chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Rash generalised, Skin irritation, Urticaria
Clinical narrative: This case was reported by a consumer (subject and GSK employee) and described the occurrence of itching of arm area in an adult female subject who was vaccinated with influenza vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to molds. The subject stated no medical history of allergies (environmental or otherwise). The subject stated she had no medical history of eczema. On 7 November 2012 the subject received a dose of influenza vaccine (unknown details). On 8 November 2012, 1 day after vaccination with influenza vaccine, the subject experienced itching of arm area ("small, itchy" "area of skin under my left armpit"), and red areas on skin. The subject stated that, on 8 November 2012, she noticed "a small, itchy, red area of skin under my left armpit, about the size of a silver dollar." On 13 November 2012, the subject experienced rash all over body, red welts, and skin irritation. The subject stated that "the rash spread all over my body, with red welts, and severe itching and irritation." The "symptoms were minimally controlled with antihistamines." On 15 November 2012, the subject sought medical attention from a physician at an urgent care facility who determined that she experienced "an allergic reaction to the flu shot." The subject was treated "with a shot of prednisone and began an oral prednisone taper." On an unknown date in 2012, the subject "subsequently saw an allergist who performed allergy skin testing." The results of the allergy skin testing were negative for everything but positive for mold. The subject stated that the allergist told the subject she had suffered "an eczema flare." The subject, however, stated no medical history of allergies (environmental or otherwise). The subject stated she had no medical history of eczema. In November 2012, the subject stated the itching resolved "shortly after beginning prednisone." In 2012, the rash resolved. "The rash was visible for about 14 to 21 days" after 15 November 2012. The outcome of the red areas on skin, red welts, skin irritation, allergic reaction, and eczema flare was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced swelling injection site, fever, chills, pain and nausea. The pharmacist via sales representative reported that the hospital had several subjects have injection site pain, dermatologic reactions and respiratory type problems. The sales representative clarified with a nurse, that three subjects experienced adverse events, two of the subjects were previously reported (cases A0999291A and A0999318A). The nurse stated for the third subject (current case A0999643), a female was administered FLUARIX and had swelling at the injection site the size of a tennis ball, fever, chills, aching and nausea. No further information was provided. At the time of reporting the outcome of the events were unspecified. For the other two cases that were previously reported please see A0999291A and A0999318A.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of arm pain at injection site in an unknown number subjects of unspecified ages and genders who were vaccinated with FLUARIX (GlaxoSmithKline). In October 2012, the subjects received a dose of FLUARIX (.5 ml, unknown details). On an unspecified date, months after vaccination with FLUARIX, the subjects experienced arm pain at injection site, and feeling sick. One subject reported fever of 99.3 degrees Fahrenheit. The nurse stated that "some nurses" reported "arm pain" 'more than usual' and 'feeling sick' following administration of FLUARIX vaccination in October 2012." The nurse stated that "the same product was given in the hospital with no complaints as the same product given in the clinic." The lot numbers were not reported and it was unknown "if it was the same lot number." At the time of reporting the outcome of the events were unspecified. The GSK sales representative reported another case on the same date. See case AA1012706A for details on the other case.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a physician and described the occurrence of reaction to flu vaccination in an adult female subject who was vaccinated with seasonal influenza vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of seasonal influenza vaccine (unknown). At an unspecified time after vaccination with seasonal influenza vaccine, the subject experienced reaction to flu vaccination. The physician inquired about down feathers allergy and the flu vaccine. It was reported that the subject, who is the mother of the physician's current client, had a "bad reaction to the flu vaccine" in the past; details regarding the brand of vaccine and date were unknown. The physician reported that the subject thought because she is "allergic to down feathers and the flu vaccines are made from eggs". The physician had no further information because the details regarding the vaccination were unknown and the subject is not his patient. At the time of reporting the outcome of the event was unspecified.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chills, Induration, Pruritus, Rash, Skin warm
Clinical narrative: Large annular rash with central induration, increased warmth, tenderness and pruritus. Subjective chills. Treated with ice pack, MOTRIN and TYLENOL #3 (codeine).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: Large annular rash with central induration, increased warmth, tenderness and pruritus. Subjective chills. Treated with ice pack, MOTRIN and TYLENOL #3 (codeine).
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Infection, Lymphadenopathy, Pain, Salivary gland enlargement
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of swollen salivary glands in a 39-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to ibuprofen, allergy to NEXIUM, allergy to PRILOSEC, codeine allergy and cold. Concurrent medications included Vitamins. On 24 October 2011 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). In 2011, about 2 weeks after vaccination with FLUARIX, the subject experienced swollen salivary glands, lymphadenopathy, pain and infection. The subject reported receiving FLUARIX and developing swollen salivary glands "under her chin" about 2 weeks after vaccination. The subject reported having pain and that when she went to the doctor, "it was called lymphadenopathy". The subject was treated with a course of antibiotics. "It was assumed she had an infection since she had pain". She indicated the swelling [of the salivary gland] was "like a golf ball". She reported she had a cold at the time of vaccination. In 2011, the events were resolved about 5-6 days after starting the antibiotics. The subject reported events after her 2012-13 FLUARIX also (rechallenged and events recurred). See case A1002313B for details regarding this case.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash, swelling around injection site.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Swelling, Urticaria
Clinical narrative: This case was reported by a physician via another manufacturer Merck and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of seasonal influenza vaccine (unknown). At an unspecified time after vaccination with seasonal influenza vaccine, the subject experienced allergic reaction, welt and swelling. The subject had an allergic reaction of welts and swelling after vaccination with an influenza vaccine. "This occurred years ago". No other information was provided. At the time of reporting the outcome of the allergic reaction, welt and swelling was unspecified.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Salivary gland enlargement
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of swollen submandibular gland in a 40-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to ibuprofen, allergy to NEXIUM, allergy to PRILOSEC, codeine allergy and cold. Concurrent medications included Vitamins. On 15 October 2012 the subject received a dose of FLUARIX (details unknown). In 2012, about 2 weeks after vaccination with FLUARIX, the subject experienced swollen submandibular gland. The subject reported that she had a swollen submandibular gland on one side, but did not have pain. She had plans to see an ENT [Ear, Nose, Throat Physician] on Friday [16 November 2012], but had not received any treatment at the time of the report. She reported that the swelling started "about 2 weeks" after vaccination and that the swelling "started 2 weeks ago" and was still present. At the time of reporting the event was unresolved. The subject reported that the swelling was "not as big this year as it was last year". See case A1002313A for details regarding swelling last year.
Age: 1.26
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria, Varicella post vaccine
Clinical narrative: Hives reaction vs small localized inactive varicella pox per Dr.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Malaise
Clinical narrative: This case was reported by a pharmacist and described the occurrence of did not feel well in a 50-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Approximately five to six years ago in 2006, the subject received 1st dose of FLUARIX (unknown). Five to six years ago in 2006, within hours of vaccination with FLUARIX, the subject experienced didn't feel well for an hour after vaccination and had to lay down for an hour after the vaccination [all consumer wanted was to lie down] and then had to leave work for the day [inability to perform daily activities]. At the time of reporting the events were resolved. Follow-up information as received on 07 November 2012 via healthcare professional who reported the events resolved on an unspecified date. It was also reported that the subject "received the vaccination this year with no complications! She took a diphenhydramine prior to injection". No other information was provided.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a healthcare professional who is a nurse and described the occurrence of Guillain Barre syndrome in an unspecified number of subjects of unspecified age and gender who were vaccinated with influenza vaccine (manufacturer unspecified). On unspecified dates the subjects received unspecified doses of influenza vaccine (unknown). At unspecified times after vaccinations with influenza vaccine, the subjects experienced Guillain Barre syndrome. The nurse was inquiring about FLULAVAL and "she mentioned that about 10 people she knows, know someone either young or elderly that have had Guillain Barre syndrome (GBS) in the past. She thinks these people were vaccinated at one time with the flu vaccine (but she didn't specifically state that). The reporter did not mention any GSK flu vaccines and GBS. The nurse just stated that people she knows; know someone who have had GBS in the past." She also stated that her "mother in law developed GBS in the 1970s after she received the swine flu vaccine." No further information was provided; reporter declined to be contacted for follow-up. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site hypersensitivity, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of local allergic reaction at injection site in a 42-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. On 10 November 2012 the subject received unspecified dose of FLUARIX (unknown, left arm). On 10 November 2012, immediately after vaccination with FLUARIX, the subject experienced local allergic reaction at injection site. The subject's reaction of redness and swelling was immediate around the injection site and was quite large in diameter, approximately 10 centimeters. The physician did not administer the vaccine, but thought it was FLUARIX. At the time of reporting the local allergic reaction at injection site, swelling injection site and injection site redness were unresolved.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in an adult male subject who was vaccinated wtih influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. In November 2012 the subject received unspecified dose of influenza vaccine (unknown). In February 2013, approximately three months after vaccination with influenza vaccine, the subject experienced influenza and vaccination failure. The subject's spouse reported "my husband (the subject) and I both got the flu shot in November and I got the pneumonia shot three years ago. Well, I went into the hospital two weeks ago with pneumonia for eight days and came home and was home for three days and he came down with the flu. He is not allowed around me at all. If I get the flu I am going to get it ten times worse so, we are really trying to avoid it as much as possible this year has been really bad because of this crazy weather pattern." This case was assessed as medically serious by GSK. At the time of reporting the outcome of the influenza was unspecified. For case regarding the spouse please see case A0981843A.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bruise injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX. On 11 October 2012 the subject received a dose of FLUARIX (.5 ml, subcutaneous, unknown arm) and experienced inappropriate route of vaccination. FLUARIX should be administered as an intramuscular injection and not injected subcutaneously. In October 2012, less than a week since vaccination with FLUARIX, the subject experienced bruise injection site, and swelling injection site. The reporter was not able to provide specific details as to the onset of the adverse events. The reporter was aware that the subject "did go see their doctor after they got the subcutaneous shot of FLUARIX, since they had swelling [injection site] and bruising at the injection site and [they] wanted to confirm with the doctor that they did not have cellulitis." At the time of reporting the outcome of the events was unknown. The pharmacist reported four cases with inappropriate route of vaccination, bruise injection site and swelling injection site. The pharmacist did not know if there were more than four employees that were given FLUARIX by subcutaneous route versus intramuscular route. See cases A0998038A, A0998039A, and A0998040A.
Sex: F
Vaccine: FLU3
Symptoms: Livedo reticularis, Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arms itching in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2012 the subject received unspecified dose of FLUARIX (unknown). On 11 October 2012, within hours of vaccination with FLUARIX, the subject experienced arms itching and mottled skin. The healthcare professional reported that the subject experienced itchiness on her arms and her arms were mottled. The subject did not have any symptoms in her throat, just her arms. The healthcare professional recommended BENADRYL and for the subject to keep an eye on the symptoms. No other details were provided because the healthcare professional was in the middle of a flu clinic. At the time of reporting the outcome of the arms itching and mottled skin was unspecified.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Chest pain, Dyspnoea, Headache
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of nausea in a 59-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergies and anxiety. Concurrent medications included Antihistamine and Citalopram. On 29 October 2012 at 09:15 the subject received a dose of FLUARIX (unknown route, right arm). On 2 November 2012, 36 hours after vaccination with FLUARIX, the subject experienced nausea and in November 2012 within 2 weeks of vaccination with FLUARIX, the subject experienced headache, muscle pain, vertigo, eye sensitive to light, shortness of breath, chest pain, irregular heartbeat, rapid heartbeat, weakness, sweating, unable to function (also described "knocked her flat down") and decreased ability to perform daily activities (described as "had to call off work"). The subject explained that the nausea started after 36 hours and the other events "crept in and it took up to two weeks for the symptoms to appear". The subject noted that her symptoms were worse at the time of the report and she had "to call off work". She reported that the "extreme" muscle pain caused an "inability to function and knocked her flat down". The subject indicated that she "did try" to seek medical attention but "was unable to get into doctor". The subject reported that she received the FLUARIX as a requirement for her employment. At the time of reporting the events were worse. The subject reported that she experienced "side effects" from the Hepatitis B three dose series. She noted she had "same symptoms" with Hepatitis B vaccine which resolved, but according to the subject, the symptoms "came back with a vengeance" when she received FLUARIX. See A1002560B for details regarding "side effects" with Hepatitis B vaccine.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Heart rate irregular, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of nausea in a 59-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergies and anxiety. Concurrent medications included Antihistamine and Citalopram. On 29 October 2012 at 09:15 the subject received a dose of FLUARIX (unknown route, right arm). On 2 November 2012, 36 hours after vaccination with FLUARIX, the subject experienced nausea and in November 2012 within 2 weeks of vaccination with FLUARIX, the subject experienced headache, muscle pain, vertigo, eye sensitive to light, shortness of breath, chest pain, irregular heartbeat, rapid heartbeat, weakness, sweating, unable to function (also described "knocked her flat down") and decreased ability to perform daily activities (described as "had to call off work"). The subject explained that the nausea started after 36 hours and the other events "crept in and it took up to two weeks for the symptoms to appear". The subject noted that her symptoms were worse at the time of the report and she had "to call off work". She reported that the "extreme" muscle pain caused an "inability to function and knocked her flat down". The subject indicated that she "did try" to seek medical attention but "was unable to get into doctor". The subject reported that she received the FLUARIX as a requirement for her employment. At the time of reporting the events were worse. The subject reported that she experienced "side effects" from the Hepatitis B three dose series. She noted she had "same symptoms" with Hepatitis B vaccine which resolved, but according to the subject, the symptoms "came back with a vengeance" when she received FLUARIX. See A1002560B for details regarding "side effects" with Hepatitis B vaccine.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia, Vertigo
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of nausea in a 59-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergies and anxiety. Concurrent medications included Antihistamine and Citalopram. On 29 October 2012 at 09:15 the subject received a dose of FLUARIX (unknown route, right arm). On 2 November 2012, 36 hours after vaccination with FLUARIX, the subject experienced nausea and in November 2012 within 2 weeks of vaccination with FLUARIX, the subject experienced headache, muscle pain, vertigo, eye sensitive to light, shortness of breath, chest pain, irregular heartbeat, rapid heartbeat, weakness, sweating, unable to function (also described "knocked her flat down") and decreased ability to perform daily activities (described as "had to call off work"). The subject explained that the nausea started after 36 hours and the other events "crept in and it took up to two weeks for the symptoms to appear". The subject noted that her symptoms were worse at the time of the report and she had "to call off work". She reported that the "extreme" muscle pain caused an "inability to function and knocked her flat down". The subject indicated that she "did try" to seek medical attention but "was unable to get into doctor". The subject reported that she received the FLUARIX as a requirement for her employment. At the time of reporting the events were worse. The subject reported that she experienced "side effects" from the Hepatitis B three dose series. She noted she had "same symptoms" with Hepatitis B vaccine which resolved, but according to the subject, the symptoms "came back with a vengeance" when she received FLUARIX. See A1002560B for details regarding "side effects" with Hepatitis B vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bruise injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX. On 11 October 2013 the subject received a dose of FLUARIX (.5 ml, subcutaneous, unknown arm) and experienced inappropriate route of vaccination. FLUARIX should be administered as an intramuscular injection and not injected subcutaneously. In October 2012, less than a week since vaccination with FLUARIX, the subject experienced bruise injection site, and swelling injection site. The reporter was not able to provide specific details as to the onset of the adverse events. At the time of reporting the outcome of the events was unknown. The pharmacist reported four cases with inappropriate route of vaccination, bruise injection site and swelling injection site. The pharmacist did not know if there were more than four employees that were given FLUARIX by subcutaneous route versus intramuscular route. See cases A0998033A, A0998039A, and A0998040A.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bruise injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX. On 11 October 2012 the subject received a dose of FLUARIX (.5 ml, subcutaneous, unknown arm) and experienced inappropriate route of vaccination. FLUARIX should be administered as an intramuscular injection and not injected subcutaneously. In October 2012, less than a week since vaccination with FLUARIX, the subject experienced bruise injection site, and swelling injection site. The reporter was not able to provide specific details as to the onset of the adverse events. At the time of reporting the outcome of the events was unknown. The pharmacist reported four cases with inappropriate route of vaccination, bruise injection site and swelling injection site. The pharmacist did not know if there were more than four employees that were given FLUARIX by subcutaneous route versus intramuscular route. See cases A0998038A, A0998039A, and A0998040A.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of warm to touch in a 30-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 6 November 2012 the subject received 1st dose of FLUARIX (unknown, left arm). On 6 November 2012, within hours of vaccination with FLUARIX, the subject experienced warm to touch, swelling injection site and injection site redness. A 30-year old subject was vaccinated with FLUARIX on 06 November 2012. The subject returned to the clinic two days later, on 08 November 2012 and was treated with MOTRIN; she displayed a reduction of the swelling at injection site. The subject was sent home and told to call the office if other events occurred. The events of warm to touch and injection site redness resolved on 06 November 2012. At the time of reporting the swelling at injection site was improved.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bruise injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX. On 11 October 2013 the subject received a dose of FLUARIX (.5 ml, subcutaneous, unknown arm) and experienced inappropriate route of vaccination. FLUARIX should be administered as an intramuscular injection and not injected subcutaneously. In October 2012, less than a week since vaccination with FLUARIX, the subject experienced bruise injection site, and swelling injection site. The reporter was not able to provide specific details as to the onset of the adverse events. At the time of reporting the outcome of the events was unknown. The pharmacist reported four cases with inappropriate route of vaccination, bruise injection site and swelling injection site. The pharmacist did not know if there were more than four employees that were given FLUARIX by subcutaneous route versus intramuscular route. See cases A0998038A, A0998039A, and A0998040A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
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 FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). On an unspecified date, a few hours after vaccination with FLUARIX, the subject experienced injection site redness, swelling injection site and injection site soreness. The events occurred within "possibly a few hours after vaccination." At the time of reporting the outcome of the events were unspecified. The pharmacist reported another subject with same events. See case A1002923A for details on the other subject.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of sore arm in a 33-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report during pregnancy. No previous pregnancies. On 11 October 2012 the subject received unspecified dose of FLUARIX (.5 ml, intramuscular, unknown). Her last menstrual period was on 17 March 2012 and estimated date of delivery was 23 December 2012. The subject was exposed to FLUARIX during third trimester. The pregnancy was by normal conception. No evidence of defect from prenatal testing. On 11 October 2012, at the time of vaccination with FLUARIX, the subject experienced vaccine exposure during pregnancy. On 11 October 2012, within hours of vaccination with FLUARIX, the subject experienced sore right arm. At the time of reporting the sore right arm was improved. 11 February 2013 - No further information provided; patient lost to follow-up.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
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 FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). On an unspecified date, a few hours vaccination with FLUARIX, the subject experienced injection site redness, swelling injection site and injection site soreness. The events occurred within "possibly a few hours after vaccination." At the time of reporting the outcome of the events were unspecified. The pharmacist reported another subject with same events. See case A1002688A for details on the other subject.
Age: 12.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, IPV, VARCEL
Symptoms: Abdominal pain, Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test urine positive, Sinusitis
Clinical narrative: Information has been received from a physician for the pregnancy Registry for GARDASIL concerning a 12 year old female patient with no pertinent medical history, no allergies or drug reactions who on 30-SEP-2011, was vaccinated with the first dose of GARDASIL (route and dose not reported) (lot number 669308/0636AA). On the same day, the patient was vaccinated with the second dose of VARIVAX (Merck) (route and dose not reported) (lot number 669602/0023AA). Concomitant therapy included poliovirus vaccine (manufacturer unknown), influenza virus split virion 3v vaccine inactivated (manufacturer unknown) and HAVRIX. On an unspecified date "after 30-SEP-2011", the patient was evaluated in the emergency room for abdominal pain and was discharged to home. On 10-NOV-2011, the patient had a positive urine pregnancy test LMP: 23-SEP-2011, EDD: 29-JUN-2012. The physician reported that the patient had currently being treated for a sinus infection with ZITHROMAX. At the time of the report the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Mycobacterium tuberculosis complex test negative, Pruritus, Pyrexia, Rash
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of pruritus in a 23-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Co-suspect product included TB skin test (Sanofi-Pasteur) placed 23 October 2012. Concurrent medications included IMURAN, Levothyroxine, T3, SEASONALE and ADDERALL. On 23 October 2012 at 10:40 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 23 October 2012, 45 minutes after vaccination with FLUARIX, the subject experienced pruritus of forearms, hives/rash on forearms, pruritus of lower extremities, pruritus of buttock, itching of stomach. Later in the afternoon on 23 October 2012, hours later, the subject experienced itching neck, itching upper arms, and a low grade fever of 99.6 degrees Fahrenheit. Medical attention was required at the emergency room and employee health. At the time of reporting the outcome of all itching events and hives/rash had improved but were still present. The outcome of the low grade fever was unresolved. Follow-up information was received on 27 November 2012 via healthcare professional. Concurrent medical conditions included asthma, attention deficit hyperactivity disorder, hypothyroidism and psoriatic arthritis. The reporter clarified the subject received FLUARIX via intramuscular injection. It was clarified that the subject made an appointment at employee health for evaluation; medical attention was not required at the emergency room. The subject has discharged from the employee health clinic in stable condition. The subject did not go to the emergency room. The reporting healthcare professional considered the events may have been associated with medical history/concurrent illness of psoriatic arthritis; unclear if associated with her symptoms. At the time of reporting the events were resolved.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of pruritus in a 23-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Co-suspect product included TB skin test (Sanofi-Pasteur) placed 23 October 2012. Concurrent medications included IMURAN, Levothyroxine, T3, SEASONALE and ADDERALL. On 23 October 2012 at 10:40 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 23 October 2012, 45 minutes after vaccination with FLUARIX, the subject experienced pruritus of forearms, hives/rash on forearms, pruritus of lower extremities, pruritus of buttock, itching of stomach. Later in the afternoon on 23 October 2012, hours later, the subject experienced itching neck, itching upper arms, and a low grade fever of 99.6 degrees Fahrenheit. Medical attention was required at the emergency room and employee health. At the time of reporting the outcome of all itching events and hives/rash had improved but were still present. The outcome of the low grade fever was unresolved. Follow-up information was received on 27 November 2012 via healthcare professional. Concurrent medical conditions included asthma, attention deficit hyperactivity disorder, hypothyroidism and psoriatic arthritis. The reporter clarified the subject received FLUARIX via intramuscular injection. It was clarified that the subject made an appointment at employee health for evaluation; medical attention was not required at the emergency room. The subject has discharged from the employee health clinic in stable condition. The subject did not go to the emergency room. The reporting healthcare professional considered the events may have been associated with medical history/concurrent illness of psoriatic arthritis; unclear if associated with her symptoms. At the time of reporting the events were resolved.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of allergic reaction in a 48-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date in 2011, the subject received dose of FLUARIX (details unknown). In 2011, at an unspecified time after vaccination with FLUARIX, the subject experienced allergic reaction. Per the reporting pharmacist, the subject came to her pharmacy to request a package insert for FLUARIX. The subject informed the pharmacist that she had an allergic reaction from FLUARIX when she received it last year. The pharmacist did not know if the reaction was local or systemic. Also, the pharmacist did not know where the vaccination occurred. It was unknown if the subject required medical attention. No further information was provided. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of itching in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced itching, erythema and swelling. At the time of reporting the outcome of the itching, erythema and swelling was unspecified. At the time of the report no other details were provided. This is one of two cases reported by the healthcare professional; please see case A0995582A.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, X-ray limb normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of radiating pain in arm in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 6 October 2012 the subject received 1st dose of FLUARIX (.5 ml, unknown, right arm). It was reported that the needle that was used for the injection was a BD 30 gauge ? inch. In October 2012, less than one month after vaccination with FLUARIX, the subject experienced radiating pain in arm and injection site pain. The healthcare professional reported the subject received FLUARIX on 06 October 2012 and came to the office on 17 October 2012 complaining of continuing radiating pain at the site of injection. The subject went to the emergency room but did not stay overnight. The subject wanted to get an x-ray of the area but she did not get an x-ray. The healthcare professional confirmed that the subject did not have any redness or swelling at the site of injection. At the time of the report no other details were provided. At the time of reporting the radiating pain at the site of injection were unresolved. Follow-up information was received on 14 November 2012 via healthcare professional who reported the subject continues to have pain of injection site that started on 06 October 2012. On 17 October 2012, the subject went to the emergency room due to the continued pain at right deltoid injection site. An x-ray of the right arm/shoulder was performed and "'negative' the subject was given a sling". At the time of the report the outcome of pain at injection site was improved; the reporter did not comment on the outcome of radiating pain in arm.
Sex: U
Vaccine: FLU3
Symptoms: Asthma
Clinical narrative: This case was reported by a pharmacist and described the occurrence of asthmatic reaction in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date, the subject received dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced asthmatic reaction. At the time of reporting the outcome of the event was unspecified. The pharmacist considered the event was possibly related to vaccination with FLUARIX. The pharmacist reported two subjects had asthmatic reactions to FLUARIX vaccinations (see case ID A0999291A for details on the other subject). He did not have any further information.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of numbness on side in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced numbness on left side. At the time of reporting the outcome of the numbness on the left side was unspecified. At the time of the report no other information was provided. This is the second of two cases reported by the healthcare professional; please see case A0995491A.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Foetal disorder, Injection site pain
Clinical narrative: This retrospective pregnancy case was reported by a consumer and described the occurrence of sore arm (injection site) in a 29-year-old female subject who was vaccinated with influenza vaccine (manufacturer unspecified) and influenza vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included gestational diabetes. The pregnancy was by normal conception and the mother was not using contraception. The mother had the Kell antibody in her blood (Kell antibody transfusion) and gestational diabetes and the father had the Kell antigen in his blood. In 2011 the subject received a dose of influenza vaccine (unknown, unknown arm) and in 2010, 2009, 2008, 2007 and October 2006 the subject received a dose of influenza vaccine (unknown arm for 2007-2011, left arm for October 2006). In October 2006, less than one month after vaccination with influenza vaccine, the subject experienced sore arm (injection site). The subject experienced vaccine exposure during the second trimester of pregnancy. The date of the last menstrual period was June 2006 and the estimated date of delivery was 13 March 2007. Approximately 5 months after the influenza vaccine, the subject gave birth to a live infant with no apparent congential anomaly due to the influenza vaccine. The mother's pregnancy was full term and the baby was hospitalized with jaundice for first 8 days due to the Kell antibody. The baby was bilaterally deaf due to a genetic reason. This was reported as medical history by the mother and was not reported as due to the vaccine. The mother was aware of the Kell antibody issues, gestational diabetes and genetic link prior to the influenza vaccination. Less than one year after vaccination with influenza vaccine, the subject experienced sore arm (injection site). The subject was vaccinated in 2006, 2007, 2008, 2009, 2010 and 2011 and experienced sore arm (injection site) after each vaccination. The subject was pregnant at the time of this report and planned to get the influenza vaccine for 2012-13, but had not received it yet. At the time of reporting the outcome of sore arm (injection site) was resolved. For details regarding the baby see case A0995817B. 11 December 2012 - No further information provided; patient lost to follow-up.
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Muscular weakness, Nonspecific reaction
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of insomnia in a female subject aged between 60 and 69 years old who was vaccinated with influenza vaccine (manufacturer unspecified). On 19 November 2012 the subject received unspecified dose of influenza vaccine (unknown). On 19 November 2012, less than one day after vaccination with influenza vaccine, the subject experienced insomnia, muscle weakness and nonspecific reaction. The sales representative was notified by the healthcare professional who is also the subject, of an adverse events related to a flu vaccine. The subject received the vaccine and she was not certain if she received GSK vaccine or not. The subject stated that she developed a severe reaction after receiving a flu vaccine. The side effect eventually resolved after many months, specific dates were unknown. The sales representative did not have specific details to report. At the time of reporting the events were resolved.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vertigo in a 61-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included vertigo. On 19 September 2012 the subject received 1st dose of FLUARIX (.5 unknown, unknown, left deltoid). On 20 September 2012, 1 day after vaccination with FLUARIX, the subject experienced vertigo. An employee health nurse reported that a nurse, who received the flu vaccine annually, received FLUARIX on 19 September 2012 and experienced vertigo on 20 September 2012. The vertigo resolved for about two to three days but then returned again. The physician at employee health did not believe the FLUARIX was related to the vertigo, so she referred him to his primary care physician. The subject previously experienced vertigo in January 2012, not related to a vaccination. At the time of reporting the vertigo was unresolved. The healthcare professional considered the event was unrelated to vaccination with FLUARIX.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in a 50-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included Tuberculin (TB skin test). On 16 October 2012 the subject received unspecified dose of FLUARIX (.5 ml, intramuscular, left arm). The healthcare professional stated the office carries two lots of FLUARIX, the subject may have received AFLUA702BA or AFLUA698AA, and both expire 30 June 2012. On 1 November 2012, 16 days after vaccination with FLUARIX, the subject experienced arm pain and unable to lift arm. The subject received FLUARIX and about two weeks later on 01 November 2012 she started noticing pain in her arm where she received the injection to the point that she can't raise her arm up above her shoulder. The subject consulted her physician and has a scheduled appointment at the clinic. She had a TB test done one day before receiving FLUARIX. At the time of reporting the arm pain and unable to lift arm were unresolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site mass
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hard lump at injection site in an unspecified number of subjects of unspecified age and gender who were vaccinated with FLUARIX (GlaxoSmithKline). On unspecified date(s) the subject(s) received a dose of FLUARIX (unknown details) and experienced hard lump at injection site. The reporter stated "multiple patients who have received FLUARIX complained about a hard lump at the injection site." At the time of reporting the outcome of the event was unspecified.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Exposure during pregnancy, Nausea, Vomiting in pregnancy
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of diarrhea in a 38-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report during pregnancy. No previous pregnancies. On 9 November 2012 the subject received unspecified dose of FLUARIX (unknown). Her last menstrual period was on 27 May 2012 and estimated date of delivery was 03 March 2013. The subject reported she is having a C-section, date not yet scheduled. The pregnancy was by normal conception with no contraception. No evidence of a defect from prenatal testing. The subject was exposed to FLUARIX during the second trimester. On 09 November 2012, at the time of vaccination with FLUARIX, the subject experienced diarrhea, nausea, morning sickness and vaccine exposure during pregnancy. Within the same week, at an unspecified time after vaccination with FLUARIX, the subject experienced diarrhea, nausea, and morning sickness. The subject stated she has not had nausea or morning sickness with her pregnancy until she received FLUARIX. The symptoms were getting better; at the time of the report the diarrhea was mild. At the time of reporting the diarrhea, nausea, and morning sickness were improved. 06 May 2013 - No further information provided; patient lost to follow-up.