chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza serology, Nausea
Clinical narrative: Per pts. mother, pt. started experiencing extreme fatigue/weakness and some nausea in morning on 08/21/2009. Pt. was taken to PCP and Hgb check was done as pt. also started menses on 08/21/2009. Pt. felt fine all weekend and then on 8/25/09 started with headache, chills, nausea, and weakness, and was again taken to PCP and was at this time tested for influenza. Per mom, PCP is unsure of course of symptoms.
Age: 38.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Shots given and instructed to use cold packs to site if soreness, redness, or inflammation occur. Pt. stopped by health dept. on 8/26 c/o pain in neck, left shoulder down to elbow. No signs of redness, swelling or infection noted. Cool to touch.
Age: 1.34
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Mild case of chicken pox.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Blood immunoglobulin E increased, Food allergy, Gait disturbance, Injection site erythema, Injection site induration
Clinical narrative: Noted orange sized, red, hard, warm area around injection site 24 hours after shot. 8/4/09. Reluctant to walk due to pain. On AM of 8/5/09 mom noted increased erythema extending to inner thigh - Now at medial, lateral and anterior thigh, sparing posterior, thigh measures 32 1/2 cm (2) and 28 1/2 cm on Rt. No other systemic Rx. Has been on ZYRTEC prior to infection and is on maintenances.  Area warm, red - no drainage.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site warmth, Milk allergy
Clinical narrative: Noted orange sized, red, hard, warm area around injection site 24 hours after shot. 8/4/09. Reluctant to walk due to pain. On AM of 8/5/09 mom noted increased erythema extending to inner thigh - Now at medial, lateral and anterior thigh, sparing posterior, thigh measures 32 1/2 cm (2) and 28 1/2 cm on Rt. No other systemic Rx. Has been on ZYRTEC prior to infection and is on maintenances.  Area warm, red - no drainage.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, RV1
Symptoms: Culture stool, Dermatitis diaper, Diarrhoea, Haematochezia, Rotavirus test
Clinical narrative: Diarrhea/ Hematocrit leading to severe diaper dermatitis.
Age: 44.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rash
Clinical narrative: Pt received TDAP (BOOSTRIX) on 16 JUN 09 developed rash on 17 JUN 09 was evaluated by provider on 24 JUN 09 + Txed with ZANTAC + PREDNISONE.
Age: 44.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Joint swelling, Malaise, Neck pain, Rash
Clinical narrative: Pt received TDAP (BOOSTRIX) on 16 JUN 09 developed rash on 17 JUN 09 was evaluated by provider on 24 JUN 09 + Txed with ZANTAC + PREDNISONE.
Age: 44.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Serum sickness, Urticaria
Clinical narrative: Pt received TDAP (BOOSTRIX) on 16 JUN 09 developed rash on 17 JUN 09 was evaluated by provider on 24 JUN 09 + Txed with ZANTAC + PREDNISONE.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Patient called our office 4 hours after receiving vaccine with c/o severe headache.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dyskinesia, Hypotension, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Jerking, shaking, "locked up" (2 minutes) unresponsive, hypotension.  911 called ER Dx: Syncope vasovagal.
Age: 52.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm, Urticaria
Clinical narrative: By 08/22/09 around 3:30 pm there was an approximately 3" X 5" area on the L upper forearm that was red, raised and swollen and warm to touch. PA prescribed "cephalexin" 500 mg. 3 X day and "diphenhydramine" 50mg 1 every 4-6 hrs. for urticaria. Instructed to return for follow-up on 08/24/09.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PPV, RVX
Symptoms: Body temperature increased, Rash
Clinical narrative: Temp up to 105 degrees duration 2 days - Rash.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Dizziness, Hot flush, Nausea, Paraesthesia, Vision blurred
Clinical narrative: Pt had HPV, Hep A, & Verasella.  Symptoms were dizzyness, nausea, hot flash, blurry eyes & tingling ears, pt layed down for 15 min w/ ice pack.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Swelling of LA, red, hot.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Presented to office with rash - Began on chest spreads to arms -8/27/ rash began.
Age: 9.0
Sex: F
Vaccine: DT
Symptoms: Chest pain, Erythema, Oedema peripheral
Clinical narrative: Erythema & swelling upper arm (16 cm) - to arms elbow.  Circumference 23 cm vs 20 cm other arm.  Pt reports chest pain X 3 days after injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Rash, Swelling
Clinical narrative: Skin rash & swelling 6x7 cm. Requires BENADRYL one tsp q 6 hours PRN.
Age: 65.0
Sex: F
Vaccine: DT, PPV
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia, Tremor
Clinical narrative: PNEUMOVAX 8/17/09 developed high fever that night with shaking chills vomiting the next day right arm was also very red and sore left arm fine. Fever lasted 4 days Low grade on 8/20/09.
Age: 65.0
Sex: F
Vaccine: DT, PPV
Symptoms: Vomiting
Clinical narrative: PNEUMOVAX 8/17/09 developed high fever that night with shaking chills vomiting the next day right arm was also very red and sore left arm fine. Fever lasted 4 days Low grade on 8/20/09.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Eye swelling, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Pt received Hep A vaccine on 8/25/09.  Mother reported generalized red itchy rash first noticied 8/25/09 in the evening, and swollen eyes 8/26/09 in AM.  Pt stated rash was itchy.  Denies any other symptoms.
Age: 37.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Cognitive disorder, Disturbance in attention, Fatigue, Full blood count normal, Headache
Clinical narrative: Developed suddenly around 21 May 08 profound fatigue, and sleeping 12-14 hours at a time and awakening unrefreshed. Also had increase in HAs, decreased concentration, and post exercise malaise. Relates this to the vaccines she received 3 weeks prior. Full work up revealed no other medical explanations for her abrupt change in sxs. Symptoms: Fatigue, Malaise >60 Days, Headache, Migraine, Abnormal sleep patterns, NOS, Cognitive deficiency.
Age: 37.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Hypersomnia, Immunology test normal, Laboratory test normal, Malaise, Migraine
Clinical narrative: Developed suddenly around 21 May 08 profound fatigue, and sleeping 12-14 hours at a time and awakening unrefreshed. Also had increase in HAs, decreased concentration, and post exercise malaise. Relates this to the vaccines she received 3 weeks prior. Full work up revealed no other medical explanations for her abrupt change in sxs. Symptoms: Fatigue, Malaise >60 Days, Headache, Migraine, Abnormal sleep patterns, NOS, Cognitive deficiency.
Age: 37.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Thyroid function test normal
Clinical narrative: Developed suddenly around 21 May 08 profound fatigue, and sleeping 12-14 hours at a time and awakening unrefreshed. Also had increase in HAs, decreased concentration, and post exercise malaise. Relates this to the vaccines she received 3 weeks prior. Full work up revealed no other medical explanations for her abrupt change in sxs. Symptoms: Fatigue, Malaise >60 Days, Headache, Migraine, Abnormal sleep patterns, NOS, Cognitive deficiency.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left arm 6 inch erythematous area. Occurred/started 8/21/09 and continued to be red & swollen still today 8/24/09 with a measurement of 5.5cm x 6cm. Tsp BENADRYL given at urgent care 8/21/09. 8/24/09 pt started on XYZAL & hydrocortisone cream.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting. 5 cm swelling and erythema at injection site, right thigh.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Fever, vomiting, diarrhea, and fussiness.  3 cm of swelling and erythema at injection site. - Right thigh.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, diarrhea, and fussiness.  3 cm of swelling and erythema at injection site. - Right thigh.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Slight swelling and redness to injection site.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Culture throat positive, Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: Rash, low grade fever, fatigue, headache loss of appetite.  VARIVAX given 8/17/09.  Symptoms started 1 week later.  Came into clinic.  Quick strep neg.  Given BENADRYL.  Throat CX positive for strep.  Treated with AMOX.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Streptococcal identification test negative
Clinical narrative: Rash, low grade fever, fatigue, headache loss of appetite.  VARIVAX given 8/17/09.  Symptoms started 1 week later.  Came into clinic.  Quick strep neg.  Given BENADRYL.  Throat CX positive for strep.  Treated with AMOX.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever 103 degrees.  Lt thigh swollen.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Fatigue, Full blood count normal, Headache, Immunology test normal
Clinical narrative: 2-3 day after flu like symptoms, lethargy, fever to 100, initial insomnia for 4 days, tired, arthralgias, and headache.  Week 2 had had swollen node in bilat neck and axilla painful nodes.  All these resolved, however, continuous joint pain in the knees, ankles and hips have continued.  Worse in the AM.  This patient meets the criteria for Refractory Persistent Myalgia/ Arthralgia Syndrome (RPMAS) and will be added to the other 224 cases in our database, and will receive a permanent exemption to the anthrax vaccine.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Influenza like illness, Insomnia, Laboratory test normal, Lethargy, Lymph node pain
Clinical narrative: 2-3 day after flu like symptoms, lethargy, fever to 100, initial insomnia for 4 days, tired, arthralgias, and headache.  Week 2 had had swollen node in bilat neck and axilla painful nodes.  All these resolved, however, continuous joint pain in the knees, ankles and hips have continued.  Worse in the AM.  This patient meets the criteria for Refractory Persistent Myalgia/ Arthralgia Syndrome (RPMAS) and will be added to the other 224 cases in our database, and will receive a permanent exemption to the anthrax vaccine.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Lymphadenopathy, Myalgia, Pyrexia, Rheumatoid factor negative, Urine analysis normal
Clinical narrative: 2-3 day after flu like symptoms, lethargy, fever to 100, initial insomnia for 4 days, tired, arthralgias, and headache.  Week 2 had had swollen node in bilat neck and axilla painful nodes.  All these resolved, however, continuous joint pain in the knees, ankles and hips have continued.  Worse in the AM.  This patient meets the criteria for Refractory Persistent Myalgia/ Arthralgia Syndrome (RPMAS) and will be added to the other 224 cases in our database, and will receive a permanent exemption to the anthrax vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased
Clinical narrative: After administration of GARDASIL vaccine patient felt like she was going to pass out.  Her blood pressure dropped to 90/52 and pulse dropped to 48.  Layed patient down, given a drink of soda.  Rechecked patient after 10 minutes and she felt better.  Blood pressure rechecked and returned to normal.  Patient released.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Injection site erythema
Clinical narrative: Pt. displayed redness at the site of injections, several minutes after administration.  Provider monitored pt. for any other adverse reaction after administration of BENDARYL 2 tsp P.O.  Redness cleared during observation.  Pt. released with no s/s of distress.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Pyrexia, Skin lesion
Clinical narrative: 12 days following vaccination pt developed fevers, chills, sweats, fatigue, decreased appetite, & 2 similar pox lesions on the (R) cheek,  appear to be the same age as the primary vaccination lesion.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Rash
Clinical narrative: Rash. Fussiness.
Age: 55.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8/10/09 - Pt in for HEP B #3 - Reports "I had a reaction to the TETANUS".  TDAP given 04/01/09 right arm IM.  Pt states initially had some "redness" yet arm became swollen/ warm to touch "from injection site to elbow".  Symptoms resolved on own/ did not seek medical care.
Age: 10.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt was given MENACTRA before he was at the recommended age to receive MENACTRA.  Pt age 10, 2 1/2 months early per CDC recommendations & guidelines.  Misadministration.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity
Clinical narrative: Back & thigh pain within 24 hrs after vaccination.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold sores
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oral herpes, Pain, Swelling
Clinical narrative: Cold sores
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HEPA
Symptoms: Injection site swelling
Clinical narrative: Parent reported increased swelling in the (L) arm, both upper & lower 2 days after a DTaP & Hep B (DAPTACEL & ENGERIX B). It improved after 2 days but treated with cortisone, KEFLEX & BENADRYL.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline).  There were no concomitant medications.  The subject had not experienced adverse events following previous vaccinations.  Concurrent medical conditions included PENICILLIN allergy.  Concurrent vaccination included MMRII (Merck) given on 15 June 2009; VARIVAX (Merck) given on 15 June 2009.  On 15 June 2009 at 10:30 the subject received 1st dose of KINRIX (.5 ml, unknown route, right arm).  On 16 June 2009, 1 day after vaccination with KINRIX, the subject experienced swelling at injection site, injection site hot to touch and injection site tenderness.  At the time of reporting the events were resolved.  This case is associated to a product complaint.  The healthcare professional reported that 3 vials of KINRIX vaccine may be defective which caused the adverse events over the past 5 weeks.  There are 22 single units left (2 full packages of 10 plus 2 single vials) and the physician in charge ordered that they not be given to other patients.  There were 3 different patients involved (see case IDs A0799437A and A0799444A for more details). Would like replacement of the 22 vials if possible.  Follow-up information from the QA department was received on 06 August 2009.  Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly.  The complaint was considered as not verified.  Follow-up information was received from the reporting nurse on 07 August 2009.  The case was reported to a Regulatory Agency.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline).  There were no concomitant medications.  The subject had not experienced adverse events following previous vaccinations.  Concurrent medical conditions included PENICILLIN allergy.  Concurrent vaccination included MMRII (Merck) given on 15 June 2009; VARIVAX (Merck) given on 15 June 2009.  On 15 June 2009 at 10:30 the subject received 1st dose of KINRIX (.5 ml, unknown route, right arm).  On 16 June 2009, 1 day after vaccination with KINRIX, the subject experienced swelling at injection site, injection site hot to touch and injection site tenderness.  At the time of reporting the events were resolved.  This case is associated to a product complaint.  The healthcare professional reported that 3 vials of KINRIX vaccine may be defective which caused the adverse events over the past 5 weeks.  There are 22 single units left (2 full packages of 10 plus 2 single vials) and the physician in charge ordered that they not be given to other patients.  There were 3 different patients involved (see case IDs A0799437A and A0799444A for more details). Would like replacement of the 22 vials if possible.  Follow-up information from the QA department was received on 06 August 2009.  Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly.  The complaint was considered as not verified.  Follow-up information was received from the reporting nurse on 07 August 2009.  The case was reported to a Regulatory Agency.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX, GlaxoSmithKline. There were no concomitant medications and no relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included MMR vaccine (non-gsk), Merck given on 13 July 2009. On 13 July 2009 at 11:00 the subject received 1st dose of KINRIX (.5ml, unknown right arm). On 14 July 2009, 1 day after vaccination with KINRIX, the subject experienced swelling at injection site, injection site hot to touch and injection site tenderness. At the time of reporting the events were resolved. This case is associated to a product complaint. The healthcare professional reported that 3 vials KINRIX vaccine may be defective which caused the adverse events over the past 5 weeks. There are 22 single units left (2 full packages of 10 plus 2 single vials) and the physician in charge ordered that the not be given to other patients. There were 3 different patients involved (see case IDS A0799441A and A0799444A for more details) would like replacement of the 22 vials if possible. Follow-up information from the QA department was received on 06 August 2009. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. The complaint was considered as not verified. Follow-up information was received from the reporting nurse on 07 August 2009. The case was reported to a Regulatory Agency. Onset date of the earliest sign or symptom was reported as 13 July 2009.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMR
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX, GlaxoSmithKline. There were no concomitant medications and no relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included MMR vaccine (non-gsk), Merck given on 13 July 2009. On 13 July 2009 at 11:00 the subject received 1st dose of KINRIX (.5ml, unknown right arm). On 14 July 2009, 1 day after vaccination with KINRIX, the subject experienced swelling at injection site, injection site hot to touch and injection site tenderness. At the time of reporting the events were resolved. This case is associated to a product complaint. The healthcare professional reported that 3 vials KINRIX vaccine may be defective which caused the adverse events over the past 5 weeks. There are 22 single units left (2 full packages of 10 plus 2 single vials) and the physician in charge ordered that the not be given to other patients. There were 3 different patients involved (see case IDS A0799441A and A0799444A for more details) would like replacement of the 22 vials if possible. Follow-up information from the QA department was received on 06 August 2009. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. The complaint was considered as not verified. Follow-up information was received from the reporting nurse on 07 August 2009. The case was reported to a Regulatory Agency. Onset date of the earliest sign or symptom was reported as 13 July 2009.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX, GlaxoSmithKline. There were no concomitant medications or relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included HAVRIX vaccine (GlaxoSmithKline) given on 24 July 2009; MMR II vaccine (non-GSK) (Merck) given on 24 July 2009; VARIVAX vaccine (Non-GSK) (Merck) given on 24 July 2009. On 24 July 2009 at 08:20 the subject received 1st dose of KINRIX (.5 mL, unknown route, left arm). On 25 July 2009, 1 day after vaccination with KINRIX, the subject experienced swelling at injection site, injection site hot to touch and injection site tenderness. At the time of reporting the events were resolved. This case is associated to a product complaint. The healthcare professional reported that 3 vials of KINRIX vaccine may be defective which caused the adverse events over the past 5 weeks. There are 22 single units left (2 full packages of 10 plus 2 single vials) and the physician in charge ordered that they not be given to other patients. There were 3 different patients involved (see case IDs A0799437A and A0799441A for more details). Would like replacement of the 22 vials if possible. Follow-up information from the QA department was received on 06 August 2009. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. The complaint was considered as not verified.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX, GlaxoSmithKline. There were no concomitant medications or relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included HAVRIX vaccine (GlaxoSmithKline) given on 24 July 2009; MMR II vaccine (non-GSK) (Merck) given on 24 July 2009; VARIVAX vaccine (Non-GSK) (Merck) given on 24 July 2009. On 24 July 2009 at 08:20 the subject received 1st dose of KINRIX (.5 mL, unknown route, left arm). On 25 July 2009, 1 day after vaccination with KINRIX, the subject experienced swelling at injection site, injection site hot to touch and injection site tenderness. At the time of reporting the events were resolved. This case is associated to a product complaint. The healthcare professional reported that 3 vials of KINRIX vaccine may be defective which caused the adverse events over the past 5 weeks. There are 22 single units left (2 full packages of 10 plus 2 single vials) and the physician in charge ordered that they not be given to other patients. There were 3 different patients involved (see case IDs A0799437A and A0799441A for more details). Would like replacement of the 22 vials if possible. Follow-up information from the QA department was received on 06 August 2009. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. The complaint was considered as not verified.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX, GlaxoSmithKline. There were no concomitant medications or relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included HAVRIX vaccine (GlaxoSmithKline) given on 24 July 2009; MMR II vaccine (non-GSK) (Merck) given on 24 July 2009; VARIVAX vaccine (Non-GSK) (Merck) given on 24 July 2009. On 24 July 2009 at 08:20 the subject received 1st dose of KINRIX (.5 mL, unknown route, left arm). On 25 July 2009, 1 day after vaccination with KINRIX, the subject experienced swelling at injection site, injection site hot to touch and injection site tenderness. At the time of reporting the events were resolved. This case is associated to a product complaint. The healthcare professional reported that 3 vials of KINRIX vaccine may be defective which caused the adverse events over the past 5 weeks. There are 22 single units left (2 full packages of 10 plus 2 single vials) and the physician in charge ordered that they not be given to other patients. There were 3 different patients involved (see case IDs A0799437A and A0799441A for more details). Would like replacement of the 22 vials if possible. Follow-up information from the QA department was received on 06 August 2009. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. The complaint was considered as not verified.
Age: 4.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain upper, Fatigue, Pyrexia
Clinical narrative: High fever, bellyache, tired....with Motrin temp came down, bellyache resolved
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Blood creatine phosphokinase normal, Chills, Full blood count normal, Hepatic enzyme increased, Laboratory test
Clinical narrative: Immediately following Anthrax vaccine I got a huge lump/nodule w/pain, swelling at the injection site. Reported this to PCM and Chief of staff after it was still there after 4 days and two other people with multiple injections received no local reaction. A couple days more I got hot/cold flashes, fever, weakness, muscle soreness. It went downhill from there as I was bedridden for 3 days and went into the ER. Temp 103 (rotated Tylenol and Motrin), headache, fatigue, cough, congestion, sore throat, abdominal pain and gas. The next morning I started vomiting and had severe respiratory problems and knew I was done. Contacted PCM and told to report to the ER. Severely dehydrated, couldn't breathe (2 words every 5 seconds, couldn't stand straight.) DX with Anthrax Allergy, then with Pneumonia (can kill.) Went through 4 bags of IV fluids/meds including steroids for Anthrax and Antibiotics, prescribed multiple meds. Went to hospital for 2 days. Put out 5 days. Then went from sore throat pain of 1 to 8 (agonizing, before the worst of excruciating) and contracted sneezing, stuffy and running nose w/headache. On about 8 meds and have been sick for 20 days! TWENTY days is extremely abnormal and still sick. I'm sick of being sick as you can imagine. Every Dr., NP, RN I talked to says they don't see me getting the shot again. PCM just said from what he reads it says to administer the 2nd dose. We'll see if the military (I'm being deployed report in a couple weeks) is naive enough to do this or will give me an exemption, or hopefully you'll intervene. If I'm given the 2nd dose (I also have to get small pox vac. even though I've already got small pox vac but it wasn't within 10 years) and something happens, YOU will be held accountable. My medical record is documented and my parents will have a copy of everything to hold you liable. In the "clinical guidelines for managing adverse events after vaccination" table I received from the military (and gave my PCM), I followed it perfectly from local reaction through systemic event. Was seen in 3 hospitals (2 MTF, 1 CIV ER) which pointed to Anthrax vac. Still not recovered. I was in PERFECT health and taking no medications before Anthrax shot.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Local reaction, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Immediately following Anthrax vaccine I got a huge lump/nodule w/pain, swelling at the injection site. Reported this to PCM and Chief of staff after it was still there after 4 days and two other people with multiple injections received no local reaction. A couple days more I got hot/cold flashes, fever, weakness, muscle soreness. It went downhill from there as I was bedridden for 3 days and went into the ER. Temp 103 (rotated Tylenol and Motrin), headache, fatigue, cough, congestion, sore throat, abdominal pain and gas. The next morning I started vomiting and had severe respiratory problems and knew I was done. Contacted PCM and told to report to the ER. Severely dehydrated, couldn't breathe (2 words every 5 seconds, couldn't stand straight.) DX with Anthrax Allergy, then with Pneumonia (can kill.) Went through 4 bags of IV fluids/meds including steroids for Anthrax and Antibiotics, prescribed multiple meds. Went to hospital for 2 days. Put out 5 days. Then went from sore throat pain of 1 to 8 (agonizing, before the worst of excruciating) and contracted sneezing, stuffy and running nose w/headache. On about 8 meds and have been sick for 20 days! TWENTY days is extremely abnormal and still sick. I'm sick of being sick as you can imagine. Every Dr., NP, RN I talked to says they don't see me getting the shot again. PCM just said from what he reads it says to administer the 2nd dose. We'll see if the military (I'm being deployed report in a couple weeks) is naive enough to do this or will give me an exemption, or hopefully you'll intervene. If I'm given the 2nd dose (I also have to get small pox vac. even though I've already got small pox vac but it wasn't within 10 years) and something happens, YOU will be held accountable. My medical record is documented and my parents will have a copy of everything to hold you liable. In the "clinical guidelines for managing adverse events after vaccination" table I received from the military (and gave my PCM), I followed it perfectly from local reaction through systemic event. Was seen in 3 hospitals (2 MTF, 1 CIV ER) which pointed to Anthrax vac. Still not recovered. I was in PERFECT health and taking no medications before Anthrax shot.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Abdominal pain, Allergy to vaccine, Asthenia, Bedridden, Cough
Clinical narrative: Immediately following Anthrax vaccine I got a huge lump/nodule w/pain, swelling at the injection site. Reported this to PCM and Chief of staff after it was still there after 4 days and two other people with multiple injections received no local reaction. A couple days more I got hot/cold flashes, fever, weakness, muscle soreness. It went downhill from there as I was bedridden for 3 days and went into the ER. Temp 103 (rotated Tylenol and Motrin), headache, fatigue, cough, congestion, sore throat, abdominal pain and gas. The next morning I started vomiting and had severe respiratory problems and knew I was done. Contacted PCM and told to report to the ER. Severely dehydrated, couldn't breathe (2 words every 5 seconds, couldn't stand straight.) DX with Anthrax Allergy, then with Pneumonia (can kill.) Went through 4 bags of IV fluids/meds including steroids for Anthrax and Antibiotics, prescribed multiple meds. Went to hospital for 2 days. Put out 5 days. Then went from sore throat pain of 1 to 8 (agonizing, before the worst of excruciating) and contracted sneezing, stuffy and running nose w/headache. On about 8 meds and have been sick for 20 days! TWENTY days is extremely abnormal and still sick. I'm sick of being sick as you can imagine. Every Dr., NP, RN I talked to says they don't see me getting the shot again. PCM just said from what he reads it says to administer the 2nd dose. We'll see if the military (I'm being deployed report in a couple weeks) is naive enough to do this or will give me an exemption, or hopefully you'll intervene. If I'm given the 2nd dose (I also have to get small pox vac. even though I've already got small pox vac but it wasn't within 10 years) and something happens, YOU will be held accountable. My medical record is documented and my parents will have a copy of everything to hold you liable. In the "clinical guidelines for managing adverse events after vaccination" table I received from the military (and gave my PCM), I followed it perfectly from local reaction through systemic event. Was seen in 3 hospitals (2 MTF, 1 CIV ER) which pointed to Anthrax vac. Still not recovered. I was in PERFECT health and taking no medications before Anthrax shot.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Dehydration, Dyspnoea, Fatigue, Feeling cold, Flatulence
Clinical narrative: Immediately following Anthrax vaccine I got a huge lump/nodule w/pain, swelling at the injection site. Reported this to PCM and Chief of staff after it was still there after 4 days and two other people with multiple injections received no local reaction. A couple days more I got hot/cold flashes, fever, weakness, muscle soreness. It went downhill from there as I was bedridden for 3 days and went into the ER. Temp 103 (rotated Tylenol and Motrin), headache, fatigue, cough, congestion, sore throat, abdominal pain and gas. The next morning I started vomiting and had severe respiratory problems and knew I was done. Contacted PCM and told to report to the ER. Severely dehydrated, couldn't breathe (2 words every 5 seconds, couldn't stand straight.) DX with Anthrax Allergy, then with Pneumonia (can kill.) Went through 4 bags of IV fluids/meds including steroids for Anthrax and Antibiotics, prescribed multiple meds. Went to hospital for 2 days. Put out 5 days. Then went from sore throat pain of 1 to 8 (agonizing, before the worst of excruciating) and contracted sneezing, stuffy and running nose w/headache. On about 8 meds and have been sick for 20 days! TWENTY days is extremely abnormal and still sick. I'm sick of being sick as you can imagine. Every Dr., NP, RN I talked to says they don't see me getting the shot again. PCM just said from what he reads it says to administer the 2nd dose. We'll see if the military (I'm being deployed report in a couple weeks) is naive enough to do this or will give me an exemption, or hopefully you'll intervene. If I'm given the 2nd dose (I also have to get small pox vac. even though I've already got small pox vac but it wasn't within 10 years) and something happens, YOU will be held accountable. My medical record is documented and my parents will have a copy of everything to hold you liable. In the "clinical guidelines for managing adverse events after vaccination" table I received from the military (and gave my PCM), I followed it perfectly from local reaction through systemic event. Was seen in 3 hospitals (2 MTF, 1 CIV ER) which pointed to Anthrax vac. Still not recovered. I was in PERFECT health and taking no medications before Anthrax shot.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Headache, Hot flush, Immediate post-injection reaction, Injection site nodule, Injection site pain
Clinical narrative: Immediately following Anthrax vaccine I got a huge lump/nodule w/pain, swelling at the injection site. Reported this to PCM and Chief of staff after it was still there after 4 days and two other people with multiple injections received no local reaction. A couple days more I got hot/cold flashes, fever, weakness, muscle soreness. It went downhill from there as I was bedridden for 3 days and went into the ER. Temp 103 (rotated Tylenol and Motrin), headache, fatigue, cough, congestion, sore throat, abdominal pain and gas. The next morning I started vomiting and had severe respiratory problems and knew I was done. Contacted PCM and told to report to the ER. Severely dehydrated, couldn't breathe (2 words every 5 seconds, couldn't stand straight.) DX with Anthrax Allergy, then with Pneumonia (can kill.) Went through 4 bags of IV fluids/meds including steroids for Anthrax and Antibiotics, prescribed multiple meds. Went to hospital for 2 days. Put out 5 days. Then went from sore throat pain of 1 to 8 (agonizing, before the worst of excruciating) and contracted sneezing, stuffy and running nose w/headache. On about 8 meds and have been sick for 20 days! TWENTY days is extremely abnormal and still sick. I'm sick of being sick as you can imagine. Every Dr., NP, RN I talked to says they don't see me getting the shot again. PCM just said from what he reads it says to administer the 2nd dose. We'll see if the military (I'm being deployed report in a couple weeks) is naive enough to do this or will give me an exemption, or hopefully you'll intervene. If I'm given the 2nd dose (I also have to get small pox vac. even though I've already got small pox vac but it wasn't within 10 years) and something happens, YOU will be held accountable. My medical record is documented and my parents will have a copy of everything to hold you liable. In the "clinical guidelines for managing adverse events after vaccination" table I received from the military (and gave my PCM), I followed it perfectly from local reaction through systemic event. Was seen in 3 hospitals (2 MTF, 1 CIV ER) which pointed to Anthrax vac. Still not recovered. I was in PERFECT health and taking no medications before Anthrax shot.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Injection site swelling, Myalgia, Nasal congestion, Oropharyngeal pain, Pneumonia
Clinical narrative: Immediately following Anthrax vaccine I got a huge lump/nodule w/pain, swelling at the injection site. Reported this to PCM and Chief of staff after it was still there after 4 days and two other people with multiple injections received no local reaction. A couple days more I got hot/cold flashes, fever, weakness, muscle soreness. It went downhill from there as I was bedridden for 3 days and went into the ER. Temp 103 (rotated Tylenol and Motrin), headache, fatigue, cough, congestion, sore throat, abdominal pain and gas. The next morning I started vomiting and had severe respiratory problems and knew I was done. Contacted PCM and told to report to the ER. Severely dehydrated, couldn't breathe (2 words every 5 seconds, couldn't stand straight.) DX with Anthrax Allergy, then with Pneumonia (can kill.) Went through 4 bags of IV fluids/meds including steroids for Anthrax and Antibiotics, prescribed multiple meds. Went to hospital for 2 days. Put out 5 days. Then went from sore throat pain of 1 to 8 (agonizing, before the worst of excruciating) and contracted sneezing, stuffy and running nose w/headache. On about 8 meds and have been sick for 20 days! TWENTY days is extremely abnormal and still sick. I'm sick of being sick as you can imagine. Every Dr., NP, RN I talked to says they don't see me getting the shot again. PCM just said from what he reads it says to administer the 2nd dose. We'll see if the military (I'm being deployed report in a couple weeks) is naive enough to do this or will give me an exemption, or hopefully you'll intervene. If I'm given the 2nd dose (I also have to get small pox vac. even though I've already got small pox vac but it wasn't within 10 years) and something happens, YOU will be held accountable. My medical record is documented and my parents will have a copy of everything to hold you liable. In the "clinical guidelines for managing adverse events after vaccination" table I received from the military (and gave my PCM), I followed it perfectly from local reaction through systemic event. Was seen in 3 hospitals (2 MTF, 1 CIV ER) which pointed to Anthrax vac. Still not recovered. I was in PERFECT health and taking no medications before Anthrax shot.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Pyrexia, Respiratory disorder, Respiratory tract congestion, Rhinorrhoea, Sneezing
Clinical narrative: Immediately following Anthrax vaccine I got a huge lump/nodule w/pain, swelling at the injection site. Reported this to PCM and Chief of staff after it was still there after 4 days and two other people with multiple injections received no local reaction. A couple days more I got hot/cold flashes, fever, weakness, muscle soreness. It went downhill from there as I was bedridden for 3 days and went into the ER. Temp 103 (rotated Tylenol and Motrin), headache, fatigue, cough, congestion, sore throat, abdominal pain and gas. The next morning I started vomiting and had severe respiratory problems and knew I was done. Contacted PCM and told to report to the ER. Severely dehydrated, couldn't breathe (2 words every 5 seconds, couldn't stand straight.) DX with Anthrax Allergy, then with Pneumonia (can kill.) Went through 4 bags of IV fluids/meds including steroids for Anthrax and Antibiotics, prescribed multiple meds. Went to hospital for 2 days. Put out 5 days. Then went from sore throat pain of 1 to 8 (agonizing, before the worst of excruciating) and contracted sneezing, stuffy and running nose w/headache. On about 8 meds and have been sick for 20 days! TWENTY days is extremely abnormal and still sick. I'm sick of being sick as you can imagine. Every Dr., NP, RN I talked to says they don't see me getting the shot again. PCM just said from what he reads it says to administer the 2nd dose. We'll see if the military (I'm being deployed report in a couple weeks) is naive enough to do this or will give me an exemption, or hopefully you'll intervene. If I'm given the 2nd dose (I also have to get small pox vac. even though I've already got small pox vac but it wasn't within 10 years) and something happens, YOU will be held accountable. My medical record is documented and my parents will have a copy of everything to hold you liable. In the "clinical guidelines for managing adverse events after vaccination" table I received from the military (and gave my PCM), I followed it perfectly from local reaction through systemic event. Was seen in 3 hospitals (2 MTF, 1 CIV ER) which pointed to Anthrax vac. Still not recovered. I was in PERFECT health and taking no medications before Anthrax shot.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Vomiting
Clinical narrative: Immediately following Anthrax vaccine I got a huge lump/nodule w/pain, swelling at the injection site. Reported this to PCM and Chief of staff after it was still there after 4 days and two other people with multiple injections received no local reaction. A couple days more I got hot/cold flashes, fever, weakness, muscle soreness. It went downhill from there as I was bedridden for 3 days and went into the ER. Temp 103 (rotated Tylenol and Motrin), headache, fatigue, cough, congestion, sore throat, abdominal pain and gas. The next morning I started vomiting and had severe respiratory problems and knew I was done. Contacted PCM and told to report to the ER. Severely dehydrated, couldn't breathe (2 words every 5 seconds, couldn't stand straight.) DX with Anthrax Allergy, then with Pneumonia (can kill.) Went through 4 bags of IV fluids/meds including steroids for Anthrax and Antibiotics, prescribed multiple meds. Went to hospital for 2 days. Put out 5 days. Then went from sore throat pain of 1 to 8 (agonizing, before the worst of excruciating) and contracted sneezing, stuffy and running nose w/headache. On about 8 meds and have been sick for 20 days! TWENTY days is extremely abnormal and still sick. I'm sick of being sick as you can imagine. Every Dr., NP, RN I talked to says they don't see me getting the shot again. PCM just said from what he reads it says to administer the 2nd dose. We'll see if the military (I'm being deployed report in a couple weeks) is naive enough to do this or will give me an exemption, or hopefully you'll intervene. If I'm given the 2nd dose (I also have to get small pox vac. even though I've already got small pox vac but it wasn't within 10 years) and something happens, YOU will be held accountable. My medical record is documented and my parents will have a copy of everything to hold you liable. In the "clinical guidelines for managing adverse events after vaccination" table I received from the military (and gave my PCM), I followed it perfectly from local reaction through systemic event. Was seen in 3 hospitals (2 MTF, 1 CIV ER) which pointed to Anthrax vac. Still not recovered. I was in PERFECT health and taking no medications before Anthrax shot.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Asthenia, Blood creatine phosphokinase normal, Burning sensation, Chest X-ray abnormal, Cough
Clinical narrative: Immediately following Anthrax vaccine I got a huge lump/nodule w/pain, swelling at the injection site. Reported this to PCM and Chief of staff after it was still there after 4 days and two other people with multiple injections received no local reaction. A couple days more I got hot/cold flashes, fever, weakness, muscle soreness. It went downhill from there as I was bedridden for 3 days and went into the ER. Temp 103 (rotated Tylenol and Motrin), headache, fatigue, cough, congestion, sore throat, abdominal pain and gas. The next morning I started vomiting and had severe respiratory problems and knew I was done. Contacted PCM and told to report to the ER. Severely dehydrated, couldn't breathe (2 words every 5 seconds, couldn't stand straight.) DX with Anthrax Allergy, then with Pneumonia (can kill.) Went through 4 bags of IV fluids/meds including steroids for Anthrax and Antibiotics, prescribed multiple meds. Went to hospital for 2 days. Put out 5 days. Then went from sore throat pain of 1 to 8 (agonizing, before the worst of excruciating) and contracted sneezing, stuffy and running nose w/headache. On about 8 meds and have been sick for 20 days! TWENTY days is extremely abnormal and still sick. I'm sick of being sick as you can imagine. Every Dr., NP, RN I talked to says they don't see me getting the shot again. PCM just said from what he reads it says to administer the 2nd dose. We'll see if the military (I'm being deployed report in a couple weeks) is naive enough to do this or will give me an exemption, or hopefully you'll intervene. If I'm given the 2nd dose (I also have to get small pox vac. even though I've already got small pox vac but it wasn't within 10 years) and something happens, YOU will be held accountable. My medical record is documented and my parents will have a copy of everything to hold you liable. In the "clinical guidelines for managing adverse events after vaccination" table I received from the military (and gave my PCM), I followed it perfectly from local reaction through systemic event. Was seen in 3 hospitals (2 MTF, 1 CIV ER) which pointed to Anthrax vac. Still not recovered. I was in PERFECT health and taking no medications before Anthrax shot.