chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dermatitis
Clinical narrative: This case was received on 14 April 2009 via a QScan search on the VAERS database, under reference number 338642. A 28 year old male patient received ACAM2000 (manufacturer and lot number not reported) on 16 September 2008. Six weeks after vaccination, the patient developed erythematous, pruritic lesions at the site of ACAM2000 vaccination. The patient was evaluated by a dermatologist and the dermatitis, focal was felt to be related to the vaccine. Medical records received 03 February 2009 report a final diagnosis of post vaccine dermatosis of unknown etiology following vaccination with primary smallpox vaccine. The records reveal that the patient experienced a normal site reaction with the scab falling off after approximately 30 days. The patient developed an erythematous pruritic bump at the inoculation site two weeks later. The bump increased in size and the patient self-treated with a topical antibiotic cream for approximately one week and improvement was seen. When the treatment was discontinued, the bump enlarged. The patient then used steroid cream until January 2009 when the bump developed into a pimple. The patient was seen by a healthcare provider for deployment clearance. A dermatology consult was done and DESONIDE was prescribed for treatment. NOTE: 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. List of Documents held by Sender: None.
Age: 28.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dermatitis, Dermatosis, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: This case was received on 14 April 2009 via a QScan search on the VAERS database, under reference number 338642. A 28 year old male patient received ACAM2000 (manufacturer and lot number not reported) on 16 September 2008. Six weeks after vaccination, the patient developed erythematous, pruritic lesions at the site of ACAM2000 vaccination. The patient was evaluated by a dermatologist and the dermatitis, focal was felt to be related to the vaccine. Medical records received 03 February 2009 report a final diagnosis of post vaccine dermatosis of unknown etiology following vaccination with primary smallpox vaccine. The records reveal that the patient experienced a normal site reaction with the scab falling off after approximately 30 days. The patient developed an erythematous pruritic bump at the inoculation site two weeks later. The bump increased in size and the patient self-treated with a topical antibiotic cream for approximately one week and improvement was seen. When the treatment was discontinued, the bump enlarged. The patient then used steroid cream until January 2009 when the bump developed into a pimple. The patient was seen by a healthcare provider for deployment clearance. A dermatology consult was done and DESONIDE was prescribed for treatment. NOTE: 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. List of Documents held by Sender: None.
Age: 28.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Scab, Vaccination complication
Clinical narrative: This case was received on 14 April 2009 via a QScan search on the VAERS database, under reference number 338642. A 28 year old male patient received ACAM2000 (manufacturer and lot number not reported) on 16 September 2008. Six weeks after vaccination, the patient developed erythematous, pruritic lesions at the site of ACAM2000 vaccination. The patient was evaluated by a dermatologist and the dermatitis, focal was felt to be related to the vaccine. Medical records received 03 February 2009 report a final diagnosis of post vaccine dermatosis of unknown etiology following vaccination with primary smallpox vaccine. The records reveal that the patient experienced a normal site reaction with the scab falling off after approximately 30 days. The patient developed an erythematous pruritic bump at the inoculation site two weeks later. The bump increased in size and the patient self-treated with a topical antibiotic cream for approximately one week and improvement was seen. When the treatment was discontinued, the bump enlarged. The patient then used steroid cream until January 2009 when the bump developed into a pimple. The patient was seen by a healthcare provider for deployment clearance. A dermatology consult was done and DESONIDE was prescribed for treatment. NOTE: 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. List of Documents held by Sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blister, Conjunctivitis infective, Eye discharge, Eyelid oedema, Ocular hyperaemia
Clinical narrative: SERIOUSNESS CRITERIA- OTHER MEDICALLY SIGNIFICANT. This case was received by Sanofi Pasteur on 07 May via a QScan search on the VAERS database, under reference number 339141. A 19 year old male received ACAM2000 vaccine (lot number not reported). Eight days later, the patient noticed that his right eye was a "little pink". The patient was prescribed VIROPTIC and ILOTYCIN drops. By Day 11, his symptoms progressed to a swollen eye lid, greenish discharge and pustules on the eye lid. The patient was seen by optometry and was treated with VIGAMOX (QID), VIROPTIC (Q2H) and acyclovir (PO 5 time/day). Viral culture of the conjunctiva (OD) and skin lesion taken on Day 13 were positive for poxvirus. Medical records received from an optometry visit on Day 15 include a diagnosis of vaccinia OD as a result of spread from recent smallpox vaccination site. The symptoms included eye pain, redness, discharge, itching and photophobia. The physical exam noted crusting, scabbing pustules along the lash margin. The patient also reported right ear pain. No additional information was provided. 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. List of Documents held by Sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash pustular
Clinical narrative: SERIOUSNESS CRITERIA- OTHER MEDICALLY SIGNIFICANT. This case was received by Sanofi Pasteur on 07 May via a QScan search on the VAERS database, under reference number 339141. A 19 year old male received ACAM2000 vaccine (lot number not reported). Eight days later, the patient noticed that his right eye was a "little pink". The patient was prescribed VIROPTIC and ILOTYCIN drops. By Day 11, his symptoms progressed to a swollen eye lid, greenish discharge and pustules on the eye lid. The patient was seen by optometry and was treated with VIGAMOX (QID), VIROPTIC (Q2H) and acyclovir (PO 5 time/day). Viral culture of the conjunctiva (OD) and skin lesion taken on Day 13 were positive for poxvirus. Medical records received from an optometry visit on Day 15 include a diagnosis of vaccinia OD as a result of spread from recent smallpox vaccination site. The symptoms included eye pain, redness, discharge, itching and photophobia. The physical exam noted crusting, scabbing pustules along the lash margin. The patient also reported right ear pain. No additional information was provided. 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. List of Documents held by Sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Conjunctivitis infective, Ear pain, Eye discharge, Eye pain, Eye pruritus
Clinical narrative: SERIOUSNESS CRITERIA- OTHER MEDICALLY SIGNIFICANT. This case was received by Sanofi Pasteur on 07 May via a QScan search on the VAERS database, under reference number 339141. A 19 year old male received ACAM2000 vaccine (lot number not reported). Eight days later, the patient noticed that his right eye was a "little pink". The patient was prescribed VIROPTIC and ILOTYCIN drops. By Day 11, his symptoms progressed to a swollen eye lid, greenish discharge and pustules on the eye lid. The patient was seen by optometry and was treated with VIGAMOX (QID), VIROPTIC (Q2H) and acyclovir (PO 5 time/day). Viral culture of the conjunctiva (OD) and skin lesion taken on Day 13 were positive for poxvirus. Medical records received from an optometry visit on Day 15 include a diagnosis of vaccinia OD as a result of spread from recent smallpox vaccination site. The symptoms included eye pain, redness, discharge, itching and photophobia. The physical exam noted crusting, scabbing pustules along the lash margin. The patient also reported right ear pain. No additional information was provided. 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. List of Documents held by Sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Eyelid margin crusting, Eyelid oedema, Ocular hyperaemia, Photophobia, Rash pustular
Clinical narrative: SERIOUSNESS CRITERIA- OTHER MEDICALLY SIGNIFICANT. This case was received by Sanofi Pasteur on 07 May via a QScan search on the VAERS database, under reference number 339141. A 19 year old male received ACAM2000 vaccine (lot number not reported). Eight days later, the patient noticed that his right eye was a "little pink". The patient was prescribed VIROPTIC and ILOTYCIN drops. By Day 11, his symptoms progressed to a swollen eye lid, greenish discharge and pustules on the eye lid. The patient was seen by optometry and was treated with VIGAMOX (QID), VIROPTIC (Q2H) and acyclovir (PO 5 time/day). Viral culture of the conjunctiva (OD) and skin lesion taken on Day 13 were positive for poxvirus. Medical records received from an optometry visit on Day 15 include a diagnosis of vaccinia OD as a result of spread from recent smallpox vaccination site. The symptoms included eye pain, redness, discharge, itching and photophobia. The physical exam noted crusting, scabbing pustules along the lash margin. The patient also reported right ear pain. No additional information was provided. 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. List of Documents held by Sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Scab, Skin lesion, Vaccinia, Virus culture positive
Clinical narrative: SERIOUSNESS CRITERIA- OTHER MEDICALLY SIGNIFICANT. This case was received by Sanofi Pasteur on 07 May via a QScan search on the VAERS database, under reference number 339141. A 19 year old male received ACAM2000 vaccine (lot number not reported). Eight days later, the patient noticed that his right eye was a "little pink". The patient was prescribed VIROPTIC and ILOTYCIN drops. By Day 11, his symptoms progressed to a swollen eye lid, greenish discharge and pustules on the eye lid. The patient was seen by optometry and was treated with VIGAMOX (QID), VIROPTIC (Q2H) and acyclovir (PO 5 time/day). Viral culture of the conjunctiva (OD) and skin lesion taken on Day 13 were positive for poxvirus. Medical records received from an optometry visit on Day 15 include a diagnosis of vaccinia OD as a result of spread from recent smallpox vaccination site. The symptoms included eye pain, redness, discharge, itching and photophobia. The physical exam noted crusting, scabbing pustules along the lash margin. The patient also reported right ear pain. No additional information was provided. 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. List of Documents held by Sender: None.
Age: 36.0
Sex: M
Vaccine: SMALL, TYP, SMALL, TYP
Symptoms: Influenza like illness, Injection site erythema, Malaise, Pain in extremity, Scar
Clinical narrative: This case was received on 07 May 2009 via a QScan search of the VAERS database, under reference number 339196.
Age: 36.0
Sex: M
Vaccine: SMALL, TYP, SMALL, TYP
Symptoms: Skin lesion
Clinical narrative: This case was received on 07 May 2009 via a QScan search of the VAERS database, under reference number 339196.
Age: 39.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: No adverse event
Clinical narrative: This case was received on 07 May 2009 via a Q Scan search of the VAERS database, under reference number 339275. A 39 year old male patient received the following vaccine on 29 January 2009: smallpox (ACAM2000, Sanofi Biologics, lot number VV04-003A). The patient suspected spreading of vaccinia due to drying himself with a towel that may have had possible contact with the vaccination site. Per the reporter, the patient did not seek medical attention and the reaction turned out to be possible mosquito bites. The outcome was not reported. No other information was provided. List of documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Cardiac enzymes normal, Chest pain, Dyspnoea, Electrocardiogram normal, Pericarditis
Clinical narrative: This case was received on 07 May 2009, under reference number 339759. A 22 year old male patient received the following vaccines on 18 December 2008: smallpox (trade name, manufacturer and lot number unknown), Typhim VI, lot number B0424, and anthrax (trade name, manufacturer and lot number unknown). Note: 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. Four days after vaccination, the patient experienced chest pain and met the criteria for "suspect" pericarditis according to CDC guidelines definition of: "typical chest pain (i.e. made worse by supine position" improved with leaning forward), no evidence for alternative likely of such chest pain, occurring within 30 days of vaccination. Medical records received stated that the patient presented on 20 December 2008 complaining of chest pain, dyspnea on exertion, cough, fever and palpitations. Initial diagnosis was upper respiratory infection but he continued to have intermittent chest pain and tachycardia. Assessment: pericarditis, acute secondary to smallpox vaccine. Testing results included normal cardiac enzymes and electrocardiogram, normal echocardiogram and troponin:0.04 (units and reference range not provided). The patient was treated with MOTRIN. The patient's outcome was reported as recovered. No other information was provided. There may be a discrepancy between the event date field and onset date information in the free test narrative field in the data reported. Latency has been calculated using the event date. List of documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Cardiac enzymes normal, Chest pain, Cough, Dyspnoea exertional, Electrocardiogram normal
Clinical narrative: This case was received on 07 May 2009, under reference number 339759. A 22 year old male patient received the following vaccines on 18 December 2008: smallpox (trade name, manufacturer and lot number unknown), Typhim VI, lot number B0424, and anthrax (trade name, manufacturer and lot number unknown). Note: 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. Four days after vaccination, the patient experienced chest pain and met the criteria for "suspect" pericarditis according to CDC guidelines definition of: "typical chest pain (i.e. made worse by supine position" improved with leaning forward), no evidence for alternative likely of such chest pain, occurring within 30 days of vaccination. Medical records received stated that the patient presented on 20 December 2008 complaining of chest pain, dyspnea on exertion, cough, fever and palpitations. Initial diagnosis was upper respiratory infection but he continued to have intermittent chest pain and tachycardia. Assessment: pericarditis, acute secondary to smallpox vaccine. Testing results included normal cardiac enzymes and electrocardiogram, normal echocardiogram and troponin:0.04 (units and reference range not provided). The patient was treated with MOTRIN. The patient's outcome was reported as recovered. No other information was provided. There may be a discrepancy between the event date field and onset date information in the free test narrative field in the data reported. Latency has been calculated using the event date. List of documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Palpitations, Pericarditis, Pyrexia, Tachycardia, Troponin I increased
Clinical narrative: This case was received on 07 May 2009, under reference number 339759. A 22 year old male patient received the following vaccines on 18 December 2008: smallpox (trade name, manufacturer and lot number unknown), Typhim VI, lot number B0424, and anthrax (trade name, manufacturer and lot number unknown). Note: 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. Four days after vaccination, the patient experienced chest pain and met the criteria for "suspect" pericarditis according to CDC guidelines definition of: "typical chest pain (i.e. made worse by supine position" improved with leaning forward), no evidence for alternative likely of such chest pain, occurring within 30 days of vaccination. Medical records received stated that the patient presented on 20 December 2008 complaining of chest pain, dyspnea on exertion, cough, fever and palpitations. Initial diagnosis was upper respiratory infection but he continued to have intermittent chest pain and tachycardia. Assessment: pericarditis, acute secondary to smallpox vaccine. Testing results included normal cardiac enzymes and electrocardiogram, normal echocardiogram and troponin:0.04 (units and reference range not provided). The patient was treated with MOTRIN. The patient's outcome was reported as recovered. No other information was provided. There may be a discrepancy between the event date field and onset date information in the free test narrative field in the data reported. Latency has been calculated using the event date. List of documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Upper respiratory tract infection
Clinical narrative: This case was received on 07 May 2009, under reference number 339759. A 22 year old male patient received the following vaccines on 18 December 2008: smallpox (trade name, manufacturer and lot number unknown), Typhim VI, lot number B0424, and anthrax (trade name, manufacturer and lot number unknown). Note: 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. Four days after vaccination, the patient experienced chest pain and met the criteria for "suspect" pericarditis according to CDC guidelines definition of: "typical chest pain (i.e. made worse by supine position" improved with leaning forward), no evidence for alternative likely of such chest pain, occurring within 30 days of vaccination. Medical records received stated that the patient presented on 20 December 2008 complaining of chest pain, dyspnea on exertion, cough, fever and palpitations. Initial diagnosis was upper respiratory infection but he continued to have intermittent chest pain and tachycardia. Assessment: pericarditis, acute secondary to smallpox vaccine. Testing results included normal cardiac enzymes and electrocardiogram, normal echocardiogram and troponin:0.04 (units and reference range not provided). The patient was treated with MOTRIN. The patient's outcome was reported as recovered. No other information was provided. There may be a discrepancy between the event date field and onset date information in the free test narrative field in the data reported. Latency has been calculated using the event date. List of documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Full blood count, Headache, Metabolic function test, Nausea, Rash erythematous
Clinical narrative: This case was received on 05 May 2009 via a QScan search of the VAERS database, under reference number 340110. A 19 year old male patient received the following vaccination on 08 February 2009: smallpox (ACAM2000, Lot number N04003A) and anthrax (Biothrax, Emergent Biosolutions, lot number not reported). Eleven days after vaccination, generalized vaccinia characterized by headache, nausea and generalized erythematous papules sparing face and neck was reported. Red blood cell sedimentation rate was increased, actual test results and date of test not reported. The outcome was not reported. No other information was provided. List of documents held by sender: None
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Rash papular, Red blood cell sedimentation rate increased, Vaccinia
Clinical narrative: This case was received on 05 May 2009 via a QScan search of the VAERS database, under reference number 340110. A 19 year old male patient received the following vaccination on 08 February 2009: smallpox (ACAM2000, Lot number N04003A) and anthrax (Biothrax, Emergent Biosolutions, lot number not reported). Eleven days after vaccination, generalized vaccinia characterized by headache, nausea and generalized erythematous papules sparing face and neck was reported. Red blood cell sedimentation rate was increased, actual test results and date of test not reported. The outcome was not reported. No other information was provided. List of documents held by sender: None
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Nausea, Rash erythematous, Rash generalised, Rash papular
Clinical narrative: This case was received on 05 May 2009 via a QScan search of the VAERS database, under reference number 340110. A 19 year old male patient received the following vaccination on 08 February 2009: smallpox (ACAM2000, Lot number N04003A) and anthrax (Biothrax, Emergent Biosolutions, lot number not reported). Eleven days after vaccination, generalized vaccinia characterized by headache, nausea and generalized erythematous papules sparing face and neck was reported. Red blood cell sedimentation rate was increased, actual test results and date of test not reported. The outcome was not reported. No other information was provided. List of documents held by sender: None
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Red blood cell sedimentation rate increased, Vaccinia
Clinical narrative: This case was received on 05 May 2009 via a QScan search of the VAERS database, under reference number 340110. A 19 year old male patient received the following vaccination on 08 February 2009: smallpox (ACAM2000, Lot number N04003A) and anthrax (Biothrax, Emergent Biosolutions, lot number not reported). Eleven days after vaccination, generalized vaccinia characterized by headache, nausea and generalized erythematous papules sparing face and neck was reported. Red blood cell sedimentation rate was increased, actual test results and date of test not reported. The outcome was not reported. No other information was provided. List of documents held by sender: None
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Biopsy skin normal, Chest X-ray normal, Immunology test, Pain, Polymerase chain reaction
Clinical narrative: This case was received on 07 May 2009 via a QScan search of the VAERS database, under reference number 340148.  A 32 year old patient (gender reported as unknown) received the following vaccines on 15 January 2009; SMALLPOX ACAM2000, (Sanofi Pasteur Biologics Co., lot number not reported), TYPHIM VI, (Sanofi Pasteur, lot number B0424), ENGERIX, (Glaxosmithkline Biologicals, lot number not reported) and BIOTHRAX, (Emergent Biosolutions, lot number not reported).  Seventeen days following vaccination, the patient experienced multiple erythematous, vesiculopapular eruptions over arms, hands, legs, chest, heels, upper back and upper trunk.  The rash was initially mildly pruritic, then became painful.  The patient reported no fever/chills or other significant symptoms.  The initial dermatologic evaluation on 04 February 2009 yielded a preliminary diagnosis of dermatitis with a differential diagnosis to include delayed hypersensitivity reaction to smallpox vaccine and less likely generalized vaccinia.  The patient was initially prescribed VALTREX.  On 09 February 2009 patient was prescribed oral steroids with taper and showed fairly rapid improvement of tenderness and gradual crusting of all vesicles.  Laboratory and biopsy results ruled out viral etiologies.  The patient was advised after medical consultation to not receive additional doses of anthrax and hepatitis B vaccine until four weeks after completing a course of oral steroids., individually and a week apart and only if the skin lesions fully resolved without recurrence.  A medical reactive exemption was given for smallpox vaccine.  Laboratory results from 04 February 2009 include:  Giemsa stain: negative, Tzanck smear:  negative, vesical base HSV Antigen DFA: negative, vesical base VZV Antigen DFA: positive, vaccinia PCR: negative, Punch biopsy left elbow:  Subepidermal vesicle with scant interstitial neutrophil.  The outcome of the patient was not reported.   No other information was provided.  List of documents held by sender:  None.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Scab, Viral DNA test positive
Clinical narrative: This case was received on 07 May 2009 via a QScan search of the VAERS database, under reference number 340148.  A 32 year old patient (gender reported as unknown) received the following vaccines on 15 January 2009; SMALLPOX ACAM2000, (Sanofi Pasteur Biologics Co., lot number not reported), TYPHIM VI, (Sanofi Pasteur, lot number B0424), ENGERIX, (Glaxosmithkline Biologicals, lot number not reported) and BIOTHRAX, (Emergent Biosolutions, lot number not reported).  Seventeen days following vaccination, the patient experienced multiple erythematous, vesiculopapular eruptions over arms, hands, legs, chest, heels, upper back and upper trunk.  The rash was initially mildly pruritic, then became painful.  The patient reported no fever/chills or other significant symptoms.  The initial dermatologic evaluation on 04 February 2009 yielded a preliminary diagnosis of dermatitis with a differential diagnosis to include delayed hypersensitivity reaction to smallpox vaccine and less likely generalized vaccinia.  The patient was initially prescribed VALTREX.  On 09 February 2009 patient was prescribed oral steroids with taper and showed fairly rapid improvement of tenderness and gradual crusting of all vesicles.  Laboratory and biopsy results ruled out viral etiologies.  The patient was advised after medical consultation to not receive additional doses of anthrax and hepatitis B vaccine until four weeks after completing a course of oral steroids., individually and a week apart and only if the skin lesions fully resolved without recurrence.  A medical reactive exemption was given for smallpox vaccine.  Laboratory results from 04 February 2009 include:  Giemsa stain: negative, Tzanck smear:  negative, vesical base HSV Antigen DFA: negative, vesical base VZV Antigen DFA: positive, vaccinia PCR: negative, Punch biopsy left elbow:  Subepidermal vesicle with scant interstitial neutrophil.  The outcome of the patient was not reported.   No other information was provided.  List of documents held by sender:  None.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Biopsy, Blister, Dermatitis, Herpes simplex serology negative, Hypersensitivity
Clinical narrative: This case was received on 07 May 2009 via a QScan search of the VAERS database, under reference number 340148.  A 32 year old patient (gender reported as unknown) received the following vaccines on 15 January 2009; SMALLPOX ACAM2000, (Sanofi Pasteur Biologics Co., lot number not reported), TYPHIM VI, (Sanofi Pasteur, lot number B0424), ENGERIX, (Glaxosmithkline Biologicals, lot number not reported) and BIOTHRAX, (Emergent Biosolutions, lot number not reported).  Seventeen days following vaccination, the patient experienced multiple erythematous, vesiculopapular eruptions over arms, hands, legs, chest, heels, upper back and upper trunk.  The rash was initially mildly pruritic, then became painful.  The patient reported no fever/chills or other significant symptoms.  The initial dermatologic evaluation on 04 February 2009 yielded a preliminary diagnosis of dermatitis with a differential diagnosis to include delayed hypersensitivity reaction to smallpox vaccine and less likely generalized vaccinia.  The patient was initially prescribed VALTREX.  On 09 February 2009 patient was prescribed oral steroids with taper and showed fairly rapid improvement of tenderness and gradual crusting of all vesicles.  Laboratory and biopsy results ruled out viral etiologies.  The patient was advised after medical consultation to not receive additional doses of anthrax and hepatitis B vaccine until four weeks after completing a course of oral steroids., individually and a week apart and only if the skin lesions fully resolved without recurrence.  A medical reactive exemption was given for smallpox vaccine.  Laboratory results from 04 February 2009 include:  Giemsa stain: negative, Tzanck smear:  negative, vesical base HSV Antigen DFA: negative, vesical base VZV Antigen DFA: positive, vaccinia PCR: negative, Punch biopsy left elbow:  Subepidermal vesicle with scant interstitial neutrophil.  The outcome of the patient was not reported.   No other information was provided.  List of documents held by sender:  None.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Laboratory test, Pain, Polymerase chain reaction, Rash erythematous, Rash pruritic
Clinical narrative: This case was received on 07 May 2009 via a QScan search of the VAERS database, under reference number 340148.  A 32 year old patient (gender reported as unknown) received the following vaccines on 15 January 2009; SMALLPOX ACAM2000, (Sanofi Pasteur Biologics Co., lot number not reported), TYPHIM VI, (Sanofi Pasteur, lot number B0424), ENGERIX, (Glaxosmithkline Biologicals, lot number not reported) and BIOTHRAX, (Emergent Biosolutions, lot number not reported).  Seventeen days following vaccination, the patient experienced multiple erythematous, vesiculopapular eruptions over arms, hands, legs, chest, heels, upper back and upper trunk.  The rash was initially mildly pruritic, then became painful.  The patient reported no fever/chills or other significant symptoms.  The initial dermatologic evaluation on 04 February 2009 yielded a preliminary diagnosis of dermatitis with a differential diagnosis to include delayed hypersensitivity reaction to smallpox vaccine and less likely generalized vaccinia.  The patient was initially prescribed VALTREX.  On 09 February 2009 patient was prescribed oral steroids with taper and showed fairly rapid improvement of tenderness and gradual crusting of all vesicles.  Laboratory and biopsy results ruled out viral etiologies.  The patient was advised after medical consultation to not receive additional doses of anthrax and hepatitis B vaccine until four weeks after completing a course of oral steroids., individually and a week apart and only if the skin lesions fully resolved without recurrence.  A medical reactive exemption was given for smallpox vaccine.  Laboratory results from 04 February 2009 include:  Giemsa stain: negative, Tzanck smear:  negative, vesical base HSV Antigen DFA: negative, vesical base VZV Antigen DFA: positive, vaccinia PCR: negative, Punch biopsy left elbow:  Subepidermal vesicle with scant interstitial neutrophil.  The outcome of the patient was not reported.   No other information was provided.  List of documents held by sender:  None.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Rash pustular, Scab, Smear test, Tenderness, Vaccinia
Clinical narrative: This case was received on 07 May 2009 via a QScan search of the VAERS database, under reference number 340148.  A 32 year old patient (gender reported as unknown) received the following vaccines on 15 January 2009; SMALLPOX ACAM2000, (Sanofi Pasteur Biologics Co., lot number not reported), TYPHIM VI, (Sanofi Pasteur, lot number B0424), ENGERIX, (Glaxosmithkline Biologicals, lot number not reported) and BIOTHRAX, (Emergent Biosolutions, lot number not reported).  Seventeen days following vaccination, the patient experienced multiple erythematous, vesiculopapular eruptions over arms, hands, legs, chest, heels, upper back and upper trunk.  The rash was initially mildly pruritic, then became painful.  The patient reported no fever/chills or other significant symptoms.  The initial dermatologic evaluation on 04 February 2009 yielded a preliminary diagnosis of dermatitis with a differential diagnosis to include delayed hypersensitivity reaction to smallpox vaccine and less likely generalized vaccinia.  The patient was initially prescribed VALTREX.  On 09 February 2009 patient was prescribed oral steroids with taper and showed fairly rapid improvement of tenderness and gradual crusting of all vesicles.  Laboratory and biopsy results ruled out viral etiologies.  The patient was advised after medical consultation to not receive additional doses of anthrax and hepatitis B vaccine until four weeks after completing a course of oral steroids., individually and a week apart and only if the skin lesions fully resolved without recurrence.  A medical reactive exemption was given for smallpox vaccine.  Laboratory results from 04 February 2009 include:  Giemsa stain: negative, Tzanck smear:  negative, vesical base HSV Antigen DFA: negative, vesical base VZV Antigen DFA: positive, vaccinia PCR: negative, Punch biopsy left elbow:  Subepidermal vesicle with scant interstitial neutrophil.  The outcome of the patient was not reported.   No other information was provided.  List of documents held by sender:  None.
Age: 32.0
Sex: U
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Viral DNA test positive
Clinical narrative: This case was received on 07 May 2009 via a QScan search of the VAERS database, under reference number 340148.  A 32 year old patient (gender reported as unknown) received the following vaccines on 15 January 2009; SMALLPOX ACAM2000, (Sanofi Pasteur Biologics Co., lot number not reported), TYPHIM VI, (Sanofi Pasteur, lot number B0424), ENGERIX, (Glaxosmithkline Biologicals, lot number not reported) and BIOTHRAX, (Emergent Biosolutions, lot number not reported).  Seventeen days following vaccination, the patient experienced multiple erythematous, vesiculopapular eruptions over arms, hands, legs, chest, heels, upper back and upper trunk.  The rash was initially mildly pruritic, then became painful.  The patient reported no fever/chills or other significant symptoms.  The initial dermatologic evaluation on 04 February 2009 yielded a preliminary diagnosis of dermatitis with a differential diagnosis to include delayed hypersensitivity reaction to smallpox vaccine and less likely generalized vaccinia.  The patient was initially prescribed VALTREX.  On 09 February 2009 patient was prescribed oral steroids with taper and showed fairly rapid improvement of tenderness and gradual crusting of all vesicles.  Laboratory and biopsy results ruled out viral etiologies.  The patient was advised after medical consultation to not receive additional doses of anthrax and hepatitis B vaccine until four weeks after completing a course of oral steroids., individually and a week apart and only if the skin lesions fully resolved without recurrence.  A medical reactive exemption was given for smallpox vaccine.  Laboratory results from 04 February 2009 include:  Giemsa stain: negative, Tzanck smear:  negative, vesical base HSV Antigen DFA: negative, vesical base VZV Antigen DFA: positive, vaccinia PCR: negative, Punch biopsy left elbow:  Subepidermal vesicle with scant interstitial neutrophil.  The outcome of the patient was not reported.   No other information was provided.  List of documents held by sender:  None.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain
Clinical narrative: This case was received by agency on 07 May 2009 via a QScan search on the VAERS database, under reference number 340190.  A 19 year old male received ACAM2000 (lot number VV04003A).  Thirteen days later, the patient reported chest pain.  No additional information was provided.  List of documents held by sender:  none
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Secondary transmission, Skin lesion
Clinical narrative: This case was received by Sanofi Pasteur on 07 May 2009 via a QScan search on the VAERS database, under reference number 340276. This report involved a male patient who developed lesions along his jaw line. The patient reports sharing towels and clothing with his roommate who received ACAM2000 on 27 January 2009. No additional information was provided. List of Documents held by Sender: None
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Skin lesion
Clinical narrative: This case was received by Sanofi Pasteur on 07 May 2009 via a QScan search on the VAERS database, under reference number 340276. This report involved a male patient who developed lesions along his jaw line. The patient reports sharing towels and clothing with his roommate who received ACAM2000 on 27 January 2009. No additional information was provided. List of Documents held by Sender: None
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Contusion, Epistaxis, Hypersensitivity, Idiopathic thrombocytopenic purpura, Mouth haemorrhage
Clinical narrative: Initial report was received on 21 April 2009 by another manufacturer that received the report from a healthcare professional on 13 April 2009. A male subject (age not reported) was vaccinated with ACAM2000, SP Biologics, lot number W04-003A) on 26 February 2009. Approximately one month later, after his deployment, he developed bleeding and bruising from nose and mouth. While abroad, he received  yellow fever vaccine (manufacturer and lot number unknown) and mefloquine. He was deployed to a foreign country where he was diagnosed with idiopathic thrombocytopenic purpura. The report also states an allergic reaction occurred in February 2009. No additional information was provided. Documents held by sender: None.
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Contusion, Epistaxis, Foreign travel, Hypersensitivity, Idiopathic thrombocytopenic purpura
Clinical narrative: Initial report was received on 21 April 2009 by another manufacturer that received the report from a healthcare professional on 13 April 2009. A male subject (age not reported) was vaccinated with ACAM2000, SP Biologics, lot number W04-003A) on 26 February 2009. Approximately one month later, after his deployment, he developed bleeding and bruising from nose and mouth. While abroad, he received  yellow fever vaccine (manufacturer and lot number unknown) and mefloquine. He was deployed to a foreign country where he was diagnosed with idiopathic thrombocytopenic purpura. The report also states an allergic reaction occurred in February 2009. No additional information was provided. Documents held by sender: None.
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Mouth haemorrhage
Clinical narrative: Initial report was received on 21 April 2009 by another manufacturer that received the report from a healthcare professional on 13 April 2009. A male subject (age not reported) was vaccinated with ACAM2000, SP Biologics, lot number W04-003A) on 26 February 2009. Approximately one month later, after his deployment, he developed bleeding and bruising from nose and mouth. While abroad, he received  yellow fever vaccine (manufacturer and lot number unknown) and mefloquine. He was deployed to a foreign country where he was diagnosed with idiopathic thrombocytopenic purpura. The report also states an allergic reaction occurred in February 2009. No additional information was provided. Documents held by sender: None.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Convulsion, Electrocardiogram, Nuclear magnetic resonance imaging, Positron emission tomogram
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 83 year old male with a history of benign prostatic hyperplasia, who on 31-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 663637/1705X) into the left arm. The patient reported that he had no allergies, he did not smoke, he had one drink of alcohol a day, and his only medication was terazosin hydrochloride 1-10mg for benign prostatic hyperplasia. On 02-APR-2009, the patient had a generalized tonic clonic seizure and was hospitalized. An electroencephalogram, a grand mal convulsion, a nuclear magnetic resonance imaging (results not reported) and a positron emission tomogram: normal, were done to establish the diagnosis. The listing indicated that the events required hospitalization and were considered to be immediately life-threatening. No further information is available. The original reporting source was provided by a consumer. The VAERS ID# 345533. A standard lot check investigation was performed. All in-process quality checks for the lot number 1705X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electroencephalogram, Grand mal convulsion, Nuclear magnetic resonance imaging, Positron emission tomogram normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 83 year old male with a history of benign prostatic hyperplasia, who on 31-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 663637/1705X) into the left arm. The patient reported that he had no allergies, he did not smoke, he had one drink of alcohol a day, and his only medication was terazosin hydrochloride 1-10mg for benign prostatic hyperplasia. On 02-APR-2009, the patient had a generalized tonic clonic seizure and was hospitalized. An electroencephalogram, a grand mal convulsion, a nuclear magnetic resonance imaging (results not reported) and a positron emission tomogram: normal, were done to establish the diagnosis. The listing indicated that the events required hospitalization and were considered to be immediately life-threatening. No further information is available. The original reporting source was provided by a consumer. The VAERS ID# 345533. A standard lot check investigation was performed. All in-process quality checks for the lot number 1705X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Nuclear magnetic resonance imaging, Positron emission tomogram normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 83 year old male with a history of benign prostatic hyperplasia, who on 31-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 663637/1705X) into the left arm. The patient reported that he had no allergies, he did not smoke, he had one drink of alcohol a day, and his only medication was terazosin hydrochloride 1-10mg for benign prostatic hyperplasia. On 02-APR-2009, the patient had a generalized tonic clonic seizure and was hospitalized. An electroencephalogram, a grand mal convulsion, a nuclear magnetic resonance imaging (results not reported) and a positron emission tomogram: normal, were done to establish the diagnosis. The listing indicated that the events required hospitalization and were considered to be immediately life-threatening. No further information is available. The original reporting source was provided by a consumer. The VAERS ID# 345533. A standard lot check investigation was performed. All in-process quality checks for the lot number 1705X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy, Biopsy bone marrow, Chemotherapy, Computerised tomogram, Deafness
Clinical narrative: Information has been received from an 80 year old female patient with hip replacement, glaucoma and sulfonamide allergy who on 02-FEB-2009 was vaccinated at her upper left arm with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included alendronate sodium (MSD). Within a few weeks of the vaccination, the patient lost all of her hearing of her right ear. Then the patient was hearing impaired by utilizing a hearing aid, but the hearing aid did not work. On 13-APR-2009, the patient had severe swollen glands on both sides of her neck and an ear, nose and throat (ENT) physician was sought. A various number of testing was performed. A CAT scan indicated there was a growth on the patient's nasopharynx which was pressing against her Eustachian tube and robbed her hearing. There were three biopsies performed to confirm the diagnosis, diffuse large B-Cells Non-HODGKINS Lymphoma. On 28-MAY-2009, the patient started chemotherapy called R-CHOP and prednisone. The R-CHOP therapy included RITUXAN, adriamycin, VINCRISTINE. It was reported that the patient visited the emergency room 9 days after her first treatment of chemotherapy due to pain. The patient was admitted for 24 hours for pain relief and it was thought she was bleeding internally from chemotherapy. After two treatments, the patient's swelling was gone down, her hearing was back to former level and her hearing aid worked. At the time of the report, the patient had undergone 3 out of 6 treatments. Her physician told her that she was making progress. Upon internal review, hearing loss and diffuse large B-Cell non Hodgkins lymphoma were determined to be an other important medical event. Additional information has been requested.