chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Injection site discolouration
Clinical narrative: Information was received 02 May 2008 from a health care professional.  A 2-month-old male patient had received an injection of IPOL, lot number A0298-2 (date, route and site of administration not reported) and on 25 March 2008, he subsequently developed a black dot at the injection site.  The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter.  This patient's case was one of four cases which were reported from the same satellite site.  The information for the other three patients is contained in case numbers 2008-01338, 2008-01427, and 2008-01429.  All facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles.  Some of the black dots were reported to have appeared immediately with some present tow months post immunization.  This event had been noticed by all health care workers at the facilities and had not been noticed in the past.  The reporter indicated follow-up information would be provided as it is obtained.  Follow-up information was received from a health care professional on 17 November 2008.  The patient initials were amended.  IPOL was administered to the patient's left thigh (date and route of administration not reported).  Vaccines administered concomitantly with IPOL included a left thigh injection of DAPTACEL (lot number C2800AA); a right thigh injection of PREVNAR (manufacturer Wyeth, lot number C49922); and oral administration of ROTATEQ (manufacturer Merck, lot number 0208X).  Routes of administration were not reported for any of the vaccines.  The patient developed a black dot only at the IPOL injection site.  The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ACTHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTAP), 2008-01338 (IPOL), 2008-01339 (FLUZONE), 2008-01427 (IPOL), and 2008-01429 (IPOL)
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Albumin CSF increased, Asthenia, Blood product transfusion, CSF immunoglobulin increased, CSF protein increased
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), and was forwarded by the CDC on 09 January 2009.  VAERS reference number 331313.  An 18-year-old male patient received an injection of MENACTRA (lot number U2227A), ADACEL (lot number C272OAA), and IPOL (lot number Y10302) on 16 June 2007.  In July 2007, he developed an upper respiratory infection.  He began experiencing weakness in August, and in September complained of numbness.  He sought medical attention, and laboratory testing in September 2007 revealed the following:  CSF IgG 11.4 (normal 0.1 to 4.2); Alb 45 (normal 11-25), Prot 88 (normal 12-20).  MRI of the C-spine and brain were within normal limits, and a CT showed sinusitis.  On 15 September 2007 he was diagnosed with acute infective polyneuritis (Guillain Barre Syndrome).  He was hospitalized for three days and treated with intravenous immunoglobin, and the symptoms resolved.  He had recurrent weakness in November and January, and on 22 January 2008 his diagnosis was changed to chronic inflammatory demyelinating polyneuritis.  At the time of the report, the patient had not yet recovered.  Additional information was received from the CDC on 12 January 2009, which noted that the event onset occurred on 05 September 2007 (also reported as "2008" on the VAERS form completed by the initial reporter).  Clarification will be requested.  Documents held by sender:  None. 1/29/2010 Per call on 27 July 09, he requires monthl IVIG. Sx recur without IVIG.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), and was forwarded by the CDC on 09 January 2009.  VAERS reference number 331313.  An 18-year-old male patient received an injection of MENACTRA (lot number U2227A), ADACEL (lot number C272OAA), and IPOL (lot number Y10302) on 16 June 2007.  In July 2007, he developed an upper respiratory infection.  He began experiencing weakness in August, and in September complained of numbness.  He sought medical attention, and laboratory testing in September 2007 revealed the following:  CSF IgG 11.4 (normal 0.1 to 4.2); Alb 45 (normal 11-25), Prot 88 (normal 12-20).  MRI of the C-spine and brain were within normal limits, and a CT showed sinusitis.  On 15 September 2007 he was diagnosed with acute infective polyneuritis (Guillain Barre Syndrome).  He was hospitalized for three days and treated with intravenous immunoglobin, and the symptoms resolved.  He had recurrent weakness in November and January, and on 22 January 2008 his diagnosis was changed to chronic inflammatory demyelinating polyneuritis.  At the time of the report, the patient had not yet recovered.  Additional information was received from the CDC on 12 January 2009, which noted that the event onset occurred on 05 September 2007 (also reported as "2008" on the VAERS form completed by the initial reporter).  Clarification will be requested.  Documents held by sender:  None. 1/29/2010 Per call on 27 July 09, he requires monthl IVIG. Sx recur without IVIG.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging normal, Sinusitis, Upper respiratory tract infection
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), and was forwarded by the CDC on 09 January 2009.  VAERS reference number 331313.  An 18-year-old male patient received an injection of MENACTRA (lot number U2227A), ADACEL (lot number C272OAA), and IPOL (lot number Y10302) on 16 June 2007.  In July 2007, he developed an upper respiratory infection.  He began experiencing weakness in August, and in September complained of numbness.  He sought medical attention, and laboratory testing in September 2007 revealed the following:  CSF IgG 11.4 (normal 0.1 to 4.2); Alb 45 (normal 11-25), Prot 88 (normal 12-20).  MRI of the C-spine and brain were within normal limits, and a CT showed sinusitis.  On 15 September 2007 he was diagnosed with acute infective polyneuritis (Guillain Barre Syndrome).  He was hospitalized for three days and treated with intravenous immunoglobin, and the symptoms resolved.  He had recurrent weakness in November and January, and on 22 January 2008 his diagnosis was changed to chronic inflammatory demyelinating polyneuritis.  At the time of the report, the patient had not yet recovered.  Additional information was received from the CDC on 12 January 2009, which noted that the event onset occurred on 05 September 2007 (also reported as "2008" on the VAERS form completed by the initial reporter).  Clarification will be requested.  Documents held by sender:  None. 1/29/2010 Per call on 27 July 09, he requires monthl IVIG. Sx recur without IVIG.
Age: 63.0
Sex: M
Vaccine: FLUX, PPV, PPV
Symptoms: Arthralgia, Blood test abnormal, Infection, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Patient came from doctor office and says he had severe joint and shoulder pain and cannot move arm at all. The arm was warm to touch, no fever. He was sent to the hospital by his doctor for x-ray and blood work. The x-ray was negative but he blood work came back positive for severe infection. He was given Tramadol and CIPRO for treatment. *Update - 3/11/09. Patient still seeing MD has not recovered. Is seeing Orthopedic doctor.
Age: 63.0
Sex: M
Vaccine: FLUX, PPV, PPV
Symptoms: Skin warm, X-ray abnormal
Clinical narrative: Patient came from doctor office and says he had severe joint and shoulder pain and cannot move arm at all. The arm was warm to touch, no fever. He was sent to the hospital by his doctor for x-ray and blood work. The x-ray was negative but he blood work came back positive for severe infection. He was given Tramadol and CIPRO for treatment. *Update - 3/11/09. Patient still seeing MD has not recovered. Is seeing Orthopedic doctor.
Age: 63.0
Sex: M
Vaccine: FLUX, PPV, PPV
Symptoms: Arthralgia, Infection, Injected limb mobility decreased, Injection site pain, Laboratory test abnormal
Clinical narrative: Patient came from doctor office and says he had severe joint and shoulder pain and cannot move arm at all. The arm was warm to touch, no fever. He was sent to the hospital by his doctor for x-ray and blood work. The x-ray was negative but he blood work came back positive for severe infection. He was given Tramadol and CIPRO for treatment. *Update - 3/11/09. Patient still seeing MD has not recovered. Is seeing Orthopedic doctor.
Age: 63.0
Sex: M
Vaccine: FLUX, PPV, PPV
Symptoms: Musculoskeletal pain, Skin warm, X-ray normal
Clinical narrative: Patient came from doctor office and says he had severe joint and shoulder pain and cannot move arm at all. The arm was warm to touch, no fever. He was sent to the hospital by his doctor for x-ray and blood work. The x-ray was negative but he blood work came back positive for severe infection. He was given Tramadol and CIPRO for treatment. *Update - 3/11/09. Patient still seeing MD has not recovered. Is seeing Orthopedic doctor.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Back pain, Chills, Headache, Hypoaesthesia
Clinical narrative: Initial report received on 09 November 2008 from the consumers parent. An 11-year-old male patient, with no concurrent illnesses and unknown past medical history, had received an intramuscular injection of ADACEL, lot number C3003 (other lot number UF452CA); and an intramuscular injection of MENACTRA (Lot number U2734AA) on 17 October 2008. The routes and sites of administration were not provided. At an unspecified amount of time later, the patient began having symptoms of severe headache, severe back pain/soreness (including low back pain), and his back was stiff with numbness and spasms. The patient was evaluated by his physician ten days later, and at that time, the back pain had improved somewhat, and the patient was additionally experiencing muscular tenderness, left arm pain, neck pain, and continued head pain. He also had chills, however he was afebrile. Diagnostic tests performed revealed the patient was positive for Lupus. Date, name, type and results of diagnostic tests were not provided. It was not reported whether the patient had received any corrective treatments. At the time of this report, the patient had not recovered. Follow-up information received on 17 November 2008 from the Centers for Disease Control and Prevention (CDC). The VAERS number was provided by the CDC as 332355. No other relevant medically significant information was provided. Follow-up information received on 25 November 2008 from the patient's parent. Per the parent, after the patient received the vaccinations with ADACEL and MENACTRA in the left arm, right away his left arm was very painful and the pain traveled to the right arm, back and neck. Then the patient started having headaches. At the time of this report, the patient was still experiencing right arm pain, spasms, painful joints in his fingers, arm numbness and decreased sensation. The patient was evaluated by his family physician and a pediatric neurologist who will be following the patient. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Laboratory test abnormal, Muscle spasms, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Initial report received on 09 November 2008 from the consumers parent. An 11-year-old male patient, with no concurrent illnesses and unknown past medical history, had received an intramuscular injection of ADACEL, lot number C3003 (other lot number UF452CA); and an intramuscular injection of MENACTRA (Lot number U2734AA) on 17 October 2008. The routes and sites of administration were not provided. At an unspecified amount of time later, the patient began having symptoms of severe headache, severe back pain/soreness (including low back pain), and his back was stiff with numbness and spasms. The patient was evaluated by his physician ten days later, and at that time, the back pain had improved somewhat, and the patient was additionally experiencing muscular tenderness, left arm pain, neck pain, and continued head pain. He also had chills, however he was afebrile. Diagnostic tests performed revealed the patient was positive for Lupus. Date, name, type and results of diagnostic tests were not provided. It was not reported whether the patient had received any corrective treatments. At the time of this report, the patient had not recovered. Follow-up information received on 17 November 2008 from the Centers for Disease Control and Prevention (CDC). The VAERS number was provided by the CDC as 332355. No other relevant medically significant information was provided. Follow-up information received on 25 November 2008 from the patient's parent. Per the parent, after the patient received the vaccinations with ADACEL and MENACTRA in the left arm, right away his left arm was very painful and the pain traveled to the right arm, back and neck. Then the patient started having headaches. At the time of this report, the patient was still experiencing right arm pain, spasms, painful joints in his fingers, arm numbness and decreased sensation. The patient was evaluated by his family physician and a pediatric neurologist who will be following the patient. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity, Paraesthesia, Systemic lupus erythematosus
Clinical narrative: Initial report received on 09 November 2008 from the consumers parent. An 11-year-old male patient, with no concurrent illnesses and unknown past medical history, had received an intramuscular injection of ADACEL, lot number C3003 (other lot number UF452CA); and an intramuscular injection of MENACTRA (Lot number U2734AA) on 17 October 2008. The routes and sites of administration were not provided. At an unspecified amount of time later, the patient began having symptoms of severe headache, severe back pain/soreness (including low back pain), and his back was stiff with numbness and spasms. The patient was evaluated by his physician ten days later, and at that time, the back pain had improved somewhat, and the patient was additionally experiencing muscular tenderness, left arm pain, neck pain, and continued head pain. He also had chills, however he was afebrile. Diagnostic tests performed revealed the patient was positive for Lupus. Date, name, type and results of diagnostic tests were not provided. It was not reported whether the patient had received any corrective treatments. At the time of this report, the patient had not recovered. Follow-up information received on 17 November 2008 from the Centers for Disease Control and Prevention (CDC). The VAERS number was provided by the CDC as 332355. No other relevant medically significant information was provided. Follow-up information received on 25 November 2008 from the patient's parent. Per the parent, after the patient received the vaccinations with ADACEL and MENACTRA in the left arm, right away his left arm was very painful and the pain traveled to the right arm, back and neck. Then the patient started having headaches. At the time of this report, the patient was still experiencing right arm pain, spasms, painful joints in his fingers, arm numbness and decreased sensation. The patient was evaluated by his family physician and a pediatric neurologist who will be following the patient. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Nausea, Pregnancy test positive, Pyrexia
Clinical narrative: Initial report was received 12 December 2008 from a health care professional.  A 14-year-old female pregnant patient had received a left deltoid injection of MENACTRA, lot number U2683AA, and an injection of GARDASIL (manufacturer Merck), lot number 0381X, and an injection of BOOSTRIX (manufacturer GlaxoSmithKline), lot number AC52B030AA, and FLUMIST (manufacturer MedImmune), lot number 550552P on 05 December 2008 and five days later, she complained of fever 102 degrees Fahrenheit, nausea, vomiting and a stomach ache.  The patient had her last menstrual period on 05 November 2008 and the duration of her pregnancy was reported as approximately eight weeks.  Her medical history, concomitant medication usage and past obstetric history were unknown.  At the time of the report, the patient's recovery status was unknown.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3
Symptoms: Vomiting
Clinical narrative: Initial report was received 12 December 2008 from a health care professional.  A 14-year-old female pregnant patient had received a left deltoid injection of MENACTRA, lot number U2683AA, and an injection of GARDASIL (manufacturer Merck), lot number 0381X, and an injection of BOOSTRIX (manufacturer GlaxoSmithKline), lot number AC52B030AA, and FLUMIST (manufacturer MedImmune), lot number 550552P on 05 December 2008 and five days later, she complained of fever 102 degrees Fahrenheit, nausea, vomiting and a stomach ache.  The patient had her last menstrual period on 05 November 2008 and the duration of her pregnancy was reported as approximately eight weeks.  Her medical history, concomitant medication usage and past obstetric history were unknown.  At the time of the report, the patient's recovery status was unknown.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Pregnancy test positive, Pyrexia
Clinical narrative: Initial report was received 12 December 2008 from a health care professional.  A 14-year-old female pregnant patient had received a left deltoid injection of MENACTRA, lot number U2683AA, and an injection of GARDASIL (manufacturer Merck), lot number 0381X, and an injection of BOOSTRIX (manufacturer GlaxoSmithKline), lot number AC52B030AA, and FLUMIST (manufacturer MedImmune), lot number 550552P on 05 December 2008 and five days later, she complained of fever 102 degrees Fahrenheit, nausea, vomiting and a stomach ache.  The patient had her last menstrual period on 05 November 2008 and the duration of her pregnancy was reported as approximately eight weeks.  Her medical history, concomitant medication usage and past obstetric history were unknown.  At the time of the report, the patient's recovery status was unknown.
Sex: M
Vaccine: MNQ
Symptoms: CSF culture positive, Meningitis meningococcal, Meningococcal infection, Serology test, Vaccination failure
Clinical narrative: Information was initially provided from the Centers for Disease Control which concerned a total of 13 cases of MENACTRA vaccine failure from January 2005 to September 2008. No individual case information or patient identifiers were provided. This information was entered into case reference number 2008-04011. It was determined that five of these cases came from the VAERS databases and had previously been entered in the Sanofi Pasteur Pharmacovigilance database (Sanofi Pasteur case reference numbers 2007-03425, 2007-03383, 2008-00038, 2008-00531, and 2008-02355. On 05 January 2009, additional information was provided for seven patients. This information included specific patient identifiers. The information for these case is contained in cases 2009-00012, 2009-00013, 2009-00014, 2009-00015, 2009-00016, 2009-00017, and 2009-00018. This serious report was received from the Centers for Disease Control and Prevention on 05 January 2009, under VAERS number 335759. A male patient, born in 1987 and with no reported medical history, received an injection of MENACTRA (lot number U1769AA) on 08 March 2006. The patient developed meningococcal disease confirmed by culture on 18 May 2007. Cerebrospinal fluid (CSF) Culture on 18 May 2007 was positive for Neisseria meningitides serogroup Y. The patient was hospitalized five days and recovered. (recovery date not provided). Documents held by sender: None.
Sex: F
Vaccine: MNQ
Symptoms: Blood culture positive, Meningitis meningococcal, Meningococcal infection, Serology test, Vaccination failure
Clinical narrative: Information was initially provided from the Centers for Disease Control (CDC) which concerned a total of 13 cases of MENACTRA vaccine failure from January 2005 to September 2008. No individual case information or patient identifiers were provided. This information was entered into case reference number 2008-04011. It was determined that five of these cases came from the VAERS database and had previously been entered in the sanofi pasteur pharmacovigilance database (sanofi pasteur case reference numbers 2007-03425, 2007-03383, 2008-00038, 2008-00531, and 2008-02355. On 05 January 2009, additional information was provided for seven patients. This information included specific patient identifiers. The information for these case is contained in cases 2009-00012, 2009-00013, 2009-00014, 2009-00015, 2009-00016, 2009-00017, 2009-00018. This serious report was received from the Centers for Disease Control and Prevention (CDC) on 05 January 2009, under VAERS number 335761. A female patient, born in 1988 and with no reported medical history, received an injection of MENACTRA (lot number U1822AA) on 31 May 2006. The patient developed meningococcal disease on 28 April 2008 (culture confirmed). Blood culture was positive for Neisseria meningitides serogroup C. The patient was hospitalized for two days, and subsequently recovered. Documents held by sender: None.
Sex: F
Vaccine: MNQ
Symptoms: CSF culture positive, Meningitis meningococcal, Meningococcal infection
Clinical narrative: Information was initially provided from the Centers for Disease Control (CDC) which concerned a total of 13 cases of MENACTRA vaccine failure from January 2005 to September 2008. No individual case information or patient identifiers were provided. This information was entered into case reference number 2008-04011. It was determined that five of these cases came from the VAERS database and had previously been entered in the Sanofi Pasteur pharmacovigilance database (sanofi Pasteur case reference numbers 2007-03425, 2007-03383, 2008-00038, 2008-00531, and 2008-02355. On 05 January 2009, additional information was provided for seven patients. This information included specific patient identifiers. The information for these case is contained in cases 2009-00012, 2009-00013, 2009-00014, 2009-00015, 2009-00016, 2009-00017 and 2009-00018. This serious report was received from the Centers for Disease Control and Prevention (CDC) on 05 January 2009, under VAERS number 335763. A female patient received an injection of MENACTRA (lot number U1572AC) on 06 July 2005. On 22 April 2008 cultures confirmed meningococcal disease. CSF (cerebrospinal fluid) culture was positive for Neisseria meningitidis serogroup C. The patient was hospitalized for 14 days. The patient recovered from the event. List of Documents held by Sender: None.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: CSF culture positive, Meningitis meningococcal, Meningococcal infection
Clinical narrative: Information was initially provided from the Centers for Disease Control (CDC) which concerned a total of 13 cases of MENACTRA vaccine failure from January 2005 to September 2008. No individual case information or patient identifiers were provided. This information was entered into case reference number 2008-04011. It was determined that five of these cases came from the VAERS database and had previously been entered in the sanofi Pasteur Pharmacovigilance database (sanofi pasteur case reference numbers 2007-03425, 2007-03383, 2008-00038, 2008-00531, and 2008-02355. On 05 January 2009, additional information was provided for seven patients. This information included specific patient identifiers. The information for these case is contained in cases 2009-00012, 2009-00013, 2009-00014, 2009-00015, 2009-00016, 2009-00017 and 2009-00018. This serious report was received from the Centers for Disease Control and Prevention (CDC) on 05 January 2009, under VAERS number 336208. A female patient, born in 1989 and whose medical history was not provided, received an injection of MENACTRA (lot number not provided) on 04 April 2006. The route and site of administration for the MENACTRA vaccine was unknown. The patient developed meningococcal disease confirmed by culture on 05 February 2007. Cerebrospinal Fluid (CSF) Culture on 05 February 2007 was positive for Neisseria meningitidis serogroup Y. The patient was hospitalized seven days and recovered (recovery date not provided). Documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient "in her 80's" who "over a year ago" was vaccinated with "single dose" of ZOSTAVAX (Oka/Merck) (lot # not available). The patient developed a terrible case of shingles recently and was hospitalized. The patient had sought medical attention from physician. As of 05-MAR-2008 the patient's terrible case of shingles persisted. The physician considered the patient's terrible case of shingles to be disabling. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection, Serology test
Clinical narrative: Information has been received from a physician concerning a 22 week male who on 15-DEC-2007 (lot number 657673/0904U), 14-MAR-2008 (659917/0017X) and 27-MAY-2008 (660596/0211X) was vaccinated with the first, second and third dose of ROTATEQ 2ml oral respectively. Subsequently the patient developed rotavirus infection. The patient was hospitalized because of this infection on 18-FEB-2009 and was discharged on 20-FEB-2009. Serologic test of the stool was performed with no result reported. The patient was recovering at the time of reporting. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Autism, Frustration
Clinical narrative: Information has been received from a consumer who saw via video clip online last month concerning a male "little kid" who was vaccinated with MMR II.  Subsequently the patient could not speak and was frustrated.  The parents of the patient stated that their child was vaccinated with MMR II and then developed autism.  The patient had sought unspecified medical attention.  The patient's can not speak persisted.  The patient's autism and aphasia persisted.  Attempts are being made to verify the existence of an identifiable patient.  Upon internal review aphasia and autism were considered to be other important medical events.  No further information is available.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Epilepsy
Clinical narrative: Information has been received from a consumer concerning her 3 year old son with allergies to certain epilepsy medication (unspecified which ones) who was vaccinated with the 2nd dose of MMR II on an unspecified date.  He received his 1st dose of MMR II in a foreign country.  Concomitant therapy included some unspecified medications.  Subsequently, after the 2nd dose, the patient started having epileptic episodes.  The now 10 year old patient was currently on a surgery list for epilepsy.  He did not recover at the time of reporting.  The patient sought unspecified medical attention.  Upon internal review, epileptic episodes was determined to be an other important medical event.  This is one of several reports received from the same source.  No further information is available.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received 4th dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced cellulitis and was hospitalized. The reporter believes that there might be a quality assurance problem that caused the adverse event. This was considered to be a product complaint. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The representative was not sure if the INFANRIX was in prefilled syringes or vials. Linked cases include A0772419A and A0772420A.
Sex: U
Vaccine: PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a consumer regarding a patient who developed autism. The patient received a dose on an unspecified date. It was reported that the patient, a child, is autistic. The outcome was not specified. No additional information was available at the time of this report.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Cervicobrachial syndrome, Electromyogram normal, Immediate post-injection reaction, Joint range of motion decreased, Nerve conduction studies normal
Clinical narrative: Initial information was received on 26 November 2008 from a health care professional in the USA. A 55 year old female patient received a right arm injection of FLUZONE (lot number and route of administration not reported). The date of vaccination was not provided. The patient called the doctor's office to report "tingling in and down her right arm" since FLUZONE was administered three weeks prior. The patient's recovery status was unknown at the time of the report. No further information is provided. Follow up information was received on 22 December 2008 from a health care professional. On 06 November 2008 the patient received FLUZONE (lot number U2754AA). Immediately following the vaccination the patient experienced tingling down her arm. On 11 December 2008 the patient went to the neurologist who ordered a cervical MRI (Magnetic resonance imaging), EMG/NCV (Electromyography/Nerve Conduction Velocity). The results were not provided. The neurologist believed it was "an uncertain relationship to the "FLUZONE". No further information was provided. Follow up information was received on 20 January 2009 from a health care professional. The reporter did not have any updates at the time. Follow-up information received on 27 February 2009 from a physician. The patient had undergone outpatient MRI scan of the cervical spine and EMG/NCV analysis since her last neurology visit on 11 December 2008. The Cervical MRI scan revealed significant foraminal disease at C5-6, and the EMG/NCV analysis was normal. The patient was re-evaluated by neurology on 14 January 2009. She had previously received treatment with Naprosyn (start date not provided) and had some relief from her pain. A comprehensive neurological examination was performed that day that revealed reduced cervical lateral range of motion and normal shoulder shrug, strength and tone. There was reduction of sensation in the right C6, but reflexes were symmetrical in all four extremities with flexor plantar responses; and the patient had no cortical release abnormalities. The patient's coordination was intact in the upper and lower extremities with normal mobility in the back. The back had no tenderness and the patient had a negative bilateral straight leg raise (SLR) test. The patient was diagnosed with right cervical radiculopathy secondary to spondylitic disease and was started on a short course of Prednisone 40mg for seven days, then 20mg for five days. After that, she was to resume Naprosyn and return in four weeks for follow-up consideration. Per this new information, this case was upgraded to serious. List of Documents held by Sender: None.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Paraesthesia, Sensory disturbance, Spinal osteoarthritis
Clinical narrative: Initial information was received on 26 November 2008 from a health care professional in the USA. A 55 year old female patient received a right arm injection of FLUZONE (lot number and route of administration not reported). The date of vaccination was not provided. The patient called the doctor's office to report "tingling in and down her right arm" since FLUZONE was administered three weeks prior. The patient's recovery status was unknown at the time of the report. No further information is provided. Follow up information was received on 22 December 2008 from a health care professional. On 06 November 2008 the patient received FLUZONE (lot number U2754AA). Immediately following the vaccination the patient experienced tingling down her arm. On 11 December 2008 the patient went to the neurologist who ordered a cervical MRI (Magnetic resonance imaging), EMG/NCV (Electromyography/Nerve Conduction Velocity). The results were not provided. The neurologist believed it was "an uncertain relationship to the "FLUZONE". No further information was provided. Follow up information was received on 20 January 2009 from a health care professional. The reporter did not have any updates at the time. Follow-up information received on 27 February 2009 from a physician. The patient had undergone outpatient MRI scan of the cervical spine and EMG/NCV analysis since her last neurology visit on 11 December 2008. The Cervical MRI scan revealed significant foraminal disease at C5-6, and the EMG/NCV analysis was normal. The patient was re-evaluated by neurology on 14 January 2009. She had previously received treatment with Naprosyn (start date not provided) and had some relief from her pain. A comprehensive neurological examination was performed that day that revealed reduced cervical lateral range of motion and normal shoulder shrug, strength and tone. There was reduction of sensation in the right C6, but reflexes were symmetrical in all four extremities with flexor plantar responses; and the patient had no cortical release abnormalities. The patient's coordination was intact in the upper and lower extremities with normal mobility in the back. The back had no tenderness and the patient had a negative bilateral straight leg raise (SLR) test. The patient was diagnosed with right cervical radiculopathy secondary to spondylitic disease and was started on a short course of Prednisone 40mg for seven days, then 20mg for five days. After that, she was to resume Naprosyn and return in four weeks for follow-up consideration. Per this new information, this case was upgraded to serious. List of Documents held by Sender: None.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TD, FLUX, HEP, PPV, TD, TYP
Symptoms: Nuclear magnetic resonance imaging, Unevaluable event
Clinical narrative: I was told by the hospital that I had no recourse, I worked as a nurse for 1 yr before all of this, volunteered as an instructor.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TD, FLUX, HEP, PPV, TD, TYP
Symptoms: Activities of daily living impaired, Arthropathy, Balance disorder, Body temperature increased, Decreased appetite
Clinical narrative: I was told by the hospital that I had no recourse, I worked as a nurse for 1 yr before all of this, volunteered as an instructor.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TD, FLUX, HEP, PPV, TD, TYP
Symptoms: Fall, Feeling hot, Gait disturbance, Memory impairment, Panic reaction
Clinical narrative: I was told by the hospital that I had no recourse, I worked as a nurse for 1 yr before all of this, volunteered as an instructor.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TD, FLUX, HEP, PPV, TD, TYP
Symptoms: Pyrexia, Sluggishness, Spinal column stenosis, Surgery
Clinical narrative: I was told by the hospital that I had no recourse, I worked as a nurse for 1 yr before all of this, volunteered as an instructor.
Age: 53.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling to injection site, no redness or discharge noted.
Age: 53.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Burning sensation, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Swelling to injection site, no redness or discharge noted.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Pt. reported: Had L) upper arm swelling starting 3/8, swollen lymph node under L) arm 3/9, Flu like sx chills, HA, neck ache 3/10, Inj site red, swollen warm 3/10. Confirmed at office: 2" Red/swollen @ inj. site 3-10-09 rx'd KEFLEX 500mg TID X 7d, warm compresses, TYLENOL.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Lymphadenopathy, Neck pain
Clinical narrative: Pt. reported: Had L) upper arm swelling starting 3/8, swollen lymph node under L) arm 3/9, Flu like sx chills, HA, neck ache 3/10, Inj site red, swollen warm 3/10. Confirmed at office: 2" Red/swollen @ inj. site 3-10-09 rx'd KEFLEX 500mg TID X 7d, warm compresses, TYLENOL.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash erythematous, Skin warm, Swelling
Clinical narrative: Left SQ red area size of 1/2 dollar - vaccine give 2/26/09 - and 2/28/09 area turned red and hot to the touch and swollen. Cheeks had a red rash with warm to the touch on 3/3/09. All symptoms subsided 3/9/09.
Age: 25.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, TYP, FLUN3, HEPA, SMALL, TYP
Symptoms: Full blood count, Haematocrit normal, Haemoglobin normal, Leukopenia, Platelet count normal
Clinical narrative: 26 y/o male ADMS is referred to the FBVHC from WAMC Allergy department for persistent leucopenia since receipt of multiple vaccines. 3/18/09-records received-office visite 3/9/09- C/O tendonitis, plantar warts, carbuncle on plantar surface. Leukopenia after participation in VHC smallpox study in 1/09. No complaints.
Age: 25.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, TYP, FLUN3, HEPA, SMALL, TYP
Symptoms: White blood cell count decreased
Clinical narrative: 26 y/o male ADMS is referred to the FBVHC from WAMC Allergy department for persistent leucopenia since receipt of multiple vaccines. 3/18/09-records received-office visite 3/9/09- C/O tendonitis, plantar warts, carbuncle on plantar surface. Leukopenia after participation in VHC smallpox study in 1/09. No complaints.
Age: 25.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, TYP, FLUN3, HEPA, SMALL, TYP
Symptoms: Carbuncle, Haemoglobin normal, Leukopenia, Lymphocyte count increased, Neutrophil count decreased
Clinical narrative: 26 y/o male ADMS is referred to the FBVHC from WAMC Allergy department for persistent leucopenia since receipt of multiple vaccines. 3/18/09-records received-office visite 3/9/09- C/O tendonitis, plantar warts, carbuncle on plantar surface. Leukopenia after participation in VHC smallpox study in 1/09. No complaints.
Age: 25.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, TYP, FLUN3, HEPA, SMALL, TYP
Symptoms: Platelet count decreased, Skin papilloma, Tendonitis, White blood cell count decreased
Clinical narrative: 26 y/o male ADMS is referred to the FBVHC from WAMC Allergy department for persistent leucopenia since receipt of multiple vaccines. 3/18/09-records received-office visite 3/9/09- C/O tendonitis, plantar warts, carbuncle on plantar surface. Leukopenia after participation in VHC smallpox study in 1/09. No complaints.
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Drooling, Flushing, Rash, Retching
Clinical narrative: About 10 minutes after vaccines administered, patient became flushed in face with some rash, drooling, runny nose, gagging, and coughing. Sent to ER.
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: About 10 minutes after vaccines administered, patient became flushed in face with some rash, drooling, runny nose, gagging, and coughing. Sent to ER.
Age: 1.1
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Cough, Influenza serology negative, Pruritus, Pyrexia, Rash pustular
Clinical narrative: Came in 3-9-09 with 101-102 degree fever for 5 days previous r. nose cough & 15 "spots" on torso. Mother called 3-10-09 to report at least 100 more "spots" that itch - no fluid in pustules. DX: Atypical Chicken Pox
Age: 1.1
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rhinorrhoea, Streptococcal identification test negative, Urticaria, Varicella
Clinical narrative: Came in 3-9-09 with 101-102 degree fever for 5 days previous r. nose cough & 15 "spots" on torso. Mother called 3-10-09 to report at least 100 more "spots" that itch - no fluid in pustules. DX: Atypical Chicken Pox
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Erythema, Full blood count, Laboratory test normal, Mononucleosis heterophile test
Clinical narrative: Given HPV & MENACTRA @ 08:30 AM Fever Pm - abd pain & facial hives - given BENADRYL - went ER @ 6 PM. Given IV steroids & BENADRYL - Home with ORAPRED & BENADRYL - face red & sore throat next AM 24 hr later.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Oropharyngeal pain, Streptococcal identification test negative, Urticaria
Clinical narrative: Given HPV & MENACTRA @ 08:30 AM Fever Pm - abd pain & facial hives - given BENADRYL - went ER @ 6 PM. Given IV steroids & BENADRYL - Home with ORAPRED & BENADRYL - face red & sore throat next AM 24 hr later.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Decreased appetite, Lethargy
Clinical narrative: Lethargy, poor feeding for 7-10 days after vaccine, no fever, no seizures.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Site of injection started to ache 3/5/09 pm. Unable to raise arm and fever. Recd. 1. Ibuprofen 600mg q 6-8 hours with food PRN discomfort 2. BENADRYL to reduce swelling.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Vaccine administered 3-3-09, on 3-4-09 Pt experienced redness and pain around the injection. Denies itching, or fever. Redness is about size of 50 cent piece.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: After administering Tdap vaccine the patient fainted. TR, BP, WNL. Water given. Was all better <1 minute.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 10 x 8cm area of erythema/tenderness (L) deltoid area (-) fever. Located above the area the injections were given.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Rash
Clinical narrative: Rash and cellulitis secondary to immunization injection given 11/24/2009. Seen in clinic 12/8/08 placed on DURICEF 500mg BID x 10 days.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Excessive (inconsolable) crying over 3 hours in next 24 hrs with fever to 103.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Vasovagal syncope- twice, oral fluids, juice remain supine Trendelenberg.  She was treated in our facility.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site urticaria, Paraesthesia oral
Clinical narrative: Immediate itching/hiving @ site & lip tingling.  No other symptoms BENADRYL by mouth given + sent to ER for further obs -> no further Rx needed.  Sent home after 4 hours.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Cold sweat, Feeling hot, Flushing, Hyperhidrosis, Throat tightness
Clinical narrative: Felt hot and sweaty about 30 min after receiving vaccine stated "I feel- not like I can't swallow but my throat feels tight- like when I take MORPHINE at the hospital"  Patient skin was clammy face flushed- BP 133/70 P 89-89 R 16-18, PO2 98% T.  98.5 oral-  Seen by in-house MD- BENADRYL 125 mg by mouth ordered & given.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever high of 104 degree F vomiting X 1.
Age: 1.3
Sex: F
Vaccine: DTAP, PNC
Symptoms: Body temperature increased, Rash
Clinical narrative: Received Dtap + PREVNAR on 2-5-09 @ 16:30.  300/am 2-6-09 reported temp 104.7 continued running temp with no other symptoms for 3 days.  Day 4 developed a rash.
Age: 0.23
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Emotional distress, Screaming
Clinical narrative: High pitched scream, inconsolable for 3 days after vaccine administration per mother's report.
Age: 37.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever and chills started about 9 hours after vax admin. 3-3-09 was given TWINRIX and ADACEL. Still feverish 24 hours later but feels better. (R) arm is sore, sl. swollen and dime size red area around injection site of ADACEL. Has MD appt 3-5-09 @ 10:00am.
Age: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Blood test, Computerised tomogram, Dizziness, Headache
Clinical narrative: 2/23/09- Dizziness, body aches, fever, headache. 2/24/09- Headache, nausea, body aches. 2/25/09- Dizziness, neck and back pain, body aches, fever. 2/25/09 Seen at emergency room.
Age: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Neck pain, Pain, Pyrexia, Urine analysis
Clinical narrative: 2/23/09- Dizziness, body aches, fever, headache. 2/24/09- Headache, nausea, body aches. 2/25/09- Dizziness, neck and back pain, body aches, fever. 2/25/09 Seen at emergency room.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Varicella
Clinical narrative: Developed VARICELLA lesions 9 days after receiving VARIVAX.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Rash on arms and torso consistent with mild VARICELLA vaccine on 3/2/09, onset of rash 3/7/09.  No other symptoms.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: Rush on checks, forearms, hands similar to varicella but also with papulovesicular lump character. Vaccine given 3/02/09, onset 3/7/09. No other systemic symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Patient thought she had shingles, no visible outside rash, had pain all over her body. Contacted MD for pain medicine.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting onset 3 hrs after vaccine lasted 8hrs.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Pain, Pyrexia
Clinical narrative: Received TDAP 3/6/09. Within 1-2 days developed fever of 102, body aches tender arm & hard bump the size of a coin where injection given.
Age: 13.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received a 3rd dose of varicella vaccine in error.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Small red rash around injection site, approximately 24 hour post injection. No itching/pain. Normal side effect.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site induration
Clinical narrative: 8X11 cm induration at site of KINRIX 36 hours following administration. No systemic symptoms. Resolved spontaneously.
Age: 0.4
Sex: M
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: On 3/2 pneumonia vaccine was given in left arm. Pt on Tuesday 3/3 am, hurt on Tuesday pm, the arm swollen and red, warm to touch and was feverish on Tuesday night this am pulse at 92 just sitting. MD March 5, 2009 11:05 AM. The patient is here today for redness in the arm in which she received her pneumococcal vaccine 3 days ago. The patient received a vaccination on Monday and by Tuesday afternoon she started noticing some soreness then she noticed redness that has increased. Patient has not noticed any purulent drainage, she's felt warm but has not had any measurable temperature.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Employee complains of dizziness approximately 15 minutes after receiving injections per employee report she got dizzy after smoking cigarette. Temp 97.7 resolved about 10:30 am.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Swelling
Clinical narrative: Mother reports evening 3/05/09 Pt developed swelling and redness at L thigh.