chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Tuberculin test negative
Clinical narrative: No fevers. Received Vaccine on 22 Jun 10. Same day, onset local tenderness, swelling followed by joint pains and worsening of chronic headaches. Feeling much better 24 Jun 10.
Age: 17.0
Sex: U
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hot/warm to the touch at site where varicella was administered. Left / SC.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Convulsion, Electrocardiogram normal, Epilepsy, Headache
Clinical narrative: Seizures nightly x 4 nights in a row with severe H/A esp. back of head - started the night vaccine received - have had seizures since Dec. 09 (Epilepsy)-saw PCP in 1 wk due to cont. sx-Doc's felt may be related to MMR-advised pt not take 2nd dose.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test normal
Clinical narrative: Seizures nightly x 4 nights in a row with severe H/A esp. back of head - started the night vaccine received - have had seizures since Dec. 09 (Epilepsy)-saw PCP in 1 wk due to cont. sx-Doc's felt may be related to MMR-advised pt not take 2nd dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid redness and swelling.  ZYRTEC.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Approx. 3 mins after giving GARDASIL immun. Pt became very pale in color. Mom states "looked like she was having a seizure". Pt was placed on floor, legs elevated. Dr was called to room to check patient. BP was taken; pt was moved & observed x 1/2 hour in another room. Cold compress applied to forehead, H2O given to drink.
Age: 0.45
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Pt had sl. swelling and urticarial lesions on leg.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Rt. arm red & swollen where imms given.
Age: 33.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Guillain-Barre syndrome
Clinical narrative: Reported that physician diagnosed her with Guillian Barre syndrome.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient states she has a red spot a little bigger than the size of a quarter on the back of her arm where vaccination was given & it itches at times.  Advised patient to take some Benadryl.
Age: 13.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Rash
Clinical narrative: Rash on both arms & stomach.
Age: 21.0
Sex: F
Vaccine: DTAP, HPV4, PPV
Symptoms: Asthma, Condition aggravated
Clinical narrative: Asthma attack.
Age: 1.06
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site swelling, Wheezing
Clinical narrative: 6/30/10 10:00 Called to see pt - received varicella and Hep A injection into left thigh. Very shortly afterwards, developed lump at injection site with surrounding ?. Gave him 2ml of BENADRYL liquid. 10:15 Reevaluated b/c parent heard wheezing. He is sitting quietly on table, no increase WOB, no retraction, no cyanosis. Lungs : CTA. POX 97-98%. Continue to monitor him. 10:55 Came to reevaluate and family just left. Had left POX on and cont to maintain 97-98%. Good color, no problem breathing. She reports injection site/swelling appears to be getting smaller.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Site of injection red, slightly swollen, hardness at site c/o slight burning sensation at injection site.
Age: 70.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Decreased appetite, Erythema, Full blood count, Insomnia, Nasopharyngitis
Clinical narrative: first noticed pain 9/10, quality: aching, patient took tylenol, took two tylenol, eased pain, at night, developed cold, mouth felt bitter, pt knew he had a fever, could not sleep, covered himself with blankets, took flomax with frequent urination, in am on 7/1/2010, lost appetite, drank water and hot tea, still had fever, swelling in arm redness 34 cm x 20 cm, pain with flexion of elbows with pruritus
Age: 70.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Oedema peripheral, Pain, Pollakiuria, Pruritus, Pyrexia
Clinical narrative: first noticed pain 9/10, quality: aching, patient took tylenol, took two tylenol, eased pain, at night, developed cold, mouth felt bitter, pt knew he had a fever, could not sleep, covered himself with blankets, took flomax with frequent urination, in am on 7/1/2010, lost appetite, drank water and hot tea, still had fever, swelling in arm redness 34 cm x 20 cm, pain with flexion of elbows with pruritus
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Varicella
Clinical narrative: Pox noted on both upper arms- Dad states client has been itching.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Syncope, Tremor
Clinical narrative: Immediate syncope after application of GARDASIL with less than 3 sec. tension of body. Immediate spontaneous recovery.
Age: 0.65
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site haematoma, Injection site macule, Injection site rash
Clinical narrative: 12.50 IZ given. 12:53 - L leg red - thigh to feet, hives - red macular rash - some swelling and bruising at injection site crying - Dr. in room cool cloth, BENADRYL and TYLENOL administered at 13:04. 13:45 Sleeping - site improved, less redness. 13:10 mild redness LLE and hives almost disappeared.
Age: 0.65
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: 12.50 IZ given. 12:53 - L leg red - thigh to feet, hives - red macular rash - some swelling and bruising at injection site crying - Dr. in room cool cloth, BENADRYL and TYLENOL administered at 13:04. 13:45 Sleeping - site improved, less redness. 13:10 mild redness LLE and hives almost disappeared.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Muscle spasms, Pain
Clinical narrative: C/o leg craps and muscle spasms throughout body - states has pain when walking, from legs cramping.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Swelling
Clinical narrative: Four hours after vaccination pt reported she experienced severe joint pain (fingers, wrists, knees) and swelling.  Resolved after 3 days.  Did not report symptoms until today 07/02/2010 when she presented for second MMR required to register for classes.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Pt had raised, red swollen, warm and painful to touch. Can't lay on it very painful.
Age: 18.0
Sex: F
Vaccine: HEPA, IPV, YF
Symptoms: Headache, Pyrexia
Clinical narrative: Mother reports fever began 2 days after receiving vaccines temp reported to be 100 -101. Associated with headache. No other symptoms. Took ADVIL 400mg, po.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No-state contacted no adverse effects.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Advice to apply cool compress, and gave BENADRYL and return if swelling, erythema or pain increase.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Advice to apply cool compress as directed and give ATARAX as directed. Return to f/u appt on 7/3.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: right arm swollen and red - worse over night to 7/2/10 more swollen measuring about 6 x 6 cm  expected to resolve
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Rash/Cellulitis on Left leg.  Around 140mm wide
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Client called today stated that she has continued to have pain in the arm she received the vaccination in.  Stated that it is difficult to lift her arm to put on her shirt and it feels weaker. No other adverse reactions to immunization, called regarding persistant pain-thought it would have gone away by now.  Pain began a couple hours after receiving vaccination.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warm to touch, slightly raised LT from Vaccine. KINRIX. Tx: Was seen By Dr today (02 JUL 2010 @ 1315) and advised to apply cold compress. Childrens MOTRIN TID PRN for swelling and pain. Monitor for increase swelling, redness, warm, Pain, and itchiness and immobility and to go to ER if other symptoms persist.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Red,raised welts from head to toe. Itchy at times. Parents describe it as "hives".
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Flat itchy rash about size of "mosquito bites" on hands, feet, back and stomach noted on 6/27.   Took to physician on 7/1.  Received BENADRYL and Calamine lotion.   Decreased itching noted on 7/02.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Full blood count normal, Oedema peripheral, Pain in extremity, Pyrexia, Ultrasound scan abnormal
Clinical narrative: Deltoid swelling and pain.  Fever.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Injection site erythema, Injection site swelling, Rash, Sneezing
Clinical narrative: He developed a rash with coughing, sneezing, drowsiness and vomiting shortly after vaccines given today with left arm swelling and redness noted first.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Somnolence, Vomiting
Clinical narrative: He developed a rash with coughing, sneezing, drowsiness and vomiting shortly after vaccines given today with left arm swelling and redness noted first.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt presented with redness, swelling and induration at injection site. Antibiotics prescribed and instructions given to parents to follow-up if symptoms do not clear up in 1-2 days.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red saucer like erythema hot to touch 10 cm diameter medial mid thigh adjacent to injection site.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blood glucose increased, Pollakiuria, Thirst, Type 1 diabetes mellitus
Clinical narrative: Excessive thirst, urinating a lot, blood check determined very high blood sugar level. Diagnosed two weeks after symptoms began. Is now on insulin.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Contusion, Erythema, Skin warm
Clinical narrative: Red, mild bruise left arm, and warm to the touch.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness and pain. MEDROL dose pak.
Age: 1.13
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Rash to face and legs.  Vesicular rash.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema
Clinical narrative: Developed cellulitis 24 hr after the shot with expanding erythema at 48 hr. He was treated for cellulitis with cephalexin 750 mg bid x 10d. Tx started today 7-2-10.
Age: 67.0
Sex: F
Vaccine: RAB
Symptoms: Cyanosis, Injection site erythema, Injection site swelling
Clinical narrative: Fingertip turned blue after 4 mins. Patient elevated hand x 15 mins. Blue fingertip resolved but then had redness/swelling below infiltration site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Local reaction, Pyrexia
Clinical narrative: Fever x 4-5 days post-DTAP/IPV vaccination - Local severe reaction x 7 days post-DTAP/IPV vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Laboratory test normal, Pyrexia, Tremor
Clinical narrative: Fever, tremors.  Woke up at 2 A on 7-2-10 with fever, 102 and full body tremors.  Taken to hosp ER.  Chem 7 done, WNL.  F/u in our office 3P today.  Afebrile in office.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Next day after vaccines developed copious diarrhea. Had fever 101 once or twice. Worse the night of vaccines.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness and swelling of the right thigh. Steroids prescription started.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Malaise, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shoulder pain in a 66-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. Concurrent medications included Aspirin, ZOCOR, Trazadone, KLONOPIN, ESTRATEST and  CLARINEX. On 18 September 2009, the subject received a dose of FLUARIX (.5 ml, unknown, left arm). On 18 September 2009, less than one day after vaccination with FLUARIX, the subject experienced shoulder pain, left trapezius pain, fatigue, malaise and neck pain. A GSK employee reported that a subject received a FLUARIX injection and experienced left should pain, trapezius pain, neck pain, fatigue and malaise. The subject was given the injection in the morning and symptoms began later in the afternoon. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with FLUARIX. Follow-up information received on 02 October 2009 indicated that the events remained unresolved. The events were considered to be possibly related to treatment with FLUARIX. Bursitis was reported as a past condition resulting from flu vaccine (manufacturer not specified).
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist and described the occurrence of supraclavicular lymph node in an adult female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). On an unspecified date the subject received a dose of Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced supraclavicular lymph node. The subject received FLUARIX or FLULAVAL. The reporting pharmacist did not have time to give full details for this report. At the time of reporting the outcome of the event was unspecified.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm soreness in a 15-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 21 September 2009 at 16:00, the subject received a dose of FLUARIX (.5 ml, unknown, left arm) and experienced drug use for unapproved indication (subject is 15 years old). On 22 September 2009, 17 hours after vaccination with FLUARIX, the subject experienced arm soreness. At the time of reporting the events were improved.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injections site soreness in a 8 to 80 subject's of unspecified age and gender who were vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subjects received unspecified dose of FLUARIX (reported as 15 mcg, subcutaneous) and experienced inappropriate route of vaccination and injection site soreness. The nurse reported that between 8 to 80 healthcare workers at this institution received FLUARIX SC (subcutaneously). Subjects complained of injection site soreness lasting more than 5 days. No additional information is known at this time. At the time of reporting the outcome of the injection site soreness was unspecified. The nurse also reported a case of injection site redness, soreness and inappropriate route of administration (see Case ID A0809114A for more details). Follow up information was received on 20 October 2009 from the reporting nurse. Initially some flu vaccine may have been given SQ (subcutaneously). Since the initial report many of the subjects who were vaccinated by the administering staff member had said they did receive an IM (intramuscular) injection so she had no further follow up. The outcome of the events were resolved.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (reported as 15 mcg, subcutaneous) and experienced inappropriate route of vaccination, injection site soreness lasting more than 5 days, and injection site redness. The nurse reported that between 8 to 80 healthcare workers at this institution received FLUARIX SC (subcutaneously). Subjects complained of injection site soreness lasting more than 5 days. This subject complained of injection site redness. No additional information is known at this time. At the time of reporting the outcome of the injection site soreness and injection site redness was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Chest pain, Injection site erythema, Injection site pain, Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked case numbers include A0809357A through A0809362A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Local reaction, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809358A through A0809362.
Sex: U
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809358A through A0809362.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Local reaction, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809357A and A0809359A through A0809362A.
Sex: U
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809357A and A0809359A through A0809362A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Local reaction, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site  pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local reaction site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked case numbers included A0809349A, A0809357A, A0809358A and A0809360A through A0809362A.
Sex: U
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site  pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local reaction site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked case numbers included A0809349A, A0809357A, A0809358A and A0809360A through A0809362A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809357A through A0809359A, A0809361A and A0809362A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Pain in extremity, Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. The subject additionally experienced left arm pain which radiated to the chest. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809357A through A0809359A and A0809362A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Local reaction, Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. The subject also experienced left arm pain which radiated down the arm. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809357A through A0809361A.
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Oedema peripheral, Rash, Rash generalised, Swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash-whole body in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). Immediately after vaccination with FLUARIX, the subject experienced rash-whole body, swelling all over body, swelling-feet and rash neck area. The pharmacist reported that the subject, an employee of the hospital, had immediate systemic reactions after receiving the FLUARIX vaccine. The subject reported a severe reaction with a rash on the neck and body immediately after receiving the vaccine. The subject also reported swelling in the feet and all over the body. At the time of reporting the outcome of the events were unspecified. This is on of three cases reported by this pharmacist, see cases A0809777A and A0809778A for the other reports.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate route of vaccination in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 September 2009 at 14:00 the subject received a dose of FLUARIX (15 mcg, subcutaneous, unknown) and experienced inappropriate route of vaccination. No additional information was known at the time of reporting. The subject received FLUARIX by subcutaneous injection. The subject also reported in "previous years" on unspecified dates, she received doses of Influenza vaccine (unspecified) (unknown). Several hours after the vaccinations she experienced flu like symptoms that would resolved with "intervention"; no other details were provided.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756558A, A0756560A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX. In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756559A, A0756561A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA); AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA); AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756560A, A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Hyperhidrosis, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a consumer, the subject's mother, and described the occurrence of sweating in a 4-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included upper respiratory-induced asthma. On an unspecified date, the subject received an unspecified flu vaccine. After an unspecified time after the flu vaccine, she experienced coughing when she was a year old. On 24 September 2009 at 19:10 the subject received unspecified dose of FLUARIX (.5 ml, unknown, right leg), and experienced drug use for unapproved indication. Six hours after vaccination with FLUARIX, the subject experienced sweating, clamminess, and warm to touch. At an unspecified time after vaccination with FLUARIX, the subject experienced leg pain. The subject was treated with MOTRIN. At the time of reporting the sweating, clamminess, and feeling of warmth were resolved and the outcome of th leg pain was unknown. The subject's mother reports that her 4 year old daughter was inadvertently administered FLUARIX. She stated that her daughter was sweating and felt clammy and warm in the middle of the night but those events resolved. These events could potentially have been a systemic reaction. She was given MOTRIN for leg pain but it is not clear if the patient actually experienced leg pain or if MOTRIN was just given as a preventative. It was reported that a health care professional was consulted regarding these events.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756561A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Rash generalised, Swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash-whole body in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). Immediately after vaccination with FLUARIX, the subject experienced rash-whole body, swelling all over body, swelling-feet and rash neck area. The pharmacist reported that the subject, an employee of the hospital, had immediate systemic reactions after receiving the FLUARIX vaccine. The subject reported a severe reaction with a rash on the neck and body immediately after receiving the vaccine. The subject also reported swelling in the feet and all over the body. At the time of reporting the outcome of the events were unspecified. This is one of three cases reported by this pharmacist, see cases A0809614A and A0809778A for the other reports.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: This case was reported by a physician and described the occurrence of arms redness in a 51-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included codeine and novacaine allergy. On 4 November 2008, the subject received a dose of FLUARIX (unknown, right arm). At an unspecified time after vaccination with FLUARIX, the subject experienced arms redness, swelling arm and arm stiffness. Physician reported a 51-year old male subject received FLUARIX on 04 November 2008 and then experienced swelling, redness, and stiffness in his right arm. He was advised to take ADVIL and use ice packs. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with FLUARIX. Follow-up information received on 05 December 2008 indicated that the events began one day following administration of FLUARIX on 05 November 2008. It was reported that the events were improved and considered by the reporter to be possibly related to FLUARIX. A history of Novacaine allergy was indicated.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of feeling woozy in a female subject of unspecified age who was vaccinated with Influenza vaccine (GlaxoSmithKline). On 10 November 2008, the subject received a dose of Influenza vaccine (unknown). On 10 November 2008, minutes after vaccination with Influenza vaccine, the subject experienced feeling woozy and bitter taste. The healthcare professional reported that a female subject received a flu shot and within minutes, she experienced a woozy feeling and bitter taste in her mouth. The subject's vital signs were stable, flu vaccine was not specified. No other information was provided. At the time of reporting the outcome of the events were unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Conjunctivitis, Eye swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bilateral conjunctivitis in a subject of unspecified age and gender who was vaccinated with Influenza vaccine (GlaxoSmithKline). On an unspecified date, the subject received a dose of Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced bilateral conjunctivitis and swollen eyes. The healthcare professional reported that a subject received a flu shot and experienced swollen eyes and bilateral conjunctivitis, no details were provided. At the time of reporting the outcome of the events were unspecified.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate irregular
Clinical narrative: This case was reported by a consumer and described the occurrence of irregular heartbeat in a 82-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included arrhythmia and atrial defibrillation. In October 2007, the subject received a dose of Influenza vaccine (unknown, right arm). In 2007, 12 hours after vaccination with Influenza vaccine, the subject experienced irregular heartbeat. The subject reported that she was concerned about taking the flu shot this year because last year about 14 to 14 hours after receiving her flu shot, she experienced irregular heartbeat. She contacted her physician, who instructed her to contact emergency medical services (EMS). She was taken to the local emergency room where she reported no treatment was given, but the irregular heart beat resolved and she was sent home about two hours later. She was not sure what product she was given, but felt strongly it was a GSK product. The subject denied any medications or blood thinners with her current history of arrhythmia and atrial fibrillation. At the time of reporting the event was resolved.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Pain, Phlebitis, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 66-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included acid reflux, chronic obstructive pulmonary disease, high cholesterol, menopausal and slow thyroid.  Concurrent medications included SYNTHROID, FORADIL, SPIRIVA, Lotrel, PREMARIN and NEXIUM.  In 2006, the subject received a dose of Influenza vaccine (unknown, left arm).  In 2006, 1 to 2 days after vaccination with Influenza vaccine, the subject experienced allergic reaction, swelling, erythema, pain and phlebitis.  The subject reported that within a day or two after receiving an unknown brand of flu vaccine with mercury in it, she experienced swelling and redness from almost her shoulder to her elbow with aching.  She also reported a form of phlebitis.  She did not consult her physician about this but just happened to be in a pediatrician's office with someone else and a nurse there told her to use ice.  She used ice packs for two days, including having to sit up all night.  After two days, the symptoms resolved.  In 2006, the events were resolved.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, No reaction on previous exposure to drug, Tinnitus
Clinical narrative: This case was reported by a pharmacist and described the occurrence of exacerbation of tinnitus in a 57-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included allergy to gentamycin, allergy to neomycin and tinnitus. Concurrent medications included KLONOPIN. On 15 November 2008 at 10:11, the subject received unspecified dose of FLUARIX (.5 ml, unknown, left arm). On 16 November 2008, 1 day after vaccination with FLUARIX, the subject experienced exacerbation of tinnitus. The pharmacist reported that the subject experienced a worsening in her tinnitus after received FLUARIX. FLUARIX was administered at the pharmacy on Saturday, and then on Sunday she noticed the worsening of her tinnitus. The time of day for the onset is unknown. The worsened tinnitus was bothersome to the subject but has not required medical treatment at this time. Of note, the subject has a history of an allergy to neomycin and gentamycin but she has had flu vaccines in the past and never had a problem, thus the decision was made to use FLUARIX even though it contains a small amount of gentamycin. At the time of reporting the event was unresolved. The pharmacist considered the event was possibly related to vaccination with FLUARIX.