chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 7 October 2011 at 15:00 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination with FLULAVAL, the subject experienced injection site pain. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported that 5 subjects had received FLULAVAL and had experienced injection site pain. This is case 4 of 5 (see case IDs A0949586A, A0949593A, A0949594A, A0949596A for details of the other reports).
Sex: U
Vaccine: FLU3
Symptoms: Injection site haematoma, 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 7 October 2011 at 15:00 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination with FLULAVAL, the subject experienced injection site pain and bruise injection site. The healthcare professional attributed the bruise to how the vaccine may have been administered. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 5 subjects had received FLULAVAL and had experienced injection site pain. This is case 5 of 5 (see case IDs A0949586A, A0949593A-A0949595A for details of the other reports).
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Cellulitis, Extensive swelling of vaccinated limb, Injection site erythema, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 53-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 October 2011 at approximately 14:00 the subject received unspecified dose of FLULAVAL at 0.5 ml in the left arm. The subject went to the emergency room on 31 October 2011 and was administered antibiotics and pain killers. it was reported that the subjects first day back to work was 03 November 2011 and she was still wearing an immobilizer on her hand. She was schedule for follow-up the week of reporting including an x-ray on her arm since swelling was so severe during the emergency room visit that an x-ray could not be taken. Events reported for this subject with no specific onset dates (2011) included severe swelling, injection site redness, tingling in the left hand, cellulitis in left arm and activities of daily living impaired. All of these events were reported to have been improved as of the day of reporting, 03 November 2011, less than one week following vaccination with FLULAVAL. All events occurred within one week of FLULAVAL administration and onset of extensive swelling of vaccinated limb began sometime between 28 October 2011 and 31 October 2011. It was also noted that the subject "bled a little" with previous flu vaccinations. No specifics were provided.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 53-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 October 2011 at approximately 14:00 the subject received unspecified dose of FLULAVAL at 0.5 ml in the left arm. The subject went to the emergency room on 31 October 2011 and was administered antibiotics and pain killers. it was reported that the subjects first day back to work was 03 November 2011 and she was still wearing an immobilizer on her hand. She was schedule for follow-up the week of reporting including an x-ray on her arm since swelling was so severe during the emergency room visit that an x-ray could not be taken. Events reported for this subject with no specific onset dates (2011) included severe swelling, injection site redness, tingling in the left hand, cellulitis in left arm and activities of daily living impaired. All of these events were reported to have been improved as of the day of reporting, 03 November 2011, less than one week following vaccination with FLULAVAL. All events occurred within one week of FLULAVAL administration and onset of extensive swelling of vaccinated limb began sometime between 28 October 2011 and 31 October 2011. It was also noted that the subject "bled a little" with previous flu vaccinations. No specifics were provided.
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Pharyngeal oedema, Pruritus, Sneezing
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of sneezing 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. Concurrent medical conditions included cat allergy. On either 12 or 13 October 2011 the subject received a dose of FLULAVAL (unknown route, left arm). One hour after vaccination with FLULAVAL, the subject experienced sneezing, itching, throat closing and swelling of eyes. It was noted that the subject had not eaten prior to the vaccination. The subject reported that co-workers had received the vaccine at the same time and no-one else experienced any adverse reactions. The subject was treated with prednisone and ZYRTEC. At the time of reporting the events were improved. The consumer refused to provide contact information for follow-up. No information is available.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site vesicles
Clinical narrative: This case was reported by a physician and described the occurrence of headache in a female subject aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 October 2011 the subject received a dose of FLULAVAL (details unknown). On 13 October 2011, 2 days after vaccination with FLULAVAL, the subject experienced headache and injection site blisters. At the time of reporting the outcome of the events was unspecified. An outcome date of 13 October 2011 was reported. The physician reported 3 subjects who had experienced adverse events following vaccination with FLULAVAL. This is case 1 of 3 (see case IDs A0949933A and A0949934A for details of the other reports).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: Swelling and whelp on left thigh. 20.5/40 mm mild itching at injection site.
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (unknown arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling injection site (arm). At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with FLULAVAL. The physician reported 3 subjects who had experienced adverse events following vaccination with FLULAVAL. This is case 2 of 3 (see case IDs A0949929A and A0949934A for details of the other reports).
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4, 7 or 8 November 2011 the subject received a dose of FLULAVAL (.5 unknown, unknown route). On an unknown date in November 2011, several hours after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. According to the pharmacist, the hospital had a flu clinic between 04 November through 08 November 2011. Approximately 40 subjects were administered FLULAVAL from the same lot. Of the 40 subjects, five subjects experienced injection site redness, swelling and pruritus. This case was associated with a pharmaceutical product complaint. The pharmacist was suspected a questionable batch of vaccine. She noted that a sister site had administered FLULAVAL with a different lot number and had no adverse events reported. At the time of reporting the outcome of the events was unspecified. This is five of five cases. See cases A0952517A, A0952520A, A0952521A and A0952522A for information regarding the other cases.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a physician and described the occurrence of side effects in a female subject of unspecified age who was vaccinated with FLULAVAL. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced unspecified side effects. The symptoms were not known. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with FLULAVAL. The physician reported 3 subjects who had experienced adverse events following vaccination with FLULAVAL. This is case 3 of 3 (see case IDs A0949929A and A0949933A for details of the other reports).
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 61-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 LAMICTAL, WELLBUTRIN and ACTONEL. On 28 October 2010 the subject received 1st dose of FLULAVAL (unknown, left arm). On 28 October 2010, immediately after vaccination with FLULAVAL, the subject experienced pain, redness, swelling and hotness at the injection site. She also noticed that she developed difficulty raising and moving her left arm and loss of mobility. The subject stated that she was concerned about the injection site because the nurse vaccinated her below the deltoid where the biceps and triceps meet in front of her arm. She believed that was about four inches lower than it was supposed to be located. These symptoms continued for several months and gradually began to improve around February 2011 and completely resolved July 2011. On an unspecified date in July 2011, the pain, redness, swelling and hotness at the injection site, difficulty raising and moving her left arm and loss of mobility resolved. The subject refused to be contacted for follow-up.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 61-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 LAMICTAL, WELLBUTRIN and ACTONEL. On 28 October 2010 the subject received 1st dose of FLULAVAL (unknown, left arm). On 28 October 2010, immediately after vaccination with FLULAVAL, the subject experienced pain, redness, swelling and hotness at the injection site. She also noticed that she developed difficulty raising and moving her left arm and loss of mobility. The subject stated that she was concerned about the injection site because the nurse vaccinated her below the deltoid where the biceps and triceps meet in front of her arm. She believed that was about four inches lower than it was supposed to be located. These symptoms continued for several months and gradually began to improve around February 2011 and completely resolved July 2011. On an unspecified date in July 2011, the pain, redness, swelling and hotness at the injection site, difficulty raising and moving her left arm and loss of mobility resolved. The subject refused to be contacted for follow-up.
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: This case was reported by a physician and described the occurrence of unable to get up in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unknown date in September 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route and site). On an unspecified date in September 2011, within 2 weeks of vaccination with FLULAVAL, the subject experienced unable to get up. The subject laid on the floor all night and her husband could not get her up off the floor until the next day. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with FLULAVAL. The physician reported administering over 100 flu vaccinations and had 8 subjects report very unusual adverse events. This case 3 of 8 (see case IDs A0946057A, A0946060A, A0946073-A0946077A for details of the other reports).
Sex: U
Vaccine: FLU3
Symptoms: Hyperhidrosis
Clinical narrative: This case was reported by a physician and described the occurrence of sweating in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in September 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route and site). On 21 September 2011, within 2 weeks of vaccination with FLULAVAL, the subject experienced "profuse" sweating. At the time of reporting the event was unresolved. The physician considered the event was probably related to vaccination with FLULAVAL. The physician reported administering over 100 flu vaccinations and had 8 subjects report very unusual adverse events. This is case 2 of 8 (see case IDs A0946057A, A0946062A, A0946073A-A0946077A) for details of the other reports).
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4,7 or 8 November 2011 the subject received a dose of FLULAVAL (.5 unknown route, unknown). On an unknown date in November 2011, several hours after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. According to the pharmacist, the hospital had a flu clinic between 04 November through 08 November 2011. Approximately 40 subjects were administered FLULAVAL from the same lot. Of the 40 subjects, five subjects experienced injection site redness, swelling and pruritus. This case was associated with a pharmaceutical product complaint. The pharmacist was suspecting a questionable batch of vaccine. She noted that a sister site had administered FLULAVAL with a different lot number and had no adverse events reported. At the time of reporting the outcome of the events was unspecified. This is four of five cases. See cases A0952517A, A0952520A, A0952521A and A0952523A for information regarding the other cases.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site reaction, Myalgia, Underdose
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site muscle soreness in a 64-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included high blood pressure. On 26 September 2011 at 15:30 the subject received a dose of FLULAVAL in the left arm. On 26 September 2011, immediately following vaccination with FLULAVAL, the subject experienced injection site muscle soreness (general soreness, muscle soreness reported as same event). The outcome of the event was unknown. In the reporter's opinion, injection site muscle soreness was probably related to vaccination with FLULAVAL. It was reported that the subject did not receive the full dose of FLULAVAL. This was a vaccine underdose.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a consumer and described the occurrence of swollen axillary lymph nodes in a 54-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date in November 2010 the subject received 1st dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced swollen axillary lymph nodes. At the time of reporting the swollen axillary lymph nodes was resolved. The consumer reported another case, see A0948278A.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site reaction, Rash erythematous
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red bump at injection site in a 54-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 22 September 2011 (between 11:30 and 13:30) the subject received a dose of FLULAVAL at 0.5 ml in the left deltoid. On 23 September 2011, 1 day after vaccination with FLULAVAL, the subject experienced hard, red bump at injection site. At the time of reporting the outcome of the event was unspecified. From the reporters discussion with the consumer, she seemed to think the event may have possibly been related to FLULAVAL vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling, Local reaction, Migraine, Nausea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of local reaction 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. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. The subject also experienced systemic reactions including 103 degree fever, nausea, vomiting, migraine headaches and hives. The subject was taken to the emergency room. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects experienced adverse events following administration with FLULAVAL. The vaccines were given from two vials with the same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cased include A0947071A, A0947173A, A0947174A, A0947175A and A0947177A. Follow-up information was received on 19 October 2011. It was reported that 0.5 ml of FLULAVAL was administered to the subject on 23 September 2011. The reported events began on 23 September 2011. The events were not considered to be serious and resolved on an unspecified date. No additional information is available. According to product complaint investigation results reported by GSK quality assurance/Biologicals on 31 October 2011, the product complaint was assessed to be unsubstantiated.
Sex: U
Vaccine: FLU3
Symptoms: Product quality issue, Pyrexia, Urticaria, Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of local reaction 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. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. The subject also experienced systemic reactions including 103 degree fever, nausea, vomiting, migraine headaches and hives. The subject was taken to the emergency room. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects experienced adverse events following administration with FLULAVAL. The vaccines were given from two vials with the same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cased include A0947071A, A0947173A, A0947174A, A0947175A and A0947177A. Follow-up information was received on 19 October 2011. It was reported that 0.5 ml of FLULAVAL was administered to the subject on 23 September 2011. The reported events began on 23 September 2011. The events were not considered to be serious and resolved on an unspecified date. No additional information is available. According to product complaint investigation results reported by GSK quality assurance/Biologicals on 31 October 2011, the product complaint was assessed to be unsubstantiated.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling, Local reaction, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of local reaction 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. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects adverse events following administration with FLULAVAL. The vaccines were given from two vials with same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cases Include A0947071A, A0947174A, A0947175A, A0947176A and A0947177A. Follow-up received from the reporting pharmacist on 18 October 2011: On 23 September 2011 the subject received a dose of FLULAVAL (0.5 ml). Later the same day, the subject experienced injection site induration and swelling at injection site. At the time of reporting, the events were resolved. The pharmacist confirmed that the events were not considered serious. FLULAVAL was identified as the suspect product, but a causality assessment was not provided. The pharmacist reported that the facility that administered the vaccine had reported the event to the CDC and returned any unused vials to pharmacy. According to product complaint investigation results by GSK quality assurance/Biologicals on 31 October 2011, the product complaint was assessed to be unsubstantiated.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of raised red bump at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in September 2011 the subject received a dose of FLULAVAL (unknown route, unknown deltoid). On an unspecified date in September 2011, the same week after vaccination with FLULAVAL, the subject experienced raised red bump at injection site. The bump covered most of the deltoid. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported 3 subjects who experienced raised red bump at injection site after vaccination with FLULAVAL. This is case 3 of 3 (see case IDs A0947999A, A0948000A for details of the other reports). The healthcare professional had reported the case to VAERS.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling, Local reaction, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of local reaction 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. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects experienced adverse events following administration with FLULAVAL. The vaccines were given from two vials with the same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cases include A0947173A, A0947174A, A0947175A, A0947176A and A0974717A. Follow-up information was received on 19 October 2011. It was reported that 0.5 ml of FLULAVAL was administered to the subject on 23 September 2011. The reported events began on 23 September 2011. The events were not considered to be serious and resolved on an unspecified date. In the reporter's opinion, the events were probably related to treatment with FLULAVAL. No additional information is available. An investigational report received via GlaxoSmithKline quality assurance on 31 October 2011 indicated that no sample was available for return. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. The FLULAVAL vaccine lot AFLLA679AA was produced in compliance with Good Manufacturing Practices and met the requirements of their specifications. This lot was checked by GSK Biologicals Quality Assurance and Quality Control accordingly.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of raised red bump at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in September 2011 the subject received a dose of FLULAVAL (unknown route, unknown deltoid). On an unspecified date in September 2011, the same week after vaccination with FLULAVAL, the subject experienced raised red bump at injection site. The bump covered most of the deltoid. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported 3 subjects who experienced raised red bump at injection site after vaccination with FLULAVAL. This is case 1 of 3 (see case IDs A0947997A, A0947999A for details of the other reports). The healthcare professional had reported the cases to VAERS.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of local reaction at injection site (induration) 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. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects experienced adverse events following administration with FLULAVAL. The vaccines were given from two vials with the same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cased include A0947071A, A0947173A, A0947174A, A0947176A and A0947177A. Follow-up information was received on 19 October 2011. It was reported that 0.5 ml of FLULAVAL was administered to the subject on 23 September 2011. The reported events began on 23 September 2011. The events were not considered to be serious and resolved on an unspecified date. No additional information is available. According to product complaint investigation results reported by GSK quality assurance/Biologicals on 31 October 2011, the product complaint was assessed to be unsubstantiated.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of local reaction at injection site (induration) 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. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (induration (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects experienced adverse events following administration with FLULAVAL. The vaccines were given from two vials with the same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cases include A0947071A, A0947173A, A0947175A, A0947176A and A0947177A. Follow-up information was received on 19 October 2011. It was reported that 0.5 ml of FLULAVAL was administered to the subject on 23 September 2011. The reported events began on 23 September 2011. The events were not considered to be serious and resolved on an unspecified date. No additional information is available. According to the product complaint investigation results reported by GSK quality assurance/ Biologicals on 31 October 2011, the product complaint was assessed to be unsubstantiated.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of raised red bump at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in September 2011 the subject received a dose of FLULAVAL (unknown route, unknown deltoid). On an unspecified date in September 2011, the same week after vaccination with FLULAVAL, the subject experienced raise red bump at injection site. The bump covered most of the deltoid. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported 3 subjects who experienced raised red bump at injection site after vaccination with FLULAVAL. This is case 2 of 3 (see case IDs A0947997A, A0948000A for details of the other reports). The healthcare professional had reported the cases to VAERS.
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Dizziness, Hyperhidrosis
Clinical narrative: This case was reported by a pharmacist and described the occurrence of light headedness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included dizziness, which the subject had experienced a few days prior to vaccination. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced light headedness and broke out in sweat. At the time of reporting the outcome of the events was unspecified.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Injection site erythema, Injection site pain, Injection site swelling, Lymph node pain
Clinical narrative: This case was reported by a consumer and described the occurrence of swollen axillary lymph nodes in a 40-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 allergy to sulfa drugs, contrast media anaphylaxis, seasonal allergy and skin ulcer. Concurrent medications included MVI, Antihistamine and Calcium. On an unspecified date in October 2010 the subject received 1st dose of FLULAVAL (unknown, right arm). On an unspecified date in October 2010, less than one day after vaccination with FLULAVAL, the subject experienced localized pain (injection site pain). One day after vaccination with FLULAVAL, the subject experienced facial swelling, axillary left swollen lymph nodes and inguinal right swollen lymph nodes that was tender to touch. At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling injection site, injection site redness, hoarseness, malaise and swelling of face. At the time of reporting the outcome of the swelling of face and swollen axillary lymph nodes resolved within 24 hours; injection site pain injection site redness and injection site swelling resolved within 36 hours. The swollen inguinal lymph node that was tender to touch resolved in March 2011. The events of malaise, hoarseness were unspecified. The subject reported that she receive last year's seasonal FLULAVAL in October 2010 at the health department. She stated that she had a localized pain, swelling and redness at the injection site. She also developed systemic reactions of hoarseness, malaise, facial swelling, swollen left axillary lymph nodes and right inguinal lymph nodes. The inguinal lymph node continued to be tender to the touch until March 2011 when it seemed to completely resolve. The localized reactions seemed to resolve after 36 hours. The subject took BENADRYL and the facial swelling and swollen axillary lymph node resolved. The consumer reported another case, see A0948347A.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Malaise, Pain, Swelling face
Clinical narrative: This case was reported by a consumer and described the occurrence of swollen axillary lymph nodes in a 40-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 allergy to sulfa drugs, contrast media anaphylaxis, seasonal allergy and skin ulcer. Concurrent medications included MVI, Antihistamine and Calcium. On an unspecified date in October 2010 the subject received 1st dose of FLULAVAL (unknown, right arm). On an unspecified date in October 2010, less than one day after vaccination with FLULAVAL, the subject experienced localized pain (injection site pain). One day after vaccination with FLULAVAL, the subject experienced facial swelling, axillary left swollen lymph nodes and inguinal right swollen lymph nodes that was tender to touch. At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling injection site, injection site redness, hoarseness, malaise and swelling of face. At the time of reporting the outcome of the swelling of face and swollen axillary lymph nodes resolved within 24 hours; injection site pain injection site redness and injection site swelling resolved within 36 hours. The swollen inguinal lymph node that was tender to touch resolved in March 2011. The events of malaise, hoarseness were unspecified. The subject reported that she receive last year's seasonal FLULAVAL in October 2010 at the health department. She stated that she had a localized pain, swelling and redness at the injection site. She also developed systemic reactions of hoarseness, malaise, facial swelling, swollen left axillary lymph nodes and right inguinal lymph nodes. The inguinal lymph node continued to be tender to the touch until March 2011 when it seemed to completely resolve. The localized reactions seemed to resolve after 36 hours. The subject took BENADRYL and the facial swelling and swollen axillary lymph node resolved. The consumer reported another case, see A0948347A.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 50-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2011 the subject received a dose of FLULAVAL (unknown route, right arm). On 4 October 2011, less than one day after vaccination with FLULAVAL, the subject experienced allergic reaction, injection site redness, warmness to touch at injection site, swelling injection site ("size of a penny"), injection site irritation and injection site pain. The subject was instructed to use BENADRYL by the physician. At the time of reporting the events were worse.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 50-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2011 the subject received a dose of FLULAVAL (unknown route, right arm). On 4 October 2011, less than one day after vaccination with FLULAVAL, the subject experienced allergic reaction, injection site redness, warmness to touch at injection site, swelling injection site ("size of a penny"), injection site irritation and injection site pain. The subject was instructed to use BENADRYL by the physician. At the time of reporting the events were worse.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Incorrect route of drug administration, Presyncope, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of almost passed out in a 64-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of FLULAVAL (subcutaneous, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced almost passed out, redness, swelling and intramuscular formulation administered by other route. The subject reported that she was administered FLULAVAL and had a reaction because it was administered subcutaneously. The subject declined to provide additional information. At the time of reporting the outcome of the almost passed out, redness, and swelling were was unspecified.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal discomfort, Pain, Tongue disorder
Clinical narrative: This case was reported by a pharmacist and described the occurrence of tongue feels thick in a 63-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 October 2011 at 11:45 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 6 October 2011, less than one day after vaccination with FLULAVAL, the subject experienced tongue feels thick in the back, painful feeling ("feeling achy") and throat discomfort ("uncomfortable almost like a sore throat"). The subject had no trouble with her breathing. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema of arm at injection site in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 November 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, unknown arm). In November 2011, less than one week after vaccination with FLULAVAL, the subject experienced erythema of arm at injection site, arm swelled at injection site, arm pain at injection site and arm warm at site of injection. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported events for this female, another female and herself with FLULAVAL. See cases A0953236A and A0953257A for details regarding the other cases.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4, 7 or 8 November 2011 the subject received a dose of FLULAVAL (.5 unknown route, unknown). On an unknown date in November 2011, several hours after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. According to the pharmacist, the hospital had a flu clinic between 04 November through 08 November 2011. Approximately 40 subjects were administered FLULAVAL from the same lot. Of the 40 subjects, five subjects experienced injection site redness, swelling and pruritus. This case was associated with a pharmaceutical product complaint. The pharmacist was suspecting a questionable batch of vaccine. She noted that a sister site had administered FLULAVAL with a different lot number and had no adverse events reported. At the time of reporting the outcome of the events was unspecified. This is three of five cases. See cases A0952517A, A0952520A, A0952522A and A0952523A for information regarding the other cases.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4, 7 or 8 November 2011 the subject received a dose of FLULAVAL (.5 unknown route, unknown). On an unknown date in November 2011, several hours after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. According to the pharmacist, the hospital had a flu clinic between 04 November through 08 November 2011. Approximately 40 subjects were administered FLULAVAL from the same lot. Of the 40 subjects, five subjects experienced injection site redness, swelling and pruritus. This case was associated with a pharmaceutical product complaint. The pharmacist was suspecting a questionable batch of vaccine. She noted that a sister site had administered FLULAVAL with a different lot number and had no adverse events reported. At the time of reporting the outcome of the events was unspecified. This is one of five cases. See cases A0952520A, A0952521A, A0952522A and A0952523A for information regarding the other cases.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer (the company owner) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the event was unspecified. The consumer reported that 5 employees of one company and one employee at another company all reported extreme redness at the injection site after receiving FLULAVAL. This is case 6 of 6 (see case IDs A0952647A, A0952653A-A0952656A for details of the other reports).
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer (the subject's daughter) and described the occurrence of sore throat 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 an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced sore throat and malaise. At the time of reporting the outcome of the events was unspecified. The consumer reported that both she and her mother received FLULAVAL on the same day and experienced the same symptoms. The consumer has asked for information regarding FLULAVAL in people with auto-immune disease. She did not provide any further information. See case ID A0952198A for details of the other case.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer (the company owner) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the event was unspecified. The consumer reported that 5 employees at one company and one employee at another company all reported extreme redness at the injection site after receiving FLULAVAL. This is case 1 of 6 (see case IDs A0952653A-A0952657A for details of the other reports).
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of sore throat 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 an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced sore throat and malaise. At the time of reporting the outcome of the events was unspecified. The consumer reported that both she and her mother received FLULAVAL on the same day and experienced the same symptoms. The consumer had asked for information regarding FLULAVAL in people with auto-immune disease. She did not provide any further information. See case ID A0952199A for details of the other case.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer (the company owner) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the event was unspecified. The consumer reported that 5 employees at one company and one employee at another company all reported extreme redness at the injection site after receiving FLULAVAL. This is case 2 of 6 (see case IDs A0952647A, A0952654A-A0952657A for details of the other reports).