chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Feeling hot, Nausea, Throat tightness
Clinical narrative: Pt c/o dizziness, nausea, feeling very warm. She was very clammy to touch and shaking uncontrollably. Her BP was 110/70 laying down and 120/78 sitting up, 122/88 standing. Pt was given juice and crackers and remained in room until pt could stand without dizziness. She also c/o her throat feeling tight.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Pt c/o dizziness, nausea, feeling very warm. She was very clammy to touch and shaking uncontrollably. Her BP was 110/70 laying down and 120/78 sitting up, 122/88 standing. Pt was given juice and crackers and remained in room until pt could stand without dizziness. She also c/o her throat feeling tight.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling, right upper arm (area above elbow) feverish, tiredness, starting day after administration of PNEUMOVAX (R), pt also received AFLURIA in left arm w/o adverse rxn.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Hypotonia, Loss of consciousness, Respiratory arrest
Clinical narrative: After vaccine administration patient became unconscious for 20 seconds. Patient turned red. Stopped breathing and became limp. Pt returned to consciousness and assessed by Dr. normal vital signs and behavior returned.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Rash generalised
Clinical narrative: Total body rash.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pustular, Rash vesicular, Secretion discharge, Skin lesion
Clinical narrative: Developed rash which looks to be chicken pox.  Few lesions present 2/7/13 approx 5-7 mm in dia, some with serous pustule in center.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Expired drug administered, No adverse event
Clinical narrative: EXPIRED IMMUNIZATION GIVEN (PREVNAR 13 EXP 01/30/2013).  IRIS/CDC NOTIFIED. PATIENTS MOTHER NOTIFIED. NO ADVERSE REACTION NOTED, PATIENTS MOTHER INFORMED THAT IMMUNIZATION NEEDS TO BE REPEATED. IMMUNIZATION MAY BE GIVEN IMMEDIATELY.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive, X-ray normal, X-ray with contrast
Clinical narrative: Presented to clinic on Sat. Feb 2, 2013 with blood in stools. Guaiac positive proceeded with barium x-ray which was negative. Blood in stools noted only Sat. Feb 2, 2013. None since.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Headache, Injection site swelling, Nausea, Throat irritation
Clinical narrative: 2/5/13 mom noticed slight swelling at injection site. 2/6/13 mom gave TYLENOL to child before he left for school. School nurse examined child and noted that redness & swelling increased. 330 child seen in this office by doctor, BENADRYL given size of softball - swollen & red additional sx - nausea & headache, scratchy throat.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's Palsy - Onset of symptoms 1/21/13. Treatment with prednisone and acyclovir. FLUMIST given 1/16/13.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Myalgia, Swelling
Clinical narrative: Next day awoke with generalized swelling more so in the hands, muscular pain & fatigue for approximately 2 weeks after.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pain, Rash, Skin lesion
Clinical narrative: Severe redness, pulsating burning pain. Rash extending under (R) breast, under (R) arm to back (middle) extending up 1/2 on back. Lesions still active as of 2/4/13.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cough, Dizziness, Dyspnoea, Palpitations
Clinical narrative: Around 7 PM, felt woozy, went to bed. Started non stop dry cough, lasted approx, 45 min. Then my heart started racing and had bad trouble breathing, worse when I laid down. Around 10:30 pm felt better and was able to sleep. Fine next morning.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Pharyngeal oedema
Clinical narrative: Throat swelling, voice hoarse, constant coughing (couldn't hold conversation). Called family member who is a nurse. She suggested BENADRYL.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, TDAP
Symptoms: Cough, Fatigue, Pain, Pyrexia, Vaccination error
Clinical narrative: Pt received intradermal vaccine in error. Mom states since administration of vaccine pt has been sick with fever, cough, & fatigue and body aches.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, TDAP
Symptoms: Chills, Disturbance in attention, Fatigue, Migraine, Pyrexia
Clinical narrative: Pt received intradermal vaccine in error. Mom states since administration of vaccine pt has been sick with fever, cough, & fatigue and body aches.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Weakness in legs.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Swelling face
Clinical narrative: Shortly after injection, pt had swelling of her face and myalgias. Resolved within a few days without seeking medical attention.
Age: 36.0
Sex: M
Vaccine: HEP, MMR, PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Pain in extremity, Skin warm
Clinical narrative: Warmth, redness, pain, blanching of right arm. Redness since injection, time of onset of other signs/symptoms unknown.  Treated with cephalexin and hydroxyzine for allergic reaction vs cellulitis.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Injection was given in the left deltoid.  Per mother, patient's arm was red and swollen for 3 days but is now fine.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Acne, Chills, Choking sensation, Heart rate increased, Pruritus
Clinical narrative: After half an hour the vaccine was administered I had a feeing like tight throat feeling, no any other symptoms. It subsided after taking 0.25 mg Xanax. 8 days after choking feeling for two days like thumb was pushing on my throat feeling. It subsided after two days. 15 days after few rash, in my back like little pimple looking, itchy, they went away after I took Xanax and put cortisone cream on them. After 3 weeks again feeling lie a thumb was pushing on my throat for one day, I took Xanax it subsided. 24 days after the vaccine again few itchy rash in front of my belly only two, I put cortisone cream and took Xanax they went away with in 15 minutes. I made an appointment to a immunoligist and allergist, because I believe this flu vaccine may have made my immune system super sensitive! I never had these kind of problems ever in my life! I always got flu shots! Never had any problems, I can't say for sure but after getting tested I will have an answer! But it will cost me because my insurance does not pay for the first 2K of my tests!
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Sensation of foreign body, Throat tightness
Clinical narrative: After half an hour the vaccine was administered I had a feeing like tight throat feeling, no any other symptoms. It subsided after taking 0.25 mg Xanax. 8 days after choking feeling for two days like thumb was pushing on my throat feeling. It subsided after two days. 15 days after few rash, in my back like little pimple looking, itchy, they went away after I took Xanax and put cortisone cream on them. After 3 weeks again feeling lie a thumb was pushing on my throat for one day, I took Xanax it subsided. 24 days after the vaccine again few itchy rash in front of my belly only two, I put cortisone cream and took Xanax they went away with in 15 minutes. I made an appointment to a immunoligist and allergist, because I believe this flu vaccine may have made my immune system super sensitive! I never had these kind of problems ever in my life! I always got flu shots! Never had any problems, I can't say for sure but after getting tested I will have an answer! But it will cost me because my insurance does not pay for the first 2K of my tests!
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Injection was given in the left deltoid.  Per pt no reaction to vaccine.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Pt was given injection in left deltoid.  Per patient's mom he did not have any reactions.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Pt received injection in left deltoid and per Mom had no reaction.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Pt received injection in left deltoid.  Per father, patient did not have any reactions.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Per father, patient did not have any reaction to the vaccine.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Pt received injection in the left deltoid.  Per father, patient did not have a reaction to the vaccine.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Pt received injection in the left deltoid.  Per mother, patient did not have a reaction to the vaccine.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Chest pain, Mobility decreased, Pain
Clinical narrative: Unable to lift arm, sharp stabbing pains. Pressure started into chest, and pain in chest. Was consistent, getting worse. Tried muscle rub cream, several aspirins, tried itch arthritis pills, hot wrap. Still unable to lift arm without stabbing pain. Not sure of if it is permanent disability, has eased up a little, but pain still there, so I am unsure what is wrong, and if it will take time to heal, so marking permanent, but unsure of future.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood creatine phosphokinase increased, Pain, Proteinuria, Swelling
Clinical narrative: Significant swelling on extremity, increased CPK, proteinuria, body aches.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Feeling abnormal, Herpes zoster, Pruritus, Rash
Clinical narrative: Child started having a rash on the back of her right arm 3 inches x 4 inches, itchy and felt weird on 1-22-13. Mom took her to see Dr. & was diagnosed with shingles. Acyclovir was prescribed for 2 weeks.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Induration, Injection site erythema, Mass, Pruritus
Clinical narrative: Patient reported swelling, itching, hard lump 3.5x1.5" area. Fiery hot & lender. Swelling went down days later, patient reports 5 days later site is pink and about 0.5" smaller.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Patient reported swelling, itching, hard lump 3.5x1.5" area. Fiery hot & lender. Swelling went down days later, patient reports 5 days later site is pink and about 0.5" smaller.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: About 2 days after vaccination pt. reports pain in elbow and numbness/tingling in middle finger and ring finger.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (L) deltoid erythema, heat & tenderness. Mild erythema at injection site also. Tx for cellulitis - cephalexin. Sx occurred on day 1 & worse on day 2 after IZ.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site inflammation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site inflammation in a female subject aged between 50 and 59 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL, intradermally. At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site inflammation (the inflammation was described as big). The subject also experienced inappropriate route of vaccination. The nurse was looking to give the subject the TB test intradermally, but accidentally administered FLULAVAL. No further details are expected.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Generalised erythema, Product quality issue, Pruritus generalised, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itch over whole body in a 36-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy and sulfa allergy. Concurrent medications included BYSTOLIC, SYNTHROID, CYMBALTA, DEXILANT. On 18 September 2012 the subject received unspecified dose of FLULAVAL (.5 unknown, unknown, right arm). On 18 September 2012, 1 hour after vaccination with FLULAVAL, the subject experienced itch over whole body, swelling over body and erythema all over body. The subject received FLULAVAL injection on 18 September 2012. Approximately one hour later, the subject began to experience redness, swelling, itching all over their body and pharmaceutical product complaint. The subject presented to the clinic and was given a dose of SOLU-MEDROL and BENADRYL. Symptoms had improved by the next day. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. This is one of three reports made by the healthcare professional, please also see A0995173A and A0995174A. On 09 October 2012, follow-up information was received from the healthcare professional. It was reported that the itch over whole body, swelling over body and erythema all over body resolved on an unspecified date. The reporter considered that the events were not serious. It was also reported that the immunization series with FLULAVAL was discontinued. According to the product complaint investigation results reported by GSK Biologicals quality assurance on 09 October 2012, the product complaint was assessed to be unsubstantiated.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 25 September 2012 at 10:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). In September 2012, at an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site tenderness. The healthcare professional reported that a female subject received a dose of FLULAVAL and developed injection site reaction consisting of redness, swelling, and tenderness. The largest diameter of the redness was approximately three inches at the widest point. It is not known when reaction began, but the nurse was made aware by the subject on 27 September 2012. No other events noted. At the time of reporting the injection site redness, swelling injection site and injection site tenderness were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 43-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Previous vaccination included influenza virus vaccine; manufacturer unspecified; details unknown; given on an unspecified date. The healthcare professional reported that the subject "had her flu shot for the season". On 9 January 2012 at 11:30 the subject received a dose of FLULAVAL (.1 units unknown, intradermal, right forearm) and experienced wrong route of administration and extra dose administered. The healthcare professional reported that the subject went to receive TB [tuberculin] injection and received FLULAVAL rather than TB. On 10 January 2012, 1 day after vaccination with FLULAVAL, the subject experienced injection site redness, raised area injection site and injection site tenderness. The healthcare professional reported that the intradermal FLULAVAL injection resulted in an injection site reaction that was red, raised and tender. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow up information received from the healthcare professional on 02 February 2012. The healthcare professional reported that the events were resolved on 24 January 2012. The healthcare professional noted that the events were not serious. The healthcare professional explained that the events could have been associated with the erroneous, intradermal, administration of FLULAVAL.
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection arm pain in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (unknown, unknown arm). Less than one month after vaccination with FLULAVAL, the subject experienced injection arm pain. The healthcare professional reported that the subject received FLULAVAL "a couple of weeks ago" and experienced persistent pain in the arm of injection since then. At the time of reporting the outcome of the event was unspecified.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Injection site induration, Injection site nodule, Injection site swelling, Tuberculosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site induration in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 May 2012 at 20:15 the subject received unspecified dose of FLULAVAL (.1 ml, intradermal, right forearm) and experienced wrong vaccine administered. On 11 May 2012, the same day, after vaccination with FLULAVAL, the subject experienced nodule injection site and swelling injection site. On 12 May 2012, one day after vaccination with FLULAVAL, the subject experienced injection site induration and suspected TB (tuberculosis) based on result. A facility was providing TB test to employees when the subject received an intradermal injection. The subject reported that after the intradermal injection, the area became swollen and developed a nodule. On 12 May 2012, the subject went to the emergency room due to a suspected TB and a chest x-ray was performed. The emergency room stated that there was an induration of 22 and ? mm. The chest x-ray was clear. The healthcare professional then discovered that the subject was inadvertently injection with FLULAVAL and not the TB test. At the time of reporting the injection site induration, nodule injection site and swelling injection site were unresolved. Follow-up information was received on 25 May 2012 via healthcare professional reported the events occurred on 17 May 2012 which conflicts with previously reported 11 May 2012 and 12 May 2012 start dates. The events had resolved by 21 May 2012. The healthcare professional did not consider the events serious. At the time of the report no other information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site induration in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 May 2012 at 20:15 the subject received unspecified dose of FLULAVAL (.1 ml, intradermal, right forearm) and experienced wrong vaccine administered. On 11 May 2012, the same day, after vaccination with FLULAVAL, the subject experienced nodule injection site and swelling injection site. On 12 May 2012, one day after vaccination with FLULAVAL, the subject experienced injection site induration and suspected TB (tuberculosis) based on result. A facility was providing TB test to employees when the subject received an intradermal injection. The subject reported that after the intradermal injection, the area became swollen and developed a nodule. On 12 May 2012, the subject went to the emergency room due to a suspected TB and a chest x-ray was performed. The emergency room stated that there was an induration of 22 and ? mm. The chest x-ray was clear. The healthcare professional then discovered that the subject was inadvertently injection with FLULAVAL and not the TB test. At the time of reporting the injection site induration, nodule injection site and swelling injection site were unresolved. Follow-up information was received on 25 May 2012 via healthcare professional reported the events occurred on 17 May 2012 which conflicts with previously reported 11 May 2012 and 12 May 2012 start dates. The events had resolved by 21 May 2012. The healthcare professional did not consider the events serious. At the time of the report no other information was provided.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Malaise, Productive cough, Respiratory tract congestion
Clinical narrative: This case was reported by a physician and described the occurrence of unintentional overdose in a 65-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Thyroid medication and Cholesterol. On an unspecified date in September 2012 at 12:00 the subject received unspecified dose of FLULAVAL (1 ml, unknown, right deltoid). On an unspecified date in September 2012, during vaccination with FLULAVAL, the subject experienced unintentional overdose. Since receiving FLULAVAL, the subject experienced not feeling well, productive cough and congestion (nos)...The subject received 1ml dose of FLULAVAL instead of 0.5 ml, approximately one week later after receiving the vaccine the subject complained to the physician that she has not felt well since receiving the vaccine and has a productive cough. The physician stated that the subject sounded congested over the phone; although has not yet seen the subject. The physician wanted to know what safety information was available when administering a double dose. At the time of reporting the outcome of not feeling well, productive cough and congestion (nos) were unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of face in a female subject aged between 20 and 29 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 September 2012 at 08:00 the subject received unspecified dose of FLULAVAL (unknown). On 19 September 2012, within hours of vaccination with FLULAVAL, the subject experienced swelling of face. The healthcare professional indicated that the vaccine was administered to the subject in the 08:00 time frame and the face swelled up was reported after "they" had left the site at about 10-10:30. At the time of reporting the outcome of the facial swelling was unspecified.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site tenderness in a 70-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Diltiazem, Lisinopril + hydrochlorothiazide, Pravastatin and GLIPIZIDE XL. On 26 October 2011 "in the morning about 11:00" the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 27 October 2011, 1 day after vaccination with FLULAVAL, the subject experienced injection site tenderness. At the time of reporting the event was unresolved. The pharmacist considered the event was probably related to vaccination with FLULAVAL.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 September 2011 at 15:45 the subject received unspecified dose of FLULAVAL (.5 ml, unknown route, left arm). Less than one year after vaccination with FLULAVAL, the subject experienced extensive swelling of vaccinated limb, erythema of arm at injection site and hardness injection site. According to the nurse, the subject's arm was swollen, red and hard four inches [101.6 mm] across at the injection site. At the time of reporting the outcome of the events was unspecified.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Rhinorrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of runny nose in a 36-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included seasonal allergy. Concurrent medications included PPD. On 10 September 2012 at approximately 1700, the subject received unspecified dose of FLULAVAL (unknown, right arm). On 12 September 2012, 2 days after vaccination with FLULAVAL, the subject experienced runny nose, sniffles and influenza. The subject consulted his physician who told him "that what he was experiencing was not from the vaccine since the virus in there is dead". At the time of reporting the Runny nose, sniffles and flu were worse.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 September 2012 the subject received dose of FLULAVAL (.5 ml, details unknown). On 21 September 2012, less than one day after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pain. On an unspecified date in September 2012, the subject experienced fever greater than 102 within 24 hours. At the time of reporting the outcome of the events was unspecified. The pharmacist also reported two other subjects experienced events after receiving FLULAVAL (see case ids A0996176A and A0996178A for more details).
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 September 2012 the subject received dose of FLULAVAL (.5 ml, details unknown). On 21 September 2012, less than one day after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pain. On an unspecified date in September 2012, the subject experienced fever greater than 101 within 24 hours. At the time of reporting the outcome of the events was unspecified. The pharmacist also reported two other subjects experienced events after receiving FLULAVAL (see case ids A0996176A and A0996177A for more details).
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Generalised erythema, Product quality issue, Pruritus generalised, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pruritus all over body in a 47-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included AMBIEN, Atorvastatin and LIPITOR. On 18 September 2012 the subject received unspecified dose of FLULAVAL (.5 unknown, unknown, right arm). On 18 September 2012, 1 hour after vaccination with FLULAVAL, the subject experienced pruritus all over body, erythema all over body, swelling all over body and pharmaceutical product complaint. The subject received FLULAVAL injection on 18 September 2012. Approximately one hour later, the subject began to experience redness, swelling and itching all over their body. The symptoms resolved the next day on 19 September 2012. The healthcare professional considered the events were probably related to vaccination with FLUVALAL. A product complaint was filed, due to "the symptoms are unlike any flu vaccine she (the reporter) has ever seen occur". These subjects were "three in a row, which prompted her to call. The reporter was not sure 100 percent if the vial was suspect or not, and requested that a Quality complaint be submitted, and the vial to be returned for analysis." This is third of three reports made by the healthcare professional, please also see A0995170A and A0995173A.  On 09 October 2012, follow-up information was received from the healthcare professional. It was reported that the pruritus all over body, erythema all over body, and swelling all over body had resolved. The reporter considered that the events were not serious. It was also reported that the immunization series with FLULAVAL was discontinued and was not delayed. According to product complaint investigation results reported by GSK Biologicals quality assurance on 09 October 2012, the product complaint was assessed to be unsubstantiated.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Product quality issue, Pruritus generalised, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pruritus all over body in a 53-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included ZYRTEC, ACTONEL, Multivitamin and LUNESTA. On 18 September 2012 the subject received unspecified dose of FLULAVAL (.5 unknown, unknown, right arm). On 18 September 2012, less than one day after vaccination with FLULAVAL, the subject experienced redness, swelling and itching all over their body and pharmaceutical product complaint. On 19 September 2012, the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. This is the second of three reports made by the healthcare professional, please also see A0995170A and A0995174A. On 09 October 2012, follow-up information was received from the healthcare professional. It was reported that the redness, swelling and itching all over their body had resolved. The reporter considered that the events were not serious. It was also reported that the immunization series with FLULAVAL was discontinued and was not delayed. According to product complaint investigation results reported by GSK Biologicals quality assurance on 09 October 2012, the product complain was assessed to be unsubstantiated.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Heart rate increased, Hypertension, Nausea
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of rapid heart rate in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2012 the subject received a dose of FLULAVAL (.5 ml, unknown details). On 4 October 2012, about 5 to 10 minutes after vaccination with FLULAVAL, the subject experienced rapid heart rate, high blood pressure, nausea, dizziness and lightheadedness, and flushing. A pharmaceutical product complaint has been reported. The nurse "suspects she has a bad batch of FLULAVAL" since this dose was one of the first injections used out of a new vial. At the time of reporting the outcome of the rapid heart rate, dizziness and lightheadedness and flushing had resolved. At the time of reporting, the outcome of the high blood pressure and nausea was unknown. The healthcare professional (nurse) reported that the events of rapid heart rate, dizziness, lightheadedness and flushing were probably related to vaccination with FLULAVAL. It was unknown if the nurse considered high blood pressure and nausea related to vaccination with FLULAVAL. The nurse reported another subject who received FLULAVAL and experienced events. See case A0999481A for details on the other subject. This case was associated with a product quality complaint for FLULAVAL. "A registered nurse reports that she received a suspect batch of FLULAVAL. She notes that she opened a new vial, and the very first 2 patients who received the injection had systemic side effects. Vials were stored under recommended conditions. Nothing looked out of normal when the product was visibly inspected." Quality Assurance (QA) results received on 19 November 2012. Based on the fact that no precise technical problem was reported, and based on the conforming results of the Quality Control visual appearance test, performed on the returned samples, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.
Sex: F
Vaccine: FLU3
Symptoms: Product quality issue
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of rapid heart rate in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2012 the subject received a dose of FLULAVAL (.5 ml, unknown details). On 4 October 2012, about 5 to 10 minutes after vaccination with FLULAVAL, the subject experienced rapid heart rate, high blood pressure, nausea, dizziness and lightheadedness, and flushing. A pharmaceutical product complaint has been reported. The nurse "suspects she has a bad batch of FLULAVAL" since this dose was one of the first injections used out of a new vial. At the time of reporting the outcome of the rapid heart rate, dizziness and lightheadedness and flushing had resolved. At the time of reporting, the outcome of the high blood pressure and nausea was unknown. The healthcare professional (nurse) reported that the events of rapid heart rate, dizziness, lightheadedness and flushing were probably related to vaccination with FLULAVAL. It was unknown if the nurse considered high blood pressure and nausea related to vaccination with FLULAVAL. The nurse reported another subject who received FLULAVAL and experienced events. See case A0999481A for details on the other subject. This case was associated with a product quality complaint for FLULAVAL. "A registered nurse reports that she received a suspect batch of FLULAVAL. She notes that she opened a new vial, and the very first 2 patients who received the injection had systemic side effects. Vials were stored under recommended conditions. Nothing looked out of normal when the product was visibly inspected." Quality Assurance (QA) results received on 19 November 2012. Based on the fact that no precise technical problem was reported, and based on the conforming results of the Quality Control visual appearance test, performed on the returned samples, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of blood glucose decreased in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date, the subject received dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced blood glucose decreased. The pharmacist reported a male subject received FLULAVAL and experienced a drop in his blood glucose. No additional information was known. At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Heart rate increased
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of dizziness in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Anti-hypercholesterolaemic. On 4 October 2012 the subject received a dose of FLULAVAL (.5 ml, unknown route, unknown arm). On 4 October 2012, 5 to 10 minutes after vaccination with FLULAVAL, the subject experienced dizziness, flushing, rapid heart rate and lightheaded. A pharmaceutical product complaint has been reported. The nurse notes that "she may have a defective batch of FLULAVAL" since this dose was one of the first injections used out of a new vial. The healthcare professional (nurse) reported that all events were probably related to vaccination with FLULAVAL. At the time of reporting the outcome of the events were resolved. The nurse reported another subject receiving FLULAVAL and experienced adverse events. See case A0999490A for details on the other subject. This case was associated with a product quality complaint for FLULAVAL. "A registered nurse reports that she received a suspect batch of FLULAVAL. She notes that she opened a new vial, and the very first 2 patients who received the injection had systemic side effects. Vials were stored under recommended conditions. Nothing looked out of normal when the product was visibly inspected." Quality Assurance (QA) results received on 19 November 2012. Based on the fact that no precise technical problem was reported, and based on the conforming results of the Quality Control visual appearance test, performed on the returned samples, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Feeling hot, Feeling of body temperature change, Ill-defined disorder, Muscle twitching
Clinical narrative: This case was reported by a consumer, the subject's significant other and described the occurrence of central nervous system effects in a 43-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 15 October 2011 the subject received unspecified dose of FLULAVAL (unknown). Expiration date was reported as 26 July 2011, GSK lot number records for AFLLA694AA had an expiration of 30 June 2012. In November 2011, 1 month after vaccination with FLULAVAL, the subject experienced central nervous system effects, body twitch, feeling hot, cold feeling, twinge, tingling, ill defined disorder and sensory disturbances. The subject has had several central nervous system side effects to FLULAVAL starting about a month after his vaccination on 15 October 2011 he began experiencing hot and cold sensations, twitching and tingling. These sensations started in his head and moved to his extremities. They appear in different parts of his body, jumping around. The reporter described "his energy flow as being off. Parts of his body can feel either hot or cold. For example he could wake up and his head would feel very cold and he would have to wear a hat. Limbs can twitch randomly". The reporter declined to be contacted for follow-up. At the time of reporting the events were worse.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Nervous system disorder, Paraesthesia, Sensory disturbance
Clinical narrative: This case was reported by a consumer, the subject's significant other and described the occurrence of central nervous system effects in a 43-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 15 October 2011 the subject received unspecified dose of FLULAVAL (unknown). Expiration date was reported as 26 July 2011, GSK lot number records for AFLLA694AA had an expiration of 30 June 2012. In November 2011, 1 month after vaccination with FLULAVAL, the subject experienced central nervous system effects, body twitch, feeling hot, cold feeling, twinge, tingling, ill defined disorder and sensory disturbances. The subject has had several central nervous system side effects to FLULAVAL starting about a month after his vaccination on 15 October 2011 he began experiencing hot and cold sensations, twitching and tingling. These sensations started in his head and moved to his extremities. They appear in different parts of his body, jumping around. The reporter described "his energy flow as being off. Parts of his body can feel either hot or cold. For example he could wake up and his head would feel very cold and he would have to wear a hat. Limbs can twitch randomly". The reporter declined to be contacted for follow-up. At the time of reporting the events were worse.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of hives in a 30-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2012 the subject received a dose of FLULAVAL (.5 ml, unknown route, left deltoid). On 1 October 2012, approximately 2 hours after vaccination with FLULAVAL, the subject experienced hives. The subject was treated with CLARITIN. "The next day her symptoms recurred probably when the CLARITIN wore off." On 2 October 2012, the event was resolved. The nurse reported two cases of adverse experiences with FLULAVAL. See case A0998207A for details.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a physician and described the occurrence of itching in a 37-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 10 October 2012 at 17:50 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 10 October 2012, at 23:00, approximately 5 hours after vaccination with FLULAVAL, the subject experienced itching. The physician stated that the subject "continues itching all over the past 9 days since receiving a FLULAVAL shot" on 10 October 2012. The subject "waited seven days, and treated /relieved the itching with over-the-counter BENADRYL on 17 October 2012." He then reported the experience to the physician on 18 October 2012. At the time of reporting the event was unresolved. The physician stated that the itching continued to persist at the time of the report. The physician reported concern over the length of time that the itching had persisted and will continue monitoring. The physician considered the event was possibly related to vaccination with FLULAVAL. Follow-up information was received on 14 November 2012 via physician who reported the subject's event of itching started on 10 October 2012 and resolved on 24 October 2012. No other information was provided.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site swollen in a 72-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to IMODIUM and allergy to KEFLEX. On 5 September 2012 the subject received 1st dose of FLULAVAL (.5 unknown, intramuscular, right arm). On an unspecified date in September 2012, at an unspecified time after vaccination with FLULAVAL, the subject experienced injection site swollen and injection site pain. The subject received FLULAVAL and complained to the healthcare professional about injection site being swollen, sore and painful. At the time of reporting the outcome of the injection site swollen and injection site pain were unspecified. The healthcare professional reported the office had up to 10 subjects or possibly more, with injection site swelling, soreness and pain, in some cases induration size of coin. Please see case A0996526A.
Sex: U
Vaccine: FLU3
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of flu shot reaction in approximately 10 adult subjects of unspecified gender who were vaccinated with FLULAVAL (GlaxoSmithKline). On unspecified dates since September 2012, the subjects received unspecified dose of FLULAVAL (.5 ml, unknown, unknown arm). At an unspecified time after vaccination with FLULAVAL, the subjects experienced flu shot reaction described as injection site redness, swelling injection site and injection site pain. The office reported that they have administered approximately 50 FLULAVAL vaccinations and about 10 of these subjects have experienced reactions to the flu shot. These reactions have ranged from minor redness at injection site to large area of redness, swelling and pain at injection site. Some of the subject required treatment with ice and prednisone. At the time of the report individual subjects could not be identified. At the time of reporting the outcome of the injection site redness, swelling injection site and injection site pain were unspecified. Follow-up information was received on 26 October 2012 via physician. The physician reported that "out of about 300 vaccinations this year with FLULAVAL he has seen a large number of adverse events, roughly 10 to 12". He described them as "one diffuse rash and the other rashes local to injection site. These local reaction range from golf ball sized hard red reactions to involving the whole extremity. He screened these patients for previous adverse events." At the time of the report the outcome of the events were unspecified.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included blockage, heart attack and heart disease. On 2 October 2012 at 14:00 the subject received unspecified dose of FLULAVAL (. 5 ml, unknown, left arm) and experienced wrong vaccine administered. On 2 October 2012, within hours of vaccination with FLULAVAL, the subject experienced injection site redness, injection site warmth and injection site pruritus. The subject was supposed to have received a TB test and was given FLULAVAL in the forearm by mistake. The area of redness is the size of the palm of a hand with irregular borders. The area has become larger since it first presented but it is no raised just discolored. At the time of reporting the injection site redness and injection site warmth were unresolved; injection site pruritus had improved. Follow-up information was received on 30 October 2012 via healthcare professional who reported the events of injection site redness, injection site warmth and injection site pruritus were resolved.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash erythematous
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 24-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included high blood pressure, SLE and sun allergy. Concurrent medications included Prednisone and Benazepril. On 18 October 2012 at 16:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, right arm). On 19 October 2012, nine hours after vaccination with FLULAVAL, the subject experienced face itching. On 20 October 2012, two days after vaccination with FLULAVAL, the subject experienced allergic reaction, redness and red spot. The subject took BENADRYL which resulted in an improvement of side effects but not complete resolution. At the time of reporting the allergic reaction, redness and red spot were improved; the face itching resolved on 20 October 2012. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.