chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Case number PHHY2017US033970, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 661045 on 21 Feb 2017. This report refers to a 70 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185285) and PREVNAR 13 (batch number: N16561) in left arm on 13 Oct 2016. Soon after (day after) injection, on 14 Oct 2016, the patient developed redness, swelling and subjective fever. The patient fully recovered from these events on an unknown date. Seriousness of the events were reported as non-serious. The causality of the vents were not reported.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHHY2017US031904 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS number: 661064) website on 21 Feb 2017. This report refers to 47 year old female patient. Current condition included migraine, concomitant medication included Escitalopram, medical history was not reported). The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 185888) into right arm on 10 Oct 2016. It was stated that might hit nerve, On an unknown date patient experienced numbness on right arm, tingling, to neck headache and fatigue. The patient was received treatment with Ibuprofen (3) dragging. The outcome of the events was condition unchanged, seriousness of the events was non serious and causality of the events was not reported.
Age: 88.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Arthritis, Chills, Pyrexia
Clinical narrative: Case number PHHY2017US031773 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661069) website on 21 Feb 2017. This report refers to an 88 year old male patient. Historical condition was reported as none. It was reported that the patient had no current illness. Concomitant medications included SYNTHROID. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 165703) intramuscularly into left arm on 17 Oct 2016. After vaccination on 19 Oct 2016, patient experienced acute onset fever, chills and severe arthritis in left ankle with exquisite pain and tenderness. It was reported that the fever and chills were subsided by morning but arthritis gradually disappeared in 24 hours. The lab data of the patient was reported as none so far. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 50.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site abscess, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2017US033447 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 661197) website on 21 Feb 2017. This report refers to 50 year old female patient. Medical history included asthma, hypercholesterolemia; current condition included rheumatoid arthritis, diabetes mellitus and hypertension. She had several comorbidities, but no known acute illnesses and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186868) intramuscular into left arm, PNEUMOVAX (other manufacturer, batch number: M036161) intramuscular into right arm and ADACEL (other manufacturer, batch number: C4775AA) intramuscular into left arm on 22 Oct 2016. On 23 Oct 2016 patient experienced redness, swelling, and pain extending from shoulder to elbow, pain was great enough that movement was limited for a time, but had gotten better now. On 24 Oct 2016, she was called with complain about her symptoms. Patient was not going to seek immediate medical attention, but was going to monitor for any worsening and will take ibuprofen, apply ice packs and BENADRYL. Patient was going to call us in a few days to follow up with any worsening or getting better. In opposite arm, patient received ADACEL and FLUCELVAX, no reaction on the arm receiving those vaccinations. The outcome of the events was unknown, seriousness of the events was non serious and causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Dizziness, Injection site pain, Injection site rash, Malaise
Clinical narrative: Case number PHHY2017US031155, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 661238) on 21 Feb 2017. This report refers to a 48-year-old female patient. The patient underwent transplant (details not specified). Her current condition included cancer. Concomitant medications included SYNTHROID, DULERA, XARELTO, and VENTOLIN. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 186685) and pneumococcal vaccine (other manufacturer, batch number: M018766); both administered intramuscularly into left arm on 22 Oct 2016. On the same day, the patient was not feeling well. She had dizziness, rash at the around injection site and pain in area of injections as both the injections were administered on the same arm. The patient visited the emergency room and was also examined at physician's office. BENADRYL was advised by registered pharmacist (RPH) and subsequently BENADRYL and TYLENOL were advised by primary care provider (PCP). The outcome of the events was reported as unknown. The events were reported as non-serious by the reporter. The causality of the events was not reported.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Case number PHHY2017US027556, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 661355) on 21 Feb 2017. This report refers to a 15 years old female patient. Historical condition was reported as anxiety prior to vaccination. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185887) intramuscularly into right arm on 24 Oct 2016. On same day immediately after vaccination, the patient felt light headed and fainted. The outcome of the events was reported as complete recovery (consciousness was regained after less than one minute and full symptom abatement after 03 minutes). The seriousness of the events was reported as non serious and causality was not reported.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Arthralgia, Chills, Dizziness, Fatigue
Clinical narrative: Case number PHHY2017US032625 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS number: 661358) website on 21 Feb 2017. This report refers to 37 year old female patient. Medical history and current illness was reported as none, concomitant medication was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number not reported) intramuscular into right arm on 20 Oct 2016. On the same day, patient experienced sweating, cold/hot alternating, localized pain as well as shooting pain down entire arm and up neck. Patient developed Joint pains, nausea, dizziness, anxiety, tiredness and shivering, high fever (101 next days). The outcome of the events was complete recovery on an unknown date, seriousness of the events was not reported and causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling of body temperature change, Hyperhidrosis, Nausea, Pain, Pain in extremity
Clinical narrative: Case number PHHY2017US032625 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS number: 661358) website on 21 Feb 2017. This report refers to 37 year old female patient. Medical history and current illness was reported as none, concomitant medication was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number not reported) intramuscular into right arm on 20 Oct 2016. On the same day, patient experienced sweating, cold/hot alternating, localized pain as well as shooting pain down entire arm and up neck. Patient developed Joint pains, nausea, dizziness, anxiety, tiredness and shivering, high fever (101 next days). The outcome of the events was complete recovery on an unknown date, seriousness of the events was not reported and causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2017US032625 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS number: 661358) website on 21 Feb 2017. This report refers to 37 year old female patient. Medical history and current illness was reported as none, concomitant medication was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number not reported) intramuscular into right arm on 20 Oct 2016. On the same day, patient experienced sweating, cold/hot alternating, localized pain as well as shooting pain down entire arm and up neck. Patient developed Joint pains, nausea, dizziness, anxiety, tiredness and shivering, high fever (101 next days). The outcome of the events was complete recovery on an unknown date, seriousness of the events was not reported and causality of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Syncope
Clinical narrative: Case number PHHY2017US027614, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 661699) website on 21 Feb 2017. This report refers to a 62 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185284) intramuscularly into the left arm on 22 Sep 2016. On the same day after vaccination, the patient experienced itching on chest and was syncopal. The patient visited the emergency room. Patient received treatment with epinephrine given by emergency department (ED). The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash papular
Clinical narrative: Case number PHHY2017US033111 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661739) website on 21 Feb 2017. This report refers to a 62 year old female patient. Medical history and concomitant medications were reported as none. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185286) intramuscularly into right arm on 13 Oct 2016. After vaccination on 19 Oct 2016, patient developed papular rash on bilateral arms and itching. The lab data of the patient was reported as none. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious and causality was not reported.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Drug administered at inappropriate site, Injection site pain, Mobility decreased
Clinical narrative: Case number PHHY2017US032603 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 661926) on 21 Feb 2017. This report refers a 33 old female patient. Her current condition included hypothyroidism. Her concomitant medications included levothyroxine 75 ug one daily for the treatment of hypothyroidism and multivitamin. She was vaccinated with FLUCELVAX quadrivalent (batch number: 185887) intramuscularly in the left arm on 29 Sep 2016. It was reported that the injection was administered above the deltoid into the joint and the patient had burning at the time of injection which continued to increase throughout the day. Over the next several days and weeks, there was continued aching in the joint and difficulty in moving the right arm above the shoulder level. She was asked to be evaluated by the employee health as this happened at work, but was told this could not occur unless this was a workers compensation issue and the flu shot was voluntary. The events outcome was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 64.0
Sex: U
Vaccine: FLUC4
Symptoms: Chest pain, Dry skin, Erythema of eyelid, Eye pruritus, Eyelid oedema
Clinical narrative: Case number PHHY2017US031234 is initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661978) website on 21 Feb 2017. This report refers to a 64 years old female patient. Medical history was not reported. Current condition included hypertension. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) on 20 Oct 2016. On the same day after vaccination, patient experienced red itchy eyes, red swollen eyelids, puffy face, high blood pressure, chest pain, dry, blotchy, itchy skin on face. Patient had cold sore in mouth that developed overnight. The symptoms started to subside after 48  hours. The final outcome of the events was complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality of the events was not reported.
Age: 64.0
Sex: U
Vaccine: FLUC4
Symptoms: Hypertension, Ocular hyperaemia, Oral herpes, Pruritus, Rash macular
Clinical narrative: Case number PHHY2017US031234 is initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661978) website on 21 Feb 2017. This report refers to a 64 years old female patient. Medical history was not reported. Current condition included hypertension. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) on 20 Oct 2016. On the same day after vaccination, patient experienced red itchy eyes, red swollen eyelids, puffy face, high blood pressure, chest pain, dry, blotchy, itchy skin on face. Patient had cold sore in mouth that developed overnight. The symptoms started to subside after 48  hours. The final outcome of the events was complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality of the events was not reported.
Age: 64.0
Sex: U
Vaccine: FLUC4
Symptoms: Swelling face
Clinical narrative: Case number PHHY2017US031234 is initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661978) website on 21 Feb 2017. This report refers to a 64 years old female patient. Medical history was not reported. Current condition included hypertension. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) on 20 Oct 2016. On the same day after vaccination, patient experienced red itchy eyes, red swollen eyelids, puffy face, high blood pressure, chest pain, dry, blotchy, itchy skin on face. Patient had cold sore in mouth that developed overnight. The symptoms started to subside after 48  hours. The final outcome of the events was complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypertension
Clinical narrative: Case number PHHY2017US028703 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 662424) website on 21 Feb 2017. This report refers to 67 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (manufacturer unknown, batch number: not reported) on an unknown date. On an unspecified date, after vaccination patient experienced high blood pressure. The outcome, seriousness and causality of the event were not reported.
Age: 68.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Inflammation, Pain, Pruritus
Clinical narrative: Case number PHHY2017US033793, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS: 662431) website on 21 Feb 2017. This report refers to a 68-year-old female patient. Historical condition was not reported. Current condition included high cholesterol. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (lot number: 185327) into left arm and PNEUMOVAX (lot number: M033086) into right arm intramuscularly on 26 Oct 2016. On 27 Oct 2016, the patient experienced large red, inflamed area. Itching and painful area. Outcome of the events was unknown. Seriousness of the events was non serious and causality was not reported.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Bowel movement irregularity, Chest discomfort, Dizziness, Headache, Pain
Clinical narrative: Case number PHHY2017US027634, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 662826) website on 21 Feb 2017. This report refers to a 42 years old male patient. Past medical history was not reported. Current condition included nasty head and cold. The patient's vaccination history included that had several influenza shots in the past and experienced injection site soreness (see case PHHY2017US027733). Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) on 30 Oct 2016. On 31 Oct 2016 after vaccination within 08 hours, the patient experienced severe body aches, lightheaded, pressure on chest, dizziness, headache, sluggishness and odd bowel movements. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Sluggishness
Clinical narrative: Case number PHHY2017US027634, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 662826) website on 21 Feb 2017. This report refers to a 42 years old male patient. Past medical history was not reported. Current condition included nasty head and cold. The patient's vaccination history included that had several influenza shots in the past and experienced injection site soreness (see case PHHY2017US027733). Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) on 30 Oct 2016. On 31 Oct 2016 after vaccination within 08 hours, the patient experienced severe body aches, lightheaded, pressure on chest, dizziness, headache, sluggishness and odd bowel movements. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2017US033267 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 662892) on 21 Feb 201. This report refers to a 59 year old female patient. She had no medical history. Her concomitant medications were LEVOXYL, valacyclovir, and BONIVA. She was vaccinated with FLUCELVAX quadrivalent (batch number: not reported) intramuscularly in the left arm on 19 Oct 2016. On 28 Oct 2016, the patient had increasing shoulder pain near injection site with decreasing range of pain of free motion. The events outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: Case number PHHY2017US026801, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 663200) website on 21 Feb 2017. This report refers to a 44 year old female patient. Historical condition was not reported. Current conditions included migraines. Concomitant medication included propranolol LA. She was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) intramuscularly into the right arm on 31 Oct 2016. After vaccination, on the same day, she experienced an onset of headache at 14:30 hours. At 10:00 hours, she had onset of chills. She had fever of 101.7 at 01:00 hours on 01 Nov 2016 which increased to 102 at 02:00 hours. By 13:00 hours that day, she started feeling better and having more energy. She was treated with EXCEDRIN Migraine (caffeine) for headache. Final outcome of the events was reported as complete recovery on an unknown date. The serious and causality of the events were not reported.
Age: 69.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Injection site inflammation, Injection site scar
Clinical narrative: Case number PHHY2017US034293, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 663282) website on 21 Feb 2017. This report refers to a 69 years old female patient. Medical history was not reported. Concomitant medication was not reported. She was vaccinated with FLUCELVAX Quadrivalent (batch number: 1618621) intramuscularly into the left arm on 27 Oct 2016. After vaccination, on 30 Oct 2016, she experienced injection site reaction, vaccination was administered high on the arm to avoid scar tissue (administration error), she had inflammation and slight scarring occurred after. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2017US032418, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 663403) website on 21 Feb 2017. This report refers to a 54 years old male patient. Medical history was not reported. Concomitant medication was not reported. He was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185285) intramuscularly into the left arm on 24 Oct 2016. After vaccination, on the same day, his arm was sore and he had a hard time moving arm. He contacted the pharmacy on 01 Nov 2016 and stated that his arm was still sore. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 20.0
Sex: F
Vaccine: FLUC4, MENB
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Rash pruritic
Clinical narrative: Case number PHHY2017US032306 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 663491) website on 21 Feb 2017. This report refers to a 20 year old female patient. Historical condition included eczema. Current condition included environmental, animal and medicine allergies and asthma. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1618901) intramuscularly into left arm on 20 Oct 2016. The patient was also vaccinated with first dose of BEXSERO (other manufacturer, batch number: 15C601) intramuscularly into left arm on 20 Oct 2016. After vaccination on 22 Oct 2016 (reported as 2 days after receiving first dose of BEXSERO vaccine), patient developed an itchy rash. It was also reported that patient had arm pain, chills, fatigue and felt feverish on an unknown date. Following the events patient visited emergency room. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Case number PHHY2017US033749 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 663580) website on 21 Feb 2017. This report refers to 57 year old male patient. Medical history and concomitant medication was not reported. Current condition reported as none. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 185284) Intramuscular into left arm on 07 Sep 2016. On an unspecified date, patient experienced bilateral upper and lower extremity urticarial. The outcome of the events was unknown, seriousness of the events was non serious and causality of the events was not reported.
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2017US034272, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 663588) website on 21 Feb 2017. This report refers to a 71 year old male patient. Past medical history was not reported. Current condition included penicillin and tetracycline allergy. Concomitant medications included levothyroxine and AMBIEN. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 186868) intramuscularly on 31 Oct 2016. The patient was also vaccinated with PNEUMOVAX (batch number: MO38216) intramuscularly on 31 Oct 2016. On 01 Nov 2016 after vaccination, the patient experienced that arm turned red, swollen, hurt and she ran a fever and was much worse that night and was told that she could take TYLENOL or ibuprofen for pain or fever. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2017US020452, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Events Reporting System (VAERS reference number: 663912) on 23 Jan 2017. This report refers to a 79 years old female patient. Medical history was not reported. Concomitant medications included amlodipine, losartan potassium and FLEXERIL. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) into right arm and PNEUMOVAX 23 (other manufacturer, batch number: M024673, expiry date: 17 Nov 2017) into left arm, both on 25 Oct 2016. On 25 Oct 2016 after vaccination, the patient experienced injection site pain at the beginning and then on 26 Oct 2016, the patient had swelling and redness in the left arm to the elbow, had an unspecified hard to the touch area and she felt feverish. The patient did not seek medical treatment. The outcome of the events was reported as not recovered/not resolved (condition unchanged). The seriousness of the events was reported as non serious. The reporter did not assess the causal relationship between the adverse events and the PNEUMOVAX 23 and causality with seasonal influenza vaccine was not reported.
Age: 57.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Case number PHHY2017US019704, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 663929) website on 23 Jan 2017. This report refers to a 57 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185285) intramuscularly into right arm on 24 Oct 2016. The patient was also vaccinated with PREVNAR 13 (batch number: M60993) in left arm deltoid on 24 Oct 2016. On 25 Oct 2017 after vaccination the patient experienced red itchy rash at the site of injection. Therapeutic measures taken as a result of red itchy rash at the site of injection was reported as just ice packs for now. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 68.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Case number PHHY2017US034205, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 664125) on 21 Feb 2017. This report refers to a 68-year-old male patient. Medical history was not reported. The patient had no reported current condition. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186685) administered intramuscularly into right arm and pneumococcal vaccine polyvalent (other manufacturer, batch number: M035104) administered intramuscularly into left arm on 02 Nov 2016. It was reported that the patient received vaccine in the afternoon and developed redness and soreness down arm before bedtime. It was reported that as of 04 Nov 2016, the symptoms persisted, but not worse. The final outcome of the events was not reported. The events were reported as non-serious by the reporter. The causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Induration, Inflammation, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2017US033287, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 664192) on 21 Feb 2017. This report refers to a 49 years old female patient. Historical condition was not reported. Current condition included asthma. Concomitant medications included PROAIR. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186868) into right arm and PNEUMOVAX 23 (batch number: M036161) into left arm; both vaccines given intramuscularly on 02 Nov 2016. On 03 Nov 2016, in the morning after administration, the patient experienced red and swollen left arm where PNEUMOVAX 23 was administered. Patient came back to the pharmacy 20 hours after administration and her arm presented with inflammation, erythema and induration. Patient went to her physician's office. Blood pressure normal, physician recommended diphenhydramine oral capsules. The patient visited emergency room on an unknown date. The patient fully recovered from these events on an unknown date. Seriousness of the events were not reported. The causality of the events not reported.
Age: 16.0
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: Case number PHHY2017US019766 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 664388) website on 23 Jan 2017. This report refers to a 16 year old female patient. Prior vaccination history included vaccination with meningococcal vaccine (manufacturer unknown, batch number: not reported) and was well tolerated and vaccination with influenza vaccine (unknown whether seasonal or pandemic, other manufacturer, batch number: not reported) on an unknown date and patient experienced pain in extremity (see case: PHHY2017US019720). Medical history and concomitant medication were not reported. The patient was vaccinated with influenza virus vaccine INN (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. After vaccination, on an unspecified date, the patient experienced peripheral swelling. The outcome, seriousness and causality of the event were not reported.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2017US017261, is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 664554) website on 23 Jan 2017. This report refers to a 46 years old female patient. Past medical history was not reported. Current condition included sulfa allergy. Concomitant medication were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in left arm on 11 Oct 2016. On 16 Oct 2016, after vaccination the patient experienced pain in shoulder with limited range of motion. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2017US035838, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 664560) website on 21 Feb 2017. This report refers to a 12 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186111) at 10:15 in left deltoid on 03 Nov 2016. On 04 Nov 2016 after vaccination at 07:00 AM, the patient experienced warm, redness, swelling injection site from left acromial process to left elbow. The patient visited the physician at 11:45 who advised the mother of patient to elevate and ice intermittently. The mother would give BENADRYL and TYLENOL for a couple of days. On 05 Nov 2016 at 10:50 the patient's condition was reported as improving and swelling was decreased. The outcome of the event was reported as condition improving. The seriousness and causality of the event were not reported.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2017US035968, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting (VAERS: 664765) website on 21 Feb 2017. This report refers to a 64-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (lot number: 185285) into left arm intramuscularly on 03 Nov 2016. On the same day of vaccination the patient complained of burning as soon as vaccine was administered. The patient called facility 30 minutes later, said injection site was swollen, red, and hot. Nurse advised her to apply cool compress, take MOTRIN, monitor for 24 hours and call back with any worsening changes. The patient called on 07 Nov 2016 and said that swelling had gone down, reported bruising at injection site. Final outcome of the event was complete recovery and seriousness of the events were reported as non serious, causality was not reported.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth
Clinical narrative: Case number PHHY2017US035968, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting (VAERS: 664765) website on 21 Feb 2017. This report refers to a 64-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (lot number: 185285) into left arm intramuscularly on 03 Nov 2016. On the same day of vaccination the patient complained of burning as soon as vaccine was administered. The patient called facility 30 minutes later, said injection site was swollen, red, and hot. Nurse advised her to apply cool compress, take MOTRIN, monitor for 24 hours and call back with any worsening changes. The patient called on 07 Nov 2016 and said that swelling had gone down, reported bruising at injection site. Final outcome of the event was complete recovery and seriousness of the events were reported as non serious, causality was not reported.
Age: 73.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Arthralgia, Blood test, Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2017US035806, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 664819) website on 21 Feb 2017. This report refers to a 73 years old female patient. Past medical history was not reported. Concomitant medications included as VESICARE and CELEXA. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) on 06 Nov 2016. The patient also vaccinated with PNEUMOVAX Vaccine (other manufacture and batch number: not reported) on 06 Nov 2016. On the same day after vaccination, the patient experienced headache, extreme pain at the injection site moving down to the wrist, red splotchy rash below injection site, nausea, vomiting and neck stiffness. The patient had blood work with no results. The patient received intravenous (IV) fluids and steroids. The patient visited emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 73.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Nausea, Pain in extremity, Rash erythematous, Rash macular, Vomiting
Clinical narrative: Case number PHHY2017US035806, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 664819) website on 21 Feb 2017. This report refers to a 73 years old female patient. Past medical history was not reported. Concomitant medications included as VESICARE and CELEXA. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) on 06 Nov 2016. The patient also vaccinated with PNEUMOVAX Vaccine (other manufacture and batch number: not reported) on 06 Nov 2016. On the same day after vaccination, the patient experienced headache, extreme pain at the injection site moving down to the wrist, red splotchy rash below injection site, nausea, vomiting and neck stiffness. The patient had blood work with no results. The patient received intravenous (IV) fluids and steroids. The patient visited emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Case number PHHY2017US033331, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 664938) website on 21 Feb 2017. This report refers to a 59 years old female patient. Past medical history was not reported. Current condition included Iodine, Sulfa, CELEBREX, LEVAQUIN and shellfish allergy. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186867A) intramuscularly on 14 Nov 2016. On 14 Nov 2016 after vaccination, the patient experienced rash both arms and chest. The patient received treatment with BENADRYL. The patient was seeing improvement and was advised to see primary physician if no further improvement in 02 to 03 days. The outcome of the events was reported as condition improving. The seriousness and causality of the event were not reported.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Lethargy, Nausea
Clinical narrative: Case number PHHY2017US033633, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 664967) website on 21 Feb 2017. This report refers to an 11 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185285) intramuscularly in right arm on 08 Nov 2016. On the same day about 05 minutes after vaccination, the patient was feeling weak and dizzy, began acting lethargic and reported nausea. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site reaction, Neuralgia
Clinical narrative: Case number PHHY2017US035257, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 664968) website on 21 Feb 2017. This report refers to a 36-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (lot number: 185284) into left arm intramuscularly on 18 Oct 2016. On 19 Oct 2016, the patient complained of soreness and nerve pain at the site of injections. Outcome of the events was unknown and seriousness was reported as non serious. Causality was not reported.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Pallor, Syncope
Clinical narrative: Case number PHHY2017US011017, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 665089) website on 23 Jan 2017. This report refers to a 09 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185888) into left arm, intramuscularly on 06 Sep 2016. It was reported that, patient was vaccinated at school located at influenza vaccination clinic. On 06 Sep 2016, the patient had fainted in class. Health Room notified and escorted to health room. Patient laid down and cool compress was applied. School nurse and clinic nurse notified and went to health room to second assess. Patient alert, oriented and still pale on 06 Sep 2016. Patient gave fluids and parents notified. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2017US036600 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (Vaers number: 665177) website on 21 Feb 2017. This report refers to 5 year old male patient. Current condition included skin allergy to cephalosporins, sulfa drugs and penicillin. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) into left leg on 07 Nov 2016. On the same day, patient experienced injection site redness, swelling, itching, hot to touch and began to spread to 6 inches by 5 inches over left thigh. The outcome of the events was complete recovery on an unknown date, seriousness of the events was non serious and causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Case number PHHY2017US034957, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 665461) website on 21 Feb 2017. This report refers to an 11 years old female patient. Vaccination history included she was vaccinated with FLUZONE (unknown manufacturer, batch number: not reported) at the age of 3 years and she experienced swelling of arm. Current illness and concomitant medications were reported as none. She was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185888) intramuscularly into the left upper arm on 08 Nov 2016. After vaccination, on the same day, she experienced swelling of left upper arm at site of injection. There was no redness, no fever, no respiratory signs and symptoms. She felt fine otherwise. It was just huge swelling of arm. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Delivery, Exposure during pregnancy, Neonatal disorder
Clinical narrative: Mother case: Case number PHHY2017US018052, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 665774) website on 23 Jan 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and had vaccine exposure during pregnancy. On an unspecified date, an unknown period after vaccination exposure, the patient gave birth to a baby with unspecified major birth defects (see case PHHY2017US018092). No adverse event was reported following exposure during pregnancy.
Age: 75.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHHY2017US019955, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS: 665786) on 23 Jan 2017. This report refers to a 75-year-old female patient. Historical condition included chronic kidney disease stage 5. The patient was polymedicated. The patient was vaccinated with first dose of FLUCELVAX Quadrivalent (batch number: 186867A) on into right arm intramuscularly on 14 Nov 2016. The patient was provided another influenza vaccine. No adverse event was reported following this medication error (extra dose administered).
Age: 61.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2017US035164 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS number: 665811) website on 21 Feb 2017. This report refers to 61 year old female patient. Medical history and concomitant medication was not reported and current condition reported as none. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) intramuscular into right arm and ZOSTAVAX (other manufacturer, batch number: M033335) subcutaneously into left arm on 10 Nov 2016. On an unspecified date, patient developed redness and swelling at the site of injection of the Herpes zoster vaccine in the left arm, area of redness and swelling measured 5 inches. Her swelling and redness stabilized by 2 days post vaccines. She had no fever or other signs of systemic illness. The outcome of the events was complete recovery on an unknown date, seriousness of the events was non serious and causality of the events was not reported. Following an internal review of the data received on 21 Feb 2017, the following changes were done: Events coding were changed from vaccination site erythema and vaccination site swelling to injection site erythema and injection site swelling.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: Case number PHHY2017US031281 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 665989) website on 21 Feb 2017. This report refers to a 54 year old female patient. Historical condition was not reported. Past medications included clindamycin, SOMA, sulfa, IMITREX, promethazine, penicillin, COMPAZINE, opioid, ibuprofen, erythromycin, epinephrine and DEMEROL. Current illness and concomitant medication were reported as none. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1619901) intramuscularly into left arm on 04 Nov 2016. After vaccination on 14 Nov 2016, patient was lightheaded and experienced dizziness. The lab data of the patient included heart rate, blood pressure, blood glucose and body temperature which were all within the normal range (results unspecified). The final outcome of the event dizziness was reported as unknown. The seriousness of the event was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Feeling hot, Hypoacusis
Clinical narrative: Case number PHHY2017US030986, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 666252) on 21 Feb 2017. This report refers to a 26 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 185284) on 14 Nov 2016 intramuscularly in left arm. On 14 Nov 2016 few minutes (15 minutes) following FLUCELVAX vaccine administration, the patient complained of feeling warm then hearing diminished, felt light headed. The patient had lay down, given fluids and rest. Nurse practitioner at clinic examined blood pressure of the patient and was found to be a normal. The patient fully recovered from these events on an unknown date. Seriousness of the events were reported as non-serious. The causality of the events were not reported.