chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV2
Symptoms: Diarrhoea, Dizziness, Ear discomfort, Ear pain, Headache
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of headache in a 16-year-old female subject who received CERVARIX. Concomitant products included CERVARIX. In June 2012, the subject received CERVARIX (Intramuscular). On an unknown date, unknown after receiving CERVARIX, the subject experienced headache (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), deafness (serious criteria clinically significant/intervention required), tinnitus (serious criteria clinically significant/intervention required), sensation of block in ear  (serious criteria clinically significant/intervention required), dizziness  (serious criteria clinically significant/intervention required), cognitive disorder (serious criteria clinically significant/intervention required), sleep disorder (serious criteria clinically significant/intervention required), constipation (serious criteria clinically significant/intervention required), diarrhoea (serious criteria clinically significant/intervention required), menstruation irregular (serious criteria clinically significant/intervention required), generalised aching (serious criteria clinically significant/intervention required), malaise (serious criteria clinically significant/intervention required), tremor (serious criteria clinically significant/intervention required), sensory aberrations (serious criteria clinically significant/intervention required), nystagmus (serious criteria clinically significant/intervention required), weakness (serious criteria clinically significant/intervention required), abdominal pain (serious criteria clinically significant/intervention required), queasy (serious criteria clinically significant/intervention required), orthostatic dysregulation (serious criteria clinically significant/intervention required), and pain in jaw (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the headache, ear pain, deafness, tinnitus, sensation of block in ear, dizziness, cognitive disorder, sleep disorder, constipation , diarrhoea, menstruation irregular, generalised aching, malaise, tremor, sensory aberrations, nystagmus, weakness, abdominal pain, queasy, orthostatic dysregulation and pain in jaw were unknown. The reporter considered the headache, ear pain, deafness, tinnitus, sensation of block in ear, dizziness, cognitive disorder, sleep disorder, constipation, diarrhoea, menstruation irregular, generalised aching, malaise, tremor, sensory aberrations, nystagmus, weakness, abdominal pain, queasy, orthostatic dysregulation and pain in jaw to be related to CERVARIX.
Sex: F
Vaccine: HPV2
Symptoms: Malaise, Menstruation irregular, Nausea, Nystagmus, Orthostatic intolerance
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of headache in a 16-year-old female subject who received CERVARIX. Concomitant products included CERVARIX. In June 2012, the subject received CERVARIX (Intramuscular). On an unknown date, unknown after receiving CERVARIX, the subject experienced headache (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), deafness (serious criteria clinically significant/intervention required), tinnitus (serious criteria clinically significant/intervention required), sensation of block in ear  (serious criteria clinically significant/intervention required), dizziness  (serious criteria clinically significant/intervention required), cognitive disorder (serious criteria clinically significant/intervention required), sleep disorder (serious criteria clinically significant/intervention required), constipation (serious criteria clinically significant/intervention required), diarrhoea (serious criteria clinically significant/intervention required), menstruation irregular (serious criteria clinically significant/intervention required), generalised aching (serious criteria clinically significant/intervention required), malaise (serious criteria clinically significant/intervention required), tremor (serious criteria clinically significant/intervention required), sensory aberrations (serious criteria clinically significant/intervention required), nystagmus (serious criteria clinically significant/intervention required), weakness (serious criteria clinically significant/intervention required), abdominal pain (serious criteria clinically significant/intervention required), queasy (serious criteria clinically significant/intervention required), orthostatic dysregulation (serious criteria clinically significant/intervention required), and pain in jaw (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the headache, ear pain, deafness, tinnitus, sensation of block in ear, dizziness, cognitive disorder, sleep disorder, constipation , diarrhoea, menstruation irregular, generalised aching, malaise, tremor, sensory aberrations, nystagmus, weakness, abdominal pain, queasy, orthostatic dysregulation and pain in jaw were unknown. The reporter considered the headache, ear pain, deafness, tinnitus, sensation of block in ear, dizziness, cognitive disorder, sleep disorder, constipation, diarrhoea, menstruation irregular, generalised aching, malaise, tremor, sensory aberrations, nystagmus, weakness, abdominal pain, queasy, orthostatic dysregulation and pain in jaw to be related to CERVARIX.
Sex: F
Vaccine: HPV2
Symptoms: Pain, Pain in jaw, Sensory disturbance, Sleep disorder, Tinnitus
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of headache in a 16-year-old female subject who received CERVARIX. Concomitant products included CERVARIX. In June 2012, the subject received CERVARIX (Intramuscular). On an unknown date, unknown after receiving CERVARIX, the subject experienced headache (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), deafness (serious criteria clinically significant/intervention required), tinnitus (serious criteria clinically significant/intervention required), sensation of block in ear  (serious criteria clinically significant/intervention required), dizziness  (serious criteria clinically significant/intervention required), cognitive disorder (serious criteria clinically significant/intervention required), sleep disorder (serious criteria clinically significant/intervention required), constipation (serious criteria clinically significant/intervention required), diarrhoea (serious criteria clinically significant/intervention required), menstruation irregular (serious criteria clinically significant/intervention required), generalised aching (serious criteria clinically significant/intervention required), malaise (serious criteria clinically significant/intervention required), tremor (serious criteria clinically significant/intervention required), sensory aberrations (serious criteria clinically significant/intervention required), nystagmus (serious criteria clinically significant/intervention required), weakness (serious criteria clinically significant/intervention required), abdominal pain (serious criteria clinically significant/intervention required), queasy (serious criteria clinically significant/intervention required), orthostatic dysregulation (serious criteria clinically significant/intervention required), and pain in jaw (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the headache, ear pain, deafness, tinnitus, sensation of block in ear, dizziness, cognitive disorder, sleep disorder, constipation , diarrhoea, menstruation irregular, generalised aching, malaise, tremor, sensory aberrations, nystagmus, weakness, abdominal pain, queasy, orthostatic dysregulation and pain in jaw were unknown. The reporter considered the headache, ear pain, deafness, tinnitus, sensation of block in ear, dizziness, cognitive disorder, sleep disorder, constipation, diarrhoea, menstruation irregular, generalised aching, malaise, tremor, sensory aberrations, nystagmus, weakness, abdominal pain, queasy, orthostatic dysregulation and pain in jaw to be related to CERVARIX.
Sex: F
Vaccine: HPV2
Symptoms: Tremor
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of headache in a 16-year-old female subject who received CERVARIX. Concomitant products included CERVARIX. In June 2012, the subject received CERVARIX (Intramuscular). On an unknown date, unknown after receiving CERVARIX, the subject experienced headache (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), deafness (serious criteria clinically significant/intervention required), tinnitus (serious criteria clinically significant/intervention required), sensation of block in ear  (serious criteria clinically significant/intervention required), dizziness  (serious criteria clinically significant/intervention required), cognitive disorder (serious criteria clinically significant/intervention required), sleep disorder (serious criteria clinically significant/intervention required), constipation (serious criteria clinically significant/intervention required), diarrhoea (serious criteria clinically significant/intervention required), menstruation irregular (serious criteria clinically significant/intervention required), generalised aching (serious criteria clinically significant/intervention required), malaise (serious criteria clinically significant/intervention required), tremor (serious criteria clinically significant/intervention required), sensory aberrations (serious criteria clinically significant/intervention required), nystagmus (serious criteria clinically significant/intervention required), weakness (serious criteria clinically significant/intervention required), abdominal pain (serious criteria clinically significant/intervention required), queasy (serious criteria clinically significant/intervention required), orthostatic dysregulation (serious criteria clinically significant/intervention required), and pain in jaw (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the headache, ear pain, deafness, tinnitus, sensation of block in ear, dizziness, cognitive disorder, sleep disorder, constipation , diarrhoea, menstruation irregular, generalised aching, malaise, tremor, sensory aberrations, nystagmus, weakness, abdominal pain, queasy, orthostatic dysregulation and pain in jaw were unknown. The reporter considered the headache, ear pain, deafness, tinnitus, sensation of block in ear, dizziness, cognitive disorder, sleep disorder, constipation, diarrhoea, menstruation irregular, generalised aching, malaise, tremor, sensory aberrations, nystagmus, weakness, abdominal pain, queasy, orthostatic dysregulation and pain in jaw to be related to CERVARIX.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Gait disturbance, Pain, Pruritus, Swelling
Clinical narrative: 1-11 Wed AM had vaccines-soreness. Wed PM very sore, hard to walk (R) leg. 1-12 Thurs-increased soreness, swollen and red-BENADRYL given. 1-13 Friday-knee to hip red, swollen, itching BENADRYL given. Office visit-BENADRYL and ORAPRED given, also Rx for cephalexin for 10 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Extreme redness, swelling cellulitis requiring antibiotic.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2015US164714 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 595424) website on 14 Dec 2015. This report refers to a 35 year female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157021) intramuscularly into left arm on 12 Sep 2015. On an unknown date, the patient developed red area surrounding site of vaccination. The outcome of the event was not reported. The events were reported to be non-serious and causality was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Case number PHHY2015US166239, is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number: 595603) website on 14 Dec 2015. This report refers to a 65 year old female patient. Past medical history of the patient was not reported. Current conditions included hypertension, diabetes mellitus and hyperlipidemia. Concomitant medications included Multivitamin, BENEFIBER, ZOLOFT, GLUCOPHAGE, Lisinopril (manufacturer unknown), PRAVACHOL, and ECOTRIN. She was vaccinated with third dose of FLUVIRIN (batch number: 1515901, expiry: not reported) intramuscularly into the right arm and PREVNAR (batch number: L77777, expiry: not reported) intramuscularly into the left arm on 04 Sep 2015. On 05 Sep 2015, patient experienced pain, swelling and redness at vaccination site. A week after, she experienced itching and continued swelling. It was reported that no testing was done and she was seen by office on 14 Sep 2015. The final outcome of the events was not reported. These events were assessed as non serious. The causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Tenderness
Clinical narrative: Case number PHHY2015US166713, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 575799) website on 14 Dec 2015. This report refers to a 52-year-old female patient. Historical condition included left breast cancer in 2003 and the patient underwent sentinel nodes removal. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157601) into left arm intramuscularly on 15 Sep 2015. On 16 Sep 2015 the patient developed swelling and tenderness noted along left supraclavicular area. The outcome of the event. The patient fully recovered from swelling and tenderness on an unknown date. Seriousness of the events were reported as non serious and causality was not reported. Following an internal review for the data received on 14 Dec 2015, significant case correction was performed: Changed labeling of the events listed to unlisted.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US165731, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 595873) website on 14 Dec 2015. This report refers to a 32-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN vaccine (manufacturer unknown and batch number: 1514901) intramuscularly in left arm on 16 Sep 2015. On 17 Sep 2015, her arm displayed erythema, red/raises circle around injection site approximately 2 inches in diameter and warm to touch. She did not report pain or discomfort. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHHY2015US164721 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596151) website on 14 Dec 2015. This report refers to a 62 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157602) intramuscularly on 17 Sep 2015. Around noon time on same day of vaccination, the patient experienced numbness from elbow to wrist. It was reported that the patient was fine by 2:30 PM. The outcome of the event was reported as complete recovery. The event was reported to be non-serious and causality was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2015US165484, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 596208) website on 14 Dec 2015. This report refers to a 32 year old female patient. Past medical history of the patient was not reported. Current conditions included mild, intermittent asthma and its onset was at the age of 12, penicillin (manufacturer unknown) allergy which was taken for the treatment of hives, clindamycin (manufacturer unknown) allergy which was taken for the treatment of abdominal pain, KEFLEX (manufacturer unknown) allergy which was taken for the treatment of hives and allergic rhinitis. Concomitant medications included ATIVAN tablet 0.5mg daily orally as and when needed for anxiety, LEXAPRO tablet for treatment of an unknown indication at a dose of 10 mg daily orally, ORTHO TRI CYCLEN LO tablet for the treatment of an unknown indication at a dose 0.18/0.215/0.25mg-25mg once daily orally and PROAIR HFA 108 aerosol solution (90 base) mcg/ACT for the treatment of an unknown indication via inhalation at a dose of 2 puffs four times a day as and when needed. She was vaccinated with FLUVIRIN (batch number: 157003, expiry: not reported) intramuscularly and PNEUMOVAX batch number K020214, expiry: not reported subcutaneously, both on 17 Sep 2015 into left arm. On 18 Sep 2015, the patient experienced swelling, redness and pain to injection site on left arm. The outcome of the events was unknown. These events were assessed as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Rash erythematous
Clinical narrative: Case number PHHY2015US167706, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 596260) website on 14 Dec 2015. This report refers to a 22-year-old female patient. Medical history was not reported. Concomitant medication included LO/OVRAL, ELAVIL, FLONASE, Ferrous Sulfate. The patient was vaccinated with FLUVIRIN (batch number: 15722P) intramuscularly into left arm on 10 Sep 2015. On same day after vaccination, the patient experienced immediate redness at site of vaccination, within 05 minutes redness spread to chest area / red rash. Patient did not experience any trouble breathing. The patient was treated with BENADRYL 50 mg and it helped the red rash with 15 minutes of administration. The patient visited emergency room. The outcome of the events was reported as complete recovery. Seriousness of the event was reported as non serious and causality not reported.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling cold, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2015US160771, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596279) website on 24 Nov 2015. This report refers to a 43 years old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: unknown) at the age of 7 years old and became very ill for 3 weeks (see case: PHHY2015US160766). The patient was vaccinated with FLUVIRIN (batch number: 157604) intramuscularly into left arm on 19 Sep 2015. On the same day after vaccination the patient had some feelings of coldness and tingling that went away. Next day the symptoms returned and intensified to the point of pains shooting up the forearm. The patient went to emergency room due to these events. The case was assessed as non-serious. Outcome and causality of the events were not reported.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Malaise
Clinical narrative: Case number PHHY2015US160771, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596279) website on 24 Nov 2015. This report refers to a 43 years old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: unknown) at the age of 7 years old and became very ill for 3 weeks (see case: PHHY2015US160766). The patient was vaccinated with FLUVIRIN (batch number: 157604) intramuscularly into left arm on 19 Sep 2015. On the same day after vaccination the patient had some feelings of coldness and tingling that went away. Next day the symptoms returned and intensified to the point of pains shooting up the forearm. The patient went to emergency room due to these events. The case was assessed as non-serious. Outcome and causality of the events were not reported.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US165527 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 596322) on 14 Dec 2015. This report refers to a 39 year old male patient. He had no medical history or current conditions. His concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514601) intramuscularly and PNEUMOVAX (other manufacturer, batch number: K010465)subcutaneously; both vaccines administered on 18 Sep 2015. On 19 Sep 2015, he had fevers, chills, vomiting. He also had localized redness, pain and swelling. He was advised ibuprofen and was monitored. The outcome of the event was unknown. The event was reported as non-serious. The causality of the event was not reported.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US165527 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 596322) on 14 Dec 2015. This report refers to a 39 year old male patient. He had no medical history or current conditions. His concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514601) intramuscularly and PNEUMOVAX (other manufacturer, batch number: K010465)subcutaneously; both vaccines administered on 18 Sep 2015. On 19 Sep 2015, he had fevers, chills, vomiting. He also had localized redness, pain and swelling. He was advised ibuprofen and was monitored. The outcome of the event was unknown. The event was reported as non-serious. The causality of the event was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: Case number PHHY2015US166357, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 596347) website on 14 Dec 2015. This report refers to a 25 years old female patient. Past medical history of the patient included gastroesophageal reflux disease and kidney reflux (vesicoureteral reflux) at birth which then resolved by eight years old. Current condition included skin abscess. Past medication included phenazopyridine (manufacturer unknown). Concomitant medications included Cephalexin (manufacturer unknown) and Sulfamethoxazole/Trimethoprim DS (manufacturer unknown). She was vaccinated with FLUVIRIN (batch number: 15734P, expiry: not reported) intramuscularly into the left arm on 20 Sep 2015. On the same day, at 19:00, the patient experienced muscle aches, at 20:00 she experienced chills. On 21 Sep 2015 at 07:30, the patient experienced lightheadedness and fever. The outcome of the events was unknown. These events were assessed as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Paraesthesia, Pruritus
Clinical narrative: Case number PHHY2015US167831, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 596412) website on 14 Dec 2015. This report refers to a 61 year old female patient. Past medical history included anaphylactic reaction to over the counter snoring medication (unspecified). Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 15753P, expiry: not reported) into the right arm on 10 Sep 2015. Fifteen minutes after vaccination, she began to have tingling/itchiness in the face and scalp followed by hands. 24 hours later, her scalp was still itchy and red. She was given BENADRYL as a treatment and events were controlled. She was advised to see doctor if the condition persists. The outcome of the events was reported as condition improving. Events were assessed as non serious. Causality of the events was not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Neck pain, Pain, Rash erythematous
Clinical narrative: Case number PHHY2015US167108, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 596551) website on 14 Dec 2015. This report refers to a 38 year old female patient. Past medical history was not reported. Concomitant medications included atenolol (manufacturer unknown), Prenatal vitamin, magnesium oxide (manufacturer unknown), Lorazepam (manufacturer unknown), ranitidine (manufacturer unknown), and birth control medications. She was vaccinated with FLUVIRIN (batch number: 15751P, expiry: not reported) intramuscularly into the left arm on 15 Sep 2015. On 16 Sep 2015, the patient experienced mild pain at injection site (left arm) shooting up to neck area and tiny red dots (5) around the injection area. She received treatment with ibuprofen (manufacturer unknown) for pain. The outcome of the events was reported as complete recovery on an unknown date. These events were assessed as non serious. The causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US166262, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 596790) website on 14 Dec 2015. This report refers to a 65-year-old female patient. Historical conditions included lower back pain, hyperlipidemia, depressive disorder, irritable bowel syndrome, herpes simplex, hypertension, osteogenesis imperfecta scoliosis, osteopenia and asthma. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516001) intramuscularly into the left arm and PNEUMOVAX (batch number: L002310) intramuscularly into the right arm on 17 Sep 2015. On 18 Sep 2015, the patient experienced injection site was red, warm, swollen and tender to touch. The patient went to urgent care on 19 Sep 2015 was instructed to take BENADRYL. The patient's symptoms are improving. Final outcome of the events was complete recovery. Events were reported as non-serious. Causality was not reported.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Case number PHHY2015US166707, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596844) website on 14 Dec 2015. This report refers to an 89-years-old female patient. Past medical history was not reported. Concomitant medications included simvastatin (manufacturer unknown) (20mg), amlodipine (manufacturer unknown (5mg), Lisinopril (manufacturer unknown) (20mg) and levothyroxine (manufacturer unknown) (112mcg). The patient was vaccinated with FLUVIRIN vaccine (manufacturer unknown and batch number: 15734P) intramuscularly in right arm on 15 Sep 2015. The patient was vaccinated with PNEUMOVAX vaccine (manufacturer unknown and batch number: K009107) intramuscularly in left arm on 15 Sep 2015. On 17 Sep 2015, the patient complained for redness, swelling, warm to touch and sore arm. The physician prescribed BENADRYL (25 mg every 6 hrs) and ice to apply on the arm in every 20 mins on and 20 mins off. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Pyrexia, Urticaria, Vaccination site inflammation, Vaccination site reaction
Clinical narrative: Case number PHHY2015US166345, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 597098) website on 14 Dec 2015. This report refers to a 60-year-old female patient. Historical condition was not reported. Current condition included asthma. Concomitant medication included QVAR. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly into left arm and ZOSTAVAX (other manufacturer), batch number: L000450) subcutaneously into right arm 22 Sep 2015. On 23 Sep 2015 after vaccination, the patient experienced redness, inflammation, welt at vaccination site (approximately half-dollar size) and fever. The outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Case number PHHY2015US166335, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597117) website on 14 Dec 2015. This report refers to a 21-year-old female patient. Past medical history and concomitant medication were reported as none. The patient was vaccinated with FLUVIRIN (batch number: 15755P) intramuscularly into left arm on 24 Sep 2015. On same day after vaccination, the patient experienced localized redness and itching at vaccination site and no other signs or symptoms was reported. The outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality as not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US166860, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 597142) website on 14 Dec 2015. This report refers to a 54-year-old female patient. Historical condition included bipolar disorder. Current conditions included complex regional pain syndrome, high blood pressure and chronic sinus infection. Concomitant medication included duloxetine, ABILIFY, LYRICA, Losartan, Zolpidem, STRATTERA, nabumetone, clonazepam, Tizanidine, tramadol, diazepam, VALTREX, Prazosin, baclofen. The patient was vaccinated with FLUVIRIN (batch number: 1514601) intramuscularly into left arm on 23 Sep 2015. On a same day little while after vaccination, the patient developed hives on face but nowhere else on body or near vaccination site. Patient reported that she was using a new moisturizer. The outcome of the event was reported as unknown. The seriousness of the event was reported as non-serious and causality not reported.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Case number PHHY2015US160737 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 597228) on 24 Nov 2015. This report refers to a 64 year old male patient. He had no medical history and current conditions. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly in the left arm on 23 Sep 2015. On 24 Sep 2015, he had hive-like rash widespread on upper torso and arms. He was advised to begin oral diphenhydramine 50 mg. He reported the event to the pharmacy on 24 Sep 2015 at around 3 pm, 24 hours after vaccination. He was asked to follow up with emergency room or primary care provider if there was no improvement or in case of worsening of symptoms or difficulty breathing. The event outcome was unknown. The event was reported as non-serious. The causality of the event was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHHY2015US167151, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 597251) website on 14 Dec 2015. This report refers to a 36 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516201) intramuscularly in the right arm on 23 Sep 2015. On the same day, after vaccination, the patient experienced redness around injection site, mild itching and feverish to touch. Outcome of the event was reported as condition unchanged. Events were reported as non serious and causality was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Dizziness, Nausea
Clinical narrative: Case number PHHY2015US166708, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597391) website on 14 Dec 2015. This report refers to a 23 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with second dose of FLUVIRIN (batch number: 157903) into left arm intramuscularly on 23 Sep 2015. On the same day of vaccination the patient experienced had dizziness at 4:00 PM, nausea, abdominal pain no energy. The patient did not get treatment, did not eat and drink until she reached to employee health on 25 Sep 2015 at 3:00 PM. The patient was sent to emergency room for evaluation of abdominal pain and nausea. The outcome of the event was reported as unknown and seriousness was reported as non serious and causality was not reported.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Rash erythematous, Rash pruritic
Clinical narrative: Case number PHHY2015US167937, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597445) 14 Dec 2015. This report refers to a 52-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with fourth dose of FLUVIRIN (batch number: 15753P) into left arm intramuscularly on 24 Sep 2015. On 26 Sep 2015, the patient experienced tiny, red, itchy spots on body which was appeared and soreness at injection site reported one to one and half days after vaccination. The outcome of the events was reported as unknown and seriousness was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Case number PHHY2015US167103, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 597558) website on 14 Dec 2015. This report refers to a 62-year-old male patient. The patient had no medical history and current illness. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: 157903) intramuscularly into the left arm along with PNEUMOVAX (batch number: K009874) intramuscularly into left arm on 25 Sep 2015. On the same day after vaccination, the patient experienced pain where the vaccine was administered and the patient was unable to lift the arm. Final outcome of the events was unknown. Event was reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Case number PHHY2015US166233 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 597564) on 14 Dec 2015. This report refers to a 71 year old female patient. Her medical history was not reported. She had no current conditions. Her concomitant medications included Citalopram; BENICAR HCT; CRESTOR; and levothyroxine. The patient was vaccinated with FLUVIRIN (batch number: 15721P) in the left arm and PREVNAR 13 (batch number: L24631) in the right arm; both vaccines given on an unknown date. On injection, it sore immediately and she felt shooting pain down. She went to emergency room. She was given ibuprofen/ice. It worked then, but stopped after 2 days and hence the treatment was changed to TYLENOL. She was still using ice and symptoms were getting worse. The outcome of the events was reported as condition unchanged. The events were reported and non-serious. The causality of the events was not reported.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Case number PHHY2015US166323 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 597602) on 14 Dec 2015. This report refers to a patient whose identifiers were not reported. Past medical history, current conditions and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157903) and PNEUMOVAX (other manufacturer, batch number: L003188); both vaccines given in the right arm on an unknown date. On an unknown date after vaccination, the patient's right arm where PNEUMOVAX was administered became swollen, red and was painful. The patient also had difficulty in moving this arm. No laboratory tests were done. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Case number PHHY2015US166336 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 597611) on 14 Dec 2015. This report refers to a 20 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516001) intramuscularly in the left arm on 24 Sep 2015. On 25 Sep 2016, she had headache, fever and malaise. She also had redness, pain and swelling at the injection site. Two days after vaccination, she returned to the pharmacy for symptoms and her injection site was red and raised approximately 5 cm x 3 cm. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2015US166336 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 597611) on 14 Dec 2015. This report refers to a 20 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516001) intramuscularly in the left arm on 24 Sep 2015. On 25 Sep 2016, she had headache, fever and malaise. She also had redness, pain and swelling at the injection site. Two days after vaccination, she returned to the pharmacy for symptoms and her injection site was red and raised approximately 5 cm x 3 cm. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2015US157888, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 597656) website on 24 Nov 2015. This report refers to a 21 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15755P) intramuscularly in left arm on 27 Sep 2015. On the same day, the patient experienced syncope episode while sitting after vaccination. The patient was given ice pack to put on neck and was asked to be seated until the patient could ambulate. Outcome of the event was complete recovery. Event was reported as non-serious. Causality was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US167165, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 597714) website on 14 Dec 2015. This report refers to a 45 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515901) intramuscularly in the left arm on 29 Sep 2015. On the same day, after the vaccination, the patient experienced hives. The patient started taking medications for hives. Outcome of the event was reported as condition unchanged. Event was reported as non serious and causality was not reported.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Case number PHHY2015US167143, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 598008) website on 14 Dec 2015. This report refers to a 62-year-old male patient. Past medical history was not reported. Current condition included allergy to sulfa and current illness reported as none. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly into left arm on 29 Sep 2015. On 30 Sep 2015 after vaccination, the patient developed arthralgia of elbow of vaccination site arm, pain in great toe metatarsophalangeal joint and pain in ankle. The outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Exposure during breast feeding
Clinical narrative: Case number PHHY2015US166979, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 598085) website on 14 Dec 2015. This report refers to a 32-year-old female patient. Medical history and concomitant medication were not reported. Patient had no current illness. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 30 Sep 2015. On same day after vaccination at 09:00 pm, the patient breast fed her son and her son woke up around 03:15 am throwing up and had a fever with body temperature 99.6 (see case: PHHY2015US166985). No adverse event was reported to patient following vaccine exposure via breast milk.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Exposure during breast feeding, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US166979, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 598085) website on 14 Dec 2015. This report refers to a 32-year-old female patient. Medical history and concomitant medication were not reported. Patient had no current illness. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 30 Sep 2015. On same day after vaccination at 09:00 pm, the patient breast fed her son and her son woke up around 03:15 am throwing up and had a fever with body temperature 99.6 (see case: PHHY2015US166985). No adverse event was reported to patient following vaccine exposure via breast milk.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Exposure during breast feeding
Clinical narrative: Case number PHHY2015US166985, is an initial spontaneous report received from a consumer (patient's mother) via Vaccine Adverse Event Reporting System (VAERS reference number: 598085) website on 14 Dec 2015. This report refers to a male patient of an unknown age. Medical history and concomitant medication were not reported. The patient's mother was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 30 Sep 2015. On same day after vaccination at 09:00 pm, the patient's mother breast fed her son (See mother case: PHHY2015US166979) and on 01 Oct 2015 around 03:15 am he woke up throwing up and had a fever with body temperature 99.6 (units unspecified). Patient's mother tried to give ibuprofen for fever reduction but emesis occurred immediately afterwards, then provided cool compress to forehead and neck areas until he went to sleep. The outcome of the event was not reported. Seriousness of the event was reported as non serious and causality not reported.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Exposure during breast feeding, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US166985, is an initial spontaneous report received from a consumer (patient's mother) via Vaccine Adverse Event Reporting System (VAERS reference number: 598085) website on 14 Dec 2015. This report refers to a male patient of an unknown age. Medical history and concomitant medication were not reported. The patient's mother was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 30 Sep 2015. On same day after vaccination at 09:00 pm, the patient's mother breast fed her son (See mother case: PHHY2015US166979) and on 01 Oct 2015 around 03:15 am he woke up throwing up and had a fever with body temperature 99.6 (units unspecified). Patient's mother tried to give ibuprofen for fever reduction but emesis occurred immediately afterwards, then provided cool compress to forehead and neck areas until he went to sleep. The outcome of the event was not reported. Seriousness of the event was reported as non serious and causality not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Case number PHHY2015US167201, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598175) 14 Dec 2015. This report refers to a 52-year-old female patient. Historical condition was not reported. The patient underwent kidney transplant on 06 Apr 2010. Current condition included allergies to, BACTRIM, ATIVAN, Erythromycin, Nitrofurantoin and LEVAQUIN. Concomitant medication included: Prograf, prednisone (manufacturer unknown), MYFORITC, Probiotic, PRILOSEC and CLARITIN. The patient was vaccinated with of FLUVIRIN (batch number: not reported) into right arm on 28 Sep 2015. On the same day after vaccination the patient experienced dizzy, light headedness, nausea and fatigue. The outcome of the events were not reported. Seriousness of the events was reported as non serious and causality was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Urticaria, Vaccination site pain, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Case number PHHY2015US167346, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598281) website on 14 Dec 2015. This report refers to a 49-year-old female patient. Historical condition was not reported. Current condition included allergy to adhesives on bandaids, electrocardiography pads. Concomitant medication included: CLARITIN, tamoxifen (manufacturer unknown) and SINGULAIR. The patient was vaccinated with FLUVIRIN (batch number: not reported) into right arm intradermal on 29 Sep 2015. On 30 Sep 2015, large red welt at vaccination site with skin hot to the touch and pain. Welt was the size of a half-day coin. The patient visited to emergency room. Doctor examined that redness, and pain persisted even after several doses of BENADRYL, TYLENOL and use of moist compresses. The outcome of the events was condition unchanged and seriousness was reported as non serious and causality was not reported. Following an internal review for the data received on 14 Dec 2015, non-significant case correction was performed: Changed labeling of the event vaccination site warmth to listed from unlisted.