chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Injection site pain, Laboratory test normal, Prenatal screening test
Clinical narrative: This prospective pregnancy case was reported by a consumer (mother of subject) and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female subject who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. The subject had no previous pregnancies. The subject was not using contraception for the current pregnancy. There was no evidence of a defect from prenatal testing. There was no maternal or paternal history which may have an impact on the current pregnancy. On 11 September 2013 the subject received a dose of FLUARIX Quadrivalent (intramuscular, unknown details) and experienced vaccine exposure during the 1st trimester of pregnancy. The gestational age was calculated to be 8 weeks. The date of last menstrual period was reported as 17 July 2013 and the estimated date of delivery was reported as 10 May 2014. There was no evidence of a defect from prenatal testing. At the time of reporting, there were no adverse events reported and the pregnancy was ongoing. On 11 September 2013, on the same day as vaccination with FLUARIX Quadrivalent (described as "on Wednesday"), the subject experienced injection site pain. The subject's mother reported that the subject experienced arm pain "where she received the vaccine on Wednesday". The outcome of the injection site pain was resolved. At the time of reporting, the mother of the subject reported that the "pain is gone".
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of injection site pain in approximately 20 subjects of unspecified age and gender who were vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). On an unspecified date in 2013 the subjects received a dose of FLUARIX Quadrivalent (unknown details). In 2013, within months of vaccination with FLUARIX Quadrivalent, the subjects experienced injection site pain, injection site redness, swelling at the injection site and nodule at the injection site. The nurse reported from multiple sources that "they have experienced fairly significant local reactions to FLUARIX" Quadrivalent. The nurse reported that one subject was a physician who contacted GlaxoSmithKline. The nurse documented that she "did not have any information on the patients affected but instructed the employees to call GlaxoSmithKline if experiencing any side effects following FLUARIX QIV administration". At the time of reporting the outcome of the events were unspecified. The nurse reported another case with FLUARIX QIV. See case A1043774A for details on the other case. Follow up was received from the nurse on 21 October 2013. The nurse reported that the case had been reported to a regulatory agency; however, the reference number was not provided. No further details were provided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Local swelling, Musculoskeletal pain, Neck pain
Clinical narrative: Arm swelled, turned red and extremely painful.  Pain extended to shoulder, up my neck, under my arm etc.  Very painful to touch. Hot to touch. Pain began to subside 6/26/2014 about 2:00 PM. As of 6/27/2014, most of pain is gone.  Still some swelling and redness.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm, Tenderness
Clinical narrative: Arm swelled, turned red and extremely painful.  Pain extended to shoulder, up my neck, under my arm etc.  Very painful to touch. Hot to touch. Pain began to subside 6/26/2014 about 2:00 PM. As of 6/27/2014, most of pain is gone.  Still some swelling and redness.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: PT has red rash around injection site on L arm. Pt described rash as itchy and hot. PT complaining that the rash started to get sore to the touch.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Local reaction, Pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in arm from flu shot in a 38-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 September 2013 (in the afternoon) the subject received a dose of FLUARIX (.5 cc, unknown route, left deltoid). On 16 September 2013, immediately after vaccination with FLUARIX, the subject experienced "shooting pain from injection site down to wrist". The event was reported as a local injection site reaction. On 17 September 2013, the event was resolved. The healthcare professional considered the event was probably related to vaccination with FLUARIX. On 11 October 2013, follow-up was received from the healthcare professional. It was reported that the 'pain in arm from flu shot' resolved on 18 September 2013 (initial report indicated the event resolved on 17 September 2013). The reporter did not consider the event to be serious. It was indicated that this case was not reported to a regulatory agency. It was reported that no action was taken with the FLUARIX. The subject had received FLUARIX before. The subject had not experienced any adverse events following previous vaccinations.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Exposure during pregnancy, Fatigue, Hyperhidrosis, Injection site erythema, Injection site mass
Clinical narrative: This case was reported by a physician (subject) and described the occurrence of red around injection site in a 37-year-old female subject who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). Concurrent medications included Vitamins. On 17 September 2013 at 15:00 the subject received a dose of FLUARIX Quadrivalent (.5 ml, unknown route, left arm). On 19 September 2013, 2 days after vaccination with FLUARIX Quadrivalent, the subject experienced red around injection site, injection site lump, injection site warmth (described as "increased warmth" at injection site), injection site tenderness. In September 2013, within days after vaccination with FLUARIX Quadrivalent, the subject experienced low grade fever, diaphoresis (described as "sweating on face") and fatigue. At the time of reporting the events of red around injection site, injection site lump, injection site warmth, low grade fever, diaphoresis, and fatigue were resolved "within 48 to 36 hours after injection." The physician reported that the injection site tenderness was unresolved and "still evident". The physician considered the events were probably related to vaccination with FLUARIX Quadrivalent. This physician mentioned that this case was also reported to GlaxoSmithKline. See case A1042502A for details on the other case. Follow up was received from physician on 31 October 2013. This prospective pregnancy case was reported by the physician on follow up. The physician reported that on 17 September 2013, she received a primary dose of FLUARIX Quadrivalent (intramuscular) and also experienced vaccine exposure during the first trimester of pregnancy. Concurrent medications included prenatal vitamin. The gestational age was calculated to be 3 weeks. The date of last menstrual period was reported as 22 August 2013. The estimated date of delivery was calculated to be 29 May 2014. At the time of reporting, the pregnancy was ongoing. The physician did not consider the events experienced as serious. The physician reported that the events began on 17 September 2013, on the same date as vaccination with FLUARIX Quadrivalent. The physician documented that all events were resolved on 20 September 2013. The diagnosis was "localized vaccine relationship." Per the physician the immunization series was not discontinued or delayed. The following information was received on 31 January 2014 via subject who is also a physician. The subject's last menstrual period occurred on 22 August 2013 and estimated date of delivery was 29 May 2014. The pregnancy was by normal conception and consisted of a single fetus. The subject was exposed to FLUARIX at 3 5/7 weeks gestation. At the time of the report the outcome of the pregnancy was ongoing and "healthy pregnancy so far".
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a physician (subject) and described the occurrence of red around injection site in a 37-year-old female subject who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). Concurrent medications included Vitamins. On 17 September 2013 at 15:00 the subject received a dose of FLUARIX Quadrivalent (.5 ml, unknown route, left arm). On 19 September 2013, 2 days after vaccination with FLUARIX Quadrivalent, the subject experienced red around injection site, injection site lump, injection site warmth (described as "increased warmth" at injection site), injection site tenderness. In September 2013, within days after vaccination with FLUARIX Quadrivalent, the subject experienced low grade fever, diaphoresis (described as "sweating on face") and fatigue. At the time of reporting the events of red around injection site, injection site lump, injection site warmth, low grade fever, diaphoresis, and fatigue were resolved "within 48 to 36 hours after injection." The physician reported that the injection site tenderness was unresolved and "still evident". The physician considered the events were probably related to vaccination with FLUARIX Quadrivalent. This physician mentioned that this case was also reported to GlaxoSmithKline. See case A1042502A for details on the other case. Follow up was received from physician on 31 October 2013. This prospective pregnancy case was reported by the physician on follow up. The physician reported that on 17 September 2013, she received a primary dose of FLUARIX Quadrivalent (intramuscular) and also experienced vaccine exposure during the first trimester of pregnancy. Concurrent medications included prenatal vitamin. The gestational age was calculated to be 3 weeks. The date of last menstrual period was reported as 22 August 2013. The estimated date of delivery was calculated to be 29 May 2014. At the time of reporting, the pregnancy was ongoing. The physician did not consider the events experienced as serious. The physician reported that the events began on 17 September 2013, on the same date as vaccination with FLUARIX Quadrivalent. The physician documented that all events were resolved on 20 September 2013. The diagnosis was "localized vaccine relationship." Per the physician the immunization series was not discontinued or delayed. The following information was received on 31 January 2014 via subject who is also a physician. The subject's last menstrual period occurred on 22 August 2013 and estimated date of delivery was 29 May 2014. The pregnancy was by normal conception and consisted of a single fetus. The subject was exposed to FLUARIX at 3 5/7 weeks gestation. At the time of the report the outcome of the pregnancy was ongoing and "healthy pregnancy so far".
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Caesarean section, Exposure during pregnancy, Fatigue, Hyperhidrosis, Injection site erythema
Clinical narrative: This case was reported by a physician (subject) and described the occurrence of red around injection site in a 37-year-old female subject who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). Concurrent medications included Vitamins. On 17 September 2013 at 15:00 the subject received a dose of FLUARIX Quadrivalent (.5 ml, unknown route, left arm). On 19 September 2013, 2 days after vaccination with FLUARIX Quadrivalent, the subject experienced red around injection site, injection site lump, injection site warmth (described as "increased warmth" at injection site), injection site tenderness. In September 2013, within days after vaccination with FLUARIX Quadrivalent, the subject experienced low grade fever, diaphoresis (described as "sweating on face") and fatigue. At the time of reporting the events of red around injection site, injection site lump, injection site warmth, low grade fever, diaphoresis, and fatigue were resolved "within 48 to 36 hours after injection." The physician reported that the injection site tenderness was unresolved and "still evident". The physician considered the events were probably related to vaccination with FLUARIX Quadrivalent. This physician mentioned that this case was also reported to GlaxoSmithKline. See case A1042502A for details on the other case. Follow up was received from physician on 31 October 2013. This prospective pregnancy case was reported by the physician on follow up. The physician reported that on 17 September 2013, she received a primary dose of FLUARIX Quadrivalent (intramuscular) and also experienced vaccine exposure during the first trimester of pregnancy. Concurrent medications included prenatal vitamin. The gestational age was calculated to be 3 weeks. The date of last menstrual period was reported as 22 August 2013. The estimated date of delivery was calculated to be 29 May 2014. At the time of reporting, the pregnancy was ongoing. The physician did not consider the events experienced as serious. The physician reported that the events began on 17 September 2013, on the same date as vaccination with FLUARIX Quadrivalent. The physician documented that all events were resolved on 20 September 2013. The diagnosis was "localized vaccine relationship." Per the physician the immunization series was not discontinued or delayed. The following information was received on 31 January 2014 via subject who is also a physician. The subject's last menstrual period occurred on 22 August 2013 and estimated date of delivery was 29 May 2014. The pregnancy was by normal conception and consisted of a single fetus. The subject was exposed to FLUARIX at 3 5/7 weeks gestation. At the time of the report the outcome of the pregnancy was ongoing and "healthy pregnancy so far".
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site mass, Injection site pain, Injection site warmth, Pyrexia, Suspected transmission of an infectious agent via product
Clinical narrative: This case was reported by a physician (subject) and described the occurrence of red around injection site in a 37-year-old female subject who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). Concurrent medications included Vitamins. On 17 September 2013 at 15:00 the subject received a dose of FLUARIX Quadrivalent (.5 ml, unknown route, left arm). On 19 September 2013, 2 days after vaccination with FLUARIX Quadrivalent, the subject experienced red around injection site, injection site lump, injection site warmth (described as "increased warmth" at injection site), injection site tenderness. In September 2013, within days after vaccination with FLUARIX Quadrivalent, the subject experienced low grade fever, diaphoresis (described as "sweating on face") and fatigue. At the time of reporting the events of red around injection site, injection site lump, injection site warmth, low grade fever, diaphoresis, and fatigue were resolved "within 48 to 36 hours after injection." The physician reported that the injection site tenderness was unresolved and "still evident". The physician considered the events were probably related to vaccination with FLUARIX Quadrivalent. This physician mentioned that this case was also reported to GlaxoSmithKline. See case A1042502A for details on the other case. Follow up was received from physician on 31 October 2013. This prospective pregnancy case was reported by the physician on follow up. The physician reported that on 17 September 2013, she received a primary dose of FLUARIX Quadrivalent (intramuscular) and also experienced vaccine exposure during the first trimester of pregnancy. Concurrent medications included prenatal vitamin. The gestational age was calculated to be 3 weeks. The date of last menstrual period was reported as 22 August 2013. The estimated date of delivery was calculated to be 29 May 2014. At the time of reporting, the pregnancy was ongoing. The physician did not consider the events experienced as serious. The physician reported that the events began on 17 September 2013, on the same date as vaccination with FLUARIX Quadrivalent. The physician documented that all events were resolved on 20 September 2013. The diagnosis was "localized vaccine relationship." Per the physician the immunization series was not discontinued or delayed. The following information was received on 31 January 2014 via subject who is also a physician. The subject's last menstrual period occurred on 22 August 2013 and estimated date of delivery was 29 May 2014. The pregnancy was by normal conception and consisted of a single fetus. The subject was exposed to FLUARIX at 3 5/7 weeks gestation. At the time of the report the outcome of the pregnancy was ongoing and "healthy pregnancy so far".
Sex: U
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of injection site pain in an unknown number of subjects of unspecified age and gender who were vaccinated with FLUARIX (GlaxoSmithKline). In 2013 the subjects received a dose of FLUARIX (unknown details, unknown deltoid). In 2013, either immediately after vaccination or within the same day as vaccination with FLUARIX, the subjects experienced injection site pain. The nurse stated that she recently conducted a flu clinic. She believed that "it is possible that the FLUARIX vaccine contributed to the events because approximately 80 percent of these patients experienced pain at injection site either immediately after vaccination or within the same day." The nurse stated that "at some point" during the flu clinic, she "changed the size of needle going from a short to long one and believes that helped." The exactly number of subject was unknown and no further details were known at the time of reporting. At the time of reporting the event was not resolved. The nurse stated that "each event only lasted a brief period of time." The healthcare professional considered the event was possibly related to vaccination with FLUARIX.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional (who is also the subject) via sales representative and described the occurrence of injection site pruritus in an adult female subject who was vaccinated with FLUARIX TETRA (GlaxoSmithKline). On 22 October 2013 the subject received a dose of FLUARIX TETRA (.5 ml, unknown, unknown arm) and experienced wrong injection technique. On 26 October 2013, 4 days after vaccination with FLUARIX TETRA, the subject experienced injection site pruritus. The subject received an injection of FLUARIX TETRA on approximately 22 October 2013. Approximately four days later, she reported itching at the injection site. The subject noted that she felt "the vaccine injection was not given exactly in the deltoid, but up higher on the arm". No other events were reported. At the time of reporting the outcome of the injection site pruritus was unspecified. Follow-up information was received on 03 December 2013 via nurse (who is also the subject). On 22 October 2013, the 56-year-old subject received FLUARIX TETRA in the left arm. The nurse reported additional events of hot to touch, swollen and sore at injection site. The events occurred approximately three to four days after injection with FLUARIX TETRA on 25 October 2013, previously reported as 26 October 2013. The nurse did not consider the events serious; she associated the events with erroneous administration of FLUARIX TETRA in which the vaccine "could have been given higher". No action was taken with FLUARIX TETRA. On 29 October 2013 the events resolved. The reporting subject denied permission to contact healthcare provider.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of injection site soreness in a 33-year-old male subject who was vaccinated with FLUARIX TETRA (GlaxoSmithKline). On 25 October 2013 the subject received a dose of FLUARIX TETRA (unknown, right arm). On 25 October 2013, less than one day after vaccination with FLUARIX TETRA, the subject experienced injection site soreness. The subject was vaccinated in the right arm with FLUARIX TETRA and experienced soreness in right arm. It was unknown if the soreness in the right arm was a local injection site reaction or systemic reaction. It was unknown if medical attention was required. At the time of reporting the outcome of the or injection site soreness was unspecified. Follow-up information was received on 09 December 2013 via healthcare professional who reported the subject received 0.5ml of FLUARIX TETRA intramuscularly on 25 October 2013. The reporter did not consider the event to be serious. No action was taken with FLUARIX TETRA. The outcome of the injection site soreness that the subject experienced was unknown.
Sex: U
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of arm pain at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In 2013 the subject received a dose of FLUARIX (unknown details). In 2013, within weeks of vaccination with FLUARIX, the subject experienced arm pain at injection site, inflammation of arm at injection site, and injection site pain radiated to rotation cuff of shoulder. This case was assessed with a product complaint as the "doctor's office wanted feedback on this specific lot number" regarding other "reports of people experiencing adverse events from the lot number." The subject had received flu shots in the past with no reactions. Per the nurse, the subject "had flu shots for years and never had trouble before." Per the nurse, "after 2 weeks" after receiving FLUARIX QUADRIVALENT, the subject reported that they are "still experiencing inflammation and pain in the arm it was given. The pain radiates up in to her shoulder." At the time of reporting the events were unresolved. Per the nurse, "after 2 weeks" the subject reported that they are "still experiencing" the events. The nurse reported 2 other case with FLUARIX QUADRIVALENT. See A1050680A and A1050681A for details on the other cases.
Sex: U
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of arm pain at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In 2013 the subject received a dose of FLUARIX (unknown details). In 2013, within weeks of vaccination with FLUARIX, the subject experienced arm pain at injection site, inflammation of arm at injection site, and injection site pain radiated to rotation cuff of shoulder. This case was associated with a product complaint as the doctor's office wanted feedback on this specific lot number" regarding other "reports of people experiencing adverse events from this lot number." The subject had received flu shots in the past with no reactions. Per the nurse, the subject "had flu shots for years and never had trouble before." Per the nurse, "after 2 weeks" after receiving FLUARIX, the subject reported that they are "still experiencing inflammation and pain in the arm it was given. The pain radiates up in their shoulder." At the time of reporting the events were unresolved. Per the nurse, "after 2 weeks" the subject reported that they are "still experiencing" the events. The nurse reported 2 other cases with FLUARIX. See A1050672A and A1050681A for details on the other cases. According to product complaint investigation results reported by GSK quality assurance on 13 December 2013, the product complaint was assessed to be unsubstantiated.
Sex: U
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site pain, Product quality issue
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of arm pain at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). In 2013 the subject received a dose of FLUARIX Quadrivalent (unknown details). In 2014, within weeks of vaccination with FLUARIX Quadrivalent, the subject experienced arm pain at injection site, inflammation of arm at injection site, and injection site pain radiated to rotation cuff of shoulder. This case was associated with a product complaint as the "doctor's office wanted feedback on this specific lot number" regarding other "reports of people experiencing adverse events from this lot number." The subject had received flu shots in the past with no reactions. Per the nurse, the subject "had flu shots for years and never had trouble before." Per the nurse, "after 2 weeks" after receiving FLUARIX Quadrivalent, the subject reported that they are "still experiencing inflammation and pain in the arm it was given. The patient radiates up in to their shoulder." At the time of reporting the events were unresolved. Per the nurse, "after 2 weeks" the subject reported that they are "still experiencing" the events. The nurse reported 2 other cases with FLUARIX Quadrivalent. See A1050672A and A1050680A for details on the other cases. According to product complaint investigation results reported by GSK quality assurance on 13 December 2013, the product complaint was assessed to be unsubstantiated.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle joint aches x 2 days. Pt took ALEVE with good effect. Pt feels better today 6/27/14.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional (nurse and GSK employee) and described the occurrence of general feeling of weakness in a 34-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included diabetes and migraine. Concurrent medications included IMITREX. On 9 October 2013 at 13:10 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 9 October 2013, at 15:25, 2 hours and 15 minutes after vaccination with FLUARIX, the subject experienced general feeling of weakness, numb (arm and leg) (described as "left arm" and "left leg" were numb) and tingling in leg ("left leg"). The subject mentioned that she had taken an IMITREX dose the night before taking the FLUARIX vaccine. The subject and the nurse did not feel like IMITREX "had anything to do with the symptoms happened soon after receiving the FLUARIX injection." Relevant test results included: The nurse stated that "she checked the patient's hand grasp which was equal and strong: she also checked her blood pressure and it was 120/92 which the patient considered normal. The patient's blood sugar was 85 which the patient considered normal." At the time of reporting the outcome of the events were unknown.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Myalgia, Pyrexia, Tenderness
Clinical narrative: On 6-26-14 pt came to report 2 days of significant body, muscle aches, low grade fever - local tenderness - "felt like horrible flu".
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Pt complained of swelling, redness, and throbbing pain at site of injection occurring within 24 hours. Went to ER, MD treated as infection with antibiotic (BACTRIM DS) and pain killers (NORCO 5/325). MD noticed 1 vesicle near area.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of joint pain in an 84-year-old female subject who was vaccinated with Influenza quadrivalent vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included lymphoma "10 years ago", "severe" osteoarthritis and "very, very" weal immune system. On 2 October 2013 the subject received unspecified dose of Influenza quadrivalent vaccine (unknown). On 2 October 2013, within hours of vaccination with Influenza quadrivalent vaccine unspecified, the subject experienced joint pain and less than a week (between 02 October and 06 October) after vaccination with Influenza quadrivalent vaccine, the subject experienced did not feel well and low grade fever. The subject reported that she "was not ill from any disease that I know of the day I took the vaccine. However, since then have had severe pain in all my joints, especially neck, back and hands. Could I be having a reaction from the flu shot? I had a brief low grade temp the night after taking the shot also. I took the shot on October 2nd, and still do not feel well (06 October)." At the time of reporting the events were unresolved except the outcome for low grade fever was resolved.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Site reaction.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of headache in a 31-year-old subject of unspecified gender who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On an unspecified date in 2013, the subject received dose of FLUARIX Quadrivalent (.5 ml, details unknown). On an unspecified date in 2013, within months of vaccination with FLUARIX Quadrivalent, the subject experienced headache, fever, vomiting and body pain. At the time of reporting the outcome of the events were unspecified. The healthcare professional also reported that two other patients experienced headache, fever, vomiting, and body pain following vaccination with FLUARIX Quadrivalent (see case IDs A1046612 and A1046613A for more details). Follow up was received from nurse on 1 November 2013. The nurse reported concurrent medications included ADDERALL and BALZIVA. The nurse reported that the events began on 2 October 2013 and ended on 5 October 2013. The outcome for the events was reported as resolved. The nurse did not consider the events to be serious. The subject does not use tobacco or alcohol. The subject had received flu vaccine in the past. The subject had not experienced any adverse events following previous vaccinations. The immunization series was not discontinued or delayed. Symptoms did recur following subsequent administration "within 24 hours" however, the nurse did not provide documentation of subsequent administration. It as unclear if the nurse misinterpreted the requested information.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of headache in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date in 2013, the subject received dose of FLUARIX (.5 ml, details unknown). On an unspecified date in 2013, within months of vaccination with FLUARIX, the subject experienced headache, fever, vomiting and body pain. At the time of reporting the outcome of the events were unspecified. The healthcare professional also reported that other patients experienced headache, fever, vomiting, and body pain following vaccination with FLUARIX (see case ids A1046610A and A1046613A for more details). Follow up was received from the nurse on 4 November 2013. The nurse described the occurrence of events in a 61 year old female subject who was vaccinated with FLUARIX. On 3 October 2013 at 17:30, the subject received dose of FLUARIX (.5 ml, details unknown). The subject awoke on 4 October 2013 with headache and nausea. At 09:30, the subject experienced vomiting that "continued through the day." The subject treated with Zofran. The subject experienced fever with generalized body aches by noon on 4 October 2013. On 5 October 2013, 2 days after onset, the events were resolved. The nurse did not consider this case serious. The nurse documented that the events were no life-threatening, did not involved severe or permanent disability, did not involve hospitalization, and did not jeopardize the subject or intervention. The nurse reported that the events could have been associated with a medical history of rheumatoid arthritis that the subject treated with Humira every 2 weeks and daily prednisone. Concurrent medical conditions included: rheumatoid arthritis, hemachromatosis, anemia, social alcohol use, and the subject does not use tobacco. The outcome of the events of headache, vomiting, fever,  and body pain were resolved. The outcome of the event of nausea was not known.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Red area at injection site.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Pain and rash at injection site.
Age: 30.0
Sex: U
Vaccine: FLU4
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of headache in a 30-year-old subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date in 2013, the subject received dose of FLUARIX (.5 ml, details unknown). On an unspecified date in 2013, within months of vaccination with FLUARIX, the subject experienced headache, fever, vomiting and body pain. At the time of reporting the outcome of the events were unspecified. The healthcare professional also reported that two other patients experienced headache, fever, vomiting, and body pain following vaccination with FLUARIX (see case ids A1046610A and A1046612A for more details).
Age: 18.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Immediate post-injection reaction, Mobility decreased, Nerve injury, Pain
Clinical narrative: ((L) arm) pt. reports pain immediately after vaccination which got worse and approx. 1 wk later, couldn't lift arm above head; was seen at urgent care and then regular physician approx. 1 week later and was given 3 day tx with prednisone which helped but as soon as d/c'd got worse again. He ortho consult and told it was nerve damage from shot. Has been in PT 3x/wk and not progressing. Pt. is to schedule MRI and appt. with neurologist.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of swelling in a 9-year-old male subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). In 2013 the subject received a dose of FLUARIX Quadrivalent (1 unknown prefilled syringe dose, unknown details). In 2013, within months of vaccination with FLUARIX Quadrivalent, the subject experienced swelling and erythema. The reporter was not specific as to whether the events were local or systemic. At the time of reporting the events were resolved.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Flushing, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of flushing of arm in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included asthma. Concurrent medical conditions included environmental allergy. Concurrent medications included ZYRTEC, PRILOSEC and NASONEX. On 16 October 2013 the subject received 1st dose of FLUARIX (.5 unknown, unknown route, right arm). On 16 October 2013, within minutes of vaccination with FLUARIX, the subject experienced flushing of arm (described as flushing of the arm, face and neck"). On 17 October 2013, 1 day after vaccination with FLUARIX, the season experienced fever, chills and fatigue. At the time of reporting the outcome of the event of flushing of arm (described as "flushing events) had resolved. The outcome of fever, chills and fatigue were was unknown at the time of reporting. The healthcare professional considered the event were probably related to vaccination with FLUARIX. Follow up was received from nurse practitioner on 12 November 2013. The nurse practitioner documented that all events were resolved on 19 October 2013. The nurse practitioner identified the suspect product as FLUARIX. The nurse practitioner did not consider this case is serious. The nurse practitioner documented that the case did not involve a congenital anomaly or birth defect. The nurse practitioner documented that the subject had "receive flu shots in the past without any problems." The nurse practitioner also reported that the subject had not experienced any adverse events following previous vaccinations.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Seizure like phenomena, Syncope
Clinical narrative: At check out dizzy, seizure like activity per mom. Fainted, fell back on wall and slid to floor.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Erythema
Clinical narrative: Patient related her arm was red and inflamed in an area about the size of a softball which resolved after 3-4 days.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Injection site of right arm became inflamed over 72 hours period; swelling and erythematous area extended from site of injection to elbow. It was treated with a MEDROL dose pack and cold compress to resolution. Patient advised not to receive pneumonia vaccine in future.
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of injection site redness in a male subject of unspecified age who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). On an unspecified date in 2013 the subject received unspecified dose of FLUARIX Quadrivalent (.5 ml, unknown, unknown arm). In 2013, within months after vaccination with FLUARIX Quadrivalent, the subject experienced enlarged injection site, injection site redness and patchiness at injection site" details were not provided. The subject was vaccinated on an unspecified date but returned to the physician's office in October 2013 for treatment. The subject was treated with BENADRYL. At the time of reporting the outcome of the events were unspecified.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness at injection site. Swelling (lump) below area.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm pain at injection site in a 70-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included Omeprazole, Lisinopril, Alphagan and Lumgan. On 3 October 2013 at 11:42 the subject received a dose of FLUAIRX (.5 ml, unknown, left deltoid) On 3 October 2013, less than one day after vaccination with FLUARIX, the subject experienced arm pain at injection site. At the time of reporting the event was unresolved. The pharmacist reported as subject who is "still experiencing pain in the arm where he received FLUARIX vaccination." The pharmacist considered the event was possibly related to vaccination with FLUARUIX.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 23 or 24 October 2013 the subject received unspecified dose of FLUARIX (unknown). In October 2013, within days of vaccination with FLUARIX, the subject experienced injection site pain, injection site redness and swelling injection site. The nurse reported that she has seen an increase of pain, redness and swelling at the injection site after FLUARIX in five female subjects; no other details were provided. The vaccine was administered between 23 and 24 October 2013. At the time of the report no other information was provided. The outcome of the events were unspecified. For the other cases please see A1048965A-A1048968A.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). On 23 or 24 October 2013 the subject received unspecified dose of FLUARIX Quadrivalent (unknown). In October 2013, within days of vaccination with FLUARIX Quadrivalent, the subject experienced injection site pain, injection site redness and swelling injection site. The nurse reported that she has seen an increase of pain, redness and swelling at the injection site after FLUARIX Quadrivalent in five female subjects; no other details were provided. The vaccine was administered between 23 and 24 October 2013. At the time of the report no other information was provided. The outcome of the events were unspecified. For the other cases please see A1048964A, A1048966A-A1048968A.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of red spot at injection site in a 36-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. On 1 October 2013 the subject received a dose of FLUARIX Quadrivalent (.5 cc, unknown route, left arm). On 2 October 2013, 1 day after vaccination with FLUARIX Quadrivalent, the subject experienced red spot at injection site. The vaccination was administered at a "flu shot clinic." The red spot was described as an "8 by 10 centimeters red spot on lower left bicep adjacent to injection site." Diagnostic results included vital signs measurement on 3 October 2013. Per the nurse practitioner, the subject "is currently stable with good vitals." At the time of reporting the event was improved. The nurse practitioner reported that medical attention was not required but the subject did consult a healthcare professional regarding the event. The healthcare professional considered the event was possibly related to vaccination with FLUARIX Quadrivalent. Follow up was received on 21 October 2013 from nurse practitioner. The reporter did not consider this case serious. The event was not life-threatening, did not involve severe of permanent disability, did not involve hospitalization, did not involve a congenital anomaly, and did not jeopardize the patient or require intervention. It was unknown if there were other details that could have been associated with the event. A biopsy was not performed. The reporter indicated that the subject had received the suspect drug before; however, provided no additional details.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus generalised, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itch all over in a 37-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 1 October 2013 the subject received a dose of FLUARIX (.5 ml, unknown route, right arm). On 2 October 2013, 1 day after vaccination with FLUARIX, the subject experienced itch all over and hives all over. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX. Follow-up was received on 09 October 2013. The nurse practitioner documented that the subject was 37 years old not 67 years old as previously documented in the report. The nurse practitioner further documented that the events were partly at the injection site but "it was pretty much all over." Follow-up information was received on 06 November 2013 via healthcare professional who reported the events occurred on 02 October "2014" and resolved on 10 October "2014", although the reporter may have intended the current year of "2013". The reporting healthcare professional did not consider the event serious. No action was taken with FLUARIX.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 23 or 24 October 2013 the subject received unspecified dose of FLUARIX (unknown). In October 2013, within days of vaccination with FLUARIX, the subject experienced injection site pain, injection site redness and swelling injection site. The nurse reported that she has seen an increase of pain, redness and swelling at the injection site after FLUARIX in five female subjects; no other details were provided. The vaccine was administered between 23 and 24 October 2013. At the time of the report no other information was provided. The outcome of the events were unspecified. For the other cases please see A1048964A-A1048966A and A1048968A.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On 23 or 24 October 2013 the subject received unspecified dose of FLUARIX quadrivalent (unknown). In October 2013, within days of vaccination with FLUARIX quadrivalent, the subject experienced injection site pain, injection site redness and swelling injection site. The nurse reported that she has seen an increase of pain, redness and swelling at the injection site after FLUARIX quadrivalent in five female subjects; no other details were provided. The vaccine was administered between 23 and 24 October 2013. At the time of the report no other information was provided. The outcome of the events were unspecified. For the other cases please see A1048964A-A1048967A.
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: This case was reported by a healthcare professional (also the subject) via sales representative and described the occurrence of headache in an adult female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On 27 September 2013 the subject received a dose of FLUARIX quadrivalent (.5 ml, unknown, left arm). In September 2013, within 24 hours of vaccination with FLUARIX quadrivalent, the subject experienced headache, body aches and pain, injection site soreness and raised area injection site. Within 24 hours of receiving FLUARIX quadrivalent, a nurse reported experiencing a headache that was between three and four on a pain scale, body aches and pains, and a local injection site reaction, clarified as sore and raised at the site. All the events lasted for about 48 hours before completely subsiding. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX quadrivalent.