chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report was received on 27 October 2011 from a health care professional, at which time this case was assessed as non-serious, listed. Based upon follow-up information received on 16 March 2012 from a health care professional, it was determined this case now meets seriousness criteria (OTHER-MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. The reporter for this case is the same as case number 2011-10458. A 51-year-old female patient received dose one of a right arm intramuscular injection of ADACEL, sanofi pasteur Ltd., lot number C3968 (sanofi pasteur Inc. lot number U4088CA) on 06 October 2011. On 16 October 2011, ten days after vaccination, the patient developed "acute local delayed local reaction" swelling, pain and redness in right arm. She applied ice to site on 17 October 2011 and swelling was decreasing. The patient sought treatment with doctor on 18 October 2011. Vital signs were noted as temperature 97.1 degrees Fahrenheit, pulse 64 beats per minute, blood pressure 124/74, and weight 150 pounds. The patient denied shortness of breath, denied any injury or hitting arm, and denied fever. The patient had right arm pain with abduction and her right upper arm had swelling, was warm and tender, and had redness two and a half centimeters (cm). The patient's energy was noted to be okay (OK), and the rest of the exam was noted to be negative. The patient was diagnosed with Cellulitis and delayed hypersensitivity local reaction, questionably an adverse reaction to ADACEL (Tdap). Treatment included BACTRIM DS twice a day for seven days "BID X 7 d." for right upper arm. The patient was instructed to call if worsens and follow-up in office in one week. The patient's medical history included an allergy to Penicillin and the patient's concomitant medications included multivitamin, nortriptyline, and acetate cream. It was noted that the patient had a negative "C-Scope" with plan to re-scope in five years. The patient had no sex drive and decreased libido. She also took concomitant medication "citalopram 10/day" and was doing "great" and the plan was to "try drug holiday". The patient denied use of tobacco or alcohol. The patient had a two step purified protein derivative (PPD) on (date not reported) that was questionably positive. She had no history of PPD exposure and had a one and a half centimeter (cm) red area (prior to PPD). The doctor requested copy of PPD test results. The patient refused "F.S.". She had elevated low-density lipoprotein (LDL) and elevated high-density lipoprotein (HDL) and was doing great with diet and exercise. Vital Signs on 06 October 2011: temperature 97.0 degrees Fahrenheit, Pulse 60 beats per minute, blood pressure 124/84 mmHg, weight 149 pounds. The patient's outcome was reported as unknown. Documents held by sender: Medical record.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Local reaction, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Initial report was received on 27 October 2011 from a health care professional, at which time this case was assessed as non-serious, listed. Based upon follow-up information received on 16 March 2012 from a health care professional, it was determined this case now meets seriousness criteria (OTHER-MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. The reporter for this case is the same as case number 2011-10458. A 51-year-old female patient received dose one of a right arm intramuscular injection of ADACEL, sanofi pasteur Ltd., lot number C3968 (sanofi pasteur Inc. lot number U4088CA) on 06 October 2011. On 16 October 2011, ten days after vaccination, the patient developed "acute local delayed local reaction" swelling, pain and redness in right arm. She applied ice to site on 17 October 2011 and swelling was decreasing. The patient sought treatment with doctor on 18 October 2011. Vital signs were noted as temperature 97.1 degrees Fahrenheit, pulse 64 beats per minute, blood pressure 124/74, and weight 150 pounds. The patient denied shortness of breath, denied any injury or hitting arm, and denied fever. The patient had right arm pain with abduction and her right upper arm had swelling, was warm and tender, and had redness two and a half centimeters (cm). The patient's energy was noted to be okay (OK), and the rest of the exam was noted to be negative. The patient was diagnosed with Cellulitis and delayed hypersensitivity local reaction, questionably an adverse reaction to ADACEL (Tdap). Treatment included BACTRIM DS twice a day for seven days "BID X 7 d." for right upper arm. The patient was instructed to call if worsens and follow-up in office in one week. The patient's medical history included an allergy to Penicillin and the patient's concomitant medications included multivitamin, nortriptyline, and acetate cream. It was noted that the patient had a negative "C-Scope" with plan to re-scope in five years. The patient had no sex drive and decreased libido. She also took concomitant medication "citalopram 10/day" and was doing "great" and the plan was to "try drug holiday". The patient denied use of tobacco or alcohol. The patient had a two step purified protein derivative (PPD) on (date not reported) that was questionably positive. She had no history of PPD exposure and had a one and a half centimeter (cm) red area (prior to PPD). The doctor requested copy of PPD test results. The patient refused "F.S.". She had elevated low-density lipoprotein (LDL) and elevated high-density lipoprotein (HDL) and was doing great with diet and exercise. Vital Signs on 06 October 2011: temperature 97.0 degrees Fahrenheit, Pulse 60 beats per minute, blood pressure 124/84 mmHg, weight 149 pounds. The patient's outcome was reported as unknown. Documents held by sender: Medical record.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Tuberculin test positive, Type IV hypersensitivity reaction
Clinical narrative: Initial report was received on 27 October 2011 from a health care professional, at which time this case was assessed as non-serious, listed. Based upon follow-up information received on 16 March 2012 from a health care professional, it was determined this case now meets seriousness criteria (OTHER-MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. The reporter for this case is the same as case number 2011-10458. A 51-year-old female patient received dose one of a right arm intramuscular injection of ADACEL, sanofi pasteur Ltd., lot number C3968 (sanofi pasteur Inc. lot number U4088CA) on 06 October 2011. On 16 October 2011, ten days after vaccination, the patient developed "acute local delayed local reaction" swelling, pain and redness in right arm. She applied ice to site on 17 October 2011 and swelling was decreasing. The patient sought treatment with doctor on 18 October 2011. Vital signs were noted as temperature 97.1 degrees Fahrenheit, pulse 64 beats per minute, blood pressure 124/74, and weight 150 pounds. The patient denied shortness of breath, denied any injury or hitting arm, and denied fever. The patient had right arm pain with abduction and her right upper arm had swelling, was warm and tender, and had redness two and a half centimeters (cm). The patient's energy was noted to be okay (OK), and the rest of the exam was noted to be negative. The patient was diagnosed with Cellulitis and delayed hypersensitivity local reaction, questionably an adverse reaction to ADACEL (Tdap). Treatment included BACTRIM DS twice a day for seven days "BID X 7 d." for right upper arm. The patient was instructed to call if worsens and follow-up in office in one week. The patient's medical history included an allergy to Penicillin and the patient's concomitant medications included multivitamin, nortriptyline, and acetate cream. It was noted that the patient had a negative "C-Scope" with plan to re-scope in five years. The patient had no sex drive and decreased libido. She also took concomitant medication "citalopram 10/day" and was doing "great" and the plan was to "try drug holiday". The patient denied use of tobacco or alcohol. The patient had a two step purified protein derivative (PPD) on (date not reported) that was questionably positive. She had no history of PPD exposure and had a one and a half centimeter (cm) red area (prior to PPD). The doctor requested copy of PPD test results. The patient refused "F.S.". She had elevated low-density lipoprotein (LDL) and elevated high-density lipoprotein (HDL) and was doing great with diet and exercise. Vital Signs on 06 October 2011: temperature 97.0 degrees Fahrenheit, Pulse 60 beats per minute, blood pressure 124/84 mmHg, weight 149 pounds. The patient's outcome was reported as unknown. Documents held by sender: Medical record.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 19 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 1 dose of TRIPEDIA; sanofi pasteur Inc. lot number U3282CA received on 24 June 2010, and 3 doses of PENTACEL; lot number C3304AA received on 26 May 2009, lot number C3362AA received on 11 August 2009 and lot number C3428AB received on 01 October 2009 (routes and sites of administration not reported). Approximately 15 months after the last dose, the subject developed a cough on 06 October 2011 and paroxysmal cough on 02 December 2011 without a whoop. The subject also experienced post-tussive vomiting. Laboratory testing included positive PCR on 05 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 06 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 06 December 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 61 days. The outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Post-tussive vomiting
Clinical narrative: Initial report received on 19 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 1 dose of TRIPEDIA; sanofi pasteur Inc. lot number U3282CA received on 24 June 2010, and 3 doses of PENTACEL; lot number C3304AA received on 26 May 2009, lot number C3362AA received on 11 August 2009 and lot number C3428AB received on 01 October 2009 (routes and sites of administration not reported). Approximately 15 months after the last dose, the subject developed a cough on 06 October 2011 and paroxysmal cough on 02 December 2011 without a whoop. The subject also experienced post-tussive vomiting. Laboratory testing included positive PCR on 05 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 06 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 06 December 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 61 days. The outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site oedema, Injection site swelling
Clinical narrative: Left leg swollen, edematous.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient called the day after injection, 3/10/12, and stated she had rash on face & neck that was red & itching continuously. Advised the patient to take BENADRYL and keep a close eye on rash. Advised that if symptoms didn't improve to see a doctor. Followed up on 3/11/12. Symptoms had improved, no itching, still slightly red.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Dtap vaccine on March 21, 2012 Mom called concerned that (R) thigh was swollen hot & red - came to office (R) thigh swollen hot red. Measured 12 cm x 14 cm area.
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blindness unilateral, Vision blurred
Clinical narrative: Case number PHEH2012US006261 is an initial spontaneous report received from a consumer on 16 Mar 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. He was vaccinated with H1N1 (manufacturer and batch number unspecified) intramuscularly on an unspecified date. It was reported that he lost his vision in left eye after receiving the vaccine. It was stated that his vision came back, but he experienced blurred vision on hot and humid days. Outcome of the events vision loss was reported as condition improving and that of vision blurred was not provided. No additional details regarding this case were available.
Age: 52.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Balance disorder, Brain stem syndrome, Central nervous system lesion, Depression
Clinical narrative: Case number PHEH2012US006254 is an initial spontaneous report received from a consumer on 16 Mar 2012. This report refers to a female patient whose age was unspecified. Her medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with H1N1 pandemic influenza vaccine (manufacturer and batch number: unspecified) intramuscularly on 13 Nov 2009 (site and dose was not reported). On Dec 2009, it was reported that she lost her balance and fell down. Her right foot went numb along with other sensory nerves in her body. On an unspecified date she experienced frostbite as she could not sense the cold from the ice and underwent shoulder surgery. She was tested by three neurologists. An electromyogram (EMG) was performed which revealed that her sensory nerves were abnormal; however transverse myelitis and multiple sclerosis were ruled out. The only possible causes were two brain elisions and an abnormal signal from her brain stem to her extremities and the latter was confirmed by another electrical test. She also experienced leg spasms and tingling and numbness in the extremities. It was stated that her reflexes were hyper-reflexive; hence Guillain-Barre syndrome was ruled out. On an unspecified date she experienced spasm, fatigue, pain and loss of muscle endurance. She was treated with NEURONTIN which relieved her from spasm but it did not help with joint pain and fatigue and she also became very depressed mentally. On an unknown date she was switched to baclofen which was ineffective. It was reported that she could not lift her arms. Her foot had been broken twice but she was walking on it for weeks because she did not know that it was broken. The outcome of the events reported as condition unchanged.
Age: 52.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Electromyogram abnormal, Fall, Fatigue, Foot fracture, Frostbite
Clinical narrative: Case number PHEH2012US006254 is an initial spontaneous report received from a consumer on 16 Mar 2012. This report refers to a female patient whose age was unspecified. Her medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with H1N1 pandemic influenza vaccine (manufacturer and batch number: unspecified) intramuscularly on 13 Nov 2009 (site and dose was not reported). On Dec 2009, it was reported that she lost her balance and fell down. Her right foot went numb along with other sensory nerves in her body. On an unspecified date she experienced frostbite as she could not sense the cold from the ice and underwent shoulder surgery. She was tested by three neurologists. An electromyogram (EMG) was performed which revealed that her sensory nerves were abnormal; however transverse myelitis and multiple sclerosis were ruled out. The only possible causes were two brain elisions and an abnormal signal from her brain stem to her extremities and the latter was confirmed by another electrical test. She also experienced leg spasms and tingling and numbness in the extremities. It was stated that her reflexes were hyper-reflexive; hence Guillain-Barre syndrome was ruled out. On an unspecified date she experienced spasm, fatigue, pain and loss of muscle endurance. She was treated with NEURONTIN which relieved her from spasm but it did not help with joint pain and fatigue and she also became very depressed mentally. On an unknown date she was switched to baclofen which was ineffective. It was reported that she could not lift her arms. Her foot had been broken twice but she was walking on it for weeks because she did not know that it was broken. The outcome of the events reported as condition unchanged.
Age: 52.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Hyperreflexia, Hypoaesthesia, Mobility decreased, Muscle spasms, Muscular weakness
Clinical narrative: Case number PHEH2012US006254 is an initial spontaneous report received from a consumer on 16 Mar 2012. This report refers to a female patient whose age was unspecified. Her medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with H1N1 pandemic influenza vaccine (manufacturer and batch number: unspecified) intramuscularly on 13 Nov 2009 (site and dose was not reported). On Dec 2009, it was reported that she lost her balance and fell down. Her right foot went numb along with other sensory nerves in her body. On an unspecified date she experienced frostbite as she could not sense the cold from the ice and underwent shoulder surgery. She was tested by three neurologists. An electromyogram (EMG) was performed which revealed that her sensory nerves were abnormal; however transverse myelitis and multiple sclerosis were ruled out. The only possible causes were two brain elisions and an abnormal signal from her brain stem to her extremities and the latter was confirmed by another electrical test. She also experienced leg spasms and tingling and numbness in the extremities. It was stated that her reflexes were hyper-reflexive; hence Guillain-Barre syndrome was ruled out. On an unspecified date she experienced spasm, fatigue, pain and loss of muscle endurance. She was treated with NEURONTIN which relieved her from spasm but it did not help with joint pain and fatigue and she also became very depressed mentally. On an unknown date she was switched to baclofen which was ineffective. It was reported that she could not lift her arms. Her foot had been broken twice but she was walking on it for weeks because she did not know that it was broken. The outcome of the events reported as condition unchanged.
Age: 52.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nerve conduction studies abnormal, Pain, Paraesthesia, Sensory loss, Shoulder operation
Clinical narrative: Case number PHEH2012US006254 is an initial spontaneous report received from a consumer on 16 Mar 2012. This report refers to a female patient whose age was unspecified. Her medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with H1N1 pandemic influenza vaccine (manufacturer and batch number: unspecified) intramuscularly on 13 Nov 2009 (site and dose was not reported). On Dec 2009, it was reported that she lost her balance and fell down. Her right foot went numb along with other sensory nerves in her body. On an unspecified date she experienced frostbite as she could not sense the cold from the ice and underwent shoulder surgery. She was tested by three neurologists. An electromyogram (EMG) was performed which revealed that her sensory nerves were abnormal; however transverse myelitis and multiple sclerosis were ruled out. The only possible causes were two brain elisions and an abnormal signal from her brain stem to her extremities and the latter was confirmed by another electrical test. She also experienced leg spasms and tingling and numbness in the extremities. It was stated that her reflexes were hyper-reflexive; hence Guillain-Barre syndrome was ruled out. On an unspecified date she experienced spasm, fatigue, pain and loss of muscle endurance. She was treated with NEURONTIN which relieved her from spasm but it did not help with joint pain and fatigue and she also became very depressed mentally. On an unknown date she was switched to baclofen which was ineffective. It was reported that she could not lift her arms. Her foot had been broken twice but she was walking on it for weeks because she did not know that it was broken. The outcome of the events reported as condition unchanged.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Fall, Head injury, Loss of consciousness, Neck pain
Clinical narrative: Patient had syncopal episode in lobby striking her head on floor & had brief LOC. Transferred to ER per EMS due to neck pain/visual disturb. Evaluated & released to home & diagn. with mild concussion. Episode occurred 10 min. after injection.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Visual impairment
Clinical narrative: Patient had syncopal episode in lobby striking her head on floor & had brief LOC. Transferred to ER per EMS due to neck pain/visual disturb. Evaluated & released to home & diagn. with mild concussion. Episode occurred 10 min. after injection.
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: VIIIth nerve lesion
Clinical narrative: Case number PHEH2012US006267 is an initial spontaneous report received from a consumer on 16 Mar 2012. This report refers to a patient of unspecified age and gender. Medical history, past drugs, current conditions and concomitant medications were not reported. The patient was vaccinated with H1N1 (manufacturer and batch number: unspecified) 0.5 ml dose, intramuscularly on an unspecified date. After vaccination, the patient had issues with the nerves in ears (onset date unspecified). Final event outcome was not reported. No further information was available.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: He received a Tdap IZ in mid-January 2012 at Hospital ER. He had a laceration that needed stitches. A few hours after receiving the vaccine he developed a fever and had flu-like symptoms that lasted 2 1/2 day. He also had site soreness (IZ was given in the thigh) for one week. Could not manage stairs for 2 days.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Myalgia, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: (L) shoulder pain, decreased ROM. (L) arm pain - triceps area, but not the actually site of injection. No redness or swelling, just tenderness, achiness.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Rotator cuff syndrome
Clinical narrative: (L) shoulder pain, decreased ROM. (L) arm pain - triceps area, but not the actually site of injection. No redness or swelling, just tenderness, achiness.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Injected limb mobility decreased, Mobility decreased, Pain in extremity, Wheelchair user
Clinical narrative: Information has been received from a physician concerning an 88 year old male patient who on 22-FEB-2012, was vaccinated with ZOSTAVAX (Merck), 0.65 ml, SC (lot number 671142/1268AA, exp 05-NOV-2012). Concomitant therapy included COUMADIN. It was reported that the patient suffered from a stroke on 23-FEB-2012 ("the day after receiving ZOSTAVAX (Merck)"). The patient called into the healthcare professional's office complaining of his left arm hurting, and the office just thought that it was due to injection site pain, since the vaccine was administered on his left arm. The patients wife told the healthcare professional's office that he couldn't lift the arm, the healthcare professional office then received a second call where the patient explained that he was not able to move his left leg. The patient came into the office after that call and had to be wheeled into the office they did not send him to the hospital. On an unknown date, the patient recovered. It was reported that therapy with ZOSTAVAX (Merck) was not reintroduced. Upon internal review, stroke was determined to be an other important medical event. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Induration
Clinical narrative: Vaccine reaction to DTaP noticed yesterday remained the same since onset no complaints noticed today at bath time 5.5 cm x 3.5 cm induration 5 cm x 4.0 cm redness.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Electroencephalogram abnormal, Fall
Clinical narrative: A serious spontaneous report of falling down has been received from a physician concerning a seven-year-old male, subsequent to FLUMIST. The patient had no significant medical history, no concomitant medications and no family history of seizures. On 28-Sep-2011, the patient received FLUMIST. From 08-Nov-2011 through 15-Nov-2011, the patient would either be sitting or standing and would suddenly "fall-out". On 28-Nov-2011, the physician saw the patient and he continued to have the episodes of falling. On 07-Dec-2011, the patient was seen by a neurologist; an EEG was abnormal. The neurologist decided to continue to observe the patient. Eventually, the patient recovered. The outcome of the event falling down was resolved.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Convulsion
Clinical narrative: A serious spontaneous report of falling down has been received from a physician concerning a seven-year-old male, subsequent to FLUMIST. The patient had no significant medical history, no concomitant medications and no family history of seizures. On 28-Sep-2011, the patient received FLUMIST. From 08-Nov-2011 through 15-Nov-2011, the patient would either be sitting or standing and would suddenly "fall-out". On 28-Nov-2011, the physician saw the patient and he continued to have the episodes of falling. On 07-Dec-2011, the patient was seen by a neurologist; an EEG was abnormal. The neurologist decided to continue to observe the patient. Eventually, the patient recovered. The outcome of the event falling down was resolved.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Pharyngeal oedema, Rash
Clinical narrative: Received injection 3-23-12 at 9:18 am. Pt reports that evening her throat was swollen, had px in throat and chest - heart racing and palpitations. Developed a rash on her cheeks. Symptoms resolved that evening. Pt called 3-28-12 to report these sy. Has had no sy since.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Nausea, Neck pain, Oedema peripheral
Clinical narrative: Pain swelling redness left arm neck pain, HA nausea fever treatment seen urgent care put on ZYRTEC 10mg. TYLENOL/ADVIL.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain swelling redness left arm neck pain, HA nausea fever treatment seen urgent care put on ZYRTEC 10mg. TYLENOL/ADVIL.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pt. reports rash behind left knee day after vaccine received, then progressively worsened into hives on torso and face within next few days after rash noticed.  Seen by doctor twice.  Was given shot of prednisone and epinephrine on day 4.  Taking prednisone pills and hydroxzine PRN for itch.
Age: 52.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left deltoid with erythema, warmth, swelling c/o itching to site, pain to touch and on elevation and rotation of arm. Warm compress & Advil since 3/27/2012. Reported to OHS on 3/29/2012 erythema, induration 4" long x 3" wide, tender to touch. Still with discomfort on elevation and rotation. Tx with warm compresses & Advil, refused Benadryl 25 mg p.o. and topical cream.
Age: 52.0
Sex: F
Vaccine: DT
Symptoms: Injection site warmth, Pain
Clinical narrative: Left deltoid with erythema, warmth, swelling c/o itching to site, pain to touch and on elevation and rotation of arm. Warm compress & Advil since 3/27/2012. Reported to OHS on 3/29/2012 erythema, induration 4" long x 3" wide, tender to touch. Still with discomfort on elevation and rotation. Tx with warm compresses & Advil, refused Benadryl 25 mg p.o. and topical cream.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was seen on 2 Dec 2011 for redness on R thigh with pain and swelling. Vital Signs P105, Resp 16, Temp 98.6, O2 100% room air, Weight 17Kg, pain 3-4/10. Pt given Keflex 250mg.
Age: 22.0
Sex: F
Vaccine: IPV, YF
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: immediate sinus with no previous problems, redness on arm where shot was given, bump on arm where shot was given, overly tired, achey body, cold like symptoms, severe dizziness began evening of 3/28/2012 until morning of 3/29/2012, and pain in arm where shot was given until 3/26/2012.
Age: 22.0
Sex: F
Vaccine: IPV, YF
Symptoms: Nasopharyngitis, Pain
Clinical narrative: immediate sinus with no previous problems, redness on arm where shot was given, bump on arm where shot was given, overly tired, achey body, cold like symptoms, severe dizziness began evening of 3/28/2012 until morning of 3/29/2012, and pain in arm where shot was given until 3/26/2012.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Nausea
Clinical narrative: Pt states that all was well until she awoke at 2am with nause. Nausea lasted intermittently until later that day. No known previously diagnosed illnesses.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Raised Red rash area at site of injection with surroning redness.  Some soreness. Does NOT itch.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at site progressing to redness around upper arm, tenderness, slight swelling.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Confusional state, Dizziness, Hyperhidrosis, Hypotension, Oedema peripheral
Clinical narrative: Arm swelled, diaphoretic, hypotensive, confused, dizziness.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LUE had swelling and redness.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain
Clinical narrative: Patient started feeling unexplained pain in back and hips.  Pain persisted until 3/29/12, where it began to lessen in severity. Patient rotated between ibuprofen, naproxen, and ketorolac at bedtime for the symptoms.
Age: 0.47
Sex: M
Vaccine: PNC
Symptoms: Convulsion
Clinical narrative: Admitted to hospital on 12/19/11 with a report of seizures (5 episodes) in a 2 week period. Dx with seizures & put on phenobarbital. First PREVNAR was administered on 12/6/2011. Within hours of receiving 2nd dose of PREVNAR on 3/22/12 pt had 20 reported seizures and airlifted to hospital. Pt was given ATIVAN to stop seizure activity, and blow by oxygen for transient desaturations. He had consultation with his neurologist who increased his phenobarbital dose and added KEPPRA. Patient has follow-up for further diagnostic testing. Has been stable on current medications with no repeating seizure activity. Specialty doctors are advising to discontinue vaccination with PREVNAR until further studies can be completed.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema/edema (R) upper arm - 2 x 4 cm yesterday - 9 x 12 cm today. Given BENADRYL 25 mg TID. Returning tomorrow for recheck.
Age: 51.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Hypoaesthesia, Pain in extremity, Upper extremity mass
Clinical narrative: Patient received 2 vaccines on 1/30/12. On 3/26/12 came in for second dose in series, reported that on left arm can still feel a lump and has soreness. Reports one week after vaccine had numbness in (L) arm and (L) face lasting 1-2 days. No external swelling or lump noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Induration, Pain
Clinical narrative: Pt. has vaccine reaction to Dtap. Pt. parents did not notice of the vaccine reaction. Induration noted. Child c/o pain, full range of movement. No redness 3.5 cm x 3.0 cm induration.
Age: 1.1
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Pyrexia, Skin irritation, Swelling
Clinical narrative: Fever, redness, irritation ans swelling and temperature of 105.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: HIVES. TO TAKE BENADRYL.
Age: 46.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Dysgeusia, Feeling cold, Hyperhidrosis, Nervousness, Pallor
Clinical narrative: Patient recieved 0.5 IM Rabies in right deltoid at approximately 12:30 PM.  In less than 1 hr after vaccination, pt noticed he had odd taste in mouth.  Pt reported to work.  Pt noted he felt cold/shaky.  At 5pm, pt was sweating, cold, shaky.  At 6pm, pt noted his lips were pale.  At 6:45pm, pt reported to the ER.  Poison control spoke with patient in person.  I spoke with patient today on the phone and he reported he is feeling fine.
Age: 46.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Chills, Dizziness, Dry mouth, Headache, Pyrexia
Clinical narrative: Patient recieved 0.5 IM Rabies in right deltoid at approximately 12:30 PM.  In less than 1 hr after vaccination, pt noticed he had odd taste in mouth.  Pt reported to work.  Pt noted he felt cold/shaky.  At 5pm, pt was sweating, cold, shaky.  At 6pm, pt noted his lips were pale.  At 6:45pm, pt reported to the ER.  Poison control spoke with patient in person.  I spoke with patient today on the phone and he reported he is feeling fine.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Dizziness, Fatigue, Mammogram, Swelling
Clinical narrative: Painful, swollen left axillary area, fatigue, "dizziness" lightheadedness.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Vaccination complication, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling beyond site of vaccination, redness, tenderness, satellite lesion.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient had unusual heat to site of injection- extremely hot to touch- compared to many other patients with injection site reaction.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Red, swollen, painful arm.  Unable to use arm.  Tightness/pressure on chest.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Entire left thigh swelling, redness, induration.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Heart rate increased, Heart rate irregular, Pulse pressure decreased
Clinical narrative: I experienced short periods of rapid, shallow, and irregular heartbeat, usually lasting 10-20 seconds. Would occur in groups of 3 or 4. Has happened twice or three times each day, beginning the day after the vaccine was given.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Patient developed soreness, fever.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Arthralgia, Erythema, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: HPV #3 given 3/28/12 at 6P in (L) deltoid - pt had mild soreness/swelling at site. On 3/29/12 at 6A child has redness/swelling/pain of (L) wrist & hand.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: HPV #3 given 3/28/12 at 6P in (L) deltoid - pt had mild soreness/swelling at site. On 3/29/12 at 6A child has redness/swelling/pain of (L) wrist & hand.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Irritability, Ultrasound abdomen abnormal
Clinical narrative: Patient received 3rd dose of ROTATEQ vaccine on 3/16/2012. On 3/25/12, he developed intermittent episodes of severe irritability followed by vomiting and decreased urine output. He was found to have blood stools on 3/26/12 and was evaluated and found to have an intussusception. It was successfully reduced by air contrast enema. He recovered uneventfully.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urine output decreased, Vomiting
Clinical narrative: Patient received 3rd dose of ROTATEQ vaccine on 3/16/2012. On 3/25/12, he developed intermittent episodes of severe irritability followed by vomiting and decreased urine output. He was found to have blood stools on 3/26/12 and was evaluated and found to have an intussusception. It was successfully reduced by air contrast enema. He recovered uneventfully.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal pain, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: Presented to clinic with c/o upper arm, shoulder neck pain with red, swollen posterior arm with 2cm wide x 3cm orange peal texture eruption IV ROCEPHIN x 3d; oral KEFLEX, PO acyclovir.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin discolouration
Clinical narrative: Presented to clinic with c/o upper arm, shoulder neck pain with red, swollen posterior arm with 2cm wide x 3cm orange peal texture eruption IV ROCEPHIN x 3d; oral KEFLEX, PO acyclovir.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Localized reaction, redness, swelling, itching.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: 6 mo. male with 2cm area of erythema around injection site that was warm and tender. The patient was afebrile in office after he had been given ADVIL and TYLENOL at home for fever of 102.8. He also had vomiting and diarrhea. Left TM was pink on exam.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Tympanic membrane hyperaemia, Vomiting
Clinical narrative: 6 mo. male with 2cm area of erythema around injection site that was warm and tender. The patient was afebrile in office after he had been given ADVIL and TYLENOL at home for fever of 102.8. He also had vomiting and diarrhea. Left TM was pink on exam.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Irritability, Vomiting
Clinical narrative: Very fussy then had several episodes of emesis that evening. By afternoon of next day was doing better. Treated with frequent small feeds of Pedialyte until was able to hold things down.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, FLUX, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Muscular weakness, Myelitis transverse, Paraesthesia
Clinical narrative: Initial report was received from a health care professional on 20 March 2012. An 11-year-old female patient had received the following vaccinations on 05 January 2012: an injection in the left arm of ADACEL, sanofi pasteur Ltd., lot number C3989AA, an injection in the left arm of MENACTRA, sanofi pasteur Inc., lot number U4243AA, an injection of FLUZONE, sanofi pasteur Inc., lot number UT441AA and an injection in the right arm of GARDASIL, Merck, lot number 0636AA. Following vaccinations, the patient experienced acute right leg weakness and bilateral leg "parathesis." The patient was diagnosed with transverse myelitis. At the time of the report, the condition persisted but has improved as of 09 February 2012. At the time of vaccination, the patient had a mild viral infection. The patient had no known allergies and took no concomitant medications. The patient's outcome was not recovered. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site induration, Pain
Clinical narrative: C/O pain.  In am 30 March 2012 site examined and induration noticed  4.2 X 2.8.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Pain in mus. in left arm - continuing as when arm is reached in a stretch position (ei) high over head or behind me - daily - with use continuing still.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, Full blood count, Irritability, Pyrexia
Clinical narrative: Fever 103, fussy after shots.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Tonic clonic movements
Clinical narrative: HepA given (L) arm then GARDASIL in (R) arm. After needle removed from (R) arm, loss of consciousness -> stiffening -> tonic-clonic movements 1-2 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Left arm swollen from shoulder down to just below elbow. Area not tender but indurated over triceps area. Also macular erythematous eruption over affected are. (L) arm 3 cm large. Then right in diameter.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypersensitivity, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Local allergic reaction - swelling, urticarial rash, surrounding vaccination. 7cm diameter within 30 minutes of vaccination.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypersensitivity, Urticaria, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Local allergic reaction - swelling, urticarial rash, surrounding vaccination. 7cm diameter within 30 minutes of vaccination.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Feeling of body temperature change, Hyperhidrosis, Inflammation, Migraine
Clinical narrative: Fever of 102, body chills, aches, hot,  cold sweats, migraines, (neck stiff - 8 hours).
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Fever of 102, body chills, aches, hot,  cold sweats, migraines, (neck stiff - 8 hours).
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Bradycardia, Dyspnoea, Pallor
Clinical narrative: Initial report was received 22 March 2012 from a consumer. A child (age and date of birth not reported) had received PENTACEL (lot number, dose number, route, site and date of administration not reported) and an unspecified amount of time later, experienced pallor, breathing difficulty and bradycardia. The patient received treatment and was "ok" (also reported as recovered). The reporter was informed of this event from a health care provider who stated that the child was a patient at someone else's practice. The reporter declined to provide contact information and stated they had no further information to provide. Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Areflexia, Ataxia, Balance disorder, CSF protein increased, Diplopia
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03170, and 2012-03172. A 59-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." Two weeks after vaccination, the patient developed diplopia, imbalance and gait ataxia. He experienced "right ptosis, bilateral vertical (upward and downward) and horizontal (abduction and adduction) ophthalmoplegia, absent vestibulo-ocular reflex, generalized areflexia, severe ataxia on finger-to-nose and heel-to-shin maneuvers." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 48 mg/dl. Electrodiagnostic testing on day 18 revealed "normal nerve conduction studies of the upper and lower extremities, the facial nerve and blink reflexes." The patient was diagnosed with Miller Fisher variant of Guillain-Barre syndrome. The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5 days)." The patient showed "slow improvement in eye movements, ataxia of gait and hands, persistent areflexia at the end of one week after IVIG." He resumed his "baseline level of activities by six months." The patient's outcome was recovered (date not reported). Authors also indicated that this patient who developed Miller Fisher variant of GBS fulfilled level 1 diagnostic certainty criteria outlined by Brighton Collaboration Working group. Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Eye movement disorder, Eyelid ptosis, Immunoglobulin therapy, Miller Fisher syndrome, Nerve conduction studies normal
Clinical narrative: Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03170, and 2012-03172. A 59-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." Two weeks after vaccination, the patient developed diplopia, imbalance and gait ataxia. He experienced "right ptosis, bilateral vertical (upward and downward) and horizontal (abduction and adduction) ophthalmoplegia, absent vestibulo-ocular reflex, generalized areflexia, severe ataxia on finger-to-nose and heel-to-shin maneuvers." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 48 mg/dl. Electrodiagnostic testing on day 18 revealed "normal nerve conduction studies of the upper and lower extremities, the facial nerve and blink reflexes." The patient was diagnosed with Miller Fisher variant of Guillain-Barre syndrome. The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5 days)." The patient showed "slow improvement in eye movements, ataxia of gait and hands, persistent areflexia at the end of one week after IVIG." He resumed his "baseline level of activities by six months." The patient's outcome was recovered (date not reported). Authors also indicated that this patient who developed Miller Fisher variant of GBS fulfilled level 1 diagnostic certainty criteria outlined by Brighton Collaboration Working group. Documents held by sender: None.