chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Needle issue, Underdose
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site hemorrhage in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in October 2010, the subject received unspecified dose of FLULAVAL (details unknown) and experienced injection site bleeding and vaccine underdose. The healthcare professional reported that the subject bled from the injection site due to defective needle and subject being on blood thinner, COUMADIN and aspirin. She believed that a portion or most of the dose came out. She refused to provide any further information. At the time of reporting the outcome of the injection site bleeding was unspecified.
Age: 5.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional who was informed by a physician's office concerning a 5 year old patient who on an unknown date was vaccinated with a dose of PEDVAXHIB (OMPC) instead of a dose of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. No further information is available.
Age: 14.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional who was informed by a physician's office concerning a 14 year old patient who on unknown dates was vaccinated with a dose of PEDVAXHIB (OMPC) instead of a dose of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. No further information is available.
Age: 11.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse concerning an 11 year old patient who on 10-NOV-2010 was vaccinated IM with 0.5 ml of a dose of possibly PEDVAXHIB (OMPC) (Lot # not reported) in error instead of MENACTRA. The nurse mentioned a staff member drew up PEDVAXHIB (OMPC) into a syringe because the staff member thought it was MENACTRA because the staff member thought the label said meningococcal derivative. The staff member then drew up TDAP in another syringe. The staff member gave one of the syringes to a patient and then realized PEDVAXHIB (OMPC) was drawn up instead of MENACTRA and did not give the other vaccine in the syringe. Both of the syringes looked the same and it was unknown which vaccine the patient received. Patient was not experiencing any known symptoms. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administration error, Inappropriate schedule of drug administration, Tenderness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of tenderness of arm in a 10-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 14 October 2010 at 13:00 the subject inadvertently received a dose of FLULAVAL 0.5 ml left arm. On 14 October 2010, at an unspecified time after vaccination with FLULAVAL, the subject experienced tenderness of arm. This was also a maladministration (asymptomatic/child too young). FLULAVAL is not indicated for use in pediatric subjects. At the time of reporting arm tenderness was resolved. It was reported that this maladministration occurred in three brothers under the age of 18. Arm tenderness only occurred in this subject. Linked cases include A0888123A and A0888124A.
Age: 0.22
Sex: M
Vaccine: DTP, DTPPHIB, HIBV, PNC
Symptoms: Eczema, Screaming
Clinical narrative: Information has been received from a consumer concerning his 12 week old male son with food allergy and prophylaxis who in approximately June 2008, was vaccinated with a dose of PEDVAXHIB (OMPC) (dose, route and Lot# not reported). Suspect vaccine included a dose of DTP (manufacturer unknown) (dose, route and Lot# not reported) on the same date. Concomitant therapy included, vitamins (unspecified), DTAP + HIB+ IPV and PREVNAR. The consumer stated that in approximately June 2008, the patient screamed for 7 hours after receiving PEDVAXHIB (OMPC) (manufacturer unknown) and DTP (manufacturer unknown). It was also reported that his doctor felt that it was from the pertussis component. In approximately June 2008 the patient recovered from this symptom. The patient sought unspecified medical attention. The patient subsequently experienced worsening of eczema while on therapy with hepatitis B virus vaccine (Lot# not reported) (MSD, WAES 1012USA02826). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of runny nose 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. On 13 October 2010 the subject received 1st dose of FLULAVAL (.5 ml, unknown route, right arm). On 15 October 2010, 2 days after vaccination with FLULAVAL, the subject experienced runny nose, "congested" (unknown congestion) and body pain. At the time of reporting the events were improved. The subject had felt better since 18 October 2010, but continued to be somewhat congested and had a runny nose. The subject reported that her husband had caught the symptoms from her. She believed that "the vaccine became activated once injected into her system".
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort
Clinical narrative: This case was reported by a pharmacist (also the subject) and described the occurrence of chest tightness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced chest tightness. At the time of reporting the outcome of the event was unspecified.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of muscle pain in a 63-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2009 the subject received 1st dose of FLULAVAL (.5 ml, left arm). In 2009, less than one day after vaccination with FLULAVAL, the subject experienced muscle pain and feeling terrible. The nurse reported that she had received FLULAVAL during the day three weeks prior to reporting of this event. The nurse began to feel horrible and experienced muscle pain on the same day. The nurse reported that these symptoms have continued ever since. At the time of this reporting, the nurse has scheduled a doctor's appointment for later in the week. At the time of reporting muscle pain and feeling terrible were unresolved. The healthcare professional considered muscle pain and feeling terrible were probably related to vaccination with FLULAVAL. This was one of two cases reported by this nurse; see case A0810811A for at least three subjects with unspecified adverse events. Follow up was received on 23 October 2009 via the subject. Onset date of muscle pain and feeling terrible was reported as approximately 01 September 2009. The subject also reported muscle soreness which began on 01 September 2009. The outcome was "the same". At the time of this reporting, muscle pain and feeling terrible were still unresolved. The subject was treated with ADVIL and ALEVE. The subject considered muscle pain and feeling terrible were not associated with medical history/concurrent illness, lack of efficacy, erroneous administration, or suspected transmission of an infectious agent via a medicinal product. This was one of two cases reported by this nurse; see case A0810811A for at least three subjects with unspecified adverse events.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of arm pain at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject had previously received the flu shot(s). On an unspecified date in September to October 2010, the subject received unspecified dose of FLULAVAL (unknown, left arm). On an unspecified date in September to October 2010, at an unspecified time after vaccination with FLULAVAL, the subject experienced prolonged arm pain at injection site (compared to previous years the vaccine has been available). Medical attention was required at a doctor's office. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with FLULAVAL. The physician wanted to obtain information on "other's experiences". She is seeing a greater number of site reaction arm pain from this year's FLULAVAL vaccine (2010). She is seeing the event greater in women than men. The arm pain is lasting as long as one month. This group of patients (unspecified number) has received Flu vaccine in the past. No other similar characteristics were noted; no medical history or concomitant medication similarities. The injections were administered by two physicians in her office and usually in the left arm. No further information was reported.
Sex: U
Vaccine: FLU3
Symptoms: Feeling abnormal, Malaise, Myalgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unspecified adverse experiences in at least three other subjects of unspecified ages and genders who were vaccinated with FLULAVAL (GlaxoSmithKline). On an unknown date, the subjects received 1st dose of FLULAVAL (unknown), and experienced unspecified adverse experiences. The nurse reported that at least three other subjects who were vaccinated at the same clinic reported having "similar problems", events were not specified. At the time of reporting the outcome of the occurrence of unspecified adverse experiences were unknown. This was one of two cases reported by this nurse; see case A0810774A for muscle pain and feeling terrible in a 63 year old female subject after FLULAVAL vaccination.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm pain in a 73-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included LORTAB, Ferrous sulfate, Nadolol and Omeprazole. On 2 October 2009 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain. At the time of reporting the event was unresolved. The pharmacist considered the event was possibly related to vaccination with FLULAVAL. On 15 October 2009, the pharmacist reported that the subject received the FLULAVAL injection on Friday, 02 October 2009. The following Monday, 05 October, the pharmacy received a call from the subject complaining of pain down his arm, the same arm in which he received the injection. However, he does not know when the pain actually started. The pain in the muscle and radiates all the way down from his bicep to his elbow. The reporter recommended an over the counter pain reliever but he does not believe the subject took anything. He said that the subject is still complaining about the pain.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Gait disturbance, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of unsteady gait in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject reported that in the early 1990's, she developed a wheal after one flu shot. Ever since then, she stopped taking the flu shot until this year (2010). On an unspecified date in 2010, the subject received unspecified dose of FLULAVAL (unknown, unknown arm). On an unspecified date in 2010, less than one day after vaccination with FLULAVAL, the subject experienced unsteady gait. At an unspecified time after the vaccination, she experienced erythema of arm at injection site and arm swelling (injection site). The subject was treated with BENADRYL. At the time of reporting, the unsteady gait was resolved and the outcome of the erythema of arm at injection site and arm swelling (injection site) was unspecified. The reporter indicated after the vaccination with FLULAVAL, she developed a localized reaction of redness and swelling on her arm. The night of the vaccine administration, she got up in the middle of the night and her gait was off to the left. This gait problem resolved by the next morning after taking BENADRYL. There was no further information provided due to the reporter's time constraints.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 16 October 2009 at 10:00 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, unknown deltoid). No other vaccines were given on 16 October 2009. On 16 October 2009, less than one day after vaccination with FLULAVAL, the subject experienced injection site pain and pain radiating down her arm to her fingertips. At the time of reporting the injection site pain was unresolved and the outcome of the pain radiating down her arm to her fingertips was unspecified. On 16 October 2009, the pharmacist reported that one of her pharmacists administered FLULAVAL today at a clinic they were conducting at a school. The subject called to ask about the pain at her injection site which was radiating down her arm to her fingertips. The subject hung up before the pharmacist could even gather her name so not many details are known.
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 3 of 5 (see case IDs A0885547A, A0885964A, A0885966A, A0885967A for the other reports).
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 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 4 of 5 (see case IDs A0885547A, A0885964A, A0885965A, A0885957A for the other reports).
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 5 of 5 (see case IDs A0885547A, A0885964A - A0885966A for the other reports).
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema in an unspecified number of subjects of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subjects received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subjects experienced erythema and swelling. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported that FLULAVAL was administered to 70 subjects, and "some" subjects experienced redness and swelling. No further information was provided.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Influenza like illness, Injection site erythema, Rash generalised
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of flu like symptoms in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to antibiotic, allergy to ciprofloxacin, allergy to clindamycin, allergy to erythromycin, allergy to PERCOCET, allergy to SUDAFED, breast cancer, codeine allergy and penicillin allergy. Concurrent medications included Tamoxifen,  OSCAL, CENTRUM mvi, Vitamin E, Vitamin C, Vitamin B12 and Fish oil. On 7 October 2010 the subject received a dose of FLULAVAL (.5 ml, unknown route and site). In October 2010, less than one month after vaccination with FLULAVAL, the subject experienced flu like symptoms, palms of hands were red, injection site redness and body rash. The subject was treated with BENADRYL. At the time of reporting the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Injection site erythema, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unintentional overdose in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 October 2010 the subject received 1st dose of FLULAVAL (1 ml, unknown) and experienced unintentional overdose. The reporter stated six subjects, including the reporter, received 1 ml of FLULAVAL. At the time of the report no other information was provided. Follow-up information was received on 25 October 2010 from another healthcare professional. The subject was a 46-year-old female. On 12 October 2010, the same day after vaccination with 1ml of FLULAVAL, the subject experienced injection site lump, red hot to touch through 18 October 2010 and low grade fever for 2 days. The subject was treated with TYLENOL. The events resolved on 18 October 2010. The events were not considered serious. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection arm reddened in a 83-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Vit B12 shot given in the right arm at the same time as vaccination. On 18 October 2010 at 15:00 the subject received a dose of FLULAVAL (.5 cc, unknown route, left arm). On 19 October 2010, 1 day after vaccination with FLULAVAL, the subject experienced injection arm reddened to her elbow and warmness to touch at injection site. At the time of reporting the event of injection arm reddened was resolved and the outcome of the warmness to touch at injection site was unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up information was received on 23 November 2010. It was reported that the events began one day following administration of FLULAVAL on 19 October 2010. The events resolved by 26 October 2010. In the reporter's opinion, the events were probably related to treatment with FLULAVAL.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm soreness at injection site in a 75-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 23 October 2010 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, left arm). On 24 October 2010, 1 day after vaccination with FLULAVAL, the subject experienced arm soreness and stiffness at injection site. On 26 October 2010, 3 days after vaccination with FLULAVAL, the subject experienced injection site pain radiating down to hand. The subject required medical attention at an unspecified location. At the time of reporting, the outcome of the arm soreness and stiffness at injection site were unresolved. The outcome of the injection site pain radiating down to hand was unspecified. The pharmacist considered the arm soreness and stiffness at injection site were probably related to vaccination with FLULAVAL. Follow-up information was received on 22 November 2010 via healthcare professional who reported subject has a history of arthritis. On 28 October 2010 the events resolved. At the time of the report, no other information was provided.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Grip strength decreased, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of arm pain in a 49-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in the past the subject had received Influenza vaccine (Unknown manufacturer) and had experienced "some local area discomfort". Concurrent medical conditions included underactive thyroid. Concurrent medications included Tuberculin, SYNTHROID and Unknown (Unspecified medication). On 25 October 2010 at 17:00 the subject received a dose of FLULAVAL (unknown route right arm). On 25 October 2010, 1 hour after vaccination with FLULAVAL, the subject experienced arm pain, wrist pain, jaw pain, neck pain and "difficult to grip". The subject did not experience chest pain and had no difficulty breathing. The subject was treated with ibuprofen and heating pad. On 26 October 2010 at 03:00, the events were resolved.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia facial, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of jaw numbness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 27 October 2010 at 10:30 the subject received unspecified dose of FLULAVAL (unknown, left arm); lot number reported as" ASLLA602AB". At an unspecified time after vaccination with FLULAVAL, the subject experienced jaw numbness, arm pain and arm tingling. The healthcare professional reported that the subject was administered FLULAVAL vaccine and experienced left jaw numbness and pain and tingling in the left arm. No additional details were provided because the vaccine was administered at a separate location. At the time of reporting the jaw numbness, arm pain and arm tingling were improved. The healthcare professional reported another case regarding FLULAVAL, see case A0890086A.
Sex: M
Vaccine: FLU3
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 27 October 2010 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced nonspecific reaction. The healthcare professional reported that the subject was administered FLULAVAL vaccine and experienced a reaction, however the reporter refuse to provide any details regarding the event. At the time of reporting the nonspecific reaction was resolved. The healthcare professional reported another case regarding FLULAVAL, see case A0890085A.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Asthenia, Hot flush
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of weakness in a 93-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included chronic obstructive pulmonary disease, elevated cholesterol, hypothyroidism, osteoporosis, pernicious anemia and restless legs syndrome. Concurrent medications included PREMARIN, SPIRIVA, SYNTHROID, Non-GSK Propanolol, Aspirin, XANAX, TANDEM Plus, PROTONIX, QUESTRAN, Vitamin D and B vitamins. On 21 September 2010 at 08:45 the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On an unspecified date, approximately 2 weeks after vaccination with FLULAVAL, the subject experienced episodic symptoms of weakness, hot flash and cardiac arrhythmia. The subject received unspecified treatment. At the time of reporting the events were unresolved. Follow-up information was received via the reporter on 08 December 2010. It was reported that the events began on 11 October 2010, 20 days following administration of FLULAVAL. The events were unresolved and reported to be unrelated to treatment with FLULAVAL.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Incorrect route of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema in an 18-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 October 2010 the subject received 1st dose of FLULAVAL (.1 ml, intradermally, left arm). On 11 October 2010, immediately after vaccination with FLULAVAL, the subject experienced "a little red, nothing else" and wrong vaccine administered. The healthcare professional reported that FLULAVAL 0.1ml was administered intradermally by mistake, she had intended to give the subject a TB test. At the time of reporting the outcome of the erythema was unspecified. Follow-up information was received via the reporter on 09 December 2010. It was reported that FLULAVAL had been administered inadvertently and via the incorrect route (intradermally). The wrong vaccine was grabbed from the refrigerator by accident. The subject experienced erythema which began on 12 October 2010 and ended on 15 October 2010. The event was not considered to be serious.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site induration, Malaise
Clinical narrative: This case was reported by a pharmacist and described the occurrence of deep chills in a 62-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Estrogen therapy. The subject had no relevant medical history. She had previously received a flu shot and had not experienced any reactions. On 12 October 2010 at 19:00 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). On 12 October 2010, less than one day after vaccination with FLULAVAL, the subject experienced deep chills, not feeling good and quarter-size hardness at injection site. At the time of the report, the pharmacist was not sure how to classify the subject's reaction. At the time of reporting the events were unresolved.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of severe swelling at injection site in a 39-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Previous and/or concurrent vaccination included pneumonia vaccine (non-gsk); Merck; unknown given on 12 October 2010. Concurrent medications included COREG, Lisinopril, NIASPAN, PLAVIX and Metoprolol. On 12 October 2010 at 15:00 the subject received 1st dose of FLULAVAL (0.5 ml, unknown, right arm). On 12 October 2010, immediately after vaccination with FLULAVAL, the subject experienced severe swelling injection site, redness and injection site hot to touch. Three to four hours after receiving FLULAVAL, the subject developed a high fever that ranged from 101 to 104 degrees Fahrenheit and right sided lymph node swelling. The subject required medical attention at the doctor's office. There was follow-up with the subject on 13 October 2010 and he was prescribed AUGMENTIN and told to take TYLENOL every four hours with fluids and rest. It was reported that the adverse events were local and systemic. At the time of reporting the severe swelling swelling at injection site, hot to touch at injection site, fever, and right sided lymph node swelling were unresolved. The outcome of the injection site redness was unspecified. The healthcare professional considered the severe swelling at injection site, hot to touch at injection site, fever of 101-103, and right sided lymph node swelling were probably related to vaccination with FLULAVAL.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of severe swelling at injection site in a 39-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Previous and/or concurrent vaccination included pneumonia vaccine (non-gsk); Merck; unknown given on 12 October 2010. Concurrent medications included COREG, Lisinopril, NIASPAN, PLAVIX and Metoprolol. On 12 October 2010 at 15:00 the subject received 1st dose of FLULAVAL (0.5 ml, unknown, right arm). On 12 October 2010, immediately after vaccination with FLULAVAL, the subject experienced severe swelling injection site, redness and injection site hot to touch. Three to four hours after receiving FLULAVAL, the subject developed a high fever that ranged from 101 to 104 degrees Fahrenheit and right sided lymph node swelling. The subject required medical attention at the doctor's office. There was follow-up with the subject on 13 October 2010 and he was prescribed AUGMENTIN and told to take TYLENOL every four hours with fluids and rest. It was reported that the adverse events were local and systemic. At the time of reporting the severe swelling swelling at injection site, hot to touch at injection site, fever, and right sided lymph node swelling were unresolved. The outcome of the injection site redness was unspecified. The healthcare professional considered the severe swelling at injection site, hot to touch at injection site, fever of 101-103, and right sided lymph node swelling were probably related to vaccination with FLULAVAL.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 64-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included arm pain. On 3 October 2010 the subject received dose of FLULAVAL (subcutaneous, left arm) and experienced inappropriate route of vaccination. FLULAVAL should be administered by the intramuscular route. The lot number was reported as AFFL59BA. On 3 October 2010, 8 days after vaccination with FLULAVAL, the subject experienced swelling injection site and injection site tenderness. At the time of reporting the swelling injection site and injection site tenderness were resolved. The healthcare professional considered the swelling injection site and injection site tenderness were probably related to vaccination with FLULAVAL.
Age: 30.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nodule on extremity, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm knots in a 30-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 October 2010 at 08:45 the subject received unspecified dose of FLULAVAL (0.5 ml, unknown, left arm) and unspecified dose of Pneumonia vaccine (details unknown). On 12 October 2010, approximately 9 hours after vaccination with FLULAVAL and Pneumonia vaccine, the subject experienced 2-3 knots formed on the arm next to the injection site and pain in arm. Approximately 10 hours after the vaccinations, he spiked a fever of 104 degrees Fahrenheit. A healthcare provider was consulted regarding the events. The subject required medical attention at the doctor's office. The reporter stated she was aware of another patient who had a similar adverse event after getting the FLULAVAL (see case id A0887476A for details on other patient). At the time of reporting the events were unresolved.
Sex: U
Vaccine: FLU3
Symptoms: Nodule on extremity, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm knots 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). After an unspecified time after receiving FLULAVAL, the subject experienced arm knots, arm pain and fever. The healthcare professional first reported on a 30-year-old male subject who experienced arm pain, 2-3 knots formed on the arm next to injection site, and a fever of 104 degrees Fahrenheit on the night of the day he received FLULAVAL and pneumonia vaccine (see case id  A0887470A for more details on this subject). At that time, the reporter also stated she is aware of another patient who had similar adverse event after getting the FLULAVAL. For this reason, this case (A0887476A) was created for the other subject. At the time of reporting the outcome of the events was unspecified.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Influenza like illness, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional via a distributor and described the occurrence of flu-like symptoms in a female subject aged between 30 and 39 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (0.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced flu-like symptoms, red and swollen arm. Medical attention was not required. At the time of reporting the outcome of the events was unspecified. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887614A, A0887616A, A0887618A, A0887619A, and A0887620A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial. Follow-up information was received on 29 October 2010. It was reported that the subject was 76 years old and that the subject received FLULAVAL on 01 October 2010. She reported flu-like symptoms on 06 October 2010. The event resolved.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional via a distributor and described the occurrence of red, swollen arm in a female subject aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (0.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced red and swollen arm. There were no other side effects. Medical attention was not required. At the time of reporting the outcome of the event was unspecified. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887614A, A0887617A, A0887618A, A0887619A, and A0887620A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial. Follow-up information was received on 29 October 2010. It was reported that the subject was 41 years old and received a flu shot, FLULAVAL, on 05 October 2010. One day later, on 06 October 2010, the subject developed a red, swollen arm. The event resolved.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Influenza like illness, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional via a distributor and described the occurrence of flu-like symptoms 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 (0.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced flu-like symptoms, red and swollen arm. Medical attention was not required. At the time of reporting the outcome of the events was unspecified. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887614A, A0887616A, A0887617A, A0887619A, and A0887620A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial. Follow-up information was received on 29 October 2010. It was reported that the subject was 37 years old and that FLULAVAL was administered on 01 October 2010. On 02 October 2010, the subject developed flu like symptoms and red, swollen arm. The symptoms resolved.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Erythema, Influenza like illness, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional via a distributor and described the occurrence of flu-like symptoms in a female subject aged between 60 and 69 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (0.5 ml, unknown). The expiration and lot number were unknown. At an unspecified time after vaccination with FLULAVAL, the subject experienced flu-like symptoms. Medical attention was not required. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887614A, A0887616A, A0887617A, A0887618A, and A0887620A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial. Follow-up information was received on 29 October 2010. It was reported that the subject was 56 years old. She received FLULAVAL on an unknown date and on 01 October 2010 developed flu like symptoms and red, swollen arm. On 07 October 2010, the subject developed bronchitis and was treated with doxycycline. In the reporter's opinion, flu like symptoms and red, swollen arm were probably related to treatment with FLULAVAL. Outcome of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a healthcare professional via a distributor and described the occurrence of flu-like symptoms in a female subject aged between 60 and 69 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (0.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced flu-like symptoms. Medical attention was not required. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887614A, A0887616A, A0887617A, A0887618A, and A0887619A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial. Follow-up information was received on 29 October 2010. It was reported that the subject was 65 years old and that she received FLULAVAL on 01 October 2010. She developed flu like symptoms on 06 October 2010. The event resolved.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Feeling cold, Feeling hot, Nausea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 23-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included migraine headache. Concurrent medications included Non-GSK INDERAL. On 9 September 2010 at 12:45 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 9 September 2010, approximately 90 minutes after vaccination with FLULAVAL, the subject experienced nausea, cold feeling, stomach cramps and tremor. The subject also experienced diarrhea and feeling hot. The subject developed nausea, shaking, stomach cramps and felt freezing cold approximately an hour and a half after receiving FLULAVAL vaccination. The nurse spoke with her on the morning of 10 September 2010 and the subject stated that she had been up all night with diarrhea and nausea. She also felt freezing cold and then really hot. The subject did not have a fever on 09 September 2010 when she was evaluated a the doctors office. At the time of reporting the events of nausea and feeling cold were unresolved. The event of shaking was improved, and the outcome of the stomach cramps and diarrhea was unknown. The healthcare professional considered the events of nausea, feeling cold, stomach cramps and shaking were not related to vaccination with FLULAVAL; a relationship was not specified for the other events. Follow-up information was received on 23 September 2010 via healthcare provider, who reported the acute onset of symptom was one to two hours after vaccination with FLULAVAL and one hour after a meal. The healthcare professional stated the events were "likely unrelated but temporal association" to vaccination with FLULAVAL. The healthcare professional also reported the events were "most likely due to Food borne illness". At the time of the report the outcome of the events was unknown.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 23-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included migraine headache. Concurrent medications included Non-GSK INDERAL. On 9 September 2010 at 12:45 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 9 September 2010, approximately 90 minutes after vaccination with FLULAVAL, the subject experienced nausea, cold feeling, stomach cramps and tremor. The subject also experienced diarrhea and feeling hot. The subject developed nausea, shaking, stomach cramps and felt freezing cold approximately an hour and a half after receiving FLULAVAL vaccination. The nurse spoke with her on the morning of 10 September 2010 and the subject stated that she had been up all night with diarrhea and nausea. She also felt freezing cold and then really hot. The subject did not have a fever on 09 September 2010 when she was evaluated a the doctors office. At the time of reporting the events of nausea and feeling cold were unresolved. The event of shaking was improved, and the outcome of the stomach cramps and diarrhea was unknown. The healthcare professional considered the events of nausea, feeling cold, stomach cramps and shaking were not related to vaccination with FLULAVAL; a relationship was not specified for the other events. Follow-up information was received on 23 September 2010 via healthcare provider, who reported the acute onset of symptom was one to two hours after vaccination with FLULAVAL and one hour after a meal. The healthcare professional stated the events were "likely unrelated but temporal association" to vaccination with FLULAVAL. The healthcare professional also reported the events were "most likely due to Food borne illness". At the time of the report the outcome of the events was unknown.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported  by a healthcare professional and described the occurrence of erythema in a 56-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included ACTONEL, Baby aspirin, Omega 3, Prednisone, Vitamin D, Glucosamine and Multivitamins. It was reported that  the patient has a history of cystolic heart failure and giant cell arthritis. There was no history of reactions following previous flu shots. On 14 September 2010 at 09:33 the subject received 1st dose of FLULAVAL at 0.5 ml in the left arm. On 15 September 2010, 1 day after vaccination with FLULAVAL, the subject experienced erythema and swelling. At the time of reporting redness was improved and the outcome of swelling was unspecified. Redness was reported to be unrelated to treatment with FLULAVAL. Swelling attribution was not known.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of malaise in a 78-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Lorazepam, Baby aspirin, CIPRO, Atenolol, Vitamin D, COUMADIN, COZAAR and CRESTOR. It was reported that the patient has a history of atrial fibrillation, osteoporosis and hyperkalemia. On 15 September 2010 at 16:30 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. An unspecified amount of time after vaccination with FLULAVAL, the subject experienced malaise, fatigue and sore throat. The events were resolved at the time of reporting. Malaise was reported to be unrelated to treatment with FLULAVAL. Attribution for fatigue and sore throat was not known.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of malaise in a 52-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included CLEOCIN, DIFFERIN, DIFLUCAN, Multivitamins and LUMIGAN. On an unspecified date, the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 06 September 2010, the subject experienced malaise, fatigue and sore throat. The events were reported to be improved by 20 September 2010. The events were reported to be unrelated to treatment with FLULAVAL.