chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: YF
Symptoms: Abdominal discomfort, Abdominal pain, Abnormal faeces, Antibody test normal, Blood lactate dehydrogenase increased
Clinical narrative: This 69 year old male received Yellow Fever vaccination UH139AA on 4/16/2012. Approximately 2 hours later he remembers eating lunch (meat sandwich w/o mayonnaise and cold drink) and experienced upset stomach with mild headache with foul smelling diarrhea 5 hours later (7 hours after vaccinated). His headache (generalized dull throb all over skull 3-4/10, no photo-phonophobia, tinnitus or nausea) lasted for 24 hours before resolving. His diarrhea was described as alternating dark liquid with soft brown formed stool. He sought medical care approximately one week 4/23/2012 for persistent diarrhea with a civilian provider who advised him to use IMMODIUM and PEPTO-BISMOL. He denied any other symptoms such as fevers, malaise, weakness, dizziness, abdominal cramps, nausea, and back or chest pain. He denied any ingestion of new food groups, or new packages of cigars or rum bottles. He denied any recent illness or exposure to. His last travel was in December 2011 where be bought a new box of hand-rolled cigars. Exposures risks: reports one other person had two days diarrhea after YF vac which resolved spontaneously. He was on a cruise Dec 2011. He likes to eat pig's feet that his wife prepares well cooked. These complaints continued over the next 3 weeks reporting "need to use restroom every 30 minutes day or night" Patient reported follow up with providers with complaints of urgency and periumbilical colicky pain with no diagnosis made but was prescribed antibiotic (starts with a D...) and to continue IMMODIUM and PEPTO-BISMOL. He reported his stool turned black. Follow up with Infectious Disease (April 2012) and Gastroenterology (May2012) identified the following: 4/30/2012 ID: CC: Wt loss 8-9 lbs in 2 weeks with periumbilical colicky pain, change in stool and diarrhea. Diarrhea began as 2-3 episodes per day then progressed up to 10/day with urgency the whole time. Stool described as sometimes black and sometimes brown, liquid without blood or mucous. After using PEPTO-BISMOL his still turned black. Exam normal. MD was "not suspicious of YF vaccine associated viscerotropic disease" due to onset of s/s was day of vaccination and hx prior YF vac 10 years ago. No LFT, CK or platelet abnormalities or evidence of dehydration at 2 week mark. Prescribed azithromycin 500 mg daily x3 days and FLAGYL 500 mg twice a day x 7 days (4/30/12). 5/3/12 GI eval: first formed stool today, less abdominal pain with pain to lower abdomen worse just before bowel movement and relieved with bowel movements. S/s resolving - no further intervention or evaluation needed. Bacterial infection less likely given prolonged course and lack of systemic symptoms. Colonoscopy 5/10/2012*: multiple large mouth diverticula from ascending to sigmoid colon. Diagnosed with colonic diverticulosis - suspected microscopic colitis and diarrhea.
Age: 69.0
Sex: M
Vaccine: YF
Symptoms: Clostridium test negative, Defaecation urgency, Diarrhoea, Diverticulum intestinal, Eosinophil count increased
Clinical narrative: This 69 year old male received Yellow Fever vaccination UH139AA on 4/16/2012. Approximately 2 hours later he remembers eating lunch (meat sandwich w/o mayonnaise and cold drink) and experienced upset stomach with mild headache with foul smelling diarrhea 5 hours later (7 hours after vaccinated). His headache (generalized dull throb all over skull 3-4/10, no photo-phonophobia, tinnitus or nausea) lasted for 24 hours before resolving. His diarrhea was described as alternating dark liquid with soft brown formed stool. He sought medical care approximately one week 4/23/2012 for persistent diarrhea with a civilian provider who advised him to use IMMODIUM and PEPTO-BISMOL. He denied any other symptoms such as fevers, malaise, weakness, dizziness, abdominal cramps, nausea, and back or chest pain. He denied any ingestion of new food groups, or new packages of cigars or rum bottles. He denied any recent illness or exposure to. His last travel was in December 2011 where be bought a new box of hand-rolled cigars. Exposures risks: reports one other person had two days diarrhea after YF vac which resolved spontaneously. He was on a cruise Dec 2011. He likes to eat pig's feet that his wife prepares well cooked. These complaints continued over the next 3 weeks reporting "need to use restroom every 30 minutes day or night" Patient reported follow up with providers with complaints of urgency and periumbilical colicky pain with no diagnosis made but was prescribed antibiotic (starts with a D...) and to continue IMMODIUM and PEPTO-BISMOL. He reported his stool turned black. Follow up with Infectious Disease (April 2012) and Gastroenterology (May2012) identified the following: 4/30/2012 ID: CC: Wt loss 8-9 lbs in 2 weeks with periumbilical colicky pain, change in stool and diarrhea. Diarrhea began as 2-3 episodes per day then progressed up to 10/day with urgency the whole time. Stool described as sometimes black and sometimes brown, liquid without blood or mucous. After using PEPTO-BISMOL his still turned black. Exam normal. MD was "not suspicious of YF vaccine associated viscerotropic disease" due to onset of s/s was day of vaccination and hx prior YF vac 10 years ago. No LFT, CK or platelet abnormalities or evidence of dehydration at 2 week mark. Prescribed azithromycin 500 mg daily x3 days and FLAGYL 500 mg twice a day x 7 days (4/30/12). 5/3/12 GI eval: first formed stool today, less abdominal pain with pain to lower abdomen worse just before bowel movement and relieved with bowel movements. S/s resolving - no further intervention or evaluation needed. Bacterial infection less likely given prolonged course and lack of systemic symptoms. Colonoscopy 5/10/2012*: multiple large mouth diverticula from ascending to sigmoid colon. Diagnosed with colonic diverticulosis - suspected microscopic colitis and diarrhea.
Age: 69.0
Sex: M
Vaccine: YF
Symptoms: Faeces discoloured, Full blood count normal, Giardia test negative, Headache, Metabolic function test normal
Clinical narrative: This 69 year old male received Yellow Fever vaccination UH139AA on 4/16/2012. Approximately 2 hours later he remembers eating lunch (meat sandwich w/o mayonnaise and cold drink) and experienced upset stomach with mild headache with foul smelling diarrhea 5 hours later (7 hours after vaccinated). His headache (generalized dull throb all over skull 3-4/10, no photo-phonophobia, tinnitus or nausea) lasted for 24 hours before resolving. His diarrhea was described as alternating dark liquid with soft brown formed stool. He sought medical care approximately one week 4/23/2012 for persistent diarrhea with a civilian provider who advised him to use IMMODIUM and PEPTO-BISMOL. He denied any other symptoms such as fevers, malaise, weakness, dizziness, abdominal cramps, nausea, and back or chest pain. He denied any ingestion of new food groups, or new packages of cigars or rum bottles. He denied any recent illness or exposure to. His last travel was in December 2011 where be bought a new box of hand-rolled cigars. Exposures risks: reports one other person had two days diarrhea after YF vac which resolved spontaneously. He was on a cruise Dec 2011. He likes to eat pig's feet that his wife prepares well cooked. These complaints continued over the next 3 weeks reporting "need to use restroom every 30 minutes day or night" Patient reported follow up with providers with complaints of urgency and periumbilical colicky pain with no diagnosis made but was prescribed antibiotic (starts with a D...) and to continue IMMODIUM and PEPTO-BISMOL. He reported his stool turned black. Follow up with Infectious Disease (April 2012) and Gastroenterology (May2012) identified the following: 4/30/2012 ID: CC: Wt loss 8-9 lbs in 2 weeks with periumbilical colicky pain, change in stool and diarrhea. Diarrhea began as 2-3 episodes per day then progressed up to 10/day with urgency the whole time. Stool described as sometimes black and sometimes brown, liquid without blood or mucous. After using PEPTO-BISMOL his still turned black. Exam normal. MD was "not suspicious of YF vaccine associated viscerotropic disease" due to onset of s/s was day of vaccination and hx prior YF vac 10 years ago. No LFT, CK or platelet abnormalities or evidence of dehydration at 2 week mark. Prescribed azithromycin 500 mg daily x3 days and FLAGYL 500 mg twice a day x 7 days (4/30/12). 5/3/12 GI eval: first formed stool today, less abdominal pain with pain to lower abdomen worse just before bowel movement and relieved with bowel movements. S/s resolving - no further intervention or evaluation needed. Bacterial infection less likely given prolonged course and lack of systemic symptoms. Colonoscopy 5/10/2012*: multiple large mouth diverticula from ascending to sigmoid colon. Diagnosed with colonic diverticulosis - suspected microscopic colitis and diarrhea.
Age: 69.0
Sex: M
Vaccine: YF
Symptoms: Neutrophil count decreased, Occult blood negative, Red blood cell sedimentation rate increased, Schistosoma test negative, Urine analysis normal
Clinical narrative: This 69 year old male received Yellow Fever vaccination UH139AA on 4/16/2012. Approximately 2 hours later he remembers eating lunch (meat sandwich w/o mayonnaise and cold drink) and experienced upset stomach with mild headache with foul smelling diarrhea 5 hours later (7 hours after vaccinated). His headache (generalized dull throb all over skull 3-4/10, no photo-phonophobia, tinnitus or nausea) lasted for 24 hours before resolving. His diarrhea was described as alternating dark liquid with soft brown formed stool. He sought medical care approximately one week 4/23/2012 for persistent diarrhea with a civilian provider who advised him to use IMMODIUM and PEPTO-BISMOL. He denied any other symptoms such as fevers, malaise, weakness, dizziness, abdominal cramps, nausea, and back or chest pain. He denied any ingestion of new food groups, or new packages of cigars or rum bottles. He denied any recent illness or exposure to. His last travel was in December 2011 where be bought a new box of hand-rolled cigars. Exposures risks: reports one other person had two days diarrhea after YF vac which resolved spontaneously. He was on a cruise Dec 2011. He likes to eat pig's feet that his wife prepares well cooked. These complaints continued over the next 3 weeks reporting "need to use restroom every 30 minutes day or night" Patient reported follow up with providers with complaints of urgency and periumbilical colicky pain with no diagnosis made but was prescribed antibiotic (starts with a D...) and to continue IMMODIUM and PEPTO-BISMOL. He reported his stool turned black. Follow up with Infectious Disease (April 2012) and Gastroenterology (May2012) identified the following: 4/30/2012 ID: CC: Wt loss 8-9 lbs in 2 weeks with periumbilical colicky pain, change in stool and diarrhea. Diarrhea began as 2-3 episodes per day then progressed up to 10/day with urgency the whole time. Stool described as sometimes black and sometimes brown, liquid without blood or mucous. After using PEPTO-BISMOL his still turned black. Exam normal. MD was "not suspicious of YF vaccine associated viscerotropic disease" due to onset of s/s was day of vaccination and hx prior YF vac 10 years ago. No LFT, CK or platelet abnormalities or evidence of dehydration at 2 week mark. Prescribed azithromycin 500 mg daily x3 days and FLAGYL 500 mg twice a day x 7 days (4/30/12). 5/3/12 GI eval: first formed stool today, less abdominal pain with pain to lower abdomen worse just before bowel movement and relieved with bowel movements. S/s resolving - no further intervention or evaluation needed. Bacterial infection less likely given prolonged course and lack of systemic symptoms. Colonoscopy 5/10/2012*: multiple large mouth diverticula from ascending to sigmoid colon. Diagnosed with colonic diverticulosis - suspected microscopic colitis and diarrhea.
Age: 69.0
Sex: M
Vaccine: YF
Symptoms: Weight decreased, White blood cells stool negative
Clinical narrative: This 69 year old male received Yellow Fever vaccination UH139AA on 4/16/2012. Approximately 2 hours later he remembers eating lunch (meat sandwich w/o mayonnaise and cold drink) and experienced upset stomach with mild headache with foul smelling diarrhea 5 hours later (7 hours after vaccinated). His headache (generalized dull throb all over skull 3-4/10, no photo-phonophobia, tinnitus or nausea) lasted for 24 hours before resolving. His diarrhea was described as alternating dark liquid with soft brown formed stool. He sought medical care approximately one week 4/23/2012 for persistent diarrhea with a civilian provider who advised him to use IMMODIUM and PEPTO-BISMOL. He denied any other symptoms such as fevers, malaise, weakness, dizziness, abdominal cramps, nausea, and back or chest pain. He denied any ingestion of new food groups, or new packages of cigars or rum bottles. He denied any recent illness or exposure to. His last travel was in December 2011 where be bought a new box of hand-rolled cigars. Exposures risks: reports one other person had two days diarrhea after YF vac which resolved spontaneously. He was on a cruise Dec 2011. He likes to eat pig's feet that his wife prepares well cooked. These complaints continued over the next 3 weeks reporting "need to use restroom every 30 minutes day or night" Patient reported follow up with providers with complaints of urgency and periumbilical colicky pain with no diagnosis made but was prescribed antibiotic (starts with a D...) and to continue IMMODIUM and PEPTO-BISMOL. He reported his stool turned black. Follow up with Infectious Disease (April 2012) and Gastroenterology (May2012) identified the following: 4/30/2012 ID: CC: Wt loss 8-9 lbs in 2 weeks with periumbilical colicky pain, change in stool and diarrhea. Diarrhea began as 2-3 episodes per day then progressed up to 10/day with urgency the whole time. Stool described as sometimes black and sometimes brown, liquid without blood or mucous. After using PEPTO-BISMOL his still turned black. Exam normal. MD was "not suspicious of YF vaccine associated viscerotropic disease" due to onset of s/s was day of vaccination and hx prior YF vac 10 years ago. No LFT, CK or platelet abnormalities or evidence of dehydration at 2 week mark. Prescribed azithromycin 500 mg daily x3 days and FLAGYL 500 mg twice a day x 7 days (4/30/12). 5/3/12 GI eval: first formed stool today, less abdominal pain with pain to lower abdomen worse just before bowel movement and relieved with bowel movements. S/s resolving - no further intervention or evaluation needed. Bacterial infection less likely given prolonged course and lack of systemic symptoms. Colonoscopy 5/10/2012*: multiple large mouth diverticula from ascending to sigmoid colon. Diagnosed with colonic diverticulosis - suspected microscopic colitis and diarrhea.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient. The patient had drug allergies towards BACTRIM, LEVAQUIN, CODEINE and iodides. The patient had no pertinent medical history. On 01-DEC-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX, (lot number reported as H013946, expiration date 25-OCT-2013). Concomitant medications included FLUVIRIN(unknown manufacturer) which was administered on 01-DEC-2012, but not the same arm as of ZOSTAVAX, Other concomitant medications included XANAX and sertraline hydrochloride. Approximately on an unknown date in December-2012, the patient developed a knot at the injection site approximately 2 inches in diameter which was red and hot to touch. There was no treatment rendered for the events. No laboratory diagnostic studies were performed. At the time of this report the patient had not recovered from the reported events The patient sought medical attention (called pharmacist). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX and ended up with a "mild case of shingles". Lot #, administration route and date were unknown. Event onset date was unknown. The outcome was unknown. The patient had gone to her doctor (HCP name unknown). The reporting pharmacist had no additional information. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Blister, Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to 5 patients who were vaccinated with doses of PNEUMOVAX 23 (dose, frequency and route unknown). Nurse was reporting that the patients reported to had reactions after receiving PNEUMOVAX 23. All the patients experienced fever and chills along with swelling and tenderness at the injection site. One patient experienced blisters (which was captured in this case). Three patients required antibiotic treatments. This case refers to one of the patients who on 10-SEP-2012 was vaccinated with a dos eof PNEUMOVAX 23 (lot # H009826, expired date not provided). At the time of reporting the patient had recovered from the adverse events. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to several unspecified patients of unknown age. The patients may have been vaccinated with VAQTA (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced vaccine was improperly stored. No adverse effect reported. Same reporter link for case 1212USA005070 RECOMBIVAX HB and case 1212USA004414 GARDASIL. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to 5 patients who were vaccinated with doses of PNEUMOVAX23 (dose, frequency and route unknown). Nurse was reporting that the patients reported to had reactions after receiving PNEUMOVAX23. All the patients experienced fever and chills along with swelling and tenderness at the injection site. One patient experienced blisters (which was captured in Marss# 1212USA005320). Three patients required antibiotic treatments. This case refers to one of the patients who on 23-OCT-2012 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#H010515, expired date 14-FEB-2013). At the time of reporting the patent had recovered from the adverse events. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to 5 patients who were vaccinated with does of PNEUMOVAX23 (dose, frequency and route unknown). Nurse was reporting that the patients reported to had reactions after receiving PNEUMOVAX23. All the patients experienced fever and chills along with swelling and tenderness at the injection site. One patient experienced blisters (which was captured in Marss# 1212USA005320). Three patients required antibiotics treatments. This case refers to one of the patients who on 20-NOV-2012 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#H010515, expired date 14-FEB-2013). At the time of reporting the patient was recovering from the adverse events. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to several unspecified patients of unknown age. The patients may have been vaccinated with RECOMBIVAX HB (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. It was reported that the vaccine was improperly stored. No treatment information was reported. No adverse effect was reported. Same reporter linked for case 1212USA004414 (GARDASIL) and case 1212USA005071 (VAQTA). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Blister, Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to 5 patients who were vaccinated with doses of PNEUMOVAX 23 (dose, frequency and route unknown). Nurse was reporting that the patients reported to had reactions after receiving PNEUMOVAX 23. All the patients experienced fever and chills along with swelling and tenderness at the injection site. One patient experienced blisters (which was captured in Marss # 1212USA005230). Three patients required antibiotic treatments. This case refers to one of the patients who on 31-OCT-2012 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H010515, expired date 14-FEB-2013). At the time of reporting the patient had recovered from the adverse events. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 25-NOV-2012 the patient was vaccinated with VARIVAX (Merck) (lot #, expiration date and route not reported) instead of ZOSTAVAX (no product confusion, just medication error). No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to 5 patients who were vaccinated with doses of PNEUMOVAX23 (dose, frequency and route unknown). Nurse was reporting that the patients reported to had reactions after receiving PNEUMOVAX23. All the patients experienced fever and chills along with swelling and tenderness at the injection site. One patient experienced blisters (which was captured in Marss# 1212USA005320). Three patients required antibiotic treatments. This case refers to one of the patients who on 19-NOV-2012 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#H010515, expired date 14-FEB-2013). At the time of reporting the patient had recovered from the adverse events. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to an unspecified number of patients (gender and age unknown). On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (lot number, route and dose were not reported). The pharmacy student reported that an unknown number of doses of RECOMBIVAX HB that were exposed to temperatures of -9 degrees Celsius for 72 hours, may have been administered. No adverse effect were reported. This case is related to case MARRS # 1212USA005526 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age (gender unspecified). On an unknown date in November 2011, the patient was vaccinated with first dose of GARDASIL (lot number, expiration date and route was not reported). No concomitant medications were reported. The nurse reported that the patient was in the office on 07-DEC-2012, to receive 2nd dose of GARDASIL. No adverse event was reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age with immunisation. The patient was vaccinated with, 1 DF ZOSTAVAX on 10-OCT-2012. No other co-suspects were reported. Concomitant medications included fenofibrate, PROTONIX, simvastatin, JANUMET, glimepiride, vitamins (unspecified), iron (unspecified), COMBIPATCH and vitamin D (unspecified). On an unknown date the patient experienced fever and redness at the injection site. Treatment given was TYLENOL (ibuprofen). The outcome of fever and redness at the injection site was reported as recovered/resolved, date unspecified. The relatedness for fever and redness at the injection site is unknown for ZOSTAVAX. No further information was provided.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: This spontaneous report was received from a physician concerning a 69 year old female patient with sulfa allergy. On 05-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number: H010916, expiry date: 15-FEB-2014) (dose, route unspecified). Concomitant medications included lisinopril, simvastatin (manufacturer unknown) and omeprazole. On 05-DEC-2012, after the administration of PNEUMOVAX23, the patient experienced localized erythema, swelling, not too much heat that spanned around the circumference of the unspecified arm of the patient. The patient visited the office and she was prescribed with prednisone (formulation, dose, frequency unspecified). It was unspecified if the laboratory diagnostic studies were performed. The outcome of localized erythema, swelling and not too much heat that spanned around the circumference of the arm of the patient was reported as not resolved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients (gender and age unknown). The nurse reported that the patients may have received improperly stored VAQTA (lot number, route and dose were not reported. Over the past three months. No symptoms were reported. No other details were provided. This case is related to case MARRS # 1212USA004564 and case MARRS # 1212USA005493 (same reporter link). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 72 years old female patient. Concurrent conditions included hypertension, hypothyroidism and hypercholesterolemia. On an unknown date, approximately in November 2007 (reported as 4 to 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, route unspecified). Concomitant medications included simvastatin (manufacturer unknown), metoprolol and levothyroxine sodium. In approximately November 2012, the patient experienced shingles and she sought an unspecified medical attention for shingles on 13-NOV-2012. She was treated with acyclovir, Methylprednisolone dose pack and Nortriptyline. The outcome of shingles was reported as not resolved. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to an unspecified number of patients (gender and age unknown). On an unknown date the patients were vaccinated with a dose of COMVAX (lot number, route and dose were not reported). The pharmacy student reported that an unknown number of dose of COMVAX that were exposed to temperatures of -9 degrees Celcius for 72 hours, may have been administered. No adverse effects were reported. This case is related to case MARRS # 1212USA004592 (same reporter link). Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: The primary report is a nurse. The nurse is reporting a 15-month-old patient was inadvertently administered the second dose of VARIVAX 4 weeks after the first dose of VARIVAX. No adverse effects reported. No further information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself if who had no drug reactions or allergies. The patients current conditions included high blood pressure and cholesterol. On 22-Jul-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported). Concomitant medications included: CRESTOR. Approximately on 29-JUL-2012 (reported as 1 week after getting the vaccine), the patient developed a raised red area at the injection site and the area itched for about 3 days and went away. No laboratory test was performed. The patient sought no medical attention and not treatment was given. Approximately on 01-AUG-2012 (reported as 10 days after getting vaccine) the patient recovered from all the reported events. Additional information is not expected.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: Consumer stated he was diagnosed shingles in his eye. He received the vaccine in 25-FEB-2012. He was wanting treatment, I provided the Sr number and also the medical team number. The consumer has no drug reactions/Allergies.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unspecified number of patients (gender and age unknown). The nurse reported that the patients may have received improperly stored doses of RECOMBIVAX HB (lot number, route and dose were not reported) over the past three months. No symptoms were reported. No other details were provided. This case is related to case MARRS # 1212USA004546 and case MARRS # 1212USA005494 (same reporter link). Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a company representative concerning a 76 year old female patient. On an unknown date, approximately in June 2012 (6 months ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose route unspecified). No concomitant medications were reported. On 30-NOV-2012, the patient experienced shingles located on the buttocks and thighs. She went to the doctor office. No treatment was provided. It was unspecified if any laboratory diagnostic tests were performed. The outcome of the event was unknown. Additional information has been requested.
Age: 30.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal
Clinical narrative: This spontaneous report as received from a nurse refers to a 30 years old patient. The patient was vaccinated with RECOMBIVAX HB about 2 years ago. No other co-suspects were reported. No concomitant medications were reported. On 27-NOV-2012 the patient experienced borderline anti-HBs titer. No treatment information was reported. The outcome of hepatitis b antibody abnormal is unknown. The relatedness for RECOMBIVAX HB. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Accidental exposure, Pruritus
Clinical narrative: This spontaneous report as received from a Medical Assistant reporting on herself, a female patient of unknown age, medical history and drug allergies not reported, who on October 2012 (two months ago) had an accidental exposure while preparing drug for administration with PNEUMOVAX 23 (lot # H013581 exp: 03-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that (two months ago) when she was aspirating a dose of PNEUMOVAX 23 from a multi-dose vial, some of the solution sprayed onto her face after she withdrew the needle from the stopper of the vial. She reported that her face itched for a while, but there was no lasting adverse effect. She reported that she did not seek medical attention after this event. The patient did not receive any treatment for adverse event. The outcome of adverse event was unknown. The relatedness for adverse event was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella post vaccine
Clinical narrative: Information has been received from a consumer, refers to her daughter, 18 years old female patient. In 1995, the patient was vaccinated with VARIVAX (merck) injection, (lot number not provided) at the age of 12 year old. No other co-suspects were reported. No concomitant medications were reported. Then later was diagnosed with a case of chickenpox in 2001. Her daughter was just recently tested and found to have no antibodies against the chicken pox virus in her system, so she received another dose of the vaccine as an adult. The outcome of the events of the patient was tested and found to have no antibodies against the chickenpox virus in her system and chickenpox was unknown. The relatedness for the patient was tested and found to have no antibodies against the chickenpox virus in her system and chickenpox was unknown for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that after vaccinated with ZOSTAVAX that her left arm started itching from her shoulder all the way down to her elbow. No treatment information was reported. The outcome of her arm started itching is unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy concerning a 76 years old female patient who many years ago was vaccinated with a first dose of 0.5 ml PNEUMOVAX 23, IM, left arm (Lot # not provided) and in 2008 was vaccinated with a 0.5ml dose of PNEUMOVAX 23, IM, left arm (lot # H018440, Exp 29-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. No adverse effects afterwards. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 69 years old female patient with no pertinent medical history, drug reaction or allergies. The patient was vaccinated subcutaneously in the left upper arm with dose of ZOSTAVAX (lot # H011430; exp date 12-SEP-2013) (dose and route not reported) on 16-NOV-2012. No other co-suspects were reported. There were no concomitant medications. The pharmacist reported that on an unknown date the patient was experiencing persistent pain near her left elbow (in 2012). The patient had self treated with MELOXICAM without any improvement. The patient sought medical attention by going by the pharmacy. No lab Diagnostic tests were performed. The outcome of persistent pain near her left elbow was reported as not recovered. The relatedness for persistent pain near her left elbow was not provided for ZOSTAVAX. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a doctor of pharmacy concerning an approximately 76 years old female patient who on an unspecified date was vaccinated with ZOSTAVAX (dose, route and lot # not provided) on 11-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that yesterday on 11-DEC-2012, 7 hours post vaccination client developed pain in the left arm and has a firm, quarter size area at the injection site of left arm, but no rash, no streaking. The pharmacist also stated that client also complained of muscle aches in her legs. The patient would go to the ER to rule out cellulitis. The pharmacist described that the client would also follow up with her health care provider. No treatment was given for the adverse events. The outcome of pain in left arm, muscle aches in her legs and firm, quarter size area at the injection site of left arm, but no rash, no streaking was reported as not recovered. The relatedness for firm, quarter size area at the injection site of left arm, but no rash, no streaking, muscle aches in her legs and pain in left arm was unknown for ZOSTAVAX. Additional information is not expected.
Age: 1.35
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a 16 months old female patient. On 30-NOV-2012, the patient was vaccinated with a dose of 0, .5 ml M-M-R II in his left thigh (Lot#H012142; Exp date: 29-JUN-2014). No other co-suspects were reported. No concomitant medications were reported. On 12-DEC-2012, the patient had fully body rash, 12 days after onset of therapy. No treatment information was reported. Medical assistant stated that rash was fading; the patient was recovering. Doctor diagnosed the rash was due to the M-M-R II vaccination. This is one report of several reports from the same source. Additional information has been requested.
Age: 1.36
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a medical assistant concerning to her son; a 16 months old male patient. On 25-OCT-2012, the patient was vaccinated with a dose of 0.5 ml M-M-R II in his right thigh (Lot#H012142; Exp date: 29-JUN-2014). No other co-suspects were reported. No concomitant medications were reported. On 07-NOV-2012, the patient broke out in a full body rash, 13 days after onset of therapy. No treatment information was reported. The issue had resolved, the rash was gone. Doctor diagnosed the rash was due to the M-M-R II vaccination. This is one report of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Malaise, Skin warm
Clinical narrative: This spontaneous report was received from a 67 years old male patient. The patient was vaccinated with ZOSTAVAX (Lot, route and dose not provided) on 12-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 14-DEC-2012 in the morning, the patient felt warm, and the area under the injection site was red, and painful. The patient stated that he felt a little sick. No treatment information was reported. The outcome of the event was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 years old female patient with no pertinent medical history and no drug reactions or allergies. The patient was inadvertently vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # H013021, expiration date 09-OCT-2013) SQ on 10-DEC-2012 instead of VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 11-DEC-2012, the patient reported that the injection site was red and swollen, although size of swelling was unspecified. The patient did not receive treatment for the adverse events. There were no Lab diagnosis or studies performed. The patient stated that the injection site was improving. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Abdominal discomfort, Chest pain, Full blood count, Myalgia, Nausea
Clinical narrative: He reported headaches and fevers 2 days prior to onset of constant, "burning", non-positional sub-sternal chest pain.  He developed diffuse ST elevations and persistently positive troponins without pericardial effusion.  There was questionable minor reduction in ejection fraction on echo but otherwise normal.  He was treated with colchicine, indomethacin, ACE-I and beta blocker.  A left-heart catheterization was performed for definitive assessment of his coronary anatomy when his troponins elevated again after an initial decline.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Troponin increased
Clinical narrative: He reported headaches and fevers 2 days prior to onset of constant, "burning", non-positional sub-sternal chest pain.  He developed diffuse ST elevations and persistently positive troponins without pericardial effusion.  There was questionable minor reduction in ejection fraction on echo but otherwise normal.  He was treated with colchicine, indomethacin, ACE-I and beta blocker.  A left-heart catheterization was performed for definitive assessment of his coronary anatomy when his troponins elevated again after an initial decline.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Catheterisation cardiac, Chest pain, Echocardiogram, Electrocardiogram ST segment elevation, Headache
Clinical narrative: He reported headaches and fevers 2 days prior to onset of constant, "burning", non-positional sub-sternal chest pain.  He developed diffuse ST elevations and persistently positive troponins without pericardial effusion.  There was questionable minor reduction in ejection fraction on echo but otherwise normal.  He was treated with colchicine, indomethacin, ACE-I and beta blocker.  A left-heart catheterization was performed for definitive assessment of his coronary anatomy when his troponins elevated again after an initial decline.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Troponin I increased
Clinical narrative: He reported headaches and fevers 2 days prior to onset of constant, "burning", non-positional sub-sternal chest pain.  He developed diffuse ST elevations and persistently positive troponins without pericardial effusion.  There was questionable minor reduction in ejection fraction on echo but otherwise normal.  He was treated with colchicine, indomethacin, ACE-I and beta blocker.  A left-heart catheterization was performed for definitive assessment of his coronary anatomy when his troponins elevated again after an initial decline.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Diarrhoea, Dizziness, Pyrexia, Vomiting
Clinical narrative: High temp. - vomiting - breathless - loose stool - dizzy.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Pyrexia, Vomiting
Clinical narrative: High temp. - vomiting - breathless - loose stool - dizzy.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Headache, Laboratory test, Sinus operation
Clinical narrative: This spontaneous report was received from a consumer regarding her 14 year old grandchild (gender unspecified). Approximately on an unknown date in December-2011 (reported as 1 year ago), the patient was vaccinated with dose 1 of GARDASIL, (lot number, expiration date and route not reported). No concomitant medications were reported. Approximately on an unknown date in March-2012 (reported as 9 months ago), the patient experienced severe, debilitating headaches. The patient has had a series of laboratory tests. The patient sought medical attention. She had consulted neurologist, gynecologist and allergist. On an unknown date in 2012, the patient has had sinus surgery and to date there has not been any resolution to the symptoms. The outcome of the events was reported as not recovered. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at upper right arm that developed 2 days following injection. Went to ER on 12-17-12 - cellulitis diagnosed & given LEVAQUIN & clindamycin in the ER with a course of 6 day 5 of more clindamycin ordered.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Intensive care, Myalgia
Clinical narrative: Guillain Barre syndrome. Admitted for myalgia & progressive weakness to intensive care.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Body temperature increased, Chills, Computerised tomogram abdomen abnormal, Computerised tomogram abnormal
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 47 years old female patient with asthma, anxiety, codeine allergy and doxycycline allergy. On 04-SEP-2012, the patient was vaccinated intramuscularly in the gluteus maximus, left side with lot # (672673/0492AE; expiration date 22-AUG-2013), first dose of, 0.5 ml PNEUMOVAX23. No other co-suspects were reported. Concomitant medications included influenza virus vaccine (GSK), fluticasone propionate, ADVAIR, XANAX, albuterol (manufacturer unspecified), albuterol sulfate, DUONEB, NEXIUM and ibuprofen. The nurse reported that the patient developed a cellulitis that required hospitalization following vaccination with PNEUMOVAX23. The patient had flu like symptoms, nausea, elevated temperature (unspecified) and a swollen, tender and painful area described as a cellulitis at the injection site of the PNEUMOVAX23 with rigors and limp. The exact development of the flu like symptoms, nausea, elevated temperatures (unspecified) and a swollen, tender and painful area described as a cellulitis at the injection of the PNEUMOVAX23 with rigors and limp was unspecified. The patient went to the office on 06-SEP-2012 and then went to the emergency room and was admitted to the hospital on 06-SEP-2012 for treatment of the cellulitis. The patient was discharged from the hospital on 09-SEP-2012, but went back to the physician office and emergency room on 11-SEP-2012 with symptoms of nausea, increased swelling, pain and tenderness at the injection site. The patient was given a computed tomography (CT) scan of the pelvis and abdomen on 11-SEP-2012 which indicated inflammation, but no abscesses or hematoma. The patient was sent to home after treatment with ZOFRAN, intravenous (IV) fluids generic (KEFLEX) and PERCOCET on 11-SEP-2012. The patient was reported to be recovered on 24-SEP-2012. The patient missed work (unspecified number of days) and could not walk right, limped. The relatedness for the events were unknown for PNEUMOVAX23. This is one report of several reports from the same source. Cellulitis, missed work and could not walk right, limped were considered to be life threatening by the registered nurse. Cellulitis was considered to be disabling by the registered nurse. Additional information has been requested.