chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 05 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 06 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 17 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 by other non-health professional via Health authority (reference no: 670377) and concerns a 32 years old male patient. The patient's historical drugs included ASA and Sulfa. The patient's concomitant medications included CLARITIN and ADVIL. On 05-Dec-2016, the patient received AFLURIA QUADRIVALENT (dose, expiry date: not reported, dose no: 14, batch no: WT55007) at right arm via intramuscular route. On an unspecified date, the patient also received BIOTHRAX (dose, expiry date: not reported, dose no: 09 batch no: FAV482A) at right arm via intramuscular route. On 06-Dec-2016 after administration of influenza vaccine and anthrax vaccine, the patient experienced swelling, pain, hot skin and redness. Action taken with the vaccine was not reported. the outcome of the events was recovered/resolved on an unknown date. Reporter's Assessment: The health authority did not provide the causality assessment of the events in relation to the AFLURIA QUADRIVALENT. This case was non-serious.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: This Spontaneous case, initially received on 12-Apr-2017, was reported by a other non-health professional and concerns a concerns a 65 years old male patient. Administration of Company suspect drug: On 08-Dec-2016, the patient administered with AFLURIA QUADRIVALENT (Dose: not reported; batch number: WT58508; Route of administration: intramuscular). Non-company suspect drug: On 08-Dec-2016, PNEUMOVAX was administered for unknown indication (Dose: not reported; batch number: 014458; Route of administration: intramuscular). Adverse reactions/events and outcomes: The patient reported that, on 08-Dec-2016 after receiving AFLURIA QUADRIVALENT he experienced pain in arm at injection site that increased over time (Vaccination site pain). Also, reported pain radiated into neck and down to elbow; Difficulty in raising arm above shoulder height (injected limb mobility decreased). Action taken with AFLURIA QUADRIVALENT was not reported. Outcome for events was unknown. Reporter's Assessment: The reporter did not provided the causality between AFLURIA QUADRIVALENT and events. Company assessed the causality between AFLURIA QUADRIVALENT and events as related. This report was not serious.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Oligomenorrhoea
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health Professional through Health Authority (FDA VAERS number: 671172) and concerns a 29 years old female patient. Administration of Company suspect drug (s): On 07-Nov-2017, AFLURIA QUADRIVALENT was administered (dose:0.5ml, unknown duration, batch number not reported, route of administration: unknown). Adverse reactions/events and outcomes: On 28-Nov-2016, the patient began menstrual cycle and still had a menstrual flow (13+ days as of today, i.e., 10-Dec-2016). Action taken was not reported. The outcome of the event oligomenorrhoea was not reported. Reporter's Assessment: The Health Authority considered the case as non-serious. The causality of the event oligomenorrhoea was not reported.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 671431) and concerns a 66-years-old elderly female patient. The patient's medical history included: gastrooesophageal reflux disease, osteoarthritis, chronic kidney disease, diabetes mellitus, hyperlipidemia and hypertension. The patient's concomitant medications included: hydrochlorothiazid, Atorvastatin, Losartan, NIFEDICAL, calcium 600 +D(3) and betamethasone, clotrimazole. Administration of Company suspect drug (s): On 10-Nov-2016, the patient was administered with AFLURIA QUADRIVALENT (0.5 ml, Batch number: WT52406) Intramuscular route on left arm. Other company suspect drug (s): On an unspecified date, the patient was administered with PNEUMOVAX (Batch number M029681) via intramuscular route on left arm. Adverse reactions/events and outcomes: On 11-Nov-2016 the patient was mildly pruritic, pain and swelling was reported. The patient reported that, she had no fever, hand pain, numbness and tingling. Action taken with influenza vaccine and pneumococcal vaccine was not reported. Outcome of the events pruritus, pain and swelling was recovered. Reporter's Assessment: The reporter did not provide the causality and company causality between influenza vaccine and pruritus, pain was assessed as related and between swelling was assessed as not related. This report was not serious.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This Spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional via regulatory authority (VAERS ID: 673659) and concerns a 66-years-old female patient. The patient's concomitant medication included: SYMBICORT, Losartan. Administration of Company suspect drug: On 19-Dec-2016, the patient administered with AFLURIA QUADRIVALENT (dosage: not reported, batch number: 13949211A, route of administration: intramuscular and anatomical location: left arm). Adverse reactions/events and outcomes: On 19-Dec-2016, the patient was experienced nausea, vomiting and diarrhea. The action taken with Influenza Vaccine was not reported. The outcome of the events was recovered. Reporter's Assessment: The reporter did not provide the causality between Influenza Vaccine and events. This report was not serious.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Dizziness, Vertigo, Vomiting
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 677168) and concerns a 69 years old female patient. Concomitant medications included: lorazepam 1 mg at night for right leg syndrome. On 23-Dec-2016, patient was administered AFLURIA QUADRIVALENT (dosage, route of administration, anatomical location: unknown), (batch number: 1619701). It was reported that, the patient tried to get out of bed at 11:00 and was terribly dizzy, got back in bed and went back to sleep. The patient woke up at 8 am and called boyfriend to visit to the emergency room as the patient was so dizzy and couldn't open eyes and had vomiting. Doctor said the patient had a vertigo and sent home with meclizine and one other medication that the patient doesn't remember the name. The patient visited the medical doctor on the following Tuesday and was sent to the therapist to treat vertigo. Patient had three other treatments that helped some, so patient went back to work. On 06-Jan-17, past Friday the events reappeared back. The patient decided to visit ENT. Laboratory test: Blood test was done which showed the result as normal. Treatment medication included: Meclizine for vertigo. Outcome of the events was not recovered. Reporter's assessment: The reporter assessed the events as Non-serious and the causality was not provided. This report was not serious.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysgeusia, Dyspepsia, Headache, Impaired work ability
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by an other non-health professional via regulatory authority (vaccine adverse event reporting system: 677347) and concerns a 52 years old adult female patient. Patient had a history of allergy to sulfa, bees and had other sensitivities. Patient's prior vaccination include influenza (seasonal) with adverse events migraine headache and body aches. Administration of Company suspect drug (s): On 06-Jan-2017 the patient was administered with AFLURIA QUADRIVALENT (dosage: 0.5ml, batch number: WT55807) via intramuscular route at right arm. Adverse reactions/events and outcomes: On 06-Jan-2017, the patient experienced migraine, nausea, inflammation, headache tingling, metallic taste, heart burn, itching all over, dizziness and reported that she was still feeling sick and missed her work. Action taken with influenza vaccine was not reported and outcome of the events was reported as not reported. Reporter's Assessment: The other non-health professional did not provide any assessment between the events and influenza vaccine. This case was non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Malaise, Migraine, Nausea, Paraesthesia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by an other non-health professional via regulatory authority (vaccine adverse event reporting system: 677347) and concerns a 52 years old adult female patient. Patient had a history of allergy to sulfa, bees and had other sensitivities. Patient's prior vaccination include influenza (seasonal) with adverse events migraine headache and body aches. Administration of Company suspect drug (s): On 06-Jan-2017 the patient was administered with AFLURIA QUADRIVALENT (dosage: 0.5ml, batch number: WT55807) via intramuscular route at right arm. Adverse reactions/events and outcomes: On 06-Jan-2017, the patient experienced migraine, nausea, inflammation, headache tingling, metallic taste, heart burn, itching all over, dizziness and reported that she was still feeling sick and missed her work. Action taken with influenza vaccine was not reported and outcome of the events was reported as not reported. Reporter's Assessment: The other non-health professional did not provide any assessment between the events and influenza vaccine. This case was non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by an other non-health professional via regulatory authority (vaccine adverse event reporting system: 677347) and concerns a 52 years old adult female patient. Patient had a history of allergy to sulfa, bees and had other sensitivities. Patient's prior vaccination include influenza (seasonal) with adverse events migraine headache and body aches. Administration of Company suspect drug (s): On 06-Jan-2017 the patient was administered with AFLURIA QUADRIVALENT (dosage: 0.5ml, batch number: WT55807) via intramuscular route at right arm. Adverse reactions/events and outcomes: On 06-Jan-2017, the patient experienced migraine, nausea, inflammation, headache tingling, metallic taste, heart burn, itching all over, dizziness and reported that she was still feeling sick and missed her work. Action taken with influenza vaccine was not reported and outcome of the events was reported as not reported. Reporter's Assessment: The other non-health professional did not provide any assessment between the events and influenza vaccine. This case was non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hypoaesthesia, Injection site erythema, Injection site pain, Muscular weakness
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine event reporting system: 677777) and concerns a 37-years-old elderly female patient. It was reported that, the patient was using and IUD (intra uterine device) at the time of vaccination. Administration of Company suspect drug: On 7-Nov-2016, the patient was administered with AFLURIA QUADRIVALENT (0.5 ml, Batch number: WT58508) via intramuscular route on left arm. Adverse reactions/events and outcomes: On 08-Nov-2016 the patient experienced regular site soreness (injection site pain) a day after administration. About 4 weeks later, on an unspecified date she noted increasing pain, redness (injection site redness), numbness in fingers and hand (numbness), weakness in the shoulder muscles and hand (weakness muscle); and persisted low grade fevers and fatigue. It was reported that, the events were resulted in emergency room visit. Action taken with the influenza vaccine was not reported. Outcome of the events was not recovered. Reporter's Assessment: The reporter did not provided the causality and company causality between influenza vaccine and injection site pain, redness and fever was assessed as related and between weakness muscle, fatigue and numbness was assessed as not related. This report was not serious.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine event reporting system: 677777) and concerns a 37-years-old elderly female patient. It was reported that, the patient was using and IUD (intra uterine device) at the time of vaccination. Administration of Company suspect drug: On 7-Nov-2016, the patient was administered with AFLURIA QUADRIVALENT (0.5 ml, Batch number: WT58508) via intramuscular route on left arm. Adverse reactions/events and outcomes: On 08-Nov-2016 the patient experienced regular site soreness (injection site pain) a day after administration. About 4 weeks later, on an unspecified date she noted increasing pain, redness (injection site redness), numbness in fingers and hand (numbness), weakness in the shoulder muscles and hand (weakness muscle); and persisted low grade fevers and fatigue. It was reported that, the events were resulted in emergency room visit. Action taken with the influenza vaccine was not reported. Outcome of the events was not recovered. Reporter's Assessment: The reporter did not provided the causality and company causality between influenza vaccine and injection site pain, redness and fever was assessed as related and between weakness muscle, fatigue and numbness was assessed as not related. This report was not serious.
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Nuclear magnetic resonance imaging, Pain, Pain in extremity, X-ray
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 677781) on 12-Apr-2017 was reported by other non-healthcare professional and concerns a 45 years old female patient. Administration of Company suspect drug (s): On 11-Oct-2016, the patient was administered by AFLURIA QUADRIVALENT, (batch number: 13649221A, route of administration: intramuscular; dose: 0.5 ml, anatomical location: right arm and expiration date: not reported). Adverse events/reactions and outcomes: On 11-Oct-2016 after administration of AFLURIA QUADRIVALENT, the patient consistent arm pain, that is worse when she raised her arm. Action taken with AFLURIA QUADRIVALENT is not reported. The outcome of the events were not recovered/not resolved. The patient has undergone relevant lab tests x ray, pending MRI (nuclear magnetic resonance imaging). Reporter's Assessment: The other non-healthcare professional did not provide causality between the events consistent arm pain, that is worse when she raises her arm and the of AFLURIA QUADRIVALENT. This case report was non-serious.
Sex: M
Vaccine: DTP, FLU4, HEP, PPV
Symptoms: Dizziness, Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health Professional through FDA VAERS ID: 678099 and concerns a 28 years old male patient. The patient's medication history included: Type 1 diabetes mellitus. The patient's concomitant medication included: LANTUS, LEXAPRO, NOVOLOG. Administration of Company suspect drug(s): On from 14-Jan-2017, AFLURIA QUADRIVALENT vaccine was administered (unknown dosage, batch number WT57206, route of administration: intramuscular, anatomical location: right arm). Non-company suspect drug(s): On from 14-Jan-2017, Hepatitis B vaccine was administered (unknown dosage, batch number: M013654, route of administration: intramuscular, anatomical location: left arm). On from 14-Jan-2017 Pneumococcal vaccine polyvalent was administered (unknown dosage, batch number: M041394, route of administration: intramuscular, anatomical location: right arm). On from 14-Jan-2017, DPT Vaccine was administered (unknown dosage, batch number: P75413, route of administration: intramuscular, anatomical location: left arm). Adverse reactions/events and outcomes: On 14-Jan-2017, the patient was administered with vaccines around 1:30 PM in the afternoon (AFLURIA QUADRIVALENT, Hepatitis B vaccine, Pneumococcal vaccine polyvalent, DPT Vaccine) and around 11 PM he went to bed. He noted that he did not feel too well at that point and experienced mild flu-like symptoms. Around 4:30 AM, the patient woke up from sleep, felt dizzy, faint, nausea, headache, pain around the temples and vomiting. He went to the emergency room, where he received IV saline solution and ZOFRAN. The patient was then released home shortly. On 15-Jan-2017, at 4:00 PM, he felt much better, but still having pain around the temples. Action taken was not applicable. Outcome of the events, dizziness, headache, influenza like illness, malaise, nausea, vomiting was recovered. Pain around the temples is not recovered. Reporter's Assessment: The Health Authority considered the case as non-serious. The causality of the events were not reported.
Sex: M
Vaccine: DTP, FLU4, HEP, PPV
Symptoms: Vomiting
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health Professional through FDA VAERS ID: 678099 and concerns a 28 years old male patient. The patient's medication history included: Type 1 diabetes mellitus. The patient's concomitant medication included: LANTUS, LEXAPRO, NOVOLOG. Administration of Company suspect drug(s): On from 14-Jan-2017, AFLURIA QUADRIVALENT vaccine was administered (unknown dosage, batch number WT57206, route of administration: intramuscular, anatomical location: right arm). Non-company suspect drug(s): On from 14-Jan-2017, Hepatitis B vaccine was administered (unknown dosage, batch number: M013654, route of administration: intramuscular, anatomical location: left arm). On from 14-Jan-2017 Pneumococcal vaccine polyvalent was administered (unknown dosage, batch number: M041394, route of administration: intramuscular, anatomical location: right arm). On from 14-Jan-2017, DPT Vaccine was administered (unknown dosage, batch number: P75413, route of administration: intramuscular, anatomical location: left arm). Adverse reactions/events and outcomes: On 14-Jan-2017, the patient was administered with vaccines around 1:30 PM in the afternoon (AFLURIA QUADRIVALENT, Hepatitis B vaccine, Pneumococcal vaccine polyvalent, DPT Vaccine) and around 11 PM he went to bed. He noted that he did not feel too well at that point and experienced mild flu-like symptoms. Around 4:30 AM, the patient woke up from sleep, felt dizzy, faint, nausea, headache, pain around the temples and vomiting. He went to the emergency room, where he received IV saline solution and ZOFRAN. The patient was then released home shortly. On 15-Jan-2017, at 4:00 PM, he felt much better, but still having pain around the temples. Action taken was not applicable. Outcome of the events, dizziness, headache, influenza like illness, malaise, nausea, vomiting was recovered. Pain around the temples is not recovered. Reporter's Assessment: The Health Authority considered the case as non-serious. The causality of the events were not reported.
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Respiratory tract congestion
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 678219) and concerns a 68-year-old elderly female patient. The patient's medical history included: anaphylactic reaction. The patient had AFLURIA shot last two years back with out any adverse events. Administration of Company suspect drug: On 16-Jan-2017, the patient was administered with AFLURIA QUADRIVALENT (0.5 ml, Batch number: WT53106) via intramuscular route on left arm. Adverse reactions/events: On 16-Jan-2017 after administration of influenza vaccine, the patient experienced shortness of breath, chest and throat congestion. Action taken with the influenza vaccine was not reported. Outcome of the events dyspnoea, respiratory tract congestion was recovered. Treatment medications included: BENADRYL 50 mg. Reporter's Assessment: The reporter did not provided the causality between influenza vaccine and the events dyspnea, respiratory tract congestion as related. This case is non-serious.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Pain, Skin abrasion, Swelling
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAER ID: 678237) on 12-Apr-2017 was reported by other non-healthcare professional and concerns a 37 years old female patient. On 14-Jan-2017 the patient was administered by AFLURIA QUADRIVALENT, (dose: 1df, route of administration: intramuscular, anatomical location: left arm, batch number: WT57108, expiration date: not reported). On 15-Jan-2017 after administration of AFLURIA QUADRIVLAENT, the patient experienced redness swelling, removal of bandages caused abrasion to adhesive side, tenderness, heat and soreness. The action taken AFLURIA QUADRIVALENT was not reported. The outcome of the event was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality between AFLURIA QUADRIVALENT and events. This case report was non-serious.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAER ID: 678237) on 12-Apr-2017 was reported by other non-healthcare professional and concerns a 37 years old female patient. On 14-Jan-2017 the patient was administered by AFLURIA QUADRIVALENT, (dose: 1df, route of administration: intramuscular, anatomical location: left arm, batch number: WT57108, expiration date: not reported). On 15-Jan-2017 after administration of AFLURIA QUADRIVLAENT, the patient experienced redness swelling, removal of bandages caused abrasion to adhesive side, tenderness, heat and soreness. The action taken AFLURIA QUADRIVALENT was not reported. The outcome of the event was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality between AFLURIA QUADRIVALENT and events. This case report was non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by a other non-health professional via health authority VAERS ID: 678433 and concerns a 17 years old female patient. Administration of Company suspect drug: On 18-Nov-2016, the patient received AFLURIA QUADRIVALENT, (dose, expiry date: not reported; batch number: WT52105) under 18 years of age at left arm via intramuscular route. Indication not reported. Adverse reactions/events and outcomes: On an unspecified date, after administration of influenza vaccine, the patient experienced bursitis type pain in arm. Action taken with the suspect vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: Reporter did not provide the causality of the events in relation to the AFLURIA QUADRIVALENT. This case was non-serious.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Insomnia, Myalgia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via Health authority (VAERS no: 678659) and concerns a 43 years old female patient. Administration of Company suspect drug: On 13-Dec-2016, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, batch no: 13749221A, expiry date: not reported) at left arm via intramuscular route. Adverse reactions/events and outcomes: On 13-Dec-2016, at the time of injection, the patient felt as though it was not right because her muscle instantly burned. A month later, her shoulder was aching and in severe pain. She could not sleep at night and had never had any pain in her left shoulder in the past. She was considering seeking medical attention to address these concerns. Action taken with the vaccine was not reported. The outcome of the events was not recovered/not resolved. Reporter's Assessment: Health Authority did not provide the causality assessment of the events in relation to the AFLURIA QUADRIVALENT. This case was non-serious.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site pain, Malaise, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 678749) and concerns a 34-years-old female patient. Administration of Company suspect drug: On 12-Jan-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 14249221A, dose: 0.5 ml) via intramuscular route in left arm. Non-company suspect drug: On 12-Jan-2017 the patient was administered with PNEUMOVAX (batch number: M043987, dose and duration: not reported) via intramuscular route in left arm. Adverse reactions/events and outcomes: On an unspecified date the patient had chills, fever, body ache, malaise and developed searing pain in entire left arm. Adverse reactions/events and outcomes: On an unspecified date the patient had chills, fever, body ache, malaise and developed searing pain in entire left arm. AFLURIA QUADRIVALENT and pneumococcal vaccine administered on left arm on same day which is characterized by "drug administration error". Action taken with the AFLURIA QUADRIVALENT and pneumococcal vaccine was not reported and outcome of the events chills, fever, body ache, malaise and developed searing pain in entire left arm was not reported and drug administration error was unknown. Reporter's Assessment: The reporter did not provide the causality between the all events and AFLURIA QUADRIVALENT. This report was not serious.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 678749) and concerns a 34-years-old female patient. Administration of Company suspect drug: On 12-Jan-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 14249221A, dose: 0.5 ml) via intramuscular route in left arm. Non-company suspect drug: On 12-Jan-2017 the patient was administered with PNEUMOVAX (batch number: M043987, dose and duration: not reported) via intramuscular route in left arm. Adverse reactions/events and outcomes: On an unspecified date the patient had chills, fever, body ache, malaise and developed searing pain in entire left arm. Adverse reactions/events and outcomes: On an unspecified date the patient had chills, fever, body ache, malaise and developed searing pain in entire left arm. AFLURIA QUADRIVALENT and pneumococcal vaccine administered on left arm on same day which is characterized by "drug administration error". Action taken with the AFLURIA QUADRIVALENT and pneumococcal vaccine was not reported and outcome of the events chills, fever, body ache, malaise and developed searing pain in entire left arm was not reported and drug administration error was unknown. Reporter's Assessment: The reporter did not provide the causality between the all events and AFLURIA QUADRIVALENT. This report was not serious.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse vent reporting system: 678861) and concerns a 60-years-old elderly female patient. The patient's concomitant medications included fiorinal, venlafaxine, Hydrochlorothiazide, Losartan. Administration of Company suspect drug(s): On 17-Jan-2016, the patient was administered with AFLURIA QUADRIVALENT (0.5 ml, Batch number: WT53206) via Intramuscular route of right arm. Other company suspect drug(s): On 17-Jan-2016, the patient was administered with ZOSTAVAX (Batch number M01593) via subcutaneous route of left arm. Adverse reactions/events and outcomes: On 18-Jan-2017 the patient experienced Skin warm, redness area increased in size from 1/18 to 1/19. Action taken with the influenza vaccine and varicella zoster vaccine, was not reported. Outcome of the events skin warm, redness was unknown. Reporter's Assessment: The reporter did not provide the causality between the events skin warm, redness and influenza vaccine. This case is non-serious.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site rash
Clinical narrative: This spontaneous case, initially received via Health Authority (VAERS ID: 679426) on 12-Apr-2017 was reported by other non-healthcare professional and concerns a 55-year-old adult female patient. The patient's concomitant medication included FLONASE, losartan, tamoxifen. Administration of Company suspect drug(s): On 03-Jan-2017, the patient received intramuscular AFLURIA QUADRIVALENT (Dosage: 0.5 ml, batch number: WT51805) at the site of left arm. Adverse reactions/events and outcomes: On 05-Jan-2017 after administration of AFLURIA QUADRIVALENT, the patient developed rash which extended from the vaccination site to the elbow. It was reported that this was happened two days after receiving the vaccine. Action taken with AFLURIA QUADRIVALENT was not reported. The outcome of the was not reported. Reporter's Assessment: The other non-health professional assessed the events as non-serious and the causality was not provided. The case was non-serious.
Age: 51.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Bursitis, Injection site joint inflammation, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reporting System (VAERS ID: 679578) on 12-Apr-2017, was reported by other non-health professional and concerns a 51-year-old adult male patient. On 13-Dec-2016, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: WT53306, route of administration: intramuscular and anatomical location: left arm). On 13-Dec-2016, the patient was administered with ZOSTAVAX (dose: not reported, batch number: M034765, route of administration: subcutaneous and anatomical location: right arm). On 14-Dec-2016, after administration of influenza vaccine, the patient experienced severe shoulder pain, pain with abduction and extension and weakness of rotator cuff muscles, bursitis and RC inflammation. The event was started to be stable and persistent over the next 6 weeks. The action taken with influenza vaccine was not reported. The outcome of the events was not recovered. Relevant Lab Tests: The physical exam revealed bursitis, RC inflammation. The patient declined imaging 2/2 other healthcare costs.  Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and the events. This report was not serious.
Age: 51.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reporting System (VAERS ID: 679578) on 12-Apr-2017, was reported by other non-health professional and concerns a 51-year-old adult male patient. On 13-Dec-2016, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: WT53306, route of administration: intramuscular and anatomical location: left arm). On 13-Dec-2016, the patient was administered with ZOSTAVAX (dose: not reported, batch number: M034765, route of administration: subcutaneous and anatomical location: right arm). On 14-Dec-2016, after administration of influenza vaccine, the patient experienced severe shoulder pain, pain with abduction and extension and weakness of rotator cuff muscles, bursitis and RC inflammation. The event was started to be stable and persistent over the next 6 weeks. The action taken with influenza vaccine was not reported. The outcome of the events was not recovered. Relevant Lab Tests: The physical exam revealed bursitis, RC inflammation. The patient declined imaging 2/2 other healthcare costs.  Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and the events. This report was not serious.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Periarthritis
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System: 679648) and concerns a 50-years-old adult female patient. The patient's concomitant medication included: vitamins, MOTRIN for unknown indication. On 02-Nov-2016, the patient was administered with AFLURIA QUADRIVALENT (dose: 05. ml, Batch number: WT54907) via intramuscular route on left arm. On 03-Nov-2016 the patient experienced frozen left shoulder at 14:00. The patient had physical therapy due to which her symptoms were improved. Treatment medications included: CELEBREX. Action taken with the influenza vaccine was not reported. Outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and the event frozen shoulder. This case is non serious.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 679915) and concerns a 53-years-old female patient. The patients medical history includes latex allergy. Administration of Company suspect drug: On 18-Jan-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular and anatomical location: right arm). Adverse reactions/events and outcomes: On 19-Jan-2017, the patient experienced warm, redness, sore injection site then over the course of 5 days worsening of redness and spreading from deltoid to 70% of bicep just past elbow, with hardness in middle. After 5 days of worsening the patient started to feel better and redness area started to shrink. After 9 days, the patient recovered. Treatment medication included: The patient used cold compresses and ADVIL. The action taken with the influenza vaccine was not reported. The outcome of the events was recovered. Reporter's Assessment: The reporter did not provide the causality between the events and influenza vaccine. This report was not serious.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blister, Cellulitis, Erythema, Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System: 679940) and concerns a 54-years-old female patient. The patient's medical history included: Type II diabetes mellitus. The patient's concomitant medication included: valacyclovir, PROAIR, LANTUS insulin, metformin, lisinopril, simvastatin. Administration of Company suspect drug: On 12-Nov-2016 the patient was administered with AFLURIA QUADRIVALENT, (dose: 0.5 ml, batch number: 1619101, route of administration: intramuscular, anatomical location: left arm). Non-company suspect drug: On 12-Nov-2016 the patient was administered with PNEUMOVAX (batch number M040004, route of administration: intramuscular, anatomical location: right arm). Adverse reactions/events and outcomes: On 15-Nov-2016 the patient experienced swelling at injection site up to shoulder to base of neck and down to elbow. Skin was red hot and blistery. Patient had severe, intense pain and limitations from swelling and adverse vaccine reaction cellulitis. Action taken with the vaccine was not reported. Outcome of the events were recovered. Reporter's Assessment: The reporter did not provide the causality between the events and vaccine. This case was non-serious.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Skin warm
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System: 679940) and concerns a 54-years-old female patient. The patient's medical history included: Type II diabetes mellitus. The patient's concomitant medication included: valacyclovir, PROAIR, LANTUS insulin, metformin, lisinopril, simvastatin. Administration of Company suspect drug: On 12-Nov-2016 the patient was administered with AFLURIA QUADRIVALENT, (dose: 0.5 ml, batch number: 1619101, route of administration: intramuscular, anatomical location: left arm). Non-company suspect drug: On 12-Nov-2016 the patient was administered with PNEUMOVAX (batch number M040004, route of administration: intramuscular, anatomical location: right arm). Adverse reactions/events and outcomes: On 15-Nov-2016 the patient experienced swelling at injection site up to shoulder to base of neck and down to elbow. Skin was red hot and blistery. Patient had severe, intense pain and limitations from swelling and adverse vaccine reaction cellulitis. Action taken with the vaccine was not reported. Outcome of the events were recovered. Reporter's Assessment: The reporter did not provide the causality between the events and vaccine. This case was non-serious.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System: 682467) and concerns a 23-years-old adult male patient. Administration of Company suspect drug(s): On 13-Feb-2017 the patient was administered with AFLURIA QUADRIVALENT (0.5 ml, Batch number: WTS8908) via intramuscular route on left arm. Adverse reactions/events and outcomes: On 13-Feb-2017 after administration of influenza vaccine the patient stood and walked to check out the station during which he passed out standing. Another nurse grabbed the patient and laid him on gurney. The patient was temporary passed out then came to shortly after when he was laid down with feet up. Action taken with influenza vaccine was not reported. Outcome of the event loss of consciousness was recovered. Reporter's Assessment: The reporter did not provide the causality between the vaccine and event. This case non-serious.
Sex: F
Vaccine: FLU4, JEV1, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 682777) and concerns a 10 years old female patient. Concomitant medications include ZYRTEC and Mupirocin (topical ointment). Administration of company suspect drug: On 13-Feb-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch no: WT58408, expiry date: not reported). Indication not reported. Administration of non-company suspect drugs: On 13-Feb-2017, the patient was administered with Japanese encephalitis vaccine (route of administration: intramuscular, anatomical location: left arm, batch no: JEV15L07E, dose, expiry date: not reported). On 13-Feb-2017, the patient was administered with MENACTRA (route of administration: intramuscular, anatomical location: right arm, batch no: U5410AA, dose, expiry date: not reported). Adverse reactions/events and outcomes: On 13-Feb-2017, the patient was administered with AFLURIA QUADRIVALENT which was considered as inappropriate age at vaccine administration. Since both vaccines were administered in right arm, it was also considered as vaccine administered at inappropriate site. After administration patient's arm was warm to touch with reddened raised area 70 mm long in length. Patient denies any pain. Action taken with the influenza vaccine was not reported. Outcome of the events were not reported. Reporter's Assessment: The other-non health professional did not provide any causality assessment. This case was non-serious. Significant case correction received on 18-MAay-2017: Event 'vaccine administered at inappropriate site' corrected to 'drug administration error'. The listedness, causality and case comment was corrected. Insignificant case correction received on 23-Jun-2017: The flag "off-label use" was corrected to "medication error".
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Peripheral coldness, Peripheral swelling
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 683066) on 05-May-2017 was reported by other non-healthcare professional and concerns a 63-year-old adult female patient. The patient's concomitant medication included estradiol patch and losartan. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT, (route of administration: intramuscular, batch number: 13949211A; dose, expiration date: not reported). Indication was not reported. On 04-Jan-2017, after AFLURIA QUADRIVALENT, the patient experienced coldness in arm then felt it become numb and swollen within 30 minutes of vaccine administration. The outcome of the events was recovered/resolved. The reporter assessed the causality between AFLURIA QUADRIVALENT and events was related. This case report was non serious. Significant case correction received on 18-May-2017: As determined causality was corrected from unassessable to related as there was clear temporal relationship (30 minutes) after administration.
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 683628) and concerns a 58 years old female patient. Administration of Company suspect drug: On 28-Oct-2016, patient was administered with AFLURIA QUADRIVALENT via intramuscular route in left arm (dose: unknown) (batch number: WT555017). Adverse reactions/events and outcomes: On 30-Oct-2016 after administration of AFLURIA QUADRIVALENT, the patient experienced Shingles. Action taken with the suspect product was not reported. Outcome of the event was recovered. Reporter's Assessment: The reporter assessed the event as non-serious and the causality was not provided. This report was not serious.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 683857) and concerns a 49-years-old female patient. The drug history included SUDAFED and MAXALT. On 24-Feb-2017, patient was administered with AFLURIA QUADRIVALENT via intramuscular route in left arm (dose: 1 DF, batch number: 13949211A). On 24-Feb-2017, after administration of influenza vaccine, the patient developed pain in her arm that had spread down to her arm. Outcome of the event was not reported. The reporter did not provide the causality between event and influenza vaccine. This report was not serious. Case correction received on 17-May-2017: The company causality was changed from not related to unassessable.
Age: 62.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 683927) and concerns a 62 years old female patient. Administration of Company suspect drug: On 27-Oct-2016, patient was administered with AFLURIA QUADRIVALENT via intramuscular route of administration in left arm (dose: unknown) (batch number: 13549221A). Indication was not reported. Non-company suspect drug: On 27-Oct-2016, patient was administered with PREVNAR 13 via intramuscular route of administration in left arm (dose: unknown) (batch number: N16560). Indication was not reported. Adverse reactions/events and outcomes: On 27-Oct-2016, after administration of AFLURIA QUADRIVALENT and PREVNAR 13, the patient experienced pain at injection site on the left arm that lasted more than 4 months and limited her range of motion that interfered her sleep. Patient was given both vaccines in the same arm (characterized as vaccine administered at inappropriate site). Action taken with the suspect product was not reported. Outcome of the events was not reported. Reporter's Assessment: The reporter assessed the events as non-serious and the causality was not provided. This report was not serious.