chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a physician and described the occurrence of intermittent left hand tingling in a 12-year-old male subject who was vaccinated BOOSTRIX (GlaxoSmithKline). On 14 October 2010, the subject received 1st dose of BOOSTRIX (unknown). On 22 October 2010, 8 days after vaccination with BOOSTRIX, the subject presented to the doctor's office complaining of intermittent left hand tingling and intermittent tingling bilateral in hands and feet that had been going on for three days. The physician reported that the subject has been otherwise a healthy kid. No further information was known at the time of reporting. At the time of reporting, the outcome of the events was unspecified.
Sex: M
Vaccine: TDAP
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of intermittent pruritus in an adult male subject aged 30-40 years old who was vaccinated with BOOSTRIX. On an unspecified date the subject received 1st dose of BOOSTRIX (details unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced mild intermittent pruritus (no redness) on different areas of his body every 3 days. The subject was treated with Benadryl when the event first occurred with temporary relief, but was no longer taking it at the time of reporting. At the time of reporting the outcome of the event was unspecified.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Bronchitis, Cough, Headache, Hyperhidrosis, Malaise
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of feeling sick in an adult female subject (also a nurse) who was vaccinated with (BOOSTRIX). On 26 August 2010 at 10:00 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On 27 August 2010, 1 day after vaccination with BOOSTRIX, the subject experienced feeling sick, body pain, cough, headache and sweating. At the time of reporting the events were improved, but not completely resolved. Follow-up information received on 13 September 2010 indicated that the subject was 29 years old at the time of event onset and she had been diagnosed with bronchitis unrelated to the BOOSTRIX vaccine. Feeling sick, body pain, cough, headache and sweating all began on 28 August 2010. Relationship of these events to BOOSTRIX was not reported.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of feeling sick in an adult female subject (also a nurse) who was vaccinated with (BOOSTRIX). On 26 August 2010 at 10:00 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On 27 August 2010, 1 day after vaccination with BOOSTRIX, the subject experienced feeling sick, body pain, cough, headache and sweating. At the time of reporting the events were improved, but not completely resolved. Follow-up information received on 13 September 2010 indicated that the subject was 29 years old at the time of event onset and she had been diagnosed with bronchitis unrelated to the BOOSTRIX vaccine. Feeling sick, body pain, cough, headache and sweating all began on 28 August 2010. Relationship of these events to BOOSTRIX was not reported.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of injection site redness in a 45-year-old female subject who was vaccinated with DTPa (with small D + P), manufacturer unspecified). On 23 July 2010 the subject received 1st dose of DTPa (with small D + P) (unknown route, right arm). Less than 2 weeks after vaccination with DTPa (with small D + P), the subject experienced injection site redness, swelling injection site and hardness injection site. On 6 August 2010, the events were resolved. The physician considered the events were probably related to vaccination with DTPa (with small D + P). The physician did not know if the subject received a BOOSTRIX or ADACEL and lot number was not known. The subject developed a large red, swollen area at the site of injection. This reaction also developed into a hard central area. The physician reported that the localized site reaction resolved after about 2 weeks.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Malaise, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 22-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included post-partum. Concurrent medications include Lortab. On an unspecified date in 2010 he subject received unspecified dose of BOOSTRIX (unknown). Approximately two days after vaccination with BOOSTRIX, the subject experienced fever, vomiting, malaise and headache. According to the sales representative BOOSTRIX was administered postpartum. At the time of reporting the outcome of the fever, vomiting, malaise and headache were unspecified. Follow-up information received from th healthcare professional on 13 October 2010: It was reported that the subject had not received BOOSTRIX previously. The BOOSTRIX was administered to the subject while she was hospitalized post-delivery. The subject experienced fever, vomiting, malaise and headache on 06 May 2010. The events resolved on 10 May 2010.  The reporter considered that the events were possibly related to the BOOSTRIX. Treatment medications included Rocephin for fever of unknown origin and Amoxicillin for fever of unknown origin and possible endometritis.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site warmth in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline. on an unspecified date the subject received 1st dose of BOOSTRIX (unknown, right arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site warmth, injection site redness and injection site reaction. At the time of reporting the injections site warmth, injection site redness and injection site reaction were resolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. A total of four subjects were report to have had an injection site reaction for the other three cases see A0911825A, A0911826A and A0911827A.
Age: 56.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: This case was reported by a physician and described the occurrence of severe upper arm pain in a 56-year-old female subject who was vaccinated with Boostrix, (GlaxoSmithKline). Concurrent medical conditions included celiac disease and reflux (nos). Concurrent vaccination included Twinrix (GlaxoSmithKline) given on 22 March 2011. There were no concurrent medications. On 22 March 2011 the subject received a dose of Boostrix in the left arm. On 22 March 2011, at an unspecified time after vaccination with Boostrix, the subject experienced severe upper arm pain. At the time of reporting the event was unresolved. The physician considered the event was possibly related to vaccination with Boostrix. Follow-up information was received on 06 May 2011 from the reporting physician. Celiac disease was removed as relevant medical history. The subject used alcohol occasionally and did not use tobacco. On 22 March 2011, the subject experienced left upper arm pain secondary to Boostrix administration. Outcome of the event was unknown. 19 April 2011, x-ray of left humerus was negative. The subject decided not to finish the Twinrix series.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 30-year-old female subject who was vaccinated with Boostrix (GlaxoSmithKline). Concurrent medications included Prenatal vitamins and Norethisterone (Nor-QD). On 14 February 2011 at 15:15 the subject received 1st dose of Boostrix (1 ml, unknown, left arm). On 14 February 2011, less than one day or on 15 February 2011 the following morning after vaccination with Boostrix, the subject experienced swelling injection site and arm pain at injection site. The swelling injection site and arm pain at injection site has continued for about nine days. The subject was treated with Advil and warm compress. At the time of reporting the swelling injections site and arm pain at injections site were unresolved. The healthcare professional considered the events were possibly related to vaccination with Boostrix. Follow-up information was received on 16 March 2011. It was reported that the events occurred the day of Boostrix administration, 14 February 2011. The outcome of the events was unknown and the causality was possible. No additional information was provided.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of fever in a 29-year-old female subject who was vaccinated with DTPa (with small D + P), manufacturer unspecified). A physician or other health care professional has not verified this report. On 18 March 2011 at 15:00 the subject received booster dose of  DTPa (with small D + P) (unknown route, unknown arm). On 19 March 2011, 24 hours after vaccination with  DTPa (with small D + P), the subject experienced fever, fatigue, injection site redness, swelling injection site and tightness at injection site. On 21 or 22 March 2011, 3-4 days after vaccination with  DTPa (with small D + P), the subject experienced headache. At the time of reporting the events were unresolved.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Skin tightness
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of fever in a 29-year-old female subject who was vaccinated with DTPa (with small D + P), manufacturer unspecified). A physician or other health care professional has not verified this report. On 18 March 2011 at 15:00 the subject received booster dose of  DTPa (with small D + P) (unknown route, unknown arm). On 19 March 2011, 24 hours after vaccination with  DTPa (with small D + P), the subject experienced fever, fatigue, injection site redness, swelling injection site and tightness at injection site. On 21 or 22 March 2011, 3-4 days after vaccination with  DTPa (with small D + P), the subject experienced headache. At the time of reporting the events were unresolved.
Age: 58.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Blister, Burning sensation, Oedema peripheral, Pruritus, Rash macular
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pruritus of hand in a 58-year-old male subject who was vaccinated with BOOSTRIX and TWINRIX. Concurrent medications included Diovan and Tricor. On 19 April 2011 at 08:00 the subject received 1st dose of BOOSTRIX at 0.5 ml in the right arm and 1st dose of TWINRIX at 1.0 ml in the left arm. On 19 April 2011, 12 hours after vaccination with BOOSTRIX and TWINRIX, the subject experienced pruritus of both hands, burning of both hands and hand swelling in both hands. The subject was treated with Benadryl. At the time of reporting the events were unresolved. Follow-up information was received on 06 May 2011 from the reporting nurse. medical conditions included hypertension and dyslipidemia. The subject did not use alcohol or tobacco. The subject did not have any adverse events following previous vaccinations. End date for the events of pruritus of both hands, burning of both hands and hand swelling in both hands was 22 April 2011. on 19 April 2011, the subject experienced small blister lesions, several less than 0.5 cm, on the distal fingers of both hands. End date of the events was 22 April 2011. On an unspecified date, the subject experienced macular-type rash on his forearms and lower legs. Outcome was unspecified for all events. The nurse reported that the events were not associated with medical history/concurrent illness, lack of efficacy, erroneous administration, suspected transmission of an infectious agent via a medical product or any other known cause. The BOOSTRIX lot number was originally reported to be AC528068AA and was noted to be incorrect on 03 May 2011 and corrected to AC52B068AA.
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache
Clinical narrative: This case was reported by a physician and described the occurrence of headache in an adult female subject of unspecified age who was vaccinated with BOOSTRIX. Concurrent medications included an unknown thyroid medication. On an unspecified date the subject received a dose of BOOSTRIX as part of a routine vaccination at the school where the subject works. A few days later (not sure how many), the subject experienced headache and fatigue. At the time of reporting the events were unresolved. It was reported that the symptoms have persisted for a few weeks.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass
Clinical narrative: This case was reported by a physician and described the occurrence of bump in armpit in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included NuvaRing. On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown, left arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced bump under arm pit of vaccinated arm (bump in armpit). At the time of reporting the bump in armpit was unresolved.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 77-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 31 May 2011 the subject received a dose of BOOSTRIX (details unknown). On an unspecified date in 2011, less than one year after vaccination with BOOSTRIX, the subject experienced injection site redness (within 2 to 3 centimeters of the injection site), injection site pain and injection site pruritus. The subject was treated with Antibiotic cream. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported 3 subjects who experienced adverse events following BOOSTRIX vaccination. This is case 3 of 3; see cases A0933920A and A0933923A for details of the other reports.
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: This case was reported by a physician and described the occurrence of severe joint pain 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 (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced severe join pain. At the time of reporting the outcome of the event was unspecified.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Fatigue, Pain
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of fatigue in a 37-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline. A physician or other health care professional has not verified this report. Relevant medical history included acid reflux and Epstein Barr virus. Concurrent medications included Prevacid. On 11 June 2011 at 16:00 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On 12 June 2011, 8 to 10 hours after vaccination with BOOSTRIX (after midnight), the subject experienced "extreme" fatigue, body pain, chills and diarrhea. At the time of reporting the event of fatigue was unresolved, and the events of body pain, chills and diarrhea were resolved on 14 June 2011.
Age: 59.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of sore arms in a 59-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Co-suspect vaccination included TWINRIX (GlaxoSmithKline) given on an unspecified date (same date as BOOSTRIX administration - opposite arm from BOOSTRIX vaccination). On an unspecified date the subject received 1st dose of BOOSTRIX in an unknown arm and 1st dose of TWINRIX in the opposite arm. An unspecified amount of time after vaccination with BOOSTRIX and TWINRIX, the subject developed sore arms. At the time of reporting the outcome of the event was unspecified.
Age: 52.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of flu-like symptoms in a 52-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Co-suspect vaccination included TWINRIX (GlaxoSmithKline) given on an unspecified date (same date as BOOSTRIX administration - opposite arm from BOOSTRIX vaccination). On an unspecified date the subject received 1st dose of BOOSTRIX in an unknown arm and 1st dose of TWINRIX in the opposite arm. One day after vaccination with BOOSTRIX and TWINRIX, the subject experienced flu-like symptoms. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of pain in an unspecified number of subjects of unspecified ages and gender who were vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subjects received unspecified dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subjects experienced pain. The healthcare professional stated the office recently switched from ADACEL to BOOSTRIX and reported that BOOSTRIX seems to hurt more than ADACEL. At the time of the report no additional information on how may subject reported pain after BOOSTRIX was available. At the time of reporting the outcome of the pain was unspecified.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of sore arm in a 41-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) while pregnant. A physician or other health care professional has not verified this report. There were no concurrent medications. On 27 April 2011 the subject received unspecified dose of BOOSTRIX in the left arm. The subject just found out that she was pregnant following vaccination. The subject experienced vaccine exposure during pregnancy. Her date of last menstrual period and estimated date of delivery were not reported. At an unspecified time following vaccination with BOOSTRIX, the subject developed a sore arm. At the time of reporting the outcome of the events was unspecified. The pregnancy was ongoing.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site pruritus in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 16 November 2010 the subject received a dose of BOOSTRIX at 0.5 ml (prefilled syringe) in an unknown deltoid. On 18 November 2010, 2 days after vaccination with BOOSTRIX, the subject experienced injection site pruritus and injection site rash. At the time of reporting the outcome of the events was unspecified.
Age: 44.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Erythema, Injected limb mobility decreased, Oedema peripheral, Skin warm
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of inability to lift arm in a 44-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Co-suspect vaccination included TWINRIX (GlaxoSmithKline) given on the same date as BOOSTRIX (date not specified). On an unspecified date the subject received unspecified dose of BOOSTRIX at 0.5 ml in the right arm. An an unspecified time after vaccination with BOOSTRIX, the subject experienced inability to life or rotate the arm (restriction of arm movement), arm swelling and red hot to the touch. At the time of reporting the outcome of the events was unspecified. Follow-up information received via the reporting nurse indicated that the onset of events was 18 April 2011. The events resolved, however, the resolution date was not clear. A note was made that the events could have been associated with the vaccine being given too high. Date of vaccination was not provided.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram normal, Cough, Insomnia, Migraine
Clinical narrative: This case was reported by a consumer and described the occurrence of nocturnal cough in a 48-year-old female subject who was vaccinated with Tdap (manufacturer unspecified), Flu vaccine and pneumonia vaccine (non-gsk). A physician or other health care professional has not verified this report. Concurrent medical conditions included gastroesophageal reflux disease and human immunodeficiency virus. Concurrent medications included TRUVADA, "Entellence", and Dexlansoprazole. Following vaccination on an unspecified date with unspecified dose of Flu vaccine (unknown manufacturer) and unspecified dose of Pneumonia vaccine (Non-GSK) (unknown) the subject reported that she experienced a cold. On 16 September 2010 the subject received unspecified dose of Tdap (unknown, right arm). On an unspecified date in 2010, after 16 September 2010 and before 05 November 2010, less than one year after vaccination with Tdap, the subject experienced nocturnal cough, migraine headache, and unable to sleep. The consumer reported that since she was vaccinated with Tdap vaccine on 16 September 2010, she has been experiencing headaches, coughing at night and has been unable to sleep. She went to the emergency room (ER) regarding her headache and the physician requested a CAT scan that came back fine and she was released from the ER. She has had one doctor's appointment since that time and stated that the physician who is treating her for HIV did not believe that her symptoms were coming from the vaccination and suggested she see a primary physician which she has not seen. She was unable to specify the date(s) when she started experiencing the side effects but insisted they started sometime after she received the vaccination on 16 September 2010. At the time of reporting the outcome of the events was unspecified.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia, Product odour abnormal, Product quality issue, Throat irritation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of throat burning in a 44-year-old female subject who was exposed to a strong odor (fumes released from BOOSTRIX, GlaxoSmithKline) packaging. On an unspecified date the subject was exposed to a strong odor, "fumes" released from BOOSTRIX packaging. It was reported that there was a very strong odor (product odor abnormal) that was inhaled by the subject (a nurse) and it caused her throat to burn. The odor also made the subject light headed. Additionally, it was reported that the odor resulted in an unpleasant taste. Product complaint was documented. At the time of reporting the outcome of the events was unspecified. It was reported that the pharmacy received a box of BOOSTRIX vaccine and when the pharmacist opened the box, strong fumes were released from the packaging. The odor was unusual and was so strong that they had to put the box outside and odor permeated the office. The smell was described as very strong plastic fumes. Lot number and expiration date were not available at the time of reporting. An investigational report received via GlaxoSmithKline Biologicals on 18 July 2011 indicated that according to the investigation performed and the sample received, this complaint was considered to be unsubstantiated.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of joint pain in arms in a 44-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 3 June 2011 at 09:00 the subject received unspecified dose of BOOSTRIX at 0.5 ml in the right arm. At an unspecified time after vaccination with BOOSTRIX, the subject experienced joint pain in the right arm and a little in the left arm. The subject also reported no strength in the right hand and wrist (decreased hand strength and decreased strength in wrists). At the time of reporting the outcome of the events was unspecified. Attribution of events to treatment with BOOSTRIX was not reported.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Vision blurred
Clinical narrative: This case was reported by a pharmacist and described the occurrence of headache in a 16-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 14 June 2011 at 09:20 the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, left arm). On 14 June 2011, 5 to 10 minutes after vaccination with BOOSTRIX, the subject experienced headache and blurred vision. On 14 June 2011, the events were resolved. The pharmacist considered the events were possibly related to vaccination with BOOSTRIX.
Sex: M
Vaccine: TDAP
Symptoms: Insomnia
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of insomnia in an adult male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 6 June 2011 the subject received 1st dose of BOOSTRIX (details unknown). On 6 June 2011, less than one day after vaccination with BOOSTRIX, the subject experienced insomnia. The healthcare professional reported that the subject was a physician at the office and had received BOOSTRIX on 06 June 2011. He complained of insomnia when he came back into work on 07 June 2011. At the time of reporting the outcome of the event was unspecified.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of influenza symptoms in a female subject aged between 30 and 39 years old who was vaccinated with Flu vaccine in 2004 (not pregnant at the time) and BOOSTRIX (GlaxoSmithKline) while pregnant in 2011. A physician or other health care professional has not verified this report. Concurrent medical conditions included hypothyroidism. Concurrent medications included Levothyroxine. It was reported that on an unspecified date in 2004, the subject received a flu shot (unknown manufacturer) and experienced mild flu like symptoms the next day. The outcome of the event was not provided. Later, on 4 May 2011 at 09:30 (at approximately two weeks gestation - unknown by the subject at the time) the subject received 1st dose of BOOSTRIX in the left arm. The subject experienced vaccine exposure during pregnancy. Her date of last menstrual period was not provided. The subject reported that her baby was due sometime in February 2012, but reported that she would not have a firm due date until her next appointment (unknown date). The subject was 13 weeks pregnant at the time of reporting.
Age: 8.0
Sex: M
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 8-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included meningitis vaccine, strain not specified (Sanofi Pasteur MSD), MMR II (Merck) and VARIVAX (Merck) all given on 13 July 2011. There were no concurrent medications. On 13 July 2011 the subject inadvertently received unspecified dose of BOOSTRIX at 0.5. this was the wrong vaccine for administration. At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling injection site and injection site redness. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Axillary mass, Injection site erythema, Injection site nodule
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 12-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergic reaction to peanut butter, diabetes and peanut allergy. Concurrent vaccination included VARIVAX (Merck) given on 14 July 2011. Concurrent medications included HUMALOG and LANTUS. It was noted that the subject had a similar reaction to what was reported in this case to flu vaccine (manufactured by PNC) administered on 21 October 2010. On 14 July 2011 (around 08:30 or 09:00) the subject received 1st dose of BOOSTRIX at 0.5 ml in the left deltoid. At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site redness, hard lump (knot) at injection site and lump under arms (pea sized area in lymph node under arm). At the time of reporting the events were unresolved.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Myalgia, Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of muscle soreness in a 49-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 13 May 2011 the subject received unspecified dose of BOOSTRIX in the left arm. On 13 May 2011, less than one day after vaccination with BOOSTRIX, the subject experienced muscle soreness, swelling and erythema. At the time of reporting, muscle soreness was unresolved and swelling and redness were resolved. The physician considered the events were probably related to vaccination with BOOSTRIX.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, VARCEL
Symptoms: Oedema peripheral, Rash, Rash erythematous, Skin swelling
Clinical narrative: This case was reported by a healthcare professional (also the mother of the subject) via a sales representative and described the occurrence of red rash on arm in a 11-year-old female subject who was vaccinated with Tdap (manufacturer unspecified), Meningitis vaccine and Varicella vaccine. On 11 July 2011 the subject received unspecified dose of Tdap in an unknown arm, unspecified dose of Meningitis vaccine in an unknown arm and unspecified dose of Varicella vaccine in an unknown arm. At an unspecified time after vaccination with Tdap, Meningitis vaccine and Varicella vaccine, the subject experienced red rash on arms, swelling arms and puffy skin (on arms) the size of approximately three inches by three inches. At the time of reporting the events were resolved. A note was made that one vaccine went in one arm and two in the other arm. The medical assistant did not know which vaccine went in which arm. Follow-up information was received on 08 August 2011 via the healthcare professional/mother of the subject. It was reported that the events of red rash on arms, swelling of arms and puffy skin (on arms) began on 12 July 2011, just one day following administration of Tdap (manufacturer unspecified), Meningitis vaccine and Varicella vaccine. The mother specifically stated that both of her daughters arms were red and rashy. The events were resolved by approximately 19 July 2011. The mother questioned a possible allergy to the latex in the gloves or bandaids used since the events involved both arms.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site induration in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 20 May 2011 the subject received unspecified dose of BOOSTRIX (unknown). On the day of BOOSTRIX administration, 20 May 2011, the subject experienced a local reaction with symptoms of injection site induration, injection site tenderness and injection site redness. The subject was seen on 09 June 2011 and was still complaining of local reaction. At the time of reporting the outcome of the events was unspecified. The physician considered the events were possibly related to vaccination with BOOSTRIX. Follow-up information received via the physician on 06 July 2011 indicated that the subject was a 56 year old, menopausal female. BOOSTRIX was administered at 0.5 ml in the left deltoid on 20 May 2011. On the same day, 20 May 2011, following vaccination with BOOSTRIX, the subject experienced a local reaction with injection site induration, injection site tenderness and injection site redness. The events resolved by 09 June 2011. In the reporter's opinion, the events were possibly related to treatment with TWINRIX.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site induration in a male subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 14 May 2011 the subject received unspecified dose of BOOSTRIX (unknown). On the same day of BOOSTRIX administration, 14 May 2011, the subject experienced a local reaction with symptoms of injection site induration, injection site tenderness and injection site redness. The subject was seen on 20 May 2011 and was still complaining of local reaction. At the time of reporting the outcome of the events was unspecified. The physician considered the events were possibly related to vaccination with BOOSTRIX. Follow-up information received via the physician on 06 July 2011 indicated that the subject was a 39 year old male. BOOSTRIX was administered at 0.5 ml in the right deltoid on 14 May 2011. On the same day, 14 May 2011, following vaccination with BOOSTRIX, the subject experienced a local reaction with injection site induration, injection site tenderness and injection site redness. The events resolved with sequelae by 20 May 2011. In the reporter's opinion, the events were possibly related to treatment with TWINRIX. Medical history included high cholesterol and GERD.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site induration in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 19 May 2011 the subject received unspecified dose of BOOSTRIX (unknown). On the same day of BOOSTRIX administration, 19 May 2011, the subject experienced a local reaction with symptoms of injection site induration, injection site tenderness and injection site redness. The subject was seen on 02 June 2011 and was still complaining of local reaction. At the time of reporting the outcome of the events was unspecified. The physician considered the events were possibly related to vaccination with BOOSTRIX. Follow-up information received via the physician on 06 July 2011 indicated that the subject was a 77 year old, menopausal female. BOOSTRIX was administered at 0.5 ml in the left deltoid on 19 May 2011. On the same day, 19 May 2011, following vaccination with BOOSTRIX, the subject experienced a local reaction with injection site induration, injection site tenderness and injection site redness. The events resolved by 02 June 2011. In the reporter's opinion, the events were possibly related to treatment with BOOSTRIX. The subject had a history of hypertension and  high cholesterol. This case was reported by the same physician as linked cases A0932824A, A0932826A and A0932827A.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 38-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 14 May 2011 the subject received a dose of BOOSTRIX (details unknown). On an unspecified date in 2011, less than one year after vaccination with BOOSTRIX, the subject experienced injection site redness (within 2 to 3 centimeters of the injection site), injection site pain and injection site pruritus. The subject was treated with Antibiotic cream. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported 3 subjects who experienced adverse events following BOOSTRIX administration. This is case 1 of 3; see cases A0933923A and A0933924A for details of the other reports.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 39-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 19 May 2011 the subject received a dose of BOOSTRIX (details unknown). On an unspecified date in 2011, less than one year after vaccination with BOOSTRIX, the subject experienced injection site redness (within 2 to 3 centimeters of the injection site), injection site pain and injection site pruritus. The subject was treated with Antibiotic cream. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported 3 subjects who experienced adverse events following BOOSTRIX vaccination. This is case 2 of 3; see cases A0933920A and A0933924A for details of the other reports.
Age: 32.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to BIAXIN and codeine allergy. Previous and/or concurrent vaccination included TWINRIX (GlaxoSmithKline); unknown; unknown given on 24 September 2010. On 24 September 2010 at 11:00 the subject received 1st dose of BOOSTRIX (.5 ml, unknown right arm). On 24 September 2010, 30 minutes after vaccination with BOOSTRIX, the subject experienced an injection site reaction described as raised and swollen at injection site, injection site warmth, injection site pruritus and injection site redness. At the time of reporting the swelling at injection site, injection site warmth, injection site pruritus and injection site redness were worse. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow-up information received on 02 November 2010 noted that the events resolved.
Age: 3.0
Sex: M
Vaccine: HEPA, HIBV, PNC, TDAP
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction in a 3-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (Sanofi Pasteur MSD), HAVRIX (GlaxoSmithKline) and SYNFLORIX (Wyeth Labs) all given on 3 November 2010. There were no concurrent medications. On 3 November 2010 at approximately 12:00 the subject inadvertently received a dose of BOOSTRIX at 0.5 ml in the right thigh. On 5 November 2010, 2 days after vaccination with BOOSTRIX, the subject experienced a large local reaction and injection site redness. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Additionally, administration of BOOSTRIX was a maladministration (asymptomatic/child too young).
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 23 December 2010 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, unknown arm). On 26 December 2010, 3 days after vaccination with BOOSTRIX, the subject spoke of injection site pain in the shoulder where the injection was given. It was noted that the pain may have started prior to 26 December 2010. The subject visit her physician in regards to the pain. At the time of reporting, the pain was unresolved and the subject was receiving ibuprofen for relief. In the reporting nurse's opinion, the subject needed something stronger for her pain. They were speculating if the pain was due to neuritis related to tetanus immunization. The subject was treated with ibuprofen. At the time of reporting the events were unresolved.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Headache, Hypoaesthesia, Nausea
Clinical narrative: This case was reported by a physician and described the occurrence of headache in a 33-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included TRAMADOL and BACTRIM DS. On 15 January 2011 the subject received unspecified dose of BOOSTRIX at 0.5 ml in the left arm. Within a couple hours of vaccination with BOOSTRIX on 15 January 2011, the subject experienced headache and nausea. The subject was unable to work on 17 and 18 January 2011. It was reported that nausea resolved on 18 January 2011 after TRAMADOL and BACTRIM were stopped on 17 January 2011. Headache was unresolved at the time of reporting. The physician considered headache probably related to vaccination with BOOSTRIX. Nausea was not considered to be related to BOOSTRIX and the inability to work was not specified. The physician reported that the subject was going to be sent for a CT scan of his head to make sure nothing else is going on. Reporting physician stated that the subject developing a throbbing, bi-frontal, persistent headache after receiving the BOOSTRIX. The subject stated the headache recurs and additionally complained of a numb forehead. The subject has not been able to return to work as of this time due to the headache. Follow-up information received via a nurse on 11 February 2011 indicated that the events began on 15 January 2011 (the day of BOOSTRIX administration). ULTRAM and BACTRIM were given also on 15 January 2011 as treatment prophylaxis following an unspecified injury. It was reported that these medications were received via an Urgent Care and not at the reporter's office. According to follow-up, the event of headache improved somewhat with discontinuation of concurrent ULTRAM. At the time of reporting, all of the events were considered to be improved and probably related to treatment with BOOSTRIX.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm redness swelling 3.5 in x 1.96 in warm to the touch, painful. No systemic sxs, no evidence of infection.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS, FLU3
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: (R) arm redness swelling 3.5 in x 1.96 in warm to the touch, painful. No systemic sxs, no evidence of infection.
Age: 1.69
Sex: M
Vaccine: VARCEL, MMR, VARCEL, MMR
Symptoms: Eyelid oedema, Lip swelling, Oedema peripheral, Rash generalised, Swelling face
Clinical narrative: A few hours after vaccines hives began at inject. site. Next morn was covered head to toe in hives; that afternoon eyes and tongue swelled, difficulty breathing.
Age: 1.69
Sex: M
Vaccine: VARCEL, MMR, VARCEL, MMR
Symptoms: Swollen tongue, Vomiting
Clinical narrative: A few hours after vaccines hives began at inject. site. Next morn was covered head to toe in hives; that afternoon eyes and tongue swelled, difficulty breathing.
Age: 1.69
Sex: M
Vaccine: VARCEL, MMR, VARCEL, MMR
Symptoms: Culture throat, Urticaria
Clinical narrative: A few hours after vaccines hives began at inject. site. Next morn was covered head to toe in hives; that afternoon eyes and tongue swelled, difficulty breathing.
Age: 1.69
Sex: M
Vaccine: VARCEL, MMR, VARCEL, MMR
Symptoms: Dyspnoea, Eye swelling, Injection site urticaria, Swollen tongue, Urticaria
Clinical narrative: A few hours after vaccines hives began at inject. site. Next morn was covered head to toe in hives; that afternoon eyes and tongue swelled, difficulty breathing.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Myalgia, Paraesthesia
Clinical narrative: Generalized pain, numbness. Infectious polyneuritis by EMG/NCS.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Nerve conduction studies abnormal, Pain
Clinical narrative: Generalized pain, numbness. Infectious polyneuritis by EMG/NCS.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Convulsion, Dizziness, Pain in extremity, Syncope
Clinical narrative: Chills, didn't feel well Friday evening. Put blankets on and went to bed. Saturday morning fainted when I went out to kitchen. Fainted a second time when I came back into master bedroom. Stayed all day in bed (Saturday). When Sunday morning came the symptoms had subsided entirely.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Malaise, Syncope
Clinical narrative: Chills, didn't feel well Friday evening. Put blankets on and went to bed. Saturday morning fainted when I went out to kitchen. Fainted a second time when I came back into master bedroom. Stayed all day in bed (Saturday). When Sunday morning came the symptoms had subsided entirely.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Feeling abnormal, Headache, Maternal exposure during pregnancy, Musculoskeletal pain
Clinical narrative: The first day I had a sore shoulder, to be expected, but I also had a runny nose, fever and head ache. By day two I had a sore throat, head ache, runny nose, congested nose, fever, body aches, and was nausea. By day three All of my symptoms were getting worse. By day four I was absolutely miserable with all symptoms continuing. Day five, six were also horrible. Day seven I finally began to feel some relief from the symptoms. The only treatment I used was Tylenol to keep my fever under control. Because I am pregnant I could not use anything else. I am severly disappionted in the CDC, FDA and Goverment for falsely reporting how long these reactions actually last. I have spoken to other family members and friends and found that 9 out of 10 have had the same reaction that I had, to include my husband. We were all vaccinated in different places and some used the Flumist instead of the injectable version but still we all have had a long lasting reaction that severly effected our ability to perform daily functions. I found in all my research that these symptoms are only supposed to last 2 days. What a lie! And how misleading! I have never before gotten a flu vaccine nor has my husband, and we will never again waste our time getting one again. Why get a vaccine that makes you just as ill as the illness its self. I'd rather take my chances getting the real thing instead of getting those same sypmtoms from the vaccine that's supposed to prevent them in the first place.