chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient with unspecified chronic pain and allergy to drugs such as MOTRIN and heparin. On 23-SEP-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # K008927, expiration date: 17-MAR-2016) 0.5 ml, intramuscularly in the right arm. The pharmacist did not know if the patient had ever received PNEUMOVAX 23 previously. Concomitant therapies included SOMA and hydrocodone. On 24-SEP-2015, the patient experienced back pain, hip pain and stiff shoulder, she was treated with unspecified muscle relaxer and pain medications. On 25-SEP-2015, the patient sought medical attention to the pharmacy in order to refill her treatment medications, when the pharmacist observed the patient's injection site had slight local redness and some swelling. The outcome of the events was reported as not recovered. The reporter did not assess the causality of the events with PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to her mother, a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX, 1 vial, (route of administration, anatomical location, lot number and expiration date were not provided). The vaccine was administered by an unspecified pharmacist. There were not concomitant medications reported. On an unknown date, the patient got a rash and swelling, and it was hot to the touch, she also felt a knot at the injection site. The patient did not seek medical attention and she treated the adverse events with ice only. There was no product quality issue involved. The outcome of injection site nodule, injection site warmth, injection site swelling and injection site rash was reported as recovered on an unspecified date, reported as "2 weeks after received the ZOSTAVAX vaccine". The reporter did not assess the relatedness of injection site nodule, injection site warmth, injection site swelling and injection site rash with ZOSTAVAX vaccine. This is one of two cases from the same reporter. Additional information is not expected since the reporter contact details were not provided.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Arthralgia, Burning sensation, Decreased appetite, Fatigue
Clinical narrative: Redness and pain at injection site, fever, generalized arthralgias, rash heat/burning sensation at (R) axilla, stomach pain, fatigue, low appetite.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Rash
Clinical narrative: Redness and pain at injection site, fever, generalized arthralgias, rash heat/burning sensation at (R) axilla, stomach pain, fatigue, low appetite.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to herself, a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX, 1 vial, (route of administration, anatomical location, lot number and expiration date were not provided). The vaccine was administered by an unspecified pharmacist. There were not concomitant medications reported. On an unknown date, the patient got a rash and swelling, and it was hot to the touch, she also felt a knot at the injection site. The patient did not see medical attention and she treated the adverse events with ice only. There was no product quality issue involved. The outcome of injection site nodule, injection site warmth, injection site swelling and injection site rash was reported as recovered on an unspecified date, reported as "2 weeks after received the ZOSTAVAX vaccine". The reporter did not assess the relatedness of injection site nodule, injection site warmth, injection site swelling and injection site rash with ZOSTAVAX vaccine. This is one of two cases from the same reporter. Additional information is not expected since the reporter contact details were not provided.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 51 year old female consumer, referring to herself. The patient's medical history included three previous cases of shingles. On an unspecified in January 2015, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose, frequency, lot # and expiration date were not reported). No concomitant medications were reported. On approximately 09-SEP-2015 (also reported as approximately 3 weeks ago), the patient developed her fourth case of shingles. The patient went to see her primary care provider who treated her with a MEDROL dose pack, but the shingles  did not improve. At the time of the report, the patient stated she was still experiencing the effects of shingles. No product quality complaint was involved. Additional information is not expected because no reporter's contact details were provided.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician concerning a 62 year old patient (gender unknown). The patient's concurrent conditions and medical history were not reported. On an unspecified date in October 2014, reported as 1 year ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot#, expiration date, route and anatomical location were not reported). Co-suspect therapies or concomitant medications were not provided. The physician reported that during a meeting, the patient, developed redness, swelling, and warmth at the injection site after administration of ZOSTAVAX, 1 year ago, an unspecified date, in October 2014. The patient was treated with ibuprofen (manufacturer unknown). The outcome of injection site erythema, injection site warmth and injection site swelling was reported as recovered in 1 week, on an unspecified date approximately in October, 2014. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Patient came in on 9/21/15 for a shingle vaccine. Patient started having redness overnight and blisters 48 hours later. She was given prednisone. Everything cleared up 1 week later.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified patient (demographics unknown). On 05-OCT-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (Lot # L009209; expiration date: 17-SEP-2016) (dose and route not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring that on multiple unspecified dates, multiple unspecified patients were administered improperly stored doses of PROQUAD, (lot #s L023111 and L023112, expiry date 24-DEC-2016). No adverse effect reported. This is one of two reports from the same reporter source (MARRS linked 1510USA004177). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: After receiving ZOSTAVAX patient came down with shingles.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring that on multiple unspecified dates, multiple unspecified patients were administered improperly stored doses of VARIVAX (Merck), (lot #s L011084, expiry date 01-APR-2017 and L013063, expiry date 17-APR-2017). No adverse effect reported. This is one of two reports from the same reporter source (MARRS linked 1510USA004258). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: This initial spontaneous report was received from a 54 year old female consumer reporting on herself, with allergy to seafood. There was no pertinent medical history described. On 05-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, frequency and lot# were not provided). Concomitant therapies included amoxicillin. The patient stated that on 06-OCT-2015 reported as "the next day", she experienced a fever to the touch of her arm (injection site warmth) and her arm developed a bruise (injection site bruising) and "fire engine red burn mark" around the ZOSTAVAX injection area (injection site erythema). She also stated that her arm appeared to be swollen (peripheral swelling). The patient did not sought medical attention and treatment was not given for the events. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of peripheral swelling, injection site erythema, pyrexia and injection site bruising was recovering. The relatedness between the events mentioned above to ZOSTAVAX was not provided. Additonal information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of M-M-R II (route, lot number and expiration date were not provided). On unknown dates, there was an incorrect product storage as the multiple unspecified patients were administered improperly stored M-M-R II. No adverse events were reported. It was unknown if the patients sought medical attention. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Tenderness
Clinical narrative: Patient went to pharmacy for shingles vaccine. On Saturday morning woke up with swelling around injection site. Swelling continued to get larger and tender therefore she came in for an appt. for evaluation. Pt. was treated with prednisone and cephalexin.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of VAQTA (route, lot number and expiration date were not reported). On unknown dates, there was an incorrect product storage as the multiple unspecified patients were administered improperly stored VAQTA. No adverse events were reported. It was unknown if the patients sought medical attention. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with doses of GARDASIL (route, lot number and expiration date were not provided). On unknown dates, there was an incorrect product storage as the multiple unspecified patients were administered improperly stored GARDASIL. No adverse events were reported. It was unknown if the patients sought medical attention. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were no provided. On unknown dates, the patients were vaccinated with dose of RECOMBIVAX HB (route, lot number and expiration date were not provided). On unknown dates, there was an incorrect product storage as the multiple unspecified patients were administered improperly stored RECOMBIVAX HB. No adverse events were reported. It was unknown if the patients sought medical attention. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Nausea, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 66 year old female. Patient's concurrent conditions included unspecified kidney problem, diabetes mellitus and renal impairment. Her medical history was not provided. Patient was reported as allergic to Penicillin. On 21-AUG-2015 the patient was vaccinated with subcutaneous injection of PNEUMOVAX 23 (lot # L012521, Expiry date: 01-FEB-2017). No concomitant medications were reported. Reporting healthcare worker stated that the patient experienced following side effects 24 hours later injection: red circular rash around injection site, pain at injection site, swollen arm, nausea, slight fever, and itchiness on 22-AUG-2015. Patient sought medical attention and she came to office on 25-AUG-2015. She was treated separately with unspecified antibiotics, TYLENOL for each symptom. Outcome of the events were unknown. The relatedness between the adverse events and vaccination with PNEUMOVAX 23 was not provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 66 year old female. Patient's concurrent conditions included unspecified kidney problem, diabetes mellitus and renal impairment. Her medical history was not provided. Patient was reported as allergic to Penicillin. On 21-AUG-2015 the patient was vaccinated with subcutaneous injection of PNEUMOVAX 23 (lot # L012521, Expiry date: 01-FEB-2017). No concomitant medications were reported. Reporting healthcare worker stated that the patient experienced following side effects 24 hours later injection: red circular rash around injection site, pain at injection site, swollen arm, nausea, slight fever, and itchiness on 22-AUG-2015. Patient sought medical attention and she came to office on 25-AUG-2015. She was treated separately with unspecified antibiotics, TYLENOL for each symptom. Outcome of the events were unknown. The relatedness between the adverse events and vaccination with PNEUMOVAX 23 was not provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dyskinesia, Gait disturbance, Pallor, Vision blurred
Clinical narrative: This initial spontaneous report was received from a nurse practitioner referring to an 11 year old female patient. There was no pertinent medical history or drug allergies/drug reactions described. On 08-SEP-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular injection (lot # L019286 with expiration date 14-SEP-2017; dose was not provided). There was no concomitant medication described. The reporter stated that 20 to 30 minutes later, while the patient was still in the office; experienced dizziness and she felt like she was going to pass out, blurry vision, paleness, mild dyskinesia and walking difficulty. The Nurse Practitioner stated that her vital signs were within normal range, that she had the patient lie down, with no additional treatment given, and that after 2 and a half hours, the patient had fully recovered. Lab diagnostics were not performed and product quality complaint (PQC) was not involved. The relatedness between the events mentioned above to GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. The medical history, concurrent conditions and allergies were not reported. On 03-OCT-2015, the patient was vaccinated with a dose of oral, ROTATEQ, (strength, dose, frequency, route and lot number were not reported), which had expired on 27-SEP-2015. No adverse effects were reported. Other suspect and concomitant therapies were not reported; and there was not product quality complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from an approximately 39 year old female patient referring to herself, who stated that she was allergic to zoledronic acid, MACROBID, iodine, IVP dye (iodine allergy), technetium contrast (contrast media allergy), computerized tomography (CAT) scan contrast (contrast media allergy), penicillin (manufacturer unknown), sulfas and sulfonamides, morphine (manufacturer unknown), MS cotton, PERCOCET (also reported as PERCASET), DILAUDID, unspecified adhesives, tetradram, ciprofloxacin, CEFTIN, bacitracin, prednisone steroid (also reported as pregnisone), tramadol, NEURONTIN, LYRICA, lidocaine, ROBAXIN, fluorometholone, MOTRIN, CELEBREX, niacin, NAPROSYN, formula 7, mold (mycotic allergy), bees (allergy to arthropod sting), pollen (pollen allergy), pine needles, weeds and seafood (food allergy). On an unknown date in2016 (reported as fall of 2006), the patient was vaccinated with a dose of Pneumococcal vaccine (manufacturer unknown) (lot#, expiration date, dose and frequency were unspecified) intramuscularly in her arm. Concomitant therapies included an unspecified cholesterol medication (manufacturer unknown), PRO AIR 90 mcg, VICODIN, PRILOSEC and FLOVENT. On an unknown date in 2016 (reported as fall of 2006) after vaccination, the patient experienced a sore arm and the area around the injection site tender. The patient also stated that she fully recovered within 2 days after being vaccinated with pneumococcal vaccine (manufacturer unknown), and that she was treated with TYLENOL. The patient did not seek for medical attention and she was not hospitalized. No PQC was involved. The relatedness of pneumococcal vaccine (manufacturer unknown) with the adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with VARIVAX (Merck) lot # L006383 expiration date: 25-FEB-2017 and lot # L018002 expiration date: 19-MAY-2017 which had been exposed to temperatures outside of the recommended range. There was no concomitant medication provided. The primary reporter was not aware of any adverse effects. There was no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning 2 unspecified patients (demographics unknown). On 05-OCT-2015, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot# L012034; expiration date: 07-APR-2017)(dose and route not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: No tx given by parents. Rt arm at injection site red, tender, and painful to touch.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L007560 with expired date 15-JUN-2017; dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patient had completed the 3-dose GARDASIL series and on an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (unknown route, strength and lot #). No adverse effects were reported. There was product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patient had completed the 3-dose GARDASIL series (unknown strength, route and dose) and on an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (unknown route, strength and lot #). On 05-OCT-2015, the patient received another dose of GARDASIL (lot # J013328 and expiry date of 12-FEB-2016). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. On 05-OCT-2015, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K008931, expiration date 04-MAR-2017, dose and route not provided)(incorrect product storage). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown date the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB (lot # L002866 with expired date 10-NOV-2017, lot# L004740 with expired date 16-NOV-2017, lot# L012838 with expired date 10-MAR-2018; dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (lot # L012038 with expired date 07-APR-2017, dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several repots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L004466 with expired date 02-AUG-2016, oral, dose was unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Local reaction
Clinical narrative: She reports she received IIV (lot number M51107 mfx CSL) and Tdap (per record vaccine is PPSV23 lot number Merck lot number 0322Z) together to her R arm which produced a local reaction of notable local edema, a 4 inch patch of erythema at the injection site, mild tenderness and pruritus, and lymphadenopathy and local edema to the axilla. The erythema resolved in about a week. She states the lymphadenopathy last for months and she was left with a local mass. She was concerned about breast cancer and imaging showed a benign mass. No further treatment. Symptoms: Enlargement, lymph nodes.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lymphadenopathy, Mass, Oedema, Ultrasound scan abnormal
Clinical narrative: She reports she received IIV (lot number M51107 mfx CSL) and Tdap (per record vaccine is PPSV23 lot number Merck lot number 0322Z) together to her R arm which produced a local reaction of notable local edema, a 4 inch patch of erythema at the injection site, mild tenderness and pruritus, and lymphadenopathy and local edema to the axilla. The erythema resolved in about a week. She states the lymphadenopathy last for months and she was left with a local mass. She was concerned about breast cancer and imaging showed a benign mass. No further treatment. Symptoms: Enlargement, lymph nodes.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Biopsy skin abnormal, Blister, Infection transmission via personal contact, Oedema peripheral, Orthopoxvirus test positive
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 576662. This case involves a 21-year-old male patient who was unvaccinated and exposed to vaccinia virus via contact transmission with a patient, who was vaccinated with ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co., route was not reported) in the left arm on 09-Apr-2015. The patient did not have any known drug allergies or current illness. Concomitant medications included whey protein, animal cuts and creatine. Prior vaccinations were not reported. On around 10-Apr-2015 or 11-April-2015, the patient received a new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, the vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the contact's LUE (Left Upper Extremity) recently tattooed came into contact with the shirt. (Contact leaned against shirt for approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, he went to Emergency Department with left axillary swelling. On 18 Apr 2015, patient experienced fever, body aches, arm swelling, and pain as well as new blisters and desquamation over tattoo surface. In addition to contact transmission, contact developed secondary infection of LUE affected by tattoo. On 22-Apr-2015, laboratory investigations included aerobic culture, specimen: skin, results: Final report Staphylococcus aureus: Many, KB (Kirby-Bauer) Sensitivity: Clindamycin Resistant, Erythromycin Resistant, Oxacillin Susceptible, Penicillin G Resistant, Trimethoprim and Sulfamethoxazole Susceptible. Punch biopsy, Specimen: Left arm, Results: Necrotic ulcer bed with attendant acute and chronic superficial and periadnexal inflammation with eosinophils, karyorrhexis, and lobular panniculitis. No intact epidermis was present to evaluate. No viral cytopathic changes were identified. Tzanck Smear, General Category: No abnormal cells were seen. Scattered mixed inflammatory cells, and scant epithelioid cells and stromal elements were seen on a background of proteinaceous fluid. Polymerase chain reaction, result was positive. Skin biopsy was abnormal. Smear site unspecified was normal. Corrective treatment was not provided. It was reported that the patient required Emergency visit. The patient had not recovered from the above mentioned events. Upon internal review, this case was considered serious due to important medical events: Orthopox virus test positive, Staphylococcus test positive, Infection transmission via personal contact and Panniculitis lobular. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pain, Pain in extremity, Panniculitis lobular, Peripheral swelling, Polymerase chain reaction positive
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 576662. This case involves a 21-year-old male patient who was unvaccinated and exposed to vaccinia virus via contact transmission with a patient, who was vaccinated with ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co., route was not reported) in the left arm on 09-Apr-2015. The patient did not have any known drug allergies or current illness. Concomitant medications included whey protein, animal cuts and creatine. Prior vaccinations were not reported. On around 10-Apr-2015 or 11-April-2015, the patient received a new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, the vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the contact's LUE (Left Upper Extremity) recently tattooed came into contact with the shirt. (Contact leaned against shirt for approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, he went to Emergency Department with left axillary swelling. On 18 Apr 2015, patient experienced fever, body aches, arm swelling, and pain as well as new blisters and desquamation over tattoo surface. In addition to contact transmission, contact developed secondary infection of LUE affected by tattoo. On 22-Apr-2015, laboratory investigations included aerobic culture, specimen: skin, results: Final report Staphylococcus aureus: Many, KB (Kirby-Bauer) Sensitivity: Clindamycin Resistant, Erythromycin Resistant, Oxacillin Susceptible, Penicillin G Resistant, Trimethoprim and Sulfamethoxazole Susceptible. Punch biopsy, Specimen: Left arm, Results: Necrotic ulcer bed with attendant acute and chronic superficial and periadnexal inflammation with eosinophils, karyorrhexis, and lobular panniculitis. No intact epidermis was present to evaluate. No viral cytopathic changes were identified. Tzanck Smear, General Category: No abnormal cells were seen. Scattered mixed inflammatory cells, and scant epithelioid cells and stromal elements were seen on a background of proteinaceous fluid. Polymerase chain reaction, result was positive. Skin biopsy was abnormal. Smear site unspecified was normal. Corrective treatment was not provided. It was reported that the patient required Emergency visit. The patient had not recovered from the above mentioned events. Upon internal review, this case was considered serious due to important medical events: Orthopox virus test positive, Staphylococcus test positive, Infection transmission via personal contact and Panniculitis lobular. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Skin exfoliation, Smear site unspecified normal, Staphylococcus test positive
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 576662. This case involves a 21-year-old male patient who was unvaccinated and exposed to vaccinia virus via contact transmission with a patient, who was vaccinated with ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co., route was not reported) in the left arm on 09-Apr-2015. The patient did not have any known drug allergies or current illness. Concomitant medications included whey protein, animal cuts and creatine. Prior vaccinations were not reported. On around 10-Apr-2015 or 11-April-2015, the patient received a new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, the vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the contact's LUE (Left Upper Extremity) recently tattooed came into contact with the shirt. (Contact leaned against shirt for approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, he went to Emergency Department with left axillary swelling. On 18 Apr 2015, patient experienced fever, body aches, arm swelling, and pain as well as new blisters and desquamation over tattoo surface. In addition to contact transmission, contact developed secondary infection of LUE affected by tattoo. On 22-Apr-2015, laboratory investigations included aerobic culture, specimen: skin, results: Final report Staphylococcus aureus: Many, KB (Kirby-Bauer) Sensitivity: Clindamycin Resistant, Erythromycin Resistant, Oxacillin Susceptible, Penicillin G Resistant, Trimethoprim and Sulfamethoxazole Susceptible. Punch biopsy, Specimen: Left arm, Results: Necrotic ulcer bed with attendant acute and chronic superficial and periadnexal inflammation with eosinophils, karyorrhexis, and lobular panniculitis. No intact epidermis was present to evaluate. No viral cytopathic changes were identified. Tzanck Smear, General Category: No abnormal cells were seen. Scattered mixed inflammatory cells, and scant epithelioid cells and stromal elements were seen on a background of proteinaceous fluid. Polymerase chain reaction, result was positive. Skin biopsy was abnormal. Smear site unspecified was normal. Corrective treatment was not provided. It was reported that the patient required Emergency visit. The patient had not recovered from the above mentioned events. Upon internal review, this case was considered serious due to important medical events: Orthopox virus test positive, Staphylococcus test positive, Infection transmission via personal contact and Panniculitis lobular. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Biopsy skin abnormal, Blister, Cell death, Culture positive, Infection transmission via personal contact
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 576662. This case involves a 21-year-old male patient who was unvaccinated and exposed to vaccinia virus via contact transmission with a patient, who was vaccinated with ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co., route was not reported) in the left arm on 09-Apr-2015. The patient did not have any known drug allergies or current illness. Concomitant medications included whey protein, animal cuts and creatine. Prior vaccinations were not reported. On around 10-Apr-2015 or 11-April-2015, the patient received a new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, the vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the contact's LUE (Left Upper Extremity) recently tattooed came into contact with the shirt. (Contact leaned against shirt for approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, he went to Emergency Department with left axillary swelling. On 18 Apr 2015, patient experienced fever, body aches, arm swelling, and pain as well as new blisters and desquamation over tattoo surface. In addition to contact transmission, contact developed secondary infection of LUE affected by tattoo. On 22-Apr-2015, laboratory investigations included aerobic culture, specimen: skin, results: Final report Staphylococcus aureus: Many, KB (Kirby-Bauer) Sensitivity: Clindamycin Resistant, Erythromycin Resistant, Oxacillin Susceptible, Penicillin G Resistant, Trimethoprim and Sulfamethoxazole Susceptible. Punch biopsy, Specimen: Left arm, Results: Necrotic ulcer bed with attendant acute and chronic superficial and periadnexal inflammation with eosinophils, karyorrhexis, and lobular panniculitis. No intact epidermis was present to evaluate. No viral cytopathic changes were identified. Tzanck Smear, General Category: No abnormal cells were seen. Scattered mixed inflammatory cells, and scant epithelioid cells and stromal elements were seen on a background of proteinaceous fluid. Polymerase chain reaction, result was positive. Skin biopsy was abnormal. Smear site unspecified was normal. Corrective treatment was not provided. It was reported that the patient required Emergency visit. The patient had not recovered from the above mentioned events. Upon internal review, this case was considered serious due to important medical events: Orthopox virus test positive, Staphylococcus test positive, Infection transmission via personal contact and Panniculitis lobular. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Oedema peripheral, Orthopoxvirus test positive, Pain, Pain in extremity, Panniculitis lobular
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 576662. This case involves a 21-year-old male patient who was unvaccinated and exposed to vaccinia virus via contact transmission with a patient, who was vaccinated with ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co., route was not reported) in the left arm on 09-Apr-2015. The patient did not have any known drug allergies or current illness. Concomitant medications included whey protein, animal cuts and creatine. Prior vaccinations were not reported. On around 10-Apr-2015 or 11-April-2015, the patient received a new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, the vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the contact's LUE (Left Upper Extremity) recently tattooed came into contact with the shirt. (Contact leaned against shirt for approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, he went to Emergency Department with left axillary swelling. On 18 Apr 2015, patient experienced fever, body aches, arm swelling, and pain as well as new blisters and desquamation over tattoo surface. In addition to contact transmission, contact developed secondary infection of LUE affected by tattoo. On 22-Apr-2015, laboratory investigations included aerobic culture, specimen: skin, results: Final report Staphylococcus aureus: Many, KB (Kirby-Bauer) Sensitivity: Clindamycin Resistant, Erythromycin Resistant, Oxacillin Susceptible, Penicillin G Resistant, Trimethoprim and Sulfamethoxazole Susceptible. Punch biopsy, Specimen: Left arm, Results: Necrotic ulcer bed with attendant acute and chronic superficial and periadnexal inflammation with eosinophils, karyorrhexis, and lobular panniculitis. No intact epidermis was present to evaluate. No viral cytopathic changes were identified. Tzanck Smear, General Category: No abnormal cells were seen. Scattered mixed inflammatory cells, and scant epithelioid cells and stromal elements were seen on a background of proteinaceous fluid. Polymerase chain reaction, result was positive. Skin biopsy was abnormal. Smear site unspecified was normal. Corrective treatment was not provided. It was reported that the patient required Emergency visit. The patient had not recovered from the above mentioned events. Upon internal review, this case was considered serious due to important medical events: Orthopox virus test positive, Staphylococcus test positive, Infection transmission via personal contact and Panniculitis lobular. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Peripheral swelling, Polymerase chain reaction positive, Pyrexia, Skin exfoliation, Skin necrosis
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 576662. This case involves a 21-year-old male patient who was unvaccinated and exposed to vaccinia virus via contact transmission with a patient, who was vaccinated with ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co., route was not reported) in the left arm on 09-Apr-2015. The patient did not have any known drug allergies or current illness. Concomitant medications included whey protein, animal cuts and creatine. Prior vaccinations were not reported. On around 10-Apr-2015 or 11-April-2015, the patient received a new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, the vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the contact's LUE (Left Upper Extremity) recently tattooed came into contact with the shirt. (Contact leaned against shirt for approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, he went to Emergency Department with left axillary swelling. On 18 Apr 2015, patient experienced fever, body aches, arm swelling, and pain as well as new blisters and desquamation over tattoo surface. In addition to contact transmission, contact developed secondary infection of LUE affected by tattoo. On 22-Apr-2015, laboratory investigations included aerobic culture, specimen: skin, results: Final report Staphylococcus aureus: Many, KB (Kirby-Bauer) Sensitivity: Clindamycin Resistant, Erythromycin Resistant, Oxacillin Susceptible, Penicillin G Resistant, Trimethoprim and Sulfamethoxazole Susceptible. Punch biopsy, Specimen: Left arm, Results: Necrotic ulcer bed with attendant acute and chronic superficial and periadnexal inflammation with eosinophils, karyorrhexis, and lobular panniculitis. No intact epidermis was present to evaluate. No viral cytopathic changes were identified. Tzanck Smear, General Category: No abnormal cells were seen. Scattered mixed inflammatory cells, and scant epithelioid cells and stromal elements were seen on a background of proteinaceous fluid. Polymerase chain reaction, result was positive. Skin biopsy was abnormal. Smear site unspecified was normal. Corrective treatment was not provided. It was reported that the patient required Emergency visit. The patient had not recovered from the above mentioned events. Upon internal review, this case was considered serious due to important medical events: Orthopox virus test positive, Staphylococcus test positive, Infection transmission via personal contact and Panniculitis lobular. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Smear site unspecified normal, Staphylococcus test positive
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 576662. This case involves a 21-year-old male patient who was unvaccinated and exposed to vaccinia virus via contact transmission with a patient, who was vaccinated with ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co., route was not reported) in the left arm on 09-Apr-2015. The patient did not have any known drug allergies or current illness. Concomitant medications included whey protein, animal cuts and creatine. Prior vaccinations were not reported. On around 10-Apr-2015 or 11-April-2015, the patient received a new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, the vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the contact's LUE (Left Upper Extremity) recently tattooed came into contact with the shirt. (Contact leaned against shirt for approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, he went to Emergency Department with left axillary swelling. On 18 Apr 2015, patient experienced fever, body aches, arm swelling, and pain as well as new blisters and desquamation over tattoo surface. In addition to contact transmission, contact developed secondary infection of LUE affected by tattoo. On 22-Apr-2015, laboratory investigations included aerobic culture, specimen: skin, results: Final report Staphylococcus aureus: Many, KB (Kirby-Bauer) Sensitivity: Clindamycin Resistant, Erythromycin Resistant, Oxacillin Susceptible, Penicillin G Resistant, Trimethoprim and Sulfamethoxazole Susceptible. Punch biopsy, Specimen: Left arm, Results: Necrotic ulcer bed with attendant acute and chronic superficial and periadnexal inflammation with eosinophils, karyorrhexis, and lobular panniculitis. No intact epidermis was present to evaluate. No viral cytopathic changes were identified. Tzanck Smear, General Category: No abnormal cells were seen. Scattered mixed inflammatory cells, and scant epithelioid cells and stromal elements were seen on a background of proteinaceous fluid. Polymerase chain reaction, result was positive. Skin biopsy was abnormal. Smear site unspecified was normal. Corrective treatment was not provided. It was reported that the patient required Emergency visit. The patient had not recovered from the above mentioned events. Upon internal review, this case was considered serious due to important medical events: Orthopox virus test positive, Staphylococcus test positive, Infection transmission via personal contact and Panniculitis lobular. List of documents held by sender: none.