chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: This prospective pregnancy case was reported by a consumer (husband of subject) and described the occurrence of arm soreness at injection site in a 26-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. Concurrent medical conditions included uterine fibroid. The subject had no previous pregnancies. The mother was not using contraception and they type of conception was normal. There was no evidence of a defect from prenatal testing. There was no paternal history which may have an impact on the outcome of this pregnancy. On 23 December 2013 at 19:30 the subject received a dose of BOOSTRIX (.5 ml, unknown details, left deltoid) and experienced vaccine exposure during the 3rd trimester of pregnancy. The gestational age at the time of vaccination was 33 weeks per the reporter. The date of last menstrual period was unknown. The estimated date of delivery was reported as 13 February 2014 per the reporter. On 23 December 2013, less than one day after vaccination with BOOSTRIX, the subject experienced arm soreness at injection site. There was no evidence of defect from prenatal testing. At the time of reporting, the pregnancy was ongoing. At the time of reporting the events were unresolved. Follow up was received from the subject on 22 January 2014. The subject provided the lot number of BOOSTRIX that was administered. The date of last menstrual period was reported as May 2013. Follow-up information was received on 13 May 2014 via healthcare professional who reported that the outcome of the pregnancy was unknown. The healthcare professional stated they did not "provide this service" (vaccination) and to contact the physician who treated the patient with BOOSTRIX. No other information was provided. The case was closed as lost to follow-up.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Amniocentesis normal, Exposure during pregnancy, Injection site pain, Ultrasound antenatal screen normal
Clinical narrative: This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) for prophylaxis during pregnancy. A physician or other health care professional has not verified this report. The subject's medical history included cut finger. Per the reporter, she received BOOSTRIX as "prophylaxis after cut on finger". There were no past pregnancies. The subject was not using contraception and the conception was normal. There was no evidence of defect from prenatal testing. There was no maternal and paternal history which may have an impact on the outcome of this pregnancy. On 17 December 2013 the subject received a dose of BOOSTRIX (.5 ml, injection, left arm) and experienced vaccine exposure during the 2nd trimester of pregnancy. The gestational age per the subject was 6 months (24 weeks). The date of last menstrual period was unknown. The estimated date of delivery was reported as 10 April 2014. Diagnostic tests included the following on unknown dates: ultrasound examination, amniocentesis, and Alphafetoprotein normal (maternal serum). There was no evidence of defect from prenatal testing. On 17 December 2013, within hours of vaccination with BOOSTRIX (described as "later that night"), the subject experienced sore arm (injection site). The subject remembered the event "because she could not sleep on her left side because of the pain." The subject reported that her "physician had told her that this might be a side effect." At the time of reporting the events were "improved a little since then." 18 June 2014- No further information was provided; patient lost to follow-up. Follow-up information was received on 19 August 2014 via subject. The subject stated she did not want any additional follow-up letters sent and is not willing to provide permission for GSK to contact her healthcare provider. No other information provided, case closed.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of sore arm in a 38-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject was not using contraception and the method of conception was intrauterine insemination. There was no evidence of defect from prenatal testing. There was no maternal and paternal history which may have an impact on the outcome of this pregnancy. On 4 November 2013 the subject received a dose of BOOSTRIX (intramuscular, unknown details) and experienced vaccine exposure during the 3rd trimester of pregnancy. The gestational age was calculated to be 30 weeks. The date of last menstrual period was reported as 9 April 2013. The estimated date of delivery was reported as 13 January 2014 per the subject. At the time of reporting, the pregnancy was ongoing. On 4 November 2013, within hours of vaccination with BOOSTRIX, the subject experienced sore arm (injection site). At the time of reporting the events were resolved. The subject reported that the event was related to the BOOSTRIX. 12 March 2014: No further information provided; patient lost to follow-up.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complained of soreness and "cannot lift his arm up" in his left arm where he received two vaccinations - Pneumovax-23 and Fluvirin PF, intramuscularly.  Complained about the arm in the evening of the same day when he received his vaccinations.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood culture negative, Injection site vesicles, Pyrexia, Vaccination site erythema
Clinical narrative: Fever up to 103.1 degrees Fahrenheit. About a 5 inch patch of erythema on upper arm where vaccine was administered. 2 blisters on the upper arm.
Age: 35.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Cold sweat, Dizziness, Fatigue, Feeling cold, Loss of consciousness
Clinical narrative: Passed out after getting simultaneous Hep B vaccination and Anthrax booster.  Cold, clammy, tunnel vision prior to passing out.  Only out for a few seconds.  Cold, clammy, thirsty, fatigued, and dizzy afterwards for about an hour.
Age: 35.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Thirst, Tunnel vision
Clinical narrative: Passed out after getting simultaneous Hep B vaccination and Anthrax booster.  Cold, clammy, tunnel vision prior to passing out.  Only out for a few seconds.  Cold, clammy, thirsty, fatigued, and dizzy afterwards for about an hour.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: BLACK & BLUE, HARD LUMP AT SITE OF INJECTION, RED STREAK FROM SITE TO ELBOW NO FEVER, NO STOMACH UPSET & NO DIARRHEA.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site streaking
Clinical narrative: BLACK & BLUE, HARD LUMP AT SITE OF INJECTION, RED STREAK FROM SITE TO ELBOW NO FEVER, NO STOMACH UPSET & NO DIARRHEA.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Headache, Thirst, Upper respiratory tract congestion
Clinical narrative: Severe headache, chills, thirst, upper respiratory congestion.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Product quality issue, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional (office manager) via sales representative and described the occurrence of pertussis in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 12 April 2012 the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced pertussis and vaccination failure. This case was associated with a product complaint as the physician questioned the lot number. No further details were provided by the healthcare professional. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. The healthcare professional reported another case with BOOSTRIX. See case A1047553A for details on the other case. Quality Assurance results and safety statement was received 06 November 2013. A safety assessment was requested, an evaluation was performed and the conclusion shows that: considering the currently available data for batch number AC52B077AA (and family), it is unlikely that the reported events are linked to a manufacturing issue. No further investigation is required. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 19 years old, non pregnant, female patient (the pharmacist's daughter). The patient did not have any pertinent medical history and drug reactions or allergies. On an unknown dates, the patient was vaccinated with GARDASIL (dose 1, 2 and 3) (doses, routes of administration, lot numbers and expiration dates were not reported). On an unknown dates, after receiving her first two doses of GARDASIL, the patient experienced pain at the injection site. The pain resolved on an unknown dates, by the next day after each injection of GARDASIL. There was no treatment given for adverse events and no lab diagnostics studies performed. The patient did not experienced pain at the injection site with the third injection of GARDASIL. The relatedness between the events and the vaccination with GARDASIL was unknown. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Vaccination site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccination site pain in a subject of unspecifie4d age and gender who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On or about 7 February 2014 the subject received a dose of BOOSTRIX (unknown). On an unspecified date in February 2014, less than one month after vaccination with BOOSTRIX, the subject experienced vaccination site pain. The reporter stated the subject received BOOSTRIX 14 days prior to this report and was experiencing pain at the injection site. At the time of the report no other information was provided. At the time of reporting the event was unresolved.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Headache, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of arm pain at injection site in a 34-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). Historic vaccination included Tetanus vaccine (non-GSK); unknown given in 2008. Medical history included vaccination site infection in 2008. Co-suspect medication included Cephalexin. On 17 February 2014 at 14:00 the subject received a dose of BOOSTRIX (.5 ml, unknown, left deltoid). On 19 February 2014, 2 days after vaccination with BOOSTRIX, the subject experienced his arm was red, hurting and that he was running a fever. The physician advised the subject to take some TYLENOL. The medical assistant reported that the subject came into the office on 20 February 2014 and reported that he had been running a temperature, though he did not have a temperature in the office. At that time, the subject also reported that the pain was radiating down his left arm. On 20 February 2014, the subject was prescribed Cephalexin. On 24 February 2014, the subject returned to the physician's office complaining of headache in addition to arm redness and arm pain at the injection site. The subject did not have a fever and the subject was prescribed Prednisone. At the time of reporting the redness at vaccination site, arm pain at the injection site, radiating pain in arm, and headache were unresolved; the fever had resolved.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of arm pain at injection site in a 34-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). Historic vaccination included Tetanus vaccine (non-GSK); unknown given in 2008. Medical history included vaccination site infection in 2008. Co-suspect medication included Cephalexin. On 17 February 2014 at 14:00 the subject received a dose of BOOSTRIX (.5 ml, unknown, left deltoid). On 19 February 2014, 2 days after vaccination with BOOSTRIX, the subject experienced his arm was red, hurting and that he was running a fever. The physician advised the subject to take some TYLENOL. The medical assistant reported that the subject came into the office on 20 February 2014 and reported that he had been running a temperature, though he did not have a temperature in the office. At that time, the subject also reported that the pain was radiating down his left arm. On 20 February 2014, the subject was prescribed Cephalexin. On 24 February 2014, the subject returned to the physician's office complaining of headache in addition to arm redness and arm pain at the injection site. The subject did not have a fever and the subject was prescribed Prednisone. At the time of reporting the redness at vaccination site, arm pain at the injection site, radiating pain in arm, and headache were unresolved; the fever had resolved.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (pharmacy intern) and described the occurrence of arm soreness at injection site in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 19 January 2014 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm). In 2014, less than one month after vaccination with BOOSTRIX, the subject experienced arm soreness at injection site and injection site movement impairment. The reporter stated that the subject's arm is "still sore." After the vaccination, the subject had not been able to "life her arm over her head." The reporter was not sure of when the events started. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow-up information was received on 14 March 2014 via healthcare professional who reported the events were unresolved. No action was taken with BOOSTRIX. At the time of the report no other information was provided.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Hepatic enzyme increased
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of increased liver enzymes in a 61-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced increased liver enzymes. No further details were provided. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was related to vaccination with BOOSTRIX. The subject, who was a physician, "complained to the nurse that he thinks it was BOOSTRIX that increased his liver enzymes."
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (office manager and subject) via sales representative and described the occurrence of fever in a female subject aged between 40 and 49 years old ("around 45 years old") who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (1 "adult dose", unknown details). On the same day as vaccination with BOOSTRIX, the subject experienced fever and pain (described as "aches and pain"). The reporter stated that the events were systemic. At the time of reporting the events were resolved within 48 hours. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis, Bursitis, Injection site discomfort, Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a healthcare professional (certified medical assistant) and described the occurrence of injection site pain in a 49-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included arthritis, bursitis, hypercholesterolemia and low back pain. Concurrent medications included amlodipine, liothyronine, multivitamins, FLONASE, ALLEGRA and SYNTHROID. On 17 January 2014 at 12:00 the subject received a dose of BOOSTRIX (.5 ml, intramuscular, left deltoid). On 17 January 2014, immediately after vaccination with BOOSTRIX, the subject experienced injection site pain (described as "achiness in her left arm") and injection site discomfort (described as constantly switching and repositioning arm). Per the pharmacist, the subject took EXCEDRIN and ibuprofen as treatment but they did not help and the achiness has worsened. Per the pharmacist, "because of her arm throbbing and aching, the [subject] has to constantly switch and reposition her arm." The pharmacist reported that, in January 2014, the subject described injection site pain as "radiating down to her left scapula." In January of 2014, weeks after vaccination with BOOSTRIX, the subject experienced worsening of bursitis and arthritis aggravated. The pharmacist stated that the subject "now says her bursitis and arthritis have been exacerbated." According to the pharmacist at the time of reporting, medical attention was not required. The subject was treated with EXCEDRIN and ibuprofen. At the time of reporting the events were worse. Follow-up information received on 19 February 2014 via medical assistant. Additional medical conditions included hypertension and chronic lymphocytic thyroiditis. The medical assistant reported the subject's diagnosis was acute shoulder pain. The onset of the events was clarified to be 28 January 2014. The medical assistant associated the events with the subject's medical history/ concurrent illness of left shoulder arthritis. No action was taken with BOOSTRIX. The reporting healthcare professional did not consider the events to be serious. At the time of the report the events were reported to be improved.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: This case was reported by a healthcare professional (certified medical assistant) and described the occurrence of injection site pain in a 49-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included arthritis, bursitis, hypercholesterolemia and low back pain. Concurrent medications included amlodipine, liothyronine, multivitamins, FLONASE, ALLEGRA and SYNTHROID. On 17 January 2014 at 12:00 the subject received a dose of BOOSTRIX (.5 ml, intramuscular, left deltoid). On 17 January 2014, immediately after vaccination with BOOSTRIX, the subject experienced injection site pain (described as "achiness in her left arm") and injection site discomfort (described as constantly switching and repositioning arm). Per the pharmacist, the subject took EXCEDRIN and ibuprofen as treatment but they did not help and the achiness has worsened. Per the pharmacist, "because of her arm throbbing and aching, the [subject] has to constantly switch and reposition her arm." The pharmacist reported that, in January 2014, the subject described injection site pain as "radiating down to her left scapula." In January of 2014, weeks after vaccination with BOOSTRIX, the subject experienced worsening of bursitis and arthritis aggravated. The pharmacist stated that the subject "now says her bursitis and arthritis have been exacerbated." According to the pharmacist at the time of reporting, medical attention was not required. The subject was treated with EXCEDRIN and ibuprofen. At the time of reporting the events were worse. Follow-up information received on 19 February 2014 via medical assistant. Additional medical conditions included hypertension and chronic lymphocytic thyroiditis. The medical assistant reported the subject's diagnosis was acute shoulder pain. The onset of the events was clarified to be 28 January 2014. The medical assistant associated the events with the subject's medical history/ concurrent illness of left shoulder arthritis. No action was taken with BOOSTRIX. The reporting healthcare professional did not consider the events to be serious. At the time of the report the events were reported to be improved.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Burning sensation
Clinical narrative: This case was reported by a physician and described the occurrence of blister of wrist in a 25-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included reaction to vaccination. The physician reported that the subject "previously had a tetanus shot in 2002 and she got blisters on her body. They would come on different areas of her body and eventually they went away." On 22 January 2014 at 16:20 the subject received a dose of BOOSTRIX (.5 ml, unknown details, left arm). On 27 January 2014, 5 days after vaccination with BOOSTRIX, the subject experienced blister of wrist and burning sensation (forearm). Per the physician, the subject developed a blister on her right wrist. The physician reported that the subject stated "her wrist was burning and she feels that another one [blister] is coming." At the time of reporting the events were unresolved.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site soreness in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to TYLENOL, chronic pain, codeine allergy and penicillin allergy. Concurrent vaccination included varicella virus vaccine (non-gsk); Merck; subcutaneous; right arm given on 20 December 2013. Concurrent medications included LEXAPRO, Bupropion hydrochloride, Alendronate sodium, LYRICA, ADVAIR diskus, SPIRIVA, BUSPAR, TOPAMAX, LIDODERM, NORCO, Metformin hydrochloride, Furosemide, LIPITOR, ZOLOFT, and VALTREX. On 20 December 2013 at 13:15 the subject received a doe of BOOSTRIX (.5 ml, unknown, left deltoid). On the evening of 21 December 2013, 1 day after vaccination with BOOSTRIX, the subject experienced "site soreness below the injection site near the medial tricep of the left arm" (injection site soreness). At the time of reporting the injection site soreness was improved. The pharmacist considered the event was possibly related to vaccination with BOOSTRIX.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Incorrect dose administered, Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema of arm at injection site in a 68-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) PNEUMOVAX. Concurrent medical conditions included allergic to sulfur. Historic vaccination included BOOSTRIX; GlaxoSmithKline; unknown; unknown given in February 2013. Concurrent medications included METFORMIN and CRESTOR. On 21 January 2014 the subject received 2nd dose of BOOSTRIX (unknown details, unknown arm), unspecified dose of PNEUMOVAX (unknown details) and experienced extra dose administered. Per the reporter, the subject "was given 2 doses of BOOSTRIX in an eleven month period." BOOSTRIX is indicated as one dose. On 21 January 2014, described as "evening time", within hours of vaccination with BOOSTRIX and PNEUMOVAX, the subject experienced erythema of arm at injection site (described as "redness in arm"). It was unclear from the report as to the specific locations of administration of two vaccinations. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX. It was unclear from the report if the healthcare professional considered the events related to PNEUMOVAX.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (.5 ml, subcutaneous, unknown site) and experienced intramuscular formulation administered by other route. The BOOSTRIX is indicated to be administered intramuscularly. At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site pain and injection site redness. The nurse practitioner reported that "BOOSTRIX was inadvertently administered subcutaneously and caused pain and redness at the injection site." At the time of reporting the outcome of the events were unspecified.
Sex: F
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via claims management company and described the occurrence of adverse event(s) in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 8 September 2013 the subject received a dose of BOOSTRIX (unknown details). Within months of vaccination with BOOSTRIX, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
Sex: U
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via claims management company and described the occurrence of adverse event(s) in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 2 January 2014 the subject received a dose of BOOSTRIX (unknown details). In January 2014, within a month of vaccination with BOOSTRIX, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
Sex: F
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via a pharmacy claims management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 5 December 2013 the subject received unspecified dose of BOOSTRIX (unknown details). In December 2013, less than one month after vaccination with BOOSTRIX, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Age: 21.0
Sex: M
Vaccine: TDAP, TYP, YF
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of syncope in a 21-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included typhoid vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 5 December 2013. Concurrent medications included Yellow fever vaccines (Non-GSK). On 5 December 2013 the subject received 1st dose of BOOSTRIX (unknown, left arm). On 5 December 2013, immediately after vaccination with BOOSTRIX, the subject experienced syncope. On 5 December 2013, the syncope was resolved.
Sex: F
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: This case was reported by a pharmacist and described the occurrence of lingering headache in an elderly female subject over the age of 70-years-old who was vaccinated with BOOSTRIX (GlaxoSmithKline). On or about 10 November 2013 at 11:00 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown). On an unspecified date in November 2013, within weeks of vaccination with BOOSTRIX, the subject experienced mild lingering headache. The pharmacist stated that the subject was over 70-years old and received BOOSTRIX because she was going to visit younger relatives and wanted to have pertussis coverage. The pharmacist stated that the vaccine was administered 12 days from this report (approximately 10 November 2013) and the headache still exists. The pharmacist believes it is probably related to BOOSTRIX because the subject does not have allergy or sinus problems. Specified details regarding the vaccination (lot number, expiration and subject details) were not available at the time of the report. At the time of reporting the lingering headache was unresolved. The pharmacist considered the event was probably related to vaccination with BOOSTRIX.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 75-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Pioglitazone, Glimepiride, Omeprazole, Atorvastatin calcium, Metformin hydrochloride, Lisinopril+Hydrochlorothiazide. On 4 November 2013 at 10:00 the subject received a dose of BOOSTRIX (unknown, left arm). On an unspecified date in November 2013, within a couple of days after vaccination with BOOSTRIX, the subject experienced swelling injection site and injection site redness. In November 2013, one to two weeks after vaccination with BOOSTRIX, the subject experienced injection site lump. The subject was administered BOOSTRIX, about one week after the injection, the subject returned to the pharmacy with redness and swelling at the injection site. The pharmacist stated that the redness and swelling was about two inches in diameter. She counseled the subject that this can occur and would resolve. The subject returned home. The subject returned to the pharmacy again after another week and the redness and swelling at injection had resolved, but she now had a lump that could be felt at the injection site (injection site lump). The reporter did not know the exact timeline of events, but the redness and swelling started a couple days after the injection and resolved sometime between one to two weeks after the injection. The pharmacist did know if the subject had sought medical attention beyond speaking with the pharmacy. At the time of reporting the swelling injection  site and injection site redness resolved; injection site lump was unresolved. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. Follow up received from pharmacist on 22 January 2014. The pharmacist reported that they "contacted the CDC for adverse reaction information but no official report was made." The pharmacist provided no additional details.
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of hives in an adult female subject who was vaccinated with DTAP (manufacturer unspecified) (non-gsk). A physician or other health care professional has not verified this report. On an unspecified date, between the mid 1970s and 2000, the subject received unspecified dose of DTAP (unknown) or unspecified dose of Tetanus vaccine (Non-GSK) (unknown). Between the mid 1970s and 2000m at an unspecified time after vaccination with DTAP or Tetanus vaccine (Non-GSK) (unknown), the subject experienced major hives and shortness of breath. The subject received either a TDAP or tetanus shot between the mid 1970s and the year 2000 and experienced adverse events or major hives and shortness of breath. The subject was given a shot (unk injection) at the physician office after administration that relieved her symptoms. She does not know the exact facility that the vaccine was administered. At the time of reporting the hives and shortness of breath were resolved.
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nodule injection site in an adult female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). Within days of vaccination with BOOSTRIX, the subject experienced nodule injection site. It was reported that a nodule formed after a female subject was vaccinated with BOOSTRIX. The subject returned to the pharmacy six days after vaccination, the pharmacist reported that the nodule was not red or painful. At the time of reporting the outcome of the nodule injection site was unspecified.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site haemorrhage, Wrong technique in drug usage process
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bruise injection site in a 68-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On or about 25 September 2013 the subject received unspecified dose of BOOSTRIX (unknown). On 25 September 2013, immediately after vaccination with BOOSTRIX, the subject experienced injection site bleeding and wrong injection technique. Within days of vaccination the subject experienced bruise injection site. The pharmacist reported the subject was vaccinated with BOOSTRIX approximately four weeks prior to this report on 25 September 2013. "It appears the vaccine was administered approximately two inches below the deltoid" (wrong injection technique). The subject experienced a quarter-size bruise which continues. The subject also noticed blood upon withdrawal of the needle from the arm at the time of injection. At the time of reporting the injection site bleeding was resolved; bruise injection site was unresolved.
Sex: U
Vaccine: TDAP
Symptoms: Discomfort, Pain, Paraesthesia, Swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling, discomfort, soreness and tingling down arm (described as "tingling down arm to hand." It was unclear from the reporter if the events occurred at the injection site. No further details were provided at the time of reporting. At the time of reporting the outcome of the events were unspecified.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse event, Syncope
Clinical narrative: This case was reported by a consumer (subject's father) via a claims benefit company and described the occurrence of fainting in a female subject (a minor) of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 12 September 2012 the subject received a dose of BOOSTRIX (unknown details). On 12 September 2012, within minutes of vaccination with BOOSTRIX, the subject experienced fainting. No additional details were provided. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 11 November 2013 via pharmacist who reported the 12-year-old subject experienced "synergetic effect" in addition to fainting within minutes of receiving BOOSTRIX intramuscularly on 20 August 2013. The pharmacist reported discrepant information regarding the onset dates; previously the onset date of the fainting was 12 September 2012, currently the onset of fainting and "synergetic effect" is 20 August 2013. The fainting and "synergetic effect" resolved on 20 August 2013. The reporting pharmacist did not consider the events serious. The pharmacist did not attribute the events to erroneous administration or suspected transmission of an infectious agent via medicinal product. No action was taken with BOOSTRIX.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Myalgia, Paraesthesia
Clinical narrative: This case was reported by a retired healthcare professional (also the subject) and described the occurrence of muscle pain in a 60-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 24 July 2013 the subject received a dose of BOOSTRIX (details unknown). During the weeks following vaccination with BOOSTRIX, the subject experienced muscle pain, tingling and stiffness. At the time of reporting the outcome of the events was unspecified. The healthcare professional declined to provide any further information.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm numbness in a 52-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to gluten. Concurrent medications included Levothyroxine. On 3 May 2013 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On the morning of 4 May 2013, 1 day after vaccination with BOOSTRIX, the subject experienced arm numbness and leg numbness. The numbness occurred in the left arm and left leg. These events resolved. On 24 May 2013, the subject sought medical attention from the doctor with "numbness in the left arm and numbness in the left leg and this resolved itself as well." The doctor referred the subject to a neurologist for evaluation. Per the reporter, the physician was "not sure if this [was] a reaction to the vaccination or not." At the time of reporting the events were resolved. Follow up was received from a physician on 10 September 2013. The physician documented that the events onset on 4 May 2013, 1 day after vaccination with BOOSTRIX. The physician documented that the outcome was unknown; however, the events were previously reported as resolved. The physician did not consider this case serious.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Wound
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of rash aggravated in a 42-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). Concurrent medical conditions included puncture wound and rash. The subject was administered BOOSTRIX on 12 August 2013 after coming into the office with a puncture wound and rash. Historic vaccination included Td vaccine; manufacturer unspecified; unknown; unknown given in 1999. On 12 August 2013 the subject received a dose of BOOSTRIX (unknown details). On 14 August 2013, 2 days after vaccination with BOOSTRIX, the subject experienced rash aggravated (described as "worsening rash"). The subject was possibly treated with prednisone. The nurse practitioner wanted to prescribed prednisone for the subject. At the time of reporting the event was worse.
Sex: F
Vaccine: TDAP
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site pain, Injection site urticaria, Skin discolouration
Clinical narrative: This case was reported by a healthcare professional (subject and receptionist of physician office) and described the occurrence of numbness at the injection site in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). In July 2013 the subject received a dose of BOOSTRIX (unknown details, left deltoid). In July 2013, less than one day after vaccination with BOOSTRIX (described as "throughout the day of receiving the vaccine"), the subject experienced numbness at the injection site (described as "localized numbness"), injection site throbbing (described as local reaction of "arm was throbbing"). In July 2013, at an unknown duration of time after vaccination with BOOSTRIX, the subject experienced red welt at injection site, bruise injection site and injection site discoloration. The reaction was described as looking "like a bruise in the deltoid muscle that was wide in circumference along with a red welt at the site of injection." The subject's arm was still green in color at the time of reporting. At the time of reporting the events of numbness at the injection site and injection site throbbing had resolved. At the time of reporting, the events of red welt at injection site, bruise at injection site and injection site discoloration had been reported as improved by the subject.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On 6 June 2013 at 11:45 the subject received a dose of KINRIX (.5 ml, unknown route, left thigh) as the 5th dose in the series, and experienced vaccine administered at inappropriate site. KINRIX was administered in the thigh rather than the deltoid as indicated. On 6 June 2013, 12 hours after vaccination with KINRIX, the subject experienced swelling injection site, injection site redness and injection site rash ("rash down leg"). The adverse events were reported as local injection site reactions. The subject was treated with antibiotics, and medical attention was required at a doctor's office. At the time of reporting the events were resolved within approximately 8 to 9 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a healthcare professional and describe the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included varicella virus vaccine (non-gsk); manufacturer unspecified; unknown given on 17 June 2013. On 17 June 2013 at 14:00 the subject received a dose of KINRIX (.5 ml, unknown route, left thigh) as the 5th dose in the series, and experienced vaccine administered at inappropriate site. KINRIX was administered in the thigh rather than the deltoid as indicated. On 18 June 2013, 24 hours after vaccination with KINRIX, the subject experienced injection site redness and swelling injection site. The adverse events of redness and swelling were reported as local injection site reactions. The subject was treated with antibiotics. The events resolved approximately 6 days later.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 43-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). The subject's medical history included umbilical hernia and wart. The subject had no allergy and no previous reaction to vaccination. On 10 June 2014 the subject received unspecified dose of BOOSTRIX (0.5 ml, intramuscular, right arm). On 11 June 2014, 1 day after vaccination with BOOSTRIX, the subject experienced fever and swelling at injection site. The injection site also became red, itchy and painful. He was seen at the office on 13 June 2014. The subject was advised to use ibuprofen, TYLENOL and KEFLEX. Fever resolved on 14 June 2014. At the time of reporting, the injection site reaction was improving. The nurse was not sure if it was a local reaction or a bacterial infection of the skin. Follow-up information received on 14 July 2014: On 10 June 2014 (not on 11 June 2014 as previously reported), less than one day after vaccination with BOOSTRIX, the subject experienced fever and swelling at injection site. The injection site also became red, itchy and painful. On 14 June 2014, the events were resolved.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site pain in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX (unknown route and injection site). Less than one week after vaccination with BOOSTRIX, the subject experienced injection site pain. The event was still unresolved 4 days after vaccination. Follow-up information received on 1 July 2014: Subject details were provided. Injection site pain occurred on 23 May 2014. Vaccine reporting physician details were provided.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 50-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included arthritis. Concurrent medications included Multivitamins and Magnesium. On 18 April 2014, the subject received booster dose of BOOSTRIX (route unknown, right arm, batch number not provided). On 19 April 2014, 1 day after vaccination with BOOSTRIX, the subject experienced injection site soreness, muscle stiffness and muscle pain in her right arm which came and went and stiff neck. Sometimes, she also had muscle pain in her left arm. On 25 April 2014, injection site soreness was resolved. At the time of reporting, muscle stiffness and pain and stiff neck were improved.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 57-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). No other vaccines were given on the same date. There were no significant allergies or any history of any reaction to a vaccine before. On 28 April 2014, the subject received an unspecified dose of BOOSTRIX (administration site and route unknown). On 28 April 2014, 5 to 10 minutes after vaccination with BOOSTRIX, the subject experienced a rash on her upper chest. The subject was treated with BENADRYL. At the time of reporting, the outcome of the event was unspecified.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 30-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). Concomitant medication was not reported. The subject had no reactions to other vaccines. No allergies to medication. On 31 March 2014, the subject received an unspecified dose of BOOSTRIX (route unknown, left arm). On 31 March 2014, immediately after vaccination with BOOSTRIX, the subject experienced swelling injection site. Then, symptoms went away. After that, she started getting injection site pain when she exercised or moved the arm. At the time of reporting, injection site pain was unresolved. Follow-up information received on 29 May 2014: At the time of reporting, injection site pain was resolved.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pruritus in a 72-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Carvedilol, Ramipril and VYTORIN. On 3 March 2014 at 13:40 the subject received a dose of BOOSTRIX (.5 unknown, unknown). Less than one week after vaccination with BOOSTRIX, the subject experienced injection site pruritus and knot at injection site. The pharmacist reported that the subject received vaccine on 03 March 2014 and for the past week he has experienced a knot and itching at the site. No treatment has been applied or taken. The subject contacted the pharmacy on 10 March 2014 at 22:00 with this report. At the time of reporting the events were unresolved. Follow-up information was received on 07 April 2014 via pharmacist who reported no action was taken with BOOSTRIX. No other information was provided. At the time of the report the outcome of the events was not specified.