chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hepatitis B antibody negative in a 52-year-old female patient who received TWINRIX adult (batch number 797K7, expiry date unknown). Co-suspect products included TWINRIN adult (batch number 797K7, expiry date unknown) and TWINRIX adult (batch number 797K7, expiry date unknown). On 21st July 2015, the patient received the 1st dose of TWINRIX adult. On 21st August 2015, the patient received the 2nd dose of TWINRIX adult. On 1st September 2016, the patient received the 3rd dose of TWINRIX adult. On 1st September 2016, not applicable after receiving TWINRIX adult and TWINRIX adult, not applicable after receiving TWINRIX adult and TWINRIX adult and an unknown time after receiving TWINRIX adult, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced hepatitis B antibody negative. On an unknown date, the outcome of the hepatitis B antibody negative and drug dose administration interval too long were unknown. It was unknown if the reporter considered the hepatitis B antibody negative to be related to TWINRIX adult, TWINRIX adult and TWINRIX adult. Additional details were provided as follows: On 1st September 2016, the patient received 3rd dose of TWINRIX adult, which led to lengthening of the vaccination schedule. The healthcare professional reported that the patient had received all the 3 doses of the TWINRIX series and when a titer was done, it showed she was not immune to Hepatitis B. The expiry date of TWINRIX adult was mistakenly reported same as that of the vaccination date of 1st dose of TWINRIX adult. It was unclear if the reported lot number 797K7 corresponded to the 1st dose, 2nd dose or 3rd dose or all the doses of the vaccine.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at the site and entire upper arm.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Pharmacy had a temperature excursion. Patient received the affected vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Headache, Nausea, Pyrexia, Tremor
Clinical narrative: Fever, headache, nausea, shaking, weakness.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red-elbow to shoulder outer aspects arm swollen-surrounding site sore-(L) arm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain in extremity, Tenderness
Clinical narrative: Left arm pain/burning. No redness/warmth/swelling on exam. (L) arm tenderness on exam.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: Approximately 1 1/2 hours after administration student present w/diffuse urticaria on face and back. Medicated with 50 mg of PO BENADRYL.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Erythema, Joint swelling, Peripheral swelling, Pruritus, Sensation of foreign body
Clinical narrative: Itchiness, redness, swelling of hands, knees, and feet claims he is feeling like there is a ball in his throat but no difficulty swallowing and breathing. Treatment to be sent out to ER.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Antinuclear antibody positive, Arthralgia, Autonomic nervous system imbalance, Chills, Fatigue
Clinical narrative: Itchiness, redness, swelling of hands, knees, and feet claims he is feeling like there is a ball in his throat but no difficulty swallowing and breathing. Treatment to be sent out to ER.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Headache, Postural orthostatic tachycardia syndrome, Pyrexia, Serum ferritin decreased, Tremor
Clinical narrative: Itchiness, redness, swelling of hands, knees, and feet claims he is feeling like there is a ball in his throat but no difficulty swallowing and breathing. Treatment to be sent out to ER.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Vitamin D decreased
Clinical narrative: Itchiness, redness, swelling of hands, knees, and feet claims he is feeling like there is a ball in his throat but no difficulty swallowing and breathing. Treatment to be sent out to ER.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Antinuclear antibody positive, Arthralgia, Asthenia, Autonomic nervous system imbalance, Chills
Clinical narrative: Itchiness, redness, swelling of hands, knees, and feet claims he is feeling like there is a ball in his throat but no difficulty swallowing and breathing. Treatment to be sent out to ER.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Fatigue, Headache, Postural orthostatic tachycardia syndrome, Pyrexia, Serum ferritin decreased
Clinical narrative: Itchiness, redness, swelling of hands, knees, and feet claims he is feeling like there is a ball in his throat but no difficulty swallowing and breathing. Treatment to be sent out to ER.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Tremor, Vitamin D decreased
Clinical narrative: Itchiness, redness, swelling of hands, knees, and feet claims he is feeling like there is a ball in his throat but no difficulty swallowing and breathing. Treatment to be sent out to ER.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Syncope
Clinical narrative: Pharmacist gave vaccine, spoke with patient for a few minutes and the patient stood up . He reached for a chair and fell backwards, fainting. A second or two went by an patient sat straight up and drank a glass of water and left after 30min-1hr.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Local reaction, Pruritus, Skin warm
Clinical narrative: Redness, swelling, heat, induration of 3 in diameter. Slight itching, local reaction resolving. This is day 4. Told to put heat on it and can take BENADRYL for itching if needed.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Redness, swelling, heat, induration of 3 in diameter. Slight itching, local reaction resolving. This is day 4. Told to put heat on it and can take BENADRYL for itching if needed.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2015US150165, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 566440) website on 23 Oct 2015. This report refers to a 21 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145605) intramuscular in left arm on an unknown 02 Oct 2014. On 03 Oct 2014 the patient experienced redness and swelling to left deltoid, following injection 24 hours prior. Reported to urgent care, was seen by a provider and medication given. The outcome of the events was unknown. Events were reported as non-serious and causality was not reported.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US150297, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System  (VAERS, reference number: 584680) website on 23 Oct 2015. This report refers to a 59 years old male patient. Historical conditions included asthma, peripheral vascular disorder, hypertension, insomnia, impaired fasting glucose, gout, and hyperlipidemia. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 123503) in left arm along with Pneumococcal Vaccine Polyvalent (other manufacture, batch number: H014283) in left arm on 13 Dec 2012. On the same day after vaccination, patient experienced urticaria and pruritis. The patient was treated with diphenhydramine (manufacture unknown) at a dose of 50 mg PRN. The outcome of the events was reported as complete recovery. Events were reported as non-serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haemorrhage
Clinical narrative: Case number PHHY2015US151726, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 590884) website on 16 Nov 2015. This report refers to a 49 year old female patient. Past medical history was not reported. Current condition included allergic to penicillin and sulfa. Concomitant medications included pantoprazole (manufacturer unknown), levothyroxine (manufacturer unknown) and citalopram (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 157021) intramuscularly on 19 Aug 2015. On the same day after vaccination, the patient experienced bleeding and bruising within a few minutes of administration. Outcome of the event was reported as recovered. Events were reported as serious and causality was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2015US151755, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 591470) website on 16 Nov 2015. This report refers to a 64 year old female patient. Past medical history included hypothyroidism. Concomitant medication included levothyroxine (manufacturer unknown). The patient was vaccinated with FLUVIRIN (Batch number: 145303) intramuscularly in left arm on 15 Oct 2014. On 16 Oct 2014, the patient arm had been sore ever since receiving vaccination. The outcome of the event pain in extremity was reported as unknown. Event was reported as non serious and causality was not reported.
Age: 56.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Case number PHHY2015US151776, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 591573) website on 16 Nov 2015. This report refers to a 56-year-old male patient. Medical history was not reported. Concomitant medication included minocycline (manufacturer unknown). The patient had no known drug allergy. The patient was vaccinated with FLUVIRIN (batch number: 1514501) intramuscularly in the right arm on 21 Aug 2015 and ZOSTAVAX (batch number: L015415) subcutaneously in the right arm on 21 Aug 2015. On 23 Aug 2015, the patient woke up with swelling in right hand. The patient went to emergency room and was given a 7 days course of cephalexin (manufacturer unknown). Outcome of the event was reported as unknown. Event was reported as serious and causality was not reported.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2015US151817, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 591614) website on 16 Nov 2015. This report refers to a 21 year old female patient. Past medical history included depression. Concomitant medication included escitalopram oxalate (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 157404) in the left arm on 13 Aug 2015. On the same day after vaccination, the patient experienced redness and she felt that her arm was warmth. She also experienced swollen spot of 2-3 inches on arm. Outcome of the events was reported as complete recovery. Events were reported as serious and causality was not reported.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Impaired work ability, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2015US152192, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 592330) website on 16 Nov 2015. This report refers to a 59 year old female patient. Past medical history was not reported. Patient had no current illness. Concomitant medication included montelukast (manufacturer unknown), NORCO, AMBIEN, PRAVACHOL, pramipexole (manufacturer unknown) and diclofenac (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 15725P) in to the right arm and PNEUMOVAX (batch number: 1003188) in to left arm both intramuscularly on 29 Aug 2015. On 30 Aug 2015 within 12 hours of vaccination, the patient experienced fever with body temperature 103, her arm was very red and swollen and she missed 02 days of work. The outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Case number PHHY2015US151792, is an initial spontaneous report received from a health care professional via health authority (593943) on 16 Nov 2015. This report refers to a 54-year-old female patient. Past medical history and concomitant medication was not reported. The patient received FLUVIRIN (batch/lot number: 1514701) intramuscularly in left arm on 03 Sep 2015. On the same day after vaccination, the patient developed redness around injection site and itching the day of vaccine, redness around injection site but no itching day 2 and 3 after vaccine. The final outcome of the events vaccination site erythema and pruritus was not reported. The seriousness of events was reported as non serious and causality was not reported.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site inflammation, Nausea, Vomiting
Clinical narrative: Case number PHHY2015US153594, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 593995) on 16 Nov 2015. This report refers to a 59 years old female patient. Past medical history and concomitant medication were not reported. The patient received FLUVIRIN (batch number: 1514501) intramuscularly in left arm on 27 Aug 2015. On the same after vaccination, patient experienced nausea, vomiting, chills and had a 7 cm diameter inflamed area at injection site. The outcome of the events was unknown. These events were assessed as non serious by health authority and causality was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Pain, Vaccination site pain
Clinical narrative: Case number PHHY2015US152275, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 593996) website on 16 Nov 2015. This report refers to a 46 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501) in to the arm intramuscularly on 28 Aug 2015. On the same day approximately 15-20 minutes after vaccination, the patient complained of feeling extremely painful at the vaccination site and felt hurt moving the vaccination arm. The body temperature was 98.6 degrees Fahrenheit. The patient was advised to take ALEVE to relieve the pain. The outcome of the events was reported as unknown. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3, TYP, YF
Symptoms: Asthenia, Fatigue
Clinical narrative: Case number PHHY2015US157748, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 594511) website on 02 Nov 2015. This report refers to a 63 years old female patient. Past medical history was included hyperlipidemia and menopause. Concomitant medications included PREMPRO and LOVAZA. The patient was vaccinated with FLUVIRIN (manufacturer unknown and batch number: 1514501) intramuscularly in right arm on 28 Aug 2015 and YF VAX vaccine (yellow fever and batch number: U1107AC) subcutaneously in left arm on 28 Aug 2015. On 28 Aug 2015, the patient experienced severe fatigue and weakness. The patient went to the emergency room. The outcome of the events was not reported. The seriousness of the events was reported as non serious by the health authority. The causality of the events was not reported. Following an internal review done for the data received on MRD 02 Nov 2015, non significant case correction was done: The suspect product coding was changed from Influenza vaccine to FLUVIRIN vaccine. Following an internal review done for the data received on MRD 02 Nov 2015, significant case correction was done: As the previous correction was significant the case follow up significant box was checked general tab.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2015US152422, is an initial spontaneous report received from a health care professional via health authority (regulatory reference number: 594513) on 16 Nov 2015. This report refers to a 44-year-old pregnant female. Past medical history and concomitant medication was not reported. The patient received FLUVIRIN (batch/lot number: 1514701) intramuscularly in left arm on 01 Sep 2015. It was reported that, patient was pregnant at time of administration. No adverse event reported. The seriousness of events was reported as non serious and causality was not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2015US152244, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 594546) website on 16 Nov 2015. This report refers to a 24 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157104) intramuscularly in the right arm on 24 Aug 2015 when she was pregnant. No adverse event was reported following administration of FLUVIRIN. Outcome of the pregnancy was unknown. Event was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHHY2015US151485 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 594548) on 16 Nov 2015. This report refers to a 33 year old female patient. Past medical history was not reported. She had no current condition. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 15731P) intramuscularly in the left arm on 20 Aug 2015, the patient had tingling down spine, arms and legs, numb hands and feet and chest heaviness. These symptoms were present for 8 hours. The patient was advised to call 911 or go to emergency room (ER) and the patient visited ER. The events outcome was unknown. The events were reported as non-serious. The causality of the event was not reported.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Case number PHHY2015US152403, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 594578) website on 16 Nov 2015. This report refers to a 75 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515101) intramuscularly in the left arm on 09 Sep 2015. On the same day, an hour after the vaccination, the patient felt lightheadedness. Outcome of the event was reported as condition improving. Event was reported as non serious and causality was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Case number PHHY2015US153055, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 595259) website on 16 Nov 2015. This report refers to a 60 year old female patient. Past medical history conditions weakening her immune system and no vaccines within the last week. Concomitant medications were not reported. Current condition included pain. The patient was vaccinated with FLUVIRIN (batch number: 1514601, expiry date: 01 May 2016) 0.5 ml intramuscularly and ZOSTAVAX (batch number: L020482, expiry date: 02 Sep 2016) 0.65 ml subcutaneously both received on 28 Aug 2015. On 29 Aug 2015, the patient experienced redness, swelling and hot to touch at the injection site, nausea, weakness and round welts. The pharmacist advised her to use a cold compress to alleviate the swelling, but it did not work. There was no lab performed. On 30-AUG-2015, she felt worse and it was unknown, if she would have the ZOSTAVAX or the FLUVIRIN again. Outcome of the events was reported as condition unchanged. Events were reported as non serious and causality was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US153055, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 595259) website on 16 Nov 2015. This report refers to a 60 year old female patient. Past medical history conditions weakening her immune system and no vaccines within the last week. Concomitant medications were not reported. Current condition included pain. The patient was vaccinated with FLUVIRIN (batch number: 1514601, expiry date: 01 May 2016) 0.5 ml intramuscularly and ZOSTAVAX (batch number: L020482, expiry date: 02 Sep 2016) 0.65 ml subcutaneously both received on 28 Aug 2015. On 29 Aug 2015, the patient experienced redness, swelling and hot to touch at the injection site, nausea, weakness and round welts. The pharmacist advised her to use a cold compress to alleviate the swelling, but it did not work. There was no lab performed. On 30-AUG-2015, she felt worse and it was unknown, if she would have the ZOSTAVAX or the FLUVIRIN again. Outcome of the events was reported as condition unchanged. Events were reported as non serious and causality was not reported.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Rash macular, Rash pruritic
Clinical narrative: Case number PHHY2015US156478, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 598679) website on 24 Nov 2015. This report refers to a 79 years old female patient. Medical history was not reported. Vaccination history included administration of high dose FLUZONE (batch number: unknown) 02 years ago when patient was 77 years old, which caused swelling and soreness. Concomitant medication was not reported and patient had no current illness. The patient was vaccinated with FLUVIRIN (batch number: 157605) and PREVNAR 13 (batch number: L84631) intramuscularly in to left arm on 14 Sep 2015. On the same day after vaccination, the patient experienced itchy rash on chest, neck, arms and blotchy red skin. The patient was treated with Diphenhydramine. Outcome of the events was reported as complete recovery at 8:45 am next day (15 Sep 2015). Seriousness of the events was reported as non serious and causality not reported. Following an internal review on 27 Jan 2016, a significant case correction was performed for the information received on MRD 24 Nov 2015: Suspect product coding changed from influenza vaccine to FLUVIRIN.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Case number PHHY2015US155218, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 597441) website on 24 Nov 2015. This report refers to an 8 year old male patient. Medical history and concomitant medication were not reported. The patient received FLUVIRIN (batch number: 15755P) intramuscularly in left arm on 25 Sep 2015. On the same day after vaccination, the patient fainted briefly for a few seconds and developed a little sweating. Patient's pulse and breathing were within normal limits. Patient was coherent and conscious. Emergency medical service (EMS) was called just in case of requirement. But EMS was not required as the condition was not life threatening. Outcome of the events was complete recovery. Events were reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2016US029979, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 610576) website on 29 Feb 2016. This report refers to 50 years old female patient. Past medical history was not reported. Current condition included seasonal allergies. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 157801) on 15 Sep 2015, on left arm. The patient felt that, vaccination left to high with shot. On the same day, after vaccination, she had trouble lifting arm (left), she could not lift arm over head and had pain in shoulder and middle arm. Events were seemed to be resolving. Final outcome of the events was reported as unknown. Seriousness of the events was reported as non serous and causality of the events was not reported.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blister, Erythema, Pyrexia
Clinical narrative: Case number PHHY2016US030871 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 610892) on 29 Feb 2016. This report refers to a 63 year old female patient. Past medication included penicillin. Concomitant medication and current illness was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157902) intramuscularly and ZOSTAVAX (other manufacturer, batch number: L031272) subcutaneously, both into left arm on 12 Nov 2015. On the same day, the patient experienced redness from elbow to armpit, blistering of approx. 6 inch diameter and low-grade fever. On 16 Nov 2015, the patient recovered from the events and only redness was remaining. The final outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: Case number PHHY2016US030029, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 610906) website on 29 Feb 2016. This report refers to 65 years old female patient. Current conditions included neck and shoulder pain, fatigue and depression. Past medications included omeprazole (manufacturer unknown) and Sulfa. Past medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1516701) on left arm and PREVNAR 13 (batch number: L99271), on right arm both on 02 Oct 2015. On the same date, she had rash left arm and was painful. Also warm to touch. She received Cephalexin 500 mg one capsule, thrice daily (TID) for 7 days. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Migraine
Clinical narrative: Case number PHHY2016US031178, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 611410) website on 29 Feb 2016. This report refers to 35 years old female patient. Past medical history included migraines. Concomitant medication included OPANA ER 15 mg. She was vaccinated with FLUVIRIN (batch number: 15724P), intramuscularly on left arm on 19 Nov 2015. On 20 Nov 2015, she had a recurrence of migraines. The final outcome of the event was unknown. The seriousness of the event was reported as non serious and causality was not reported.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Case number PHHY2016US031231, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 611556) website on 29 Feb 2016. This report refers to 66 years old male patient. Past medical history included Crohn's Disease and blood clots. Concomitant medication included ARIXTRA 7.5 mg/0.6 mL. He was vaccinated with FLUVIRIN (batch number: 1515301), intramuscularly in right arm and PNEUMOVAX (batch number: L017265), intramuscularly on left arm, both received on 23 Nov 2015. On same day, after vaccination he had swelling and pain. On an unknown date, he went to emergency room. The final outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 91.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Rash, Urticaria
Clinical narrative: Case number PHHY2016US031951, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 611640) website on 29 Feb 2016. This report refers to 91 years old male patient. Current conditions included hypertension and chronic kidney disease (CKD). Past medical history included diverticulosis, hypothyroidism and benign prostatic hyperplasia (BPH). Concomitant medications included enalapril (manufacturer unknown), levothyroxine (manufacturer unknown), pentoxifylline (manufacturer unknown), prednisone (manufacturer unknown), silodosin (manufacturer unknown), tamsulosin (manufacturer unknown) and venlafaxine (manufacturer unknown). He was vaccinated with FLUVIRIN (batch number: 1517401), intramuscularly on left arm and PREVNAR 13 (other manufacturer, batch number: L010598), intramuscularly on left arm, both received on 24 Nov 2015. On 25 Nov 2015, he had symptoms of hives, rash and swelling in hands. No shortness of breath and no chest pain were reported. Final outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising
Clinical narrative: Case number PHHY2016US031980, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 612135) website on 29 Feb 2016. This report refers to 50 years old female patient. Past medical history was not reported. Concomitant medications included ibuprofen (manufacturer unknown) and Trazodone (manufacturer unknown). She was vaccinated with FLUVIRIN (batch number: 1515301), intramuscularly on right arm and PREVNAR 13 (other manufacturer, batch number: L99262), intramuscularly on left arm, both on 01 Oct 2015. On same day, she had a bruise a little larger than a 1/2 dollar 5 1/2 inches below right shoulder. She had no pain. The final outcome of the event was unknown. The seriousness of the event was reported as non serious and causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Panic attack
Clinical narrative: Case number PHHY2016US030157, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 612270) on 29 Feb 2016. This report refers to a 42 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517801) into left arm on 28 Nov 2015. On the same day after vaccination the patient felt dizzy and had a panic attack. EMT was contacted but the patient did not want to go to the hospital. The next day patient's father called and said that the patient was been really tired. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Arthralgia, Erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Case number PHHY2016US030158, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 612361) on 29 Feb 2016. This report refers to a 61 years old male patient. Medical history was not reported. Historical drug included sulfa drugs. Concomitant medications included FLONASE, SOMA, SINGULAIR, loratadine, pravastatin, ketorolac and lisinopril. The patient was vaccinated with FLUVIRIN (batch number: 1516901) intramuscularly into left arm on 17 Nov 2015. On the same day the patient was also vaccinated with PREVNAR 13 (batch number: M20659, other manufacturer) intramuscularly into right arm and ZOSTAVAX (batch number: L028286, other manufacturer) subcutaneously into left arm. On 23 Nov 2015, on day 6 after vaccination, the patient experienced swelling and tenderness at site of injection. On day 7 the patient experienced redness/swelling alongside length of arm and joint pain on same side elbow. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Peripheral coldness, Sleep disorder
Clinical narrative: Case number PHHY2016US030160, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 612716) on 29 Feb 2016. This report refers to a 54 years old female patient. Medical history included coronary artery disease. The patient had no current illness. Concomitant medications included spironolactone, metoprolol tartrate, clopidogrel, atorvastatin, vitamin and ALEVE. The patient was vaccinated with FLUVIRIN (batch number: 157901) intramuscularly into left arm on 29 Sep 2015. On 02 Oct 2015 the patient had soreness in arm and was unable to lift arm without pain in left arm. Further the patient was unable to sleep on left side and sometimes had cold/numbness in hand. The patient went to emergency room due to these events. Outcome of the events was reported as not recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Nausea, Nervousness, Pyrexia
Clinical narrative: Case number PHHY2016US031006 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 613017) on 29 Feb 2016. This report refers to a 44 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157901) intramuscularly on 02 Dec 2015. On same day, the patient experienced nausea, mild fever and felt clammy, shaky and dizzy. The outcome of the events was reported as unknown. Events were reported as non-serious. Causality of the events was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2016US031040 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 613184) on 29 Feb 2016. This report refers to a 3 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157902) into left arm on 19 Nov 2015. It was reported that patient's mother was fine with it and did not want child to be revaccinated. No adverse events were reported following this maladministration (drug administered to patient of inappropriate age).
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Case number PHHY2016US031635 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 613405) on 29 Feb 2016. This report refers to a 54 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501) into right arm and PNEUMOVAX (other manufacturer, batch number: L035686) into left arm, both intramuscularly on 23 Nov 2015. On 24 Nov 2015, the patient experienced swelling of arm and redness reaction at site of injection. The patient was recommended BENADRYL and ice. he got checked up on 25 Nov 2015 and it was mentioned that now his arm was significantly better and just soreness at site of injection was there. The final outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2016US030001, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 615650) website on 29 Feb 2016. This report refers to 42 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 157901) on 21 Nov 2015, intramuscularly on left arm. On 25 Nov 2015, she had severe left upper arm/shoulder pain especially picking things up. The outcome of the events was condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Tremor
Clinical narrative: Case number PHHY2016US030880, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 615722) on 29 Feb 2016. This report refers to a 26 years old female patient. Medical history included constipation, dysphagia, esophagitis, gastrooesophageal reflux disease (GERD), psychoses and seizure without medications. Current conditions were none. Concomitant medications included AMITIZA, omeprazole and sertraline. The patient was vaccinated with FLUVIRIN (batch number: 1517001) intramuscularly into left arm on 18 Dec 2015. On the same day after vaccination the patient was unable to stand for a second, then when her mother picked her up she felt a shake from a patient. It was reported that the patient has a possible seizure or syncope. Spoke to mother about an hour later and next day, she said patient was fine, patient acted normal and also slept fine. Final outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2016US030143, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 615762) website on 29 Feb 2016. This report refers to a female patient of an unknown age. Historical condition was not reported. Current condition included asthma. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515001) and PMUEMOVAX ((other manufacturer) batch number: K009874) both intramuscularly into left arm on 11 Dec 2015. On 13 Dec 2015, the patient could not move arm without a sharp pain, there was a large red spot between the shoulder and the elbow, it also burnt, tingled and hurt when her shirt touched the area. The patient would be contacting her primary care physician on Monday (date unspecified). Final outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Case number PHHY2016US030143, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 615762) website on 29 Feb 2016. This report refers to a female patient of an unknown age. Historical condition was not reported. Current condition included asthma. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515001) and PMUEMOVAX ((other manufacturer) batch number: K009874) both intramuscularly into left arm on 11 Dec 2015. On 13 Dec 2015, the patient could not move arm without a sharp pain, there was a large red spot between the shoulder and the elbow, it also burnt, tingled and hurt when her shirt touched the area. The patient would be contacting her primary care physician on Monday (date unspecified). Final outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Full blood count normal, Pruritus, Red blood cell sedimentation rate normal, Skin warm
Clinical narrative: Case number PHHY2016US030190, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS ID: 616034) website on 29 Feb 2016. This report refers to 70 years old female patient. Historical condition was not reported. Past medications included Penicillin and Aspirin. Current condition included asthma. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517301) and PREVNAR 13 (other manufacturer, batch number: M06899) into right arm, both intramuscularly on 15 Dec 2015. On 17 Dec 2015 after vaccination, the patient experienced redness, warm area, itchiness. The patient visited emergency room on an unknown date. The patient's doctor ordered laboratory data for complete blood count and sedimentation rate which was normal (all within range) and a course of antibiotics. The final outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Influenza, Nasopharyngitis
Clinical narrative: Case number PHHY2016US029976, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 616395) website on 29 Feb 2016. This report refers to a 59 years old male patient. Current condition included hypertension and diabetes. Historical condition was not reported. Concomitant medication included VIAGRA, CRESTOR, Lisinopril and metformin. The patient was vaccinated with FLUVIRIN (batch number: 1515701) into right arm and PNEUMOVAX (batch number: 007720) into left arm, both intramuscularly on 23 Sep 2015. On 24 Sep 2015, the patient experienced chills, flu and cold symptoms. The outcome of the events was reported as completely recovered. Seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Case number PHHY2016US030015, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 616500) website on 29 Feb 2016. This report refers to 31 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 15731P) on 05 Nov 2015, on left arm. On 05 Nov 2015, she had left arm pain and weakness, which was continued to present (condition unchanged). The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: M
Vaccine: FLU3, IPV, MMR
Symptoms: Headache, Injection site pain, Injection site swelling, Myalgia, Tenderness
Clinical narrative: Case number PHHY2016US029959, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 616747) website on 29 Feb 2016. This report refers to 42 years old male patient. Past medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1514601) on 17 Sep 2015, intramuscularly on left arm. On same day, he was also vaccinated with MMR II (other manufacturer, batch number: L002873), subcutaneously on left arm and with IPOL (other manufacturer, batch number: L1442), intramuscularly on left arm. On 04 Oct 2015, he had swollen and tender injection site, headache, muscle aches and tender armpit. The outcome of the events was complete recovery. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: Case number PHHY2016US034574 is a initial spontaneous received from a health care professional via company (reference number: 617026) on 15 Mar 2016. This report refers to a 60-year-old female patient. Historical condition was not reported. Current condition included penicillin allergy. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514901) into right arm intramuscularly 30 Dec 2015 and ZOSTAVAX (manufacturer unknown, lot number: L028285) into right arm subcutaneously 30 Dec 2015. On 30 Dec 2015 the patient experienced stinging, itching, red/swollen area about 2 inches by 3 inches in size, no limitation in range of motion, only 4 days since vaccine was administered. The outcome of the events were unknown. And seriousness and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Cluster headache, Dizziness, Echocardiogram, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2016US034624, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 617472) website on 15 Mar 2016. This report refers to 50 years old female patient. Past medical history included vertigo. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 158104), intramuscularly on left arm on 21 Oct 2015. On same day, she had dizziness, muscle weakness and cluster headaches (left). Dizziness lasted for 7 weeks, muscle weakness lasted for 2 weeks and cluster headache (left) for 4 weeks. On an unknown date, she went to emergency room. On an unknown date, echocardiogram, X ray and nuclear magnetic resonance imaging (MRIs) were done and result was not reported. Final outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Case number PHHY2016US034624, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 617472) website on 15 Mar 2016. This report refers to 50 years old female patient. Past medical history included vertigo. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 158104), intramuscularly on left arm on 21 Oct 2015. On same day, she had dizziness, muscle weakness and cluster headaches (left). Dizziness lasted for 7 weeks, muscle weakness lasted for 2 weeks and cluster headache (left) for 4 weeks. On an unknown date, she went to emergency room. On an unknown date, echocardiogram, X ray and nuclear magnetic resonance imaging (MRIs) were done and result was not reported. Final outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Case number PHHY2016US034560, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 617477) website on 15 Mar 2016. This report refers to a 54 years old female patient. Past medical history was not reported. Current condition included as allergies to shellfish and latex. Concomitant medications was not reported. The patient was vaccinated FLUVIRIN (batch number: 1515001) into left arm on 19 Nov 2015. On the same day after vaccination, the patient experienced hardness at immunization site (no inflammation), complains of severe pain when using arm above chest high with weakness and tingling of 3rd, 4th and 5th digits. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHHY2016US034783, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 617745) website on 15 Mar 2016. This report refers to a 21 years old female patient. Past medical history was not reported. Concomitant medications included as PPD. The patient was vaccinated with FLUVIRIN (batch number: 1515401) into right arm, intradermal in error on 05 Jan 2016. It was reported that, the patient aware, injection site evaluated by physician. The patient visited to the emergency room. The seriousness of the event was reported as non serious. The causality of the event was not reported. No adverse events were reported following the medication error.