chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site dermatitis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site dermatitis in a female subject aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 September 2010 at 15:00 the subject received a dose of FLULAVAL (.5 cc, unknown route, left arm). On 1 October 2010, 1 day after vaccination with FLULAVAL, the subject experienced injection site dermatitis. The subject treated the dermatitis at home (details not specified). At the time of reporting the event was improved. The healthcare professional considered the event was possibly related to vaccination with FLULAVAL. Follow-up received on 20 October 2010 from the healthcare professional: The subject was 48 years-old. FLULAVAL was administered intramuscularly in the left deltoid. The reporter indicated that the subject took action with TYLENOL. The events resolved on 06 October 2010. The subject had received flu shots in the last with no reactions.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Oropharyngeal pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 12-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications and no relevant medical history. On 15 September 2010 at 16:30 the subject inadvertently received a dose of FLULAVAL at 0.5 ml in the left arm. On 16 September 2010, 1 day after vaccination with FLULAVAL, the subject experienced nausea, diarrhea and sore throat. It was indicated that the events lasted for 24 hours (outcome of 16 September 2010), however, they were noted as improved at the time of report. All events were considered unrelated to treatment with FLULAVAL.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Breast engorgement, Breast pain, Breast swelling, Injection site erythema
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of injection site redness in a 35-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject had never previously received a flu shot. Concurrent medications included VIVANCE. On 30 September 2010 at 18:15 the subject received a dose of FLULAVAL (unknown route, left arm). On 30 September 2010, less than one day after vaccination with FLULAVAL, the subject experienced injection site redness. On 01 October 2010, the subject experienced breast engorgement, impression of swollen breast, soreness breast, sore arm and soreness armpit. The subject reported left breast soreness, including her left arm underside and left armpit. The events began with a feeling of breast engorgement and swelling. At the time of reporting the outcome of the breast engorgement and impression of swollen breast was unspecified. The injection site redness resolved on 01 October 2010, and the other events were improved, but not resolved.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of injection site redness in a 35-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject had never previously received a flu shot. Concurrent medications included VIVANCE. On 30 September 2010 at 18:15 the subject received a dose of FLULAVAL (unknown route, left arm). On 30 September 2010, less than one day after vaccination with FLULAVAL, the subject experienced injection site redness. On 01 October 2010, the subject experienced breast engorgement, impression of swollen breast, soreness breast, sore arm and soreness armpit. The subject reported left breast soreness, including her left arm underside and left armpit. The events began with a feeling of breast engorgement and swelling. At the time of reporting the outcome of the breast engorgement and impression of swollen breast was unspecified. The injection site redness resolved on 01 October 2010, and the other events were improved, but not resolved.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 4 October 2010 the subject received a dose of FLULAVAL (details unknown). On either 4 or 5 October 2010, less than one week after vaccination with FLULAVAL, the subject experienced a 2-4 inch area of injection site tenderness, injection site redness and hotness at injection site. At the time of reporting the events were improved. The healthcare professional reported that she gave approximately 40 vaccinations to employees and has had 7 reports of a 2-4 inch area around the injection site that was tender, red and warmer than the surrounding skin. This is case 2 of 7 (see case IDs A0885121A, A0885269A - A0885273A for the other reports). The healthcare professional also reported an additional subject who experienced different adverse events following vaccination with FLULAVAL (see case ID A0885114A for more details). Follow-up information received on 26 October 2010 indicated that the subject was 45 years old at the time of events. No additional information was reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 the subject received a dose of FLULAVAL (details unknown). On either 4 or 5 October 2010, less than one week after vaccination with FLULAVAL, the subject experienced a 2-4 inch area of injection site tenderness, injection site redness and hotness at injection site. At the time of reporting the events were improved. The healthcare professional reported that she gave approximately 40 vaccinations to employees and has had 7 reports of a 2-4 inch area around the injection site that was tender, red and warmer than the surrounding skin. This is case 3 of 7 (see case IDs A0885121A, A0885268A, A0885270A - A0885273A for the other reports). The healthcare professional also reported an additional subject who experienced different adverse events following vaccination with FLULAVAL (see case ID A0885114A for more details). Follow-up information received on 26 October 2010 indicated that the subject was 36 years old at the time of the events. No additional information was provided.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 the subject received a dose of FLULAVAL (details unknown). On either 4 or 5 October 2010, less than one week after vaccination with FLULAVAL, the subject experienced a 2-4 inch area of injection site tenderness, injection site redness and hotness at injection site. At the time of reporting the events were improved. The healthcare professional reported that she gave approximately 40 vaccinations to employees and has had 7 reports of a 2-4 inch area around the injection site that was tender, red and warmer than the surrounding skin. This is case 4 of 7 (see case IDs A0885121A, A0885268A, A0885269A, A0885271A - A0885273A for the other reports). The healthcare professional also reported an additional subject who experienced different adverse events following vaccination with FLULAVAL (see case ID A0885114A for more details). Follow-up information indicated that this subject was 29 years old at the time of events. No additional information was provided.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 the subject received a dose of FLULAVAL (details unknown). On either 4 or 5 October 2010, less than one week after vaccination with FLULAVAL, the subject experienced a 2-4 inch area of injection site tenderness, injection site redness and hotness at injection site. At the time of reporting the events were improved. The healthcare professional reported that she gave approximately 40 vaccinations to employees and has had 7 reports of 2-4 inch area around the injection site that was tender, red and warmer than the surrounding skin. This is case 5 of 7 (see case IDs A0885121A, A0885268A - A0885270A, A0885272A, A0885273A for the other reports). The healthcare professional also reported an additional subject who experienced different adverse events following vaccination with FLULAVAL (see case ID A0885114A for more details). Follow-up information received on 26 October 2010. It was indicated that the subject was 26 years old at the time of the events. The events began on 04 October 2010, the day on vaccination. Events resolved on 05 October 2010. It was noted that subject's weight value was 95, however, units were not provided.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 the subject received a dose of FLULAVAL (details unknown). On either 4 or 5 October 2010, less than one week after vaccination with FLULAVAL, the subject experienced a 2-4 inch area of injection site tenderness, injection site redness and hotness at injection site. At the time of reporting the events were improved. The healthcare professional reported that she gave approximately 40 vaccinations to employees and has had 7 reports of a 2-4 inch area around the injection site that was tender, red and warmer than the surrounding skin. This is case 6 of 7 (see case IDs A0885121A, A0885268A - A0885271A, A0885273A for the other reports). The healthcare professional also reported an additional subject who experienced different adverse events following vaccination with FLULAVAL (see case ID A0885114A for more details). Follow-up information was received on 26 October 2010. It was reported that the subject was 54 years old at the time of events. No additional information was provided.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 the subject received a dose of FLULAVAL (details unknown). On either 4 or 5 October 2010, less than one week after vaccination with FLULAVAL, the subject experienced a 2-4 inch area of injection site tenderness, injection site redness and hotness at injection site. At the time of reporting the events were improved. The healthcare professional reported that she gave approximately 40 vaccinations to employees and has had 7 reports of 2-4 inch area around the injection site that was tender, red and warmer than the surrounding skin. This is case 7 of 7 (see case IDs A0885121A, A0885268A - A0885272A for the other reports). The healthcare professional also reported an additional subject who experienced different adverse events following vaccination with FLULAVAL (see case ID A0885114A for more details). Follow-up information received on 26 October 2010 indicated that the subject was 60 years old at the time of the events. No additional information was provided.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site hives in a female subject (a nurse) aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 5 October 2010 at 09:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 5 October 2010, less than one day after vaccination with FLULAVAL, the subject experienced injection site hives and injection site pruritus. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. Follow-up information was received on 18 November 2010 via healthcare professional. The reporting healthcare professional associated the events with concurrent illness of an abscessed tooth which was being treated with antibiotics at the time of the FLULAVAL injection. On 08 October 2010, the injection site hives and pruritus resolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red spot at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (.5 ml, unknown route and site). At an unspecified time after vaccination with FLULAVAL, the subject experienced red spot at injection site and itching. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 5 out of 70 subjects who received FLULAVAL experienced the events as noted. The facility used a single dose syringe vaccine last year and did not have any complaints of this nature. This is case 1 of 5 (see case IDs A0885964A - A0885967A for the other reports).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in a 59-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included shoulder problems. Concurrent medical conditions included thyroid problems. Concurrent medications included Multivitamins and Levothyroxine. On 4 October 2010 at 10:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, left deltoid). On 4 October 2010, 5 hours after vaccination with FLULAVAL, the subject experienced left arm pain that radiated to her fingers, joint pain that radiated to her hand, paresthesia, left arm numbness and tingling in her left arm. The healthcare professional considered that the events were a systemic reaction. The subject was treated with TYLENOL and MOTRIN. At the time of reporting the events were unresolved.
Sex: U
Vaccine: FLU3
Symptoms: Blood glucose increased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of high blood sugar reading in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in October 2010 the subject received a dose of FLULAVAL (details unknown). Less than one week after vaccination with FLULAVAL, the subject experienced high blood sugar readings. At the time of reporting the outcome of the event was unspecified. No further information was provided.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test negative, Influenza like illness, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of flu like symptoms in a 67-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included kidney transplant. Concurrent medical conditions included high cholesterol and hypertension. Concurrent medications included MYFORTIC, LIPITOR, LOPRESSOR, NORVASC and Unknown. On 30 September 2010 at 13:00 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, left arm). On 30 September 2010, 7 hours after vaccination with FLULAVAL, the subject experienced flu like symptoms. The subject was given a rapid AB flu test and the results were negative. Her infectious disease physician diagnosed her symptoms as a reaction to the FLULAVAL vaccine. The subject was treated as if she had a staph infection; she was given steroids and antibiotics. At the time of reporting the flu like symptoms improved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. Follow-up received from the reporting healthcare professional on 26 October 2010: The healthcare professional reported the diagnosis per subject as "reaction to influenza vaccination" which resolved on 08 October 2010 and was not considered serious by the reporter. The reporter stated that "health care provider initiated BACTRIM DS...for possible cellulitis and BACTROBAN subject's oncologist D/C". The event of possible cellulitis was assessed as medically serious by GSK. The onset date and outcome of possible cellulitis was not specified. It was unknown whether the events could have been associated with any other cause.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red spot at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (.5 ml, unknown route and site). At an unspecified time after vaccination with FLULAVAL, the subject experienced red spot at injection site and itching. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 5 out of 70 subjects who received FLULAVAL experienced the events as noted. The facility used a single dose syringe vaccine last year and did not have any complaints of this nature. This is case 2 of 5 (see case IDs A0885547A, A0885965A - A0885967A for the other reports).
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysgeusia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of chest tightness in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included ventricular dysfunction. On 14 September 2010 at 11:20 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 14 September 2010, within minutes of vaccination with FLULAVAL, the subject experienced mercury taste. Approximately 40 minutes later, on 14 September 2010, the subject experienced chest tightness. At the time of the report, the subject's vital signs were good. On 14 September 2010, the chest tightness and taste abnormality were resolved. The nurse reported two additional patients, see cases A0882705A and A0882706A.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Rhinorrhoea, Sensory disturbance
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swimming sensation in head in a 21-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included ZYRTEC. On 14 September 2010 at 12:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 14 September 2010, one hour after vaccination with FLULAVAL, the subject experienced head felt swimmy, dizziness and nose poured clear liquid. At the time of the report, the subject's vital signs were good. On 14 September 2010, the swimming sensation in head, dizziness and clear runny nose were resolved. The nurse reported two additional patients, see cases A0882394A and A0882706A.
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of head buzzing in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 14 September 2010 at 12:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 14 September 2010, one hour after vaccination with FLULAVAL, the subject experienced head buzzing. At the time of the report, the subject's vital signs were good. On 14 September 2010, the head buzzing was resolved. The nurse reported two additional patients, see cases A0882394A and A0882705A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (.5 ml, unknown, left arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site pain. The healthcare professional reported that a couple of subjects had excessive injection site pain. Specific details regarding the subjects were unknown. The subjects reported the pain began after injection and lasted for a few days. The healthcare professional was uncertain if medical attention was required and reported vaccinations were administered at health clinics held at various facilities. At the time of reporting the pain at injection site was improved.
Sex: U
Vaccine: FLU3
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nonspecific reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced nonspecific reaction. At the time of reporting the outcome of the event was unspecified.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of full body rash in a 65-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 25 September 2010 at 08:50 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, left arm). On 25 September 2010, approximately 5 hours after vaccination with FLULAVAL, the subject experienced full body rash. The subject was instructed by his physician to treat it with BENADRYL. At the time of reporting the outcome of the full body rash was unspecified. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. Follow-up information received on 02 November 2010 indicated that the event of full body rash occurred on 25 September 2010 (the day of vaccination with FLULAVAL) and ended the same day. The event was considered to be resolved. Additionally, it was noted that FLULAVAL was given intramuscularly. Concurrent medications included Ramipril, Metoprolol, Metformin HCl, LIPITOR, ACTOS, TUSSIONEX Pennkinetic, Vitamin B-12, SLO-NIACIN, Multivitamins and Aspirin.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm numbness in a female subject aged between 20 and 29 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 29 September 2010 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced numbness down the arm from injection site. At the time of reporting the outcome of the arm numbness was unspecified. This is one of two cases reported by the nurse, see case A0884296A. Follow-up information received via the reporting nurse indicated that this patient was a temporary employee and specific medical information requested is not available. Follow-up information was received on 25 October 2010. It was reported that the subject was 22 years old at the time of events. It was indicated that the subject experienced a vaccine reaction. Arm numbness was reported. Events resolved. Numbness was present for a time period of approximately 1 to 1 and a half hours. Subject nervousness prior to the shot may have contributed to the adverse reactions.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm numbness in a 30-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced numbness down the arm from injection site. At the time of reporting the outcome of the arm numbness was unspecified. This is the second of two cases by the nurse, see case A0884295A. Follow-up information received via the reporting nurse indicated that this patient was a temporary employee and specific medical information requested is not available. Follow-up information was received on 25 October 2010. It was reported that the patient was 37 years old at the time of events. He received a dose of FLULAVAL on 29 September 2010 and an unknown amount of time following and on the same day, the patient experienced a vaccine reaction. Arm numbness was reported. The events were considered to be resolved on 29 September 2010. Numbness occurred for less than one hour. It was noted that the patient had a fear of needles and tensed his arm muscle during FLULAVAL administration which may have been associated with the reported events.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Incorrect route of drug administration, Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (subcutaneous, unknown) and experienced inappropriate route of vaccination. At an unspecified time after vaccination with FLULAVAL, the subject experienced erythema and soreness. At the time of reporting the outcome of the erythema, soreness were unspecified.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Insomnia, Pain of skin, Skin ulcer, Skin warm
Clinical narrative: This case was reported by a consumer and described the occurrence of chest hot to touch in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included sulfa allergy. There were no concurrent medications. On 28 September 2010 at 12:00 the subject received 1st dose of FLULAVAL at 0.5 ml in the right arm. On 28 September 2010, an unspecified amount of time after vaccination with FLULAVAL, the subject experienced chest hot to touch, sores on chest (anything that touches the area causes sores), insomnia, skin sensitive to touch and sensitive skin on chest (nothing could be against the skin on her chest). At the time of reporting the events were unresolved.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bedridden, Gait disturbance, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This case was reported by a consumer and described the occurrence of chest hot to touch in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included sulfa allergy. There were no concurrent medications. On 28 September 2010 at 12:00 the subject received 1st dose of FLULAVAL at 0.5 ml in the right arm. On 28 September 2010, an unspecified amount of time after vaccination with FLULAVAL, the subject experienced chest hot to touch, sores on chest (anything that touches the area causes sores), insomnia, skin sensitive to touch and sensitive skin on chest (nothing could be against the skin on her chest). At the time of reporting the events were unresolved.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Injection site warmth, Muscle twitching, Paraesthesia, Paralysis
Clinical narrative: This case was reported by a consumer and described the occurrence of chest hot to touch in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included sulfa allergy. There were no concurrent medications. On 28 September 2010 at 12:00 the subject received 1st dose of FLULAVAL at 0.5 ml in the right arm. On 28 September 2010, an unspecified amount of time after vaccination with FLULAVAL, the subject experienced chest hot to touch, sores on chest (anything that touches the area causes sores), insomnia, skin sensitive to touch and sensitive skin on chest (nothing could be against the skin on her chest). At the time of reporting the events were unresolved.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a 59-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included a lot of allergies, such as preservatives and antibiotics. There were no concurrent medications. On 7 October 2009 at 10:30 the subject received unspecified dose of FLULAVAL (unknown, right arm). On an unspecified date the subject received unspecified dose Flu vaccine (unknown). On 8 October 2009, one day after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. On an unspecified date, at an unspecified time after vaccination with Flu vaccine, the subject experienced injection site pain. At the time of reporting the swelling injection site resolved on 13 October 2009, injection site pruritus resolved on 13 October 2009, and injection site redness resolved on 14 October 2009. The outcome of the injection site pain was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, Fatigue, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of arm soreness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 16 October 2009 and on an unspecified date the subject received unspecified dose of FLULAVAL (unknown). On an unspecified date, at an unspecified time after the previous vaccination with FLULAVAL, the subject experienced arm soreness and tiredness. On 16 October 2009, less than one day after vaccination with FLULAVAL, the subject experienced arm soreness and expired vaccine used. On an unspecified date in October 2009, a few days after vaccination with FLULAVAL, the subject experienced tiredness. At the time of reporting the outcome of the arm soreness and tiredness (after the previous dose of FLULAVAL) was unspecified. The outcome of the arm soreness and tiredness (after the 16 October 2009 dose of FLULAVAL) was unresolved. The subject consulted a health care professional regarding the event (s). On 21 October 2009, the subject reported that she received FLULAVAL last year and experienced side effects similar to what she had experienced with the FLULAVAL dose given on 16 October 2009 (arm soreness and tiredness). She received last year's FLULAVAL again this year and the product expired (July 2009). No other information can be obtained, the subject preferred to remain anonymous.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Muscle spasms, Muscular weakness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of leg weakness in a 63-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included dizziness and sulfa allergy. Concurrent medications included Meclizine. On 27 October 2009 at 12:30 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). On 27 October 2009, approximately 15 minutes after vaccination with FLULAVAL, the subject experienced leg weakness, walking difficulty and muscle cramp. At the time of reporting the outcome of the events was unknown. The pharmacist considered the events were possibly related to vaccination with FLULAVAL. On 27 October 2009, the pharmacist reported that another pharmacist injected a female subject with FLULAVAL. After approximately 15 minutes, the subject began to feel weak in the legs, had muscular cramping, and had difficulty walking. The subject went home and the husband planned to take her to an emergency room. At the time of reporting, the outcome was not known. It was reported that the subject received FLULAVAL at 12:30 and experienced the events at 13:00 (reported as approximately 15 minutes later). The subject consulted a health care professional regarding the event(s).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Overdose, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sore arm in a female subject aged between 20 and 29 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 23 October 2009, in the late afternoon, the subject received unspecified dose of FLULAVAL (5 to 6 ml, unknown, unknown arm). On 23 October 2009, less than one day after vaccination with FLULAVAL, the subject experienced sore arm, fever and overdose. At the time of reporting, the outcome of the overdose was unresolved. At the time of reporting the outcome of the sore arm and fever was unspecified. On 26 October 2009, the nurse reported that the subject allegedly received five to six ml of FLULAVAL. She experienced a sore arm and a fever. The subject consulted a health care professional regarding the event(s). Follow up information was received on 18 November 2009 via the reporting nurse (employer). The nurse reported that a 32-year-old female subject (employee) received a dose of FLULAVAL (2.5 ml (5 doses)) in the left arm. The subject had a low grade temperature of 99-100 on an unspecified day in October 2009. Approximately on 30 October 2009, the events were resolved.
Sex: F
Vaccine: FLU3
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a pharmacist, via a sales representative, and described the occurrence of nonspecific reaction in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown, unknown deltoid). At an unspecified time after vaccination with FLULAVAL, the subject experienced nonspecific reaction. At the time of reporting the outcome of the event was unspecified. On 28 October 2009, the pharmacist notified the sales representative via voicemail that a subject had a reaction to FLULAVAL. The pharmacist reported that the dose was given in the deltoid region and the reaction was probably self-limiting.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, Flushing, Malaise
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of facial flushing in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 October 2009 at 14:00 the subject received unspecified dose of FLULAVAL (0.5 cc, left arm). On 28 October 2009 in the evening, within hours of vaccination with FLULAVAL, the subject experienced facial flushing, red face, bad feeling and malaise. It was reported that the injection site "looked fine". The subject was treated with BENADRYL without improvement. At the time of reporting the events were unresolved. The subject was not experiencing any shortness of breath or fever at the time of reporting. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Off label use
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in an 8-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (.5 ml, unknown) and experienced drug use for unapproved indication. No other vaccines were given on the same date. At an unspecified time after vaccination with FLULAVAL, the subject experienced redness (for a few days) and pain at injection site. The pharmacist considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the injection site redness was resolved and the outcome of the injection site pain was unknown. The pharmacist considered the injection site redness was probably related to vaccination with FLULAVAL, and the causality of the injection site pain was unknown. On 04 November 2009, the pharmacist reported that an eight-year-old female subject was given a dose of FLULAVAL. The subject developed redness and pain at the injection site. Specific dates were not known. The pharmacist noted that the parents may have given some medications to alleviate the redness and pain, but was not sure. It was unknown if the subject consulted a health care professional regarding the event(s).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in right upper arm in a 32-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 October 2009 the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 19 October 2009, less than one day after vaccination with FLULAVAL, the subject experienced pain in right upper arm. At the time of reporting the pain in right upper arm was unresolved. The nurse reported the subject had pain in upper right arm since receiving FLULAVAL. This is one of three cases reported by the nurse; see case A0816149A and A0816150A for subjects who had pain in upper right arm following vaccination with FLULAVAL.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in right upper arm in a 53-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 October 2009 the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 19 October 2009, less than one day after vaccination with FLULAVAL, the subject experienced pain in right upper arm. At the time of reporting the pain in right upper arm was unresolved. This is one of three cases reported by the nurse; see case A0815869A and A0816150A for subjects who had pain in upper right arm following vaccination with FLULAVAL.
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in right upper arm in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 October 2009 the subject received a dose of FLULAVAL (.5 ml, unknown). In 2009, at an unspecified time after vaccination with FLULAVAL, the subject experienced pain in right upper arm. At the time of reporting the outcome of the pain in right upper arm was unspecified. This is one of three cases reported by the nurse; see case A0815869A and A0816149A for subjects who had pain in upper right arm following vaccination with FLULAVAL.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Heart rate abnormal
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of general head pain in a 19-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Multivitamin and Z-PAK. On 3 November 2009 the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 3 November 2009, less than one day after vaccination with FLULAVAL, the subject experienced general head pain. On 6 November 2009, three days after vaccination with FLULAVAL, the subject experienced sore throat, productive cough, fever, weak pulse, feeling faint, serum sickness, joint pain and exhausted. The mother of the subject did not feel comfortable providing any further information at time of reporting. At the time of reporting, only partial information was provided. At the time of reporting the subject's serum sickness, joint pain and exhausted were unresolved. At the time of reporting, the outcome of general head pain, sore throat, productive cough, fever, weak pulse, and feeling faint was unknown.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Productive cough, Pulse pressure decreased, Pyrexia, Serum sickness
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of general head pain in a 19-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Multivitamin and Z-PAK. On 3 November 2009 the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 3 November 2009, less than one day after vaccination with FLULAVAL, the subject experienced general head pain. On 6 November 2009, three days after vaccination with FLULAVAL, the subject experienced sore throat, productive cough, fever, weak pulse, feeling faint, serum sickness, joint pain and exhausted. The mother of the subject did not feel comfortable providing any further information at time of reporting. At the time of reporting, only partial information was provided. At the time of reporting the subject's serum sickness, joint pain and exhausted were unresolved. At the time of reporting, the outcome of general head pain, sore throat, productive cough, fever, weak pulse, and feeling faint was unknown.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of sore shoulder in a 56-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 September 2009 the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced sore shoulder and bone pain. It was reported that the subject's shoulder hurt in the bone. She has received the flu vaccine "every year for a while and had never had this happen before". At the time of reporting the outcome of the sore shoulder and bone pain was unspecified.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Musculoskeletal pain, Neck pain, Wrong technique in drug usage process
Clinical narrative: This case was reported by a consumer and described the occurrence of wrong injection technique in a 65-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included severe allergies (she had to carry an EPIPEN). The subject had received influenza vaccinations previously and had no adverse events. Concurrent medications included SYNTHROID, PREVACID, CRESTOR, Fish oil; VIVELLE, Iron, Vitamin C, Vitamin B and Multiple vitamin. On 1 September 2010 at 13:00 the subject received unspecified dose of FLULAVAL. The vaccine was not shaken prior to administration. The subject did not consult a healthcare professional regarding this event. Follow-up received from the consumer on 03 September 2010: The subject's past medical history included neck pain and shoulder pain. On 01 September at 18:00, 5 hours after vaccination with FLULAVAL, the subject experienced neck pain and shoulder pain. At the time of reporting, the evens were unresolved. The consumer reported that she had consulted a healthcare professional regarding these events. The consumer noted that she had experienced neck and shoulder pain prior to vaccination with FLULAVAL, and that it might be flaring up because she was anxious about developing Guillain Barre Syndrome since she has a history of sensitivity to so many other things.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of raised red bump at injection site in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included allergy to antibiotic and cellulitis leg. On 7 September 2010 at 14:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown route, right arm). On 7 September 2010, 1 hour after vaccination with FLULAVAL, the subject experienced raised red bump at injection site, injection site blisters, injection site hot to touch and itching near injection site. The subject was treated with warm compress, cool compress and clarithromycin. At the time of reporting the events of raised red bump at injection site and injection site blisters were worse, the itching near injection site was unresolved and the outcome of the injection site blisters was unknown. The subject experienced a raised red area at the injection site that covered an area on her arm approximately 10 inches long by 4 inches wide. It was hot to the touch and blistered and the outer edges were itchy. Her physician recommended alternating lukewarm and cold compresses and pt her on clarithromycin. She had taken 3 doses at the time of the reporting and the redness was getting worse and spreading.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of raised red bump at injection site in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included allergy to antibiotic and cellulitis leg. On 7 September 2010 at 14:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown route, right arm). On 7 September 2010, 1 hour after vaccination with FLULAVAL, the subject experienced raised red bump at injection site, injection site blisters, injection site hot to touch and itching near injection site. The subject was treated with warm compress, cool compress and clarithromycin. At the time of reporting the events of raised red bump at injection site and injection site blisters were worse, the itching near injection site was unresolved and the outcome of the injection site blisters was unknown. The subject experienced a raised red area at the injection site that covered an area on her arm approximately 10 inches long by 4 inches wide. It was hot to the touch and blistered and the outer edges were itchy. Her physician recommended alternating lukewarm and cold compresses and pt her on clarithromycin. She had taken 3 doses at the time of the reporting and the redness was getting worse and spreading.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Grand mal convulsion, Inappropriate schedule of drug administration, Lumbar puncture, Pyrexia, Stomatitis
Clinical narrative: Grand mal seizures, Sores in mouth and fever. Required over 6 weeks of hospitalization.
Age: 28.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: L DELTOID SWELLING/ REDNESS/ ON SMALL0POX SITE, CELLULITIES DIAGNOSIS, PATIENT RECIEVED BACTRIM DS #14 T1 PO BID,F/U PRN.
Age: 28.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Laboratory test abnormal
Clinical narrative: L DELTOID SWELLING/ REDNESS/ ON SMALL0POX SITE, CELLULITIES DIAGNOSIS, PATIENT RECIEVED BACTRIM DS #14 T1 PO BID,F/U PRN.