chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Acne, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Received 3 shots on June 20. LD KINRIX LA subq PROQUAD RD HepA. No reaction evident on (R) arm. Two areas of redness, swelling, pain, hardness on left arm where shots were given. Also had slight fever. 6/27/17 Band-Aid off 3 days ago-had little dried pimples around them. Muscle still a little swollen-but not red anymore.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Pyrexia
Clinical narrative: Received 3 shots on June 20. LD KINRIX LA subq PROQUAD RD HepA. No reaction evident on (R) arm. Two areas of redness, swelling, pain, hardness on left arm where shots were given. Also had slight fever. 6/27/17 Band-Aid off 3 days ago-had little dried pimples around them. Muscle still a little swollen-but not red anymore.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Blood culture negative, Dyskinesia, Full blood count normal, Metabolic function test normal, Urine analysis normal
Clinical narrative: 6.5 hours after DTaP administration had 15 second rhythmic movements of bilateral upper extremities. Seen in ER at Hospital, normal exam, discharged with neurology follow up.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Contusion, Pain, Skin warm, Urticaria
Clinical narrative: Pt reported soreness and bruising x 3 days, then reported warmth and weal on arm; went to urgent care (6/25/17) and rcvd dx of cellulitis.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Erythema, Lethargy, Pyrexia, Tremor
Clinical narrative: Parents concerned at "shaking, lethargy and fever" that started within 12 hrs of immunizations on 6/23. Highest temp per father 101 approximately lasted x2 days. Also "slight red" on day 2.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Erythema, Injection site erythema, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient received Td to left deltoid on 6/24/17 at approx 4:30 PM. On 6/26/17, woke with redness, swelling to area of vaccine admin. Within 1 hour, developed radiating pain down extremity into hand. Pain is constant, aggravated by movement and interfering with ADLs.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: Patient received Td to left deltoid on 6/24/17 at approx 4:30 PM. On 6/26/17, woke with redness, swelling to area of vaccine admin. Within 1 hour, developed radiating pain down extremity into hand. Pain is constant, aggravated by movement and interfering with ADLs.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Headache, fatigue, pain at injection site, myalgia, nausea.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Feeling jittery, Hyperhidrosis, Nausea
Clinical narrative: Patient reports feeling hot/sweaty, nausea, and 'jittery' starting the morning after vaccine administration, and continuing until today (still present). Denies fever, abdominal pain, vomiting.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction left deltoid, swelling, redness, pain. Recommended OTC analgesics TYLENOL/ibuprofen, could try antihistamine for itch, use icepack regularly.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site swelling, Rash
Clinical narrative: Patient said she had a four inch raised area at site of injection. She also developed rash with blister on the opposite arm.
Age: 63.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2017US033770 is initial spontaneous report received from pharmacist via vaccine adverse event reporting system (VAERS number: 656435) website on 21 Feb 2017. This report refers to 63 year old female patient. Medical history and concomitant medication was not reported, current condition reported as unknown. The patient was vaccinated with FLUAD (batch number: not reported) and PNEUMOVAX (other manufacturer, batch number: L035687) intramuscular into left deltoid on 07 Sep 2016. On 08 Sep 2016, patient experienced swelling and redness in a straight line, from her deltoid down to her elbow. The patient had called a pharmacist for medical attention, but no treatment was received. No lab diagnostics studies were performed. The outcome of the events was not recovered at the report time. The outcome of the events was condition unchanged, seriousness of the events was non serious and causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Case number PHHY2017US031115 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 660118) on 21 Feb 2017. This report refers to a 65 year old female patient. Her medical history was not reported. She had no reported current conditions. Her concomitant medications included SYNTHROID, NEXIUM and atorvastatin. She was vaccinated with FLUAD (batch number: 165803) in the right arm, and PREVENAR 13 (batch number: M94708) in the left arm; both vaccines administered intramuscularly on 08 Oct 2016. Twenty four hours after PREVENAR vaccination, on 09 Oct 2016, the patient developed a red itchy area from injection site down to elbow area. A rash formed in line from injection area to inside of elbow. The patient still had rash at the time of reporting. The events outcome was reported as condition unchanged. The event was reported as non-serious. The causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Case number PHHY2017US032517, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 660601) website on 21 Feb 2017. This report refers to an adult female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with Seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient experienced dizziness. The outcome, seriousness and causality of the event were not reported.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHHY2017US033076 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 660747) website on 21 Feb 2017. This report refers to 30 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on an unknown date. On an unspecified date, after vaccination patient experienced numbness in arm. The outcome, seriousness and causality of the event were not reported.
Age: 70.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Migraine
Clinical narrative: Case number PHHY2017US033665, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 660846) website on 21 Feb 2017. This report refers to a 70 years old female patient. Medical history was not reported. Current conditions included coronary artery disease, hyperlipidaemia, hypertension and type 2 Diabetes Mellitus. Concomitant medications included atorvastatin, clopidogrel, NITROSTAT, Aspirin and lisinopril hydrochlorothiazide. She was vaccinated with FLUAD (batch number: 166001) into the left arm and PREVENAR 13 (other manufacture, batch number: N34936) into the right arm; intramuscularly on 13 Oct 2016. After vaccination, on 14 Oct 2016, she experienced migraine headache for the first time. The outcome of the event was reported as complete recovery on an unknown date. The seriousness and causality of the event were not reported.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site swelling
Clinical narrative: Case number PHHY2017US032665, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 661028) on 21 Feb 2017. This report refers to a 71-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUAD (batch number: 165801) intramuscularly on 23 Oct 2016. On the same day after vaccination the patient experienced very large swelling around the injection site. Swelled to about 1 inch in diameter and 1/4 inch height. Swelling did go down to normal after 15 min. Outcome of the event was complete recovery. Seriousness of the event was reported as non serious and causality was not reported.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain, Sensation of foreign body
Clinical narrative: Case number PHHY2017US031913 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS number: 661186) website on 21 Feb 2017. This report refers to 70 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUAD (batch number: 165801) intramuscular on 14 Oct 2016. On 16 Oct 2016, patient when moves arm in backwards swinging motion and felt as there was a needle in his arm and not sore when he moves his arm in any other direction. The outcome of the event was unknown, seriousness of the event was non serious and causality of the event was not reported.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain, Pain in extremity
Clinical narrative: Case number PHHY2017US032959, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 661705) on 21 Feb 2017. This report refers to a 73 years old male patient. Medical history and current illness were reported as none. Concomitant medication was not reported. The patient was vaccinated with FLUAD (batch number: 166101) on 20 Oct 2016 intramuscularly. On 20 Oct 2016, soon after receiving vaccination, the patient developed shooting pain down arm. The patient fully recovered from pain on an unknown date. Seriousness of the event was reported as non-serious. The causality of the event was not reported.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Case number PHHY2017US032694 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 662023) website on 21 Feb 2017. This report refers to 68 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUAD (batch number: 165803) and PNEUMOVAX (batch number: M015418) on 26 Sep 2016 (Monday). On the same day, 12 midnight patient woke up with chills. She was treated with TYLENOL. Patient experienced redness on shot spot and hard and hurt to touch. The outcome of the events was unknown, seriousness of the events was non serious and causality of the events was not reported.
Age: 75.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Case number PHHY2017US034013, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 662318) website on 21 Feb 2017. This report refers to a 75 years old male patient. Past medical history was not reported. Concomitant medication included MOBIC. The patient was vaccinated with FLUAD (batch number: 166102) intramuscularly in left arm on 25 Oct 2016. The patient was also vaccinated with PNEUMOVAX (batch number: L035687) intramuscularly in right arm on 25 Oct 2016. On 26 Oct 2016 after vaccination in the morning, the patient experienced that under arm became red, swollen and sore and area grew in size. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 71.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Case number PHHY2017US033787, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS: 662414) on 21 Feb 2017. This report refers to a 71-year-old male patient. Medical history was not reported. Concomitant medications included Oxycodone and meloxicam. The patient was vaccinated with FLUAD (batch number: 165901) into left arm intramuscular, PNEUMOVAX (batch number: M036161) into left arm intramuscular on 26 Oct 2016. On the same day of vaccination the patient experienced localized pain, swelling, and redness. Outcome of the events was complete recovery. Seriousness of the events was reported as non serious. Causality of the events was not reported.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site pruritus, Urticaria
Clinical narrative: Case number PHHY2017US034709, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 663190) on 21 Feb 2017. This report refers to a 70 years old female patient. Medical history and Concomitant medication was not reported. The patient was vaccinated with FLUAD (batch number: 165703) on 01 Oct 2016 intramuscularly in left arm. On 24 Oct 2016, 3 weeks after injection, the patient developed itching and pain at the injection site also small welts appeared a few days after that. The outcome of the events was unknown. Seriousness of the events were reported as non-serious. The causality of the events were not reported.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Case number PHHY2017US034331, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 664031) website on 21 Feb 2017. This report refers to a 66 years old female patient. Medical history was unknown. Current illness was reported as none. Concomitant medication was not reported. She was vaccinated with FLUAD (batch number: 165803) intramuscularly into the left arm on 17 Oct 2016. After vaccination, on the same day, she experienced extremely sore arm after the shot. She believed the pharmacist had administered the shot too high (administrations error). She was sore that day and the following day. She mad an appointment with her doctor to see if anything was wrong. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the event were not reported.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2017US034975, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 664106) website on 21 Feb 2017. This report refers to a 65 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number UI698AA) in left arm on 20 Oct 2016. On 21 Oct 2016 after vaccination, the patient experienced extreme swelling and rash at the injection site. The patient referred to prescribed if persists beyond diphenhydramine use. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported. Follow up received on 07-Apr-2017 (Case correction): The outcome is changed from recovered to not recovered.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Discomfort, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2017US031606, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 664178) on 21 Feb 2017. This report refers to a 68 years old female patient. Historical condition was not reported. Current condition included cephalosporin allergy. Concomitant medication was not reported. The patient was vaccinated with FLUAD (batch number: 165902) in left arm and PNEUMOVAX (batch number: M039669) in right arm on 01 Nov 2016 intramuscularly (reported as the patient given a FLUAD (flu) shot in opposite arm on same day). On 01 Nov 2016, the patient had heat and swelling in right arm. Significant enough that the patient called to report. The patient still having discomfort several days later though not worsening. The patient fully recovered from peripheral swelling and skin warm on an unknown date. The outcome of the event discomfort was reported as condition unchanged (reported as still having discomfort). Seriousness of the events were reported as non-serious. The causality of the events were not reported.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Headache, Injection site erythema, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: Case number PHHY2017US035804, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 664736) website on 21 Feb 2017. This report refers to a 73 years old male patient. Medical history was not reported. Concomitant medication was not reported. He was vaccinated with FLUAD (batch number: 165703) intramuscularly into the left arm on 05 Nov 2016. After vaccination, on 06 Nov 2016, he had raised, red welt around injection site. He said the welt was warm to touch. He also had a headache and 101 degree fever. He did visit the physician on 07 Nov 2016 who prescribed him Z-PAK. He visited the emergency room on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2017US035804, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 664736) website on 21 Feb 2017. This report refers to a 73 years old male patient. Medical history was not reported. Concomitant medication was not reported. He was vaccinated with FLUAD (batch number: 165703) intramuscularly into the left arm on 05 Nov 2016. After vaccination, on 06 Nov 2016, he had raised, red welt around injection site. He said the welt was warm to touch. He also had a headache and 101 degree fever. He did visit the physician on 07 Nov 2016 who prescribed him Z-PAK. He visited the emergency room on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 79.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dizziness, Erythema, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Case number PHHY2017US034090 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 665465) on 21 Feb 2017. This report refers to a 79 year old female patient. Her current condition included allergy to DARVON. Her concomitant medications were phenytoin, pantoprazole, oxybutynin, nitrofurantoin, propranolol and meloxicam. She was vaccinated with FLUAD (batch number: 165703) in the right arm and PNEUMOVAX (batch number: L036437) in the left arm; both vaccines administered on 08 Nov 2016. On the same day, the patient experienced redness, tenderness, soreness in the left arm, fever and dizziness. The events started 30 to 40 minutes after the shot. She went to emergency room and the doctor put her on antibiotic. The events outcome were unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2017US031942, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 665907) website on 21 Feb 2017. This report refers to a 89 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: not reported) on 10 Nov 2016. On the same day after vaccination the patient experienced large red area clearly defined around shoulder and arm where shot was administered. Recommended patient to call their physician, or go to emergency room if worse. The patient said it was better than yesterday. The outcome of the event was reported as complete recovery on an unspecified date. The seriousness and causality of the event were not reported.
Sex: M
Vaccine: FLUX
Symptoms: Sinus disorder
Clinical narrative: Case number PHHY2017US032590, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 665950) website on 21 Feb 2017. This report refers to a male patient of unspecified age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date. On an unspecified date after vaccination the patient experienced sinus disorder. The outcome, seriousness and causality of the event were not reported.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Bedridden, Chills, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: Case number PHHY2017US031387 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 666663) website on 21 Feb 2017. This report refers to 71 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown, batch number not reported, dose not specified) high dose in 2014 (date not reported). In 2014, patient experienced chills, fever (102, unit and normal range were not reported), nausea, bed-ridden for 36 hours. She felt bad another 24 hours. The outcome of the events was unknown, seriousness of the events was non serious and causality of the events was not reported.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2017US033238, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667056) website on 21 Feb 2017. This report refers to a 76 years old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUAD (batch number: 165801) intramuscularly into the left arm on 14 Nov 2016. After vaccination, on the same day, she experienced severe pain in arm and shoulder and neck. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2017US033653, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667063) website on 21 Feb 2017. This report refers to a 77 years old male patient. Medical history was not reported. Current illness was reported as none. Concomitant medication was not reported. He was vaccinated with FLUAD (batch number: 165903) into the right arm on 11 Nov 2016. After vaccination, on 12 Nov 2016, swelling, redness and it was slightly warm at the site of injection. He called the physician and was told to put cold compress. He was doing well as of this report. 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: 86.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: Case number PHHY2017US033908 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667384) website on 21 Feb 2017. This report refers to an 86 year old female patient. No medical history of the patient was reported. Concomitant medications included latanoprost, timolol, levothyroxine and omeprazole. The patient was vaccinated with FLUAD (batch number: 165903) intramuscularly into right arm on 01 Nov 2016. After vaccination on 02 Nov 2016, patient experienced little bleeding on BAND-AID after shot and on an unknown date (reported as in next few days) the patient noticed bruising around the injection site. It was reported that the patient was not on any blood thinners and reported that there was no numbness and tingling. 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 events was reported as non serious and causality was not reported.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Neck pain
Clinical narrative: Case number PHHY2017US033487, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (Vaers: 667600) on 21 Feb 2017. This report refers to a 77-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUAD (lot number: 166102) into left arm on 19 Nov 2016. On the same day of vaccination the patient experienced neck pain three hours after flu shot. Neck pain was subsided after 12 hours (complete recovery). Seriousness of the event was not reported. Causality was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Case number PHHY2017US035682 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667845) website on 21 Feb 2017. This report refers to a male patient of unspecified age. Medical history and concomitant medications were not reported. The patient was vaccinated with first dose of seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on an unknown date. On an unspecified date, after vaccination patient experienced arm redness, warmth and pain with pressure. The outcome, seriousness and causality of the events were not reported.
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Skin warm
Clinical narrative: Case number PHHY2017US033180, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668056) website on 21 Feb 2017. This report refers to an 85 years old female patient. Medical history was unknown. Concomitant medication was not reported. She was vaccinated with FLUAD (batch number: 165801) into the left arm on 15 Nov 2016. After vaccination, on 17 Nov 2016, she experienced redness and warmth on the medial side of her arm, opposite of her deltoid muscle. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Swelling
Clinical narrative: Case number PHHY2017US033750, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 669013) website on 21 Feb 2017. This report refers to an adult female patient. Medical history and current history were reported as none. Concomitant medication was not reported. She was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) into the right arm on an unknown date in 2015. After vaccination, on an unknown date she experienced soreness and swelling in the armpit. The outcome, seriousness and causality of the events were not reported.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Peripheral swelling
Clinical narrative: This Spontaneous case, initially received on 12-Apr-2017 was reported by a other healthcare professional and concerns a 65 years old male patient. Administration of Company suspect drug(s): On 18-Oct-2016, the patient was administered by Influenza vaccine (site of administration: left arm; dosage, batch number, route of administration: not reported). Non-company products: On 18-Oct-2016, the patient was also administered by Pneumococcal 13 valent vaccine (site of administration: right arm, dosage, batch number, router of administration: unknown). Adverse reactions/events and outcomes: It was reported that after administration of INN flu vaccine, the right arm appeared swollen. Action taken with INN flu vaccine was not reported. The outcome of peripheral swelling was unknown. Reporter's Assessment: The other healthcare professional assessed the event (peripheral swelling) as non-serious and did not provide the causality. This case report was non-serious.
Age: 81.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by a pharmacist via Health Authority (VAERS number: 669731) and concerns 81 years old female patient. Administration of company suspect drug: On 07-Oct-2016, patient was administered with INN flu vaccine seasonal (dosage: 0.5ml, batch number: not reported, route of administration: unknown, anatomical location: left arm). Non-company suspect drug: On 07-Oct-2016, patient was also administered with PREVNAR (dosage: 0.5ml, batch number: not reported, route of administration: unknown, anatomical location: right arm). Adverse reactions/events and outcomes: On an unspecified date of 2016, the patient experienced right bicep pain. Action taken with the suspect product was not reported. Outcome of the event was not recovered/not resolved. Reporter's Assessment: Health Authority did not provided any causality assessment for the event. Health Authority considered this report as non-serious.
Age: 90.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site discolouration, Injection site haematoma
Clinical narrative: Case number PHHY2017US029376, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 670539) website on 21 Feb 2017. This report refers to a 90 years old female patient. Past medical history was not reported. Concomitant medication included prednisone. The patient was vaccinated with FLUAD (batch number: 165803) intramuscularly on 28 Nov 2016. On 29 Nov 2016 after vaccination, the patient experienced 03 inches X 02 inches hematoma or fluid pocket developed at injection site and color was dark purple. It was palpitated and was soft and fluid filled. No pain, no SOB (shortness of breath), no tingling or discomfort was reported. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Pain in extremity, Vomiting
Clinical narrative: This Spontaneous case received from Vaccine Adverse Events Reporting System (VAERS reference number: 670619), originally received on 12-Apr-2017 was reported by a pharmacist and concerns a 72 years old female patient. The patient's concomitant medication included COZAAR, CYTOMEL, SYNTHROID and omeprazole. Administration of Company suspect drug(s): On 07-Nov-2016, the patient was administered by Influenza virus vaccine (unspecified) (site of administration: arm, dosage, batch number, route of administration, expiration date: unknown). Other company suspect drug: On the same day, the patient was also administered by PNEUMOVAX 23 (site of administration: arm, batch number: M029680, rout of administration: intramuscular, dosage: unknown). Adverse reactions/events and outcomes: On 07-Nov-2016, the patient experienced swelling and redness in the whole arm from the shoulder to an inch above the elbow to that arm received the PNEUMOVAX 23. On 09-Nov-2016 the patient experienced vomiting and felt weak. On an unspecified date in approximately November 2016, the patient was seen by an unknown healthcare provider and was treated with unspecified "topical steroids". The current illness of the patient was prophylaxis. The outcome of the events was unknown. Report's Assessment: The pharmacist assessed the events asthenia, vomiting, injection site erythema and the events injection site erythema, injection site swelling and asthenia was as non-serious, and the causality of the events injection site erythema, injection site swelling, pain in arm and asthenia was not related. The causality of the event vomiting was not reported. This case report was non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2017US034404 is an initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS number: 670753) website on 21 Feb 2017. This report refers to male patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine (manufacturer unknown, batch number: not reported) on an unknown date. On an unspecified date, patient experienced red at site. The outcome of the event was unknown, seriousness of the event was non serious and causality of the event was not reported.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by a Pharmacist via Health Authority (VAERS number: 670813) and concerns a 1 year old male patient. Administration of Company suspect drug(s): On 29-Nov-2016 influenza virus vaccine polyvalent was administered via unknown route of administration (unknown dosage) and batch number was not reported. Non-company suspect drugs: On 01-Dec-2016, Hepatitis A, PROQUAD (batch number: M031567) and VARIVAX (batch number: M025867) was administered. Adverse reactions/events and outcomes: It was reported that the patient had administered extra dose and no adverse event was reported. Outcome of the event was not reported. Reporter's Assessment: The Pharmacist did not provide the causality for the event. This report is not serious.
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Oropharyngeal pain, Pruritus, Swelling, Urticaria
Clinical narrative: Case number PHHY2017US030435, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 671760) on 21 Feb 2017. This report refers to a 72 years old female patient. Historical condition included allergy to various items, including preservatives. Concomitant medication was not reported. Concomitant medication was not reported. The patient was vaccinated with first dose of FLUAD (batch/lot number: 165902) on 01 Dec 2016 intramuscularly. On 02 Dec 2016, the patient developed itchiness, redness, a little swelling; looked like hives. On an unknown date, the patient developed sore throat. It was reported that patient had vaccine last year with no reaction. The patient was treated with BENADRYL for treatment of an unknown indication. The patient fully recovered from erythema, swelling, urticarial and pruritus on an unknown date. The outcome of the event oropharyngeal pain was reported as condition improving (reported as recovering). Seriousness of the events erythema, pruritus, urticaria, and swelling was reported as non-serious. Seriousness of the event oropharyngeal pain was not reported. The causality of the events were not reported.
Age: 23.0
Sex: F
Vaccine: FLUC3
Symptoms: Asthenia, Bacterial infection, Decreased immune responsiveness, Herpes virus infection, Influenza
Clinical narrative: This serious initial Spontaneous case, was received from other non-health professional (consumer) via health authority (VAERS ID: 672081) on 12-Apr-2017 concerning a 23-year-old female patient. The patient's concomitant medication included LOESTRIN FE. On 12-Jan-2015, the patient received FLUCELVAX TIV (dose: 0.5 ml (one single dose), batch number: 012022A and expiry date: 31-Mar-2015) at right arm via intramuscular route.  On 12-Jan-2015 after administration influenza vaccine, the patient had excessive decrease in energy levels, excessive decrease in immunity and felt sick (considered as immediate post-injection reaction). The patient stated that she was constantly sick due to mild bacterial infection, viral infections such as a mild cold, persistent mild UTI's (Urinary tract infection) and contracted strep occurred on 01-Sep-2015. The patient stated that, these illnesses persisted for many months and on an unspecified date she had a mild UTI that developed into an aggressive double kidney infection which hospitalized her for 1 day. On an unspecified date, urine sampling was done. On an unspecified date, she contracted to the flu (for the first time in 15 years) and contracted to a severe herpes type 1 infection extending from half of her upper left lip all the way up to her nose. The patient stated that the series of events decreased her quality of life. On an unspecified date, the patient was treated with Antibiotics (intravenous) and Fluids for kidney infection. At the time of this report, the outcome of the events was recovered. The reporter did not provide the causality of the events in relation to the FLUCELVAX TIV. Follow-up report was received on 15-Jun-2017 along with the information received from other health care professional via a company representative on 23-Jun-2017: Case was updated to medically confirmed. Other health care professional was added as a reporter. According to the batch number the suspect product was changed from INN Flu Vaccine Seasonal to FLUCELVAX TIV, indication, batch number and expiry date of suspect vaccine were updated. Onset date of events was updated.
Age: 23.0
Sex: F
Vaccine: FLUC3
Symptoms: Kidney infection, Malaise, Quality of life decreased, Streptococcal infection, Urinary tract infection
Clinical narrative: This serious initial Spontaneous case, was received from other non-health professional (consumer) via health authority (VAERS ID: 672081) on 12-Apr-2017 concerning a 23-year-old female patient. The patient's concomitant medication included LOESTRIN FE. On 12-Jan-2015, the patient received FLUCELVAX TIV (dose: 0.5 ml (one single dose), batch number: 012022A and expiry date: 31-Mar-2015) at right arm via intramuscular route.  On 12-Jan-2015 after administration influenza vaccine, the patient had excessive decrease in energy levels, excessive decrease in immunity and felt sick (considered as immediate post-injection reaction). The patient stated that she was constantly sick due to mild bacterial infection, viral infections such as a mild cold, persistent mild UTI's (Urinary tract infection) and contracted strep occurred on 01-Sep-2015. The patient stated that, these illnesses persisted for many months and on an unspecified date she had a mild UTI that developed into an aggressive double kidney infection which hospitalized her for 1 day. On an unspecified date, urine sampling was done. On an unspecified date, she contracted to the flu (for the first time in 15 years) and contracted to a severe herpes type 1 infection extending from half of her upper left lip all the way up to her nose. The patient stated that the series of events decreased her quality of life. On an unspecified date, the patient was treated with Antibiotics (intravenous) and Fluids for kidney infection. At the time of this report, the outcome of the events was recovered. The reporter did not provide the causality of the events in relation to the FLUCELVAX TIV. Follow-up report was received on 15-Jun-2017 along with the information received from other health care professional via a company representative on 23-Jun-2017: Case was updated to medically confirmed. Other health care professional was added as a reporter. According to the batch number the suspect product was changed from INN Flu Vaccine Seasonal to FLUCELVAX TIV, indication, batch number and expiry date of suspect vaccine were updated. Onset date of events was updated.
Age: 23.0
Sex: F
Vaccine: FLUC3
Symptoms: Urine analysis, Viral infection
Clinical narrative: This serious initial Spontaneous case, was received from other non-health professional (consumer) via health authority (VAERS ID: 672081) on 12-Apr-2017 concerning a 23-year-old female patient. The patient's concomitant medication included LOESTRIN FE. On 12-Jan-2015, the patient received FLUCELVAX TIV (dose: 0.5 ml (one single dose), batch number: 012022A and expiry date: 31-Mar-2015) at right arm via intramuscular route.  On 12-Jan-2015 after administration influenza vaccine, the patient had excessive decrease in energy levels, excessive decrease in immunity and felt sick (considered as immediate post-injection reaction). The patient stated that she was constantly sick due to mild bacterial infection, viral infections such as a mild cold, persistent mild UTI's (Urinary tract infection) and contracted strep occurred on 01-Sep-2015. The patient stated that, these illnesses persisted for many months and on an unspecified date she had a mild UTI that developed into an aggressive double kidney infection which hospitalized her for 1 day. On an unspecified date, urine sampling was done. On an unspecified date, she contracted to the flu (for the first time in 15 years) and contracted to a severe herpes type 1 infection extending from half of her upper left lip all the way up to her nose. The patient stated that the series of events decreased her quality of life. On an unspecified date, the patient was treated with Antibiotics (intravenous) and Fluids for kidney infection. At the time of this report, the outcome of the events was recovered. The reporter did not provide the causality of the events in relation to the FLUCELVAX TIV. Follow-up report was received on 15-Jun-2017 along with the information received from other health care professional via a company representative on 23-Jun-2017: Case was updated to medically confirmed. Other health care professional was added as a reporter. According to the batch number the suspect product was changed from INN Flu Vaccine Seasonal to FLUCELVAX TIV, indication, batch number and expiry date of suspect vaccine were updated. Onset date of events was updated.
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Injection site pain, Middle insomnia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by Pharmacist via regulatory authority (VAERS ID: 672568) and concerns a female patient of unspecified date. Administration of Company suspect drug: On 30-Aug-2016, patient was administered influenza virus vaccine polyvalent via unknown route in opposite arm. Non-company suspect drugs: On 30-Aug-2016, patient was also administered ZOSTAVAX (lot no M018453, expiration date 28-Jun-2017) of (dose: 0.65 ml) via subcutaneous route of administration in an unspecified arm. Adverse reactions/events and outcomes: On an unspecified date, the patient experienced pain at the ZOSTAVAX injection site which makes her wake up at night. The patient sought medical attention and it was reported that the patient contacted her pharmacist on 18-Nov-2016. No treatment for the event was provided. Outcome of the events was reported as not recovered. Reporter's Assessment: The Health Authority assessed the events as non-serious and did not provide the causality for the event Injection site pain and middle insomnia. This report is not serious.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Urticaria, Vomiting
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by an other non-health care professional regulatory authority (vaccine adverse event reporting system: 672608) and concerns a 1-years-old infant male patient. Concomitant medications: MOTRIN 1.875 mg. Administration of Company suspect drug(s): On 28-Oct-2016 the patient was administered with influenza virus vaccine polyvalent, hepatitis A, measles-mumps-rubella virus vaccine, varicella vaccine, dosage, batch number, route of administration: not reported. Adverse reactions/events and outcomes: On 28-Oct-2016 the patient began violently throwing up, could not keep water down, or any type of fluid or food. Vomited throughout the evening hours until he kept down 4 oz of formula at 10:00 AM. On 29-Oct-2016 the patient continued vomiting's throughout the day on next day the patient covered in hives from head to toe. The patient was consulted by paediatrician on 30-Oct-2016 recommended BENADRYL or CLARITIN to control hives. The action taken with the INN flu vaccine seasonal was not reported. The outcome of the events was recovered. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Back pain, Dyspnoea, Pain, Pain in extremity
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 672735) on Apr-2017 was reported by other non-healthcare professional and concerns a 76 years old elderly male patient. Administration of Company suspect drug(s): On 28-Nov-2016, the patient was administered by FLUAD (TIV) (batch number: 165801, route of administration: intramuscular; dose and expiration date: not reported). Indication not reported. Adverse events/reactions and outcomes: On 28-Nov-2016 after administration of FLUAD (TIV), the patient felt very weak, had trouble in breathing, pain in his lower back that kept shooting down his right leg. Action taken with FLUAD (TIV) is not reported. The outcome of the events was recovered/resolved. Reporter's Assessment: The other non-healthcare professional did not provide causality between the events very weak, having trouble in breathing, pain in his lower back that kept shooting down his right leg and the FLUAD (TIV). This case report was non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Headache, Peripheral swelling
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by other non-health professional via health authority (VAERS no: 672812) and concerns a female patient of an unknown age and gender. Administration of Company suspect drug: On 20-Oct in unspecified year, the patient received influenza vaccine, dose, expiry date, batch no, route of administration: not reported). Adverse reactions/events and outcomes: On unspecified date after administration of influenza vaccine, the patient experienced red and swollen arm along with the headache. On 17 Nov in unspecified year, the patient went to see the doctor. Laboratories investigations were not reported. The action taken with the vaccine was not reported. the outcome of the events was unknown. Treatment medication: VASELINE as a corrective treatment. Reporter's Assessment: Health Authority did not provide the causality assessment of the events in relation to the INN Flu Vaccine Seasonal. This case report was non-serious.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 672955) on Apr-2017 was reported by other non-healthcare professional and concerns a 44-year-old female patient. The patient's medical history included rheumatoid arthritis. Administration of Company suspect drug (s): On 18-Oct-2016, the patient received influenza virus vaccine polyvalent as injection at upper/top joint area of shoulder (left arm) by a nurse who was conducting flu clinic. Indication not reported. Adverse reactions/events and outcomes: On 21-Oct-2016 after administration of influenza virus vaccine polyvalent, the patient experienced left shoulder has been in pain and since range of motion affected. Action taken with influenza virus vaccine polyvalent was not reported. The events outcome of the events was not recovered. Reporter's Assessment: The reporter assessed event as non serious and the causality was related.