chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2014US006152 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 512310) web site on 06 Jan 2014. This report refers to a 65-year-old polymedicated female patient. Her concurrent conditions included asthma and allergic to penicillin and iodine. She was vaccinated with FLUVIRIN (batch number: 310101) intramuscularly on 07 Nov 2013. On the same day, she was also vaccinated with PNEUMOVAX (other manufacturer and batch number: 006931) intramuscularly and ZOSTAVAX (other manufacturer and batch number: J006153) subcutaneously. On 08 Nov 2013, one day after vaccinations, she developed a red, swollen rash on the shingle shot injection site (left arm) around 3 inch length. Outcome of the events was reported as condition unchanged as of 10 Nov 2013. Seriousness and causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2014US001070 is an initial spontaneous report received from a consumer Vaccine Adverse Event Reporting System (VAERS, reference number: 5102419) website on 06 Jan 2014. This report refers to a 64-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly into left arm on 19 Sep 2013. On the same day, she was also vaccinated with PNEUMOVAX (other manufacturer and batch number: 14014283) intramuscularly into left arm. On the same day, post vaccinations, soreness began within 4-6 hrs and worsened 24 hrs period. 24 hrs after shots she experienced chills and fever of 101.9 degrees. It was reported that the pain arm was severe. She had an improvement after 48 hrs. Final outcome of the event was reported as recovered. Seriousness and causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2014US001075 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 512457) website on 06 Jan 2014. This report refers to a 43-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number: 1308301) into right arm on 22 Oct 2013. On 08 Nov 2013, 17 days after vaccination, her shoulder where shot given hurt immensely, was sore and she could hardly lift it over her shoulder. Outcome of the events was condition unchanged as of 11 Nov 2013. Seriousness and causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2014US001080 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 512460) website on 06 Jan 2014. This report refers to a 65-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1310101) intramuscularly into left arm on 04 Nov 2013. On the same day, she was also vaccinated with PNEUMOVAX (other manufacturer and batch number: J004747) intramuscularly into right arm. On 05 Nov 2013, one day after vaccinations, she experienced pain and difficulty moving left arm (extreme pain). She went to emergency room due to these events. She was prescribed urgent care with antibiotics for 10 days, ibuprofen and narcotic and was recovered on 12 Nov 2013. Seriousness and causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Insomnia, Pain
Clinical narrative: Case number PHHY2014US001083 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 512560) website on 06 JAN 2014. This report refers to a 62-year-old poly medicated female patient. Her medical history was not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309101) intramuscularly into right arm on 08 NOV 2013. She experienced lot of pain immediately after her flu shot administration. She has had pain for last 5 days to the point where she cannot lay on that arm at night. Outcome of the event was condition unchanged as of 12 NOV 2013. Seriousness and causality of the event was not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Case number PHHY2014US001090 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 512587) website on 06 Jan 2014. This report refers to a 40-year-old female patient. Her medical history was not reported. Concomitant medication included ZOLOFT. She was vaccinated with FLUVIRIN, (batch number: 1308801) intramuscularly into left arm on 25 Oct 2013. On 28 Oct 2013, three days after vaccination, she experienced rash on abdomen and mild pruritis. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Rash, Tenderness
Clinical narrative: Case number PHHY2014US001092 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 512588) website on 06 Jan 2014. This report refers to a 58-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309501) intramuscularly into left arm on 30 Oct 2013. On the same day, post vaccination, she experienced tenderness, rash, swelling and pain that radiated 4 to 6 inches from the injection site down her left arm. Outcome of the events was condition unchanged as of 12 Nov 2013. Seriousness and causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Myalgia, Neuralgia, Tenderness
Clinical narrative: Case number PHHY2014US001100 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 512615) website on 06 JAN 2014. This report refers to a 58-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13464P) intramuscularly into arm on 04 NOV 2013. On the same day, she was also vaccinated with Pneumovax (other manufacturer and batch number: J004334) intramuscularly into arm. On the same day, post vaccinations, she experienced muscle soreness, tenderness and nerve pain from neck, injection site and arm. Soreness has subsided, however, nerve pain from neck to arm after 6 days persists. Seriousness and causality of the events was not reported.
Age: 53.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US001106 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 512624) website on 06 Jan 2014. This report refers to a 53-year-old patient of an unknown gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly into left arm on 05 Nov 2013. On the same day, post vaccination, the patient experienced pain, swelling and redness around the injection site. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Case number PHHY2014US001109 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 512712) website on 06 JAN 2014. This report refers to a 35-year-old male patient. His medical history was not reported. Concomitant medications included Clonazepam, Zolpidem and Fluoxetine. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 13425P) intramuscularly into right arm on 29 OCT 2013. On 30 OCT 2013, one day after vaccination, he experienced pain at the injection site and down the arm. Very painful and sore muscle and cannot lift arm up. It was hard for him to drive and function normally without  muscle pain. Outcome of the events was reported as condition unchanged as of 13 NOV 2013. Seriousness and causality of the events was not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Case number PHHY2014US001116 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 512715) website on 06 JAN 2014. This report refers to a 40-year-old female patient. She had a medical history of asthma and her historical drug included penicillin levofloxacin, moxifloxacin. Her concomitant medications included Singulair. On 11 NOV 2013, she was vaccinated with FLUVIRIN 2013/2014 (batch number 13425P) intramuscularly in the left arm. On 12 NOV 2013, after vaccination, she woke up low grade fever and experienced joint and muscle pain along with headache and mild nausea. The event outcome was reported as completely recovered as of 12 NOV 2013. The seriousness and causality of the events were not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2014US001136 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 512822) website on 06 Jan 2014. This report refers to a 55-year-old female patient who had a current condition of bipolar disorder. Her medical history included chronic pain and seizures. Her concomitant medications were not reported. On 30 Aug 2013, she was vaccinated with FLUVIRIN, (batch number: 1307601) intramuscularly in the arm. On the same day after vaccination, she felt hurt at the site of vaccination. On 30 Oct 2013, she reported via call, that she was still experiencing the event. The event outcome was reported as condition unchanged as of 06 Nov 2013. The seriousness and causality of the events were not reported.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US001138 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 512826) website on 06 Jan 2014. This report refers to a 47-year-old female patient. Her medical history and concomitant medications were not reported. on 05 Nov 2013, she was vaccinated with FLUVIRIN, (batch number: 1307601) along with PNEUMOVAX, (batch number: J007059) intramuscularly in the left arm. On 06 Nov 2013, she experienced redness, soreness, and slight swelling at injection site. On an unknown date, she visited the emergency room. The event outcome was reported as condition unchanged as of 07 Nov 2013. The seriousness and causality of the events were not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Case number PHHY2014US001160 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 512899) on 06 JAN 2014. This report refers to a 30 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13471P) into left arm on 11 NOV 2013. On the same day after vaccination, se experienced redness and soreness at site of injection  (it hurt as the injection was given) and the circle of redness was about 1 inch in diameter. The vaccination area felt like a bruise and itched sometimes. The outcome of the events was reported as condition unchanged as of 13 NOV 2013. The seriousness and causality of the events were not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2014US013269, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513078) website on 03 FEB 2014. This report refers to a 53-year-old female patient. Her medical history was not reported and concomitant medication included levothyroxine and simvastatin. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 130959) intramuscularly in the left arm on 26 OCT 2013. Within 24 hours of vaccination, she experienced hives on both legs. On third and fourth day after vaccination (28 or 29 OCT 2013), she developed hives up back and elbows. She was visited to the emergency room or physician. The final outcome of the events was reported as condition unchanged as of 14 NOV 2013. The seriousness and causality of the events were not reported. No additional information was available.
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Nodule
Clinical narrative: Case number PHHY2014US013349, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513136) website on 03 FEB 2014. This report refers to a 59-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 13402P) intramuscularly in the left arm on 03 OCT 2013. On the same day after vaccination, he experienced swelling at injection site and know on injected arm. The final outcome of the events was reported as condition unchanged as of 14 NOV 2013. The seriousness and causality of the events were not reported. No additional information was available.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Case number PHHY2014US013359, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513261) website on 03 FEB 2014. This report refers to a 51-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308301) on 11 OCT 2014. On 12 OCT 2013, she experienced a rash on her stomach which was red, blotchy, and itchy. She took Benadryl and a topical anti-itch cream. The rash persisted for 4 days and it spread to the arms. The patient got recovered from the events on an unknown date. The seriousness and causality of the events were not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Case number PHHY2014US013402, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513271) website on 03 FEB 2014. This report refers to a 49-year old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1342SP) intramuscularly in the left arm on 27 SEP 2013. On an unknown date, after vaccination she was unable to raise her arm above parallel and had swelling of hand. The final outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Paraesthesia
Clinical narrative: Case number PHHY2014US013426, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513294) website on 03 FEB 2014. This report refers to a 53-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309601) in the left arm on 10 OCT 2013. On the same date, 11 days after vaccination she experienced tingling in left arm. It was reported that the patient also had pain in the shoulder area. The patient visited the emergency room. The final outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2014US013470, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513306) website on 03 FEB 2014. This report refers to a 32-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: UH900AE) intramuscularly in the left arm on 27 OCT 2013. On the same date, after vaccination she experienced muscle ache, pain in arm and also had tingling in left arm which then spread towards collar bone and neck. Two days after vaccination, she had some chest tightness. She was treated with Motrin and ice. Patient was referred to MD. The final outcome of the events reported as not recovered. The seriousness and causality of th events were not reported.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2014US043273 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 513318) website on 03 FEB 2014. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number 13472P) intramuscularly into left arm on 06 NOV 2013. Within 24 hours of vaccination, he experienced quarter sized redness, warm and raised at site of vaccination. He also experienced normal soreness following vaccination. Outcome of the events was reported as condition unchanged as of 07 NOV 2013. Seriousness and causality of the events was not reported.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US013303 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 513426) website on 03 FEB 2014. This report refers to an 80-year-old female patient. Her concurrent conditions included allergy to morphina, Levaquin, and adhesive bandage. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13462P) into left arm on 14 NOV 2013. On the same day, she was also vaccinated with Pneumovax (other manufacturer, batch number: J006242) into left arm. On the same day, post vaccinations, she experienced redness, swelling, heat in left arm above elbow. She took two Benadryl 25 mg on 16 NOV 2013 at 12:00 PM. When she went to pharmacy to report reaction she was told to go to emergency room. She was prescribed with Claritin and prednisone. Outcome of the events was reported as condition unchanged as of 16 NOV 2013. Seriousness and causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity, X-ray normal
Clinical narrative: Case number PHHY2014US013308 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 513440) website on 03 FEB 2014. This report refers to a 27-year-old female patient. Her medical history was not reported. Concomitant medication included "Minestrin 24 FE". She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309701) on 23 OCT 2013. She experienced arm pain and decrease range of motion which started day after vaccine. She had a visit to emergency room. She had an X-ray imaging which showed no signs of damage. She started physical therapy. Outcome of the events was reported as condition unchanged as of 15 NOV 2013. Seriousness and causality of the events as not reported.  Following an internal review on 18 FEB 2014 of the data received on 03 FEB 2014, it was found that the event "joint range of motion decreased" was wrongly coded instead of "injected limb mobility decreased". Hence the event was recoded.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache
Clinical narrative: Case number PHHY2014US013847, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513553) website on 03 FEB 2014. This report refers to a 04-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2012/2013 (batch number: 1308501) in the left arm on 08 JAN 2013. On the same day after vaccination , he experienced stomach ache and headache. The final outcome of the events was reported as complete recovery as of 09 JAN 2013. The seriousness and causality of the events were not reported. No additional information was available.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Malaise, Nausea, Pyrexia, Respiratory tract congestion
Clinical narrative: Case number PHHY2014US007045 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513653) website on 20 JAN 2014. This report refers to a 35-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13394P) intramuscularly into left arm on 30 SEP 2013. She felt ill 2 days post flu vaccination; noted to have congestion, weakness and nausea 4 days later, have had fever 5 days later. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2014US01378 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 513676) website on 03 FEB 2014. This report refers to a 27 year old female patient. Her medical history was not reported and concomitant medication included Microgestin. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308601) intramuscularly in the left arm on 10 OCT 2013. On 13 NOV 2013 at 21:30 PM, she reported that, she is still experiencing pain and limited mobility of her left arm from 10 OCT 2013 without fever, swelling and redness. The final outcome of the events was reported as condition unchanged as of 14  NOV 2013. The seriousness and causality of the events were not reported. No additional information was available.
Sex: F
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Case number PHHY2014US013910, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513688) website on 03 Feb 2014. This report refers to a 62-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN, (batch number: 1304201) intramuscularly in the right arm on 16 Nov 2013. On 17 Nov 2013, she experienced back pain. The final outcome of the event was reported as condition unchanged as of 18 Nov 2013. The seriousness and causality of the event were not reported. No additional information was available.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US013900 is an initial spontaneous report receivd from Vaccine Adverse Event Reporting System (VAERS reference number: 513693) website on 03 Feb 2014. This report refers to a 52-year-old female patient. Her medical history was not reported. Her concomitant medication included Levothyroxine. She was vaccinated with FLUVIRIN (batch number: 1308001) in to he left arm on 31 Oct 2013. She came back to the pharmacy on 18 Nov 2013, complaining that she was still experiencing pain in her arm from the Flu shot. Final outcome of the event was reported as condition unchanged as on 18 Nov 2013. No further information about seriousness and causality was reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US013905 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 513703) website on 03 FEB 2014. This report refers to a 45-year-old female patient. Her medical history included allergy to sulfa, Biaxin, various foods, tress, pollen, grass, etc. Her concomitant medication was not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch  number: 1308301) in to the left arm on 13 NOV 2013. On the same day after vaccination, she experienced burning sensation at the injection site and surrounding area that lasted approximately 30 minutes. Approximately two to three inches of area around the injection site swelled, became hard, warm to the touch and red. The reaction worsened and became redder as the day went on and became hot to the touch and lasted until 16 NOV 2013. The area was more  pink then red but it was still swollen. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Case number PHHY2014US013906 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 513756) website on 03 Feb 2014: This report refers to a patient of unknown age and gender. This patient's medical history was not reported. Concomitant medications included Fluoxetine, Vitamin B12 injection, Atorvastatin and Amlodipine. This patient was vaccinated with FLUVIRIN, (batch number: 1309301) along with PNEUMOVAX, (batch number: H021941) on 14 Oct 2013. Both the vaccines were administered in the left arm. On the same day after vaccinations, this patient's left upper arm became quite swollen. The patient visited emergency room (ER) following the reaction. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chest discomfort, Pulmonary pain
Clinical narrative: Case number PHHY2014US012782, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513779) website on 03 Feb 2014. This report refers to a 57-year-old female patient. Her medical history included asthma and short of breath with exertion. Her current condition included cold (no fever) started approximately two weeks before vaccination. Concomitant drugs included ADVAIR and MAXAIRE. On 23 Oct 2013, she was vaccinated with FLUVIRIN, (batch number: 13431P) in the left arm and BOOSTRIX, (batch number: 4ZB4N) in the right arm. On the same date, 2-3 hours after vaccinations she experienced chest tightness and "ache in lungs". She used inhalers and got some relief. Her symptoms continued with lessening affects till 24 Oct 2013 and she did not seek any medical attention. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US013865 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 513781) website on 03 FEB 2014. This report refers to a 66-year-old poly medicated female patient. Her concurrent conditions included asthma, diabetes mellitus and kidney disease. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309201) intramuscularly into left arm on 07 OCT 2013. On 08 OCT 2013, one day after vaccination, she experienced upper arm sore and that did not lover long period of time. She had to see doctor for pain. Outcome of the event was reported as condition unchanged as of 13 NOV 2013. Seriousness and causality of the event was not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia
Clinical narrative: Case number PHHY2014US013866 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513785) website on 03 FEB 2014. This report refers to a 28-ear old female patient. Her medical history was not reported. Concomitant medication included Nuvaring. She was vaccinated with FLUVIRIN 2013/2014 (batch number 1308501) intramuscularly into left arm on 21 SEP 2013. On 22 SEP 2013, one day after vaccination, she experienced numbness in the arm where flu shot was given. It was code to 2 months and no improvement was noticed. She had seen her primary physician but was referred to a physical therapist. Outcome of the event was reported as condition unchanged as of 14 NOV 2013. Seriousness and causality of the event was not reported.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2014US013867 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number 513790) website on 03 FEB 2014. This report refers to an 88-year-old poly medicated female patient. Her concurrent condition included diabetes. She was vaccinated with FLUVIRIN 2013/2014 (batch number 1307701) intramuscularly in to left arm in 12 SEP 2013. She experienced pain in left arm day after vaccination . She called pharmacist 2 weeks after vaccination with complaint of continued severe arm pain stating she can't raise her arm since getting shot, has to use right arm to left arm for activities like dressing. She was been taking ibuprofen 400 mg OTC at AM and PM. She was advised to contact physician. Outcome of the events was reported as condition unchanged as of 05 OCT 2013. Seriousness and causality of the events was not reported.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia, Skin tightness
Clinical narrative: Case number PHHY2014US013874 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513841) website on 03 FEB 2014. This report refers to a 46-year old female patient. Her medical history included removal of her spleen. Concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1310101) intramuscularly into right arm on 15 NOV 2013. On the same day, she was also vaccinated with Pneumovax (other manufacturer, batch number H02194) intramuscularly on right arm. On 16 NOV 2013, one day after vaccination, she experienced reactioin at injection site stating that the area being red, swollen and tight. She had also run a fever of 103 degrees F over the weekend. Outcome of the events was reported as condition unchanged as of 19 NOV 2013. Seriousness and causality of the events was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US013875 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 513847) website on 03 FEB 2014. This report refers to a 45-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number 13391P) subcutaneously into left arm on 07 NOV 2013. On the same day, post vaccination , she experienced severe muscle tenderness and sensitivity at injection site. The pain worsened daily after the shot had been given. On 19 NOV 2013, she said it feels as though there was a ball in her muscle when she touches her deltoid. Symptoms were not getting better as of 19 NOV 2013. Seriousness and causality of the events was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site induration, Injection site reaction, Myalgia
Clinical narrative: Case number PHHY2014US013875 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 513847) website on 03 FEB 2014. This report refers to a 45-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number 13391P) subcutaneously into left arm on 07 NOV 2013. On the same day, post vaccination , she experienced severe muscle tenderness and sensitivity at injection site. The pain worsened daily after the shot had been given. On 19 NOV 2013, she said it feels as though there was a ball in her muscle when she touches her deltoid. Symptoms were not getting better as of 19 NOV 2013. Seriousness and causality of the events was not reported.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash generalised, Urticaria
Clinical narrative: Case number PHHY2014US007357 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 513894 website on 20 JAN 2014. This report refers to a 47-year-old male patient. Past medical history included allergic to eggs and concomitant medications were not reported. It was reported that at the time of vaccination with FLUVIRIN he was not sick. He was vaccinated with FLUVIRIN 2013/2014 (batch number 1308511) into the right arm intramuscularly on 23 SEP 2013. On the same day after vaccination, he developed rash on his body, rash on arms along with redness and hives. He visited the emergency room (ER) following these events. Treatment for the events was rendered with Benadryl. The outcome of the events was complete recovery. The seriousness and causality of the events were not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Paraesthesia
Clinical narrative: Case number PHHY2014US013879 is an initial spontaneous report received from the Vaccine Event Reporting System (VAERS reference number 513907) website on 03 FEB 2014. This report refers to a 64-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number 1309701) into left arm on 08 NOV 2013. She had a sudden strange cold feeling. She also had feeling of pins and needles on tongue and lips. These occurred about 1 hr after the vaccination. She responded to diphenhydramine and events recovered. Seriousness and causality of the events was not reported.  Following an internal review on 18 FEB 2014 of the data received on 03 FEB 2014, it was found that the event "feeling abnormal" was wrongly coded. Hence it was removed.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: Vaccine Adverse Event Reporting System (VAERS reference number 513916) website on 03 FEB 2014. This report refers to a 41-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number 1309701) into left arm on 28 OCT 2013. She felt like runny bone was hit although the needle hit no bone. On the same day post vaccination, she experienced tingling and numbness in arm; now she cannot raise her arm. She had a visit to emergency room due to these events. Outcome of the events was reported as condition unchanged as of 19  NOV 2013. Seriousness and causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Case number PHHY2014US007174 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 514127) website on 20 JAN 2014. This report refers to a 49-year-old female patient. Past medical history included diabetes mellitus, hyperlipidemia, hypothyroidism and thyroid cancer. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1310101) intramuscularly in to the left arm, on 18 NOV 2013. On 20  NOV 2013, she was evaluated at health care clinic and was diagnosed with a localized reaction to influenza vaccine. Her site would be rechecked the next day and intermittent application of ice was suggested as treatment measure. Final outcome was reported as condition unchanged as of 20 NOV 2013. The seriousness and causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2014US013834 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 514144) website on 03 FEB 2014. This report refers to a 48-year-old female patient. Past medical history included tetanus and historical drugs included Darvocet and Gly oxide. She was administering multiple (unspecified) concomitant medications. She was vaccinated with FLUVIRIN 2013/2014 (batch number 13464P) intramuscularly into the left arm on 14 NOV 2013. On same day after vaccination , she experienced hives on arms and legs. Also she experienced itching. She did not have respiratory symptoms. She saw her physician and treatment for the events was rendered with steroids. She visited the emergency room (ER) following this reaction. This final outcome of the event hives were recovered and itching was not recovered as of 15 NOV 2013. The seriousness and causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Case number PHHY2014US012775 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 514605) website on 03 FEB 2014. This report refers to a 66 year old female patient. Her medical history was not reported and her concomitant medications included Levothyroxin, Gemfibrozil, and Singulair. She was vaccinated with FLUVIRIN 2012/2013 (batch number: 49281039278) intramuscularly into right arm on 15 OCT 2012. On the same day after vaccination, she experienced itching at injection site which did not stop even after one year of vaccination. She did not experience redness, swelling or other reaction. The outcome of the event was reported as condition unchanged as of 25 NOV 2013. The causality and seriousness of the event were not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Case number PHHY2014US014554, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 514965) website on 03 FEB 2014. This report refers to a 38-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2013/2014 9batch number 1309501) intramuscularly in the right arm on 05 NOV 2013. On the same day after vaccination, she experienced arm pain and cannot lift the arm past mid body without pain. The final outcome of the events was reported as condition unchanged as of 27 NOV 2013. The seriousness and causality of the events were not reported. No additional information was available.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Case number PHHY2014US007010 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number 515288) website on 20 JAN 2014. This report refers to a 37-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number 1309401) intramuscularly into left arm on 21 NOV 2013. He broke out with itchy, red hives about an hour after vaccination. He came back to pharmacy two days later and did present with rash. Suggested to try oral Benadryl and contact primary care physician. Outcome of the events was reported as condition unchanged as of 24 NOV 2013. Seriousness and causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash macular
Clinical narrative: Case number PHHY2014US007184 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number 515313) website on 20 JAN 2014. This report refers to a 58-year-old female patient. Past medical history included osteoporosis. GERD and allergies to penicillin, sulfa and ferrous sulfate. Her concomitant medications included Fosamax and Pantoprazole. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly in to the left arm on 22 OCT 2013. On 29 OCT 2013, she called up the physician's office and stated she thought she had a rash down her arm as a result of the flu injection, which started four days after vaccination. The physician was notified and orders were given to her to take Benadryl during the night and Claritin during the day. She was instructed to call the clinic again for a visit to the physician if no improvement was seen by 31 OCT 2013. On 15 NOV 2013, there was a slight rash all over and she was wondering if it was from the flu shot. A phone call was made to the CDC on 22 NOV 2013 to clarify if the rash was possibly from the influenza vaccine given. She reported that she experienced an initial rash to the arm where injection was given. She was observed on an undetermined date and the health care professional noted that there was a very fine scattered macular generalized non-pruritic rash. When she was contacted on 02 DEC 2013, she stated that the rash seemed to be subsiding. On 02 DEC 2013, she was contacted again and she reported that the rash had completely resolved. The seriousness and causality of the events was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Case number PHHY2014US014543 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 515419) website on 03 FEB 2014. This report refers to a 32-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number 1308601) intramuscularly into right arm on 22 NOV 2013. On the same day, she was also vaccinated with Pneumovax (other manufacturer, batch number J009827) intramuscularly into right arm. On the same day, post vaccinations, she developed rash on arm and fever. She went to emergency room (ER) and was given intravenous fluids, Benadryl and antibiotics. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US094568 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516867) website on 24 JUN 2014. This report refers to a 79 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number 1309401) intramuscularly into left arm on 09 SEP 2013. On the same day after vaccination, he experienced pain in arm and the pain radiated to his hand. Treatment was rendered with warm compresses and ibuprofen. He was asked to see MD if the events persist. The reporter informed that the events "have been this way since he received the vaccine" (condition unchanged). The events were reported as non-serious. Causality was not reported.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain
Clinical narrative: Case number PHHY2014US095100 is an initial spontaneous report received from a pharmacist via the Vaccine Adverse Event Reporting System (VAERS reference number: 517024) web site on 24 Jun 2014. This report refers to a 69 year old female patient. Her vaccination history included vaccination with a pneumococcal vaccine (manufacturer and batch number: not reported) on unspecified date. She was a non-tobacco user. She was vaccinated with FLUVIRIN (batch number: 1309001) along with ZOSTAVAX (other manufacturer, batch number: J002777, expiry date: 07 Jun 2014) both via subcutaneous route into right arm on 09 Oct 2013. The ZOSTAVAX was given at a dose of 0.65 ml. On the same day, she was also given a diluent (unspecified) at 0.7 ml (batch number: J004088, expiry date: 31 Aug 2015) at right deltoid ('area at 5/8'). On an unknown day after vaccination, she experienced soreness. The pharmacist suggested her to massage as deep to help with the soreness. She did not seek medical attention. The outcome of soreness was unknown. The event was reported as non-serious. Causality was not reported.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Case number PHHY2014US0984850, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 517727) website on 24 JUL 2014. This report refers to a 52-year-old male patient. His medical history included penicillin allergy, epilepsy, diabetic and high cholesterol. He was vaccinated with FLUVIRIN 2013/2014 (batch number 1347) intramuscularly on 19 DEC 2013. On 23 DEC 2013, he experienced deep muscle pain. It was reported that his arm hurts to lift anything and he cannot even shake his right arm (after washing hands, he cannot shake water off his  hand). It was reported that the pain hurts from below shoulder to above inside of wrist. The final outcome of the events was not reported. The events reported as non-serious. The causality of the events was not reported.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US094465, is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS id: 517799) received on 24 JUL 2014. This report refers to a 25 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 13472P) intramuscular into left arm on 18 DEC 2013. On the same day the patient developed pain all the way down arm. He was advised to seek medical assistance if pain persists. The final outcome of the event was unknown. Seriousness and causality assessment was not reported.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Cough
Clinical narrative: Case number PHHY2014US094463, in an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517996) website on 24 JUL 2014. This report refers to a an 81-year old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: not reported) on 10 OCT 2013. On 17 OCT 2013, she experienced cough. The outcome of the event was condition unchanged. The event was reported as non-serious. Causality was not reported.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US055229 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 523140) website on 06 MAY 2014. This report refers to 15 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUCELVAX (batch number: 0100119) intramuscular into left arm on 08 JAN 2014. No adverse event was reported following this mal administration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014 of the data received on 06 MAY 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHHY2014US0555236 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 523142) website on 06 MAY 2014. This report refers to 15 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUCELVAX (batch number: 010011A) intramuscular into left arm on 08 JAN 2014. No adverse event was reported following this mal administration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 06 MAY 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".