chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of hives in a subject of unspecified age and gender who was vaccinated with Influenza vaccine (manufacturer unspecified). Concurrent medical conditions included splenectomy. On an unspecified date the subject received a dose of Influenza vaccine (details unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced hives. The physician reported that he had a "patient who developed hives from the flu vaccine". He explained that the subject needed HIBERIX as the subject was status post a splenectomy and that the "package insert states that patients should not get the HIBERIX if they are allergic to any of its ingredients". The physician stated that he did not see a list of ingredients for HIBERIX and asked if getting HIBERIX would be a problem for the subject. At the time of reporting the outcome of the event was unspecified. The physician considered the event was related to vaccination with Influenza vaccine ("hives from the flu vaccine").
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Irritability
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of irritability in a neonate (less than 24 hours old) male subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 27 December 2011 at 00:20 the less than 24 hour old subject inadvertently received a dose of FLUARIX in the left leg. This was an inappropriate age at vaccine administration. On 27 December 2011, less than one day after vaccination with FLUARIX, the subject experienced irritability. On 29 December 2011, the event resolved. The mother reported that the hospital intended to give the newborn his vaccination of hepatitis B, but mistakenly administered FLUARIX. This was the wrong vaccine for administration. The newborn was discharged on time from the hospital following birth on 27 December 2011 at approximately 14:)0 and has visited the pediatrician office for normal visits twice since his birth. The mother was notified of the maladministration by phone call after they were home.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Neuropathy peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of brachial neuropathy in an adult subject of unspecified gender who was vaccinated with Influenza vaccine (manufacturer not clear). On an unspecified date the subject received a dose of Influenza vaccine (details unknown). The healthcare professional reported the subject received a "flu vaccine, probably GSK vaccine'. Two weeks after vaccination with Influenza vaccine, the subject experienced brachial neuropathy. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 13 March 2012. It was reported that the subject was a 49 year old male. FLUARIX was administered in the left deltoid. It was reported that the subject has received influenza virus vaccine yearly. Brachial neuropathy began on approximately 02 November 2011. With a 2 week time to onset previously reported, influenza virus vaccine was administered on an unknown date in October 2011. Brachial neuropathy was improved at the time of reporting. Attribution of the event to influenza virus vaccine was unknown.
Sex: U
Vaccine: FLU3
Symptoms: Arthritis, Bursitis, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and the inflammation spread to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is two of eight. See A0956566A, A0956567A, A0956568A, A0956569A, A0956571A, A0956572A and A0956573A for details regarding the additional cases.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (physician assistant), via another manufacturer (Merck), and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent vaccination included influenza virus vaccine; GlaxoSmithKline; unknown, unknown given on an unspecified date. On an unspecified date the subject received 2nd dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site pain and swelling injection site. The subject was administered one dose of FLUARIX and then 3 months later administered another dose. The subject experienced pain and swelling at the injection site only after the second dose. The healthcare professional reported this to a Merck Field employee. At the time of reporting the events were resolved.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 44-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included Oral contraceptive, SINGULAIR and ALLEGRA. On 28 September 2011 the subject received a dose of FLUARIX (.5 unknown, unknown route, left arm). On 5 October 2011, 7 days after vaccination with FLUARIX, the subject experienced injection site soreness. AT the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with FLUARIX.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site soreness/tenderness in a 51-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 17 October 2011 the subject received a dose of FLUARIX (.5 ml, unknown route, left deltoid). Between 17 and 19 October 2011, less than one week after vaccination with FLUARIX, the subject experienced injection site soreness/tenderness and injection site warmth. The subject was treated with ibuprofen. At the time of reporting the events were unresolved. The pharmacist considered the events were possibly related to vaccination with FLUARIX.
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Cough, Eye pain, Headache
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sneezing in a female subject in her 40's who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2011 at 13:30 the subject received a dose of FLUARIX. On 12 October 2011, 1 day after vaccination with FLUARIX, the subject experienced sneezing. On 22 October 2011, 11 days after vaccination with FLUARIX, the subject developed chills, a sore throat, body pain, cough, nausea, vomiting, headache and eye pain. At the time of reporting, sneezing and body pain were improved and chills and sore throat were resolved. According to the reporter, all four of these events were probably related to vaccination with FLUARIX. The outcome and FLUARIX attribution of cough, nausea, vomiting, headache and eye pain were not known, although a note was made that these symptoms lasted several days. It was indicated that a coworker who did not receive the FLUARIX vaccination, but had been exposed to the subject had not gotten sick; therefore, the reporter believes the subject's symptoms were not a contagious illness, but rather a reaction to the vaccine. Two additional subjects experienced events following vaccination with FLUARIX. Linked cases are A0951445A and A0951452A. Follow-up information was received from the healthcare professional on 6 December 2011. Immediately after the subject received FLUARIX on 11 October 2011, she experienced mild runny nose and sneezing. No others who came in contact with the subject became ill. The events "caused loss of work". On unspecified date(s), all events resolved.
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Nausea, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sneezing in a female subject in her 40's who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2011 at 13:30 the subject received a dose of FLUARIX. On 12 October 2011, 1 day after vaccination with FLUARIX, the subject experienced sneezing. On 22 October 2011, 11 days after vaccination with FLUARIX, the subject developed chills, a sore throat, body pain, cough, nausea, vomiting, headache and eye pain. At the time of reporting, sneezing and body pain were improved and chills and sore throat were resolved. According to the reporter, all four of these events were probably related to vaccination with FLUARIX. The outcome and FLUARIX attribution of cough, nausea, vomiting, headache and eye pain were not known, although a note was made that these symptoms lasted several days. It was indicated that a coworker who did not receive the FLUARIX vaccination, but had been exposed to the subject had not gotten sick; therefore, the reporter believes the subject's symptoms were not a contagious illness, but rather a reaction to the vaccine. Two additional subjects experienced events following vaccination with FLUARIX. Linked cases are A0951445A and A0951452A. Follow-up information was received from the healthcare professional on 6 December 2011. Immediately after the subject received FLUARIX on 11 October 2011, she experienced mild runny nose and sneezing. No others who came in contact with the subject became ill. The events "caused loss of work". On unspecified date(s), all events resolved.
Sex: F
Vaccine: FLU3
Symptoms: Sneezing, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sneezing in a female subject in her 40's who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2011 at 13:30 the subject received a dose of FLUARIX. On 12 October 2011, 1 day after vaccination with FLUARIX, the subject experienced sneezing. On 22 October 2011, 11 days after vaccination with FLUARIX, the subject developed chills, a sore throat, body pain, cough, nausea, vomiting, headache and eye pain. At the time of reporting, sneezing and body pain were improved and chills and sore throat were resolved. According to the reporter, all four of these events were probably related to vaccination with FLUARIX. The outcome and FLUARIX attribution of cough, nausea, vomiting, headache and eye pain were not known, although a note was made that these symptoms lasted several days. It was indicated that a coworker who did not receive the FLUARIX vaccination, but had been exposed to the subject had not gotten sick; therefore, the reporter believes the subject's symptoms were not a contagious illness, but rather a reaction to the vaccine. Two additional subjects experienced events following vaccination with FLUARIX. Linked cases are A0951445A and A0951452A. Follow-up information was received from the healthcare professional on 6 December 2011. Immediately after the subject received FLUARIX on 11 October 2011, she experienced mild runny nose and sneezing. No others who came in contact with the subject became ill. The events "caused loss of work". On unspecified date(s), all events resolved.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Auricular swelling, Injection site pruritus, Injection site rash, Injection site warmth, Rash pruritic
Clinical narrative: Adverse reaction reported on 8/8/12 after receiving note from FNP requesting follow up. ZOSTAVAX vaccine administered on 6/22/12 without incidence. Client stated approximately ten days later small rash on her right arm near injection site the size of pinky tip. Warm to touch. On 7/24/12 "pinky tip" size rash on right ear lobe, both rashes "itchy". Additional rash on right eyebrow "pinky tip" size again. On 7/28/12 right ear swollen and patch/rash on right arm above elbow gradually spread to hand same side. Administered BENADRYL topically to affected areas. Rash currently on right waist size of 2 half dollars. Saw PCP on 8/7/12 and was given "cortisone type" shot for allergic reaction and prescription for VALTREX. No further symptoms, no fever, no malaise, no pain experienced. Only complaint, pruritus at rash sites.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Muscular weakness, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in arms and legs in a 50-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included acid reflux, bipolar disorder and heart murmur. Concurrent medications included LAMICTAL. On 29 September 2011 the subject received a dose of FLUARIX (details unknown). On 4 October 2011, 5 days after vaccination with FLUARIX, the subject experienced pain in arms and legs, upper and lower extremity weakness and fatigue. The subject sought medical attention with the reporting healthcare professional. At the time of reporting the events were unresolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard and a blister formed. It was reported that it took a week for the events  to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950541A, A0950542A, A0950543A, A0950544A, A0950545A and A0950546A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard (hardness injection site) and a blister formed (injection site blisters). It was reported that it took a week for the events (issue) to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950536A, A0950541A, A0950542A, A0950543A, A0950544A and A0950545.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Gestational hypertension, Live birth, Maternal exposure during pregnancy, Neonatal disorder
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included rheumatoid arthritis. On 14 October 2011 at 11:00 the subject received a dose of FLUARIX (.5 ml, unknown route, right deltoid), and experienced vaccine exposure during the second trimester of her pregnancy. Gestational age at the time of vaccination was not specified. Date of last menstrual period was not reported. The estimated date of delivery was 05 February 2012. At the time of reporting the subject had not experienced adverse events. The healthcare professional reported 6 subjects who received FLUARIX during pregnancy. See case IDs A0952863A, A0952838A-A0952840A, A0952842A for details of the other reports. Follow-up information was received on 02 December 2011. It was reported that the conception was normal with one fetus noted. The date of last menstrual period was 02 May 2011. FLUARIX was administered intramuscularly at 24 weeks gestation on 14 October 2011. The lot number was reported to be AFUA653AA on follow-up, but kept the original reported lot number, AFLUA653AA, as it was more appropriately matched GSK batch numbers. Follow-up information was received on 24 April 2012 via healthcare professional. The subject had a previous history of one spontaneous abortion and one therapeutic abortion. On 17 January 2012, at 36 weeks and 5 days gestation age the subject was induced due to gestational hypertension. The subject gave birth to a female live infant via normal vaginal delivery, weight 3420 grams, length 51 centimeters, head circumference 31.5 and Apgar score of 8/9. The neonate was born had persistent hypoxia immature lungs. The outcome of the gestational hypertension was unknown. Please see report A0952841B for details regarding the baby case. Follow-up information was received on 08 May 2012 via healthcare professional who reported the event of gestational hypertension resolved on "14 December 1982". Additional medical conditions included obesity, preeclampsia and "MIID". At the time of the report no other information was available.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard (hardness injection site) and a blister formed (injection site blisters). It was reported that it took a week for the events (issue) to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950536A, A0950542A, A0950543A, A0950544A, A0950545A and A0950546A.
Sex: F
Vaccine: FLUX
Symptoms: Throat irritation
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of strange feeling in throat in a currently 42-year-old female subject who was vaccinated with Flu vaccine (Unknown Manufacturer). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to fish and allergy to molds. In 2010, "approximately one year ago", the subject received a dose of Flu vaccine (unknown route). Less than one year after vaccination with Flu vaccine, the subject experienced strange ("weird") feeling in throat. The subject was treated with BENADRYL. At the time of reporting the outcome of the event was unspecified. The subject reported events with flu shot on 03 November 2011. See A0952703A for details regarding the first report case.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard (hardiness injection site) and a blister formed (injection site blisters). It was reported that it took a week for the events (issue) to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950536A, A0950541A, A0950543A, A0950544A, A0950545A and A0950546A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard and a blister formed. It was reported that it took a week for the events to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950536A, A0950541A, A0950542A, A0950543A, A0950545A and A0950546A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard (hardiness injection site) and a blister formed (injection site blisters). It was reported that it took a week for the events (issue) to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950536A, A0950541A, A0950542A, A0950544A, A0950545A and A0950546A.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer and described the occurrence of sore throat in a female subject of unspecified age who was vaccinated with Flu shot (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medication included TYKERB tablet for malignant breast neoplasm and previous Flu shot. On an unspecified date the subject received Flu shot. At an unspecified time after vaccination with Flu shot, the subject experienced getting sick, "always gets sick after". At the time of the report the outcome of getting sick was unknown. On an unspecified date the subject started Lapatinib (unknown) at 250 mg five times per day. On an unspecified date in October 2011 the subject received unspecified dose of Flu shot (unknown). On an unspecified date in October 2011, within one week of receiving the Flu shot and at an unspecified time after the initial dose of Lapatinib, the subject experienced sore throat and cold. The subject stated "had flu shot last week and always get sick after that". At the time of reporting the outcome of the sore throat, cold and sick were unspecified.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hive in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 4 October 2011 the subject received 1st dose of FLUARIX (.5 ml, unknown, left arm); FLULAVAL was reported but the lot number of the administered vaccine corresponded to FLUARIX. On 4 October 2011, less than one day after vaccination with FLUARIX, the subject experienced hives on left arm and left hip as well as muscle aches. The subject required medical attention in which she received treatment with BENADRYL in the clinic at the hospital where she is an employee. The subject missed one day of work. At the time of reporting the hives and muscle aches were improved. The pharmacist considered the hives and muscle aches were possibly related to vaccination with FLUARIX. Follow-up information was received on 02 November 2011. It was reported that the female subject was 31 years old. She received vaccination with FLUARIX on 04 October 2011 and events of hives and muscle pain began on the same day, 04 October 2011. The events resolved on 06 October 2011.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 56-year-old female subject who was vaccinated with INFLUENZA (manufacturer unspecified). Concurrent medical conditions included disc herniation and thyroid disorder. On 5 October 2011 the subject received a dose of Flu vaccine (subcutaneous, back of right arm). This was an inappropriate route of vaccination. On 5 October 2011, less than one day after vaccination with Flu vaccine, the subject experienced injection site redness, swelling injection site and injection site pruritus. At the time of reporting the events were unresolved.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of bumps around injection site in a 57-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Hypertension med. On 7 October 2011 at 09:00 the subject received a dose of FLUARIX (unknown route, left arm). On 7 October 2011, 11 hours after vaccination with FLUARIX, the subject experienced bumps around injection site, injection site rash and bumpy rash. The subject reported bumps around the site of the injection as well as a few on her forearms and knuckles. Approximately 10 bumps had a yellow tinge to the fluid within the bumps. The bumps were not itchy and had not worsened or improved at the time of reporting. The subject was treated with BENADRYL. At the time of reporting the events were unresolved.
Sex: F
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, Influenza
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza in a child female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified), FLULAVAL. There were no concurrent medications. On an unspecified date in 2010 the subject received a dose of Influenza vaccine (unspecified, manufacturer unknown). At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced influenza. Outcome and attribution of the event to vaccination with Influenza vaccine was not known. On 31 August 2011 at 12:00 the 5 year old subject received a dose of (dose 1 for 2011) of FLULAVAL at 0.5 ml in the left arm. This was the wrong vaccine for administration as FLULAVAL is not indicated for use in subjects under the age of 18. No additional details were provided. It was reported that this event occurred in three siblings. See linked sibling cases A0943421A and A0943422A. Follow-up information received on 27 September 2011 indicated that there were "no adverse reactions to report." No additional details were provided.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral, Periarthritis
Clinical narrative: This case was reported by a physician and described the occurrence of swelling of underside of arm in a 58-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included high blood pressure. Concurrent medications included Ramipril. ON an unknown date in September 2009 the subject received a dose of FLUARIX (unknown, left arm) at work. On an unknown date in September 2009, less than one month after vaccination with FLUARIX, the subject experienced swelling of underside of left arm ("left arm swelling in axillary region") and frozen left shoulder. At the time of reporting the events were resolved.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Myalgia, Nasal congestion, Pain in extremity, Rhinorrhoea
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of throat closing up in a 42-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to fish and allergy to molds. On 3 November 2011 at 14:00 the subject received a dose of Flu vaccine (unknown route, left arm). On 3 November 2011, 10 minutes after vaccination with Flu vaccine, the subject experienced throat closing up and rapid pulse. Less than a day after vaccination with Flu vaccine on 03 November 2011, the subject experienced arm soreness and gluteal muscle pain. She also experienced runny nose and stuffy nose. The subject stated that at 24 hours post vaccination, all the events were resolved. She stated that she knows that she received a GSK flu vaccine, but does not know which brand. The subject was treated with liquid BENADRYL. On 4 November 2011, the events were resolved. The subject reported that she had a flu shot approximately a year ago and experienced a weird feeling in her throat and she took BENADRYL as treatment. See A0952703B for details regarding this second case.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Throat tightness
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of throat closing up in a 42-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to fish and allergy to molds. On 3 November 2011 at 14:00 the subject received a dose of Flu vaccine (unknown route, left arm). On 3 November 2011, 10 minutes after vaccination with Flu vaccine, the subject experienced throat closing up and rapid pulse. Less than a day after vaccination with Flu vaccine on 03 November 2011, the subject experienced arm soreness and gluteal muscle pain. She also experienced runny nose and stuffy nose. The subject stated that at 24 hours post vaccination, all the events were resolved. She stated that she knows that she received a GSK flu vaccine, but does not know which brand. The subject was treated with liquid BENADRYL. On 4 November 2011, the events were resolved. The subject reported that she had a flu shot approximately a year ago and experienced a weird feeling in her throat and she took BENADRYL as treatment. See A0952703B for details regarding this second case.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Application site warmth, Extensive swelling of vaccinated limb, Injection site discomfort, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer and described the occurrence of arm hot at application site in a 56-year-old female subject who was vaccinated with Influenza vaccine (unspecified, GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included autoimmune disorder, Hashimoto's disease and mitral valve prolapse. Concurrent medications included LIPITOR, Multivitamin, Vitamin C, Biotin, Vitamin B12 and Vitamin D. In 2011 (either the last week in September or the first week in October) the subject received a dose of known GlaxoSmithKline Seasonal Influenza vaccine (unspecified) on the back, underside of her arm. In 2011, 1 day after vaccination with Seasonal Influenza vaccine, the subject experienced arm hot at application site. Two days after vaccination with Seasonal Influenza vaccine, the subject developed injection site pruritus, injection site pain, extensive swelling of vaccinated limb (underside of arm 3 to 4 inches (101.6 mm) long and half an inch swollen ("felt like skin stretching"). Also reported with no specific onset date was injection site discomfort. The subject was treated with Cold compress. At the time of reporting, the events were resolved with the exception of periodic itching (improved). The subject also reported reactions to previous flu vaccines (manufacturers unspecified). The subject stated that she has received flu vaccine very year for the last "8" years, prior to the report of this year (received at Pharmacy). The first "vaccine" she ever received, she reported feeling sick, like a "mini flu". Other times she reported a sore arm about a day or so after the injection, but nothing other than that.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of arm hot at application site in a 56-year-old female subject who was vaccinated with Influenza vaccine (unspecified, GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included autoimmune disorder, Hashimoto's disease and mitral valve prolapse. Concurrent medications included LIPITOR, Multivitamin, Vitamin C, Biotin, Vitamin B12 and Vitamin D. In 2011 (either the last week in September or the first week in October) the subject received a dose of known GlaxoSmithKline Seasonal Influenza vaccine (unspecified) on the back, underside of her arm. In 2011, 1 day after vaccination with Seasonal Influenza vaccine, the subject experienced arm hot at application site. Two days after vaccination with Seasonal Influenza vaccine, the subject developed injection site pruritus, injection site pain, extensive swelling of vaccinated limb (underside of arm 3 to 4 inches (101.6 mm) long and half an inch swollen ("felt like skin stretching"). Also reported with no specific onset date was injection site discomfort. The subject was treated with Cold compress. At the time of reporting, the events were resolved with the exception of periodic itching (improved). The subject also reported reactions to previous flu vaccines (manufacturers unspecified). The subject stated that she has received flu vaccine very year for the last "8" years, prior to the report of this year (received at Pharmacy). The first "vaccine" she ever received, she reported feeling sick, like a "mini flu". Other times she reported a sore arm about a day or so after the injection, but nothing other than that.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Gastrointestinal disorder, Nausea, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of dry heaves in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 28 October 2011 the subject received a dose of FLUARIX (unknown route). On 28 October 2011 at 19:00, less than one day after vaccination with FLUARIX, the subject experienced dry heaves, chills, fever, weakness and intestinal problems. The events were resolved after a 12 hour period. On 29 October 2011 the events were resolved. Follow up information received from the healthcare professional (nurse) on 05 December 2011. The 55-year-old subject's concurrent medical conditions included codeine allergy, hypertension, increased triglycerides and social alcohol drinker. On 28 October 2011, subject received a dose of FLUARIX (0.5 ml intramuscular, left upper deltoid). Less than one day after vaccination with FLUARIX, the subject was diagnosed with nausea and chills. The healthcare professional identified FLUARIX as the suspect product, but causality assessment was listed as unknown. The healthcare professional indicated the events were not serious.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Retching
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of dry heaves in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 28 October 2011 the subject received a dose of FLUARIX (unknown route). On 28 October 2011 at 19:00, less than one day after vaccination with FLUARIX, the subject experienced dry heaves, chills, fever, weakness and intestinal problems. The events were resolved after a 12 hour period. On 29 October 2011 the events were resolved. Follow up information received from the healthcare professional (nurse) on 05 December 2011. The 55-year-old subject's concurrent medical conditions included codeine allergy, hypertension, increased triglycerides and social alcohol drinker. On 28 October 2011, subject received a dose of FLUARIX (0.5 ml intramuscular, left upper deltoid). Less than one day after vaccination with FLUARIX, the subject was diagnosed with nausea and chills. The healthcare professional identified FLUARIX as the suspect product, but causality assessment was listed as unknown. The healthcare professional indicated the events were not serious.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard (hardiness injection site) and a blister formed (injection site blisters). It was reported that it took a week for the events (issue) to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950536A, A0950541A, A0950542A, A0950543A, A0950544A and A0950546A.
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Nerve injury
Clinical narrative: This case was reported by a lawyer and described the occurrence of injection site pain in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other healthcare professional has not verified this report. On 11 October 2011 the subject received a dose of FLUARIX in the left arm. Within months of vaccination with FLUARIX (described as "shortly after the injection" and the report was received by GlaxoSmithKline on 17 November 2011), the subject experienced injection site pain (severe pain in the left arm at the site of the injection). At the time of reporting, the subject was wearing a sling on her left arm. She was unable to move the arm and activities of daily living were impaired (she had missed several weeks of work because of her condition). It was reported that the subject had recently consulted with a neurologist and the neurologist thought that the subject's condition was caused by defective vaccine. It was reported that the subject may have serious and permanent nerve damage in her left arm which may result in her inability to work and continue in her employment as a realtor. At the time of reporting the outcome of the events was unresolved.
Sex: F
Vaccine: FLUX
Symptoms: Headache, Malaise, Pain
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of "made [her] ill" in a female subject aged 30-39 years who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. In 2000 the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, unknown site). At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced "made [her] feel ill", body pain and headache. At the time of reporting the outcome of the events were unspecified. The consumer also reported adverse events following subsequent flu vaccine in 2011 (see case ID A0953793A for details).
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Migraine
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of migraine in a 42-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Lamotrigine. The subject also reported "mad me ill", headache, body ache reaction with flu shot (unknown manufacturer) in 2000 (see case A0953793B). On 28 October 2011 at 08:00 the subject received a dose of Influenza vaccine unspecified 2011-12 season (unknown route, unknown site). On 2 November 2011, 5 days after vaccination with Influenza vaccine unspecified 2011-12 season, the subject experienced migraine, dizziness and lightheadedness. The subject went to the emergency room for these events. At the time of reporting the events were unresolved.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a healthcare professional, via a GSK sales representative, and described the occurrence of pain in whole arm in a 61-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included eye stye. On 10 October 2011 the subject received a dose of FLUARIX (.5 ml, intramuscular, left arm). On 10 October 2011, less than one day after vaccination with FLUARIX, the subject experienced pain in whole left arm. The subject reported that the pain was through her entire arm and had gotten worse. She was trying to obtain therapy for her arm. At the time of reporting the event was worse. Follow-up information was received from the healthcare professional on 19 December 2011: The event resolved on 15 November 2011. The healthcare professional confirmed that the event was not considered serious. No diagnostic tests, investigations or procedures were performed. The subject was offered to proceed with physical therapy, but informed the healthcare professional that "with the business of the holidays can't fit it in". The healthcare professional considered that the events were not associated with medical history or a concurrent condition, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via a medicinal product. The healthcare professional considered that the events may have been caused by tai chi, which was started the same time as the subject received FLUARIX.
Sex: U
Vaccine: FLU3
Symptoms: Arthritis, Bursitis, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and the inflammation to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is four of eight. See A0956566A, A0956567A, A0956568A, A0956570A, A0956571A, A0956572A and A0956573A for details regarding the additional cases.
Sex: U
Vaccine: FLU3
Symptoms: Arthritis, Bursitis, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and the inflammation spread to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is three of eight. See A0956566A, A0956567A, A0956569A, A0956570A, A0956571A, A0956572A and A0956573A for details regarding the additional cases.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza symptoms in a male subject aged between 40 and 49 years old who was vaccinated with Flu vaccine (manufacturer unspecified). On an unspecified date in September 2011 the subject received a dose of Flu vaccine (details unknown). On 19 September 2011, less than one week after vaccination with Flu vaccine, the subject experienced "full blown" influenza symptoms. The healthcare professional reported that the subject almost went to the emergency. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Flu vaccine. The healthcare professional reported two subject's who experienced adverse events following vaccination with Flu vaccine. This is case 2 of 2 (see case ID A0945847A for details of the other reports).
Sex: F
Vaccine: FLUX
Symptoms: Headache, Influenza like illness, Nausea, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza symptoms in a female subject aged between 30 and 39 years old who was vaccinated with Flu vaccine (manufacturer unspecified). Concurrent medications included SYNTHROID. On an unspecified date in September 2011 the subject received a dose of Flu vaccine (details unknown). Less than one week after vaccination with Flu vaccine, the subject experienced influenza symptoms, nausea, headache and pain. It was reported that the subject had "never felt that bad" after flu shot before. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with Flu vaccine. The healthcare professional reported two subject's who experienced adverse events following vaccination with Flu vaccine. This is case 1 of 2 (see case ID A0945851A for details of the other reports).
Sex: M
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, Influenza, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza in a child male subject who was vaccinated with INFLUENZA (unspecified, manufacturer unspecified), FLULAVAL. Concurrent medications included Albuterol and SINGULAIR. The subject's medical history was significant for asthma. On an unspecified date in 2010 the subject received a dose of INFLUENZA (manufacturer unspecified). At an unspecified time after vaccination with INFLUENZA (unspecified), the subject experienced influenza. Outcome and attribution of the event to vaccination with INFLUENZA was not known. On 31 August 2011 at 12:00 the 10 year old subject received a dose (dose 1 for 2011) of FLULAVAL at 0.5 ml in the left arm This was the wrong vaccine administration as FLULAVAL is not indicated for use in subjects under the age of 18. No additional details were provided. It was reported that this event occurred in three siblings. See linked sibling cases A0943409A and A0943421A.