chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates between 07-JAN-2016 and 25-JAN-2016, the patients were vaccinated with improperly stored ROTATEQ lot # K023159 (exp date 09-JUL-2016) (dose and frequency were not provided). No adverse effects were reported. Concomitant medications were not reported. Concomitant medications were not reported. No product quality complaint (PQC) was reported. The reporter stated that vaccines were stored at a temperature of 30 degrees Fahrenheit as lowest, for a time frame of 318 hours cumulative since 07-JAN-2016 to 25-JAN-2016. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 10-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot # L029466, expiration date 06-AUG-2017, exact dose and route of administration were not reported). No adverse effects were reported. The nurse also reported that the temperature excursion was secondary to human error. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-JAN-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot # L013188, expiration date: 02-NOV-2016 (exact dose was not reported). There were no concomitant medications provided. Administered doses of vaccines experienced the temperature excursion of 31.1 degrees Fahrenheit for 22 hours, 30 minutes. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-JAN-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot # L013188, expiration date: 02-NOV-2016 (exact dose was not reported). There were no concomitant medications provided. Administered doses of vaccines experienced the temperature excursion of 31.3 degrees Fahrenheit for 22 hours, 30 minutes. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unknown number of patients of unknown ages and genders. No concurrent or historical conditions were reported. Since 18-JAN-2016, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot # L026410, expiration date 15-FEB-2017), doses, routes and anatomical locations were not provided. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Temperature was reported as -11C, time frame 65.5 hours, outcome of excursion: supported. No previous temperature excursion was reported. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-SEP-2015, the patient was vaccinated with an improperly stored doses of ROTATEQ lot # L008053 with expiration date on 30-NOV-2016, oral, (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccines were exposed to temperature excursion of 34 degrees F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest pain, Local swelling, Nausea, Pain in extremity
Clinical narrative: Case number PHHY2014US148639, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540180) website on 13 Nov 2014. This report refers to a 54-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1411201) and PNEUMOVAX (batch number: K004542) both intramuscular into left arm on an unknown dates. On an unspecified date post vaccination she experienced pain down left arm and upper left chest area, swelling in left armpit area, upper back pain and some nausea. Outcome of the event was condition unchanged as of 18 AUG 2014. Causality assessment was not reported. Events were reported as non-serious.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Case number PHHY2014US153250 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System on 13 Nov 2014. This report refers to a 27 year old female patient. Her past medical history and concomitant medications were not reported. On 05 Aug 2014, she was vaccinated with FLUVIRIN (batch number: 144401) into her left arm. On the same day, four hours after the vaccination, she developed a red, hot circular rash measuring 10 cm X 13 cm. The patient used ice pack and was treated with ibuprofen for the events. The patient completely recovered from the events, 48 hours after the onset. The events were reported as non serious and the causality of the events was not reported.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Case number PHHY2014US149737, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540619) website on 13 NOV 2014. This report refers to a 47-year-old male patient. Historical conditions and current illness were none. Concomitant medications included benazepril and hydrochlorothiazide. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145201) intramuscularly on 06 AUG 2014. On 07 AUG 2014, he experienced cramps in his right leg, back, hip and chest. The outcome of the event was reported as not recovered. The event was reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Bacterial infection, Bacterial test positive, Blood count abnormal, Computerised tomogram abnormal
Clinical narrative: Case number PHHY2014US150111, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540689) website on 13 NOV 2014. This report refers to a 54-year-old female patient. Her medical history included HIV. Concomitant drugs included Lexiva, Combivir and cyclobenzaprine. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) intramuscularly in the left arm on 16 AUG 2014, she experienced chronic abdominal pain which was very sharp and she felt it was hard to walk. She went to emergency room and diagnosed with infection and poor blood count, although previously it was considered as good. Her abdominal CT scan revealed new infection in intestine and blood work found low grade bacterial infection. Final diagnosis was stated as intestinal infection. The final outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Gastrointestinal infection
Clinical narrative: Case number PHHY2014US150111, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540689) website on 13 NOV 2014. This report refers to a 54-year-old female patient. Her medical history included HIV. Concomitant drugs included Lexiva, Combivir and cyclobenzaprine. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) intramuscularly in the left arm on 16 AUG 2014, she experienced chronic abdominal pain which was very sharp and she felt it was hard to walk. She went to emergency room and diagnosed with infection and poor blood count, although previously it was considered as good. Her abdominal CT scan revealed new infection in intestine and blood work found low grade bacterial infection. Final diagnosis was stated as intestinal infection. The final outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Rash
Clinical narrative: Case number PHHY2014US150206, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540709) website on 13 NOV 2014. This report refers to a 61-year-old female patient. She had no known allergies. On 11 AUG 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 145002) intramuscularly in the right arm along with ZOSTAVAX (other manufacturer, batch number: J014810) intramuscular in the left arm. On 13 AUG 2014, she experienced severe swelling and redness around the site of injection. She had 3 inches of blister like appearance around injection site. She had a breakout around neck and it looked like spotted. The patient visited the emergency room. It was reported that the same was collected at physician's office (no further details provided). The outcome of the events reported as not recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site vesicles
Clinical narrative: Case number PHHY2014US149452, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540884) website on 13 NOV 2014. This report refers to a 66-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145223) intramuscularly into right arm on 22 AUG 2014. On 23 AUG 2014, the patient experienced blister, redness and inflammation at injection site. Outcome of the events was reported as unknown. These events were reported as non-serious. Causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Mastication disorder, Pain in jaw
Clinical narrative: Case number PHHY2014US149581, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 541053) website on 13 NOV 2014. This report refers to a 57-year-old female patient. Medical history included crohn's disease, systemic rheumatoid and osteoarthritis. Concomitant  medications included Nexium, Robaxin, Robinul forte, Claritin and piroxicam. She was vaccinated with FLUVIRIN 2014/2015 (batch number: V0481) intramuscularly into right arm on 19 AUG 2014. On 20 AUG 2014, about 12 hours after vaccination, she awoke with extreme lower left jaw pain, a muscular event. It prevented her from chewing on that side of the mouth for 3 days. The site of the pain was the lower jaw rear muscle/conjunction towards the back of the skull. After about three days of acute pain it dissipated as quickly as its onset. Final outcome of the events was reported as recovered. These events were reported as non-serious. Causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: Case number PHHY2014US153753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541275) website on 13 NOV 2014. This report refers to a 49-year-old female patient. Current conditions included slightly feverish the day before vaccination. Concomitant medications included venlafaxine, clonazepam and estradiol. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145002) into the left arm on 24 AUG 2014. On the same after vaccination, she had extreme fatigue and was sleeping all the time since receiving vaccine two days ago. Also she feels weak and feverish. The outcome of the events was unknown. The events were reported as non-serious; causality to be related to vaccine.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Neck pain
Clinical narrative: Case number PHHY2014US154002, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541331) website on 13 NOV 2014. This report refers to a 15-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) intramuscularly on 19 AUG 2014. On the same day after vaccination approximately starting at 09:00 PM, the patient experienced pain in neck radiating to engulf her head, causing a knife-stabbing like pain. She was taken to emergency room and pain subsided. She was not treated at the ER per patient mother. The outcome of the event was complete recovery. The event was reported as non-serious. Causality was not reported.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case number PHHY2014US153723, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541643) website on 13 NOV 2014. This report refers to a 26-year-old female patient. She had no reported allergies, birth defects or medical conditions or illnesses at the time of vaccination. Concomitant drug included Ortho-Tri-Cyclen. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145304) intramuscularly in the left arm on 28 AUG 2014. On the same date, after vaccination she experienced bleeding upon withdrawal of needle at injection site, soreness at injection site, soreness of injected left arm and stiffness of injected left arm. The final outcome of the events was unknown. The events reported as non serious. The causality of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Local swelling
Clinical narrative: Case number PHHY2014US150593 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 541648) website on 13 NOV 2014. This report refers to a 62 year old male patient. He had no medical history or current illness. Concomitant medication was not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145223) intramuscularly in left arm and ZOSTAVAX (other manufacturer, batch number K000727 ) subcutaneously in left arm both on 28 AUG 2014. On the same day after vaccination, he experienced swelling around his neck. Final outcome was complete recovery. The event was reported as non-serious. Causality was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2014US154150, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541895) website on 13 NOV 2014. This report refers 56-year-old female patient. Her concomitant medications included Abilify 15 mg, ibuprofen 800 mg and Augmentin 875 mg. On 28 AUG 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 145223) along with PNEUMOVAX (other manufacturer, batch number: K004483) both intramuscularly. On 31 AUG 2014, she experienced red arm which she felt as hot and swollen. It was reported that the patient used her arm to do heavy work the day after her vaccination. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Paraesthesia, Vision blurred
Clinical narrative: Case number PHHY2014US150046, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542113) website on 13 NOV 2014. This report refers to a 22-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: unknown) on 22 SEP 2014. On the same day, after vaccination, she experienced dizziness, tingling in feet and fuzzy vision. She went in emergency room due to these events. Outcome of the events was reported as unknown. The events was reported as non-serious. Causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Influenza like illness, Malaise, Pain, Peripheral swelling
Clinical narrative: Case number PHHY2014US154036, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542140) website on 13 NOV 2014. This report refers to a 43 year old female patient. Her medical history and concomitant medications was not report4ed. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145202) intramuscular into left arm and PNEUMOVAX (batch number: J009689, other manufacturer) intramuscular into right arm on 28 AUG 2014. On an unspecified date post vaccination she experienced swollen right arm, red hot rash and pain to touch. She described that her pain was very severe unbearable that she almost went to emergency room. Rash was about one and half inch, felt sick, headache and flu like. She had 2 separate vaccines on different arms; she complained about the arm where she had PNEUMOVAX. Outcome of the events was unknown. Events were reported as non-serious. Causality assessment was not reported.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Case number PHHY2014US154036, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542140) website on 13 NOV 2014. This report refers to a 43 year old female patient. Her medical history and concomitant medications was not report4ed. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145202) intramuscular into left arm and PNEUMOVAX (batch number: J009689, other manufacturer) intramuscular into right arm on 28 AUG 2014. On an unspecified date post vaccination she experienced swollen right arm, red hot rash and pain to touch. She described that her pain was very severe unbearable that she almost went to emergency room. Rash was about one and half inch, felt sick, headache and flu like. She had 2 separate vaccines on different arms; she complained about the arm where she had PNEUMOVAX. Outcome of the events was unknown. Events were reported as non-serious. Causality assessment was not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Case number PHHY2014US154082, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542206) website on 13 NOV 2014. This report refers to a 40 year old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410901) into left arm on 26 AUG 2014. On the same day post vaccination she experienced dizzy and nauseous immediately after vaccination. Patient sat down, put fan on her and gave water. She felt better and recovered in about 10 minutes. Outcome of th events was completely recovered. Events were reported as non-serious. Causality assessment was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Pain, Peripheral swelling, Rash generalised
Clinical narrative: Case number PHHY2014US150065, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542228) website on 13 NOV 2014. This report refers to a 29-year-old female patient. Medical history and concomitant medications were not reported. Concurrent illness included seasonal allergies. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145305) intramuscularly into right arm on 27 AUG 2014. On 30 AUG 2014, she experienced rash all over and pain. She also experienced swelling in feet, knees and hands which started in the evening and began to resolve slowly. She did not seek or require medical treatment. It was reported that the pain was moderate to severe. Final outcome of the events was reported as condition unchanged. These events were reported as non-serious. Causality of the events was not reported.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Urticaria
Clinical narrative: Case number PHHY2014US154100, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542244) website on 13 NOV 2014. This report refers to a 25 year old female patient. She had no known drug allergies and no environmental allergies. Concomitant medications included Gianvi oral contraceptive and TB skin test (no details provided). She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145303) intramuscular into left arm on 26 AUG 2014. On 27 AUG 2014, she developed hives on right arm. No other reactions. No treatment. Hives appeared approximately 24 hours after injection, warm discrete, 2 cm in diameter, raised, red and  minimal pruritus. Outcome of the events was completely recovered. Events were reported as non-serious. Causality assessment was not reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dysgeusia, Headache, Malaise
Clinical narrative: Case number PHHY2014US153744, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542631) website on 13 NOV 2014. This report refers to a 46-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: unknown) intramuscularly into left arm on 04 SEP 2014. Within few minutes after vaccination, the patient experienced metallic taste in mouth then later headache, backache and malaise. Outcome of the events was reported as recovered. These events were reported as non-serious. Causality of the events was not reported.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2014US155077, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542741) website on 13 NOV 2014. This report refers to an 84 year old male patient. His historical condition and concomitant medication was not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145304) intramuscularly in right arm on 04 SEP 2014. On an unknown date, the patient developed soreness at injection site with a little redness and sensation of pressure at raising arm. He sais that he would take Advil or Tylenol. Final outcome was unknown. Events were reported as non-serious. Causality was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Feeling abnormal, Feeling cold, Flatulence, Pyrexia
Clinical narrative: Case number PHHY2014US154204, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 542798) website on 13 NOV 2014. This report refers to a 61-year-old female patient. Historical conditions and current illness were none. Concomitant medication was none. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411301) intramuscularly on 07 SEP 2014. On the same day after vaccination, she experienced severe flatulence (atypical for her) lasting about four hours; followed by intense, profuse diarrhea. Diarrhea lasted another four hours or so. Also she had minor fever, chills which are not a concern. She still feels under-the-weather twenty-four hours later. The patient did not see a doctor. The outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Neck pain
Clinical narrative: Case number PHHY2014US150474, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542924) website on 13 NOV 2014. This report refers to a 46-year-old female patient. Her historical drugs included penicillin, sulfa drugs, morphine and ibuprofen. The patient was allergic to pineapple and strawberry. Her previous vaccination included tetanus vaccine. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410901) in the right arm on 03 SEP 2014. On 05 SEP 2014, she experienced pain radiating up her neck and in her chest and back. She had no trouble breathing. The outcome of the events was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia
Clinical narrative: Case number: PHHY2014US154965, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542959) website on 13 NOV 2014. This report refers to a 52-year-old female patient. Current condition included allergy to penicillin, acetyl salicylic acid, Celebrex and Vicodin. Concomitant medicaitons included amlodipine, omeprazole, Albuterol and paroxetine. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145221) intramuscularly on 08 SEP 2014. On the same day after vaccination, she experienced metallic taste in mouth and feelings of dizziness. She was instructed to sit down in store. The outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Vomiting
Clinical narrative: Case number PHHY2014US155231, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543142) on 13 NOV 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 2014/2015 (batch number: 1411001) intramuscularly in left arm on 08 SEP 2014. She was also vaccinated with PNEUMOVAX (other manufacturer, batch number: J004332) intramuscularly in right arm on 08 SEP 2014. It was reported that after 5 hours of vaccination she presented with swelling, redness in most of upper right arm as well as itching. She also experienced vomiting. She was advised to seek medical attention. She went to emergency room on 08 SEP 2014 and was told that the needle possibly hit a vein. She was feeling better. The outcome of the events was reported as condition improving . The health authority reported that the events were non-serious and causality of the events was not reported.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Induration, Nodule, Pain
Clinical narrative: Case number PHHY2014US154142, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543321) on 13 NOV 2014. This report refers to a 60 years old male patient. His medical history included high cholesterol. His current conditions included diabetes and hypertension. His concomitant medications include Zestoretic, Lipitor, Amaryl and Glucophase. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) intramuscularly in left arm on 04 SEP 2014. He was also vaccinated with ZOSTAVAX (other manufacturer, batch number: K000996) subcutaneously in right arm on 04 SEP 2014. It was reported that on 06 SEP 2014, 48 hours after vaccination he experienced red, painful, hard knot approximately half dollar size. On 10 SEP 2014 the knot has reduced in size and redness. The outcome of the event was reported as condition improving. The health authority reported that the events were non-serious and causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Case number PHHY2014US155261, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543323) on 13 NOV 2014. This report refers to a 66 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) intramuscularly on 06 SEP 2014. She was also vaccinated with PNEUMOVAX (other manufacturer, batch number: K001504) intramuscularly on 06 SEP 2014. On 08 SEP 2014, she presented with swollen arm which was red to touch and itching from shoulder to wrist. She was advised to take Benadryl and was observed. She visited emergency room on 08 SEP 2014 and was given antibiotics. The outcome of the events was reported as complete recovery. The health authority reported that the events were non-serious and causality of the events was not reported.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Injection site erythema, Injection site swelling, Pain, Tremor
Clinical narrative: Case number PHHY2014US155312, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543334) on 13 NOV 2014. This report refers to a 66 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145302) intramuscularly in left arm on 08 SEP 2014. He was also vaccinated with PNEUMOVAX (other manufacturer, batch number: K004483) intramuscularly in right arm on 08 SEP 2014. It was reported that he developed red raised bump at injection site. He was shaking and could not get warm. It was also reported that he experienced severe pain. He visited emergency room and was treated with Percocet. The outcome of the event was reported as complete recovery. The health authority reported that the events are non-serious and causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: Case number PHHY2014US154779, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543336) website on 13 NOV 2014. This report refers to a 61-year-old male patient. He had no known drug allergies. His current condition included abnormal blood pressure. On 03 SEP 2014, he was vaccinated with FLUVIRIN 2014/2015 (batch number: 145305) in the left arm along with ZOSTAVAX (other manufacturer, batch number: J013453) in the right arm. On 08 SEP 2014, he noticed discoloration of skin on both the arms and felt sore in arms. The outcome of the events reported as not recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Oral herpes, Pruritus, Rash, Rash erythematous
Clinical narrative: Case number PHHY2014US151662 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543337) website on 13 NOV 2014. This report refers to a 79 years old female patient. Her medical history wa snot reported and concomitant medications included Lotemax and Restasis ophthalmic gel. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145404) intramuscularly in the left arm on 08 SEP 2014. On 08 SEP 2014, 10 minutes after the shot, she developed red rashes on the left ankle and blotch on inside of upper right thigh, it was inflamed, red and itchy. Next morning, she got cold sores in the mouth and more rashes on the leg and the rashes were spreading up. She used a little bit of cortisone cream and by night time, rash spread on both leg and arms. It as affecting her joints now. She took one table of Zyrtec. On 10 SEP 2014 AM, rashes were blotchy and all over chest. She would be seeing a MD. The final outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the event was not reported.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Case number PHHY2014US151662 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543337) website on 13 NOV 2014. This report refers to a 79 years old female patient. Her medical history wa snot reported and concomitant medications included Lotemax and Restasis ophthalmic gel. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145404) intramuscularly in the left arm on 08 SEP 2014. On 08 SEP 2014, 10 minutes after the shot, she developed red rashes on the left ankle and blotch on inside of upper right thigh, it was inflamed, red and itchy. Next morning, she got cold sores in the mouth and more rashes on the leg and the rashes were spreading up. She used a little bit of cortisone cream and by night time, rash spread on both leg and arms. It as affecting her joints now. She took one table of Zyrtec. On 10 SEP 2014 AM, rashes were blotchy and all over chest. She would be seeing a MD. The final outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the event was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Fatigue, Lethargy
Clinical narrative: Case number PHHY2014US151301 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 543345) website on 13 NOV 2014. This report refers to a 61 years old male patient. His current condition included mycoplasma pneumonia for which he was undergoing current antibiotic treatment for over 1 year. His concomitant medications included azithromycin 500 mg, sulfamethoxazole/trimethroprim DS, desloratidine 5 mg and metformin 500 mg. He was vaccinated with FLUVIRIN 2014/2015 (batch number 1410901) intramuscularly in the right arm on 227 AUG 2014. On 28 AUG 2014, he experienced diarrhea, malaise, lethargy, weakness, fatigue, loss of appetite, swollen glands and rosacea. The final outcome was reported as condition unchanged. The events were reported non-serious. The causality of the event was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy, Malaise, Rosacea
Clinical narrative: Case number PHHY2014US151301 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 543345) website on 13 NOV 2014. This report refers to a 61 years old male patient. His current condition included mycoplasma pneumonia for which he was undergoing current antibiotic treatment for over 1 year. His concomitant medications included azithromycin 500 mg, sulfamethoxazole/trimethroprim DS, desloratidine 5 mg and metformin 500 mg. He was vaccinated with FLUVIRIN 2014/2015 (batch number 1410901) intramuscularly in the right arm on 227 AUG 2014. On 28 AUG 2014, he experienced diarrhea, malaise, lethargy, weakness, fatigue, loss of appetite, swollen glands and rosacea. The final outcome was reported as condition unchanged. The events were reported non-serious. The causality of the event was not reported.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Anticoagulation drug level increased, Injection site discolouration, Injection site pruritus
Clinical narrative: Case number PHHY2014US152030, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 5435131) on 13 NOV 2014. This report refers to a 59 year old female patient. Medical history was not reported. Concurrent conditions included asthma, hypertension and medical condition of blood clotting. Concomitant medication was Coumadin. She was vaccinated with FLUVIRIN 2014/2015 (batch number:1452001) in left arm on 21 AUG 2014. One hour after vaccination, the patient started to experience itching around the injection site. Later in that night, she developed blue/purple skin around injection site. She waited one day and on Saturday (sate not known) she went to see doctor. She was taken to emergency room. Physician found high Coumadin level in her blood. But physician assured her that high Coumadin level would go away in a couple of days and everything was normal. Final outcome was complete recovery. These events were reported as non-serious. Causality was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Insomnia, Musculoskeletal pain, Neck pain
Clinical narrative: Case number PHHY2014US151274, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543571) 13 NOV 2014. This report refers to a 48 year old female patient. Historical condition was not reported. Current condition was none. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2104/2015 (batch number: 1412901) and BOOSTRIX (other manufacturer, batch number: 7KM4D) both in right arm 10 SEP 2014. On the same day after vaccination, the patient developed extreme pain up into neck and shoulder. She could not sleep at night. pain level was reported as 10 (no further details given). There was no swelling or redness. She elevated her arm above her head for relief. The events felt more than normal reaction. The patient treatment included ibuprofen. Final outcome was condition unchanged. These events were reported as non-serious. Causality was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2014US151093, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543637) website on 13 NOV 2014. This report refers to a 67-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) intramuscularly into left arm on 15 AUG 2014. On 16 AUG 2014, she experienced soreness in arm. She had trouble lifting her arm to put on and take off her bra as if some nerve problem exists. Outcome of the events was reported as unknown. These events were reported as non-serious. Causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Case number PHHY2014US154651, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543703) website on 13 NOV 2014. This report refers to a 55 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated FLUVIRIN 2014/2015 (batch number: 1413301) intramuscular on 11 SEP 2014. On the same day post vaccination rash appeared on stomach and complained of nausea and vomiting. She was asked to go to emergency room. Outcome of t he events was unknown. Events were reported as non-serious. Causality assessment was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nodule, Pain, Swelling
Clinical narrative: Case numberPHHY2014US154663, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543708) website on 13 NOV 2014. This report refers to a 54 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145223) intramuscular on 08 SEP 2014. On 08 SEP 2014, she developed red, swollen, pain and knot. It was tennis ball size red circle. Outcome of the events was completely recovered. Events were reported as non-serious. Causality assessment was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2014US155202 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543715) website on 15 NOV 2014. This report refers to a 44-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412701) intramuscularly into left arm on an unknown date. She was also vaccinated with PNEUMOVAX (batch number: K009107, other manufacturer) intramuscularly into left arm on an unknown date. After vaccinations, on an unknown date, the patient experienced pain in arm, swelling and difficulty moving her arm. She went to emergency room due to these events. Outcome of the events was reported as unknown. These events were reported as non-serious. Causality of the events was not reported.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Insomnia, Limb immobilisation, Pain
Clinical narrative: Case number PHHY2014US154200, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543737) website on 13 NOV 2014. This report refers to a 42-year-old female patient. Concurrent condition included asthma. Concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410901) into right arm along with PNEUMOVAX (batch number: J004332, other manufacturer) into right arm and BOOSTRIX (batch number: AC52B110CA, other manufacturer) into left arm intramuscularly on 04 SEP 2014 at 03:30 PM. On the same day, at around 08:00 PM, the patient started experiencing shooting pain from shoulder to elbow. She also had trouble sleeping and immobility in right arm. The physician prescribed Lortab. Outcome of the events was reported as unknown. These events were reported as non-serious. Causality of the events was not reported.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US170973, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543801) website on 29 DEC 2014. This report refers to a 79-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307701) intramuscularly into the left arm on 08 OCT 2013. On 10 OCT 2013, the patient's arm started to hurt. It was reported that the patient believed that the needle had hit his bone. The patient had visited his primary doctor. The final outcome of the events was not recovered. The events were reported as non-serious. Causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity, Poor quality sleep
Clinical narrative: Case number PHHY2014US170920, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543808) website on 29 DEC 2014. This report refers to a 53-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141120) intramuscularly into the left arm on 12 AUG 2014. On 26 AUG 2014, the patient experienced pain in arm. The pain in arm was radiating to fingers and it progressed to decreased range of motion of the arm. The pain at times had bought the patient on her knees and wakes her up. The patient went to see a doctor and it was unknown if any tests were performed. The final outcome of the events was not recovered. The events were reported as non-serious. Causality was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Case number PHHY2014US171042 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 543813) on 29 DEC 2014. This report refers to a 36 years old female patient. Her current conditions included Human Immune deficiency Virus (HIV), hepatitis B and End Stage Renal Disease (ESRD) secondary to hypertension. Her concomitant medications were Adalat, Emla, Flonase, hydralazine, labetalol, Nephrocaps, Novir, Tivicay, Phoslo, Restoril and Sensipar. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly in the right arm on 02 SEP 2014. On 02 SEP 2014, she had complaints of scratchy throat 15 minutes after receiving the dose. She took Benadryl which gave some relief. She was treated with prednisone for 5 days and was instructed to pick up Benadryl for 3 days and Zantac for 5 days. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Insomnia, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2014US171051 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 543872) on 29 DEC 2014. This report refers to a 38 years old female patient. Her medical history was not reported and concomitant medications included pantoprazole and Ambien. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145225) in the left arm on 26 AUG 2014. On 15 SEP 2014, she experienced pain in shoulder area, decrease of usage in deltoid and biceps and numbness. She had sleeping difficulty. She believed that her neck muscle was trying to compensate and hence she had stiff neck. The outcome of events was reported s unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2014US171060, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544120) website on 29 DEC 2014. This report refers to a 69-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2014/2015 (batch number: 145205) intramuscularly instead of discussed FLUZONE HD (batch number: not reported) on 15 SEP 2014. No adverse event was reported following the maladministration (wrong vaccine administered).
Age: 58.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash pustular
Clinical narrative: Case number PHHY2014US171518, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544181) website on 29 DEC 2014. This report refers to a 58-year-old patient of unknown gender. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2014/2015 (batch number: 1411001) into the left arm on 03 SEP 2014. On 11 SEP 2014, the patient developed redness, pus and itching. The patient was treated with hydrogen peroxide and Neosporin. The patient responded to the treatment and later the patient had just redness and itching. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Gait disturbance, Pyrexia, Respiration abnormal
Clinical narrative: Case number PHHY2014US171021, an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544194) website on 29 DEC 2014. This report refers to a 78-year-old male patient. Historical conditions were not reported at the time of vaccination. Concomitant medication included lisinopril. The patient was not sick at the time of vaccination. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412201) intramuscularly into the left arm on 16 SEP 2014. On the same day after vaccination, in the middle of the night, the patient experienced chills, fever, and the patient could hardly walk. The patient went to the emergency room and the patient was given a nebulizer to help with his breathing. The final outcome of the events was unknown. The events were reported as non-serious. The event "given a nebulizer to help with breathing (respiration abnormal NOS)" was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.