chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Dose administered after 30-day Use By Date; No adverse event; Patient was due to receive their Moderna Bivalent booster, but received a 0.25 dose of a Moderna Monovalent; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was due to receive their Moderna Bivalent booster, but received a 0.25 dose of a Moderna Monovalent), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015B22A and 045J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2023, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 16-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was due to receive their Moderna Bivalent booster, but received a 0.25 dose of a Moderna Monovalent) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was due to receive their Moderna Bivalent booster, but received a 0.25 dose of a Moderna Monovalent), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient was due to receive their Moderna Bivalent booster, but received a 0.25 dose of a Moderna Monovalent), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Initially the vial was stored in the refrigerator on 15Dec2022.  No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product temperature excursion issue
Clinical narrative: The physician reports that doses were given following possible excursions in August, September, and October of 2022.; Product temperature excursion issue; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The physician reports that doses were given following possible excursions in August, September, and October of 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The physician reports that doses were given following possible excursions in August, September, and October of 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The physician reports that doses were given following possible excursions in August, September, and October of 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The physician reports that doses were given following possible excursions in August, September, and October of 2022.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    No concomitant medications were reported. It was reported that he physician reported that doses were given following possible excursions in August, September, and October of 2022.  No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Inappropriate schedule of vaccine administered; They had COVID twice after receiving Moderna.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (They had COVID twice after receiving Moderna.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 032L20A, 016M20A, 939901 and 013G22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced COVID-19 (They had COVID twice after receiving Moderna.). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, COVID-19 (They had COVID twice after receiving Moderna.) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive. In December 2022, SARS-CoV-2 test: Negative. On 20-Dec-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. It was reported that the patient was going to get the other Moderna booster shot the second week of January. No treatment medicine were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: if the dose was given more than 12 hours after it was punctured; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (if the dose was given more than 12 hours after it was punctured) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (if the dose was given more than 12 hours after it was punctured) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (if the dose was given more than 12 hours after it was punctured) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (if the dose was given more than 12 hours after it was punctured).    No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 43rd of 43 adult patients described by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients were administered pediatric monovalent vaccines instead of bivalent boosters).    Concomitant products were not reported.  This case contains information for the 10th of 16 patients described by the reporter.   Treatment medications were not reported.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Patient administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster).    This case contains information for the 11th of 16 adult patients described by the reporter. No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:master case
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Anaemia, Asthenia, BK polyomavirus test negative, Biopsy colon normal
Clinical narrative: Patient enrolled in the Janssen study received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022. Of note, the patient was recently admitted 12/2/2022 -12/8/2022 with worsening fatigue and weakness, poor appetite, weight loss, Acute kidney injury and found to have CMV viremia was initiated on Valcyte. improved to 3.5 with IV fluids. Myfortic was held and prednisone increased. Discharged from hospital on 12/8/2022 prescribed home health care to follow up with kidney transplant nephrology. Unfortunately, patient required direct admission to the hospital on12/27/22 with reports of continued weight loss (10 kg over 1 month) and was unable to eat due to pressure in abdomen. He reported ongoing diarrhea and significant weakness, extreme difficulty even getting out of a chair. Creatinine was 2.4; IVF were started. CMV was negative and BK urine and blood were undetected. Urine culture was negative. GI was consulted and EGD and flex sigmoidoscopy were done. EGD showed esophageal plaques consistent w/ candidiasis. Fluconazole was started 12/29 with plan to continue through 1/18/2023. Colonic mucosa was grossly normal. He did have perianal hemorrhoids and non-bleeding external and internal hemorrhoids. Biopsies in colon, stomach and duodenum were negative for CMV. The flex sigmoidoscopy report suggested the sigmoid colon had focal features suggestive for mild graft-versus-host disease and focal nonspecific acute colitis. GI enteric pathogen panel was negative. GI pathogen panel was positive for norovirus and the patient was started on nitazoxanide 500mg BID x3 days. His diarrhea resolved. Case reviewed with both GI and hem/oncology who felt this finding in the sigmoid colon was due to norovirus rather than GVHD therefore no further treatment was pursued. Due to two negative CMV PCR, Valcyte was discontinued 12/30 and we will continue to monitor with weekly CMV DNA PCR. During admission, he had anemia requiring blood transfusion and Aranesp. Nutrition team was consulted, and thiamine was initiated for refeeding syndrome (multivitamin continued). He initially required phosphorous repletion, now only potassium supplementation and has been provided a prescription upon discharge. Physical therapy recommends home health PT. He has all needed equipment at home. By 1/4/2023, diarrhea has resolved, appetite improved, and Creatinine improved overall. Patient discharged with low dose Lasix due to edema. Patient discharged on 1/4/2023 condition stable. Discharge diagnosis: candidiasis and norovirus. Principal Investigator assessed causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy small intestine normal, Biopsy stomach normal, Blood creatinine increased, Condition aggravated, Culture urine negative
Clinical narrative: Patient enrolled in the Janssen study received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022. Of note, the patient was recently admitted 12/2/2022 -12/8/2022 with worsening fatigue and weakness, poor appetite, weight loss, Acute kidney injury and found to have CMV viremia was initiated on Valcyte. improved to 3.5 with IV fluids. Myfortic was held and prednisone increased. Discharged from hospital on 12/8/2022 prescribed home health care to follow up with kidney transplant nephrology. Unfortunately, patient required direct admission to the hospital on12/27/22 with reports of continued weight loss (10 kg over 1 month) and was unable to eat due to pressure in abdomen. He reported ongoing diarrhea and significant weakness, extreme difficulty even getting out of a chair. Creatinine was 2.4; IVF were started. CMV was negative and BK urine and blood were undetected. Urine culture was negative. GI was consulted and EGD and flex sigmoidoscopy were done. EGD showed esophageal plaques consistent w/ candidiasis. Fluconazole was started 12/29 with plan to continue through 1/18/2023. Colonic mucosa was grossly normal. He did have perianal hemorrhoids and non-bleeding external and internal hemorrhoids. Biopsies in colon, stomach and duodenum were negative for CMV. The flex sigmoidoscopy report suggested the sigmoid colon had focal features suggestive for mild graft-versus-host disease and focal nonspecific acute colitis. GI enteric pathogen panel was negative. GI pathogen panel was positive for norovirus and the patient was started on nitazoxanide 500mg BID x3 days. His diarrhea resolved. Case reviewed with both GI and hem/oncology who felt this finding in the sigmoid colon was due to norovirus rather than GVHD therefore no further treatment was pursued. Due to two negative CMV PCR, Valcyte was discontinued 12/30 and we will continue to monitor with weekly CMV DNA PCR. During admission, he had anemia requiring blood transfusion and Aranesp. Nutrition team was consulted, and thiamine was initiated for refeeding syndrome (multivitamin continued). He initially required phosphorous repletion, now only potassium supplementation and has been provided a prescription upon discharge. Physical therapy recommends home health PT. He has all needed equipment at home. By 1/4/2023, diarrhea has resolved, appetite improved, and Creatinine improved overall. Patient discharged with low dose Lasix due to edema. Patient discharged on 1/4/2023 condition stable. Discharge diagnosis: candidiasis and norovirus. Principal Investigator assessed causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Cytomegalovirus test negative, Cytomegalovirus viraemia, Decreased appetite, Diarrhoea, Discomfort
Clinical narrative: Patient enrolled in the Janssen study received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022. Of note, the patient was recently admitted 12/2/2022 -12/8/2022 with worsening fatigue and weakness, poor appetite, weight loss, Acute kidney injury and found to have CMV viremia was initiated on Valcyte. improved to 3.5 with IV fluids. Myfortic was held and prednisone increased. Discharged from hospital on 12/8/2022 prescribed home health care to follow up with kidney transplant nephrology. Unfortunately, patient required direct admission to the hospital on12/27/22 with reports of continued weight loss (10 kg over 1 month) and was unable to eat due to pressure in abdomen. He reported ongoing diarrhea and significant weakness, extreme difficulty even getting out of a chair. Creatinine was 2.4; IVF were started. CMV was negative and BK urine and blood were undetected. Urine culture was negative. GI was consulted and EGD and flex sigmoidoscopy were done. EGD showed esophageal plaques consistent w/ candidiasis. Fluconazole was started 12/29 with plan to continue through 1/18/2023. Colonic mucosa was grossly normal. He did have perianal hemorrhoids and non-bleeding external and internal hemorrhoids. Biopsies in colon, stomach and duodenum were negative for CMV. The flex sigmoidoscopy report suggested the sigmoid colon had focal features suggestive for mild graft-versus-host disease and focal nonspecific acute colitis. GI enteric pathogen panel was negative. GI pathogen panel was positive for norovirus and the patient was started on nitazoxanide 500mg BID x3 days. His diarrhea resolved. Case reviewed with both GI and hem/oncology who felt this finding in the sigmoid colon was due to norovirus rather than GVHD therefore no further treatment was pursued. Due to two negative CMV PCR, Valcyte was discontinued 12/30 and we will continue to monitor with weekly CMV DNA PCR. During admission, he had anemia requiring blood transfusion and Aranesp. Nutrition team was consulted, and thiamine was initiated for refeeding syndrome (multivitamin continued). He initially required phosphorous repletion, now only potassium supplementation and has been provided a prescription upon discharge. Physical therapy recommends home health PT. He has all needed equipment at home. By 1/4/2023, diarrhea has resolved, appetite improved, and Creatinine improved overall. Patient discharged with low dose Lasix due to edema. Patient discharged on 1/4/2023 condition stable. Discharge diagnosis: candidiasis and norovirus. Principal Investigator assessed causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Gastrointestinal pathogen panel, Haemorrhoids, Mineral supplementation
Clinical narrative: Patient enrolled in the Janssen study received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022. Of note, the patient was recently admitted 12/2/2022 -12/8/2022 with worsening fatigue and weakness, poor appetite, weight loss, Acute kidney injury and found to have CMV viremia was initiated on Valcyte. improved to 3.5 with IV fluids. Myfortic was held and prednisone increased. Discharged from hospital on 12/8/2022 prescribed home health care to follow up with kidney transplant nephrology. Unfortunately, patient required direct admission to the hospital on12/27/22 with reports of continued weight loss (10 kg over 1 month) and was unable to eat due to pressure in abdomen. He reported ongoing diarrhea and significant weakness, extreme difficulty even getting out of a chair. Creatinine was 2.4; IVF were started. CMV was negative and BK urine and blood were undetected. Urine culture was negative. GI was consulted and EGD and flex sigmoidoscopy were done. EGD showed esophageal plaques consistent w/ candidiasis. Fluconazole was started 12/29 with plan to continue through 1/18/2023. Colonic mucosa was grossly normal. He did have perianal hemorrhoids and non-bleeding external and internal hemorrhoids. Biopsies in colon, stomach and duodenum were negative for CMV. The flex sigmoidoscopy report suggested the sigmoid colon had focal features suggestive for mild graft-versus-host disease and focal nonspecific acute colitis. GI enteric pathogen panel was negative. GI pathogen panel was positive for norovirus and the patient was started on nitazoxanide 500mg BID x3 days. His diarrhea resolved. Case reviewed with both GI and hem/oncology who felt this finding in the sigmoid colon was due to norovirus rather than GVHD therefore no further treatment was pursued. Due to two negative CMV PCR, Valcyte was discontinued 12/30 and we will continue to monitor with weekly CMV DNA PCR. During admission, he had anemia requiring blood transfusion and Aranesp. Nutrition team was consulted, and thiamine was initiated for refeeding syndrome (multivitamin continued). He initially required phosphorous repletion, now only potassium supplementation and has been provided a prescription upon discharge. Physical therapy recommends home health PT. He has all needed equipment at home. By 1/4/2023, diarrhea has resolved, appetite improved, and Creatinine improved overall. Patient discharged with low dose Lasix due to edema. Patient discharged on 1/4/2023 condition stable. Discharge diagnosis: candidiasis and norovirus. Principal Investigator assessed causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Norovirus infection, Norovirus test positive, Oedema, Oesophageal candidiasis
Clinical narrative: Patient enrolled in the Janssen study received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022. Of note, the patient was recently admitted 12/2/2022 -12/8/2022 with worsening fatigue and weakness, poor appetite, weight loss, Acute kidney injury and found to have CMV viremia was initiated on Valcyte. improved to 3.5 with IV fluids. Myfortic was held and prednisone increased. Discharged from hospital on 12/8/2022 prescribed home health care to follow up with kidney transplant nephrology. Unfortunately, patient required direct admission to the hospital on12/27/22 with reports of continued weight loss (10 kg over 1 month) and was unable to eat due to pressure in abdomen. He reported ongoing diarrhea and significant weakness, extreme difficulty even getting out of a chair. Creatinine was 2.4; IVF were started. CMV was negative and BK urine and blood were undetected. Urine culture was negative. GI was consulted and EGD and flex sigmoidoscopy were done. EGD showed esophageal plaques consistent w/ candidiasis. Fluconazole was started 12/29 with plan to continue through 1/18/2023. Colonic mucosa was grossly normal. He did have perianal hemorrhoids and non-bleeding external and internal hemorrhoids. Biopsies in colon, stomach and duodenum were negative for CMV. The flex sigmoidoscopy report suggested the sigmoid colon had focal features suggestive for mild graft-versus-host disease and focal nonspecific acute colitis. GI enteric pathogen panel was negative. GI pathogen panel was positive for norovirus and the patient was started on nitazoxanide 500mg BID x3 days. His diarrhea resolved. Case reviewed with both GI and hem/oncology who felt this finding in the sigmoid colon was due to norovirus rather than GVHD therefore no further treatment was pursued. Due to two negative CMV PCR, Valcyte was discontinued 12/30 and we will continue to monitor with weekly CMV DNA PCR. During admission, he had anemia requiring blood transfusion and Aranesp. Nutrition team was consulted, and thiamine was initiated for refeeding syndrome (multivitamin continued). He initially required phosphorous repletion, now only potassium supplementation and has been provided a prescription upon discharge. Physical therapy recommends home health PT. He has all needed equipment at home. By 1/4/2023, diarrhea has resolved, appetite improved, and Creatinine improved overall. Patient discharged with low dose Lasix due to edema. Patient discharged on 1/4/2023 condition stable. Discharge diagnosis: candidiasis and norovirus. Principal Investigator assessed causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Oesophageal disorder, Oesophagogastroduodenoscopy abnormal, Sigmoidoscopy abnormal, Transfusion, Vitamin supplementation
Clinical narrative: Patient enrolled in the Janssen study received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022. Of note, the patient was recently admitted 12/2/2022 -12/8/2022 with worsening fatigue and weakness, poor appetite, weight loss, Acute kidney injury and found to have CMV viremia was initiated on Valcyte. improved to 3.5 with IV fluids. Myfortic was held and prednisone increased. Discharged from hospital on 12/8/2022 prescribed home health care to follow up with kidney transplant nephrology. Unfortunately, patient required direct admission to the hospital on12/27/22 with reports of continued weight loss (10 kg over 1 month) and was unable to eat due to pressure in abdomen. He reported ongoing diarrhea and significant weakness, extreme difficulty even getting out of a chair. Creatinine was 2.4; IVF were started. CMV was negative and BK urine and blood were undetected. Urine culture was negative. GI was consulted and EGD and flex sigmoidoscopy were done. EGD showed esophageal plaques consistent w/ candidiasis. Fluconazole was started 12/29 with plan to continue through 1/18/2023. Colonic mucosa was grossly normal. He did have perianal hemorrhoids and non-bleeding external and internal hemorrhoids. Biopsies in colon, stomach and duodenum were negative for CMV. The flex sigmoidoscopy report suggested the sigmoid colon had focal features suggestive for mild graft-versus-host disease and focal nonspecific acute colitis. GI enteric pathogen panel was negative. GI pathogen panel was positive for norovirus and the patient was started on nitazoxanide 500mg BID x3 days. His diarrhea resolved. Case reviewed with both GI and hem/oncology who felt this finding in the sigmoid colon was due to norovirus rather than GVHD therefore no further treatment was pursued. Due to two negative CMV PCR, Valcyte was discontinued 12/30 and we will continue to monitor with weekly CMV DNA PCR. During admission, he had anemia requiring blood transfusion and Aranesp. Nutrition team was consulted, and thiamine was initiated for refeeding syndrome (multivitamin continued). He initially required phosphorous repletion, now only potassium supplementation and has been provided a prescription upon discharge. Physical therapy recommends home health PT. He has all needed equipment at home. By 1/4/2023, diarrhea has resolved, appetite improved, and Creatinine improved overall. Patient discharged with low dose Lasix due to edema. Patient discharged on 1/4/2023 condition stable. Discharge diagnosis: candidiasis and norovirus. Principal Investigator assessed causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Patient enrolled in the Janssen study received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022. Of note, the patient was recently admitted 12/2/2022 -12/8/2022 with worsening fatigue and weakness, poor appetite, weight loss, Acute kidney injury and found to have CMV viremia was initiated on Valcyte. improved to 3.5 with IV fluids. Myfortic was held and prednisone increased. Discharged from hospital on 12/8/2022 prescribed home health care to follow up with kidney transplant nephrology. Unfortunately, patient required direct admission to the hospital on12/27/22 with reports of continued weight loss (10 kg over 1 month) and was unable to eat due to pressure in abdomen. He reported ongoing diarrhea and significant weakness, extreme difficulty even getting out of a chair. Creatinine was 2.4; IVF were started. CMV was negative and BK urine and blood were undetected. Urine culture was negative. GI was consulted and EGD and flex sigmoidoscopy were done. EGD showed esophageal plaques consistent w/ candidiasis. Fluconazole was started 12/29 with plan to continue through 1/18/2023. Colonic mucosa was grossly normal. He did have perianal hemorrhoids and non-bleeding external and internal hemorrhoids. Biopsies in colon, stomach and duodenum were negative for CMV. The flex sigmoidoscopy report suggested the sigmoid colon had focal features suggestive for mild graft-versus-host disease and focal nonspecific acute colitis. GI enteric pathogen panel was negative. GI pathogen panel was positive for norovirus and the patient was started on nitazoxanide 500mg BID x3 days. His diarrhea resolved. Case reviewed with both GI and hem/oncology who felt this finding in the sigmoid colon was due to norovirus rather than GVHD therefore no further treatment was pursued. Due to two negative CMV PCR, Valcyte was discontinued 12/30 and we will continue to monitor with weekly CMV DNA PCR. During admission, he had anemia requiring blood transfusion and Aranesp. Nutrition team was consulted, and thiamine was initiated for refeeding syndrome (multivitamin continued). He initially required phosphorous repletion, now only potassium supplementation and has been provided a prescription upon discharge. Physical therapy recommends home health PT. He has all needed equipment at home. By 1/4/2023, diarrhea has resolved, appetite improved, and Creatinine improved overall. Patient discharged with low dose Lasix due to edema. Patient discharged on 1/4/2023 condition stable. Discharge diagnosis: candidiasis and norovirus. Principal Investigator assessed causality as not study related.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Breast cancer female, Breast cancer stage I, Hormone receptor positive HER2 negative breast cancer, Hormone receptor positive breast cancer
Clinical narrative: No breast cancer in close family genes, negative genetic testing for both. Cousin was diagnosed with exact same breast cancer just a few months ago after covid vaccine. Covid vaccine Pfizer - few months after two shots and one booster I was diagnosed with breast cancer on same side as vaccine. mammograms' and PET CT scan clear month before first shots. Dr did PET scan for another disorder that came back negative for everything. Booster April 18, 2022 (1st booster) shot was painful, raised a bump looking spot, that turned into egg shaped know and arm swelled up. Lasted about two weeks. It left a permeant mark exactly where shot was given. Two days after mastectomy on left side (Oct 12, 2022) that little bump left over on arm from last vaccine, grew to crusty pencil size spot that kept growing. On Jan 4th 2023 I had it biopsied at dermatologist, that spot left by vaccine that grew was diagnosed as Squamous Cell Carcinoma. Dr convinced me that it was ok to get second booster this past week so I would not get severely ill from COVID. Step father just caught covid at his cancer apt because the medical facility and cancer center stopped wearing masks due to CDC rules. Had to get in right arm. Now my right arm is swollen, huge red area about 3-4 inches big where shot was given, another mark left, and this time right hand swelled up. Terrifed that I will be getting more cancers or the breast will spread or grow. I was early stage 1, grade 2, estogen Pret positive, HER2 negative., onco type 8, no chemo or radiation, did flat closure Contacted CDC, no response, contacted Pfizer. No response until this past week Pfizer sent me a form to fill out that also seems to have legal language in it. Need more space. Breast cancer tests and results, vaccine data and skin cancer info
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Laboratory test
Clinical narrative: No breast cancer in close family genes, negative genetic testing for both. Cousin was diagnosed with exact same breast cancer just a few months ago after covid vaccine. Covid vaccine Pfizer - few months after two shots and one booster I was diagnosed with breast cancer on same side as vaccine. mammograms' and PET CT scan clear month before first shots. Dr did PET scan for another disorder that came back negative for everything. Booster April 18, 2022 (1st booster) shot was painful, raised a bump looking spot, that turned into egg shaped know and arm swelled up. Lasted about two weeks. It left a permeant mark exactly where shot was given. Two days after mastectomy on left side (Oct 12, 2022) that little bump left over on arm from last vaccine, grew to crusty pencil size spot that kept growing. On Jan 4th 2023 I had it biopsied at dermatologist, that spot left by vaccine that grew was diagnosed as Squamous Cell Carcinoma. Dr convinced me that it was ok to get second booster this past week so I would not get severely ill from COVID. Step father just caught covid at his cancer apt because the medical facility and cancer center stopped wearing masks due to CDC rules. Had to get in right arm. Now my right arm is swollen, huge red area about 3-4 inches big where shot was given, another mark left, and this time right hand swelled up. Terrifed that I will be getting more cancers or the breast will spread or grow. I was early stage 1, grade 2, estogen Pret positive, HER2 negative., onco type 8, no chemo or radiation, did flat closure Contacted CDC, no response, contacted Pfizer. No response until this past week Pfizer sent me a form to fill out that also seems to have legal language in it. Need more space. Breast cancer tests and results, vaccine data and skin cancer info
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mastectomy, Peripheral swelling, Scab, Skin cancer, Squamous cell carcinoma
Clinical narrative: No breast cancer in close family genes, negative genetic testing for both. Cousin was diagnosed with exact same breast cancer just a few months ago after covid vaccine. Covid vaccine Pfizer - few months after two shots and one booster I was diagnosed with breast cancer on same side as vaccine. mammograms' and PET CT scan clear month before first shots. Dr did PET scan for another disorder that came back negative for everything. Booster April 18, 2022 (1st booster) shot was painful, raised a bump looking spot, that turned into egg shaped know and arm swelled up. Lasted about two weeks. It left a permeant mark exactly where shot was given. Two days after mastectomy on left side (Oct 12, 2022) that little bump left over on arm from last vaccine, grew to crusty pencil size spot that kept growing. On Jan 4th 2023 I had it biopsied at dermatologist, that spot left by vaccine that grew was diagnosed as Squamous Cell Carcinoma. Dr convinced me that it was ok to get second booster this past week so I would not get severely ill from COVID. Step father just caught covid at his cancer apt because the medical facility and cancer center stopped wearing masks due to CDC rules. Had to get in right arm. Now my right arm is swollen, huge red area about 3-4 inches big where shot was given, another mark left, and this time right hand swelled up. Terrifed that I will be getting more cancers or the breast will spread or grow. I was early stage 1, grade 2, estogen Pret positive, HER2 negative., onco type 8, no chemo or radiation, did flat closure Contacted CDC, no response, contacted Pfizer. No response until this past week Pfizer sent me a form to fill out that also seems to have legal language in it. Need more space. Breast cancer tests and results, vaccine data and skin cancer info
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood disorder, Blood test abnormal, Blood thyroid stimulating hormone normal, Blood urea increased, C-reactive protein normal
Clinical narrative: On 12-6-22 I received the Pfizer-BioNTech bivalent COVID-19 vaccine. On 12-24-22 I suddenly had diplopia (double vision). The image from my left eye is not lining up with the image from the right eye. I am a healthy 64 year old female with no risk factors for stroke On 12-26-22 I had an MRI and multiple blood and urine tests. My BUN and %Monocytes were slightly elevated. All other results were normal. The MRI showed no sign of ischemia. On 12-27-22 my optometrist performed tests and found no problem within the eyeballs. She referred me to an ophthalmologist, who I saw on 12-30-22. She said I have Sixth Nerve Palsy, which she described as a micro-stroke, too small to be seen on an MRI. The blood vessel which feeds the nerve controlling the left lateral rectus muscle had been interrupted. She said the blood should find another pathway and my vision should return to normal or near-normal in 3-6 months. I did not report this on my latest V-Safe check-in from the CDC because it did not occur to me that it could be related to the vaccine. But, as I stated, I have no other risk factors for the occurrence of stroke. I have pages of reports from the blood work which I can provide if needed. As I stated, all values were normal except the BUN and %Monocytes, which were only slightly high. Tests done were: CRP, Urinalysis, T-4 Assay Free, ESR, TSH-Thyroid Stimulating Hormone, Comprehensive Metabolic Panel and CBC/Auto Diff.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Differential white blood cell count normal, Diplopia, Full blood count normal, Magnetic resonance imaging head normal, Metabolic function test normal
Clinical narrative: On 12-6-22 I received the Pfizer-BioNTech bivalent COVID-19 vaccine. On 12-24-22 I suddenly had diplopia (double vision). The image from my left eye is not lining up with the image from the right eye. I am a healthy 64 year old female with no risk factors for stroke On 12-26-22 I had an MRI and multiple blood and urine tests. My BUN and %Monocytes were slightly elevated. All other results were normal. The MRI showed no sign of ischemia. On 12-27-22 my optometrist performed tests and found no problem within the eyeballs. She referred me to an ophthalmologist, who I saw on 12-30-22. She said I have Sixth Nerve Palsy, which she described as a micro-stroke, too small to be seen on an MRI. The blood vessel which feeds the nerve controlling the left lateral rectus muscle had been interrupted. She said the blood should find another pathway and my vision should return to normal or near-normal in 3-6 months. I did not report this on my latest V-Safe check-in from the CDC because it did not occur to me that it could be related to the vaccine. But, as I stated, I have no other risk factors for the occurrence of stroke. I have pages of reports from the blood work which I can provide if needed. As I stated, all values were normal except the BUN and %Monocytes, which were only slightly high. Tests done were: CRP, Urinalysis, T-4 Assay Free, ESR, TSH-Thyroid Stimulating Hormone, Comprehensive Metabolic Panel and CBC/Auto Diff.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Monocyte percentage increased, Muscle disorder, Red blood cell sedimentation rate normal, Scan with contrast normal, Thyroxine free normal
Clinical narrative: On 12-6-22 I received the Pfizer-BioNTech bivalent COVID-19 vaccine. On 12-24-22 I suddenly had diplopia (double vision). The image from my left eye is not lining up with the image from the right eye. I am a healthy 64 year old female with no risk factors for stroke On 12-26-22 I had an MRI and multiple blood and urine tests. My BUN and %Monocytes were slightly elevated. All other results were normal. The MRI showed no sign of ischemia. On 12-27-22 my optometrist performed tests and found no problem within the eyeballs. She referred me to an ophthalmologist, who I saw on 12-30-22. She said I have Sixth Nerve Palsy, which she described as a micro-stroke, too small to be seen on an MRI. The blood vessel which feeds the nerve controlling the left lateral rectus muscle had been interrupted. She said the blood should find another pathway and my vision should return to normal or near-normal in 3-6 months. I did not report this on my latest V-Safe check-in from the CDC because it did not occur to me that it could be related to the vaccine. But, as I stated, I have no other risk factors for the occurrence of stroke. I have pages of reports from the blood work which I can provide if needed. As I stated, all values were normal except the BUN and %Monocytes, which were only slightly high. Tests done were: CRP, Urinalysis, T-4 Assay Free, ESR, TSH-Thyroid Stimulating Hormone, Comprehensive Metabolic Panel and CBC/Auto Diff.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urine analysis normal, VIth nerve paralysis
Clinical narrative: On 12-6-22 I received the Pfizer-BioNTech bivalent COVID-19 vaccine. On 12-24-22 I suddenly had diplopia (double vision). The image from my left eye is not lining up with the image from the right eye. I am a healthy 64 year old female with no risk factors for stroke On 12-26-22 I had an MRI and multiple blood and urine tests. My BUN and %Monocytes were slightly elevated. All other results were normal. The MRI showed no sign of ischemia. On 12-27-22 my optometrist performed tests and found no problem within the eyeballs. She referred me to an ophthalmologist, who I saw on 12-30-22. She said I have Sixth Nerve Palsy, which she described as a micro-stroke, too small to be seen on an MRI. The blood vessel which feeds the nerve controlling the left lateral rectus muscle had been interrupted. She said the blood should find another pathway and my vision should return to normal or near-normal in 3-6 months. I did not report this on my latest V-Safe check-in from the CDC because it did not occur to me that it could be related to the vaccine. But, as I stated, I have no other risk factors for the occurrence of stroke. I have pages of reports from the blood work which I can provide if needed. As I stated, all values were normal except the BUN and %Monocytes, which were only slightly high. Tests done were: CRP, Urinalysis, T-4 Assay Free, ESR, TSH-Thyroid Stimulating Hormone, Comprehensive Metabolic Panel and CBC/Auto Diff.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache chills and fatigue Narrative: