chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Oedema, Pain in extremity, Prothrombin time, Pyrexia, Ultrasound scan
Clinical narrative: This case was received on 06 March 2012 via a third party query tool search on the VAERS database, under reference number 444591. A 30-year-old male patient received the following vaccinations on 15 November 2011: a left arm ACAM2000 (lot number VV04003A) and a right arm intramuscular injection of anthrax (Emergent, lot number FAV294). The patient had no medical history, no current illnesses and other medications were reported as not applicable. The patient's previous vaccinations were not reported. The patient required an Emergency visit when he experienced fever, chills and pain at 8 of 10 in bilateral calves that lasted 1-2 hours then +3 pitting edema and ecchymosis of bilateral lower extremities set in. The patient was medevaced to the hospital and admitted for 2 days with the diagnosis of vasculitis. He had the following laboratory testing performed: chest x-ray, ultrasound of lower extremities, CBC, PT and PTT (results not provided). The patient was released on 29 November 2011 and was fit for full duty asymptomatic. The outcome was reported as recovered. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Vasculitis
Clinical narrative: This case was received on 06 March 2012 via a third party query tool search on the VAERS database, under reference number 444591. A 30-year-old male patient received the following vaccinations on 15 November 2011: a left arm ACAM2000 (lot number VV04003A) and a right arm intramuscular injection of anthrax (Emergent, lot number FAV294). The patient had no medical history, no current illnesses and other medications were reported as not applicable. The patient's previous vaccinations were not reported. The patient required an Emergency visit when he experienced fever, chills and pain at 8 of 10 in bilateral calves that lasted 1-2 hours then +3 pitting edema and ecchymosis of bilateral lower extremities set in. The patient was medevaced to the hospital and admitted for 2 days with the diagnosis of vasculitis. He had the following laboratory testing performed: chest x-ray, ultrasound of lower extremities, CBC, PT and PTT (results not provided). The patient was released on 29 November 2011 and was fit for full duty asymptomatic. The outcome was reported as recovered. Documents held by sender: None.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Musculoskeletal stiffness, Pain, Vaccination site pain
Clinical narrative: Local reference number: 11/1126. This case is linked to case numbers 2011-12441. Follow up information received on 04 May 2012: An 86-year-old female patient medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number UH439A), at left deltoid, intramuscularly on 24 October 2011. The reporter stated that the patient had experienced vaccination site pain, throbbing pain and discomfort after a week of administration. She also experienced neck stiffness after an unknown duration. At the time of reporting the events had not resolved. Documents held by sender: none. Follow-up information received on 16 July 2012: It was reported that, the patient had no real resolution of symptoms. The patient complained of the arm having intermittent throbbing pain, especially when tried to reach way up or down and when she sleep.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Cough
Clinical narrative: This case was received on 06 March 2012 via a third party query tool search on the VAERS database, under reference number 444960. A 23-year-old male patient received the following vaccination on 29 November 2011: ACAM2000 (lot number VV04003A). On 06 December 2011, the patient developed a sudden onset of non-radiating chest pain 2/10 in severity. He had no diaphoresis, no shortness of breath, no dizziness and no difference upon exertion. He also had a slight non-productive cough. The patient was sent to the Emergency Room ambulatory via an ambulance to rule out myo/peri/endocarditis. The outcome was not reported.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: This case was received on 06 March 2012 via a third party query tool search on the VAERS database, under reference number 445065. A 26-year-old male patient received the following vaccination on 09 December 2011: a left arm ACAM2000 (lot number VV04003A) and an intramuscular right arm injection of EMERGENT (lot number FAV297). The patient had no medical history and took no concomitant medications. He had a current illness of stiffness. On 09 December 2011, the patient developed chest tightness and shortness of breath along with light-headedness. The patient was seen by provider and after vital signs were taken was told to call 911 if anything changed. The outcome was reported as unknown. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Biopsy skin abnormal, Culture wound positive, Hypoaesthesia, Impaired healing, Injection site discharge
Clinical narrative: This case was received on 06 March 2012 via a third party query tool search on the VAERS database, under reference number 445221. A 21-year-old male patient received the following vaccinations on 23 August 2011: a left arm ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and anthrax (manufacturer unknown and lot number not reported). Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient had no medical history, no current illnesses and took no other medications. His prior vaccinations were not reported. Two months after the smallpox vaccine administration the patient was seen at a clinic with the complaints of pus oozing from site and skin breaking when changing bandaid. The patient was seen again on 16 November 2011 with continual symptoms of injection site not healing, pus, and numbness down the arm. The patient was sent to a Dermatologist where he underwent a skin punch biopsy and wound culture with coagulase negative staphylococcus organism growth. He had been treated with oral (PO) sulfamethoxazole and trimethoprim (TMP) 800-160 tablets twice a day (bid) for 7 days. The wound was healing. Another follow-up on 12 December 2011 showed formation of new pustule. The outcome was reported as not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site erosion, Injection site pustule, Injection site reaction, Rash pustular, Staphylococcus test positive
Clinical narrative: This case was received on 06 March 2012 via a third party query tool search on the VAERS database, under reference number 445221. A 21-year-old male patient received the following vaccinations on 23 August 2011: a left arm ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and anthrax (manufacturer unknown and lot number not reported). Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient had no medical history, no current illnesses and took no other medications. His prior vaccinations were not reported. Two months after the smallpox vaccine administration the patient was seen at a clinic with the complaints of pus oozing from site and skin breaking when changing bandaid. The patient was seen again on 16 November 2011 with continual symptoms of injection site not healing, pus, and numbness down the arm. The patient was sent to a Dermatologist where he underwent a skin punch biopsy and wound culture with coagulase negative staphylococcus organism growth. He had been treated with oral (PO) sulfamethoxazole and trimethoprim (TMP) 800-160 tablets twice a day (bid) for 7 days. The wound was healing. Another follow-up on 12 December 2011 showed formation of new pustule. The outcome was reported as not recovered. Documents held by sender: None.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: This case was received on 06 March 2012 via a third party query tool search on the VAERS database, under reference number 445586. A 22-year-old female patient received the following vaccinations on 20 September 2011: a left arm ACAM2000 (lot #VV04003A) and an intramuscular right arm injection of EMERGENT (lot number FAV284). The patient had no medical history, no current illnesses and took no concomitant medications. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. The patient received the smallpox (vaccinia) vaccine on 23 August 2011 and two doses of anthrax vaccine with one given on 23 August 2011 and the other on 20 September 2011. The patient was deployed and returned because she had a positive pregnancy test on 24 November 2011. The patient had vaccine exposure during pregnancy with no adverse event. This was the patient's first pregnancy. The outcome was not reported. Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: A 37-year-old male patient had received an injection of FLUZONE SV 2011-2012; lot number UH477AB (route and site of administration not reported) on 08 November 2011. On 11 November 2011, the patient developed "yellow spots" on his hands. No further information was available at the time of the report. The patient outcome was not reported. Follow-up information was received from a healthcare professional on 06 March 2012. The patient had received an intramuscular (IM) injection of FLUZONE SV 201-2012 in left deltoid on 06 December 2011 originally reported as 08 November 2011. The date of event was originally reported on 11 November 2011; upon follow-up it was determined that the event was on 09 December 2011. The patient concomitant medication included RELAFEN, SOMA, PROVENTIL; MEGA-3 fatty acids, onetouch ultra, onetouch control, onetouch ultra strips and lancets and continuous positive airway pressure (C-PAP). The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: JEV1, SMALL, HEPAB, JEV1, SMALL, TYP
Symptoms: Axillary mass, Chest pain, Encephalitis, Encephalomyelitis, Headache
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 446845. A 20-year-old male patient received the following vaccinations on 05 October 2011: ACAM2000 (SP Biologics Co. lot number VV04003A), TYPHIM VI (sanofi pasteur SA, lot number E04421), IXIARO (Intercell, lot number JEV10656F) and TWINRIX (GlaxoSmithKline, lot number AHABB223CA). On 13 November 2011, the patient experienced headache (HA), nausea, vomiting photophobia, chest pain and lump in axilla. The patient had encephalitis vs encephalomyelitis due to smallpox vaccine. The patient was hospitalized. Laboratory data was not reported. Current illnesses, history, other medications and prior vaccinations were not reported. The patient's outcome was recovered. Note, the PT Pneumothorax was coded in VAERS, however this was not mentioned in the narrative. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: JEV1, SMALL, HEPAB, JEV1, SMALL, TYP
Symptoms: Laboratory test abnormal, Nausea, Photophobia, Pneumothorax, Vomiting
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 446845. A 20-year-old male patient received the following vaccinations on 05 October 2011: ACAM2000 (SP Biologics Co. lot number VV04003A), TYPHIM VI (sanofi pasteur SA, lot number E04421), IXIARO (Intercell, lot number JEV10656F) and TWINRIX (GlaxoSmithKline, lot number AHABB223CA). On 13 November 2011, the patient experienced headache (HA), nausea, vomiting photophobia, chest pain and lump in axilla. The patient had encephalitis vs encephalomyelitis due to smallpox vaccine. The patient was hospitalized. Laboratory data was not reported. Current illnesses, history, other medications and prior vaccinations were not reported. The patient's outcome was recovered. Note, the PT Pneumothorax was coded in VAERS, however this was not mentioned in the narrative. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: JEV1, SMALL, HEPAB, JEV1, SMALL, TYP
Symptoms: Nausea, Photophobia, Vomiting
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 446845. A 20-year-old male patient received the following vaccinations on 05 October 2011: ACAM2000 (SP Biologics Co. lot number VV04003A), TYPHIM VI (sanofi pasteur SA, lot number E04421), IXIARO (Intercell, lot number JEV10656F) and TWINRIX (GlaxoSmithKline, lot number AHABB223CA). On 13 November 2011, the patient experienced headache (HA), nausea, vomiting photophobia, chest pain and lump in axilla. The patient had encephalitis vs encephalomyelitis due to smallpox vaccine. The patient was hospitalized. Laboratory data was not reported. Current illnesses, history, other medications and prior vaccinations were not reported. The patient's outcome was recovered. Note, the PT Pneumothorax was coded in VAERS, however this was not mentioned in the narrative. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cardiac electrophysiologic study, Dizziness, Electrocardiogram, Heart rate increased, Respiration abnormal
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on the VAERS database, under reference number 446897. The country of occurrence is not reported: the country of the reporter is not reported: and the country where the patient was vaccinated is not reported. As the patient was administered by the military. A 23-year-old male patient received the ACAM2000 (lot number VV04003A) and BIOTHRAX (lot number FAV148) 07 August 2008. On 20 August 2008 it was reported that the patient complained of dizziness, increase in heart rate, abnormal respiration and light headed. (The events of dizziness, increase in heart rate and abnormal respiration were included in the coding from the VAERS database and coded for this case; however only the event of light headed had been mentioned in the narrative.) Lab details included: Cardiac electrophysiologic study and electrocardiogram. The outcome was reported as not recovered. Documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Generalised vaccinia, Injection site papule, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 447152. A 26-year-old female patient received an injection of ACAM2000 (SP Biologics Co. lot number not reported) on 27 December 2011. On 07 January 2012, the patient appeared to have generalized vaccinia with diffuse maculopapular rash with intense pruritis, some lesions coalescing into larger papules especially around the site of smallpox vaccination, lesions cross hairline and are on all parts of body essentially, systemic symptoms of a viral syndrome as well including nausea, sub fever/chills (F/C), myalgias, malaise and sore throat. The patient required an emergency visit. The patient's other medications included doxycycline for malaria prophylaxis. Current illnesses were reported as no, history was reported as none and prior vaccinations were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Pruritus, Rash maculo-papular, Skin lesion, Viral infection
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 447152. A 26-year-old female patient received an injection of ACAM2000 (SP Biologics Co. lot number not reported) on 27 December 2011. On 07 January 2012, the patient appeared to have generalized vaccinia with diffuse maculopapular rash with intense pruritis, some lesions coalescing into larger papules especially around the site of smallpox vaccination, lesions cross hairline and are on all parts of body essentially, systemic symptoms of a viral syndrome as well including nausea, sub fever/chills (F/C), myalgias, malaise and sore throat. The patient required an emergency visit. The patient's other medications included doxycycline for malaria prophylaxis. Current illnesses were reported as no, history was reported as none and prior vaccinations were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Chills, Generalised vaccinia, Injection site papule, Malaise, Myalgia
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 447152. A 26-year-old female patient received an injection of ACAM2000 (SP Biologics Co. lot number not reported) on 27 December 2011. On 07 January 2012, the patient appeared to have generalized vaccinia with diffuse maculopapular rash with intense pruritis, some lesions coalescing into larger papules especially around the site of smallpox vaccination, lesions cross hairline and are on all parts of body essentially, systemic symptoms of a viral syndrome as well including nausea, sub fever/chills (F/C), myalgias, malaise and sore throat. The patient required an emergency visit. The patient's other medications included doxycycline for malaria prophylaxis. Current illnesses were reported as no, history was reported as none and prior vaccinations were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Nausea, Oropharyngeal pain, Papule, Pruritus, Pyrexia
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 447152. A 26-year-old female patient received an injection of ACAM2000 (SP Biologics Co. lot number not reported) on 27 December 2011. On 07 January 2012, the patient appeared to have generalized vaccinia with diffuse maculopapular rash with intense pruritis, some lesions coalescing into larger papules especially around the site of smallpox vaccination, lesions cross hairline and are on all parts of body essentially, systemic symptoms of a viral syndrome as well including nausea, sub fever/chills (F/C), myalgias, malaise and sore throat. The patient required an emergency visit. The patient's other medications included doxycycline for malaria prophylaxis. Current illnesses were reported as no, history was reported as none and prior vaccinations were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Rash maculo-papular, Skin lesion, Viral infection
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 447152. A 26-year-old female patient received an injection of ACAM2000 (SP Biologics Co. lot number not reported) on 27 December 2011. On 07 January 2012, the patient appeared to have generalized vaccinia with diffuse maculopapular rash with intense pruritis, some lesions coalescing into larger papules especially around the site of smallpox vaccination, lesions cross hairline and are on all parts of body essentially, systemic symptoms of a viral syndrome as well including nausea, sub fever/chills (F/C), myalgias, malaise and sore throat. The patient required an emergency visit. The patient's other medications included doxycycline for malaria prophylaxis. Current illnesses were reported as no, history was reported as none and prior vaccinations were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Rash pruritic
Clinical narrative: Initial case received from health care professional, who was the patient, on 11 January 2012. A 46-year-old male patient received a left deltoid intradermal injection of FLUZONE INTRADERMAL, sanofi pasteur Inc. lot number UT4163AA, on 07 October 2011 at 13:50pm. The patient had no medical history, took no concomitant medications and had no illnesses at the time of vaccination. On 10 October 2011, the patient developed raised site of erythema and tenderness about 2-3 inches in diameter. The patient, who was a physician, diagnosed the event as a pruritic rash. The outcome was reported as recovered. Follow-up information was received from a health care professional on 26 March 2012. The patient received the vaccination on 07 October 2011 at 1:50 PM and experienced the adverse events on 08 October 2011 in the morning (AM). The patient recovered on 10 October 2011. The patient received no other vaccinations within four weeks of FLUZONE and received an annual influenza vaccine from 2005-2011. The patient's outcome remained recovered. Documents held by sender: None.
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Rash pruritic, Swelling, Tenderness
Clinical narrative: Initial case received from health care professional, who was the patient, on 11 January 2012. A 46-year-old male patient received a left deltoid intradermal injection of FLUZONE INTRADERMAL, sanofi pasteur Inc. lot number UT4163AA, on 07 October 2011 at 13:50pm. The patient had no medical history, took no concomitant medications and had no illnesses at the time of vaccination. On 10 October 2011, the patient developed raised site of erythema and tenderness about 2-3 inches in diameter. The patient, who was a physician, diagnosed the event as a pruritic rash. The outcome was reported as recovered. Follow-up information was received from a health care professional on 26 March 2012. The patient received the vaccination on 07 October 2011 at 1:50 PM and experienced the adverse events on 08 October 2011 in the morning (AM). The patient recovered on 10 October 2011. The patient received no other vaccinations within four weeks of FLUZONE and received an annual influenza vaccine from 2005-2011. The patient's outcome remained recovered. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chills, Pyrexia
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 447263. A 24-year-old male patient received the following vaccinations on 07 January 2012: ACAM2000 (SP BIOLOGICS CO. lot number: VV04-003-A) in left arm, TYPHIM VI *lot number: G1124) in right arm, EMERGENT (lot number: FAV288) in right arm. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient current illnesses and other medications were reported as none. Prior vaccinations were not reported. On 07 January 2012, the patient experienced fever and chills. The patient received corrective treatment of Ibuprofen 200mg at 0200 and at 0600 hours. The outcome of the  event was unknown. Documents held by sender:  None
Age: 22.0
Sex: F
Vaccine: ANTH, HEPA, SMALL, TYP, ANTH, HEPA, SMALL, TYP
Symptoms: Dyspnoea, Flushing, Hypopnoea
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 447265. A 22-year-old female patient received the following vaccination on 07 January 2012: ACAM2000 (MFR UNK, lot number: VV04003A) in left arm, TYPHIM VI (sanofi pasteur SA, lot number: G1124) in right arm, Anthrax (MICHIGAN DPH, lot number: FAV288) and HAVRIX (GLAXOSMITHKLINE, lot number: AHAVB469AA) in right arm. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of patient's vaccination. The patient current illnesses and other medications were reported as none. The patient drug history was reported as Amoxicillin penicillin (PCN). Prior vaccinations were not reported. On 07 January 2012, the patient developed SOB like Dyspnoea, hypopnoea along with periods of feeling flush. Laboratory data was not reported. The patient's outcome was unknown. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling
Clinical narrative: Follow-up information was received from a healthcare professional on 17 February 2012. The patient received an Intradermal (ID) injection of FLUZONE in right arm. The swelling has decreased from one inch to five centimeters; however, the patient has developed a darkened area in right arm, upper outer aspect (near deltoid muscle area). The patient outcome was reported as not recovered/not resolved. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site discolouration
Clinical narrative: Follow-up information was received from a healthcare professional on 17 February 2012. The patient received an Intradermal (ID) injection of FLUZONE in right arm. The swelling has decreased from one inch to five centimeters; however, the patient has developed a darkened area in right arm, upper outer aspect (near deltoid muscle area). The patient outcome was reported as not recovered/not resolved. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lacrimation increased, Ocular hyperaemia
Clinical narrative: Initial report was received from a health care professional on 13 January 2012. A 51-year-old female patient had received an Intramuscular (IM) injection of FLUZONE; lot number UT499AA in left arm on 06 January 2012. On the same day several hours after vaccination, the patient developed a feeling of "grainy" and reddened of eyes. She also developed a rash over arms and upper torso. The patient corrective treatment was not reported. No further information was available at the time of this report. The patient outcome was reported as recovered/resolved. Follow-up information was received from a health care professional on 26 March 2012. The patient received the vaccination on 06 January 2012 at 1400 and experienced the adverse events four hours later at 1800. The patient recovered on 07 January 2012. The patient had no known illness at the time of vaccination and took no known concomitant medications. The patient's outcome remained recovered. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye irritation, Ocular hyperaemia, Rash
Clinical narrative: Initial report was received from a health care professional on 13 January 2012. A 51-year-old female patient had received an Intramuscular (IM) injection of FLUZONE; lot number UT499AA in left arm on 06 January 2012. On the same day several hours after vaccination, the patient developed a feeling of "grainy" and reddened of eyes. She also developed a rash over arms and upper torso. The patient corrective treatment was not reported. No further information was available at the time of this report. The patient outcome was reported as recovered/resolved. Follow-up information was received from a health care professional on 26 March 2012. The patient received the vaccination on 06 January 2012 at 1400 and experienced the adverse events four hours later at 1800. The patient recovered on 07 January 2012. The patient had no known illness at the time of vaccination and took no known concomitant medications. The patient's outcome remained recovered. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Post vaccination autoinoculation
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 448098. A 22-year-old male patient received the following vaccinations on 08 January 2012: ACAM2000 (SP Biologics Co. lot number VV04003A), TYPHIM Vi (Sanofi Pasteur SA, lot number G1124) and BIOTHRAX (EMERGENT, lot number FAV288). Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. On an unspecified date, the patient experienced post vaccination autoinoculation when the primary pox bursted and went from 3 pox to 11 pox. Laboratory data was not reported. Current illnesses and history were reported as none. Other medications and prior vaccinations were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Erythema multiforme, Induration, Pruritus, Rash vesicular
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 448301. A 21-year-old male patient received the following vaccinations on 30 May 2011: ACAM2000 (SP Biologics Co. lot number not reported), TYPHIM Vi (sanofi pasteur SA, lot number not reported) and BIOTHRAX (EMERGENT, lot number not reported). Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. On 13 June 2011, the patient developed firm vesicular eruptions on flexor surfaces of both knees and elbows with minor itching. The patient was diagnosed with erythema multiforme on 15 June 2011 by dermatology. The patient was treated with prednisone for two weeks. The patient had a mild rebound rash that resolved around 12 July 2011. Laboratory data was not available. Current illnesses, history and other medications were reported as none. Prior vaccinations were not reported. The patient's outcome was unknown. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Arthralgia, Circadian rhythm sleep disorder, Dermatitis acneiform, Erythema, Eschar
Clinical narrative: This case was received on 11 May 2012 via a third party query tool search on the VAERS database, under reference number 448586. A 40-year-old female patient received the following vaccination on 03 February 2011: ACAM2000 (lot number not reported) in the left posterior deltoid. Beginning on 10-11 February 2011, the patient developed lymphadenopathy in left axilla and erythema in entire left deltoid/axilla region. These symptoms (sxs) resolved after two days. The patient arrived abroad on 12 February 2011 and on that day developed numerous pustules on her chest. Evaluation on 15 February 2011 noted headache, fatigue, joint pain and swelling. Rash described as erythematous "spots" on chest, back and a few on abdomen. The exam noted temperature 98.2, heart rate (HR) 70, blood pressure (BP) 130/79, respiratory rate (RR) 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back and eschar on arm. The assessment included arthralgias consistent with (c/w) possible low-grade, concurrent viral prodrome which was treated with naprosyn, headache that was treated with acetaminophen two tabs twice daily, malaise c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. The patient reported rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks. Concomitant medications included doxycycline and SYNTHROID. The patient had no current illnesses and a history of being diagnosed (dx'd) with hypothyroidism in 2003, around the same time developed bilateral CTS, started SYNTHROID and the carpal tunnel syndrome (CTS) symptoms resolved. The patient's outcome was recovered. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Fatigue, Headache, Injection site erythema, Lymphadenopathy, Macule
Clinical narrative: This case was received on 11 May 2012 via a third party query tool search on the VAERS database, under reference number 448586. A 40-year-old female patient received the following vaccination on 03 February 2011: ACAM2000 (lot number not reported) in the left posterior deltoid. Beginning on 10-11 February 2011, the patient developed lymphadenopathy in left axilla and erythema in entire left deltoid/axilla region. These symptoms (sxs) resolved after two days. The patient arrived abroad on 12 February 2011 and on that day developed numerous pustules on her chest. Evaluation on 15 February 2011 noted headache, fatigue, joint pain and swelling. Rash described as erythematous "spots" on chest, back and a few on abdomen. The exam noted temperature 98.2, heart rate (HR) 70, blood pressure (BP) 130/79, respiratory rate (RR) 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back and eschar on arm. The assessment included arthralgias consistent with (c/w) possible low-grade, concurrent viral prodrome which was treated with naprosyn, headache that was treated with acetaminophen two tabs twice daily, malaise c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. The patient reported rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks. Concomitant medications included doxycycline and SYNTHROID. The patient had no current illnesses and a history of being diagnosed (dx'd) with hypothyroidism in 2003, around the same time developed bilateral CTS, started SYNTHROID and the carpal tunnel syndrome (CTS) symptoms resolved. The patient's outcome was recovered. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Malaise, Papule, Rash pustular, Swelling
Clinical narrative: This case was received on 11 May 2012 via a third party query tool search on the VAERS database, under reference number 448586. A 40-year-old female patient received the following vaccination on 03 February 2011: ACAM2000 (lot number not reported) in the left posterior deltoid. Beginning on 10-11 February 2011, the patient developed lymphadenopathy in left axilla and erythema in entire left deltoid/axilla region. These symptoms (sxs) resolved after two days. The patient arrived abroad on 12 February 2011 and on that day developed numerous pustules on her chest. Evaluation on 15 February 2011 noted headache, fatigue, joint pain and swelling. Rash described as erythematous "spots" on chest, back and a few on abdomen. The exam noted temperature 98.2, heart rate (HR) 70, blood pressure (BP) 130/79, respiratory rate (RR) 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back and eschar on arm. The assessment included arthralgias consistent with (c/w) possible low-grade, concurrent viral prodrome which was treated with naprosyn, headache that was treated with acetaminophen two tabs twice daily, malaise c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. The patient reported rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks. Concomitant medications included doxycycline and SYNTHROID. The patient had no current illnesses and a history of being diagnosed (dx'd) with hypothyroidism in 2003, around the same time developed bilateral CTS, started SYNTHROID and the carpal tunnel syndrome (CTS) symptoms resolved. The patient's outcome was recovered. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Malaise, Papule, Rash, Rash erythematous, Rash pustular
Clinical narrative: This case was received on 11 May 2012 via a third party query tool search on the VAERS database, under reference number 448586. A 40-year-old female patient received the following vaccination on 03 February 2011: ACAM2000 (lot number not reported) in the left posterior deltoid. Beginning on 10-11 February 2011, the patient developed lymphadenopathy in left axilla and erythema in entire left deltoid/axilla region. These symptoms (sxs) resolved after two days. The patient arrived abroad on 12 February 2011 and on that day developed numerous pustules on her chest. Evaluation on 15 February 2011 noted headache, fatigue, joint pain and swelling. Rash described as erythematous "spots" on chest, back and a few on abdomen. The exam noted temperature 98.2, heart rate (HR) 70, blood pressure (BP) 130/79, respiratory rate (RR) 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back and eschar on arm. The assessment included arthralgias consistent with (c/w) possible low-grade, concurrent viral prodrome which was treated with naprosyn, headache that was treated with acetaminophen two tabs twice daily, malaise c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. The patient reported rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks. Concomitant medications included doxycycline and SYNTHROID. The patient had no current illnesses and a history of being diagnosed (dx'd) with hypothyroidism in 2003, around the same time developed bilateral CTS, started SYNTHROID and the carpal tunnel syndrome (CTS) symptoms resolved. The patient's outcome was recovered. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Swelling
Clinical narrative: This case was received on 11 May 2012 via a third party query tool search on the VAERS database, under reference number 448586. A 40-year-old female patient received the following vaccination on 03 February 2011: ACAM2000 (lot number not reported) in the left posterior deltoid. Beginning on 10-11 February 2011, the patient developed lymphadenopathy in left axilla and erythema in entire left deltoid/axilla region. These symptoms (sxs) resolved after two days. The patient arrived abroad on 12 February 2011 and on that day developed numerous pustules on her chest. Evaluation on 15 February 2011 noted headache, fatigue, joint pain and swelling. Rash described as erythematous "spots" on chest, back and a few on abdomen. The exam noted temperature 98.2, heart rate (HR) 70, blood pressure (BP) 130/79, respiratory rate (RR) 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back and eschar on arm. The assessment included arthralgias consistent with (c/w) possible low-grade, concurrent viral prodrome which was treated with naprosyn, headache that was treated with acetaminophen two tabs twice daily, malaise c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. The patient reported rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks. Concomitant medications included doxycycline and SYNTHROID. The patient had no current illnesses and a history of being diagnosed (dx'd) with hypothyroidism in 2003, around the same time developed bilateral CTS, started SYNTHROID and the carpal tunnel syndrome (CTS) symptoms resolved. The patient's outcome was recovered. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Robust take following exposure to vaccinia virus, Skin lesion, Vaccination complication, Wound secretion
Clinical narrative: This case was received on 11 May 2012 via a third party query tool search on the VAERS database, under reference number 448615. A 20-year-old male patient received the following vaccination on 20 January 2012: ACAM2000 (lot number VV04-003-A) in the left arm. The patient's symptoms began on 01 February 2012. The patient presented with tegaderm and gauze covered lesion, dressing had not been removed since placement and was showing large amount of drainage. Robust take was seen with several satellite lesions after the dressing was removed. Lesion was covered with band aids and instruction of care was given. The patient had a pregnant wife and one-year-old son in the home. The patient had no current illnesses and no history. The patient's outcome was recovered. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Robust take following exposure to vaccinia virus, Secretion discharge, Skin lesion, Vaccination complication
Clinical narrative: This case was received on 11 May 2012 via a third party query tool search on the VAERS database, under reference number 448615. A 20-year-old male patient received the following vaccination on 20 January 2012: ACAM2000 (lot number VV04-003-A) in the left arm. The patient's symptoms began on 01 February 2012. The patient presented with tegaderm and gauze covered lesion, dressing had not been removed since placement and was showing large amount of drainage. Robust take was seen with several satellite lesions after the dressing was removed. Lesion was covered with band aids and instruction of care was given. The patient had a pregnant wife and one-year-old son in the home. The patient had no current illnesses and no history. The patient's outcome was recovered. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 23 January 2012. A 20-year-old male subject received ACAM2000 (lot number not reported) on 07 November 2011. The subject had no significant medical history. On 21 November 2011, the subject had an abnormal troponin I of 1.74, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 21 November 2011, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 11 May 2012 via a third party query tool on the VAERS database. The reference number was 448858. Documents held by sender: None.
Age: 32.0
Sex: M
Vaccine: ANTH, FLU3, HEPA, SMALL, TYP, ANTH, FLU3, HEPA, SMALL, TYP
Symptoms: Rash maculo-papular, Rash pruritic, Skin lesion
Clinical narrative: This case was received on 11 May 2012 via a third party query tool search on the VAERS database, under reference number 449084. A 32-year-old male patient received the following vaccinations on 31 October 2011: ACAM2000 (SP Biologics Co. lot number VV04-003-A), TYPHIM VI (Sanofi Pasteur SA lot number E05491), FLUZONE SV (Sanofi Pasteur Inc. lot number U1454912), anthrax (EMERGENT, lot number FAV281) and VAQTA (Merck lot number AHAVB459CB). The patient received the smallpox vaccine (SPV) in his left upper arm. He reported received two previous SPV during childhood and taking precautions to prevent autoinoculation and contact transmission. The patient had been changing the SPV site dressing after showering and reports normal site progression. The patient denied any fever, chills, myalgias, arthralgias or headaches during the first week post-vaccination. Also, denied any flushing, dyspnea, wheezing, facial swelling, itching or swelling of tongue, mouth or throat, or GI-related symptoms following vaccine receipt. The patient first noted the itchy rash on his neck 2 days ago (7 days post-vaccination, 07 November 2011) which spread to his chest and then "all over". The patient denied any lesions in his mouth or on his palms or soles. The rash was described as red bumps, no drainage from lesions, no scaling or peeling. Denied history of any similar rashes in the past. Denied any chronic skin conditions such as eczema, psoriasis, acne, etc. Denied allergies to medications, foods, latex or stings/bites. Only complaint today was itching. No chest pain, shortness of breath or palpitations. Results of the patient's exam included: alert, in no acute distress, not ill-appearing, oral cavity had no lesions seen in mouth, lungs clear to auscultation (CTA), no adventitious sounds were present, heart rate and rhythm were normal, heart sounds were normal, no murmurs were heard, more than 15 skin lesions primarily maculopapular lesions on the face, neck, trunk, chest, arms, thighs (reported, not examined), very few lesions below knees with no lesions on hands or feet. The exam was normal except as noted. The assessment of the injection site showed no abnormalities, the smallpox vaccination site on the left upper arm was examined and had scabbing with minimal drainage, minimal erythema surrounding area, no satellite lesions and no edema. At the follow-up visit on 14 November 2011, the rash on the face and neck markedly improved and new lesions on lower extremities (some appearing ecchymotic). No systemic symptoms. Photos and clinical notes from 09 November 2011 and 14 November 2011 will be sent with VAERS report. The patient's immune complex studies were pending. The patient had no current illnesses, a history of no known drug allergies (NKDA) and a tooth extraction on day of vaccine receipt and was started on penicillin (PCN), ibuprofen, TYLENOL #3 which the patient took for three days. The patient's outcome was not recovered. Documents held by sender: None.
Age: 32.0
Sex: M
Vaccine: ANTH, FLU3, HEPA, SMALL, TYP, ANTH, FLU3, HEPA, SMALL, TYP
Symptoms: Ecchymosis, Immune complex assay, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: This case was received on 11 May 2012 via a third party query tool search on the VAERS database, under reference number 449084. A 32-year-old male patient received the following vaccinations on 31 October 2011: ACAM2000 (SP Biologics Co. lot number VV04-003-A), TYPHIM VI (Sanofi Pasteur SA lot number E05491), FLUZONE SV (Sanofi Pasteur Inc. lot number U1454912), anthrax (EMERGENT, lot number FAV281) and VAQTA (Merck lot number AHAVB459CB). The patient received the smallpox vaccine (SPV) in his left upper arm. He reported received two previous SPV during childhood and taking precautions to prevent autoinoculation and contact transmission. The patient had been changing the SPV site dressing after showering and reports normal site progression. The patient denied any fever, chills, myalgias, arthralgias or headaches during the first week post-vaccination. Also, denied any flushing, dyspnea, wheezing, facial swelling, itching or swelling of tongue, mouth or throat, or GI-related symptoms following vaccine receipt. The patient first noted the itchy rash on his neck 2 days ago (7 days post-vaccination, 07 November 2011) which spread to his chest and then "all over". The patient denied any lesions in his mouth or on his palms or soles. The rash was described as red bumps, no drainage from lesions, no scaling or peeling. Denied history of any similar rashes in the past. Denied any chronic skin conditions such as eczema, psoriasis, acne, etc. Denied allergies to medications, foods, latex or stings/bites. Only complaint today was itching. No chest pain, shortness of breath or palpitations. Results of the patient's exam included: alert, in no acute distress, not ill-appearing, oral cavity had no lesions seen in mouth, lungs clear to auscultation (CTA), no adventitious sounds were present, heart rate and rhythm were normal, heart sounds were normal, no murmurs were heard, more than 15 skin lesions primarily maculopapular lesions on the face, neck, trunk, chest, arms, thighs (reported, not examined), very few lesions below knees with no lesions on hands or feet. The exam was normal except as noted. The assessment of the injection site showed no abnormalities, the smallpox vaccination site on the left upper arm was examined and had scabbing with minimal drainage, minimal erythema surrounding area, no satellite lesions and no edema. At the follow-up visit on 14 November 2011, the rash on the face and neck markedly improved and new lesions on lower extremities (some appearing ecchymotic). No systemic symptoms. Photos and clinical notes from 09 November 2011 and 14 November 2011 will be sent with VAERS report. The patient's immune complex studies were pending. The patient had no current illnesses, a history of no known drug allergies (NKDA) and a tooth extraction on day of vaccine receipt and was started on penicillin (PCN), ibuprofen, TYLENOL #3 which the patient took for three days. The patient's outcome was not recovered. Documents held by sender: None.