the events. At 07:45, she had nausea, burning in forearm, induration of 10x12 cm from shoulder to elbow,  hot to touch, numbness and headache with no redness. On the same day, she was unable to work due to reaction. She took Benadryl 50 mg. At 21:00, she experienced still had slight nausea and arm was very painful but was able to lift arm, all joints ache and had  headache. On 08 OCT 2014 in the morning, she had slight nausea, arm was very sore, no headache and mild joint pain. The final outcome of the events was complete recovery. The events were assessed as  non-serious. The causality assessment of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia, Swelling, White blood cell count increased
Clinical narrative: Case number PHHY2015US032812, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554371) website on 16 MAR 2015. This report refers to a 43-year-old female patient. Her historical conditions and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413801) and PNEUMOVAX (other manufacturer and batch number: K007262) intramuscularly on 13 NOV 2014. On the same date, after vaccination the patient experienced fever, redness, swelling and lab test of white blood cell (WBC) showed increased WBC. The patient was treated with antibiotics. Following the events, the patient had an emergency visit. Final outcome of the events reported as recovered. Seriousness of the events reported as non-serious. Causality of the events was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Case number PHHY2015US033184, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554422) website on 16 MAR 2015. This report refers to a 54-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412601) intramuscularly on 23 OCT 2014. On the same day after vaccination, the patient developed pain in left shoulder after receiving flu shot and pain was persistent with movement of her (L) shoulder. The outcome of the event was unknown. The event was assessed as non-serious. The causality assessment of the event was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, White blood cell count increased
Clinical narrative: Case number PHHY2015US032790, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554433) website on 16 MAR 2015. This report refers to a 62-year-old female patient. Concurrent conditions included controlled type 2 diabetes mellitus, hypertension, allergic rhinitis and asthma. Concomitant medications were not reported. On 17 NOV 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413401) into left arm intramuscularly and PNEUMOVAX (other manufacturer, batch number K009876) into right arm intramuscularly. On the same date, after vaccinations the patient experienced severe acute myalgia to right upper extremity. Due to this patient wen to local ER. The pain score was 10/10. The laboratory data showed normal CMP and WBC at 14 (unspecified units). The patient did not undergo manual difference. Outcome of the events was condition unchanged. The events were assessed as non-serious. Causality of the events was not reported.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US116485 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 554526) on 10 SEP 2015. This report refers toa 3 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412201) in the right arm, HAVRIX (other manufacturer, batch number: 4B299) in the left arm. INFANRIX (other manufacturer, batch number: 93HY5) in the left arm; all vaccines administered intramuscularly on 06 NOV 2014. On 07 NOV 2014, he experienced redness, swelling, warmth and itching surrounding the injection site. He had no swollen lips, difficulty in breathing or hives. He was given diphenhydramine as treatment and parents were advised emergency precautions. The events outcome was reported as complete recovery. The event was reported as non-serious. The causality of the events was not reported.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve injury, Syncope
Clinical narrative: Case number PHHY2015US033180, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554807) website on 16 MAR 2015. This report refers to a 20-year-old male patient. His medical history and concomitant medications was not reported. His concurrent condition included allergies to nuts. He was vaccinat4d with FLUVIRIN 2014/2015 (batch number: 145601) intramuscularly into the right arm on 18 NOV 2014. On the same day after vaccination, the vaccine had appeared to hit the nerve in arm and the patient fainted. The outcome of the events was complete recovery. The events were assessed as non-serious. The causality assessment of the events was not reported.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Neuralgia
Clinical narrative: Case number PHHY2015US033178, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555058) website on 16 MAR 2015. This report refers to a 90-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412901) intramuscularly into the left arm on 10 OCT 2014. On 11 OCT 2014, she had radiating nerve pain that shot down her arm. She was unable to sleep and went to the local urgent care where she was given cortisone shot that relieved her pain. The patient stated that the event lasted for three days. The outcome of the events was complete recovery. The events were assessed as non-serious. The causality assessment of the events was not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Case number PHHY2015US033033, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 555204) on 16 Mar 2015. This report refers to a 63-year-old female patient. Her historical conditions were not reported. Concomitant medication included lisinopril/hydrochlorothiazide (20/25). She was vaccinated with FLUVIRIN, (batch number: 1415404) intramuscularly in the right arm on 16 Oct 2014. On 17 Oct 2014, the patient experienced bruising and hurting arm lasting for few weeks. Final outcome of the events was unknown. Seriousness of the events reported as non-serious. Causality of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Anxiety, Dyspnoea, Erythema, Inflammation, Swelling
Clinical narrative: Case number PHHY2015US032725, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555989) web site on 16 Mar 2015. This report refers to a 62-year-old male patient. His historical conditions and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly, PNEUMOVAX (other manufacturer and batch number: K010466) intramuscularly and ZOSTAVAX (other manufacturer and batch number: K010968) subcutaneously on 24 Nov 2014. On 25 Nov 2014, the patient experienced redness, swelling, inflammation, difficulty breathing and anxiety. Final outcome of the events was unknown. Seriousness of the events reported as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Palpitations
Clinical narrative: Case number PHHY2015US033273, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 556083) website on 16 Mar 2015, with a follow up report received on 10 Aug 2015. This report refers to a 31 year old female patient. Her medical history included pregnancy in the past. She was vaccinated with FLUVIRIN, (batch number: 1410901) intramuscularly into left arm on 08 Oct 2014. On the same day after vaccination, the patient was noted to be pregnant which she denied initially. Her heart was racing when she re-visited the clinic. The events were reported as non-serious. Outcome of the events was unknown. Causality of the events was not reported. Follow up report received on 10 Aug 2015: updated lost to follow up information.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Vaccination error
Clinical narrative: Case number PHHY2015US033303, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556102) website on 16 MAR 2015. This report refers to a 38 year old male patient. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412501) into the left  arm on 28 OCT 2014. It was reported that the patient might have  received an under dose of vaccine or a possible second dose was given. There was a vaccination error. No adverse events were reported following the vaccination error. The case reported as non-serious.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Vaccination error
Clinical narrative: Case number PHHY2015US033310, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 556105) website on 16 Mar 2015. This report refers to a 42-year-old female patient. Historical conditions and concomitant medication were none. She was vaccinated with FLUVIRIN, (batch number: 1412501) intramuscularly into the right arm on 28 Oct 2014. She might had an under-dose of vaccine or a possible second dose was given to the patient. There was a vaccination error. No adverse event reported following this vaccination error. The case reported as non-serious.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2015US033319, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556217) website on 16 MAR 2015. This report refers to a 55 year old male patient. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412501) into the right arm intramuscularly on 28 OCT 2014. It was reported that the patient received an under dose of vaccine or a possible second dose was given to the patient. No adverse events were reported following the maladministration. The case reported as non-serious.