chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Balance disorder, Dysstasia, Gait disturbance, Headache
Clinical narrative: 7/3/08 headache - base of neck, tingling extremities 7/4 and 7/5 - tingling increasing 7/6 and 7/7 trouble standing/balance/walking; numbness; increasing weakness 7/8 hospitalized - 29 days 8/5 rehab inhouse 57 days. 9/30 starting outpatient rehab.
Age: 32.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 7/3/08 headache - base of neck, tingling extremities 7/4 and 7/5 - tingling increasing 7/6 and 7/7 trouble standing/balance/walking; numbness; increasing weakness 7/8 hospitalized - 29 days 8/5 rehab inhouse 57 days. 9/30 starting outpatient rehab.
Age: 58.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Alopecia, Insomnia, Neurological symptom, Visual disturbance, Weight decreased
Clinical narrative: On 18 SEP 2008 we received via agency the following information from a consumer: a 58-year-old female patient, born on 23 JUN 1949, was vaccinated i.m. with a rabies vaccine (manufacturer unknown) approximately 1 year ago, in 2007. It was reported that she had rapid weight loss, lack of sleep for over a year, hair loss, vision issues and neurological symptoms. Caller further states that she has had an abnormal antinuclear antibody titer which her doctor suggests may be scleroderma. Physician attributes her symptoms to possible autoimmune disease and not rabies vaccine received more than a year ago. Company assessment: Seriousness criterion: medically significant. Causality: not related (time interval much too long; physician explained, symptoms caused by scleroderma). Expectedness assessment according to agency label: The reported symptoms are not expected after vaccination with RabAvert. No change in benefit-risk-ratio. No measures necessary. Local log no. NA08-003620 Addendum On 23 SEP 2008 was received the information that RabAvert was used with the batch no. 419011A (expiry date 20 JUL 2010).  No change in assessment.
Age: 58.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Anxiety, Dysphonia, Immediate post-injection reaction, Insomnia, Laboratory test
Clinical narrative: On 18 SEP 2008 we received via agency the following information from a consumer: a 58-year-old female patient, born on 23 JUN 1949, was vaccinated i.m. with a rabies vaccine (manufacturer unknown) approximately 1 year ago, in 2007. It was reported that she had rapid weight loss, lack of sleep for over a year, hair loss, vision issues and neurological symptoms. Caller further states that she has had an abnormal antinuclear antibody titer which her doctor suggests may be scleroderma. Physician attributes her symptoms to possible autoimmune disease and not rabies vaccine received more than a year ago. Company assessment: Seriousness criterion: medically significant. Causality: not related (time interval much too long; physician explained, symptoms caused by scleroderma). Expectedness assessment according to agency label: The reported symptoms are not expected after vaccination with RabAvert. No change in benefit-risk-ratio. No measures necessary. Local log no. NA08-003620 Addendum On 23 SEP 2008 was received the information that RabAvert was used with the batch no. 419011A (expiry date 20 JUL 2010).  No change in assessment.
Age: 58.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Madarosis, Nail bed inflammation, Night sweats, Photopsia, Rash
Clinical narrative: On 18 SEP 2008 we received via agency the following information from a consumer: a 58-year-old female patient, born on 23 JUN 1949, was vaccinated i.m. with a rabies vaccine (manufacturer unknown) approximately 1 year ago, in 2007. It was reported that she had rapid weight loss, lack of sleep for over a year, hair loss, vision issues and neurological symptoms. Caller further states that she has had an abnormal antinuclear antibody titer which her doctor suggests may be scleroderma. Physician attributes her symptoms to possible autoimmune disease and not rabies vaccine received more than a year ago. Company assessment: Seriousness criterion: medically significant. Causality: not related (time interval much too long; physician explained, symptoms caused by scleroderma). Expectedness assessment according to agency label: The reported symptoms are not expected after vaccination with RabAvert. No change in benefit-risk-ratio. No measures necessary. Local log no. NA08-003620 Addendum On 23 SEP 2008 was received the information that RabAvert was used with the batch no. 419011A (expiry date 20 JUL 2010).  No change in assessment.
Age: 58.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Skin atrophy, Tachycardia, Tremor, Vitreous detachment, Weight decreased
Clinical narrative: On 18 SEP 2008 we received via agency the following information from a consumer: a 58-year-old female patient, born on 23 JUN 1949, was vaccinated i.m. with a rabies vaccine (manufacturer unknown) approximately 1 year ago, in 2007. It was reported that she had rapid weight loss, lack of sleep for over a year, hair loss, vision issues and neurological symptoms. Caller further states that she has had an abnormal antinuclear antibody titer which her doctor suggests may be scleroderma. Physician attributes her symptoms to possible autoimmune disease and not rabies vaccine received more than a year ago. Company assessment: Seriousness criterion: medically significant. Causality: not related (time interval much too long; physician explained, symptoms caused by scleroderma). Expectedness assessment according to agency label: The reported symptoms are not expected after vaccination with RabAvert. No change in benefit-risk-ratio. No measures necessary. Local log no. NA08-003620 Addendum On 23 SEP 2008 was received the information that RabAvert was used with the batch no. 419011A (expiry date 20 JUL 2010).  No change in assessment.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Laboratory test
Clinical narrative: Information has been received through the Merck Pregnancy Registry from a physician concerning a 24 year old female, with no pertinent medical history, who on 21-JUN-2007 was vaccinated with a first dose of GARDASIL. Subsequently, the patient became pregnant. On an unspecified date the patient was seen in the doctor's office for an obstetrics visit. "The routine obstetrics lab work was taken" (results not reported). Her last menstrual period was 27-MAY-2007 and the estimated date of delivery was 02-MAR-2008. Follow-up information was received via phone call on 22-SEP-2008 from two other health professionals indicating that the baby was born on 28-FEB-2008 by C-section. The baby was born normal and healthy. There were no problems with the mother or the baby. The mother was seen for post partum visit and "everything is just fine". Upon internal review, birth by C-section was determined to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Breech presentation, Caesarean section, Drug exposure during pregnancy, Foetal disorder, Ultrasound scan normal
Clinical narrative: Information has been received from Merck pregnancy registry through a health professional concerning a 16 year old female with a medical history of tonsillectomy 4 years ago, and with no allergies, who on 23-JAN-2008 was vaccinated IM with the first dose of GARDASIL (lot# 659657/1487U). Concomitant therapy included Tdap and MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD). On 28-Feb-2008 it was determined that the patient was pregnant with a LMP of 09-Dec-2007. The patient will be seeing the physician. The patient's outcome is unknown. Follow up information was received from a physician who reported that the patient was taking prenatal vitamins during her pregnancy. On 02-MAY-2008 the patient had ultrasound test for sex of baby and the result indicated within normal limits. On 01-SEP-2008 due to the baby was breech, the patient underwent c-section and delivered a normal, but small male baby whose weight was 4 pounds and 9 ounces and height was 17 inches. Upon internal review, c-section due to breech presentation was determined to be an other important medical event. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blindness, Hair disorder, Headache, Immune system disorder
Clinical narrative: Information has been received from a 22 year old female who in December 2006, received the second vaccination of GARDASIL (lot # not provided). Concomitant therapy included unspecified vitamins. The patient reported "constant sickness", her "vision was really screwed up," and hair loss and hair change on her 2nd dose of GARDASIL. She "had no side effects on the 1st dose and chose not to have the 3rd dose". The patient reported she "felt fine" after her 2nd shot but the next morning at work her vision "completely went". She felt "like there was a white veil over" her eyes, "like half of 1 of the eyes was working, the other half was gray". She had to be driven home since she could not see. She said she "had a very bad headache". Her gynecologist, did not know the cause of her symptoms. The patient reported she in general does not get very sick, but from her 2nd dose to June 2007, she was "constantly sick with the same cold and infection". The patient believes GARDASIL "knocked" her immune system. She "could not keep anything down for 6 months and had stool samples done last year after the shot". In June 2007, the patient and her hairdresser noticed her "hair part was so wide" and the patient's "hair looked like it was thinning". She visited a dermatologist. She said now her "hair is not as bad as June 2007, maybe because of popping 8-9 vitamins a day" (manufacturer unspecified), but she does "not see a lot of regrowth". She does "not have baldness spots, but it has fallen out more" than she has ever seen. Dr. ran bloodwork less than a week ago. The patient is also concerned about her fertility, but has not reported fertility problems. The patient had no pertinent medical history. At the time of the report, the patient was recovering. Upon internal review, loss of vision was considered to be an other important medical event. Additional information has been requested.   12/26/2008 MR received from PCP. Reported to PCP on 3/2/07 that since receiving HPV vax pt has been having blurry vision and dizziness. Returned 3/8/07 with c/o feeling weak and tired. ? side effect from HPV vaccine. Returned 3/20/07 with c/o sore throat, T=101, some cough and clear mucus. Heart rate noted to be irregular.  Likely sinusitis. Tx-abx. Retuened 4/16/07 with return of sinus pressure. Tx-abx. Returned 5/21/07 with c/o stomach pain x 1 1/2 weeks, dizziness on/off,and vomiting.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Infection, Laboratory test, Malaise, Nasopharyngitis, Visual disturbance
Clinical narrative: Information has been received from a 22 year old female who in December 2006, received the second vaccination of GARDASIL (lot # not provided). Concomitant therapy included unspecified vitamins. The patient reported "constant sickness", her "vision was really screwed up," and hair loss and hair change on her 2nd dose of GARDASIL. She "had no side effects on the 1st dose and chose not to have the 3rd dose". The patient reported she "felt fine" after her 2nd shot but the next morning at work her vision "completely went". She felt "like there was a white veil over" her eyes, "like half of 1 of the eyes was working, the other half was gray". She had to be driven home since she could not see. She said she "had a very bad headache". Her gynecologist, did not know the cause of her symptoms. The patient reported she in general does not get very sick, but from her 2nd dose to June 2007, she was "constantly sick with the same cold and infection". The patient believes GARDASIL "knocked" her immune system. She "could not keep anything down for 6 months and had stool samples done last year after the shot". In June 2007, the patient and her hairdresser noticed her "hair part was so wide" and the patient's "hair looked like it was thinning". She visited a dermatologist. She said now her "hair is not as bad as June 2007, maybe because of popping 8-9 vitamins a day" (manufacturer unspecified), but she does "not see a lot of regrowth". She does "not have baldness spots, but it has fallen out more" than she has ever seen. Dr. ran bloodwork less than a week ago. The patient is also concerned about her fertility, but has not reported fertility problems. The patient had no pertinent medical history. At the time of the report, the patient was recovering. Upon internal review, loss of vision was considered to be an other important medical event. Additional information has been requested.   12/26/2008 MR received from PCP. Reported to PCP on 3/2/07 that since receiving HPV vax pt has been having blurry vision and dizziness. Returned 3/8/07 with c/o feeling weak and tired. ? side effect from HPV vaccine. Returned 3/20/07 with c/o sore throat, T=101, some cough and clear mucus. Heart rate noted to be irregular.  Likely sinusitis. Tx-abx. Retuened 4/16/07 with return of sinus pressure. Tx-abx. Returned 5/21/07 with c/o stomach pain x 1 1/2 weeks, dizziness on/off,and vomiting.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a 22 year old female who in December 2006, received the second vaccination of GARDASIL (lot # not provided). Concomitant therapy included unspecified vitamins. The patient reported "constant sickness", her "vision was really screwed up," and hair loss and hair change on her 2nd dose of GARDASIL. She "had no side effects on the 1st dose and chose not to have the 3rd dose". The patient reported she "felt fine" after her 2nd shot but the next morning at work her vision "completely went". She felt "like there was a white veil over" her eyes, "like half of 1 of the eyes was working, the other half was gray". She had to be driven home since she could not see. She said she "had a very bad headache". Her gynecologist, did not know the cause of her symptoms. The patient reported she in general does not get very sick, but from her 2nd dose to June 2007, she was "constantly sick with the same cold and infection". The patient believes GARDASIL "knocked" her immune system. She "could not keep anything down for 6 months and had stool samples done last year after the shot". In June 2007, the patient and her hairdresser noticed her "hair part was so wide" and the patient's "hair looked like it was thinning". She visited a dermatologist. She said now her "hair is not as bad as June 2007, maybe because of popping 8-9 vitamins a day" (manufacturer unspecified), but she does "not see a lot of regrowth". She does "not have baldness spots, but it has fallen out more" than she has ever seen. Dr. ran bloodwork less than a week ago. The patient is also concerned about her fertility, but has not reported fertility problems. The patient had no pertinent medical history. At the time of the report, the patient was recovering. Upon internal review, loss of vision was considered to be an other important medical event. Additional information has been requested.   12/26/2008 MR received from PCP. Reported to PCP on 3/2/07 that since receiving HPV vax pt has been having blurry vision and dizziness. Returned 3/8/07 with c/o feeling weak and tired. ? side effect from HPV vaccine. Returned 3/20/07 with c/o sore throat, T=101, some cough and clear mucus. Heart rate noted to be irregular.  Likely sinusitis. Tx-abx. Retuened 4/16/07 with return of sinus pressure. Tx-abx. Returned 5/21/07 with c/o stomach pain x 1 1/2 weeks, dizziness on/off,and vomiting.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Asthenia, Bundle branch block right, Dizziness, Electrocardiogram abnormal, Malaise
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 13-AUG-2008 was vaccinated with GARDASIL (lot #659184/0843X) and BOOSTRIX (lot #AC52B027AA) both via IM into her left arm at 2:00 PM.  After the vaccination at 2:25 p.m., the patient did not feel good, then she was feeling dizzy.  She was talking, but later on was weak, so she was placed on the table to lie down and an ambulance was called.  An electrocardiogram (EKG) showed right bundle branch block.  Her outcome was not provided.  The reporter considered the events to be other important medical events.  Additional information has been requested. 10/10/2008 MR received for ER visit 8/13/08 with Dx: Vasovagal syncope. Pt passed out shortly after receiving Gardasil injection. Transported by EMS to ER. Normal exam in ER except EKG showed possible RVH. D/C home.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Bundle branch block right, Electrocardiogram abnormal, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 13-AUG-2008 was vaccinated with GARDASIL (lot #659184/0843X) and BOOSTRIX (lot #AC52B027AA) both via IM into her left arm at 2:00 PM.  After the vaccination at 2:25 p.m., the patient did not feel good, then she was feeling dizzy.  She was talking, but later on was weak, so she was placed on the table to lie down and an ambulance was called.  An electrocardiogram (EKG) showed right bundle branch block.  Her outcome was not provided.  The reporter considered the events to be other important medical events.  Additional information has been requested. 10/10/2008 MR received for ER visit 8/13/08 with Dx: Vasovagal syncope. Pt passed out shortly after receiving Gardasil injection. Transported by EMS to ER. Normal exam in ER except EKG showed possible RVH. D/C home.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a vaccine nurse concerning 6 or 7 kids who were vaccinated with GARDASIL (lot # not provided).  Subsequently the patients experienced seizure.  The patients sought for unspecified medical attention.  Upon internal review, "seizure" was considered to be an other important medical event.  Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Arteriogram renal, Catheterisation cardiac normal, Ear discomfort, Ear pain, Exercise test normal
Clinical narrative: Information has been received from a female registered nurse with 72 drug allergies and a history of scoliosis when was child who on 21-MAY-2008 was vaccinated with one dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included vitamins and "something for pain".  On an unspecified date, the nurse developed general malaise for one week, injection site reaction with swelling and pain at the site, severe headache over the right eye, the nurse thought "she was having a brain tumor", right ear ache that then became "stuffy", severe jaw pain, the nurse thought "she was having a coronary", uncontrollable hypertension (190/100).  Her blood pressure use to run in the 130's.  She also developed a rash on the trunk that was resolved.  The nurse felt "like she was losing her mind".  The nurse has seen an ear, nose and throat specialist and it is questionable if she is suffering from temporomandibular joint.  The nurse also saw a cardiologist and has been placed on medication for the hypertension that has not been controlled at the time of the report.  The nurse was hospitalized due to hypertension and was discharged on 15-SEP-2008.  The nurse has undergone a "cardiac cath" that was negative, a cardiac stress test that was negative, a renal sonogram that was negative and a renal arteriogram that was pending.  The nurse also mentioned that she had developed a rash after receiving the influenza virus vaccine (unspecified).  She did not received influenza virus vaccine (unspecified) and ZOSTAVAX (Oka/Merck) at the same time.  The nurse's status at the time of the report was not recovered.  Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Hypertension, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a female registered nurse with 72 drug allergies and a history of scoliosis when was child who on 21-MAY-2008 was vaccinated with one dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included vitamins and "something for pain".  On an unspecified date, the nurse developed general malaise for one week, injection site reaction with swelling and pain at the site, severe headache over the right eye, the nurse thought "she was having a brain tumor", right ear ache that then became "stuffy", severe jaw pain, the nurse thought "she was having a coronary", uncontrollable hypertension (190/100).  Her blood pressure use to run in the 130's.  She also developed a rash on the trunk that was resolved.  The nurse felt "like she was losing her mind".  The nurse has seen an ear, nose and throat specialist and it is questionable if she is suffering from temporomandibular joint.  The nurse also saw a cardiologist and has been placed on medication for the hypertension that has not been controlled at the time of the report.  The nurse was hospitalized due to hypertension and was discharged on 15-SEP-2008.  The nurse has undergone a "cardiac cath" that was negative, a cardiac stress test that was negative, a renal sonogram that was negative and a renal arteriogram that was pending.  The nurse also mentioned that she had developed a rash after receiving the influenza virus vaccine (unspecified).  She did not received influenza virus vaccine (unspecified) and ZOSTAVAX (Oka/Merck) at the same time.  The nurse's status at the time of the report was not recovered.  Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in jaw, Rash, Ultrasound kidney normal
Clinical narrative: Information has been received from a female registered nurse with 72 drug allergies and a history of scoliosis when was child who on 21-MAY-2008 was vaccinated with one dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included vitamins and "something for pain".  On an unspecified date, the nurse developed general malaise for one week, injection site reaction with swelling and pain at the site, severe headache over the right eye, the nurse thought "she was having a brain tumor", right ear ache that then became "stuffy", severe jaw pain, the nurse thought "she was having a coronary", uncontrollable hypertension (190/100).  Her blood pressure use to run in the 130's.  She also developed a rash on the trunk that was resolved.  The nurse felt "like she was losing her mind".  The nurse has seen an ear, nose and throat specialist and it is questionable if she is suffering from temporomandibular joint.  The nurse also saw a cardiologist and has been placed on medication for the hypertension that has not been controlled at the time of the report.  The nurse was hospitalized due to hypertension and was discharged on 15-SEP-2008.  The nurse has undergone a "cardiac cath" that was negative, a cardiac stress test that was negative, a renal sonogram that was negative and a renal arteriogram that was pending.  The nurse also mentioned that she had developed a rash after receiving the influenza virus vaccine (unspecified).  She did not received influenza virus vaccine (unspecified) and ZOSTAVAX (Oka/Merck) at the same time.  The nurse's status at the time of the report was not recovered.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 4 year old male with asthma and eczema and no known drug reactions/allergies who on 23-JUL-2008 afternoon was vaccinated in right arm with the second dose of VARIVAX (LOT# 661443/0528X) and was also vaccinated with the second dose of MMR II (LOT# 656864/0412U) in the same arm. Other vaccinations included IPOL (unspecified) (WYETH - LOT# A0126) and INFANRIX (LOT# AC14B067BA) in the other arm. Other concomitant therapy included montelukast sodium. There was no illness at time of vaccination. On 28-JUL-2008 the patient developed vesicular rash at sites of eczema. On 29-JUL-2008 the patient returned to clinic and presented with an itchy rash in the eczema area and in the bend of the same arm he received the VARIVAX. The patient was prescribed acyclovir (manufacturer unspecified), BENADRYL and standard topical steroid cream. The patient was consulted with dermatologist. The patient's symptoms persisted. The patient was held out of daycare. Vesicular pruritic rash at sites of eczema was considered to be disabling. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Idiopathic thrombocytopenic purpura, Pyrexia
Clinical narrative: C/O fever and ITP x5-6 days - Mom went to ped E.D. 9/15/08 at 10 AM for evaluation - then admitted to inpatient for further mgmt by ped. hematology. Currently being treated with supportive therapy and empiric IV antibiotic therapy - awaiting culture results (see note) and bone marrow pathology. 10/1/08 Reviewed hospital medical records of 9/15-9/18/2008. FINAL DX: atypical idiopathic thrombocytopenic, extension of chronic skin condition Records reveal patient experienced fever x 10 days, nasal congestion, mild periumbilical pain, fatigue, thigh myalgias, bruising/petechia, 4-hour nosebleed, gum bleeding x 1 week.  Tx w/IVF, IV antibiotics, steroids. Derm & Rheum consults done.  Derm felt rash probably viral exanthem.  Rheum felt probable evolving SLE.  Improved & d/c to home on tapering steroids to be f/u in heme/onc clinic.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: CSF culture positive, Depressed level of consciousness, Gram stain positive, Listless, Pallor
Clinical narrative: Family called at 4:44 am on 9-13-08. Pt had T -> 100.5 earlier in PM, (V) xT, and was listless and pale with decreased responsiveness. Sent to ER.   10/10/08 Reviewed hospital medical records of 9/13-9/27/2008. FINAL DX: streptococcus pneumoniae meningitis, right OM w/effusion, let hemiparesis & focal left-sided seizures, both secondary to strep pneumoniae. Records reveal patient experienced fever, rash 1 week prior that had resolved by admit, irritability, decreased appetite, sleepiness, projectile emesis & loose stool x 1 day, listless, pale.  Seen at outlying ER & transferred to higher level of care.  Admitted to PICU & tx w/IV antibiotics.  Developed respiratory distress & failure along w/seizures.  Intubated & tx w/antiseizure meds.  Neuro & ID consults done.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Streptococcal identification test positive
Clinical narrative: Family called at 4:44 am on 9-13-08. Pt had T -> 100.5 earlier in PM, (V) xT, and was listless and pale with decreased responsiveness. Sent to ER.   10/10/08 Reviewed hospital medical records of 9/13-9/27/2008. FINAL DX: streptococcus pneumoniae meningitis, right OM w/effusion, let hemiparesis & focal left-sided seizures, both secondary to strep pneumoniae. Records reveal patient experienced fever, rash 1 week prior that had resolved by admit, irritability, decreased appetite, sleepiness, projectile emesis & loose stool x 1 day, listless, pale.  Seen at outlying ER & transferred to higher level of care.  Admitted to PICU & tx w/IV antibiotics.  Developed respiratory distress & failure along w/seizures.  Intubated & tx w/antiseizure meds.  Neuro & ID consults done.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Hearing impaired, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Vaccine administered around 11:30 am in (L) arm. Pt immediately felt a little unusual gi upset. Once she got to lobby, she broke out in drenching sweat and sat down and passed out for 5-10 sec. Vision and hearing seemed "fuzzy". Symptoms resolved by 3:30 pm
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Vaccine administered around 11:30 am in (L) arm. Pt immediately felt a little unusual gi upset. Once she got to lobby, she broke out in drenching sweat and sat down and passed out for 5-10 sec. Vision and hearing seemed "fuzzy". Symptoms resolved by 3:30 pm
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Joint range of motion decreased, Oedema
Clinical narrative: Pt. called on 9-17-08 complaining of pain at injection site since given 09-03-08. 9/18/08 pt seen in office-treated by NP. 9/22/08 PC to pt, feeling better, decreased redness and edema, better ROM. NP
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash under arms, breasts and waist areas.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture, Crying, Cyanosis, Decreased appetite, Fluid intake reduced
Clinical narrative: Fever up to 102.5, swelling of hands, feet, legs and forearms, whining and crying, decreased appetite, decreased fluid intake, blotchy bluish skin color of hands and forearms.  Patient treated with Rocephin IM prophylactically for possible "blood infection".
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count, Metabolic function test, Pyrexia, Rash macular, Swelling
Clinical narrative: Fever up to 102.5, swelling of hands, feet, legs and forearms, whining and crying, decreased appetite, decreased fluid intake, blotchy bluish skin color of hands and forearms.  Patient treated with Rocephin IM prophylactically for possible "blood infection".
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urine analysis
Clinical narrative: Fever up to 102.5, swelling of hands, feet, legs and forearms, whining and crying, decreased appetite, decreased fluid intake, blotchy bluish skin color of hands and forearms.  Patient treated with Rocephin IM prophylactically for possible "blood infection".
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Patient complained of swelling in area afternoon after shot.  Some itching.  Pink area 7 cm x 5.5 x cm with dark, red area in center 3 cm x 3 cm.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Fatigue, Pain
Clinical narrative: Patient states the day after receiving TDAP she felt dizzy, body aches, trouble breathing, very tired.  She stated "she knows her body and wanted to report this" to make sure she did not get the shot again.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None Stated.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Cellulitis right arm
Age: 5.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: R shoulder 25.8 cm, L shoulder 21.6 cm, R bicep 22 cm, L bicep 18 cm, R elbow 19 cm, L elbow 17 cm.  Redness, swelling noted 9/25 by parents.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Gave vaccine and 2 days later pt had a normal reaction to vaccine (bumps around injection site).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on trunk starting 2 day after immunizations. Grandmother gave Benadryl 9/24/08 in PM after call to nurse and hives had resolved by late 9/24/08. Sulfa stopped by grandmother on 9/24/08 PM.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Lymphadenopathy, Pruritus generalised, Rash
Clinical narrative: Rabies vaccine #2 of possible 3 - had itching all over body w/ rash, swollen lymph node to left side of neck.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC, VARCEL
Symptoms: Injection site abscess
Clinical narrative: Vaccines were given on 9/9/08. Pt was seen in the ER on 9/17. He was diagnosed with bilateral abscesses of the upper legs.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site pain, Oedema peripheral, Pyrexia
Clinical narrative: Received DTaP, HPV and IPV afternoon of 9-19-08. Began that evening with fever to 103 and leg pain. Continued through 9-21-08. Evening of 9-21-08, leg noted to be swollen. Today (9-22-08) red area noted. Non tender. Prescribed Keflex 250mg BID x 7d. DTaP given in (R) thigh - area of pain and redness.
Age: 1.6
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pronounced area of erythema (5"x3.5") and induration, warmth surrounding DTaP injection site. Resulted in ER and clinic visit.
Age: 1.1
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Injection site urticaria
Clinical narrative: Varicella vaccine was given in left anterior thigh. Immediately following the vaccine the patients leg appeared very red with welts measuring about 2 inches. no systemic signs. Observed patient for 30 mins in office and applied cold compress for 8 minutes.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Cough, Pruritus, Urticaria, Vomiting
Clinical narrative: Abdominal pain, emesis, cough, urticarial rash and pruritis - all symptoms within approximately 10-15 minutes of vaccine administration.  He was given Benadryl 25mg and Solu-Medrol 60mg IM in office and transported to ER in stable condition.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine reaction w/swollen and redness on (B) arms. MOTRIN and BENADRYL were given. ((L) 4/2 cm (R) 10x11 cm) & cold compression.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Crying, Lethargy, Pyrexia
Clinical narrative: Patient's mother came to clinic with his sibling.  She refused to allow this child to get an IPV.  After questioning, she stated patient had ran a high fever after he was given an IPV.  She stated he had a IPV on 8/22/08 in A.M. between 8 & 10 and by noon he had a temperature of 104.2, this lasted 4 days.  He was lethargic and crying.  She called Call-A-Nurse and spoke with her doctor during this time, he was not seen by anyone.  She stated she alternated Tylenol and Motrin dosages, as she was instructed, until the fever subsided.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: redness, itching, hot, hard welt appeared at injection site
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Albumin globulin ratio normal, Aspartate aminotransferase increased, Band neutrophil percentage, Basophil count normal, Beta globulin normal
Clinical narrative: Kounis syndrome: Acute myocardial infarct from histamine release.   9/30/08 Case closed with medical records that accompanied report. FINAL DX: allergic induced acute inferior wall MI secondary to histamine release; Kounis syndrome Records reveal patient experienced fever, HA, myalgias, nausea, vomiting, burning chest pain, sleep disturbance, pale, fatigue, injection site redness.  Hospitalized 9/6-9/8/08.  Cardio consult done & felt MI due to massive histamine release leading to coronary spasm.  Tx w/meds & improved.  D/C to home.  Readmitted to hospital 9/20-21/2008 for non-cardiac chest pain thought to be secondary to recent med change. Meds adjusted upward & also referred to allergist.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride normal
Clinical narrative: Kounis syndrome: Acute myocardial infarct from histamine release.   9/30/08 Case closed with medical records that accompanied report. FINAL DX: allergic induced acute inferior wall MI secondary to histamine release; Kounis syndrome Records reveal patient experienced fever, HA, myalgias, nausea, vomiting, burning chest pain, sleep disturbance, pale, fatigue, injection site redness.  Hospitalized 9/6-9/8/08.  Cardio consult done & felt MI due to massive histamine release leading to coronary spasm.  Tx w/meds & improved.  D/C to home.  Readmitted to hospital 9/20-21/2008 for non-cardiac chest pain thought to be secondary to recent med change. Meds adjusted upward & also referred to allergist.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Blood creatine phosphokinase increased, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium decreased
Clinical narrative: Kounis syndrome: Acute myocardial infarct from histamine release.   9/30/08 Case closed with medical records that accompanied report. FINAL DX: allergic induced acute inferior wall MI secondary to histamine release; Kounis syndrome Records reveal patient experienced fever, HA, myalgias, nausea, vomiting, burning chest pain, sleep disturbance, pale, fatigue, injection site redness.  Hospitalized 9/6-9/8/08.  Cardio consult done & felt MI due to massive histamine release leading to coronary spasm.  Tx w/meds & improved.  D/C to home.  Readmitted to hospital 9/20-21/2008 for non-cardiac chest pain thought to be secondary to recent med change. Meds adjusted upward & also referred to allergist.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Blood urea normal, Carbon dioxide normal, Chest X-ray normal, Eosinophil count normal, Haematocrit decreased
Clinical narrative: Kounis syndrome: Acute myocardial infarct from histamine release.   9/30/08 Case closed with medical records that accompanied report. FINAL DX: allergic induced acute inferior wall MI secondary to histamine release; Kounis syndrome Records reveal patient experienced fever, HA, myalgias, nausea, vomiting, burning chest pain, sleep disturbance, pale, fatigue, injection site redness.  Hospitalized 9/6-9/8/08.  Cardio consult done & felt MI due to massive histamine release leading to coronary spasm.  Tx w/meds & improved.  D/C to home.  Readmitted to hospital 9/20-21/2008 for non-cardiac chest pain thought to be secondary to recent med change. Meds adjusted upward & also referred to allergist.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Haemoglobin decreased, Hypersensitivity, Leukocytosis, Lymphocyte count decreased, Mean cell haemoglobin concentration
Clinical narrative: Kounis syndrome: Acute myocardial infarct from histamine release.   9/30/08 Case closed with medical records that accompanied report. FINAL DX: allergic induced acute inferior wall MI secondary to histamine release; Kounis syndrome Records reveal patient experienced fever, HA, myalgias, nausea, vomiting, burning chest pain, sleep disturbance, pale, fatigue, injection site redness.  Hospitalized 9/6-9/8/08.  Cardio consult done & felt MI due to massive histamine release leading to coronary spasm.  Tx w/meds & improved.  D/C to home.  Readmitted to hospital 9/20-21/2008 for non-cardiac chest pain thought to be secondary to recent med change. Meds adjusted upward & also referred to allergist.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Mean cell haemoglobin normal, Mean cell volume, Monocyte count normal, Platelet count normal, Protein total normal
Clinical narrative: Kounis syndrome: Acute myocardial infarct from histamine release.   9/30/08 Case closed with medical records that accompanied report. FINAL DX: allergic induced acute inferior wall MI secondary to histamine release; Kounis syndrome Records reveal patient experienced fever, HA, myalgias, nausea, vomiting, burning chest pain, sleep disturbance, pale, fatigue, injection site redness.  Hospitalized 9/6-9/8/08.  Cardio consult done & felt MI due to massive histamine release leading to coronary spasm.  Tx w/meds & improved.  D/C to home.  Readmitted to hospital 9/20-21/2008 for non-cardiac chest pain thought to be secondary to recent med change. Meds adjusted upward & also referred to allergist.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Red blood cell count decreased, Red cell distribution width normal, Troponin I increased, White blood cell count increased
Clinical narrative: Kounis syndrome: Acute myocardial infarct from histamine release.   9/30/08 Case closed with medical records that accompanied report. FINAL DX: allergic induced acute inferior wall MI secondary to histamine release; Kounis syndrome Records reveal patient experienced fever, HA, myalgias, nausea, vomiting, burning chest pain, sleep disturbance, pale, fatigue, injection site redness.  Hospitalized 9/6-9/8/08.  Cardio consult done & felt MI due to massive histamine release leading to coronary spasm.  Tx w/meds & improved.  D/C to home.  Readmitted to hospital 9/20-21/2008 for non-cardiac chest pain thought to be secondary to recent med change. Meds adjusted upward & also referred to allergist.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Hypoaesthesia, Pruritus generalised
Clinical narrative: Itching all over my upper body, fingers going numb,; its been going on for 2-3 days.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Patient broke out in welts on the back of his neck and chest and face and chin. No respiratory distress or SOB patient was given benadryl symptoms went away. Symptoms continued to reoccur for 2 days straight.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Developed mild case of chicken pox.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Feeling hot, Injection site pain, Myalgia
Clinical narrative: At 7:00 PM I received the flu shot. At 12:15 AM I start coughing because I felt like something was suddenly in my throat. My throat quickly warmed and the warming sensation traveled along my throat down into my chest. I then start having chills and shaking. Vomiting and dry heaving followed with extreme muscle ache. The muscle was so intense that it hurt to lay down and I could not get comfortable. These symptoms lasted until about 4:00 Am. I had muscle soreness and a tender arm where I received the injection for 2 days following.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Retching, Sensation of foreign body, Tremor, Vomiting
Clinical narrative: At 7:00 PM I received the flu shot. At 12:15 AM I start coughing because I felt like something was suddenly in my throat. My throat quickly warmed and the warming sensation traveled along my throat down into my chest. I then start having chills and shaking. Vomiting and dry heaving followed with extreme muscle ache. The muscle was so intense that it hurt to lay down and I could not get comfortable. These symptoms lasted until about 4:00 Am. I had muscle soreness and a tender arm where I received the injection for 2 days following.
Age: 16.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Activities of daily living impaired, Pyrexia, Testicular pain
Clinical narrative: Patient received an unauthorized meningitis shot and tetanus shot as part of a routine sports physical. Patient has a moderate case of CMT, affecting only his lower extremities. Within three hours he began complaining of pain in his testicles. The pain increased to the point he was sent home from basketball practice and could not attend school for two days. He had a fever of about 102 degrees.The pain moved to his upper groin area and subsided on day three. We are concerned about potential long term effects of this problem.
Age: 14.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Dizziness, Erythema, Hypertonia, Immediate post-injection reaction, Pallor
Clinical narrative: Pt received flu vaccine in left deltoid and then Menactra in right deltoid;immediately after Menactra given as bandaid about to be applied,pt became very pale and faint.Pt was assisted to a supine position and then noted to be very red in the face,eyes staring,unresponsive,arms and legs tonic for approx 10 seconds.Immediately afterwards pt talking and responsive.examined by Dr. Pt given juice and crackers and remained supine for approx 20mins then allowed to sit but pallor returned slightly so he reclined again.After further 20 mins pt gradually acheived a sitting position.Eventually able to leave office in a wheelchair expressing acute hunger for lunch.
Age: 14.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Pt received flu vaccine in left deltoid and then Menactra in right deltoid;immediately after Menactra given as bandaid about to be applied,pt became very pale and faint.Pt was assisted to a supine position and then noted to be very red in the face,eyes staring,unresponsive,arms and legs tonic for approx 10 seconds.Immediately afterwards pt talking and responsive.examined by Dr. Pt given juice and crackers and remained supine for approx 20mins then allowed to sit but pallor returned slightly so he reclined again.After further 20 mins pt gradually acheived a sitting position.Eventually able to leave office in a wheelchair expressing acute hunger for lunch.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient devloped redness, heat and swelling below injection site.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Areflexia, Blood pressure normal, Blood test normal, Diplegia
Clinical narrative: She recieved the Gardasil series, which ended in June of 2008. In the first weeks of September 2008, she began to suffer from her tongue becoming paralyzed. On September 23rd, 2008 she woke up and could no longer walk. Her legs had become so weak and then paralyzed. She was hospitalized and now cannot walk, her arms are now becoming weak, and her speech has slowed and has stuttering.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphemia, Electrocardiogram normal, Lumbar puncture normal, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: She recieved the Gardasil series, which ended in June of 2008. In the first weeks of September 2008, she began to suffer from her tongue becoming paralyzed. On September 23rd, 2008 she woke up and could no longer walk. Her legs had become so weak and then paralyzed. She was hospitalized and now cannot walk, her arms are now becoming weak, and her speech has slowed and has stuttering.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Reflex test abnormal, Speech disorder, Tongue paralysis
Clinical narrative: She recieved the Gardasil series, which ended in June of 2008. In the first weeks of September 2008, she began to suffer from her tongue becoming paralyzed. On September 23rd, 2008 she woke up and could no longer walk. Her legs had become so weak and then paralyzed. She was hospitalized and now cannot walk, her arms are now becoming weak, and her speech has slowed and has stuttering.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: left arm swollen, pain down arm, not relieved by anti-inflamatory, some nausea....limited range of motion
Age: 26.0
Sex: F
Vaccine: ANTH, ANTH, ANTH
Symptoms: Asthenia, Fatigue, Migraine, Nodule
Clinical narrative: Weakness in upper-body.  Extreme fatigue.  Chronic migranes.  Nodular bumps on scalp and back.  Currently being test for arthritis.
Age: 26.0
Sex: F
Vaccine: ANTH, ANTH, ANTH
Symptoms: Asthenia, Fatigue, Headache, Hypoaesthesia, Neck pain
Clinical narrative: Weakness in upper-body.  Extreme fatigue.  Chronic migranes.  Nodular bumps on scalp and back.  Currently being test for arthritis.
Age: 26.0
Sex: F
Vaccine: ANTH, ANTH, ANTH
Symptoms: Nodule, Pain in extremity
Clinical narrative: Weakness in upper-body.  Extreme fatigue.  Chronic migranes.  Nodular bumps on scalp and back.  Currently being test for arthritis.
Sex: F
Vaccine: ANTH, ANTH, ANTH
Symptoms: Asthenia, Fatigue, Migraine, Nodule
Clinical narrative: Headaches, nodulars, fatigue, numbness and weakness in upperbody, neck and arm pain--chronic.
Sex: F
Vaccine: ANTH, ANTH, ANTH
Symptoms: Asthenia, Fatigue, Headache, Hypoaesthesia, Neck pain
Clinical narrative: Headaches, nodulars, fatigue, numbness and weakness in upperbody, neck and arm pain--chronic.
Sex: F
Vaccine: ANTH, ANTH, ANTH
Symptoms: Nodule, Pain in extremity
Clinical narrative: Headaches, nodulars, fatigue, numbness and weakness in upperbody, neck and arm pain--chronic.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Asthenia, Fatigue, Headache, Hypoaesthesia, Neck pain
Clinical narrative: Headaches, nodulars, fatigue, numbness and weakness in upperbody, neck and arm pain--chronic.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Nodule, Pain in extremity
Clinical narrative: Headaches, nodulars, fatigue, numbness and weakness in upperbody, neck and arm pain--chronic.
Sex: U
Vaccine: ANTH
Symptoms: Asthenia, Fatigue, Headache, Hypoaesthesia, Neck pain
Clinical narrative: Headaches, nodulars, fatigue, numbness and weakness in upperbody, neck and arm pain--chronic.