chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from healthcare professional on 29 Jan 2010: This patient received FLUVIRIN batch number 102136P, expiry date Mar 2010, 0.5 mL intramuscular on unspecified date.  No adverse reaction was reported.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report was received from a Nurse on 03 Feb 2010: This patient (under four years of age) was vaccinated with 0.5 ml of FLUVIRIN (batch number 102135P1) intramuscularly on 03 Feb 2010.  The outcome of patient's condition was not reported.  The seriousness criteria of the patient was not reported.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Anaphylactic reaction
Clinical narrative: Report received from a Merck representative on 24-Jun-2010 (case number SR # 1-3606807075).  An adult female (DOB unknown) who is also a nurse, received one dose of H1N1 injection (manufacturer and lot number not provided) in the "fall of 2009", one month after receiving the seasonal flu vaccine (manufacturer unknown).  After receiving the H1N1 vaccine, the patient developed an anaphylactic reaction.  The patient was taken to the hospital emergency room for treatment and was released home.  The representative indicated "the nurse has other allergies" but specific allergies were not provided.  The patient recovered (date not specified).  No additional information is available.  This case was considered serious due to medical significance.  The company considered event possibly related to PANVAX, given the brand name is unknown.  Information derived from this AE report does not change the current safety profile of the product.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Dyspnoea, Immediate post-injection reaction, Myalgia
Clinical narrative: Report received from a registered nurse on 20-Nov-2009. A female patient received H1N1 (brand unknown) for immunization on an unknown date. The patient has a medical history of allergies to Penicillin, Sulfa and other non-drug items. No concomitant medication was provided. On the date of vaccine administration, the patient immediately experienced weakness, SOB (shortness of breath) and muscle aches. Her reaction did subside a few hours after receiving the vaccination. Additional information has been requested. The company assessed the event causality as possibly due to the suspect drug. Information derived from this AE report does not change the safety profile of the product.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Conjunctivitis, Dysphagia, Eye discharge, Joint swelling
Clinical narrative: Report received from a MD on 23-Nov-2009 on behalf of his wife who is the patient.  A 40 year-old female patient received H1N1 (Pre-filled syringe lot 00949611A) which was administered IM deltoid.  The vaccine was administered to the patient by her husband, who is also a physician, in their home at 9:00 PM on 20-Nov-2009.  The patient has a medical history of allergy to Thimerasol, and had a prior allergic reaction to a prior flu vaccination (product contained Thimerasol) when the patient was 33 years of age (??-???-1999).  On 21-Nov-2009, 15 hours 30 minutes after the H1N1 vaccine was administered (12:30 PM), the patient developed the following adverse reactions: severe nausea, dysphagia, conjunctival infection followed by eye discharge, and swollen joints.  She also experienced myalgia and arthralgia for 24 hours.  The company assessed the event causality as possible in relation to the suspect drug.  Information derived from this AE report does not change the safety profile of the product.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Myalgia, Nausea
Clinical narrative: Report received from a MD on 23-Nov-2009 on behalf of his wife who is the patient.  A 40 year-old female patient received H1N1 (Pre-filled syringe lot 00949611A) which was administered IM deltoid.  The vaccine was administered to the patient by her husband, who is also a physician, in their home at 9:00 PM on 20-Nov-2009.  The patient has a medical history of allergy to Thimerasol, and had a prior allergic reaction to a prior flu vaccination (product contained Thimerasol) when the patient was 33 years of age (??-???-1999).  On 21-Nov-2009, 15 hours 30 minutes after the H1N1 vaccine was administered (12:30 PM), the patient developed the following adverse reactions: severe nausea, dysphagia, conjunctival infection followed by eye discharge, and swollen joints.  She also experienced myalgia and arthralgia for 24 hours.  The company assessed the event causality as possible in relation to the suspect drug.  Information derived from this AE report does not change the safety profile of the product.
Age: 36.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Local swelling
Clinical narrative: Report received from a Health professional on 04-Dec-2009.  A 36 year old female patient received pre-filled H1N1 (lot 00749611A, exp date 30-Jun-2010) on 25-Nov-2009.  On 03-Dec-2009, the patient presented with neck swelling and neck redness.  The physician examined the patient.  The patient had no shortness of breath, there were no physician orders and the patient will be monitored.  Awaiting further information from the reporter.  The company considered events unlikely to PANVAX administration given the 9 day time interval from vaccination to onset of events.  Information derived from this report does not change the current safety profile of the product.  10-FEB-2010 - The reporter has been contacted twice and no further information expected.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Eye pain, Feeling abnormal, Headache, Pain, Photophobia
Clinical narrative: Report received from a consumer on 09-Dec-2009.  A female patient, who is a CSL company employee received Panvax H1N1 (lot 00349611A) intramuscularly on the morning of 03-Dec-2009.  On 03-Dec-2009 later that same day as vaccine administration, the patient developed a severe headache.  The headache continued through Friday and Saturday (she slept all day due to the headache).  The headache eventually resolved on Tuesday, 08-Dec-2009.  Awaiting further information.  The company considered events possibly related to vaccine administration.  Information derived from this AE report does not change the current safety profile of the product.  Follow-up was received from the initial reporter on 29-DEC-2009.  The 44 year old female received the H1N1 vaccination on 03-DEC-2009 at 13:00.  She was not pregnant at the time of vaccination.  On 04-DEC-2009 at 10:00 hours, the female experienced an unbelievable, migraine-like headache.  She had "throbbing pain on the right side of her head, including the eye, sensitivity to light.  Out of order!"  The female was not a migraine sufferer and knew something unusual might be going on.  She recovered on 07-DEC-2009.  No further information is expected.  Batch review request received for 00349611A on 29-DEC-2009.  On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues related to this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Age: 37.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash on trunk and arms in a female subject aged between 40 and 49 years old who was vaccinated with TWINRIX (GlaxoSmithKline) and H1N1 (unspecified).  On 8 March 2010 at approximately 15:00 the subject received 1st dose of TWINRIX (unknown).  On 8 March 2010 the subject received 1st dose of H1N1 unspecified.  On 9 March 2010, 1 day after vaccination with H1N1 unspecified and TWINRIX, the subject experienced rash on trunk and arm and itching of trunk and arm which lasted for three to four days.  The subject was treated with BENADRYL.  At the time of reporting the events were resolved.  The subject received TWINRIX for travel.  The pharmacist considered the H1N1 unspecified was a co-suspect vaccine, except that the rash started at the arm that TWINRIX was administered.  The rash spread to the subject's trunk.  The pharmacist was not sure that the vaccination series should be continued.  The subject's husband received TWINRIX and did not have a reaction.  Follow-up information received from pharmacist on 28 May 2010: The subject was 37 years-old.  The pharmacist indicated that the subject did not receive H1N1 unspecified.  The events started on 08 March 2010, the same day after vaccination with TWINRIX (1 ml, right).  The events were resolved on 12 March 2010.  The pharmacist did not specify a causal relationship to vaccination with TWINRIX, but indicated that TWINRIX was the suspect product.  The vaccination series with TWINRIX was delayed until the physician continued the series at hospital.  The events did not recur following subsequent administration of TWINRIX.  The subject had not experienced adverse events following previous vaccinations.
Sex: F
Vaccine: HEPAB
Symptoms: VIIth nerve paralysis
Clinical narrative: This case was reported by a healthcare professional, via GSK representative, and described the occurrence of Bell's palsy in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included TWINRIX; GlaxoSmithKline given on an unspecified date. On an unspecified date the subject received 2nd dose of TWINRIX (details unknown) 7 days after the 1st dose as per the accelerated schedule. At an unspecified time after vaccination with TWINRIX, the subject experienced Bell's palsy. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. The vaccination course with TWINRIX was discontinued. The healthcare professional considered the event was probably related to vaccination with TWINRIX. It was reported that the subject was referred to a neurologist who confirmed that the Bell's palsy was due to administration of the accelerated schedule of TWINRIX.
Sex: U
Vaccine: HEPAB
Symptoms: Antibody test negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of non-seroconversion in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 3rd dose of TWINRIX (unknown). The subject had received TWINRIX according to the accelerated schedule. At an unspecified time after completing the 3 dose series of TWINRIX, the subject was found to have not seroconverted. No additional information was provided. It was reported that this event occurred in two students. There were no patient identifiers.
Sex: M
Vaccine: HEPAB
Symptoms: No adverse event, No therapeutic response
Clinical narrative: This case was reported by a consumer and described the occurrence of not responding to therapy in an adult male subject who was vaccinated with Hepatitis a + b vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received 3rd dose of Hepatitis a + b vaccine (unknown). After vaccination with Hepatitis a + b vaccine, the subject felt that he had not developed antibodies to the vaccine. He felt that he had not responded to therapy. No adverse events were noted at the time of reporting.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Drug eruption
Clinical narrative: This case was reported by a physician and described the occurrence of a drug rash in a 34-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 8 June 2010 the subject received unspecified dose of TWINRIX (1 ml, unknown route, left arm). On 11 June 2010, 3 days after vaccination with TWINRIX, the subject experienced drug rash. At the time of reporting the event was unresolved. The vaccination course with TWINRIX was discontinued. The physician considered the event was probably related to vaccination with TWINRIX.
Sex: M
Vaccine: HEPAB
Symptoms: Antibody test abnormal, Inappropriate schedule of drug administration, Laboratory test abnormal
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of lab test abnormal in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose, 2nd dose, 3rd dose and 4th dose of TWINRIX (details unknown), and experienced inappropriate schedule of vaccine administered. The subject received 1st and 2nd dose of TWINRIX on two separate occasions over the past several years. At an unknown time after vaccination with TWINRIX, the subject experienced lab test abnormal. Recently, the subject had blood titer drawn and was informed by his hepatologist that he needed the TWINRIX three complete dose series because his titers were not within the correct ranges. At the time of reporting the outcome of the events was unspecified. The consumer refused to provide any further information.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Headache, Nausea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 46-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline).  Concurrent medications included LEVOXYL and Fluoxetine hydrochloride.  On 27 May 2010 at 10:35 the subject received 1st dose of TWINRIX (1 ml, unknown route, left arm).  On 27 May 2010 in the afternoon, less than one day after vaccination with TWINRIX, the subject experienced headache and nausea.  The subject almost attended the Emergency Room due to the nausea being so bad later that afternoon.  The healthcare professional considered the events were disabling.  On 28 May 2010, the events were resolved.  The healthcare professional considered the events were probably related to vaccination with TWINRIX.
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Petechiae
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of petechial rash on arm in a 36-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included allergy to amoxicillin. Previous vaccination included Salmonella typhi Vi capsular polysaccharide vaccine; manufacturer unspecified; oral given on 20 April 2010. On 5 May 2010 at 14:50 the subject received 2nd dose of TWINRIX (1 ml, unknown route, left arm). On 16 May 2010, 11 days after vaccination with TWINRIX, the subject experienced petechial rash on left arm. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with TWINRIX. Follow-up information received from healthcare professional on 06 August 2010: The healthcare professional reported that there were no concurrent illnesses. The immunization series with TWINRIX was discontinued. The reporter considered the events could have been associated with the subject's medical history (not specified), and indicated that there was no other possible causes.
Age: 25.0
Sex: F
Vaccine: HEPAB, HPV4
Symptoms: Immediate post-injection reaction, Thyroid function test abnormal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of increase in thyroid levels in a 25-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included hypothyroidism. Concurrent vaccination included GARDASIL (non-gsk); Merck; unknown; unknown given on 30 April 2010. Concurrent medications included LOESTRIN. On 30 April 2010 the subject received 1st dose of TWINRIX (unknown route, right arm). On 30 April 2010, immediately after vaccination with TWINRIX, the subject experienced increase in thyroid levels. Relevant test results included thyroid levels over 100. At the time of reporting the outcome of the event was unspecified. The vaccination course with TWINRIX was discontinued. The subject was consulting with thyroid specialist. Follow-up information received on 03 August 2010 reported that following administration of TWINRIX and GARDASIL (given at the same time in the subject's left arm on 30 April 2010) the subject's thyroid levels immediately increased. GARDASIL was also reported to be suspect. It was noted that further vaccinations with TWINRIX were discontinued at the present time.
Age: 64.0
Sex: M
Vaccine: HEPAB, YF
Symptoms: Condition aggravated, Pruritus, Swelling, Urticaria, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling in a 64-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included local reaction to intravenous dyes and local reaction to bee sting. Previous and/or concurrent vaccination included yellow fever vaccines (non-gsk); Sanofi; unknown; unknown given on 15 July 2010. On 15 July 2010 the subject received 1st dose of TWINRIX (1 ml, unknown route, left arm) as part of the accelerated dosing regimen. On 16 July 2010, 1 day after vaccination with TWINRIX, the subject experienced swelling, hives under arm and itching under arm. On 17 July 2010, the events were resolved. After the next vaccination with TWINRIX the events recurred. On 22 July 2010 the subject received 2nd dose of TWINRIX (1 ml, unknown route, left arm). On 23 July 2010, 1 day after vaccination with TWINRIX, the subject experienced swelling, hives under arm and itching under arm. On 25 July 2010, the events were resolved. The healthcare professional considered the events were related to vaccination with TWINRIX. The subject did not inform the healthcare professional of the adverse events experienced following the 1st dose of TWINRIX. He received the 2nd dose and the reactions were more exaggerated and lasted a little longer. The reporter did not know whether the reaction was systemic or localized. The reporter had initially thought that the yellow fever vaccine could be a co-suspect vaccination. However, they now believe that TWINRIX was the cause because the events recurred after the 2nd dose and were worse. Follow up information was received on 16 August 2010. It was reported that the 2nd dose of TWINRIX was given intramuscularly. It was noted that the accelerated dosing schedule of TWINRIX was postponed while waiting for primary care physician recommendation.
Sex: U
Vaccine: HEPAB
Symptoms: Fatigue, Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of swollen gland in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications at the time of the 2nd dose of TWINRIX included Antibiotics. On 26 April 2010 and 20 August 2010 the subject received 1st dose and 2nd dose of TWINRIX (details unknown). In April 2010 and August 2010, within 1 or 2 days of each vaccination with TWINRIX, the subject experienced swollen glands and exhaustion. The events occurred after each dose of TWINRIX. The healthcare professional was inquiring as to whether the subject should receive the 3rd dose of TWINRIX. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown). On an unspecified date, the subject experienced hepatitis B antibody negative. The subject received 3 doses of TWINRIX and was tested for protection within the appropriate time frame after the 3rd dose. The nurse reported that he was not protected against hepatitis B per the results. The subject also reported that his father had not responded to hepatitis B vaccination (see case ID A0880973A).
Sex: U
Vaccine: HEPAB
Symptoms: Adverse event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of adverse event 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 (injection, unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced adverse event. The nurse reported a subject "in the recent past developed an adverse event to TWINRIX and the subject refused another shot". At the report no other information was provided. At the time of reporting the outcome of the event was unspecified. The nurse reported additional cases see A0882436A, A0882437A and previously reported A0797402A.
Age: 31.0
Sex: F
Vaccine: HEPAB, IPV, TDAP, TYP
Symptoms: Erythema, Pruritus generalised
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema in a female subject of unspecified age who was vaccinated with TWINRIX adult (GlaxoSmithKline). Concurrent medical conditions included allergies. Previous and/or concurrent vaccination included poliomyelitis vaccine, unspecified; manufacturer unspecified; unknown; unknown given on 2 September 2010; BOOSTRIX; GlaxoSmithKline; unknown; unknown given on 2 September 2010; typhoid vaccine (non-gsk); manufacturer unspecified; unknown; unknown given on 2 September 2010. On 2 September 2010 the subject received 1st dose of TWINRIX adult (unknown). On 10 September 2010, 8 days after vaccination with TWINRIX adult, the subject experienced erythema and itching inside. The subject described the itching as sensation of itching inside from head to toe and was red. The subject took BENADRYL and went to bed. By the next day on 11 September 2010, the effects were gone. The nurse stated she could not make the determination if the other vaccines the subject received the same day were also suspect. On 11 September 2010, the erythema and itching were resolved. The nurse reported additional cases see A0882391A, A0882437A and previously reported A0797402A.
Sex: F
Vaccine: HEPAB
Symptoms: Bone pain, Syringe issue
Clinical narrative: This case was reported by a healthcare professional via GSK representative and described the occurrence of bone pain in clavicular region in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX, and experienced bone pain in clavicular region and syringe issue. When the nurse was administering the TWINRIX to the subject, the nurse reported having more difficulty than usual depressing all of the vaccine out of the syringe while injecting the subject. At unknown time after vaccination with TWINRIX, the subject reported pain going up to her collar bone. At the time of reporting the outcome of the events were unspecified. No further information was provided.
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal discomfort, Faeces discoloured, Pain, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of ache(s) in a 45-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included SYNTHROID and Birth control pills. On 5 October 2009 the subject received 1st dose of TWINRIX (unknown, unknown). On an unspecified day in October 2009, at an unspecified time after vaccination with 1st dose of TWINRIX, the subject experienced ache(s)  and low grade fever for eight hours. On 6 November 2009 in the morning, the subject received 2nd dose of TWINRIX (1 ml, unknown, left arm). At the time of reporting the outcome of ache(s) and low grade fever were unspecified. On 6 November 2009 in the morning, the subject received 2nd dose of TWINRIX and experienced drug dose administration interval too long. On 07 November 2009, one day after vaccination with 2nd dose of TWINRIX, the subject experienced tingling (arms, legs and face), low grade fever, salivary gland pain and gastrointestinal upset. On an unspecified day in November 2009, at an unspecified time after vaccination with 2nd dose of TWINRIX, the subject experienced stool discolored. Relevant test results included a body temperature ranging from 99 to 99.5 on 07 November 2009. The subject felt sick on the day she was scheduled to have the second dose in the TWINRIX series 30 days later, so she postponed the vaccination for two days. On 06 November 2009, the subject was given the second dose in the series of TWINRIX. The following day (07 November 2009) she developed a low grade fever ranging from 99 to 99.5. The subject also suffered from gastrointestinal upset resulting in change in her stool color. The subject said as of 11 November 2009 all of these symptoms were improving. At the time of reporting the outcome of tingling (arms. legs and face), low grade fever, salivary gland pain, gastrointestinal upset, and stool discolored were improved.
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Salivary gland pain
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of ache(s) in a 45-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included SYNTHROID and Birth control pills. On 5 October 2009 the subject received 1st dose of TWINRIX (unknown, unknown). On an unspecified day in October 2009, at an unspecified time after vaccination with 1st dose of TWINRIX, the subject experienced ache(s)  and low grade fever for eight hours. On 6 November 2009 in the morning, the subject received 2nd dose of TWINRIX (1 ml, unknown, left arm). At the time of reporting the outcome of ache(s) and low grade fever were unspecified. On 6 November 2009 in the morning, the subject received 2nd dose of TWINRIX and experienced drug dose administration interval too long. On 07 November 2009, one day after vaccination with 2nd dose of TWINRIX, the subject experienced tingling (arms, legs and face), low grade fever, salivary gland pain and gastrointestinal upset. On an unspecified day in November 2009, at an unspecified time after vaccination with 2nd dose of TWINRIX, the subject experienced stool discolored. Relevant test results included a body temperature ranging from 99 to 99.5 on 07 November 2009. The subject felt sick on the day she was scheduled to have the second dose in the TWINRIX series 30 days later, so she postponed the vaccination for two days. On 06 November 2009, the subject was given the second dose in the series of TWINRIX. The following day (07 November 2009) she developed a low grade fever ranging from 99 to 99.5. The subject also suffered from gastrointestinal upset resulting in change in her stool color. The subject said as of 11 November 2009 all of these symptoms were improving. At the time of reporting the outcome of tingling (arms. legs and face), low grade fever, salivary gland pain, gastrointestinal upset, and stool discolored were improved.
Sex: U
Vaccine: HEPAB
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional, via Merck, and described the occurrence of not responding to therapy in an unknown number of subjects of unspecified age and gender who were vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subjects received unspecified dose of TWINRIX (unknown). On an unspecified date, on an unspecified time after vaccination with TWINRIX, the subjects experienced not responding to therapy. After the next vaccination with TWINRIX the event did not recur. On 17 November 2009, it was reported that a nurse mentioned an unknown number of subjects who received TWINRIX or ENGERIX-B had negative titers. These subjects repeated the series and responded. No further information was available. (Please see case ID A0817640A for details on the unknown number of subjects who received ENGERIX-B).
Sex: M
Vaccine: HEPAB
Symptoms: Muscle twitching
Clinical narrative: This case was reported by a consumer and described the occurrence of arm twitching in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included 1st and 2nd doses of TWINRIX (GlaxoSmithKline) given in April 2009 and May 2009, both in the left arm. There were no concurrent medications. In October 2009 the subject received 3rd dose of TWINRIX (unknown, left arm). On 8 December 2009, approximately 2 months after vaccination with TWINRIX, the subject experienced arm twitching in his upper left arm. The twitch was reported to be involuntary and not painful, occurring about 3 to 4 times a day, mostly in the evening. At the time of reporting the event was unresolved.
Age: 30.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in a 30-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included ADACEL (Sanofi) in the left arm given on 23 November 2009. On 23 November 2009 the subject received 1st dose of TWINRIX (1 ml, unknown, right arm). On 23 November 2009, immediately after vaccination with TWINRIX, the subject experienced arm pain. On 23 November 2009, less than one day after vaccination with TWINRIX, the subject experienced dull soreness of the arm and arm tingling. At an unspecified time after vaccination with TWINRIX, the subject experienced injection site redness. The subject received vaccination with TWINRIX on 23 November 2009. Immediately the subject encountered pain in the right arm where the injection was given. The subject also experienced dull soreness of the arm and tingling. She was given an ADACEL injection the same day in the left arm. She was seen at the physician office on 26 January 2010 and provides the side effect information. It was also noted on assessment that the subject had a faint red area at the injection site. She was prescribed a LIDODERM patch and instructed to contact the office for worsening pain. The subject was treated with LIDODERM patch. At the time of reporting the arm pain, arm tingling and injection site redness were unresolved. The healthcare professional considered the arm tingling and injection site redness were probably related to vaccination with TWINRIX and arm pain was possibly related to vaccination with TWINRIX. Follow-up information received on 11 January 2010 indicated that the events began on or around 23 November 2009 and the subject presented with complaints on 26 November 2010. At the time of follow-up, the outcome of the events was unknown and the events were considered possibly related to treatment with TWINRIX. It was reported that concurrent ADACEL was given intramuscularly and that Hepatitis A and B immunizations would be given separately.
Sex: F
Vaccine: HEPAB
Symptoms: Injury associated with device, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of needle stick injury in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown) and experienced needle stick injury and pharmaceutical product complaint. The sales representative reported while the nurse administered the vaccine, "there was an air bubble in the body of the syringe and the syringe blew up; it was not known if the needle was in the subject at the time of the explosion". The contents of the vaccine went into the nurse's eyes (see case A0853360A). At the time of reporting the outcome of the needle stick injury was unspecified.
Age: 53.0
Sex: F
Vaccine: FLUX(H1N1), HEPAB
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash on trunk and arms in a 50-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline).  Previous and/or concurrent vaccination included H1N1; manufacturer unspecified; unknown; unknown given on 22 March 2010.  On 22 March 2010 at 18:00 the subject received 1st dose of TWINRIX (unknown, unknown arm).  On 23 March 2010, 1 day after vaccination with TWINRIX, the subject experienced rash on trunk and arms and itching of trunk and arms which originated from the arm that TWINRIX was given in.  The subject started BENADRYL on her own.  Follow-up information received from pharmacist on 01 June 2010: The subject was 53 years-old.  Concomitant vaccination included H1N1 unspecified given on 16 March 2010.  The subject received TWINRIX vaccination (right arm) on 16 March 2010.  On 18 March 2010, 2 days after vaccination with TWINRIX, the subject experienced rash and itching.  The events resolved on 24 March 2010.  The pharmacist did not specify a causal relationship with TWINRIX, but did identify TWINRIX as the suspect product.  The vaccination series with TWINRIX was delayed until plan with primary physician.  The symptoms did not recur following subsequent administration.
Age: 47.0
Sex: F
Vaccine: HEPAB, TDAP, VARCEL, YF
Symptoms: Condition aggravated, Pruritus, Scab
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itching in a 47-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included DTAP (Sanofi), VARIVAX (Merck) and yellow fever vaccines (Sanofi) all given on 10 March 2010. On 10 March 2010 the subject received 1st dose of TWINRIX at 1.0 ml in the left arm. On 17 March 2010, 7 days after vaccination with TWINRIX, the subject experienced itching and scab formation. The events resolved on 14 April 2010. The healthcare professional considered the events possibly related to vaccination with TWINRIX. On 14 April 2010 the subject received 2nd dose of TWINRIX at 1.0 ml again in the left arm. Later the same day after vaccination with TWINRIX, she experienced itching and scab formation. The events resolved on an unknown date. The healthcare professional considered the events probably related to vaccination with TWINRIX. The subject was referred to a physician for follow-up for the 3rd dose of TWINRIX.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Constipation, Diarrhoea, Fatigue, Myalgia, Paraesthesia
Clinical narrative: Initial consumer report received on 16 Dec 2009: This patient's medical condition included autoimmune disorder.  The patient received FLUVIRIN (batch no. unknown) on 03 Nov 2009.  Within one week after vaccination, she experienced tingling in her hands, arms, feet and legs.  She also experienced fatigue, myalgia, diarrhea and constipation.  Neurologist diagnosed polyneuropathy and prescribed Neurontin 300 mg TID and Elavil 10 mg daily.  She would be visiting her current neurologist but also planning to seek second opinion from "more specialized neurologist".  Her symptoms were unchanged.  Following internal review on 08 Jan 2010 of the information received on 16 Dec 2009 polyneuropathy was considered medically significant and hence upgraded.  Following internal review on 14 Apr 2010 of the data received on 16 Dec 2009, it was noted that suspect vaccine was incorrectly reported as FLUVIRIN.  The correct suspect vaccine was H1N1 (manufacturer and batch number unknown).
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Polyneuropathy
Clinical narrative: Initial consumer report received on 16 Dec 2009: This patient's medical condition included autoimmune disorder.  The patient received FLUVIRIN (batch no. unknown) on 03 Nov 2009.  Within one week after vaccination, she experienced tingling in her hands, arms, feet and legs.  She also experienced fatigue, myalgia, diarrhea and constipation.  Neurologist diagnosed polyneuropathy and prescribed Neurontin 300 mg TID and Elavil 10 mg daily.  She would be visiting her current neurologist but also planning to seek second opinion from "more specialized neurologist".  Her symptoms were unchanged.  Following internal review on 08 Jan 2010 of the information received on 16 Dec 2009 polyneuropathy was considered medically significant and hence upgraded.  Following internal review on 14 Apr 2010 of the data received on 16 Dec 2009, it was noted that suspect vaccine was incorrectly reported as FLUVIRIN.  The correct suspect vaccine was H1N1 (manufacturer and batch number unknown).
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Diarrhoea, Headache, Influenza like illness, Pyrexia
Clinical narrative: Initial report received from a Liability Claims representative on 16 November 2010. A male patient, (age not provided) received on 06 October 2007 a right deltoid injection (route not provided) of FLUZONE SV 2007-2008, lot number U2452AA. The patient was claiming he was diagnosed with Guillain Barre Syndrome as a result of this shot. No further information was available. The outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received from a Liability Claims representative on 16 November 2010. A male patient, (age not provided) received on 06 October 2007 a right deltoid injection (route not provided) of FLUZONE SV 2007-2008, lot number U2452AA. The patient was claiming he was diagnosed with Guillain Barre Syndrome as a result of this shot. No further information was available. The outcome was not reported. Documents held by sender: None.
Age: 0.63
Sex: M
Vaccine: DTPIPV, FLUX, HIBV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Swelling in both thighs after admin of the vaccines. The thighs were bright red, hot and swollen to the touch. He began to have a hive on his upper lip. Benadryl was given and he was monitored for 20-30 minutes.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Woke up with migraine.  Migraine gone by late AM on 11/16/2010.  Took a total of 3 prescribed migraine pills from onset until next morning to get rid of migraine.  This is the 1st time patient has had a migraine occur as a result of receiving the flu vaccine.  Has received the seasonal flu vaccine every year since 2002 resulting in just a sore arm afterwards.
Age: 44.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Inflammation, Lymphadenopathy
Clinical narrative: Inflamed Lymph Nodes above collar bone on same side as vaccination.  Same thing happened last year.  Last year, CT scan with contrast showed inflammation but no problems.  I have not returned to the doctor this year, just notified them via phone.  Other lymph nodes around my neck are swollen now as well.
Age: 1.07
Sex: F
Vaccine: MMR
Symptoms: Blood culture, Chest X-ray abnormal, Culture urine, Pyrexia, Upper respiratory tract infection
Clinical narrative: URI symptoms reappeared 11.8 and started having fever's on/off, few episodes of vomiting but otherwise good appetite, in general good energy level and remained playful. Fever continued (not daily) until 11/16 without any obvious origin, 11/16 blood cx done, urine cx done, eventually positive xray for early infiltrate on 11/16.
Age: 1.07
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: URI symptoms reappeared 11.8 and started having fever's on/off, few episodes of vomiting but otherwise good appetite, in general good energy level and remained playful. Fever continued (not daily) until 11/16 without any obvious origin, 11/16 blood cx done, urine cx done, eventually positive xray for early infiltrate on 11/16.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Rash macular
Clinical narrative: Infant had red blotchy areas forming on his forehead and temple areas.  Slightly reddened across upper back between shoulder blades.  Lungs were clear, no cough.  No other symptoms noted.  Called his doctor, administered 1/2 teaspoon liquid Benadryl at 4:20PM.  Symptom began to subside.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Headache, Hypoaesthesia oral, Malaise, Oedema peripheral
Clinical narrative: Self reported: swelling of feet, chest tightness with inspiration, facial swelling, numb sensation on the inside of the mouth, feeling unwell, headache.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: Self reported: swelling of feet, chest tightness with inspiration, facial swelling, numb sensation on the inside of the mouth, feeling unwell, headache.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives on neck
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: Patient called the office complaining of a nickel-sized area of swelling in her right arm at the injection site and pain in her arm that occurs with movement.  She denies fever, rash, difficulty breathing, or other complaints.  She was advised to try OTC ibuprofen and moist heat at the injection site and to follow up next week if her symptoms have not improved.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthma, Condition aggravated, Cough, Dyspnoea
Clinical narrative: On October 14, 2010 I received this year's flu vaccination. Within 48 hours I developed a cough and cold like symptoms, no fever. The cough proceeded to worsen and at night I had post nasal drip. This triggered my asthma where for the first time since 2004 I went from being able to run a marathon to having breathing problems walking up stairs. With the intervention of prednisone and antibiotics I am just back to being able to run again. I am reporting this because my wife developed a similar cough after her flu shot the same day. Also my daughter - age 32 - and son-in-law - age 33 - who received the nasal spray version of the flu vaccine this year also developed coughs that persisted for approx. 5 weeks. While this may be coincidence I thought it worthwhile reporting as this is the first year the flu vaccine provides protection for both the regular and swine flu.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis, Pulmonary function test, Upper-airway cough syndrome
Clinical narrative: On October 14, 2010 I received this year's flu vaccination. Within 48 hours I developed a cough and cold like symptoms, no fever. The cough proceeded to worsen and at night I had post nasal drip. This triggered my asthma where for the first time since 2004 I went from being able to run a marathon to having breathing problems walking up stairs. With the intervention of prednisone and antibiotics I am just back to being able to run again. I am reporting this because my wife developed a similar cough after her flu shot the same day. Also my daughter - age 32 - and son-in-law - age 33 - who received the nasal spray version of the flu vaccine this year also developed coughs that persisted for approx. 5 weeks. While this may be coincidence I thought it worthwhile reporting as this is the first year the flu vaccine provides protection for both the regular and swine flu.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Rt. upper arm - injection site red - 1 inch from site red - hot area - arm swollen - hard to touch.
Age: 1.5
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "18 month old received a second dose of H1N1 with no complications", was received from a registered nurse/health professional concerning an 18-month-old male. Neither relevant medical history nor concomitant medications were reported. On an unknown date, the patient received first dose of H1N1, Intranasal and on 24-Nov-2010, the patient received second dose of the vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Discomfort, Fatigue, General physical health deterioration
Clinical narrative: I had "flu like sx" the following day & since that time I have awakened almost daily w/painful & swollen joints. The joints include hands/fingers, elbows, wrists, shoulders, knees, ankles & my entire back aches. Some days are worse than others but this has been almost constant & new since rec'd this vaccine. I am experiencing ongoing fatigue, malaise & a general feeling of poor health. I have req'd large amounts of Ibuprofen to keep the discomfort somewhat diminished.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Joint swelling, Malaise
Clinical narrative: I had "flu like sx" the following day & since that time I have awakened almost daily w/painful & swollen joints. The joints include hands/fingers, elbows, wrists, shoulders, knees, ankles & my entire back aches. Some days are worse than others but this has been almost constant & new since rec'd this vaccine. I am experiencing ongoing fatigue, malaise & a general feeling of poor health. I have req'd large amounts of Ibuprofen to keep the discomfort somewhat diminished.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Muscular weakness, Osteosclerosis
Clinical narrative: 11/9/10 FLUZONE Lot UH223AC exp 6/11. CLL stage 0 osteosclerosis. CIDP x 20 y increased 1999 - H1N1 SC and 11/9/10 - H1N1 SC.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood glucose normal, Dyspnoea, Dysstasia, Hyperhidrosis
Clinical narrative: Received TIV (IM) on 11-18-10. On 11-20-10, while deer hunting developed SOB, profuse sweating, muscle cramps in both arm & hands. "Could hardly stand up to walk" weakness. Hx of DM - states blood sugar OK. States my heart is OK. Went home - took BENADRYL. Subsided.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Received TIV (IM) on 11-18-10. On 11-20-10, while deer hunting developed SOB, profuse sweating, muscle cramps in both arm & hands. "Could hardly stand up to walk" weakness. Hx of DM - states blood sugar OK. States my heart is OK. Went home - took BENADRYL. Subsided.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received  flu shot and arm swelled and became red from deltoid past elbow.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, CSF test, Electromyogram abnormal, Gait disturbance, Grip strength decreased
Clinical narrative: 10/18/10: low back pain, feeling of malaise, decreased sensation in hands and feet, difficulty holding things and with ambulation. 5 days of immune globulin treatment, also pain control and physical therapy.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Malaise, Nerve conduction studies abnormal
Clinical narrative: 10/18/10: low back pain, feeling of malaise, decreased sensation in hands and feet, difficulty holding things and with ambulation. 5 days of immune globulin treatment, also pain control and physical therapy.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory loss
Clinical narrative: 10/18/10: low back pain, feeling of malaise, decreased sensation in hands and feet, difficulty holding things and with ambulation. 5 days of immune globulin treatment, also pain control and physical therapy.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Pruritus, Rash, Vomiting
Clinical narrative: Vaccine obtained Friday 11/12. At 9 AM 11/13 began to have migraine, vomiting lasting until 7PM. On Sunday 11/14 noticed rash and itch on face still present 11/19.