chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from other health professional via other corporation (manufacturer control # 2014PROUSA03980) refers to a 76 year old male patient who did not use tobacco or alcohol. The patient's concurrent condition included exostosis (L1-L2, L2-L3), intervertebral disc displacement, lumbar spinal stenosis, hypermetropia, essential hypertension, gout, gastrooesophageal reflux disease, hypogonadism male, eczema, increased tendency to bruise, hypercholesterolaemia, nocturia, nodule in prostate, type 1 diabetes mellitus, prostatic specific antigen increased, depression, flushing, erectile dysfunction, cardiac murmur, urine flow decreased, pollakiuria, urinary retention, micturition urgency, anaemia vitamin B12 deficiency, spinal fracture, aortic valve calcification, osteoporosis, obesity, breast enlargement and prostate cancer. The patient's medical history included berylliosis, osteopenia, spinal fusion surgery (L1-S1), large intestine polyp, facial bones fracture, chemotherapy, haemorrhoids, calculus urinary, cholecystectomy, limb operation and radiotherapy. On 26-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, route and dose were not reported). Concomitant therapies included LUPRON and CASODEX. In 2014 (unspecified date), the patient experienced low grade fever, erythema, edema and pain at injection site after received ZOSTAVAX. The outcome of these events was unknown. The relationship between ZOSTAVAX and these events was not reported. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 year old patient of unknown gender. On 26-AUG-2013 the patient was vaccinated with a dose of VAQTA (lot# and frequency unknown) injection, strength: 25/0.5 (unit unknown), 0.5 ml, intramuscular. No adverse effects were reported. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 2 month old patient of unknown gender. On 08-DEC-2014 the patient was vaccinated with a dose of VAQTA, 50/1.0 U/mL injection, 0.5 ml, once, intramuscular. The patient received VAQTA instead of RECOMBVAX HB. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 09-JAN-2015 the patient was administered an improperly stored dose of VARIVAX (Merck) (lot#, expiry date, dose, route unspecified). No adverse events were reported. No PQC involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. In approximately September 2014 (reported as 2 months before the second dose), the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, expiration date, dose and route not reported). In approximately November 2014 (reported as 2 months ago), the patient was in the office to receive with the second dose of RECOMBIVAX HB injection, 1 ml (lot #, expiration date and route not reported), which was outside of recommended schedule for RECOMBIVAX HB. No adverse effects were reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site streaking
Clinical narrative: Hard lump and red streak at site of injection per patient phone report 8/26/14.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Herpes zoster, Pain of skin, Pruritus
Clinical narrative: This spontaneous report as received from a 80 year old male physician with high cholesterol and latex allergy reporting on himself. The patient was retired as a physician. The physician reported that "about 15 years ago" he volunteered to be in a clinical study with ZOSTAVAX at the end of the study he found out that he received the placebo so he stated that after the study was completed, he was eligible to receive ZOSTAVAX. The physician stated that he received a dose of ZOSTAVAX after the study was completed. On an unspecified day approximately in 2000 (reported as "about 15 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose, route and frequency not reported). Concomitant therapies included pravastatin sodium, LUMIGAN, aspirin, multivitamins (unspecified), chondroitin sulfate sodium (+) glucosamine sulfate and CoQ10. In approximately 19-DEC-2014 (reported as "about two weeks ago"), the physician was diagnosed with shingles on the left side of his scalp by his dermatologist. The physician stated that he developed itching and pain on the left side of his scalp "a couple of days prior" to being seen by his dermatologist. He was prescribed "probetathal propionate" topical solution for the itching on his scalp on an unspecified date as well as he applied desonide cream an unspecified amount of times to his scalp for the itching as well since an unspecified date. On approximately 23-DEC-2014 (reported as "about ten days ago"), the physician had a biopsy of the shingles on his scalp and was awaiting the results. At the time of the report, the patient was reported as recovering from shingles. No further information was provided. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a female patient who received HAVRIX (batch number 793JR, expiry date 15th February 2016). Co-suspect products included ENGERIX B (batch number 35F27, expiry date 1st February 2016) and TWINRIX. Previously administered products included TWINRIX (dose 1) and TWINRIX (dose 2). On 28th October 2014, the patient received the 1st dose of HAVRIX 1 ml and the 1st dose of ENGERIX B 1 ml. On an unknown date, the patient received the 3rd dose of TWINRIX. On an unknown date, an unknown time after receiving HAVRIX, ENGERIX B and TWINRIX, the patient experienced wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and inappropriate schedule of vaccine administered were unknown. Additional information received: Patient received TWINRIX 2 doses in March and then in April. Now wants the third dose, however the minute clinic does not have TWINRIX. The nurse gave HAVRIX and ENGERIX B on 10/28/2014. Instead of 3rd dose of TWINRIX, the patient received a dose of ENGERIX B and a dose of HAVRIX. These were the wrong vaccine administered and therefore the patient received the wrong schedule of TWINRIX.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Since 08-JAN-2015 the patients were vaccinated with VARIVAX (Merck) (administered subcutaneously, dose and indication were not reported) which underwent supported defrost cycling. No adverse effects reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis after ZOSTAVAX vaccination. Needed antibiotic therapy approximately 4 days after vaccination.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Pain
Clinical narrative: The pneumonia vaccine was administered by a nurse's assistant. I experienced intense pain the next day and then itching in the area for 1 week.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Hyperventilation, Loss of consciousness, Syncope
Clinical narrative: A few minutes after receiving HPV #2, patient fainted and fell from exam table to floor. He was unconscious for just a few seconds. Doctor checked him over, administered O2. Patient started to hyperventilate. Breathed through paper bag. Felt better after 20 min and was discharged. Ambulated without assistance.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with unspecified doses of alternate doses (over one year between doses) of GARDASIL (dose, route, lot number and expiration date not reported). No adverse effects were noted. Additional information is not expected because the reporter refused additional contact.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Exposure during pregnancy
Clinical narrative: This prospective pregnancy was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's past medical history did not include previous pregnancies. The subject did not use contraception. On 21 April 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 25 September 2013 and estimated date of delivery was on 02 July 2014. It was a normal conception. The subject was exposed to the vaccine during the third trimester. During the prenatal testing performed no evidence of a defect were observed. At the time of reporting the pregnancy was ongoing. Follow-up information received on 23 September 2014 from a nurse: Some of the subject's details and VAERS details were provided. This pregnancy was a normal conception. On 24 June 2014, after 39 weeks gestation, the subject gave birth to a male live infant without congenital anomaly, by cesarean section. The infant had an Apgar score of [1-7], a weight of 3.305 kg. The height of birth and the cranial circumference were not available. Follow-up information received on 29 September 2014: No new information was reported (duplicate Pregnancy Outcome form received).
Age: 37.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate schedule of vaccine administered in a 37-year-old female patient who received Hepatitis B vaccine. Co-suspect products included TWINRIX. Previously administered products included TWINRIX (dose 1 in 2002). In June 2014, the patient received Hepatitis B vaccine. On 28th October 2014, the patient received the 2nd dose of TWINRIX. On an unknown date, an unknown time after receiving Hepatitis B vaccine and TWINRIX, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown. Additional information received: TWINRIX given to adult patient in 2002, then Hep B vaccine given to same patient 6/2014, and a final TWINRIX on 10/28/2014. No lot numbers or exp date currently available.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 11-FEB-2011, 01-JUL-2011 and 05-AUG-2011, the patient was vaccinated with three doses of RECOMBIVAX HB respectively (dose, route, application site and lot# not reported). On 07-JAN-2015, the patient received an expired fourth dose of RECOMBIVAX HB, lot # H018689, expiry date: 07-NOV-2014, (dose, route, application site and lot# not reported). The fourth dose of RECOMBIVAX HB did not have any previous temperature excursions and was supported with post-expiry data. No adverse symptoms reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Red bump appeared 3 days after immunization. It got larger each day then a rash spread to other areas of the body after 5 more days. Patient went to urgent care and was given prednisone/BENADRYL.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Foetal disorder, Malaise, Syncope
Clinical narrative: This spontaneous retrospective pregnancy report as received from a female patient of unknown age via a company representative refers to herself. Medical history and current condition were unknown. The patient was pregnant with the last menstrual period (LMP) of approximately 30-JAN-1998 and an estimated date of conception being 13-FEB-1988 approximately. On 30-JUN-1988 the patient was vaccinated with M-M-R II, vaccine (dose/route/frequency unknown) at a county clinic. It was reported that the patient was vaccinated with the live vaccine without her permission. The patient was approximately 5 months pregnant while being vaccinated. The patient was ill off and on for the reminder of her pregnancy. The patient indicated that their lives changed forever and was suggested by her physician to 'consider abortion' since her infant could be born blind/mentally ill/ may die. She fainted when she was told what was done to her and her unborn son. On an unknown date in 1988, the patient delivered a male baby who was normal at birth but later presented seizures, high fever, bumps all over the body which looked like measles, was crying in pain and blindness in one eye (MARRS # ). The outcome of the maternal events 'ill off and on' and 'faint' was unknown. The reporter's causality statement was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2013US141141 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 501159) on 03 Dec 2013. This report refers to a 64-year-old male patient. Current condition of this patient included myelodysplastic syndrome and anemia. He was vaccinated with FLUVIRIN (batch number: 123001: expiry date: not reported) to left arm and PNEUMOVAX (batch number: 0556AE; expiry date: not reported) to right arm on 28 Sep 2013. On 29 Sep 2013 he developed large, red, raised, painful area on right deltoid and also developed fever. He was treated with prednisone 20 mg once per week and cetirizine 10 mg once per week. Outcome of the event was reported as complete recovery. Seriousness and causality were not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US14033 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 503439) website on 03 Dec 2013. This report refers to a 67-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly on 19 Sep 2013. On 20 Sep 2013, she called the pharmacy indicating her injection site was swollen, red, and warm to the touch. The event outcome was condition unchanged as on 20 Sep 2013. The seriousness and causality was not reported. No additional information was available.
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Case number PHHY2013US140342 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 503460) website on 03 Dec 2013. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 13393P) intramuscularly into left arm on an unspecified date. She presented rash and itching on the face that started 15 minutes after vaccination. She went to the emergency room due to these events. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Case number PHHY2013US140356 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 503571) website on 03 Dec 2013. This report refers to a 52-year-old female patient. Her medical history included allergic to Penicillin and UTI which was recovered. This polymedicated patient was vaccinated with FLUVIRIN (Batch number: 1307701) intramuscularly into the left arm on 14 Sep 2013. On the same day, after vaccination, she experienced large red welt size of 50 cent piece at the injection site (left upper arm) which was very tender. Next day welt became rectangular 2 1/2 x 3 1/2 in size and received 400 mg ibuprofen and swelling at the injection site was reduced. She also took BENADRYL. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Case number PHHY2013US140361 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 503589) website on 03 Dec 2013. This report refers to a 67-year-old female patient. Her medical history included drug hypersensitivity (with BENADRYL), asthma. Her vaccination history included administration of first dose of PNEUMOVAX (batch number: unknown) into arm and second dose of PNEUMOVAX (batch number: H018380) intramuscularly into arm on 17 Sep 2013. On the same day, after vaccination, she developed a rash at the injection site and soreness at the injection site. She sought medical attention (called pharmacist) she was treated with Aspirin to treat the soreness and causality was reported for the events.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Case number PHHY2013US140392 is an initial report received form vaccine adverse event reporting system (VAERS reference number: 503683) on 03 Dec 2013. This report refers to a 57-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 503683) on 03 Dec 2013. This report refers to a 57-year-old male patient. He was vaccinated with FLUVIRIN (Batch number: 1308501; expiry date: not reported) to left arm on 23 Sep 2013. On the same day of vaccination (23 Sep 2013) blood came from the site of injection. The site became swollen about the size of a marble. Patient stated that no pain was experienced. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2013US140310 is an initial spontaneous report from a Vaccine Adverse Event Reporting System (reference number: 504432) received on 03 Dec 2013. This report refers to a female patient of an unknown age. She had a history of acute asthma and concurrent condition included sulfa allergy. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly on arm on 18 Sep 2013. On the same day, she was also vaccinated with PNEUMOVAX (other manufacturer and batch number: H021941) subcutaneously on left arm. On the same day, post vaccinations, she experienced local injection site redness and swelling (severe). It was reported that no apparent reaction at time of administration was noted. Events worsened over 2 days and she was treated with ER (emergency room). Outcome of the events was recovered. Seriousness and causality of the events was not reported.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin, Blood thyroid stimulating hormone, Condition aggravated, Full blood count, Glycosylated haemoglobin
Clinical narrative: Case number PHHY2013US140315, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 505076) website on 03 Dec 2013. This report refers to a 46-year-old male patient. His medical history included rash from unknown vaccination. Concurrent condition included pityriasis. Concomitant medications included fish oil and multivitamin. he was vaccinated with a dose of FLUVIRIN (batch number unknown) intramuscularly into his right arm on 24 Sep 2013. On 28 Sep 2013 four days after vaccination, he had a return of rash to axilla and groin from prior pityriasis. He was taken to Emergency Room (ER) for medical support. He underwent skin biopsy, complete blood count, blood thyroid stimulating hormone (TSH), comprehensive metabolic panel (CMP) and glycosylated hemoglobin tests and results were unknown.  Outcome of the event was reported as recovered. The seriousness and causality of the event was not reported.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Metabolic function test, Rash
Clinical narrative: Case number PHHY2013US140315, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 505076) website on 03 Dec 2013. This report refers to a 46-year-old male patient. His medical history included rash from unknown vaccination. Concurrent condition included pityriasis. Concomitant medications included fish oil and multivitamin. he was vaccinated with a dose of FLUVIRIN (batch number unknown) intramuscularly into his right arm on 24 Sep 2013. On 28 Sep 2013 four days after vaccination, he had a return of rash to axilla and groin from prior pityriasis. He was taken to Emergency Room (ER) for medical support. He underwent skin biopsy, complete blood count, blood thyroid stimulating hormone (TSH), comprehensive metabolic panel (CMP) and glycosylated hemoglobin tests and results were unknown.  Outcome of the event was reported as recovered. The seriousness and causality of the event was not reported.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2013US140338 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505172) website on 03 Dec 2013. This report refers to a 76-years-old female patient. Her concomitant medications and medical history were not reported. On 30 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1309001) along with PNEUMOVAX (batch number: J006921) both intramuscularly. On 01 Oct 2013, her arm was swollen and warm. On an unknown date she visited the emergency room and was advised to take BENADRYL. The event outcome was reported as condition unchanged as of 01 Oct 2013. The seriousness and causality of the events were not reported.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Case number PHHY2013US140343 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505181) website on 03 Dec 2013. This report refers to a 62-years-old male patient. His concomitant medications and medical history were not reported. On 11 Sep 2013, he was vaccinated with FLUVIRIN (batch number: 1307601) along with PNEUMOVAX (batch number: J004080) intramuscularly. On 12 Sep 2013, after vaccination, he experienced body aches, chills and fever (2 x 3 days). His treatment medication included TYLENOL and MOTRIN. The event outcome was reported as completely recovered. The seriousness and causality of the events were not reported.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site swelling
Clinical narrative: Case number PHHY2014US000760, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505387) website on 06 Jan 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, (batch number: 1307601) intramuscularly in the left arm on 02 Oct 2013. Immediately after vaccination to the left deltoid, she experienced swelling and hard bump. The outcome of the events was reported as completely recovered as of 02 Oct 2013. The seriousness and causality of the events was not reported. No additional information was available.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination site inflammation, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2014US000772 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505929) website on 06 Jan 2014. This report refers to a 77-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly in the left arm and PNEUMOVAX (batch number: H004747) intramuscularly in the right arm on 04 Oct 2013. On 05 Oct 2013, she experienced hot, tender, inflammation and swelling at site of vaccination arm. She was applying ice to the inflammation area and was going down. Advised her to continue icing and to take BENADRYL and apply Hydrocortisone 1%. The outcome of the events was reported as condition unchanged as of 06 Oct 2013. The seriousness and causality of the events was not reported. No additional information was available. Following internal review of the data received on 06 Jan 2014: The events vaccination site swelling, warmth and tenderness linked under vaccination site inflammation.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site inflammation, Injection site warmth, Pain in extremity
Clinical narrative: Case number PHHY2013US140393 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 505999) website on 03 Dec 2013. This case refers to a 70-year-old female patient. Her medical history included asthma. Concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number 1309301) and PNEUMOVAX (batch number H016295) on 02 Oct 2013. On the same date after vaccination around 10 PM she started feeling pain/numbness in arm and injection site became hot/inflamed. She took pain medication (not specified). On 03 Oct 2013 the patient went to pharmacy at 1:30 PM and pharmacist noted redness/inflammation in 4-5 inch area around injection site. She saw nurse who recommended going to emergency room for possible cellulitis. At emergency room the physician said that there was no cellulitis. The physician stated her to continue with compresses and prescribed antibiotics if needed. The outcome of the event was reported as condition unchanged as of 04 Oct 2013. The seriousness and causality assessment of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Case number PHHY2013US140397 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 506022) website on 03 Dec 2013. This case refers to a 62-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated  with FLUVIRIN (batch number 1309601) on 02 Oct 2013. On 03 Oct 2013 after vaccination she had redness near injection site and the area was hot as well. Following the events she visited emergency room. The outcome of the event was reported as condition unchanged as of 04 Oct 2013. The seriousness and causality assessment of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Case number PHHY2013US140417 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 506096) website on 03 Dec 2913. This case refers to a 49-year-old female patient. Her medical history included cancer. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307601) in her left arm on 25 Sep 2013. On the same date after vaccination she had red rash on both arms with some itching which started 1 hour post vaccination. She took diphenhydramine. She contacted her physician who stated that the rash was not too severe to take prednisone. The outcome of the event was reported as condition unchanged as of 25 Sep 2013. The seriousness and causality assessment of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Case number PHHY2014US000783, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506222) website on 06 Jan 2014. This report refers to a 67-year-old female patient. On 26 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1308501) in the right arm and PNEUMOVAX (batch number: not reported, other manufacturer) in the left arm. On the same date, after vaccination her arm was extremely swollen. She visited the emergency room and her MD have Prednisone 40 mg daily for 4 days. The final outcome of the event reported as not recovered.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2013US140314 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 506459) website on 03 Dec 2013. This case refers to a 60-year-old female patient. Her medical history was not reported. Concomitant medication included simvastatin. She was vaccinated with FLUVIRIN (batch number 1309401) in her right arm and ZOSTAVAX (other manufacturer batch number J004266) in her left arm on 01 Oct 2013. On 03 Oct 2013 after vaccination she had redness at the site of injection. The outcome of the events was reported as condition unchanged as of 03 Oct 2013. The seriousness and causality assessment of the events was not reported.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2013US140320 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 506460) web site on 03 Dec 2013. This report refers to a 56-year-old male patient. His medical history included diabetes and hypertension. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309101) and PNEUMOVAX (other manufacturer batch number H011780) in his left arm on 27 Sep 2013. On the same day after vaccination he had redness and swelling at the site of injection and also had a temperature of 100.3. The outcome of the events was reported as complete recovery as of 29 Sep 2013. The seriousness and causality assessment of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Diarrhoea, Injection site rash, Rash
Clinical narrative: Case number PHHY2013US140353 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506525) web site on 03 Dec 2013. This report refers to a 57-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1038601) intramuscularly into left arm on 01 Oct 2013. On the same day, she was also vaccinated with PNEUMOVAX (other manufacturer, batch number: 0709AE) intramuscularly into right arm and ZOSTAVAX (other manufacturer and batch number: J001005) subcutaneously into left arm. On 07 Oct 2013 six days after vaccinations, she had a prickly rash on her shin/knee and under arm/shoulder area that following a line. She also stated that she had diarrhea. It was reported that she could have a rah around the injection site but since it had spread she would see her physician in the morning to access the rash. Outcome of the events was reported as condition unchanged as of 08 Oct 2013. The seriousness and causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2013US0140477 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 506546) web site on 03 Dec 2013. This report refers to a 67-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501) in her left arm and PNEUMOVAX (other manufacturer, batch number J004080) in her right arm on 28 Sep 2013. On 29 Sept 2013 after vaccination her arm swelled up from elbow to shoulder and got warm. It lasted 3 days. The outcome of the events was reported as complete recovery as of 08 Oct 2013. The seriousness and causality assessment of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2013US140481 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 506557) website on 03 Dec 2013. This case refers to a 29-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1309101) in her right arm on 07 Oct 2013. On the same date after vaccination she had diffuse pruritus and urticarial rash. Following the events she visited emergency room. The outcome of the events was reported as complete recovery as of 08 Oct 2013. The seriousness and causality assessment of the events was not reported.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2013US140496 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506770) website on 03 Dec 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly on 08 Oct 2013. After vaccination on 09 Oct 2013, he experienced rash on chest and face and neck. Following the events, he was advised to take BENADRYL and call the physician if the symptoms get worse or do not improve. The outcome of the event was reported as condition unchanged as of 09 Oct 2013. The seriousness and causality of the event was not reported. No more information was available.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2013US0140504, is an initial spontaneous report received from a consumer (mother of the patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 506781) web site on 03 Dec 2013. This report refers to a 24-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly into her left arm on 08 Oct 2013. On the same day after vaccination, she experienced a bad diarrhea, vomiting and fever. The final outcome of the events was reported as condition unchanged as of 08 Oct 2013. The causality and seriousness of the events were not reported. No more information was available.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2013US140512, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506852) website on 03 Dec 2013. This report refers to an 82-year-old female patient. Her medical history was not reported. Concomitant medications included atorvastatin and NEXIUM. She was vaccinated with FLUVIRIN (batch number: 1307601) into the left arm on 27 Aug 2013. On the same day she experienced giant hives on back, arms and legs. Treatment for the event was rendered with a shot of BENADRYL and prednisone in the emergency room. Later she was prescribed a five day course of prednisone. The outcome of the event was reported as condition unchanged as of 04 Oct 2013. The seriousness and causality of the event were not reported. No additional information was available.
Age: 65.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2013US140513 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506919) web site on 03 Dec  2013. 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: 13435P) intramuscularly on left arm on 07 Oct 2013. On the same day, she was also vaccinated with ZOSTAVAX (other manufacturer and batch number: J005720) subcutaneously on left arm. On 08 Oct 2013, 01 day after vaccinations, he experienced injection site reaction (redness, swelling, itching). Outcome of the events was reported as condition unchanged as of 10 Oct 2013. Seriousness and causality of the events was not reported.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Pyrexia, Vaccination site warmth
Clinical narrative: Case number PHHY2014US000790 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 507197) on 06 Jan 2014. This report refers to a 47 year old male patient. His medical history included heart attack prior to heart surgery, diabetes, sinus surgery, seizures in childhood, and thyroid disorder. Her concomitant medications included PROZAC, AMARYL, testosterone, LAMISIL and PERCOCET. He was vaccinated with FLUVIRIN (batch number: 13391P) in the left arm and PNEUMOVAX (batch number: J006242) in the right arm; both vaccines administered intramuscularly on 12 Oct 2013. On 13 Oct 2013, he had redness and warmth at the vaccination site, headache and fever with a body temperature of 98 to 102 degrees and the events started in the midnight. He took TYLENOL for fever and BENADRYL for warmth and redness. He also applied cold compresses. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Headache, Pain, Paraesthesia
Clinical narrative: Case number PHHY2013US147744 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507275) web site on 16 Dec 2013. This report refers to a 54-year-old female patient. Her concurrent conditions included environmental allergies (hay fever, dust, etc.). Concomitant medications included liquid multivitamin with minerals aloe vera juice (both OTC medications had been taken for the past two years with no recent changes). She was vaccinated with FLUVIRIN (batch number: 13401P) intramuscularly into left arm on 14 Oct 2013. About 30 minutes post vaccination, she started having headache. One hour later by 13:00, she was vomiting, continued to generally feel poor (aches, chills). She also experienced tingling in the throat for which she took a 50 mg dose of BENADRYL and required no further treatment. On 15 Oct 2013 followed up with the patient and she was still feeling poor but improved from the day before. It was reported that she experienced similar symptoms one year prior after receiving a seasonal influenza vaccine (see case: PHHY2013US152698). The time course was similar. Final outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHHY2013US147744 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507275) web site on 16 Dec 2013. This report refers to a 54-year-old female patient. Her concurrent conditions included environmental allergies (hay fever, dust, etc.). Concomitant medications included liquid multivitamin with minerals aloe vera juice (both OTC medications had been taken for the past two years with no recent changes). She was vaccinated with FLUVIRIN (batch number: 13401P) intramuscularly into left arm on 14 Oct 2013. About 30 minutes post vaccination, she started having headache. One hour later by 13:00, she was vomiting, continued to generally feel poor (aches, chills). She also experienced tingling in the throat for which she took a 50 mg dose of BENADRYL and required no further treatment. On 15 Oct 2013 followed up with the patient and she was still feeling poor but improved from the day before. It was reported that she experienced similar symptoms one year prior after receiving a seasonal influenza vaccine (see case: PHHY2013US152698). The time course was similar. Final outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US000821 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 507304) website on 06 Jan 2014. This report refers to a 48-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13441P) intramuscularly into left arm on 09 Oct 2013. On the same day, she was also vaccinated with PNEUMOVAX (other manufacturer and batch number: J005067) intramuscularly into left arm. On 10 Oct 2013, one day after vaccinations, she experienced fever (102 F), chills, nausea and body aches. She also experienced injection site swollen, red, sore and hot. Outcome of the events was reported as condition unchanged as of 15 Oct 2013. Seriousness and causality of the event was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Case number PHHY2014US000821 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 507304) website on 06 Jan 2014. This report refers to a 48-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13441P) intramuscularly into left arm on 09 Oct 2013. On the same day, she was also vaccinated with PNEUMOVAX (other manufacturer and batch number: J005067) intramuscularly into left arm. On 10 Oct 2013, one day after vaccinations, she experienced fever (102 F), chills, nausea and body aches. She also experienced injection site swollen, red, sore and hot. Outcome of the events was reported as condition unchanged as of 15 Oct 2013. Seriousness and causality of the event was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Case number PHHY2014US000848, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507332) website on 06 Jan 2014. This report refers to a 50-year-old female patient. Her medical history and concomitant medication were not reported. Her historical drugs included macrolides and erythromycin. She was vaccinated with FLUVIRIN, (batch number: 1338SP) intramuscularly in the left arm on 18 Sep 2013. On the same day after vaccination, she experienced muscle aches, which lasted for a month. The final outcome of the event was reported as condition unchanged as of 15 Oct 2013. The seriousness and causality of the events was not reported. No additional information was available.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2014000857, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507323) website on 06 Jan 2014. This report refers to a 20-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 13392P) intramuscularly in the right arm on 23 Sep 2013. On 24 Sep 2013, she experienced excruciating pain at vaccination site and especially bad at night. The outcome of the event was reported as condition unchanged (still present) as of 15 Oct 2013. The seriousness and causality of the event was not reported. No additional information was available.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, No adverse event
Clinical narrative: Case number PHHY2014US000859 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507353) web site on 06 Jan 2014. This report refers to a 44-year-old female patient. Her concurrent condition included allergy to aspirin. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13382P) intramuscularly into left arm on 16 Oct 2013. On the same day, she experienced ping-pong ball sized swelling at site of injection (left deltoid muscle). She sat and applied ice and gave diphenhydramine (25mg tablet). No systemic symptoms reported. She was able to return to work after. Outcome of the event was reported as condition unchanged as of 16 Oct 2013. Seriousness and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Neuralgia, Pain
Clinical narrative: Case number PHHY2013US147831, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507423) website on 16 DEC 2013. This report refers to a 81-year-old female patient. This poly medicated patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 13435P) intramuscularly in the left arm on 01 OCT 2013. On 07 OCT 2013, she experienced muscle pain that was not relieved after several days, and was made worse with any movement. The patient visited the emergency room. She was diagnosed with nerve pain which was likely due to the flu vaccine administration. The final outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Pain
Clinical narrative: Case number PHHY2014US000906 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507535) web site on 06 Jan 2014. This report refers to a 59-year-old polymedicated female patient. Her concurrent conditions included allergic to sulfa drugs, latex allergy, fibromyalgia, gastrooesophageal reflux disease and paroxysmal atrial tachycardia. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 06 Oct 2013. On the same day, post vaccination, she experienced sweats, chills, body aches (severe) which were lasted about 1/2 hours. She was treated with ADVIL. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site swelling
Clinical narrative: Case number PHHY2014US000910 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507543) website on 06 JAN 2014. This report refers to a 70-year-old poly medicated female patient. Her concurrent conditions included chronic obstructive pulmonary disease, hypertension, anxiety, depression, panic attacks, cervical cancer, insomnia, chronic pain, herniated disc, degenerative joint disease and osteoarthritis. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308901) intramuscularly into right arm on 14 OCT 2013. On the same day, she also was vaccinated with PNEUMOVAX (other manufacturer and batch number: H0109161) intramuscularly into left arm and ZOSTAVAX (other manufacturer and batch number: H019998) subcutaneously into left arm. On 15 OCT 2013, one day after vaccinations, she experienced swelling at injection site and arm, elbow to shoulder. She went to emergency room due to these events. Outcome of the events was reported as condition unchanged as of 17 OCT 2013. Seriousness and causality of the events was not reported.