chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Pyrexia, Rash macular, Streptococcal identification test
Clinical narrative: Extensive macular rash started 2 days after vaccine was given & a fever of ? degree was reported by his mother. He had no fever when seen 6/19/09.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC
Symptoms: Hypokinesia, Myelitis transverse, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging abnormal
Clinical narrative: progressive decreased motor skills LE >> VE Dxd - " transverse myelitis".  7/2/09 Hospital records received DOS 5/29/09 to 6/2/09. Assessment: Transverse myelitis, constipation, mild anemia, left empty scrotum or cryptorchism. Patient presented with bilateral lower extremity weakness. More fussy than usual, waking up during the night, not rolling over, fell over from sitting position, will not bear weight and 'crumble' to the ground. No movement lower extremities. PO intake decreased. 4-5 wet diapers. 1 small hard bowel movement last 24 hours. Patellar and Achilles reflexes 3+/5 bilaterally. Ankle clonus. Limited hand extension and weaker pincer on right. Truncal weakness. 7/22/09-ICD-9 code 341.20
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Pyrexia
Clinical narrative: One day after administration of vaccine, patient developed erythema, pain, vesicle at site of innoculation/fever of 102 degrees approximately 48 hrs after admin required treatment with antibiotics.
Age: 63.0
Sex: M
Vaccine: HEPA
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: Evening of injection: Chills, Nausea, Diarrhea & fatigue. 2nd day vomiting & fatigue persists.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site rash
Clinical narrative: Red papular rash at injection site - (R) SQ-thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Developed AM of 6/25/09 L upper arm redness, induration, swelling, and increase warmth. Suspect cellulitis. Tx with KEFLEX 250/5ml one tsp TID x 10 D with recheck 24 hours.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Chills, Condition aggravated, Diarrhoea, Fatigue
Clinical narrative: Migraine. Migraine with loss of central vision. Felt sickly. Diarrhea. Slight headache. Fatigue. Chills. Aches. Report received from a consumer on 05-Nov-2008. An adult female patient (initials: SW; DOB: unknown) received FLURIA (CSL influenza vaccine) on 29-Oct-2008 at 8:00 am. At 4:00 pm on 29 Oct-2008, the patient had a migraine with loss of vision (patient could not see clearly out of both eyes). For the next day and a half, she felt sickly and had diarrhea. She saw her family physician on 29-Oct-2008 and her blood pressure was fine and had no droopy eye. No treatment was given but physician may prescribe IMITREX. On 03-Nov-2008, the patient saw an eye specialist and everything was fine; no detached retinal. Patient complained of a slight headache on 05-Nov-2008, but feels much better. A brain MRI is scheduled for 06-Nov-2008. Patient has had 1/2 dozen migraines in her life. She has received flu shots in the past with no problems. ASSESSMENT: No serious criteria mentioned. The company considered events as possibly related to the suspect drug. Follow-up information received on 11-Nov-2008 from the consumer. A 59 year old non-pregnant female received AFLURIA, lot 02549111A, IM arm on 29-Oct-2008 at 8:00 am. At the time of vaccination, she had no illness. Patient does have a history of hypothyroidism and osteoarthritis. Concomitant medications include SYNTHROID, MOBIC, PREMPRO, doses unspecified. On 29-Oct-2008 at 4:00 pm, patient reported that she had a migraine headache, loss of central vision, fatigue, aches, and chills. Patient had an MRI of brain and orbital sockets, and a complete blood count (CBC) and ferritin level was obtained. Blood work was done on 10-Nov-2008; results not yet received. She is being tested for anemia. If anything is not right with her blood work, she will report back to us. Patient stated that she recovered by 04-Nov-2008 from all reactions. No further information is expected. No change in assessment. Information derived from this AE report does not change the current safety profile of AFLURIA (CSL influenza vaccine).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Headache, Malaise, Migraine, Nuclear magnetic resonance imaging brain
Clinical narrative: Migraine. Migraine with loss of central vision. Felt sickly. Diarrhea. Slight headache. Fatigue. Chills. Aches. Report received from a consumer on 05-Nov-2008. An adult female patient (initials: SW; DOB: unknown) received FLURIA (CSL influenza vaccine) on 29-Oct-2008 at 8:00 am. At 4:00 pm on 29 Oct-2008, the patient had a migraine with loss of vision (patient could not see clearly out of both eyes). For the next day and a half, she felt sickly and had diarrhea. She saw her family physician on 29-Oct-2008 and her blood pressure was fine and had no droopy eye. No treatment was given but physician may prescribe IMITREX. On 03-Nov-2008, the patient saw an eye specialist and everything was fine; no detached retinal. Patient complained of a slight headache on 05-Nov-2008, but feels much better. A brain MRI is scheduled for 06-Nov-2008. Patient has had 1/2 dozen migraines in her life. She has received flu shots in the past with no problems. ASSESSMENT: No serious criteria mentioned. The company considered events as possibly related to the suspect drug. Follow-up information received on 11-Nov-2008 from the consumer. A 59 year old non-pregnant female received AFLURIA, lot 02549111A, IM arm on 29-Oct-2008 at 8:00 am. At the time of vaccination, she had no illness. Patient does have a history of hypothyroidism and osteoarthritis. Concomitant medications include SYNTHROID, MOBIC, PREMPRO, doses unspecified. On 29-Oct-2008 at 4:00 pm, patient reported that she had a migraine headache, loss of central vision, fatigue, aches, and chills. Patient had an MRI of brain and orbital sockets, and a complete blood count (CBC) and ferritin level was obtained. Blood work was done on 10-Nov-2008; results not yet received. She is being tested for anemia. If anything is not right with her blood work, she will report back to us. Patient stated that she recovered by 04-Nov-2008 from all reactions. No further information is expected. No change in assessment. Information derived from this AE report does not change the current safety profile of AFLURIA (CSL influenza vaccine).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Migraine. Migraine with loss of central vision. Felt sickly. Diarrhea. Slight headache. Fatigue. Chills. Aches. Report received from a consumer on 05-Nov-2008. An adult female patient (initials: SW; DOB: unknown) received FLURIA (CSL influenza vaccine) on 29-Oct-2008 at 8:00 am. At 4:00 pm on 29 Oct-2008, the patient had a migraine with loss of vision (patient could not see clearly out of both eyes). For the next day and a half, she felt sickly and had diarrhea. She saw her family physician on 29-Oct-2008 and her blood pressure was fine and had no droopy eye. No treatment was given but physician may prescribe IMITREX. On 03-Nov-2008, the patient saw an eye specialist and everything was fine; no detached retinal. Patient complained of a slight headache on 05-Nov-2008, but feels much better. A brain MRI is scheduled for 06-Nov-2008. Patient has had 1/2 dozen migraines in her life. She has received flu shots in the past with no problems. ASSESSMENT: No serious criteria mentioned. The company considered events as possibly related to the suspect drug. Follow-up information received on 11-Nov-2008 from the consumer. A 59 year old non-pregnant female received AFLURIA, lot 02549111A, IM arm on 29-Oct-2008 at 8:00 am. At the time of vaccination, she had no illness. Patient does have a history of hypothyroidism and osteoarthritis. Concomitant medications include SYNTHROID, MOBIC, PREMPRO, doses unspecified. On 29-Oct-2008 at 4:00 pm, patient reported that she had a migraine headache, loss of central vision, fatigue, aches, and chills. Patient had an MRI of brain and orbital sockets, and a complete blood count (CBC) and ferritin level was obtained. Blood work was done on 10-Nov-2008; results not yet received. She is being tested for anemia. If anything is not right with her blood work, she will report back to us. Patient stated that she recovered by 04-Nov-2008 from all reactions. No further information is expected. No change in assessment. Information derived from this AE report does not change the current safety profile of AFLURIA (CSL influenza vaccine).
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: No reaction on previous exposure to drug, Pruritus generalised, Urticaria
Clinical narrative: Report received from a nurse on 03-11-2008.  An 80 year-old male patient received AFLURIA 0.5 ml pre-filled syringe on 14-Oct-2008.  Concomitant medications include Prilosec (omeprazole), which the patient has been taking for many years.  The patient has no known allergies;  no allergies to eggs.  He has had a flu shot every year for the last 15 years with no reactions.  On 21-Oct-2008, seven days after vaccination, the patient experienced hives which were itchy all over his body.  The patient went to the clinic on 23-Oct-2008 and was given a Decadron (dexamethasone) shot.  This helped but the patient reports 30% of the hives remained a few days after the Decadron shot.  The nurse states that 10 days later (31-Oct-2008), the patient still had some hives.  At the time of reporting (03-Nov-2008), the nurse was not sure how the patient was doing.  Awaiting further information.
Sex: U
Vaccine: FLU3
Symptoms: Chest discomfort, Influenza like illness, Malaise, Myalgia, Nasal congestion
Clinical narrative: Report received from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four (4) patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise). One (1) out of the four (4) experienced chest congestion (see case 200914610). All four (4) patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three (3) days later (01-Nov-2008). As of 05-Nov-2008, all symptoms are milder for all patients. No patient went to the emergency room. (See cases 200914608, 200914609, and 200914610). Several attempts have been made to the reporter to confirm and verify the number of patients involved. To date, reporter has not provided a response. Patient outcome is unknown. No further information is expected. The manufacturer considered causality possible in relation to the administration of AFLURIA. Information derived from this ADR report does not change the current safety profile of the product.
Sex: U
Vaccine: FLU3
Symptoms: Chest discomfort, Influenza like illness, Malaise, Myalgia, Nasal congestion
Clinical narrative: Report received from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise). One out of the four experienced chest congestion (see case 200914610). All four patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three days later (01-Nov-2008). As of 05-Nov-2008, all symptoms are milder for all patients. No patients went to the emergency room. (See cases 200914591, 200914609, and 200914610). Several attempts have been made to the reporter to confirm and verify the number of patients involved. To date, reporter has not provided a response. Patient outcome is unknown. No further information is expected. The manufacturer considered causality as possible in relation to the administration of AFLURIA. Information derived from this ADR report does not change the current safety profile of the product.
Sex: U
Vaccine: FLU3
Symptoms: Chest discomfort, Influenza like illness, Malaise, Myalgia, Nasal congestion
Clinical narrative: Report received from a paramedic/fire fighter on 05-Nov-2008.  Reporter stated that four (4) patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise).  One (1) out of the four (4) experienced chest congestion (200914610).  All four (4) patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three (3) days later (01-Nov-2008).  As of 05-Nov-2008, all symptoms are milder for all patients.  No patients went to the emergency room.  (See cases 200914591, 200914608, and 200914610).  Several attempts have been made to the reporter to confirm and verify the number of patients involved.  To date, reporter has not provided a response.  Patient outcome is unknown.  No further information is expected.  The manufacturer considered causality possible in relation to the administration of AFLURIA.  Information derived from this ADR report does not change the current safety profile of the product.
Sex: U
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Report received from a paramedic/fire fighter on 05-Nov-2008.  Reporter stated that four (4) patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise).  One (1) out of the four (4) experienced chest congestion (200914610).  All four (4) patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three (3) days later (01-Nov-2008).  As of 05-Nov-2008, all symptoms are milder for all patients.  No patients went to the emergency room.  (See cases 200914591, 200914608, and 200914610).  Several attempts have been made to the reporter to confirm and verify the number of patients involved.  To date, reporter has not provided a response.  Patient outcome is unknown.  No further information is expected.  The manufacturer considered causality possible in relation to the administration of AFLURIA.  Information derived from this ADR report does not change the current safety profile of the product.
Sex: U
Vaccine: FLU3
Symptoms: Chest discomfort, Influenza like illness, Malaise, Myalgia, Nasal congestion
Clinical narrative: Report received from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four (4) patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise) One (1) out of four (4) experienced chest congestion. All four (4) patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three (3) days later (01-Nov-2008). As of 05-Nov-2008, all symptoms are milder for all patients. No patients went to the emergency room. (See cases 200914591, 200914608, and 200914609). Patient outcome is unknown. Several attempts have been made to the reporter to confirm and verify the number of patients involved. To date, reporter has not provided a response. No further information is expected. Manufacturer considered causality possible in relation to the administration of AFLURIA. Information derived from this ADR report does not change the current safety profile of the product
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Injection site pain lasting 3 months
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Autoimmune disorder, Balance disorder, Burning sensation
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced muscle spasms, sweats, chills, fatigue, numbness, tingling, poor balance, memory problems, burning, shooting pains and concentration problems.  He additionally suffered from confusion, tremors, difficulty walking, sitting and writing, decreased activities of daily life, decreased ability to participate in recreational activities, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.  Medical records for this subject were received on 11 June 2009.  The subject underwent an evaluation on 18 November 2003 for tremor in the right hand.  It was noted stated that the subject took a Lyme's vaccine to treat tick fever and one and a half years later, his immune system started failing.  Evaluation including an EMG within normal limits indicated severe demyelinating polyneuropathy.  The conduction velocity was reduced in all the motor nerves.  An evaluation dated 14 May 2008 indicated that the subject suffered from Stage II Parkinson's disease.  This condition appeared to be medical history for this subject and not attributable to treatment with LYMERIX vaccine.
Sex: M
Vaccine: LYME
Symptoms: Chills, Cognitive disorder, Confusional state, Decreased activity, Demyelinating polyneuropathy
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced muscle spasms, sweats, chills, fatigue, numbness, tingling, poor balance, memory problems, burning, shooting pains and concentration problems.  He additionally suffered from confusion, tremors, difficulty walking, sitting and writing, decreased activities of daily life, decreased ability to participate in recreational activities, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.  Medical records for this subject were received on 11 June 2009.  The subject underwent an evaluation on 18 November 2003 for tremor in the right hand.  It was noted stated that the subject took a Lyme's vaccine to treat tick fever and one and a half years later, his immune system started failing.  Evaluation including an EMG within normal limits indicated severe demyelinating polyneuropathy.  The conduction velocity was reduced in all the motor nerves.  An evaluation dated 14 May 2008 indicated that the subject suffered from Stage II Parkinson's disease.  This condition appeared to be medical history for this subject and not attributable to treatment with LYMERIX vaccine.
Sex: M
Vaccine: LYME
Symptoms: Disturbance in attention, Dysgraphia, Electroencephalogram abnormal, Fatigue, Gait disturbance
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced muscle spasms, sweats, chills, fatigue, numbness, tingling, poor balance, memory problems, burning, shooting pains and concentration problems.  He additionally suffered from confusion, tremors, difficulty walking, sitting and writing, decreased activities of daily life, decreased ability to participate in recreational activities, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.  Medical records for this subject were received on 11 June 2009.  The subject underwent an evaluation on 18 November 2003 for tremor in the right hand.  It was noted stated that the subject took a Lyme's vaccine to treat tick fever and one and a half years later, his immune system started failing.  Evaluation including an EMG within normal limits indicated severe demyelinating polyneuropathy.  The conduction velocity was reduced in all the motor nerves.  An evaluation dated 14 May 2008 indicated that the subject suffered from Stage II Parkinson's disease.  This condition appeared to be medical history for this subject and not attributable to treatment with LYMERIX vaccine.
Sex: M
Vaccine: LYME
Symptoms: Hyperhidrosis, Hypoaesthesia, Memory impairment, Muscle spasms, Nervous system disorder
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced muscle spasms, sweats, chills, fatigue, numbness, tingling, poor balance, memory problems, burning, shooting pains and concentration problems.  He additionally suffered from confusion, tremors, difficulty walking, sitting and writing, decreased activities of daily life, decreased ability to participate in recreational activities, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.  Medical records for this subject were received on 11 June 2009.  The subject underwent an evaluation on 18 November 2003 for tremor in the right hand.  It was noted stated that the subject took a Lyme's vaccine to treat tick fever and one and a half years later, his immune system started failing.  Evaluation including an EMG within normal limits indicated severe demyelinating polyneuropathy.  The conduction velocity was reduced in all the motor nerves.  An evaluation dated 14 May 2008 indicated that the subject suffered from Stage II Parkinson's disease.  This condition appeared to be medical history for this subject and not attributable to treatment with LYMERIX vaccine.
Sex: M
Vaccine: LYME
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Pain, Paraesthesia
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced muscle spasms, sweats, chills, fatigue, numbness, tingling, poor balance, memory problems, burning, shooting pains and concentration problems.  He additionally suffered from confusion, tremors, difficulty walking, sitting and writing, decreased activities of daily life, decreased ability to participate in recreational activities, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.  Medical records for this subject were received on 11 June 2009.  The subject underwent an evaluation on 18 November 2003 for tremor in the right hand.  It was noted stated that the subject took a Lyme's vaccine to treat tick fever and one and a half years later, his immune system started failing.  Evaluation including an EMG within normal limits indicated severe demyelinating polyneuropathy.  The conduction velocity was reduced in all the motor nerves.  An evaluation dated 14 May 2008 indicated that the subject suffered from Stage II Parkinson's disease.  This condition appeared to be medical history for this subject and not attributable to treatment with LYMERIX vaccine.
Sex: M
Vaccine: LYME
Symptoms: Tremor
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced muscle spasms, sweats, chills, fatigue, numbness, tingling, poor balance, memory problems, burning, shooting pains and concentration problems.  He additionally suffered from confusion, tremors, difficulty walking, sitting and writing, decreased activities of daily life, decreased ability to participate in recreational activities, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.  Medical records for this subject were received on 11 June 2009.  The subject underwent an evaluation on 18 November 2003 for tremor in the right hand.  It was noted stated that the subject took a Lyme's vaccine to treat tick fever and one and a half years later, his immune system started failing.  Evaluation including an EMG within normal limits indicated severe demyelinating polyneuropathy.  The conduction velocity was reduced in all the motor nerves.  An evaluation dated 14 May 2008 indicated that the subject suffered from Stage II Parkinson's disease.  This condition appeared to be medical history for this subject and not attributable to treatment with LYMERIX vaccine.
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Antinuclear antibody positive, Arthralgia, Arthritis
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of arthralgia in a female subject in her fifties who was vaccinated with LYMERIX (GlaxoSmithKline). On July 1999, the subject received the second dose of LYMERIX (unknown). According to the statement of injuries, at an unspecified time after vaccination with LYMERIX, the subject experienced "arthralgias, fatigue, dizziness, expressive difficulties, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all caused by vaccination with LYMERIX, including but not limited to those set forth above. She has decreased activities of daily life and decreased ability to participate in recreational activities." At the time of reporting the outcome of the events was unspecified. Information via medical records was also received at the time of the statement of injuries. This case was reported to VAERS (VAERS i.d. 197950). Medical history was notable for right knee arthroscopy in 1990 with a partial medial meniscectomy and debridement, and a left rotator cuff tear in 1997 due to a snowmobile accident with rotator cuff repair on 17 March 1999. According to medical records dated 09 July 2002, the subject received the LYMERIX vaccine in June 1999 and July 1999 and another booster in July 2000. Sometime after the second shot, she started developing joint pains and predominantly confusion with short-term memory problems. The subject was not sure of the exact onset of the events. Following receipt of LYMERIX, the subject also developed joint pains in her hands, swelling in the joints, memory disorder, arthritis and pins and needles sensations. The subject was treated with SYNVISC, CELEBREX, VIOXX, ULTRAM, physical therapy and also was hospitalized for a right knee replacement in April 2001. Pathological findings of the right knee components revealed degenerative joint disease. Physical examination on 09 July 2002 revealed mild peripheral neuropathy. Laboratory analyses performed on 28 November 2006 indicated no evidence of inflammatory arthritis. Review of medical notes from physician office visits in 2008 were notable for a diagnosis of osteoarthritis. Treatments for her symptoms included ADVIL, corticosteroid injections, physical therapy and orthotics.
Sex: F
Vaccine: LYME
Symptoms: Autoimmune disorder, Cognitive disorder, Confusional state, Dizziness, Fatigue
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of arthralgia in a female subject in her fifties who was vaccinated with LYMERIX (GlaxoSmithKline). On July 1999, the subject received the second dose of LYMERIX (unknown). According to the statement of injuries, at an unspecified time after vaccination with LYMERIX, the subject experienced "arthralgias, fatigue, dizziness, expressive difficulties, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all caused by vaccination with LYMERIX, including but not limited to those set forth above. She has decreased activities of daily life and decreased ability to participate in recreational activities." At the time of reporting the outcome of the events was unspecified. Information via medical records was also received at the time of the statement of injuries. This case was reported to VAERS (VAERS i.d. 197950). Medical history was notable for right knee arthroscopy in 1990 with a partial medial meniscectomy and debridement, and a left rotator cuff tear in 1997 due to a snowmobile accident with rotator cuff repair on 17 March 1999. According to medical records dated 09 July 2002, the subject received the LYMERIX vaccine in June 1999 and July 1999 and another booster in July 2000. Sometime after the second shot, she started developing joint pains and predominantly confusion with short-term memory problems. The subject was not sure of the exact onset of the events. Following receipt of LYMERIX, the subject also developed joint pains in her hands, swelling in the joints, memory disorder, arthritis and pins and needles sensations. The subject was treated with SYNVISC, CELEBREX, VIOXX, ULTRAM, physical therapy and also was hospitalized for a right knee replacement in April 2001. Pathological findings of the right knee components revealed degenerative joint disease. Physical examination on 09 July 2002 revealed mild peripheral neuropathy. Laboratory analyses performed on 28 November 2006 indicated no evidence of inflammatory arthritis. Review of medical notes from physician office visits in 2008 were notable for a diagnosis of osteoarthritis. Treatments for her symptoms included ADVIL, corticosteroid injections, physical therapy and orthotics.
Sex: F
Vaccine: LYME
Symptoms: Immunology test, Immunology test normal, Joint swelling, Memory impairment, Nervous system disorder
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of arthralgia in a female subject in her fifties who was vaccinated with LYMERIX (GlaxoSmithKline). On July 1999, the subject received the second dose of LYMERIX (unknown). According to the statement of injuries, at an unspecified time after vaccination with LYMERIX, the subject experienced "arthralgias, fatigue, dizziness, expressive difficulties, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all caused by vaccination with LYMERIX, including but not limited to those set forth above. She has decreased activities of daily life and decreased ability to participate in recreational activities." At the time of reporting the outcome of the events was unspecified. Information via medical records was also received at the time of the statement of injuries. This case was reported to VAERS (VAERS i.d. 197950). Medical history was notable for right knee arthroscopy in 1990 with a partial medial meniscectomy and debridement, and a left rotator cuff tear in 1997 due to a snowmobile accident with rotator cuff repair on 17 March 1999. According to medical records dated 09 July 2002, the subject received the LYMERIX vaccine in June 1999 and July 1999 and another booster in July 2000. Sometime after the second shot, she started developing joint pains and predominantly confusion with short-term memory problems. The subject was not sure of the exact onset of the events. Following receipt of LYMERIX, the subject also developed joint pains in her hands, swelling in the joints, memory disorder, arthritis and pins and needles sensations. The subject was treated with SYNVISC, CELEBREX, VIOXX, ULTRAM, physical therapy and also was hospitalized for a right knee replacement in April 2001. Pathological findings of the right knee components revealed degenerative joint disease. Physical examination on 09 July 2002 revealed mild peripheral neuropathy. Laboratory analyses performed on 28 November 2006 indicated no evidence of inflammatory arthritis. Review of medical notes from physician office visits in 2008 were notable for a diagnosis of osteoarthritis. Treatments for her symptoms included ADVIL, corticosteroid injections, physical therapy and orthotics.
Sex: F
Vaccine: LYME
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging brain abnormal, Osteoarthritis, Paraesthesia, Pathology test
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of arthralgia in a female subject in her fifties who was vaccinated with LYMERIX (GlaxoSmithKline). On July 1999, the subject received the second dose of LYMERIX (unknown). According to the statement of injuries, at an unspecified time after vaccination with LYMERIX, the subject experienced "arthralgias, fatigue, dizziness, expressive difficulties, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all caused by vaccination with LYMERIX, including but not limited to those set forth above. She has decreased activities of daily life and decreased ability to participate in recreational activities." At the time of reporting the outcome of the events was unspecified. Information via medical records was also received at the time of the statement of injuries. This case was reported to VAERS (VAERS i.d. 197950). Medical history was notable for right knee arthroscopy in 1990 with a partial medial meniscectomy and debridement, and a left rotator cuff tear in 1997 due to a snowmobile accident with rotator cuff repair on 17 March 1999. According to medical records dated 09 July 2002, the subject received the LYMERIX vaccine in June 1999 and July 1999 and another booster in July 2000. Sometime after the second shot, she started developing joint pains and predominantly confusion with short-term memory problems. The subject was not sure of the exact onset of the events. Following receipt of LYMERIX, the subject also developed joint pains in her hands, swelling in the joints, memory disorder, arthritis and pins and needles sensations. The subject was treated with SYNVISC, CELEBREX, VIOXX, ULTRAM, physical therapy and also was hospitalized for a right knee replacement in April 2001. Pathological findings of the right knee components revealed degenerative joint disease. Physical examination on 09 July 2002 revealed mild peripheral neuropathy. Laboratory analyses performed on 28 November 2006 indicated no evidence of inflammatory arthritis. Review of medical notes from physician office visits in 2008 were notable for a diagnosis of osteoarthritis. Treatments for her symptoms included ADVIL, corticosteroid injections, physical therapy and orthotics.
Sex: F
Vaccine: LYME
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of arthralgia in a female subject in her fifties who was vaccinated with LYMERIX (GlaxoSmithKline). On July 1999, the subject received the second dose of LYMERIX (unknown). According to the statement of injuries, at an unspecified time after vaccination with LYMERIX, the subject experienced "arthralgias, fatigue, dizziness, expressive difficulties, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all caused by vaccination with LYMERIX, including but not limited to those set forth above. She has decreased activities of daily life and decreased ability to participate in recreational activities." At the time of reporting the outcome of the events was unspecified. Information via medical records was also received at the time of the statement of injuries. This case was reported to VAERS (VAERS i.d. 197950). Medical history was notable for right knee arthroscopy in 1990 with a partial medial meniscectomy and debridement, and a left rotator cuff tear in 1997 due to a snowmobile accident with rotator cuff repair on 17 March 1999. According to medical records dated 09 July 2002, the subject received the LYMERIX vaccine in June 1999 and July 1999 and another booster in July 2000. Sometime after the second shot, she started developing joint pains and predominantly confusion with short-term memory problems. The subject was not sure of the exact onset of the events. Following receipt of LYMERIX, the subject also developed joint pains in her hands, swelling in the joints, memory disorder, arthritis and pins and needles sensations. The subject was treated with SYNVISC, CELEBREX, VIOXX, ULTRAM, physical therapy and also was hospitalized for a right knee replacement in April 2001. Pathological findings of the right knee components revealed degenerative joint disease. Physical examination on 09 July 2002 revealed mild peripheral neuropathy. Laboratory analyses performed on 28 November 2006 indicated no evidence of inflammatory arthritis. Review of medical notes from physician office visits in 2008 were notable for a diagnosis of osteoarthritis. Treatments for her symptoms included ADVIL, corticosteroid injections, physical therapy and orthotics.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4
Symptoms: Gaze palsy, Immediate post-injection reaction, Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter with no medical history and drug reactions who on 09-APR-2009 was vaccinated with her 1st dose of GARDASIL, 0.5 ml, IM. She went blind, got dizzy and then passed out. She fully recovered that same day. On 15-JUN-2009, the patient was vaccinated with the 2nd dose of GARDASIL, 0.5ml, IM. There was no concomitant medication. Then she passed out immediately, and had 3 mini-seizures. The mother didn't know if there was blindness or dizziness because her daughter passed out immediately. Since then she had nausea and vomiting and couldn't keep anything down. The patient had recovered from the seizures and syncope, but her nausea and vomiting persisted. The patient had sought medical attention. There were no labs and diagnostic tests performed. The mother felt that her daughter's blindness and 3 mini-seizures were considered to be important medical events. Additional information has been requested.  7/13/09 Medical records received DOS 4/7/09 to 6/19/09. Assessment: Shuddering episode related to syncope. Post vaccination patient became pale, eyes rolled back, got very stiff, shook 2 or 3 times. Loss of memory during episode. 5 vomiting episodes later at home. Also received PPD that day. Nausea, abdominal pain, 'not feeling right'. Dizziness, anxiety.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter with no medical history and drug reactions who on 09-APR-2009 was vaccinated with her 1st dose of GARDASIL, 0.5 ml, IM. She went blind, got dizzy and then passed out. She fully recovered that same day. On 15-JUN-2009, the patient was vaccinated with the 2nd dose of GARDASIL, 0.5ml, IM. There was no concomitant medication. Then she passed out immediately, and had 3 mini-seizures. The mother didn't know if there was blindness or dizziness because her daughter passed out immediately. Since then she had nausea and vomiting and couldn't keep anything down. The patient had recovered from the seizures and syncope, but her nausea and vomiting persisted. The patient had sought medical attention. There were no labs and diagnostic tests performed. The mother felt that her daughter's blindness and 3 mini-seizures were considered to be important medical events. Additional information has been requested.  7/13/09 Medical records received DOS 4/7/09 to 6/19/09. Assessment: Shuddering episode related to syncope. Post vaccination patient became pale, eyes rolled back, got very stiff, shook 2 or 3 times. Loss of memory during episode. 5 vomiting episodes later at home. Also received PPD that day. Nausea, abdominal pain, 'not feeling right'. Dizziness, anxiety.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4
Symptoms: Blindness transient, Convulsion, Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter with no medical history and drug reactions who on 09-APR-2009 was vaccinated with her 1st dose of GARDASIL, 0.5 ml, IM. She went blind, got dizzy and then passed out. She fully recovered that same day. On 15-JUN-2009, the patient was vaccinated with the 2nd dose of GARDASIL, 0.5ml, IM. There was no concomitant medication. Then she passed out immediately, and had 3 mini-seizures. The mother didn't know if there was blindness or dizziness because her daughter passed out immediately. Since then she had nausea and vomiting and couldn't keep anything down. The patient had recovered from the seizures and syncope, but her nausea and vomiting persisted. The patient had sought medical attention. There were no labs and diagnostic tests performed. The mother felt that her daughter's blindness and 3 mini-seizures were considered to be important medical events. Additional information has been requested.  7/13/09 Medical records received DOS 4/7/09 to 6/19/09. Assessment: Shuddering episode related to syncope. Post vaccination patient became pale, eyes rolled back, got very stiff, shook 2 or 3 times. Loss of memory during episode. 5 vomiting episodes later at home. Also received PPD that day. Nausea, abdominal pain, 'not feeling right'. Dizziness, anxiety.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4
Symptoms: Nausea, Syncope, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter with no medical history and drug reactions who on 09-APR-2009 was vaccinated with her 1st dose of GARDASIL, 0.5 ml, IM. She went blind, got dizzy and then passed out. She fully recovered that same day. On 15-JUN-2009, the patient was vaccinated with the 2nd dose of GARDASIL, 0.5ml, IM. There was no concomitant medication. Then she passed out immediately, and had 3 mini-seizures. The mother didn't know if there was blindness or dizziness because her daughter passed out immediately. Since then she had nausea and vomiting and couldn't keep anything down. The patient had recovered from the seizures and syncope, but her nausea and vomiting persisted. The patient had sought medical attention. There were no labs and diagnostic tests performed. The mother felt that her daughter's blindness and 3 mini-seizures were considered to be important medical events. Additional information has been requested.  7/13/09 Medical records received DOS 4/7/09 to 6/19/09. Assessment: Shuddering episode related to syncope. Post vaccination patient became pale, eyes rolled back, got very stiff, shook 2 or 3 times. Loss of memory during episode. 5 vomiting episodes later at home. Also received PPD that day. Nausea, abdominal pain, 'not feeling right'. Dizziness, anxiety.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Acoustic stimulation tests, Autism
Clinical narrative: Information has been received from a consumer concerning her cousin's 15 year old son who was vaccinated with MMR II (lot number not available) when he was 18 months old. The patient started to slowly become autistic after the vaccination (age at onset not reported). It was noted that the patient has severe autism but other than that, he was fine. Unspecified medical attention was sought. A hearing test was performed (results not provided). At the time of this report, the patient's severe autism persisted. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 22 year old female with a history of papanicolaou smear abnormal and cervical dysplasia who on 05-AUG-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM in her left upper arm. Concomitant therapy included "FOUCACIO". On 02-SEP-2008 the patient went to the office and blood work was drawn. The patient was positive for pregnancy. No adverse event was reported. On 03-SEP-2008 the patient was 2 or 3 weeks gestation. The last menstrual period was approximately 12-AUG-2008. The estimated due date is 19-MAY-2009. Additional information has been received from a Pregnancy Registry memo. The patient underwent an elective termination of pregnancy prior to 20-OCT-2008 for reasons that are not related to the vaccine. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Blood glucose normal, Lethargy, Nausea, Pallor
Clinical narrative: Information has been received from a Physician Assistant (P.A) concerning a 15 year old female patient who on 13-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot # not reported). It was reported that the patient fainted right after receiving the first dose of GARDASIL on 13-JUN-2009. It was reported that the patient was was brought to the emergency room and stayed there for a few hours. The patient was not admitted to the hospital. The patient sought medical attention with the Physician Assistant. There was a blood work performed (results not provided). It was reported that the adverse event had improved at the time of the report. All telephone attempts to contact the reporter have been unsuccessful. Follow up information was received from a Physician Assistant (P.A) on 23-JUN-2009 via telephone reported that the patient with no pertinent medical history or known drug allergies was vaccinated with the first dose of GARDASIL (Lot # 661846/1312X) on 13-JUN-2009. On 13-JUN-2009 the patient was very anxious and hadn't eaten since the night before. There were no concomitant medications and no other vaccinations given that day. After having fainted for only a few seconds, the patient was monitored in the office for the next 45 minutes. The vital signs and blood sugars were normal, but the patient was nauseous, lethargic and pale. She was transported to the emergency room. It was unknown what tests - other than blood work - were performed. The event was considered disabling for about five hours. The patient had fully recovered. The reporter considered fainted, nauseous, lethargic and pale to be significant disability/disabling. No further information is available.