chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPAB, MMR, PNC, VARCEL
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a child subject of unspecified gender who was vaccinated with TWINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk), MMR vaccine (non-gsk) and PREVNAR (Wyeth). On 20 June 2011 the subject received unspecified dose of TWINRIX (unknown), varicella virus vaccine (Non-GSK), MMR vaccine (Non-GSK), and a dose of PREVNAR (Wyeth). On 20 June 2011, less than one day after vaccination with MMR vaccine, PREVNAR, TWINRIX and varicella virus vaccine, the subject experienced allergic reaction. The healthcare professional considered the event was clinically significant (or requiring intervention). The child was treated in the emergency room and then released. At the time of reporting the event was improved. No further details were known at the time of reporting. The lot number for TWINRIX was reported as 0125AA from the reporter; however, based on a TWINRIX lot number review, it was decided to enter the batch number as AHABB0125AA?. Expiration was not provided.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1), HEPAB, PPV
Symptoms: Blood test abnormal, No therapeutic response, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of not responding to therapy in a 49-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), HAVRIX and ENGERIX B. Concurrent medical conditions included allergy to MOTRIN, allergy to PYRIDIUM, aspirin allergy, human immunodeficiency virus and lactose intolerance. Historic vaccination included pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given in 2004. Concurrent vaccination included pandemic vaccine H1N1 (non-gsk); Novartis; unknown; unknown given on 7 January 2010; pneumococcal vaccines (non-gsk); Merck; unknown; unknown given on 7 January 2010. Concurrent medications included HALCION, COLACE, KLONOPIN; with TWINRIX series NEURONTIN, SOMA, ESTRACE cream, FLEXERIL; with ENGERIX B series INVEGA, DESYREL, Benztropine mesylate, ZOLOFT and Morphine. On 7 January 2010, 4 March 2010 and 18 November 2010 the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown route). On 21 June 2011 the subject received a dose of HAVRIX as the 4th dose in the series (unknown) and experienced wrong vaccine administered. The nurse reported that the subject was administered ENGERIX B, but the lot number provided for the vaccine administered was for a HAVRIX vaccination. On 27 July 2011 and 29 December 2011 the subject received a dose of ENGERIX B (unknown) as the 5th and 6th doses in the series (1st and 2nd ENGERIX B vaccine, but the nurse thought it was the 2nd and 3rd). On 26 January 2011, 69 days after vaccination with TWINRIX, 11 months after vaccination with TWINRIX, 13 months after vaccination with TWINRIX, the subject experienced not responding to therapy. Blood work was drawn on 26 January 2011 after 3 doses of TWINRIX and the subject showed seroconversion for Hepatitis A, but "non-immune" for Hepatitis B. On 21 February 2012, 54 days after vaccination with ENGERIX B, 7 months after vaccination with ENGERIX B, the subject experienced decreased therapeutic response. The nurse thought that the subject had received 3 doses of ENGERIX B, but the first dose of what the nurse reported as ENGERIX B was HAVRIX based on the lot number. According to the nurse, the blood drawn on 21 February 2012, showed "borderline antibody protection". On 06 April 2012, updated lot number information was received from a safety review. The lot number was reported as AHAVB944BB for HAVRIX with expiration of 17 March 2013 from the reporter; however, based on safety lot number review, the reported lot has an expiration of 29 March 2013.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 52-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), ENERGIX B. On 4 April 2011 the subject received 1st dose of TWINRIX in the left arm. On 25 May 2011 and 8 November 2011 the subject received 2nd dose (left arm) and 3rd dose (right arm) of ENERGIX B. On 5 January 2012, 58 days after vaccination with ENGERIX B, 7 months after vaccination with ENGERIX B, 9 months after vaccination with TWINRIX, the subject experienced not responding to therapy (non-reactive or non-quantitative titer drawn). The subject had no hepatitis B antibodies. No additional information was reported.
Age: 43.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antibody positive, Hepatitis B core antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 52-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown). At an unknown time after completing the vaccination series with TWINRIX, the subject experienced not responding to therapy. The healthcare professional did not know if there was a specific blood test result, or if the subject did not respond to hepatitis A coverage, hepatitis B coverage or both. Follow-up was received on 9 December 2011 from a healthcare professional. The subject has a relevant medical history of primary biliary cirrhosis and autoimmune type I hepatitis. The subject received TWINRIX vaccinations on 6 February 2002, 6 March 2002 and July 2002. On 7 June 2011, lab work showed hepatitis A antibody total as positive and hepatitis B core antibody total as negative. The subject received a booster hepatitis B vaccine. A titre was to be rechecked after 4 weeks. The outcome was unknown. The healthcare professional indicated that the event was non-serious and unknown if related to vaccination with TWINRIX. The healthcare professional indicated that the event may have been associated with lack of efficacy (details not provided).
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis B, Hepatitis B virus test positive
Clinical narrative: This case was reported by a consumer and described the occurrence of hepatitis B in a 47-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). This report has not been medically confirmed by a healthcare professional. Concurrent medical conditions included anemia and cystic acne. Concurrent medications included Iron salt and Spironolactone. On 26 September 2011 at 12:00 the subject received 1st dose of TWINRIX in the left arm. On 29 September 20111, 3 days after vaccination with TWINRIX, the subject tested positive for hepatitis B after giving blood. At the time of reporting the event was unresolved.
Sex: U
Vaccine: HEPAB
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of allergic reaction 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 (unknown details). At an unspecified time after vaccination with TWINRIX, the subject experienced allergic reaction. The pharmacist stated that the subject had an "allergic reaction to TWINRIX a long time ago". She explained that the patient did not have an anaphylactic reaction, but the exact nature of the reaction was not known to the pharmacist. The pharmacist had learned of the information from a co-worker and did not have any additional detail to provide. At the time of reporting the outcome of the event was unspecified.
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Headache, Malaise, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of vomiting in a 39-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 Multivitamins and other unspecified concurrent medications. On 17 November 2011 at 18:00 the subject received 1st dose of TWINRIX at 1 ml in the left arm. On 23 November 2011, 6 days after vaccination with TWINRIX, the subject became sick. She reported that she woke up on the morning of 23 November 2011 at approximately 06:00, started vomiting and had a headache. The subject described the vomiting as continuous and nonstop. She reported that she could not even keep water down and was very sick. The subject went to her physician around 11:00 or 11:30 in the morning. She reported that her physician felt it was "just a sickness". She ended up going to the emergency room at about 19:00. The subject was treated with anti-emetic in the emergency room which she reported did not stop the vomiting. The subject went home about 23:30 or 00:00 and finally stopped vomiting the next day, 24 November 2011. The headache was reported to have resolved on 23 November 2011. The outcome of feeling "sick" was not specifically stated. She noted that she suffered for 13 hours. The subject reported that she was supposed to have received the 2nd dose of TWINRIX on 17 December 2011, but was afraid to do so and had not received it at the time of reporting.
Age: 33.0
Sex: M
Vaccine: HEPAB
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of leg pain in a 33-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. On 2 June 2011 the subject received 1st dose of TWINRIX (unknown route, left arm). On an unspecified date in 2011, less than one year after vaccination with TWINRIX, the subject experienced leg pain and cramping. The subject received the 2nd dose of TWINRIX on 11 July 2011 and reported the events of leg pain and cramping after the 1st dose. At the time of reporting the events were unresolved.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 38-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On unspecified dates the subject received 1st dose and 2nd dose of TWINRIX (details unknown). On 8 August 2011 the subject received 3rd dose of TWINRIX (unknown, left deltoid). On an unspecified date in 2011, 5 weeks after vaccination with the 3rd dose of TWINRIX, the subject experienced decreased therapeutic response. It was reported that "serologic testing 5 weeks post dose 3" showed the subject had a "low response to TWINRIX".
Age: 9.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: CSF test, Guillain-Barre syndrome, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Guillain-Barre Syndrome (GBS).
Age: 9.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome (GBS).
Age: 9.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Guillain-Barre Syndrome (GBS).
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TDAP, TYP, ANTH, SMALL, TDAP, TYP
Symptoms: Axillary pain, C-reactive protein normal, Cardiac enzymes normal, Chest discomfort, Chest pain
Clinical narrative: This case was received on 19 September 2012 via a third party query tool search on the VAERS database, under the reference number 456837. A 26-year-old male patient received a dose of ACAM2000, SP Biologicals Co., lot number VV04003A (site unknown); and a dose of TYPHIM Vi, sanofi pasteur SA, lot number G1130, (site unknown); a dose of BIOTHRAX, Michigan DPH, lot number FAV305, (route and site unknown) and a dose of BOOSTRIX, GlaxoSmithKline, lot number AC52B076BA, (route and site unknown) on 15 May 2012. On 23 May 2012, eight days post vaccination, the patient woke up with pain in chest, but did not think much of it as he had a different type pain under his arm and left lateral rib cage are that was tender to touch. The chest pain was described as heaviness over left breast area, which eased with leaning forward, but worsened with lying flat. The pain had no radiation, "n/c," no diaphoresis, and questionable (?) shortness of breath (SOB). The pain persisted for one to two days. On 26 May 2012, eleven days post vaccination, the patient presented with a rash on hands and feet, associated with pain and tenderness. Laboratory and diagnostic testing data was reported as c-reactive protein, (CRP); cardiac enzymes were all normal and an electrocardiogram was as reported as normal. The patient was treated with steroids (40 milligrams (mg) x 5, then 20 mg  x 5) (route and dates of administration were not reported) for rash. The patient's past medical history and current illnesses were reported as none. The patient's outcome was reported as recovered on an unspecified date. Follow-up information received via search of the literature on 22 November 2012. A 26 year-old previously healthy male presented with benign targetoid, erythema multiforme (EM)-like rash. He presented with exquisitely painful and pruritic, fixed, erythematous, targetoid and polycyclic plaques with dusky centers on bilateral palms and soles that occurred 11 days after receiving the smallpox, typhoid, anthrax and BOOSTRIX vaccinations. On post vaccination day 2, he developed a transient low-grade fever lasting 36 hours. On post vaccination day 5, the patient had intermittent shortness of breath, chest pain, and axillary tenderness. Shortness of breath and chest pain resolved within several hours, but the axillary tenderness persisted. On review of systems, the patient reported feeling more fatigued than usual, but was otherwise negative. He reported no history of recent illnesses or exposure to ill persons, no history of recurrent herpes infections, no risk factor associated with a sexually transmitted illness, or history of recent travel to wooded areas. A rapid plasma reagin was nonreactive and c-reactive protein, cardiac enzymes, and an electrocardiogram, were all normal. The patient was treated with a course of oral glucocorticosteroids. All symptoms, including the EM-like rash had completely resolved 12 days after their onset. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TDAP, TYP, ANTH, SMALL, TDAP, TYP
Symptoms: Electrocardiogram normal, Musculoskeletal chest pain, Pain, Rash, Tenderness
Clinical narrative: This case was received on 19 September 2012 via a third party query tool search on the VAERS database, under the reference number 456837. A 26-year-old male patient received a dose of ACAM2000, SP Biologicals Co., lot number VV04003A (site unknown); and a dose of TYPHIM Vi, sanofi pasteur SA, lot number G1130, (site unknown); a dose of BIOTHRAX, Michigan DPH, lot number FAV305, (route and site unknown) and a dose of BOOSTRIX, GlaxoSmithKline, lot number AC52B076BA, (route and site unknown) on 15 May 2012. On 23 May 2012, eight days post vaccination, the patient woke up with pain in chest, but did not think much of it as he had a different type pain under his arm and left lateral rib cage are that was tender to touch. The chest pain was described as heaviness over left breast area, which eased with leaning forward, but worsened with lying flat. The pain had no radiation, "n/c," no diaphoresis, and questionable (?) shortness of breath (SOB). The pain persisted for one to two days. On 26 May 2012, eleven days post vaccination, the patient presented with a rash on hands and feet, associated with pain and tenderness. Laboratory and diagnostic testing data was reported as c-reactive protein, (CRP); cardiac enzymes were all normal and an electrocardiogram was as reported as normal. The patient was treated with steroids (40 milligrams (mg) x 5, then 20 mg  x 5) (route and dates of administration were not reported) for rash. The patient's past medical history and current illnesses were reported as none. The patient's outcome was reported as recovered on an unspecified date. Follow-up information received via search of the literature on 22 November 2012. A 26 year-old previously healthy male presented with benign targetoid, erythema multiforme (EM)-like rash. He presented with exquisitely painful and pruritic, fixed, erythematous, targetoid and polycyclic plaques with dusky centers on bilateral palms and soles that occurred 11 days after receiving the smallpox, typhoid, anthrax and BOOSTRIX vaccinations. On post vaccination day 2, he developed a transient low-grade fever lasting 36 hours. On post vaccination day 5, the patient had intermittent shortness of breath, chest pain, and axillary tenderness. Shortness of breath and chest pain resolved within several hours, but the axillary tenderness persisted. On review of systems, the patient reported feeling more fatigued than usual, but was otherwise negative. He reported no history of recent illnesses or exposure to ill persons, no history of recurrent herpes infections, no risk factor associated with a sexually transmitted illness, or history of recent travel to wooded areas. A rapid plasma reagin was nonreactive and c-reactive protein, cardiac enzymes, and an electrocardiogram, were all normal. The patient was treated with a course of oral glucocorticosteroids. All symptoms, including the EM-like rash had completely resolved 12 days after their onset. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TDAP, TYP, ANTH, SMALL, TDAP, TYP
Symptoms: Dyspnoea, Electrocardiogram normal, Erythema, Erythema multiforme, Fatigue
Clinical narrative: This case was received on 19 September 2012 via a third party query tool search on the VAERS database, under the reference number 456837. A 26-year-old male patient received a dose of ACAM2000, SP Biologicals Co., lot number VV04003A (site unknown); and a dose of TYPHIM Vi, sanofi pasteur SA, lot number G1130, (site unknown); a dose of BIOTHRAX, Michigan DPH, lot number FAV305, (route and site unknown) and a dose of BOOSTRIX, GlaxoSmithKline, lot number AC52B076BA, (route and site unknown) on 15 May 2012. On 23 May 2012, eight days post vaccination, the patient woke up with pain in chest, but did not think much of it as he had a different type pain under his arm and left lateral rib cage are that was tender to touch. The chest pain was described as heaviness over left breast area, which eased with leaning forward, but worsened with lying flat. The pain had no radiation, "n/c," no diaphoresis, and questionable (?) shortness of breath (SOB). The pain persisted for one to two days. On 26 May 2012, eleven days post vaccination, the patient presented with a rash on hands and feet, associated with pain and tenderness. Laboratory and diagnostic testing data was reported as c-reactive protein, (CRP); cardiac enzymes were all normal and an electrocardiogram was as reported as normal. The patient was treated with steroids (40 milligrams (mg) x 5, then 20 mg  x 5) (route and dates of administration were not reported) for rash. The patient's past medical history and current illnesses were reported as none. The patient's outcome was reported as recovered on an unspecified date. Follow-up information received via search of the literature on 22 November 2012. A 26 year-old previously healthy male presented with benign targetoid, erythema multiforme (EM)-like rash. He presented with exquisitely painful and pruritic, fixed, erythematous, targetoid and polycyclic plaques with dusky centers on bilateral palms and soles that occurred 11 days after receiving the smallpox, typhoid, anthrax and BOOSTRIX vaccinations. On post vaccination day 2, he developed a transient low-grade fever lasting 36 hours. On post vaccination day 5, the patient had intermittent shortness of breath, chest pain, and axillary tenderness. Shortness of breath and chest pain resolved within several hours, but the axillary tenderness persisted. On review of systems, the patient reported feeling more fatigued than usual, but was otherwise negative. He reported no history of recent illnesses or exposure to ill persons, no history of recurrent herpes infections, no risk factor associated with a sexually transmitted illness, or history of recent travel to wooded areas. A rapid plasma reagin was nonreactive and c-reactive protein, cardiac enzymes, and an electrocardiogram, were all normal. The patient was treated with a course of oral glucocorticosteroids. All symptoms, including the EM-like rash had completely resolved 12 days after their onset. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TDAP, TYP, ANTH, SMALL, TDAP, TYP
Symptoms: Musculoskeletal chest pain, Pain in extremity, Pruritus, Pyrexia, Rash
Clinical narrative: This case was received on 19 September 2012 via a third party query tool search on the VAERS database, under the reference number 456837. A 26-year-old male patient received a dose of ACAM2000, SP Biologicals Co., lot number VV04003A (site unknown); and a dose of TYPHIM Vi, sanofi pasteur SA, lot number G1130, (site unknown); a dose of BIOTHRAX, Michigan DPH, lot number FAV305, (route and site unknown) and a dose of BOOSTRIX, GlaxoSmithKline, lot number AC52B076BA, (route and site unknown) on 15 May 2012. On 23 May 2012, eight days post vaccination, the patient woke up with pain in chest, but did not think much of it as he had a different type pain under his arm and left lateral rib cage are that was tender to touch. The chest pain was described as heaviness over left breast area, which eased with leaning forward, but worsened with lying flat. The pain had no radiation, "n/c," no diaphoresis, and questionable (?) shortness of breath (SOB). The pain persisted for one to two days. On 26 May 2012, eleven days post vaccination, the patient presented with a rash on hands and feet, associated with pain and tenderness. Laboratory and diagnostic testing data was reported as c-reactive protein, (CRP); cardiac enzymes were all normal and an electrocardiogram was as reported as normal. The patient was treated with steroids (40 milligrams (mg) x 5, then 20 mg  x 5) (route and dates of administration were not reported) for rash. The patient's past medical history and current illnesses were reported as none. The patient's outcome was reported as recovered on an unspecified date. Follow-up information received via search of the literature on 22 November 2012. A 26 year-old previously healthy male presented with benign targetoid, erythema multiforme (EM)-like rash. He presented with exquisitely painful and pruritic, fixed, erythematous, targetoid and polycyclic plaques with dusky centers on bilateral palms and soles that occurred 11 days after receiving the smallpox, typhoid, anthrax and BOOSTRIX vaccinations. On post vaccination day 2, he developed a transient low-grade fever lasting 36 hours. On post vaccination day 5, the patient had intermittent shortness of breath, chest pain, and axillary tenderness. Shortness of breath and chest pain resolved within several hours, but the axillary tenderness persisted. On review of systems, the patient reported feeling more fatigued than usual, but was otherwise negative. He reported no history of recent illnesses or exposure to ill persons, no history of recurrent herpes infections, no risk factor associated with a sexually transmitted illness, or history of recent travel to wooded areas. A rapid plasma reagin was nonreactive and c-reactive protein, cardiac enzymes, and an electrocardiogram, were all normal. The patient was treated with a course of oral glucocorticosteroids. All symptoms, including the EM-like rash had completely resolved 12 days after their onset. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TDAP, TYP, ANTH, SMALL, TDAP, TYP
Symptoms: Skin plaque, Tenderness, Treponema test negative
Clinical narrative: This case was received on 19 September 2012 via a third party query tool search on the VAERS database, under the reference number 456837. A 26-year-old male patient received a dose of ACAM2000, SP Biologicals Co., lot number VV04003A (site unknown); and a dose of TYPHIM Vi, sanofi pasteur SA, lot number G1130, (site unknown); a dose of BIOTHRAX, Michigan DPH, lot number FAV305, (route and site unknown) and a dose of BOOSTRIX, GlaxoSmithKline, lot number AC52B076BA, (route and site unknown) on 15 May 2012. On 23 May 2012, eight days post vaccination, the patient woke up with pain in chest, but did not think much of it as he had a different type pain under his arm and left lateral rib cage are that was tender to touch. The chest pain was described as heaviness over left breast area, which eased with leaning forward, but worsened with lying flat. The pain had no radiation, "n/c," no diaphoresis, and questionable (?) shortness of breath (SOB). The pain persisted for one to two days. On 26 May 2012, eleven days post vaccination, the patient presented with a rash on hands and feet, associated with pain and tenderness. Laboratory and diagnostic testing data was reported as c-reactive protein, (CRP); cardiac enzymes were all normal and an electrocardiogram was as reported as normal. The patient was treated with steroids (40 milligrams (mg) x 5, then 20 mg  x 5) (route and dates of administration were not reported) for rash. The patient's past medical history and current illnesses were reported as none. The patient's outcome was reported as recovered on an unspecified date. Follow-up information received via search of the literature on 22 November 2012. A 26 year-old previously healthy male presented with benign targetoid, erythema multiforme (EM)-like rash. He presented with exquisitely painful and pruritic, fixed, erythematous, targetoid and polycyclic plaques with dusky centers on bilateral palms and soles that occurred 11 days after receiving the smallpox, typhoid, anthrax and BOOSTRIX vaccinations. On post vaccination day 2, he developed a transient low-grade fever lasting 36 hours. On post vaccination day 5, the patient had intermittent shortness of breath, chest pain, and axillary tenderness. Shortness of breath and chest pain resolved within several hours, but the axillary tenderness persisted. On review of systems, the patient reported feeling more fatigued than usual, but was otherwise negative. He reported no history of recent illnesses or exposure to ill persons, no history of recurrent herpes infections, no risk factor associated with a sexually transmitted illness, or history of recent travel to wooded areas. A rapid plasma reagin was nonreactive and c-reactive protein, cardiac enzymes, and an electrocardiogram, were all normal. The patient was treated with a course of oral glucocorticosteroids. All symptoms, including the EM-like rash had completely resolved 12 days after their onset. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis, Rash, Rash erythematous, Skin warm
Clinical narrative: RUE cellulitis s/p admin of flu and PNEUMOVAX vaccine at local pharmacy.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Blood culture negative, Cellulitis
Clinical narrative: RUE cellulitis s/p admin of flu and PNEUMOVAX vaccine at local pharmacy.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Asthenia, Chills, Fatigue, Malaise, Migraine
Clinical narrative: Fever, chills, weakness, fatigue, malaise, headache, syncope.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, chills, weakness, fatigue, malaise, headache, syncope.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Fever, chills, weakness, fatigue, malaise, headache, syncope.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Syncope
Clinical narrative: Fever, chills, weakness, fatigue, malaise, headache, syncope.
Age: 49.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Headache, Neck pain, Pain in extremity, Pruritus, Rash
Clinical narrative: Started getting neck pain, headache, worsening over 24 hrs, vomiting, then developed pain in injection site extending into neck and base of skull, pain in arm, fatigue, continuing to get worse.
Age: 49.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Fatigue, Headache, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Started getting neck pain, headache, worsening over 24 hrs, vomiting, then developed pain in injection site extending into neck and base of skull, pain in arm, fatigue, continuing to get worse.
Age: 49.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Vomiting
Clinical narrative: Started getting neck pain, headache, worsening over 24 hrs, vomiting, then developed pain in injection site extending into neck and base of skull, pain in arm, fatigue, continuing to get worse.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Anticonvulsant drug level therapeutic, Electrocardiogram normal, Grand mal convulsion, Mental status changes, Pain
Clinical narrative: This spontaneous report was received from a office manager via company representative refers to a 55 year old male patient. The patient's historical condition included epilepsy. On 13-SEP-2012, the patient was vaccinated with single dose of 0.5 ml PNEUMOVAX 23, (lot number H010661, expiration date 02-FEB-2014, Route not reported). Concomitant medications included (UMC) unspecified medications for epilepsy. On 13-SEP-2012, the patient experienced seizure and low grade fever and was hospitalized for 2 days and was transferred to medical center on 15-SEP-2012. The discharge date was unknown. At the medical center levels for epilepsy were checked and were at therapeutic levels. Treatment was unspecified. On an unknown date, the outcome of seizure and low grade fever were reported as recovered. The patient sought medical attention (unspecified). Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a office manager via company representative refers to a 55 year old male patient. The patient's historical condition included epilepsy. On 13-SEP-2012, the patient was vaccinated with single dose of 0.5 ml PNEUMOVAX 23, (lot number H010661, expiration date 02-FEB-2014, Route not reported). Concomitant medications included (UMC) unspecified medications for epilepsy. On 13-SEP-2012, the patient experienced seizure and low grade fever and was hospitalized for 2 days and was transferred to medical center on 15-SEP-2012. The discharge date was unknown. At the medical center levels for epilepsy were checked and were at therapeutic levels. Treatment was unspecified. On an unknown date, the outcome of seizure and low grade fever were reported as recovered. The patient sought medical attention (unspecified). Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Anticonvulsant drug level therapeutic, Convulsion, Pyrexia
Clinical narrative: This spontaneous report was received from a office manager via company representative refers to a 55 year old male patient. The patient's historical condition included epilepsy. On 13-SEP-2012, the patient was vaccinated with single dose of 0.5 ml PNEUMOVAX 23, (lot number H010661, expiration date 02-FEB-2014, Route not reported). Concomitant medications included (UMC) unspecified medications for epilepsy. On 13-SEP-2012, the patient experienced seizure and low grade fever and was hospitalized for 2 days and was transferred to medical center on 15-SEP-2012. The discharge date was unknown. At the medical center levels for epilepsy were checked and were at therapeutic levels. Treatment was unspecified. On an unknown date, the outcome of seizure and low grade fever were reported as recovered. The patient sought medical attention (unspecified). Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Enuresis, Erythema infectiosum, Injection site discolouration, Injection site haematoma, Injection site rash
Clinical narrative: Swollen left leg; rash covering whole leg; rash turning purple for two weeks, hematoma, wetting pants every night after shots for a week, wetting pants during day, foul smelling urine for a week, developed Fifths disease from vaccine (foreign virus entering body and causing immune extreme immune response where body goes into hyper reaction, thus the large scale rash all over body (a year later child is developing rash similar to the one from vaccine administration, is currently being investigated by physicians for known virus or cause?); spot where injection was given last November is still visible and flares up out of no where from time to time (looks like large white blister sometimes, injection site.)
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site swelling, Injection site vesicles, Rash generalised, Urine odour abnormal
Clinical narrative: Swollen left leg; rash covering whole leg; rash turning purple for two weeks, hematoma, wetting pants every night after shots for a week, wetting pants during day, foul smelling urine for a week, developed Fifths disease from vaccine (foreign virus entering body and causing immune extreme immune response where body goes into hyper reaction, thus the large scale rash all over body (a year later child is developing rash similar to the one from vaccine administration, is currently being investigated by physicians for known virus or cause?); spot where injection was given last November is still visible and flares up out of no where from time to time (looks like large white blister sometimes, injection site.)
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Blood test, Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, X-ray
Clinical narrative: Shoulder pain, limited movement.  Pain increased every day for 7 days until ER visit.  Follow up determined by doctor that vaccine was injected into bursa area which caused severe pain and limited movement.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Crying, Emotional distress
Clinical narrative: Uncontrollable crying (very unusual) that lasted for 3 days. Unable to talk without crying and sobbing.  Only relief was when asleep. No treatment given, although doctor prescribed Prozac.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness unilateral, Cough, Lacrimation increased, Loss of consciousness, Optic neuritis
Clinical narrative: Runny nose, sore throat, cough, watery eye with 10-15 minute blackouts numerous times a day.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose, sore throat, cough, watery eye with 10-15 minute blackouts numerous times a day.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Experienced immediate pain radiating from injection site.  Pain got progressively worse over next 24 hours to point where I could not lift my arm.  Pain has continued since and I cannot lift my right arm over my head.
Age: 11.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: SEVERE SWELLING REDNESS AND PAIN AT INJECTION SITE AND IRRITABILITY.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Bone pain, Bone scan normal, Clonus, Complex regional pain syndrome
Clinical narrative: This spontaneous report as received from a male physician refers to a 19 years old female patient with none drug reactions or allergies and none pertinent medical history. The patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly in April 2011 and with the second dose of GARDASIL, 0.5 ml, intramuscularly in July 2011. No other co-suspects were reported. There was no concomitant medications. The patient left for college in August 2011 and shortly after started to complain of pain in her "shins", swelling of the knees and difficulty walking. It was also reported that the patient had developed debilitating muscle weakness and pain after being administered GARDASIL. The physician reported she was getting worse. The "bone pain" had continued, the weakness had progressed (she was in a wheelchair), and there were signs of tremor/clonus. The patient was hospitalized due to adverse events. The patient had undergone an extensive work-up at several major medical centers. She had been tentatively diagnosed with RSD (reflex sympathetic dystrophy) by some physicians. The patient was a champion horseback rider prior to the onset of that illness. Because of her exposure to horses and farms, the physician's current evaluation would be looking for evidence of Eastern Equine Encephalitis and organophosphate exposure. KEPPRA, fentanyl, PAXIL and LYRICA were given as a treatment for the adverse events. Treatment with LYRICA and KEPPRA had been unsuccessful. Multiple MRIs (brain, spinal cord, extremities), EMGs and bone scans had been negative. It was also reported that CT scan, blood labs were performed with no results provided. She might undergo muscle and biopsies. At the time of the report the patient had not recovered. The relatedness for the adverse events was not reported for GARDASIL. Pain in her "shins", swelling of the knees, difficulty walking, debilitating muscle weakness, signs of tremor/clonus and RSD (reflex sympathetic dystrophy) were considered to be disabling by the reporting physician. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Electromyogram normal, Gait disturbance, Joint swelling, Muscular weakness
Clinical narrative: This spontaneous report as received from a male physician refers to a 19 years old female patient with none drug reactions or allergies and none pertinent medical history. The patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly in April 2011 and with the second dose of GARDASIL, 0.5 ml, intramuscularly in July 2011. No other co-suspects were reported. There was no concomitant medications. The patient left for college in August 2011 and shortly after started to complain of pain in her "shins", swelling of the knees and difficulty walking. It was also reported that the patient had developed debilitating muscle weakness and pain after being administered GARDASIL. The physician reported she was getting worse. The "bone pain" had continued, the weakness had progressed (she was in a wheelchair), and there were signs of tremor/clonus. The patient was hospitalized due to adverse events. The patient had undergone an extensive work-up at several major medical centers. She had been tentatively diagnosed with RSD (reflex sympathetic dystrophy) by some physicians. The patient was a champion horseback rider prior to the onset of that illness. Because of her exposure to horses and farms, the physician's current evaluation would be looking for evidence of Eastern Equine Encephalitis and organophosphate exposure. KEPPRA, fentanyl, PAXIL and LYRICA were given as a treatment for the adverse events. Treatment with LYRICA and KEPPRA had been unsuccessful. Multiple MRIs (brain, spinal cord, extremities), EMGs and bone scans had been negative. It was also reported that CT scan, blood labs were performed with no results provided. She might undergo muscle and biopsies. At the time of the report the patient had not recovered. The relatedness for the adverse events was not reported for GARDASIL. Pain in her "shins", swelling of the knees, difficulty walking, debilitating muscle weakness, signs of tremor/clonus and RSD (reflex sympathetic dystrophy) were considered to be disabling by the reporting physician. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal cord normal, Pain in extremity
Clinical narrative: This spontaneous report as received from a male physician refers to a 19 years old female patient with none drug reactions or allergies and none pertinent medical history. The patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly in April 2011 and with the second dose of GARDASIL, 0.5 ml, intramuscularly in July 2011. No other co-suspects were reported. There was no concomitant medications. The patient left for college in August 2011 and shortly after started to complain of pain in her "shins", swelling of the knees and difficulty walking. It was also reported that the patient had developed debilitating muscle weakness and pain after being administered GARDASIL. The physician reported she was getting worse. The "bone pain" had continued, the weakness had progressed (she was in a wheelchair), and there were signs of tremor/clonus. The patient was hospitalized due to adverse events. The patient had undergone an extensive work-up at several major medical centers. She had been tentatively diagnosed with RSD (reflex sympathetic dystrophy) by some physicians. The patient was a champion horseback rider prior to the onset of that illness. Because of her exposure to horses and farms, the physician's current evaluation would be looking for evidence of Eastern Equine Encephalitis and organophosphate exposure. KEPPRA, fentanyl, PAXIL and LYRICA were given as a treatment for the adverse events. Treatment with LYRICA and KEPPRA had been unsuccessful. Multiple MRIs (brain, spinal cord, extremities), EMGs and bone scans had been negative. It was also reported that CT scan, blood labs were performed with no results provided. She might undergo muscle and biopsies. At the time of the report the patient had not recovered. The relatedness for the adverse events was not reported for GARDASIL. Pain in her "shins", swelling of the knees, difficulty walking, debilitating muscle weakness, signs of tremor/clonus and RSD (reflex sympathetic dystrophy) were considered to be disabling by the reporting physician. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Wheelchair user
Clinical narrative: This spontaneous report as received from a male physician refers to a 19 years old female patient with none drug reactions or allergies and none pertinent medical history. The patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly in April 2011 and with the second dose of GARDASIL, 0.5 ml, intramuscularly in July 2011. No other co-suspects were reported. There was no concomitant medications. The patient left for college in August 2011 and shortly after started to complain of pain in her "shins", swelling of the knees and difficulty walking. It was also reported that the patient had developed debilitating muscle weakness and pain after being administered GARDASIL. The physician reported she was getting worse. The "bone pain" had continued, the weakness had progressed (she was in a wheelchair), and there were signs of tremor/clonus. The patient was hospitalized due to adverse events. The patient had undergone an extensive work-up at several major medical centers. She had been tentatively diagnosed with RSD (reflex sympathetic dystrophy) by some physicians. The patient was a champion horseback rider prior to the onset of that illness. Because of her exposure to horses and farms, the physician's current evaluation would be looking for evidence of Eastern Equine Encephalitis and organophosphate exposure. KEPPRA, fentanyl, PAXIL and LYRICA were given as a treatment for the adverse events. Treatment with LYRICA and KEPPRA had been unsuccessful. Multiple MRIs (brain, spinal cord, extremities), EMGs and bone scans had been negative. It was also reported that CT scan, blood labs were performed with no results provided. She might undergo muscle and biopsies. At the time of the report the patient had not recovered. The relatedness for the adverse events was not reported for GARDASIL. Pain in her "shins", swelling of the knees, difficulty walking, debilitating muscle weakness, signs of tremor/clonus and RSD (reflex sympathetic dystrophy) were considered to be disabling by the reporting physician. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Circulatory collapse, Erythema, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Large red welt increasing from inj. site to entire arm. "All veins collapsed". Pt now on ZYVOX & cephalexin.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Immediate post-injection reaction, Inflammation, Mobility decreased
Clinical narrative: See attached. Dr asked me to send my reaction to the pneumonia vaccine. As I didn't see an e-mail address for dr on the website. I knew you'd see that he received this. Friday, 11/30, 9:50 received inoculation and immediately felt more soreness than had ever experienced before with inoculations. Friday, 11/30, around 2:00 - upper arm lost range of motion, chills, aches throughout body. Friday, 11/30-evening-slept 14 hours. Saturday, 11/31 afternoon-upper arm from elbow to shoulder, inflamed and swollen, full range of motion compromised more than the day previous. Sunday, 12/1-aches remain, able to move arm a bit more. Monday, 12/2-AM, arm looked less swollen, and the color was not as vividly red. Monday, 12/2 PM-bright color and swollenness returned.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: See attached. Dr asked me to send my reaction to the pneumonia vaccine. As I didn't see an e-mail address for dr on the website. I knew you'd see that he received this. Friday, 11/30, 9:50 received inoculation and immediately felt more soreness than had ever experienced before with inoculations. Friday, 11/30, around 2:00 - upper arm lost range of motion, chills, aches throughout body. Friday, 11/30-evening-slept 14 hours. Saturday, 11/31 afternoon-upper arm from elbow to shoulder, inflamed and swollen, full range of motion compromised more than the day previous. Sunday, 12/1-aches remain, able to move arm a bit more. Monday, 12/2-AM, arm looked less swollen, and the color was not as vividly red. Monday, 12/2 PM-bright color and swollenness returned.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Nausea
Clinical narrative: Pt. felt very weak since she got the shot, very exhausted, a little pain in the site of administration. There was a 2" diameter redness. Pt was nauseated. Symptoms started in 11/29 at night time.
Age: 37.0
Sex: U
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: 1 day after vaccination, patient developed facial tingling, numbness, soreness to shoulders & arms.
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Insomnia, Pain, Pain in extremity
Clinical narrative: Case number PHEH2012US023559 is an initial spontaneous report received from a consumer on 28 Nov 2012: This report refers to a female patient of unknown age group. She was vaccinated with FLUVIRIN (batch number: 1200501 and expiry date: Jun 2013) intramuscularly into the left arm at a dose of 0.5 ml on 01 Oct 2012. On 02 Oct 2012, she experienced a locked arm with crippling pain that had limited movement of her left arm for 30 days. She presented with inability to sleep for one month because the pain was bothersome, she was unable to put on sleeves when dressing, she had to use her right arm/hand to move her left arm and she was unable to lift and hold items with her left arm. One month after the pain started, she went to a clinic where the physician suggested that she had experienced a rotary cuff injury; however she denied the claim. She had reported this incident to the Vaccine Adverse Event Reporting System (VAERS). Although the intensity of the pain had subsided significantly there was residual pain and discomfort with the movement of her left arm that still persisted. No further information was available.