chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023; She states that no adverse reactions have been reported by any patients; Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) 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)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, 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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) 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 (She states that no adverse reactions have been reported by any patients) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023).    Concomitant medications were not reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions.  Treatment information was not reported.  This case is reported for patient 47 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023; She states that no adverse reactions have been reported by any patients; Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) 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)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, 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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) 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 (She states that no adverse reactions have been reported by any patients) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023).    Concomitant medications were not reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions.  Treatment information was not reported.  This case is reported for patient 48 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID 19) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (COVID 19). At the time of the report, COVID-19 (COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that around Oct or Nov-2022 patient had mild case of covid. The reporter did not provide more information on patient  symptoms of covid-19  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735448 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2023: Live significant Follow-up information received contains patient information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735448:Master Case ( wife case)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) 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. 066H21A) for COVID-19 prophylaxis.     Medical History or Condition was not reported.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding. Concomitant product use was not provided by the reporter. Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.    This case contains information about patient 2nd out of 8 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case, 2 out of 8 patients
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) 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. 066H21A) for COVID-19 prophylaxis.     HCP did not describe Medical History or Condition.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding.  Concomitant product use was not provided by the reporter.  Expiry date of the vaccine was 04-Apr-2022. All the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 3rd out of 8 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Vaccine was administered to patient after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry) 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. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry).    No concomitant medication was reported.  Patients were both male and female, none of the patients reported being pregnant or breastfeeding. No treatment information was reported.  This case contains information for patient 4 out of 8.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) 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. 066H21A) for COVID-19 prophylaxis.     HCP did not describe Medical History or condition.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding.  Concomitant product use was not provided by the reporter.  Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 5th out of 8 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case, 5 out of 8 patient
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was administered to patient after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry) 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. 066H21A) for COVID-19 prophylaxis.     It was reported that HCP did not describe medical history or condition.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding. Concomitant product use was not provided by the reporter. Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided. This case contains information about patient 6th out of 8 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case, patient 6 out of 8
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) 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. 066H21A) for COVID-19 prophylaxis.     Medical History or Condition were not reported.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding.  Concomitant product use was not provided by the reporter.  Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 7th out of 8 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case, Patient 1
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) 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. 066H21A) for COVID-19 prophylaxis.     Medical History or Condition was not reported.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).      Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding. Concomitant product use was not provided by the reporter. Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.   This case contains information about patient 8th out of 8 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case, Patient 8 out of 8
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: First responder at a hospital, took the moderna two doses and came down with the COVID virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (First responder at a hospital, took the moderna two doses and came down with the COVID virus) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (First responder at a hospital, took the moderna two doses and came down with the COVID virus). At the time of the report, COVID-19 (First responder at a hospital, took the moderna two doses and came down with the COVID virus) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  It was reported that the first responder at a hospital, took the Moderna two doses and came down with the COVID virus It was mandatory to take it.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735150 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735150:Master case
Sex: U
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: thyroid disease; This spontaneous case was reported by a patient and describes the occurrence of THYROID DISORDER (thyroid disease) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THYROID DISORDER (thyroid disease). At the time of the report, THYROID DISORDER (thyroid disease) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735928 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735928:Case for the First responder
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Laboratory test, Ovarian cancer stage III
Clinical narrative: Patient was diagnosed with cancer stage 3 (ovary cancer) after taking the COVID vaccine booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OVARIAN CANCER STAGE III (Patient was diagnosed with cancer stage 3 (ovary cancer) after taking the COVID vaccine booster) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Non-smoker.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2023, the patient experienced OVARIAN CANCER STAGE III (Patient was diagnosed with cancer stage 3 (ovary cancer) after taking the COVID vaccine booster) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, OVARIAN CANCER STAGE III (Patient was diagnosed with cancer stage 3 (ovary cancer) after taking the COVID vaccine booster) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2023, Computerised tomogram: cancer stage 3 (ovary cancer). On 22-Jul-2023, Laboratory test: came up with cancer on the ovaries stage 3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient didn't drink. The patient complained about stomach pain. They removed some fluid from stomach and they did cancer test on fluid and it came up with cancer on the ovaries stage 3. Caller says he heard about cancer vaccine. She has scheduled a surgery to have her tumor removed. No treatment information was reported. Company Comment: This is a spontaneous case concerning a 42-year-old female patient with a history of non-smoker, who experienced the serious (due to life threatening, medically significant and hospitalization) unexpected, event of ovarian cancer stage III which occurred with unknown latency after a dose of mRNA-1273 vaccine, received as the fourth dose of COVID-19 vaccination schedule. It was reported that patient was diagnosed with cancer stage 3 (ovary cancer) after taking the COVID vaccine booster. She doesn't smoke or drink. She started complaining about stomach pain, she was taken to emergency room, got a CTscan and doctor diagnosed her for it. They removed some fluid from stomach and they did cancer test on fluid and it came up with cancer on the ovaries stage 3. The outcome of the event was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Rash, Rash vesicular
Clinical narrative: Pt called and left voicemail that he had a  painful itchy blistery rash on his left arm. Pt reported this 6 days after injection, unable to reach pt after multiple attempts to try to confirm the exact onset and symptoms.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient presented to the pharmacy requesting her first dose of Shingrix. Prior to receiving the vaccine, the patient completed a consent form where she did not indicate that she had previously received the Shingrix vaccine. The pharmacist then confirmed the written information verbally prior to administering. The vaccine was then administered in her left deltoid and the patient was counseled on potential adverse effects. A few hours after leaving the pharmacy, the patient called to inform the pharmacy staff that she recalled receiving her first dose of Shingrix on 7/18/23.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Vaccination error
Clinical narrative: LPN administered a third dose of Shingrix on July20, 2023 when the patient had already received their second and final dose on April 15, 2022. There was not adequate documentation on April 15, 2022 nurse visit to register with the system that he received the 2nd and final dose. The third dose was given in error.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Asthenia, Blood potassium decreased, COVID-19, Computerised tomogram abdomen abnormal
Clinical narrative: Patient is a 84 y.o. female patient of a MD with history of breast and colon cancer, HTN, neuropathy who presented to a local Medical Center with generalized weakness and COVID-19 .   Covid-19 Virus Infection Date of onset of symptoms: 4 days ago Symptoms present on admission: cough, dyspnea on exertion Date of covid positive test: 7/23/2023 at 1701 Vaccination status: vaccinated Imaging: CTA - bilateral basilar infiltrates, however this was also seen on CT in 2013 Oxygen requirements on admission: None Current oxygen requirements: None Medical therapy: not indicated Consultants following: e-consult to ID for paxlovid Anticipated special isolation end date: evening of 8/2/2023 Discontinued Discontinued paxlovid as patient with hallucinations/paranoia Mentation back to baseline 7/26 Generalized weakness Pt having great difficulty walking over the last week, uses a walker at home Likely exacerbated by COVID-19 infection PT/OT and CM consulted; plan for HH Fall precautions   Ocular irritation Suspect dry eyes No vision impairment Artifical eye drops ordered Suspect this is due to paxlovid paranoia Resolved after discontinuing paxlovid 7/26   Abnormal CT abdomen History of breast and colon cancers Heterogenous enhancement of liver seen on CTA Completed treatment for breast CA in 2008, colon CA in 1992 per daughter Liver MRI without suspicious lesion   Hypokalemia K 3.3 Replaced and will follow   Primary HTN Continue home Dyazide, propranolol  As needed hydralazine ordered
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dry eye, Dyspnoea exertional, Essential hypertension
Clinical narrative: Patient is a 84 y.o. female patient of a MD with history of breast and colon cancer, HTN, neuropathy who presented to a local Medical Center with generalized weakness and COVID-19 .   Covid-19 Virus Infection Date of onset of symptoms: 4 days ago Symptoms present on admission: cough, dyspnea on exertion Date of covid positive test: 7/23/2023 at 1701 Vaccination status: vaccinated Imaging: CTA - bilateral basilar infiltrates, however this was also seen on CT in 2013 Oxygen requirements on admission: None Current oxygen requirements: None Medical therapy: not indicated Consultants following: e-consult to ID for paxlovid Anticipated special isolation end date: evening of 8/2/2023 Discontinued Discontinued paxlovid as patient with hallucinations/paranoia Mentation back to baseline 7/26 Generalized weakness Pt having great difficulty walking over the last week, uses a walker at home Likely exacerbated by COVID-19 infection PT/OT and CM consulted; plan for HH Fall precautions   Ocular irritation Suspect dry eyes No vision impairment Artifical eye drops ordered Suspect this is due to paxlovid paranoia Resolved after discontinuing paxlovid 7/26   Abnormal CT abdomen History of breast and colon cancers Heterogenous enhancement of liver seen on CTA Completed treatment for breast CA in 2008, colon CA in 1992 per daughter Liver MRI without suspicious lesion   Hypokalemia K 3.3 Replaced and will follow   Primary HTN Continue home Dyazide, propranolol  As needed hydralazine ordered
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Gait disturbance, Hepatic angiogram, Hypokalaemia, Lung infiltration
Clinical narrative: Patient is a 84 y.o. female patient of a MD with history of breast and colon cancer, HTN, neuropathy who presented to a local Medical Center with generalized weakness and COVID-19 .   Covid-19 Virus Infection Date of onset of symptoms: 4 days ago Symptoms present on admission: cough, dyspnea on exertion Date of covid positive test: 7/23/2023 at 1701 Vaccination status: vaccinated Imaging: CTA - bilateral basilar infiltrates, however this was also seen on CT in 2013 Oxygen requirements on admission: None Current oxygen requirements: None Medical therapy: not indicated Consultants following: e-consult to ID for paxlovid Anticipated special isolation end date: evening of 8/2/2023 Discontinued Discontinued paxlovid as patient with hallucinations/paranoia Mentation back to baseline 7/26 Generalized weakness Pt having great difficulty walking over the last week, uses a walker at home Likely exacerbated by COVID-19 infection PT/OT and CM consulted; plan for HH Fall precautions   Ocular irritation Suspect dry eyes No vision impairment Artifical eye drops ordered Suspect this is due to paxlovid paranoia Resolved after discontinuing paxlovid 7/26   Abnormal CT abdomen History of breast and colon cancers Heterogenous enhancement of liver seen on CTA Completed treatment for breast CA in 2008, colon CA in 1992 per daughter Liver MRI without suspicious lesion   Hypokalemia K 3.3 Replaced and will follow   Primary HTN Continue home Dyazide, propranolol  As needed hydralazine ordered
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging hepatobiliary, Mental status changes, SARS-CoV-2 test positive, Walking aid user
Clinical narrative: Patient is a 84 y.o. female patient of a MD with history of breast and colon cancer, HTN, neuropathy who presented to a local Medical Center with generalized weakness and COVID-19 .   Covid-19 Virus Infection Date of onset of symptoms: 4 days ago Symptoms present on admission: cough, dyspnea on exertion Date of covid positive test: 7/23/2023 at 1701 Vaccination status: vaccinated Imaging: CTA - bilateral basilar infiltrates, however this was also seen on CT in 2013 Oxygen requirements on admission: None Current oxygen requirements: None Medical therapy: not indicated Consultants following: e-consult to ID for paxlovid Anticipated special isolation end date: evening of 8/2/2023 Discontinued Discontinued paxlovid as patient with hallucinations/paranoia Mentation back to baseline 7/26 Generalized weakness Pt having great difficulty walking over the last week, uses a walker at home Likely exacerbated by COVID-19 infection PT/OT and CM consulted; plan for HH Fall precautions   Ocular irritation Suspect dry eyes No vision impairment Artifical eye drops ordered Suspect this is due to paxlovid paranoia Resolved after discontinuing paxlovid 7/26   Abnormal CT abdomen History of breast and colon cancers Heterogenous enhancement of liver seen on CTA Completed treatment for breast CA in 2008, colon CA in 1992 per daughter Liver MRI without suspicious lesion   Hypokalemia K 3.3 Replaced and will follow   Primary HTN Continue home Dyazide, propranolol  As needed hydralazine ordered
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, COVID-19, COVID-19 pneumonia, Computerised tomogram thorax abnormal
Clinical narrative: Patient is a 44 y.o. female with a history of relapsing-remitting MS on Ocrevus, chronic fatigue on Adderall, hypothyroidism, depression/insomnia, who presented to a HCF on 7/19/23 for worsening shortness of breath, found to be COVID+ with multifocal PNA on CTPA, negative for PE.    1. COVID pneumonia: Test positive 7/19/23, symptom worsening 3-4 days prior to admit, though subacute cough for the month prior. CT chest with multifocal pneumonia. Normal WBC. Immunosuppressed while on Ocrevus (anti-CD20) for MS. Stable on room air during admission. Received remdesivir x 3d. Deferred antibiotics without clear signs of bacterial pneumonia. ID consulted. Dr. not convinced that Sx are 100% related to . ID consulted. Dr. not convinced that Sx are 100% related to COVID. Respiratory PCR panel neg. Blastomyces, Cryptococcus, histoplasma, coccidioides pending on dc. Covid-19 cycle threshold with elevated viral load. Transitioned to paxlovid 7/22/23 x 5d. Patient will be called if any other serologies come back positive. 2. Subacute cough, fevers: Per patient, ongoing for 1 month, started after she came back from a trip end of 6/2023. Immunosuppressed. Doubt COVID caused the original symptoms with multiple negative home tests. Crypto neg. Coccidioides, Histo, blasto pending. ID consulted as above. Symptomatic care. 3. RUE DVT: extravasation of IV into right arm with pain and swelling. RUE duplex + DVT 7/22/23. Eliquis x 3mo per PVC. Entire 3mo script given on dc, as were coupons. 4. Hypokalemia: POA. Replaced and monitored 5. Chronic fatigue: Due to MS, worsened by infection. Continued home Adderall, though patient only takes PRN. 6. Urinary retention: Prescribed Flomax, no longer uses. Thought possible adverse effect to scopolamine patch previously. 7. Hypothyroidism: Continued home thyroid supplement.  8. Depression with insomnia: Continued home Wellbutrin, Ambien.  9. Obesity: BMI 39. Weight loss upon discharge as able..
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Cryptococcus test, Deep vein thrombosis, Depression
Clinical narrative: Patient is a 44 y.o. female with a history of relapsing-remitting MS on Ocrevus, chronic fatigue on Adderall, hypothyroidism, depression/insomnia, who presented to a HCF on 7/19/23 for worsening shortness of breath, found to be COVID+ with multifocal PNA on CTPA, negative for PE.    1. COVID pneumonia: Test positive 7/19/23, symptom worsening 3-4 days prior to admit, though subacute cough for the month prior. CT chest with multifocal pneumonia. Normal WBC. Immunosuppressed while on Ocrevus (anti-CD20) for MS. Stable on room air during admission. Received remdesivir x 3d. Deferred antibiotics without clear signs of bacterial pneumonia. ID consulted. Dr. not convinced that Sx are 100% related to . ID consulted. Dr. not convinced that Sx are 100% related to COVID. Respiratory PCR panel neg. Blastomyces, Cryptococcus, histoplasma, coccidioides pending on dc. Covid-19 cycle threshold with elevated viral load. Transitioned to paxlovid 7/22/23 x 5d. Patient will be called if any other serologies come back positive. 2. Subacute cough, fevers: Per patient, ongoing for 1 month, started after she came back from a trip end of 6/2023. Immunosuppressed. Doubt COVID caused the original symptoms with multiple negative home tests. Crypto neg. Coccidioides, Histo, blasto pending. ID consulted as above. Symptomatic care. 3. RUE DVT: extravasation of IV into right arm with pain and swelling. RUE duplex + DVT 7/22/23. Eliquis x 3mo per PVC. Entire 3mo script given on dc, as were coupons. 4. Hypokalemia: POA. Replaced and monitored 5. Chronic fatigue: Due to MS, worsened by infection. Continued home Adderall, though patient only takes PRN. 6. Urinary retention: Prescribed Flomax, no longer uses. Thought possible adverse effect to scopolamine patch previously. 7. Hypothyroidism: Continued home thyroid supplement.  8. Depression with insomnia: Continued home Wellbutrin, Ambien.  9. Obesity: BMI 39. Weight loss upon discharge as able..
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hypokalaemia, Hypothyroidism, Infection
Clinical narrative: Patient is a 44 y.o. female with a history of relapsing-remitting MS on Ocrevus, chronic fatigue on Adderall, hypothyroidism, depression/insomnia, who presented to a HCF on 7/19/23 for worsening shortness of breath, found to be COVID+ with multifocal PNA on CTPA, negative for PE.    1. COVID pneumonia: Test positive 7/19/23, symptom worsening 3-4 days prior to admit, though subacute cough for the month prior. CT chest with multifocal pneumonia. Normal WBC. Immunosuppressed while on Ocrevus (anti-CD20) for MS. Stable on room air during admission. Received remdesivir x 3d. Deferred antibiotics without clear signs of bacterial pneumonia. ID consulted. Dr. not convinced that Sx are 100% related to . ID consulted. Dr. not convinced that Sx are 100% related to COVID. Respiratory PCR panel neg. Blastomyces, Cryptococcus, histoplasma, coccidioides pending on dc. Covid-19 cycle threshold with elevated viral load. Transitioned to paxlovid 7/22/23 x 5d. Patient will be called if any other serologies come back positive. 2. Subacute cough, fevers: Per patient, ongoing for 1 month, started after she came back from a trip end of 6/2023. Immunosuppressed. Doubt COVID caused the original symptoms with multiple negative home tests. Crypto neg. Coccidioides, Histo, blasto pending. ID consulted as above. Symptomatic care. 3. RUE DVT: extravasation of IV into right arm with pain and swelling. RUE duplex + DVT 7/22/23. Eliquis x 3mo per PVC. Entire 3mo script given on dc, as were coupons. 4. Hypokalemia: POA. Replaced and monitored 5. Chronic fatigue: Due to MS, worsened by infection. Continued home Adderall, though patient only takes PRN. 6. Urinary retention: Prescribed Flomax, no longer uses. Thought possible adverse effect to scopolamine patch previously. 7. Hypothyroidism: Continued home thyroid supplement.  8. Depression with insomnia: Continued home Wellbutrin, Ambien.  9. Obesity: BMI 39. Weight loss upon discharge as able..
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Obesity, Pyrexia, Respiratory viral panel, SARS-CoV-2 RNA increased
Clinical narrative: Patient is a 44 y.o. female with a history of relapsing-remitting MS on Ocrevus, chronic fatigue on Adderall, hypothyroidism, depression/insomnia, who presented to a HCF on 7/19/23 for worsening shortness of breath, found to be COVID+ with multifocal PNA on CTPA, negative for PE.    1. COVID pneumonia: Test positive 7/19/23, symptom worsening 3-4 days prior to admit, though subacute cough for the month prior. CT chest with multifocal pneumonia. Normal WBC. Immunosuppressed while on Ocrevus (anti-CD20) for MS. Stable on room air during admission. Received remdesivir x 3d. Deferred antibiotics without clear signs of bacterial pneumonia. ID consulted. Dr. not convinced that Sx are 100% related to . ID consulted. Dr. not convinced that Sx are 100% related to COVID. Respiratory PCR panel neg. Blastomyces, Cryptococcus, histoplasma, coccidioides pending on dc. Covid-19 cycle threshold with elevated viral load. Transitioned to paxlovid 7/22/23 x 5d. Patient will be called if any other serologies come back positive. 2. Subacute cough, fevers: Per patient, ongoing for 1 month, started after she came back from a trip end of 6/2023. Immunosuppressed. Doubt COVID caused the original symptoms with multiple negative home tests. Crypto neg. Coccidioides, Histo, blasto pending. ID consulted as above. Symptomatic care. 3. RUE DVT: extravasation of IV into right arm with pain and swelling. RUE duplex + DVT 7/22/23. Eliquis x 3mo per PVC. Entire 3mo script given on dc, as were coupons. 4. Hypokalemia: POA. Replaced and monitored 5. Chronic fatigue: Due to MS, worsened by infection. Continued home Adderall, though patient only takes PRN. 6. Urinary retention: Prescribed Flomax, no longer uses. Thought possible adverse effect to scopolamine patch previously. 7. Hypothyroidism: Continued home thyroid supplement.  8. Depression with insomnia: Continued home Wellbutrin, Ambien.  9. Obesity: BMI 39. Weight loss upon discharge as able..
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Serology test, Ultrasound Doppler abnormal, Urinary retention, Vascular access site extravasation
Clinical narrative: Patient is a 44 y.o. female with a history of relapsing-remitting MS on Ocrevus, chronic fatigue on Adderall, hypothyroidism, depression/insomnia, who presented to a HCF on 7/19/23 for worsening shortness of breath, found to be COVID+ with multifocal PNA on CTPA, negative for PE.    1. COVID pneumonia: Test positive 7/19/23, symptom worsening 3-4 days prior to admit, though subacute cough for the month prior. CT chest with multifocal pneumonia. Normal WBC. Immunosuppressed while on Ocrevus (anti-CD20) for MS. Stable on room air during admission. Received remdesivir x 3d. Deferred antibiotics without clear signs of bacterial pneumonia. ID consulted. Dr. not convinced that Sx are 100% related to . ID consulted. Dr. not convinced that Sx are 100% related to COVID. Respiratory PCR panel neg. Blastomyces, Cryptococcus, histoplasma, coccidioides pending on dc. Covid-19 cycle threshold with elevated viral load. Transitioned to paxlovid 7/22/23 x 5d. Patient will be called if any other serologies come back positive. 2. Subacute cough, fevers: Per patient, ongoing for 1 month, started after she came back from a trip end of 6/2023. Immunosuppressed. Doubt COVID caused the original symptoms with multiple negative home tests. Crypto neg. Coccidioides, Histo, blasto pending. ID consulted as above. Symptomatic care. 3. RUE DVT: extravasation of IV into right arm with pain and swelling. RUE duplex + DVT 7/22/23. Eliquis x 3mo per PVC. Entire 3mo script given on dc, as were coupons. 4. Hypokalemia: POA. Replaced and monitored 5. Chronic fatigue: Due to MS, worsened by infection. Continued home Adderall, though patient only takes PRN. 6. Urinary retention: Prescribed Flomax, no longer uses. Thought possible adverse effect to scopolamine patch previously. 7. Hypothyroidism: Continued home thyroid supplement.  8. Depression with insomnia: Continued home Wellbutrin, Ambien.  9. Obesity: BMI 39. Weight loss upon discharge as able..
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vascular access site pain, Vascular access site swelling, White blood cell count normal
Clinical narrative: Patient is a 44 y.o. female with a history of relapsing-remitting MS on Ocrevus, chronic fatigue on Adderall, hypothyroidism, depression/insomnia, who presented to a HCF on 7/19/23 for worsening shortness of breath, found to be COVID+ with multifocal PNA on CTPA, negative for PE.    1. COVID pneumonia: Test positive 7/19/23, symptom worsening 3-4 days prior to admit, though subacute cough for the month prior. CT chest with multifocal pneumonia. Normal WBC. Immunosuppressed while on Ocrevus (anti-CD20) for MS. Stable on room air during admission. Received remdesivir x 3d. Deferred antibiotics without clear signs of bacterial pneumonia. ID consulted. Dr. not convinced that Sx are 100% related to . ID consulted. Dr. not convinced that Sx are 100% related to COVID. Respiratory PCR panel neg. Blastomyces, Cryptococcus, histoplasma, coccidioides pending on dc. Covid-19 cycle threshold with elevated viral load. Transitioned to paxlovid 7/22/23 x 5d. Patient will be called if any other serologies come back positive. 2. Subacute cough, fevers: Per patient, ongoing for 1 month, started after she came back from a trip end of 6/2023. Immunosuppressed. Doubt COVID caused the original symptoms with multiple negative home tests. Crypto neg. Coccidioides, Histo, blasto pending. ID consulted as above. Symptomatic care. 3. RUE DVT: extravasation of IV into right arm with pain and swelling. RUE duplex + DVT 7/22/23. Eliquis x 3mo per PVC. Entire 3mo script given on dc, as were coupons. 4. Hypokalemia: POA. Replaced and monitored 5. Chronic fatigue: Due to MS, worsened by infection. Continued home Adderall, though patient only takes PRN. 6. Urinary retention: Prescribed Flomax, no longer uses. Thought possible adverse effect to scopolamine patch previously. 7. Hypothyroidism: Continued home thyroid supplement.  8. Depression with insomnia: Continued home Wellbutrin, Ambien.  9. Obesity: BMI 39. Weight loss upon discharge as able..