chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in a 58-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to ceclor, allergy to cipro and bactrim allergy. Concurrent medications included Calcium with vitamin D, Benefiber, Aspirin, Metronidazole, Fish oil, Pravastatin, Stool softener and CLARITIN. On 17 August 2012 at about 17:00 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left arm). On 17 August 2012, within hours of vaccination with BOOSTRIX, the subject experienced injection site pain and painful to move arm. The physician reported the subject had continuing pain at the injection site from her BOOSTRIX vaccine. The site is not tender to the touch, but whenever she moves her arm it pulls at the site. This has been continuing since the date of injection. The pain has improved slightly since the injection. At the time of reporting the injection site pain and painful to move arm were improved. The physician considered the events were probably related to vaccination with BOOSTRIX.
Age: 63.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of stiff neck in a 63-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included seasonal influenza vaccine (non-gsk); Novartis; unknown; unknown given on 3 September 2012; varicella virus vaccine (non-gsk); Merck; unknown; unknown given on 3 September 2012. Concurrent medications included NEXIUM, Allopurinol, Amiodarone, COUMADIN, Digoxin, Diovan HCT, Furosemide, KLOR-CON, Levothyroxine and Zolpidem. On 3 September 2012 at 12:15 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On 4 September 2012, 1 day after vaccination with BOOSTRIX, the subject experienced stiff neck, neck pain and the pharmacist thought the subject was experiencing an arthus-type reaction. The pharmacist explained that she was not sure of the seriousness of the reaction since the subject had not seen a physician yet. At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. Follow up received from pharmacist on 31 October 2012. The pharmacist noted that she spoke with the subject and that the event was not an arthus-type reaction but "was just muscle soreness/stiffness" of neck that "resolved on its on with NSAID therapy in 24 hours." On 5 September 2012, 24 hours after stiff neck muscles and muscle pain in neck began, the pharmacist noted that stiff neck muscles and muscle pain in neck symptoms had resolved. The pharmacist did not consider this event to be serious.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 67-year old female subject who was vaccinated with BOOSTRIX. Concurrent medical conditions included latex allergy. Concurrent medications included unspecified medications. The subject was taking several medications but there were no new medications. On 29 August 2012 at 11:35 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm). On 31 August 2012, 2 days after vaccination with BOOSTRIX, the subject experienced injection site redness and injection site warmth. The subject was given antibiotics as treatment. 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 18 September 2012 via healthcare professional who reported the onset date was 30 August 2012, previously reported as 31 August 2012. At the time of the report the events had improved.
Age: 69.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Dysphonia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of dizziness in a 69-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) FLUZONE. On 27 August 2012 at 12:35 the subject received a dose of BOOSTRIX (.5 ml, unknown, right arm) and on 27 August 2012 the subject received a dose of FLUZONE (details unknown). On 27 August 2012, within hours of vaccination with BOOSTRIX and FLUZONE, the subject experienced dizziness and on 29 August 2012, 2 days after vaccination with BOOSTRIX and FLUZONE, the subject experienced hoarseness. According to the pharmacist, the subject experienced the dizziness when she turned over while lying in bed the evening of the vaccinations, 27 August 2012. On 29 August 2012, the subject was told that she sounded hoarse while talking on the phone. At the time of reporting the dizziness was resolved and the hoarseness was unresolved. The lot number was reported as AC2B081AA by the reporter, but was corrected to AC52B081AA based on the BOOSTRIX rules for the vaccine batch numbering system.
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint pain, Injection site pain, Type III immune complex mediated reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of Arthus-type reaction in a female subject aged between 50 and 59 years old who was vaccinated with BOOSTRIX. In 2012, "approximately two weeks ago", the subject received a dose of BOOSTRIX (unknown route, left arm). In 2012, less than one month after vaccination with BOOSTRIX, the subject experienced Arthus-type reaction, injection arm pain and shoulder pain in injection arm. The subject complained to the pharmacist of arm aching along with shoulder joint of left arm whenever her arm was used. The pharmacist asked how long an Arthus type reaction may last. The subject advised the pharmacist that she received the BOOSTRIX vaccine approximately two weeks ago at the physician's office and that whenever she used her arm it ached along with her shoulder joint. The pharmacist thought it was her left arm where the subject was administered the vaccine. The pharmacist did not know when the subject received her last Td vaccine. According the pharmacist, the subject called the physician's office and they informed her that this was a possible reaction to the vaccine. At the time of reporting the events were unresolved.
Sex: U
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nodule injection site in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 16 August 2012 the subject received a dose of BOOSTRIX (details unknown). On 17 August 2012, 1 day after vaccination with BOOSTRIX, the subject experienced injection site soreness, 3 days after vaccination with BOOSTRIX, the subject experienced injection site pruritus and less than a week after vaccination with BOOSTRIX, the subject experienced nodule injection site. The subject developed a "knot under the skin" (nodule injection site) at the BOOSTRIX injection site. The subject had injection site soreness the day after the injection, but it was resolved at the time of the report. The pharmacist stated that the knot was not painful, but was not going away. The pharmacist stated the knot did not develop on the dame day at the injection, but some time later. According to the pharmacist, the knot itched yesterday [19 August 2012], but that had resolved. At the time of the report, the nodule injection site was resolved and the injection site soreness and injection site pruritus were resolved in August 2012.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Myalgia, Neuralgia, Pain, Radiculitis brachial
Clinical narrative: This case was reported by a consumer and described the occurrence of brachial neuritis in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Historic vaccination include Salmonella Typhi Vi Capsular Polysaccharide vaccine; manufacturer unspecified; unknown; unknown given on an unspecified date; Smallpox Vaccine; manufacturer unspecified; unknown; unknown given on an unspecified dated. On 23 July 2012 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown). On or about 11 August 2012, 19 days after vaccination with BOOSTRIX, the subject experienced brachial neuritis, injections site pain, pain, not eating, not sleeping, not thinking, deep muscle pain and nerve pain. The subject reported she "never had a bad reaction to any of the many immunizations I have received. Living overseas I had smallpox, typhus vaccine, etc.)." Nineteen days after receiving BOOSTRIX she suddenly developed excruciating stabbing, constant pain at the injections site (left arm), left shoulder, upper left back, neck, upper front chest and down the length of left arm. She described the pain as "the kind of pain that prevent you from eating, sleeping, thinking etc. Brachial neuritis fits the bill. I am not enduring the sixth day of unrelenting pain; my doctor has prescribed pain killer as there is no cure' for this condition. It feels like I am getting the shot over and over again at the actual injections site. I have never in my life experienced such intense pain. Pain is the main symptom, no rash, no swelling etc It is a deep muscular/nerve pain". At the time of reporting the events were unresolved.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Sleep disorder, Thinking abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of brachial neuritis in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Historic vaccination include Salmonella Typhi Vi Capsular Polysaccharide vaccine; manufacturer unspecified; unknown; unknown given on an unspecified date; Smallpox Vaccine; manufacturer unspecified; unknown; unknown given on an unspecified dated. On 23 July 2012 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown). On or about 11 August 2012, 19 days after vaccination with BOOSTRIX, the subject experienced brachial neuritis, injections site pain, pain, not eating, not sleeping, not thinking, deep muscle pain and nerve pain. The subject reported she "never had a bad reaction to any of the many immunizations I have received. Living overseas I had smallpox, typhus vaccine, etc.)." Nineteen days after receiving BOOSTRIX she suddenly developed excruciating stabbing, constant pain at the injections site (left arm), left shoulder, upper left back, neck, upper front chest and down the length of left arm. She described the pain as "the kind of pain that prevent you from eating, sleeping, thinking etc. Brachial neuritis fits the bill. I am not enduring the sixth day of unrelenting pain; my doctor has prescribed pain killer as there is no cure' for this condition. It feels like I am getting the shot over and over again at the actual injections site. I have never in my life experienced such intense pain. Pain is the main symptom, no rash, no swelling etc It is a deep muscular/nerve pain". At the time of reporting the events were unresolved.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On or about 4 August 2012 the subject received unspecified dose of BOOSTRIX (unknown). Less than one week after vaccination with BOOSTRIX, the subject experienced injection site pain, swelling injection site and injection site redness. The pharmacist reported that the subject complained of pain, swelling and redness at the injection site; the subject received BOOSTRIX seven days prior to this report. At the time of reporting the outcome of the events were unspecified.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bumps around injection site in a 71-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 24 July 2012 the subject received 1st dose of BOOSTRIX (.5 ml, unknown, left arm). On an unspecified date in 2012, less than one month after vaccination with BOOSTRIX, the subject experienced bumps around injection site. At the time of reporting the event was unresolved. At the time of the report no other information was provided.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Gait disturbance, Laboratory test abnormal
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of walking difficulty in a 11-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included meningococcal acwy vaccine (non-gsk); Sanofi Pasteur MSD; unknown given on 23 July 2012; varicella virus vaccine (non-gsk); Merck; unknown given on 23 July 2012. There were no concurrent medications. There were no reactions, up to date on vaccinations. On 23 July 2012 in early PM, the subject received 1st dose of BOOSTRIX (.5 ml, unknown, right deltoid). On 25 July 2012 at approximately 10:00, two days after vaccination with BOOSTRIX, the subject experienced walking difficulty. The reporting healthcare professional reported that "within 48 hours" after receiving the BOOSTRIX, the subject had difficulty walking without assistance. The reporter strongly recommended to the subject's mother, who was a registered nurse, that they see a physician about the reaction because of "concern over Guillain-Barre". The subject was not hospitalized or considered to be in serious condition. The subject was seen immediately in the doctor's office and labs were drawn. The physician found one lab elevated (unknown which one), but was not concerned and was not concerned about the subject's reaction. By 30 July 2012, the subject was much improved and was getting around walking fine. There was no other information available at the time of reporting. On 30 July 2012, the event was resolved. The vaccination course with BOOSTRIX was discontinued.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal distension, Abdominal pain, Joint swelling, Local swelling, Lymphadenopathy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of neck pain in a 52-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included asthma, cluster headache, hypotension, hypothyroidism, insomnia, migraine headache, obesity, restless legs syndrome and vitamin d deficiency. Concurrent medications included ARMOUR THYROID, atenolol, SINGULAIR, ADVAIR, BACTROBAN, clotrimazole, fluorometholone, eye medication (eye drop), MAXALT, RESTORIL, ropinirole, "Robinsonade" (Unknown medication), triamcinolone cream, VENTOLIN HFA, ZOFRAN, CLARITIN and ibuprofen. On 30 May 2013 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route, left arm). On 8 June 2013, 9 days after vaccination with BOOSTRIX, the subject experienced neck pain, neck swelling, shoulder pain, shoulder swelling, pain in trunk, swelling of torso and supraclavicular lymphadenopathy. At the time of reporting the outcome of the events was unspecified.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of neck pain in a 52-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included asthma, cluster headache, hypotension, hypothyroidism, insomnia, migraine headache, obesity, restless legs syndrome and vitamin d deficiency. Concurrent medications included ARMOUR THYROID, atenolol, SINGULAIR, ADVAIR, BACTROBAN, clotrimazole, fluorometholone, eye medication (eye drop), MAXALT, RESTORIL, ropinirole, "Robinsonade" (Unknown medication), triamcinolone cream, VENTOLIN HFA, ZOFRAN, CLARITIN and ibuprofen. On 30 May 2013 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route, left arm). On 8 June 2013, 9 days after vaccination with BOOSTRIX, the subject experienced neck pain, neck swelling, shoulder pain, shoulder swelling, pain in trunk, swelling of torso and supraclavicular lymphadenopathy. At the time of reporting the outcome of the events was unspecified.
Age: 67.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 67-year-old subject of unspecified gender who was vaccinated with BOOSTRIX. On an unspecified date the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, right arm). Approximately three to four days after vaccination with BOOSTRIX, the subject experienced pain and swelling at injection site. Pharmacist stated that the subject reported feeling pain and swelling at the injection site three to four days after the BOOSTRIX injection. Six to seven days after, the subject is complaining of more pain/increased with intensity with some swelling near the injection site (slightly below the injection site). At the time of the report no other information was available. At the time of reporting the pain and swelling at injection site were worse.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Cold sweat, Erythema, Extensive swelling of vaccinated limb, Injected limb mobility decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sore (nos) in a 55-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to DURAGESIC, codeine allergy and sulfa allergy. Concurrent medications included Lisinopril, Furosemide, Potassium, Pravastatin and Estradiol vaginal cream. On 9 May 2013 at 10:30 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm); Lot number was reported as 432TJ. On 10 May 2013, 1 day after vaccination with BOOSTRIX, the subject experienced "feeling a little sore". On 11 May 2013 the subject had nausea and a temperature of 102 degrees. On 12 May 2013, the subject was feeling sore and clammy. On 13 May 2013, her left arm started to get red. On 14 May 2013 her left arm had become swollen and painful. it was warm to the touch, and she had decreased range of motion. The subject was started on a five day course of Cephalexin 500 mg on the night of 14 May 2013. On the morning of 15 May 2013, after one dose of Cephalexin, the subject was seen at the office. Her reaction, described as red, warm and significantly swollen had expanded to nearly the top of the shoulder and was 22x18 centimeters in size. Compared to the previous day, it had already started clearing at this point. The reporting healthcare professional found it strange that the location of the actual shot was where it began clearing first, described as a big band of red around the shot area. On 16 May 2013, the healthcare professional had not yet spoken to the subject but described the reaction as improving based on the subject's last visit. At the time of reporting the sore (nos), nausea, increased temperature, clamminess, arm swollen, arm pain, warm to touch, decreased range of motion, injection site pain, injection site redness, injection site warmth, extensive swelling of vaccinated limb and red around injection site were improved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local swelling, Nausea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sore (nos) in a 55-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to DURAGESIC, codeine allergy and sulfa allergy. Concurrent medications included Lisinopril, Furosemide, Potassium, Pravastatin and Estradiol vaginal cream. On 9 May 2013 at 10:30 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm); Lot number was reported as 432TJ. On 10 May 2013, 1 day after vaccination with BOOSTRIX, the subject experienced "feeling a little sore". On 11 May 2013 the subject had nausea and a temperature of 102 degrees. On 12 May 2013, the subject was feeling sore and clammy. On 13 May 2013, her left arm started to get red. On 14 May 2013 her left arm had become swollen and painful. it was warm to the touch, and she had decreased range of motion. The subject was started on a five day course of Cephalexin 500 mg on the night of 14 May 2013. On the morning of 15 May 2013, after one dose of Cephalexin, the subject was seen at the office. Her reaction, described as red, warm and significantly swollen had expanded to nearly the top of the shoulder and was 22x18 centimeters in size. Compared to the previous day, it had already started clearing at this point. The reporting healthcare professional found it strange that the location of the actual shot was where it began clearing first, described as a big band of red around the shot area. On 16 May 2013, the healthcare professional had not yet spoken to the subject but described the reaction as improving based on the subject's last visit. At the time of reporting the sore (nos), nausea, increased temperature, clamminess, arm swollen, arm pain, warm to touch, decreased range of motion, injection site pain, injection site redness, injection site warmth, extensive swelling of vaccinated limb and red around injection site were improved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sore (nos) in a 55-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to DURAGESIC, codeine allergy and sulfa allergy. Concurrent medications included Lisinopril, Furosemide, Potassium, Pravastatin and Estradiol vaginal cream. On 9 May 2013 at 10:30 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm); Lot number was reported as 432TJ. On 10 May 2013, 1 day after vaccination with BOOSTRIX, the subject experienced "feeling a little sore". On 11 May 2013 the subject had nausea and a temperature of 102 degrees. On 12 May 2013, the subject was feeling sore and clammy. On 13 May 2013, her left arm started to get red. On 14 May 2013 her left arm had become swollen and painful. it was warm to the touch, and she had decreased range of motion. The subject was started on a five day course of Cephalexin 500 mg on the night of 14 May 2013. On the morning of 15 May 2013, after one dose of Cephalexin, the subject was seen at the office. Her reaction, described as red, warm and significantly swollen had expanded to nearly the top of the shoulder and was 22x18 centimeters in size. Compared to the previous day, it had already started clearing at this point. The reporting healthcare professional found it strange that the location of the actual shot was where it began clearing first, described as a big band of red around the shot area. On 16 May 2013, the healthcare professional had not yet spoken to the subject but described the reaction as improving based on the subject's last visit. At the time of reporting the sore (nos), nausea, increased temperature, clamminess, arm swollen, arm pain, warm to touch, decreased range of motion, injection site pain, injection site redness, injection site warmth, extensive swelling of vaccinated limb and red around injection site were improved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 50-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (DTPa (with small D + P), manufacturer unspecified). Concurrent medical conditions included diabetes. On 223 April 2013 the subject received unspecified dose of DTPa (with small D + P) (.5 ml, unknown, left arm). On 23 April, less than one day after vaccination with DTPa (with small D + P), the subject experienced swelling injection site, injection site pruritus and fever. The subject received the vaccine at a physician's office on 23 April 2013. The subject asked the pharmacist about the side effects of the vaccine. The pharmacist was uncertain if the subject received BOOSTRIX or another Tdap vaccine. At the time of reporting the outcome of the events were unspecified.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional (office manager) and described the occurrence of injection site pain in a 47-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 26 March 2013 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left deltoid). On 29 March 2013, 3 days after vaccination with BOOSTRIX, the subject experienced injection site pain (also described as "under arm pain"), injection site pruritus, swelling injection site, and injection site redness. This case was associated with a product quality complaint. The subject was seen by a physician and "diagnosed with erythema of about 3-4 centimeters in size." At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. The reporter documented 2 other cases with BOOSTRIX. See cases A1021182A and A1021180A for details on the other cases. Quality Assurance (QA) follow up was received on 23 May 2013. Based on the currently available safety information and the nature of the complaint, it can be concluded that there is no evidence for a safety signal concern for the batch AC52B100CA of BOOSTRIX and its similar batches. The OC investigation performed on the received samples shows that the complaint samples are conform to the specification for the description. GlaxoSmithKline Biologicals considers this complaint to be unsubstantiated.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Product quality issue
Clinical narrative: This case was reported by a healthcare professional (office manager) and described the occurrence of injection site pain in a 28-year-old female subject who was vaccinated with BOOSTRIX. Concurrent medications included Cabergoline and Ortho-cept (Orthocept). On 4 April 2013 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left deltoid). On 4 April 2013, less than one day after vaccination with BOOSTRIX, the subject experienced injection site pain (described as "pain under the left arm and left upper breast"). This case was associated with a product quality complaint. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. The reporter documented 2 other cases with BOOSTRIX. See cases A1021182A and A1021183A for details on the other cases. Quality Assurance (QA) follow up was received on 23 May 2013. Based on the currently available safety information and the nature of the complaint. It can be concluded that there is no evidence for a safety signal concern for the batch AC52B100CA of BOOSTRIX vaccine and its similar batches. The QC investigation performed on the received sample shows that the complaint samples are conform to the specification for the description. GlaxoSmithKline Biologicals considers this complaint to be unsubstantiated.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein, Exposure during pregnancy, Injection site pain, Ultrasound scan
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of injection site soreness in a 34-year-old female subject who was vaccinated with BOOTRIX (GlaxoSmithKline), FLUZONE during pregnancy. A physician or other health care professional has not verified this report. The subject's medical history included no previous pregnancies. The subject was not using contraception. The conception was by normal methods. There was no evidence of prenatal testing. There was no maternal history that may have an impact on the outcome of the current pregnancy. The subject's paternal history included mother with diabetes that may have an impact on the current pregnancy. On 11 March 2013 the subject received a dose of BOOSTRIX (unknown route, left arm), in January 2013 the subject received unspecified dose of FLUZONE (.5 ml, unknown details) and experienced unspecified dose of FLUZONE (.5 ml, unknown details) and experienced vaccine exposure during pregnancy. The gestational age at the time of vaccination was calculated to be approximately 25 weeks for exposure to BOOSTRIX and between 15 to 20 weeks for exposure to FLUZONE. The date of last menstrual period was reported to be in September 2012 per the reporter. The estimated date of delivery was reported as 19 June 2013. There was no evidence of defect from prenatal testing. On an unknown date the subject received an ultrasound examination and A (MS) AFP test (maternal serum-aminofetoprotein test). On 12 March 2013, 1 day after vaccination with BOOSTRIX, the subject experienced injection site soreness. The reporter stated that her arm was "slightly sore at injection site." The subject considered that this event was related to the BOOSTRIX vaccination. At the time of reporting the events were improved. The reporter also reported another case involving BOOSTRIX. See case A1016238A for details on the other case. Follow up from the subject received on 5 April 2013. The subject documented that her estimated due date was 19 July 2012, not June as previously reported. She documented that the date of her last menstrual period was middle to late September 2012. Follow-up information was received on 16 May 2013 via physician who reported the subject's pregnancy consisted of one fetus, was not by in-vitro fertilization but was not a normal conception. At the time of the report there were no pregnancy complications.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer (subject's wife) and described the occurrence of injection site soreness in a 37-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Vitamin C and Mens formula multivitamin. On 9 March 2013 at 13:00 the subject received a dose of BOOSTRIX (unknown route, left arm). On the morning of 10 March 2013, 1 day after vaccination with BOOSTRIX, the subject experienced injection site soreness. The subject did not consult a health care provider regarding the event. On 11 March 2013, the event was resolved. The reporter also reported another case involving BOOSTRIX. See case A1016239A for details on the other case.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (pharmacy student) and described the occurrence of swelling injection site in a 11-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included Tdap; GlaxoSmithKline; unknown; unknown given on an unspecified date. On 8 March 2013 the subject received 1st dose of BOOSTRIX (.5 ml, unknown details). In March 2013, within days of vaccination with BOOSTRIX, the subject experienced swelling injection site and injection site pain. The reporter stated that the subject experienced "localized swelling and pain at the injection site after he received his shot of BOOSTRIX. The patient came back to the hospital" on 11 March 2013. The subject was treated with BENADRYL and ibuprofen "to treat his reaction." At the time of reporting the outcome of the events were unspecified.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included meningococcal ACWY vaccine (non-gsk); Merck; unknown; unknown given on an unspecified date. On an unspecified date the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site redness, swelling injection site and injection site pain. The nurse reported that the BOOSTRIX and MENACTRA were administered "at separate sites" but did not provide additional details. At the time of reporting the outcome of the events were unspecified.
Sex: F
Vaccine: TDAP
Symptoms: Injection site extravasation, Injection site nodule
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of nodule injections site in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On approximately 6 February 2013 the subject received a dose of BOOSTRIX (.5 ml, subcutaneous, right deltoid) and experienced intramuscular formulation administered by other routed. On approximately 6 February 2013, within the same day as the vaccination with BOOSTRIX, the subject experienced medication leaking from injections site. The nurse reported that the BOOSTRIX was administered "possibly via the subcutaneous route. She noted some vaccine may have leaked out of the area." On approximately 7 February 2013, 1 to 2 days after vaccination with BOOSTRIX, the subject experienced nodule injection site ("knot at the site of injections"). The subject reported to the nurse that 1 to 2 days after administration (possibly administered on 6 February 2013) a knot appeared at the site of injections. At the time of reporting the outcome of the events were unspecified.
Age: 13.0
Sex: M
Vaccine: RAB
Symptoms: Meningitis aseptic
Clinical narrative: Case number PHHY2013US108666 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT from 1997 to 2005. This report refers to a 13-years-old male patient. His medical history included ear tube placement and concomitant medications were not reported. He was vaccinated with RABAVERT (batch number: not reported) on an unknown date. Four days after vaccination, he experienced aseptic meningitis. The outcome of the event was reported as complete recovery. The author stated that the ongoing evaluation of VAERS reports did not suggest at high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Erythema, Headache, Skin warm
Clinical narrative: Patient given flu inj 9/25/13 called next day stating arm red, warm, also having bad headache. Pt told to ice arm, TYLENOL/ADVIL for headache, brought in on 9/27/13 to be seen by doctor.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, TDAP, VARZOS
Symptoms: Death, Pyrexia, Surgery
Clinical narrative: Pt received 3 vaccines. ER visit due to hi fever reported. Pt passed away at unknown date. Cause of death unknown.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, TDAP, VARZOS
Symptoms: Death, Pyrexia
Clinical narrative: Pt received 3 vaccines. ER visit due to hi fever reported. Pt passed away at unknown date. Cause of death unknown.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt presented to Emergency Department with pain, redness and swelling of her upper arm where the vaccine was administered.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Back pain, Skin burning sensation
Clinical narrative: Burning sensation on my skin. Pain in my back muscle. Pain in my stomach later that night.
Age: 27.0
Sex: M
Vaccine: ANTH, MMR
Symptoms: Injection site swelling
Clinical narrative: Swelling began at site of injection on Left deltoid.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Gastrointestinal disorder, Headache, Vomiting
Clinical narrative: Weakness, headache, vomiting, severe gastrointestinal reaction. Severe headache for three days resulting in taking Monday off of work. Weakness persisted for three additional days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Injection site erythema, Injection site swelling, Rash papular, Rash pruritic
Clinical narrative: Redness and swelling at site of injection; Ring-shaped perimeter swelling around injection site; Bumpy, red, itchy rash on arms, legs and torso; on 10/02/2013 ring-shaped perimeter swelling became VERY ITCHY; on 10/03/2013 bumpy, red rash on extremities and torso became more inflamed and ITCHIER!
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever and chills, fatigue.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Malaise.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain
Clinical narrative: Fatigue, muscle soreness at inj site.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue, sore arm.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue, sore arm.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: Chills, shivering.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Tenderness
Clinical narrative: Headache and local tenderness.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea, vomiting and entire arm pain, chills/shivering.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle aches.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea, vomiting and sore arm, muscle aches.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Monoplegia
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 73 year old female patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). Other suspect therapy included Influenza Virus Vaccine (manufacturer unknown) (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. It was reported that on an unknown date, the patient experienced shortness of breath from the Influenza Virus Vaccine (manufacturer unknown) and experienced short term paralysis after administration of PNEUMOVAX23. It was reported that both the vaccines were administered at another unspecified site. The pharmacist had no information about the administration of the vaccines, including when they were administered or if they were administered together or separately. It was unspecified if any treatment was given or if any lab tests were performed. On an unknown date, the patient recovered from the events. The reporter considered the shortness of breath to be related to Influenza Virus Vaccine (manufacturer unknown). The relatedness for short term arm paralysis was unknown for PNEUMOVAX23 and Influenza Virus Vaccine (manufacturer unknown). Upon internal review, short term arm paralysis was considered as medically significant. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Local swelling
Clinical narrative: Patient's caregiver came to the pharmacy 8 days after patient received flu shot, explaining how she was rushed to the emergency room about 3 hours after the flu shot. The patient was having a seizure (caregiver could not say which kind), and stayed in the hospital for 4 days. Patient also has some leg swelling that has not gone away, she has a follow-up for Wed.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Pt presented to pharmacy for flu shot. Responded negative when questioned on precautions on consent form. About 30 min after vaccine, pt felt faint and lowered herself to knees.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Blood test, Computerised tomogram, Face oedema, Fatigue
Clinical narrative: After lunch, patient developed nausea, fatigue, elevated B/P, blood shot eyes, facial edema. EPI PEN administered and instructed to go to ER. Husband came and transported to hospital.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Ocular hyperaemia
Clinical narrative: After lunch, patient developed nausea, fatigue, elevated B/P, blood shot eyes, facial edema. EPI PEN administered and instructed to go to ER. Husband came and transported to hospital.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope. VS taken - WNL.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Developed 6cm diameter red rash around injection site - w/ mild pain and itching, no swelling, no discharge.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Haematoma, Pain, Skin discolouration, Swelling
Clinical narrative: Next day after flu shot pt got a hematoma in his arm muscle the size of an orange. Pt went to urgent care Sunday 9/13/13/ and Dr. (PCP) on Mon 9/16/13. Pt had 2 previous hematomas this year and his COUMADIN contributed to it. After few days swelling subsided. Still black and blue sore and swollen 10 days later.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Feeling hot, Injection site nodule, Pruritus, Swelling
Clinical narrative: 4x3 knot on Rt back of arm where Varicella was given. Red-swollen-hot-itching-last night soreness, this arm huge knot getting bigger. 10/01/13 (day received vaccination) Ibuprofen 400 mg po at 4:30 PM, applied cool paper towel and wrapped arm. Called in Benadryl. Will come to clinic tomorrow.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Friday night had mild hives itching to abdomen.  Those symptoms were resolved by Sat. morning, however EE noted mild swelling to the lip left corner of her mouth. Saturday afternoon her entire lip surface was swollen. Sunday 09/29/13 noted sweiing to her periorbital area. Monday am entire face swollen and she sought care at an Urgent Care. She was given Hydrocortisone and placed on a Prednisone dose pack.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site pain, Lymphadenopathy
Clinical narrative: Discomfort caused by moderate swelling of the axillary lymph nodes in the same arm as injection was given as well as soreness at the injection site. Swelling has lasted 4 days thus far.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Raised, red area at injection site, "itching"; no medications given (child at school, area marked on skin by school nurse; no hives or breathing problems reported.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Feeling abnormal, Feeling cold, Insomnia
Clinical narrative: Arm swollen, red, patient cold all night couldn't sleep, felt terrible. Patient went to work next day for a brief time, back home slept all day, chilled, decreased appetite. Somewhat better 2 days later but not 100%.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Arm swollen, red, patient cold all night couldn't sleep, felt terrible. Patient went to work next day for a brief time, back home slept all day, chilled, decreased appetite. Somewhat better 2 days later but not 100%.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Pain in extremity, Urine analysis
Clinical narrative: Began with numbing of thumb on left hand (site of vaccine). Achiness in arm. This has lasted from Sat. 9/28 through today 10/03.  The pain/achiness rendered the arm almost useless.  It is slowly decreasing.  However, the numbness has spread from my thumb to my first and second fingers on that same hand.  That has not abated.
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, MMRV, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash in lower lips. Temp in AM 103.2 and @ 4pm 102.5 Pt mom give Tylenol to child and monitoring .
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Sensation of heaviness
Clinical narrative: Arm felt heavy, then left side of face felt somewhat numb. face/neck/arm of left side all feel heavy/numb. Left leg is also feeling this a little bit.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Cough, Headache, Pain in jaw, Pharyngeal oedema
Clinical narrative: Throat felt full, severe chills, headache, cough, severe jaw pain, fever.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Throat felt full, severe chills, headache, cough, severe jaw pain, fever.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphonia, Dyspnoea, Exposure during pregnancy, Heart rate increased
Clinical narrative: Dizziness, difficulty breathing, hoarseness and wheezing, fast heart beat.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Dizziness, difficulty breathing, hoarseness and wheezing, fast heart beat.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, warm induration at injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Limb discomfort, Lymphangitis, Ultrasound scan normal
Clinical narrative: Pt noted discomfort along the medial rt leg the morning after her vaccination. This progressed to red streaking (lymphangitis) within 48-72 hours. Venous duplex negative for superficial thrombophlebitis. The pt then developed shingles in same extremity at day 14 following the vaccination.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain
Clinical narrative: Tender solitary lymph node left posterior cervical chain.  This is the same side of injection into left deltoid.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Swelling, redness, hot to touch, hard lump in center of the red swelling approx 2x3 inch circle.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood sodium decreased, Confusional state, Hyponatraemia, Nausea
Clinical narrative: Weakness, nausea vomiting, panocytopenia, mental confusion, hyponatremia.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Pancytopenia, Platelet count decreased, Vomiting
Clinical narrative: Weakness, nausea vomiting, panocytopenia, mental confusion, hyponatremia.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Lymphadenitis
Clinical narrative: 9/30/13 - received flu shot; shortly after had a ear ache - relieved by TYLENOL. 24 hours later discover swelling under (R) armpit - same arm she received the flu shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Hyperhidrosis, Muscle tightness, Pallor, Syncope
Clinical narrative: PT experienced minor syncopal episode after recieving vaccinations.  PT was placed on the bed and became responsive with tightening of muscles and crying. PT was diaphoretic, and pale.  A&Ox3 with vitals in expected range post episode.
Age: 0.75
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives began appearing all over babies body.