chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of nonspecific reaction in a subject of unspecified age and gender who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (.5 ml, unknown). In 2009, at an unspecified time after vaccination with BOOSTRIX, the subject experienced nonspecific reaction. The medical assistance reported that two subjects reacted to BOOSTRIX. No specific complaints about the appearance or characteristics of the BOOSTRIX were provided. The sales representative had limited information. She could not provide details on the type of reaction the subjects experienced or whether the reaction was local or systemic. The reported believed that a quality assurance problem may have caused the adverse event. No specific physical complaints with the product's appearance, etc. were provided. The medical assistant just thought that the adverse event could be due to a bad lot of BOOSTRIX since two subjects reacted. It was unknown which presentation of BOOSTRIX (vial or prefilled syringe) was used. Please see A0774664A for the second report of unspecified reaction to BOOSTRIX. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the unspecified reaction was possibly related to vaccination with BOOSTRIX. Follow-up received as quality statement performed on 15 May 2009: As per quality statement, the BOOSTRIX vaccine lot AC52B031AB met the requirements of the specifications and was confirmed as suitable for vaccination purpose.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure, Skin laceration
Clinical narrative: This case was reported by a healthcare professional (also the subject) via a sales representative and described the occurrence of a cut thumb in a 38-year-old female subject of who was vaccinated with BOOSTRIX, GlaxoSmithKline. On 18 March 2009 the subject picked up a BOOSTRIX vial and it shattered and she cut herself on the glass fragment. A co-worker (nurse) cleaned and bandaged the wound. The wound is healing, but she still has the bandage. A product complaint was associated with this report. At the time of reporting the event was improved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow-up information was received from the healthcare professional (subject) in April 2009. On 18 March 2009, the BOOSTRIX shattered in the subject's hand and cut her left thumb. The event resolved on 01 April 2009. The cut thumb was considered related to treatment with BOOSTRIX. The subject's physician was not contacted regarding this event.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a 34 year-old female subject who was vaccinated with BOOSTRIX GlaxoSmithKline. A physician or other health care professional has not verified this report. Concurrent medication included Oral contraceptive (Birth control pills) and M.V.I. On 1 April 2009 the subject received 1st dose of BOOSTRIX (0.5ml, unknown, left arm). On 1 April 2009, within 3 hours after vaccination with BOOSTRIX, the subject was self-treating with IMMODIUM. At the time of reporting the event was unresolved.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injection site discomfort, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 38-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). There were no concurrent medications. On 13 April 2009 at 10:41 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, right arm). On 13 April 2009, 1 hour after vaccination with BOOSTRIX, the subject experienced swelling at the injection site and discomfort. On an unspecified date between 13 April 2009 and 15 April 2009, within several days after vaccination with BOOSTIRX, the subject experienced 11 x 12 centimeter induration with no redness. Medical attention was required at the clinic where the vaccine was administered. The subject was treated with ibuprofen. At the time of reporting, the outcome of the injection site swelling and discomfort was improved. The outcome of the induration was unspecified. Follow-up received 06 May 2009 from the reporter: The events resolved on 24  April 2009. The reported considered the events could have been associated with " last tetanus diphtheria vaccine was 2005". The reported considered the events were related to vaccination with BOOSTRIX.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site pain in a 31-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  On 13 April 2009, in the morning, the subject received 1st dose of BOOSTRIX (0.5 ml, route unknown, right arm).  On 13 April 2009, almost immediately after vaccination with BOOSTRIX, the subject experienced injection site pain, stiffness in neck and down left arm.  The events were "much improved" two days later.  At the time of reporting the events were improved.  Follow-up received from the reporting healthcare professional on 13 May 2009:  BOOSTRIX was administered intramuscularly.  The events resolved on 24 April 2009.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site induration, Migraine, Musculoskeletal stiffness, Neck pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of induration over injection site in a 29-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and accellular pertussis vaccine, absorbed (Boostrix, GlaxoSmithKline) for prophylaxis. The subject's medical history included migraine. The subject had no history of drug allergies. On 13 April 2009 at 10:39 the subject received unspecified dose of Boostrix (0.5ml, unknown route, left arm). On 13 April 2009 at 13:00, approximately 2 hours after vaccination with Boostrix, the subject experienced 3.75 centimeter induration at injection site, headache, neck stiffness and soreness and tingling in distal part of left arm. The subject was treated with ibuprofen and ice (Ice pack). At the time of reporting the events were unresolved.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of induration over injection site in a 29-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and accellular pertussis vaccine, absorbed (Boostrix, GlaxoSmithKline) for prophylaxis. The subject's medical history included migraine. The subject had no history of drug allergies. On 13 April 2009 at 10:39 the subject received unspecified dose of Boostrix (0.5ml, unknown route, left arm). On 13 April 2009 at 13:00, approximately 2 hours after vaccination with Boostrix, the subject experienced 3.75 centimeter induration at injection site, headache, neck stiffness and soreness and tingling in distal part of left arm. The subject was treated with ibuprofen and ice (Ice pack). At the time of reporting the events were unresolved.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Neck pain
Clinical narrative: This case was reported by a nurse and described the occurrence of headache radiating to neck in a 42-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  The subject does not consume alcohol and is a non-smoker.  The subject had not received prior BOOSTRIX vaccine as an adult.  Concurrent medical conditions included seasonal allergy.  Concurrent medications included ALLEGRA D and VERAMYST.  On 13 April 2009 at 10:46 the subject received unspecified dose of BOOSTRIX (0.5 ml, unknown route, right arm).  On 13 April 2009 at 10:00, approximately 7 hours after vaccination with BOOSTRIX, the subject experienced headache that went from the top of his head to his neck and fatigue.  The subject was treated with a heat pack.  At the time of reporting the events were resolved on 14 April 2009.  The healthcare professional considered the events were related to vaccination with BOOSTRIX.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema, Feeling abnormal, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse and described the occurrence of ache(s) in a 30-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  Concurrent medications included ADVIL.  On 13 April 2009 at 10:44 the subject received 1st dose of BOOSTRIX (0.5 ml, unknown route, right arm).  Later that night, within hours of vaccination with BOOSTRIX, the subject experienced feeling achy and had neck ache.  The next morning on 14 April 2009, the subject felt groggy and felt like he was getting the flu.  He went to work.  That night, the subject was feverish with temperature of 100.8 degrees Fahrenheit.  The subject also experienced stiffness down arm.  On 15 April 2009, the subject was feeling better.  The subject also experienced a 3-4 centimeter irregularly rounded erythema without swelling, which was observed by the reporter on 15 April 2009.  At the time of reporting the outcome of the events were was unspecified.  Follow-up received from the reporting healthcare professional on 12 May 2009:  BOOSTRIX was administered intramuscularly.  The first signs and symptoms occurred on 13 April 2009.  The events were resolved on 24 April 2009.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain, Pain, Pyrexia, Somnolence
Clinical narrative: This case was reported by a nurse and described the occurrence of ache(s) in a 30-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  Concurrent medications included ADVIL.  On 13 April 2009 at 10:44 the subject received 1st dose of BOOSTRIX (0.5 ml, unknown route, right arm).  Later that night, within hours of vaccination with BOOSTRIX, the subject experienced feeling achy and had neck ache.  The next morning on 14 April 2009, the subject felt groggy and felt like he was getting the flu.  He went to work.  That night, the subject was feverish with temperature of 100.8 degrees Fahrenheit.  The subject also experienced stiffness down arm.  On 15 April 2009, the subject was feeling better.  The subject also experienced a 3-4 centimeter irregularly rounded erythema without swelling, which was observed by the reporter on 15 April 2009.  At the time of reporting the outcome of the events were was unspecified.  Follow-up received from the reporting healthcare professional on 12 May 2009:  BOOSTRIX was administered intramuscularly.  The first signs and symptoms occurred on 13 April 2009.  The events were resolved on 24 April 2009.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a 41-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  There were no concurrent medications.  On 13 April 2009 at 11:46 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left arm).  On 13 April 2009, less than one day after vaccination with BOOSTRIX, the subject experienced injection site tenderness, erythema and local reaction at injection site.  The subject sought medical attention by visiting the nurse on duty at the clinic.  At the time of reporting the outcome of the events was unspecified.  Follow up received from reporting healthcare professional on 22 May 2009:  BOOSTRIX was administered intramuscularly.  The onset of the events was reported as 16 April 2009, 3 days after vaccination with BOOSTRIX.  The events were resolved on 19 May 2009.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional, an occupational health nurse, and described the occurrence of swelling injection site in a 50-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 15 April 2009 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown left arm). On 15 April 2009, than one day after vaccination with BOOSTRIX, the subject experienced swelling injection site and injection site redness in the left arm. On an unspecified date, the subject sought medical attention by calling the nurse practioner on duty at occupation health. At the time of reporting the events were unresolved. Follow-up information received on 27 May 2009 indicated that the events began on 15 April 2009 and resolved by 07 May 2009. In the reporter's opinion, the events were considered to be related to treatment with BOOSTRIX.
Age: 39.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Hypoaesthesia facial, Malaise, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of facial numbness in an adult female subject who was vaccinated with (BOOSTRIX, GlaxoSmithKline), and (TWINRIX). The subject stated that she felt "slightly unwell" before the vaccinations. On an unspecified date the subject received unspecified dose of BOOSTRIX (details unknown), unspecified dose of TWINRIX (details unknown). The next morning when she awoke, approximately 24 hours after vaccination with BOOSTRIX and TWINRIX, the subject experienced facial numbness. At the time of reporting the outcome of the event was unspecified. Follow-up received from reporting healthcare professional on 22 May 2009: The subject was 39-years-old. Past medical history included genital herpes. The subject does not drink or smoke. Concurrent medications included VALTREX. On 05 May 2009, the subject received a dose of BOOSTRIX (0.5 mL) and 1st dose of TWINRIX (1mL). Facial numbness occurred on 06 May 2009. The event resolved on 07 May 2009. The healthcare professional considered the event was possibly related to vaccination with BOOSTRIX and TWINRIX. The healthcare professional also considered the event could have been associated with medical history or a concurrent illness, an reported that the symptoms subsided when VALTREX was taken.
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 adult female subjects (unknown number of subjects) who were vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included being thin, with weight ranging between 90 - 100 pounds. On unspecified dates the subjects received doses of BOOSTRIX (details unknown). A few days after vaccination with BOOSTRIX, the subjects experienced "severe" injection site pain and pain all over body. At the time of reporting the events were resolved (unknown timeframe). The physician was making a general observation that she had been noticing over an unknown period of time occurring in an unknown number of subjects.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional (who was also the subject's mother) via a GSK representative, and described the occurrence of lymph node swelling a 15-year-old male subject who was vaccinated with Boostrix (GlaxoSmithKline). There were no concomitant medications or vaccinations. On 8 May 2009 the subject received unspecified dose of Boostrix (unknown route, right arm). On 9 May 2009, the morning after vaccination with Boostrix, the subject experienced lymph node swelling in the right arm. The subject was treated with Tylenol and/or Advil. The swelling had improved on 10 May 2009, and more on 11 May 2009. The subject refused Tylenol on 11 May 2009 "since it was better". The healthcare professional considered the event was probably related to vaccination with Boostrix.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of swelling injection site in a 42-year old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and accellular pertussis vaccine, absorbed BOOSTRIX, (GlaxoSmithKline). The subject received her last tetanus diphtheria vaccine four years previously, but had not received BOOSTRIX. There was no relevant medical history, concurrent conditions or allergies. The subject did not use tobacco and her alcohol use was described as social. Concurrent medications included LOESTRIN FE, AMBIEM and LEXAPRO. On an unspecified date the subject received 1st dose of BOOSTRIX (0.5 cc, intramuscular, left deltoid). On 9 April 2009, at an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling at injection site and injection site soreness. On 21 April 2009, the events were resolved. The healthcare professional considered the events were related to vaccination with BOOSTRIX.
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional (also the subject's colleague) via a representative and described the occurrence of fever in a female subject aged 40 - 49 years old who was vaccinated with BOOSTRIX (Glaxosmithkline). On an unspecified date the subject received 1st dose of BOSSTRX (details unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced fever. At the time of reporting the outcome of the event was unspecified.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Oedema peripheral, Pain in extremity, Rash generalised
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of injection site pain in a 44-year-old female subject who was vaccinated with BOOSTRIX vaccine (GlaxoSmithKline). On 20 May 2009 the subject received a dose of BOOSTRIX in an unknown arm. Four days after receiving BOOSTRIX, the subject developed injection site pain in the arm. An unspecified time after vaccination with BOOSTRIX, the subject developed a rash on the whole body. She was seen at the hospital and was prescribed ZITHROMAX and prednisone pack for treatment. The rash was improved at the time of reporting, but the outcome of injection site pain was not known. The physician treating the subject considered the rash probably related to treatment with BOOSTRIX and injection site pain possibly related to vaccination with BOOSTRIX. It was unknown if the subject required an overnight stay at the hospital. Follow-up information was received on 29 June 2009, via physician. The physician reported the events started on 25 May 2009, a the subject also experienced right arm pain and swelling. The events resolved, date not provided. The physician considered the events not related to vaccination with BOOSTRIX.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cough, Pertussis, Pertussis identification test positive
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of pertussis in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (Glaxosmithkline). On 16 May 2008 the subject received unspecified dose of BOOSTRIX (details unknown). On 18 May 2009, 12 months after vaccination with BOOSTRIX, the subject developed pertussis. It was reported that others in the subject's family may also be infected and that the health department has been contacted. The family was being treated. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 18 June 2009 indicated that the subject was a 12 year old female. She received BOOSTRIX and developed pertussis, whooping cough and or cough. The events resolved and were considered by the reported to be unrelated to treatment with BOOSTRIX. MENACTRA was administered concurrently on 16 May 2008.+
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Heart rate decreased, Hypotension, Immediate post-injection reaction, Pallor, Presyncope
Clinical narrative: This case was reported by a physician, via a GSK representative and described the occurrence of lips white in a 10-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included nervousness prior to receiving the vaccination. On 17 July 2009 the subject received unspecified dose of BOOSTRIX (details unknown). On 17 July 2009, immediately after vaccination with BOOSTRIX, the subject experienced lips white, low blood pressure (63/36), pulse lower (66) and seeing white spots before eyes. On 17 July 2009, the events were resolved. Within 4 minutes after vaccination, the subject's blood pressure stabilized to 95/57 and his pulse increased to 108. The physician considered the events were unrelated to vaccination with BOOSTRIX, and that it was a vagal  response.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Visual impairment
Clinical narrative: This case was reported by a physician, via a GSK representative and described the occurrence of lips white in a 10-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included nervousness prior to receiving the vaccination. On 17 July 2009 the subject received unspecified dose of BOOSTRIX (details unknown). On 17 July 2009, immediately after vaccination with BOOSTRIX, the subject experienced lips white, low blood pressure (63/36), pulse lower (66) and seeing white spots before eyes. On 17 July 2009, the events were resolved. Within 4 minutes after vaccination, the subject's blood pressure stabilized to 95/57 and his pulse increased to 108. The physician considered the events were unrelated to vaccination with BOOSTRIX, and that it was a vagal  response.
Age: 11.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Cold compress therapy, Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: This care was reported by a healthcare professional and described the occurrence of swelling injection site in a 11-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). The subject was delayed in receiving his initial primary vaccinations. There were no concomitant medications and no known relevant medical history. The subject had not experienced adverse events following previous vaccinations. Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine (manufacturer unspecified) given 6 months earlier; inactivated poliomyelitis virus vaccine (manufacturer unspecified) given on 23 July 2009. On 23 July 2009 the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, left arm). On 24 July 2009, 1 day after vaccination with BOOSTRIX, the subject experienced swelling at injection site and injection site redness. Routine instructions of care were given: cold compress to sight and monitor. The subject also experienced drug dose administration interval too short as BOOSTRIX was administered earlier than recommended after DTaP vaccination. At the time of reporting the events were unresolved.
Age: 20.0
Sex: F
Vaccine: HEPAB
Symptoms: Streptococcal identification test negative, Throat tightness
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of throat tightness in a 20 year-old female subject who was vaccinated with TWINRIX, GlaxoSmithKline. On 18 September 2008 the subject received 1st dose of TWINRIX (UNKNOWN). On 18 September 2008, at an unspecified time after vaccination with  TWINRIX. The subject went to the emergency room and was treated with BENADRYL and Dexamethasone. At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with TWINRIX. Follow-up information received on 28 October 2008 indicated that the events were all resolved and the reporter considered them to be related to treatment with TWINRIX. A strep test was performed on 18 September 2008 which was negative. It was reported that TWINRIX was administered intramuscularly. No additional information was provided.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Activities of daily living impaired, Arthralgia, Blood test normal, Borrelia burgdorferi serology positive, Fatigue
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of knee arthralgia in a 50-year-old female subject who was vaccinated with (TWINRIX, GlaxoSmithKline). Previous vaccination included 1st and 2nd dose of (TWINRIX, GlaxoSmithKline) with the 1st dose started in October 2007. Yellow fever vaccine (manufacturer unspecified) was given in November 2007. Concurrent medications included MALARONE. The subject started the TWINRIX series at 1.0 ml in October 2007. In November 2007, while away for two weeks, the subject developed "syndrome" consisting of knee arthralgia, urticaria, fatigue and joint pain. Various unspecified lab tests were done: non specific-reaction to Lyme, CBC was negative, babasia titers were negative. The subject was placed on antibiotics, but the physician did not believe it helped much. Five days prior to reporting, the physician recommended the subject stop the antibiotics but the events continued, although they improved. The physician considered the events were disabling because they did interfere with her daily activities. She was, however, still able to work. The events were also considered to be clinically significant (or requiring intervention). the physician reported that he was not sure the events were related to TWINIRX because it may be something that she developed while away. The physician stated that the subject completed her Twinrix series,but did not have the dates on hand. Additionally, the physician stated the events were not related to MALARONE.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Full blood count normal, Laboratory test normal, Urticaria
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of knee arthralgia in a 50-year-old female subject who was vaccinated with (TWINRIX, GlaxoSmithKline). Previous vaccination included 1st and 2nd dose of (TWINRIX, GlaxoSmithKline) with the 1st dose started in October 2007. Yellow fever vaccine (manufacturer unspecified) was given in November 2007. Concurrent medications included MALARONE. The subject started the TWINRIX series at 1.0 ml in October 2007. In November 2007, while away for two weeks, the subject developed "syndrome" consisting of knee arthralgia, urticaria, fatigue and joint pain. Various unspecified lab tests were done: non specific-reaction to Lyme, CBC was negative, babasia titers were negative. The subject was placed on antibiotics, but the physician did not believe it helped much. Five days prior to reporting, the physician recommended the subject stop the antibiotics but the events continued, although they improved. The physician considered the events were disabling because they did interfere with her daily activities. She was, however, still able to work. The events were also considered to be clinically significant (or requiring intervention). the physician reported that he was not sure the events were related to TWINIRX because it may be something that she developed while away. The physician stated that the subject completed her Twinrix series,but did not have the dates on hand. Additionally, the physician stated the events were not related to MALARONE.
Age: 31.0
Sex: F
Vaccine: HEPAB
Symptoms: Drug exposure during pregnancy, Injection site pain
Clinical narrative: This case  was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (Glaxosmithkline). On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with TWINRIX injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot. Follow-up information was received on 04 November 2008, by a physician and described the occurrence of injection site stinging in a 31 year old female subject who was vaccinated with TWINRIX (Glaxosmithkline). On an unspecified date the subject received 1st dose of TWINRIX (unknown). On 1 October 2008, at an unspecified time after vaccination with TWINRIX, the subject experienced injection site stinging, injection site burning, possible irritating substance in lot AGABB128AB (product complaint). The lot was removed from further vaccinations. Upon follow-up the physician reported the subject was pregnant and experienced vaccine exposure during pregnancy. On 1 October 2008, the injection site stinging and injection site burning were resolved. The physician considered the events related to vaccination with TWINRIX.
Age: 1.22
Sex: M
Vaccine: MMR
Symptoms: Autism, Staring, Stereotypy
Clinical narrative: This is in follow-up to report (s) previously submitted on 09/21/2006; 10/23/2006. Information has been received from a consumer concerning her approximately 12 month old son with no known allergies or pertinent medical history who, 6 1/2 years ago, in approximately March 2000, was vaccinated with a 0.5ml first dose of MMR II. There was no concomitant medication. Subsequently, "around the same time" the vaccine was given, the patient started "showing signs" of autism. No tests were done, the patient was not hospitalized. At the time of the report the patient had not recovered. No further information was available. There was no product quality complaint involved. Additional information from the physician indicated that she is not able to provide further information because she does not feel that patient suffered an adverse reaction to any of the medications or vaccines given to the patient at that office. Follow up information has been received from a consumer concerning her around 15 month old son who in approximately June 2000 received a dose of MMR II (lot# not reported). Then around October 2000, the patient started to developed signs of autism like blank stares and repetitive movement. The consumer reported that the patient was diagnosed with autism and had received the booster dose of MMR II. The consumer reported that she was not sure if MMRII caused the autism. The patient's brother (WAES#0609USA02487) also had an adverse experience after vaccination with MMR II. Upon internal review, autism was considered to be an other important medical event. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Musculoskeletal pain, Pain
Clinical narrative: Report received from a registered nurse on 02-DEC-2009. A 19 year old male (DOB: 10-JAN-1991) received AFLURIA 0.5 ml IM in the left deltoid on 23-SEP-2009 (lot# 0694911A with an expiration date of 30-JUN-2009). At an unknown time after vaccination, the male initially experienced pain in the arm and shoulder and then increasingly worsened. He had weakness and atrophy of the shoulder girdle. His whole arm was weak. The physician felt that this might be a possible "PARSONAGE TURNER Syndrome". The physician felt the male's experience was not related to injection technique, as the atrophy was proximal to the injection site. The nurse reported the patient's weakness and pain involved the suprascapular nerve and rotator cuff. The physician felt that this may be an autoimmune reaction to the influenza vaccine. The male was scheduled to be seen by the physician on 03-DEC-2009. This was originally reported to VAERS (report# E35603). Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Atrophy, Expired drug administered, Muscular weakness, Musculoskeletal pain, Pain
Clinical narrative: Report received from a registered nurse on 02-DEC-2009. A 19 year old male (DOB: 10-JAN-1991) received AFLURIA 0.5 ml IM in the left deltoid on 23-SEP-2009 (lot# 0694911A with an expiration date of 30-JUN-2009). At an unknown time after vaccination, the male initially experienced pain in the arm and shoulder and then increasingly worsened. He had weakness and atrophy of the shoulder girdle. His whole arm was weak. The physician felt that this might be a possible "PARSONAGE TURNER Syndrome". The physician felt the male's experience was not related to injection technique, as the atrophy was proximal to the injection site. The nurse reported the patient's weakness and pain involved the suprascapular nerve and rotator cuff. The physician felt that this may be an autoimmune reaction to the influenza vaccine. The male was scheduled to be seen by the physician on 03-DEC-2009. This was originally reported to VAERS (report# E35603). Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Report received from a registered nurse on 02-DEC-2009. A 19 year old male (DOB: 10-JAN-1991) received AFLURIA 0.5 ml IM in the left deltoid on 23-SEP-2009 (lot# 0694911A with an expiration date of 30-JUN-2009). At an unknown time after vaccination, the male initially experienced pain in the arm and shoulder and then increasingly worsened. He had weakness and atrophy of the shoulder girdle. His whole arm was weak. The physician felt that this might be a possible "PARSONAGE TURNER Syndrome". The physician felt the male's experience was not related to injection technique, as the atrophy was proximal to the injection site. The nurse reported the patient's weakness and pain involved the suprascapular nerve and rotator cuff. The physician felt that this may be an autoimmune reaction to the influenza vaccine. The male was scheduled to be seen by the physician on 03-DEC-2009. This was originally reported to VAERS (report# E35603). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Erythema, Pallor, Pruritus, Rash macular
Clinical narrative: Large local reaction-15 x 20 cm. Erythema, induration. Warm to touch. Tender.
Age: 3.0
Sex: M
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Erythema, Feeling hot, Induration, Local reaction, Tenderness
Clinical narrative: Large local reaction-15 x 20 cm. Erythema, induration. Warm to touch. Tender.
Age: 1.07
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Febrile convulsion
Clinical narrative: Child was sleeping and parent heard her making a funny noise.  She went to check on her and picked her up.  She noticed her daughter burning up to touch and her eyes were open but staring.  The skin around her lips were blue, but child was breathing.  She continued making the weird noise.  Mom figured she was having a seizure and called 911.  The seizure lasted about 3 min. then she was able to be brought out of the seizure.  Her temp was 103.9 axillary. Child was brought to the ER where she received a large dose of Tylenol, and a shot of Rocephin just in case it was bacterial.  They also did blood work and chest x-ray.  Fever did come down in ER a little bit.  Child was feeling better in 24 hours.  They followed up with a pediatrican.
Age: 1.07
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Blood test, Chest X-ray, Convulsion, Cyanosis, Feeling hot
Clinical narrative: Child was sleeping and parent heard her making a funny noise.  She went to check on her and picked her up.  She noticed her daughter burning up to touch and her eyes were open but staring.  The skin around her lips were blue, but child was breathing.  She continued making the weird noise.  Mom figured she was having a seizure and called 911.  The seizure lasted about 3 min. then she was able to be brought out of the seizure.  Her temp was 103.9 axillary. Child was brought to the ER where she received a large dose of Tylenol, and a shot of Rocephin just in case it was bacterial.  They also did blood work and chest x-ray.  Fever did come down in ER a little bit.  Child was feeling better in 24 hours.  They followed up with a pediatrican.
Age: 1.07
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Pyrexia, Staring
Clinical narrative: Child was sleeping and parent heard her making a funny noise.  She went to check on her and picked her up.  She noticed her daughter burning up to touch and her eyes were open but staring.  The skin around her lips were blue, but child was breathing.  She continued making the weird noise.  Mom figured she was having a seizure and called 911.  The seizure lasted about 3 min. then she was able to be brought out of the seizure.  Her temp was 103.9 axillary. Child was brought to the ER where she received a large dose of Tylenol, and a shot of Rocephin just in case it was bacterial.  They also did blood work and chest x-ray.  Fever did come down in ER a little bit.  Child was feeling better in 24 hours.  They followed up with a pediatrican.
Age: 0.57
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site discolouration
Clinical narrative: Patient has no temp, area not reddened, not irritated, not warm to touch.  There is a small area where the needles was inserted, that has a grey to silver particle that is just under the skin.  Area is not raised and Dad/mom has not noticed area.  Area of injection was left upper vastus lateralis.
Age: 61.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Rash
Clinical narrative: Rapid onset urticaria; rapid pulse; elevated blood pressure
Age: 61.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Blood pressure increased, Heart rate increased, Urticaria
Clinical narrative: Rapid onset urticaria; rapid pulse; elevated blood pressure
Age: 1.5
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia
Clinical narrative: really high temperature 103.6, as high as 104 at the dr's office at 8:45 pm went to dr at 6:30pm called all day and that was only time available
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Influenza like illness, Laboratory test
Clinical narrative: The evening of the TDAP vaccine, I experienced flu like symptoms and severe lower back and joint pain. I was unable to work for 2 days after the vaccination. Some of the symptoms subsided however the joint and back pain persisted. Late October, early November I was unable to move my arms when I woke up due to excriating pain in both shoulders, wrists and fingers. The swelling and pain was worse on the right side (the vaccination was administerd in the right deltoid). I went to a rheumatologist who noted that I have muscle wasting in my right shoulder. My right shoulder is now lower than my left. I am being worked up for rheumatoid arthritis. The rheumatologist is suspicious that this may have been caused by the vaccination. I am currently on high dose steroids and NSAIDS. I suffer from bilateral joint pain hands, feet, shoulders and wrists. In addition I have noticed since the vaccination that I experience muscle spasms on the right side of my back and shoulder. I am still under the care of a rheumatologist.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Muscle atrophy, Muscle spasms, Pain, Swelling
Clinical narrative: The evening of the TDAP vaccine, I experienced flu like symptoms and severe lower back and joint pain. I was unable to work for 2 days after the vaccination. Some of the symptoms subsided however the joint and back pain persisted. Late October, early November I was unable to move my arms when I woke up due to excriating pain in both shoulders, wrists and fingers. The swelling and pain was worse on the right side (the vaccination was administerd in the right deltoid). I went to a rheumatologist who noted that I have muscle wasting in my right shoulder. My right shoulder is now lower than my left. I am being worked up for rheumatoid arthritis. The rheumatologist is suspicious that this may have been caused by the vaccination. I am currently on high dose steroids and NSAIDS. I suffer from bilateral joint pain hands, feet, shoulders and wrists. In addition I have noticed since the vaccination that I experience muscle spasms on the right side of my back and shoulder. I am still under the care of a rheumatologist.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray
Clinical narrative: The evening of the TDAP vaccine, I experienced flu like symptoms and severe lower back and joint pain. I was unable to work for 2 days after the vaccination. Some of the symptoms subsided however the joint and back pain persisted. Late October, early November I was unable to move my arms when I woke up due to excriating pain in both shoulders, wrists and fingers. The swelling and pain was worse on the right side (the vaccination was administerd in the right deltoid). I went to a rheumatologist who noted that I have muscle wasting in my right shoulder. My right shoulder is now lower than my left. I am being worked up for rheumatoid arthritis. The rheumatologist is suspicious that this may have been caused by the vaccination. I am currently on high dose steroids and NSAIDS. I suffer from bilateral joint pain hands, feet, shoulders and wrists. In addition I have noticed since the vaccination that I experience muscle spasms on the right side of my back and shoulder. I am still under the care of a rheumatologist.
Age: 28.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Rash, Sinus congestion
Clinical narrative: SINUS CONGESTION, WEAKNESS, AND RASH ON FACE AND RIGHT ARM.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Pain, Pruritus, Rash generalised, Rash macular
Clinical narrative: Reported by mother.  Awoke in morning following receipt of H1N1 vaccination with a shooting pain in her leg.  Soon a blotchy, red itchy rash developed all over the child's body.  The child's physician was consulted by phone.  The child was treated with over-the-counter Benadryl every four hours, with gradual resolution of symptoms over the course of four days.  Has had influenza vaccinations previously without trouble.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Throat tightness, Urticaria
Clinical narrative: Hives, throat tightness approximately 5 hours after immunizations - patient visited ER - given BENADRYL.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Heat therapy, Injection site pain
Clinical narrative: Left arm soreness lasting more than 1 week, analgesics, warm compresses.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Purpura, Skin discolouration
Clinical narrative: Purple discoloration dorsum both hands, started  bd morning of 11/11/09, following flu vaccine given 11/10/09. Recalls now "allergic to eggs." Resolved in 4-5 days. No other symptoms.
Age: 53.0
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Headache, Migraine, Nausea, Pain
Clinical narrative: #1 Seasonal headache that progressed into migraine (2 days) nausea & body aches. # 2 H1N1 severe headache x 2 days.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Right arm erythema 24 hours after PNEUMOVAX given. ? cellulitis. Vancomycin.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Mobility decreased, Pain
Clinical narrative: Decreased mobility shoulder, inflammation, soreness lasting >2 months post injection.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Body temperature increased
Clinical narrative: H1N1 vaccine at 11:45, to nurses' clinic with c/o abd. pain and temp 103.2 at 13:35. No skin manifestations, lungs clear to auscultation. P 104 regular, BP 90/50,  R 28, T 102.8 at 12:50pm. Temp 101.8 at 1:25pm TYLENOL 10cc at 1:28pm.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Rash macular
Clinical narrative: 9:45A immunization (H1N1-inactivated). 10:45A flat (macular) rash, red L ear ear to R ear and posterior neck. T-97.4 Axillary. 11:05A rash gone 11:25 returned to classroom.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient given DTaP vaccine at 10:30am physical on 12-8-09. Patient came back to office at 3pm for possible immunization reaction. At that time patient had a 7 1/2cm x 7cm circular area of mild swelling and erythema. No pain. Treatment: cool compresses, Benadryl PRN and call back if worsen reaction.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: 4 large rashes with bumps, red one on shoulder where shot was administered and three on front of arm.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia
Clinical narrative: EE states day after vaccine had tingling in Rt arm/hand /feet. Spread to rt foot/lower leg. Left side still tingling
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fatigue, Influenza, Myalgia, Rash generalised, Respiratory disorder
Clinical narrative: Rash on body- Respiratory problems-5 days later -> flu symptoms. Body aches, fatigue chills, cough.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Shortness of breath dizzy.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives; Benadryl given and hives resolved within 2 hours of Benadryl.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chills, Diarrhoea, Headache, Vomiting
Clinical narrative: Developed chills, headache, vomiting and diarrhea lasting approximately 1.5 hours.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dry mouth, Hot flush
Clinical narrative: Chills and hot flashes, stomach pains.  Reporting flu like symptoms, cotton mouth, and diarrhea.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Influenza like illness
Clinical narrative: Chills and hot flashes, stomach pains.  Reporting flu like symptoms, cotton mouth, and diarrhea.
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dyspnoea, Nausea
Clinical narrative: Light-headed, nausea, shortness of breath.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: Elevated temperature and rash all over his body.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dysgeusia, Flushing, Headache
Clinical narrative: Headache- 36 hours - took Excedrin. Metallic taste- 12 hours. Flushed- 12 hours.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash
Clinical narrative: Fine rash on cheeks and neck and it is itching.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Asthenia, Ataxia, Balance disorder, Blood product transfusion, CSF test normal
Clinical narrative: WEAKNESS IN LOWER EXTREMETIES, ASCENDING PARALISIS. CAN'T STAND ON HIS OWN. HEADACHE, DIZZINESS. WILL BE TREATED WITH GAMMAGLOBULINE 25 MG STAT DAILY X 5 DAYS. STILL HOSPITALIZED.  12/10/09 vaccination record DOS 12/04/09 and hospital admission note, physician orders and laboratory tests received for DOS 12/08/09-12/09/09 Dx: Suspected Guillain-Barre Syndrome.  Patient presented with complaint of leg and arm weakness and pain. A spinal tap was performed and the patient was treated with IV Gamma globulin.     12/14/2009 hospital records received for DOS 12/08/2009-12/13/09. Dx: Cerebillitis s/p H1N1 vaccine  Patient experienced leg weakness and pain, ataxia, loss of balance and loss of strength. On discharge, patient could walk with assistance and was alert and orientated with a mild headache.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Computerised tomogram normal, Dizziness, Dysstasia, Encephalitis, Full blood count normal
Clinical narrative: WEAKNESS IN LOWER EXTREMETIES, ASCENDING PARALISIS. CAN'T STAND ON HIS OWN. HEADACHE, DIZZINESS. WILL BE TREATED WITH GAMMAGLOBULINE 25 MG STAT DAILY X 5 DAYS. STILL HOSPITALIZED.  12/10/09 vaccination record DOS 12/04/09 and hospital admission note, physician orders and laboratory tests received for DOS 12/08/09-12/09/09 Dx: Suspected Guillain-Barre Syndrome.  Patient presented with complaint of leg and arm weakness and pain. A spinal tap was performed and the patient was treated with IV Gamma globulin.     12/14/2009 hospital records received for DOS 12/08/2009-12/13/09. Dx: Cerebillitis s/p H1N1 vaccine  Patient experienced leg weakness and pain, ataxia, loss of balance and loss of strength. On discharge, patient could walk with assistance and was alert and orientated with a mild headache.