chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Sinus node dysfunction
Clinical narrative: The diagnosis was sick sinus syndrome; This spontaneous case was reported by a patient and describes the occurrence of SINUS NODE DYSFUNCTION (The diagnosis was sick sinus syndrome) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 013L20A and 012L20A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS NODE DYSFUNCTION (The diagnosis was sick sinus syndrome) (seriousness criterion medically significant). At the time of the report, SINUS NODE DYSFUNCTION (The diagnosis was sick sinus syndrome) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Heart rate: 54. On 08-Mar-2021, Heart rate: dropped to 43.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  On 14Jan2021, she had the first dose of Moderna vaccine. Four days later on 18Jan2021, her heart rate was 54, which is very normal for her, at her doctor's office. On 8Feb2021, she got the second dose of Moderna. One month later on 8Mar2021, she went back to her doctor, and the heart rate dropped to 43. She had to wear a halter monitor, and her heart rate would drop to 30 at certain times of the day. Then on 21May2021 she got a pacemaker. The diagnosis was sick sinus syndrome. She is not saying that the Moderna vaccine caused this. She is reporting that all of this happened within a very tight window.  Company comment: This spontaneous case concerns an adult female patient with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of sinus node dysfunction (sick sinus syndrome). The event occurred approximately 1-3 months after the second dose of mRNA-1273. As reported, one month after 2nd dose of mRNA-1273, patient went back to her doctor, and the heart rate dropped to 43 (previously 54 after 1st dose of Moderna vaccine, described as normal for the patient). Patient had to wear a halter monitor, and her heart rate would drop to 30 at certain times of the day. Reportedly, 3.5 months after 2nd dose patient got a pacemaker. The diagnosis was sick sinus syndrome. The patient is not associating Moderna vaccine as the cause but reporting that all of mentioned happened in a very tight window. The patient received booster dose 6 months after pacemaker insertion. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator Lot 071B22A on 5-APR-2023, vial was expired on 12-MAR-2023 and administered to the patient on 06-APR-2023; No adverse event; Patient was administered a dose on 06-APR-2023 from the Moderna lot 071B22A which had expired on 12-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose on 06-APR-2023 from the Moderna lot 071B22A which had expired on 12-MAR-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator Lot 071B22A on 5-APR-2023, vial was expired on 12-MAR-2023 and administered to the patient on 06-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 06-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose on 06-APR-2023 from the Moderna lot 071B22A which had expired on 12-MAR-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator Lot 071B22A on 5-APR-2023, vial was expired on 12-MAR-2023 and administered to the patient on 06-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose on 06-APR-2023 from the Moderna lot 071B22A which had expired on 12-MAR-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator Lot 071B22A on 5-APR-2023, vial was expired on 12-MAR-2023 and administered to the patient on 06-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose on 06-APR-2023 from the Moderna lot 071B22A which had expired on 12-MAR-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator Lot 071B22A on 5-APR-2023, vial was expired on 12-MAR-2023 and administered to the patient on 06-APR-2023).    No concomitant medications were reported.  HCP stated that when they had received the Moderna monovalent vaccine, the expiration date stated 31-Dec-2069 and they did not realize that they had to check for the manufacturer expiration date.  The vial was initially stored in the refrigerator on 5-Apr-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2023: Non Significant follow up appended contains no new information
Age: 59.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Health Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Health Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023) and NO ADVERSE EVENT (No adverse event) in a 59-year-old 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. 065H22A) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 07-Apr-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 07-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Health Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Health Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023) 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 (Health Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023).    No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live follow up received included non-significant information- patient name updated.
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure fluctuation
Clinical narrative: her sister had blood pressure issues as well after receiving the COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLOOD PRESSURE FLUCTUATION (her sister had blood pressure issues as well after receiving the COVID-19 vaccine) in an adult female patient 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 BLOOD PRESSURE FLUCTUATION (her sister had blood pressure issues as well after receiving the COVID-19 vaccine). At the time of the report, BLOOD PRESSURE FLUCTUATION (her sister had blood pressure issues as well after receiving the COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior).    No concomitant medication was reported. It was reported that Monovalent vaccine was given as a second dose to two individuals under the age of 18. HCP stated that two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior. The patients had not reported any adverse reactions to this dose. Vial size was reported as 2.5 mL. It was reported that the vial was initially stored in the refrigerator on 21-MAR-2023. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720581 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live follow up received contains nonsignificant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720581:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I got tinnitus right after my 2nd vaccination (Jun 2021) and only in the right ear which was on the same right side as the arm that received the Moderna shot; Note to Case Processing Team: "Specific product able to be determined from information provided, the decision tree was not utilized to determine the product." Note to case processing-In the source document suspect product dosage text is coded as second dose with different administration date . Hence kindly reassess Reported Adverse Event Information: I got tinnitus right after my 2nd vaccination (Jun 2021) and only in the right ear which was on the same right side as the arm that received the Moderna shot. I'd been switching arms for each round of vaccine in the series of 3 that I got. The tinnitus caused my ear to feel stuffy and there was a constant low rushing sound like when you listen to a seashell. It lasted for about 6 months and ultimately went away on its own. During the 6 months I tried all sorts of over-the-counter treatments (wax removal, homeopathic, etc) and saw my PCP, who referred me to an ENT specialist, who referred me to an audiologist. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Is Moderna authorized to communicate with the patient's / your healthcare provider? Yes
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; One dose was administered on 4/5/23 and was placed in the refrigerator storage on 3/31/23. / doses were administered after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One dose was administered on 4/5/23 and was placed in the refrigerator storage on 3/31/23. / doses were administered after the expiration date.) 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)) (batch no. 047C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-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-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (One dose was administered on 4/5/23 and was placed in the refrigerator storage on 3/31/23. / doses were administered after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One dose was administered on 4/5/23 and was placed in the refrigerator storage on 3/31/23. / doses were administered after the expiration date.) 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 (One dose was administered on 4/5/23 and was placed in the refrigerator storage on 3/31/23. / doses were administered after the expiration date.).    No concomitant medication details was reported. The vial was initially stored in the refrigerator on 31-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720850:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose was administered after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered after the expiration date.) 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)) (batch no. 047C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Mar-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 29-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered after the expiration date.) 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 (Dose was administered after the expiration date.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The manufacture date was 24-Mar-2023. The unknown vial was initially stored in the refrigerator 07-Mar-2023 and did not underwent any temperature excursions. All three vials remained in the correct refrigerated storage until administration with no temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720851, US-MODERNATX, INC.-MOD-2023-720845 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720851: US-MODERNATX, INC.-MOD-2023-720845:
Age: 63.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Bivalent vaccine that was past it's use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) and NO ADVERSE EVENT (No adverse event) in a 63-year-old 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. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-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 13-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) outcome was unknown and NO ADVERSE EVENT (No adverse event) had not resolved.        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 (Patient received Moderna Bivalent vaccine that was past it's use by date).    Concomitant medications were not reported.  It was reported that patient had received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live follow up received. Patient name was added.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was adminstered past 30 day thawing date Vaccine expired on 14-Apr-2023  and was used for vaccination on 20-Apr-23; No adverse event; Patient was administered vaccine past in 30 day thawing date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past in 30 day thawing date), PRODUCT STORAGE ERROR (Vaccine was adminstered past 30 day thawing date Vaccine expired on 14-Apr-2023  and was used for vaccination on 20-Apr-23) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-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 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past in 30 day thawing date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was adminstered past 30 day thawing date Vaccine expired on 14-Apr-2023  and was used for vaccination on 20-Apr-23) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past in 30 day thawing date), PRODUCT STORAGE ERROR (Vaccine was adminstered past 30 day thawing date Vaccine expired on 14-Apr-2023  and was used for vaccination on 20-Apr-23) 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 EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past in 30 day thawing date) and PRODUCT STORAGE ERROR (Vaccine was adminstered past 30 day thawing date Vaccine expired on 14-Apr-2023  and was used for vaccination on 20-Apr-23).    No concomitant medications were reported.  No treatment information was provided.
Age: 58.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Bivalent vaccine that was past it's use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) and NO ADVERSE EVENT (No adverse event) in a 58-year-old 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. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Mar-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 30-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) had not resolved 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 (Patient received Moderna Bivalent vaccine that was past it's use by date).    No Concomitant medication was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live non significant follow up- patient name update
Age: 45.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was moved from freezer to refrigerator on 27-Feb-2023 with BUD as 29-Mar-2023 was administered to patient after 29-Mar-2023; No adverse event; Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 27-Feb-2023 with BUD as 29-Mar-2023 was administered to patient after 29-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 45-year-old 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. 065H22A) for COVID-19 prophylaxis.     It was reported that there were no information about previous COVID-19 vaccination doses.     On 07-Apr-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 07-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 27-Feb-2023 with BUD as 29-Mar-2023 was administered to patient after 29-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 27-Feb-2023 with BUD as 29-Mar-2023 was administered to patient after 29-Mar-2023) 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 EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023) and PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 27-Feb-2023 with BUD as 29-Mar-2023 was administered to patient after 29-Mar-2023).    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that the Moderna 6 years plus booster vaccine was administered past its use by date of 29-Mar-2023.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live follow up received, updated patient's name, vaccine expiry date, vial storage condition and event product storage error was added.
Age: 44.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Moderna Bivalent vaccine that was past it's use by date of 29-Mar-2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of 29-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 44-year-old 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. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-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 13-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of 29-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of 29-Mar-2023) 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 (Patient received Moderna Bivalent vaccine that was past it's use by date of 29-Mar-2023).    Concomitant products were not reported.  It was reported that  Adverse Event reported by a Nurse with the Department of Health Patient received Moderna Bivalent vaccine that was past it's use by date of 29-Mar-2023.   Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live non significant follow up- patient name updated.
Age: 44.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023) and NO ADVERSE EVENT (No adverse event) in a 44-year-old 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. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Apr-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 18-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023) 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 (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023).    No concomitant product reported by the reporter.  Moderna Bivalent was administered to the patient past it's use by date of 29-Mar-2023.  No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Significant live follow up added. Patient name updated.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Cough, Fatigue, Hypersomnia, Laboratory test normal, Malaise
Clinical narrative: On the night of 2/26/2023, I had a scratchy throat. On 2/27/2023, I continued to have a scratchy throat. I took a home antigen test and got a negative result. On 2/28/2023, I began to have a severe sore throat. I took yet another home antigen test and got another negative result. I then developed a severe migraine. On 3/1/2023, I woke up feeling very sick. I had the sore throat and migraine. I took another home antigen test and got a positive result. I was sick for over two weeks. I also had severe fatigue and spent a lot of time sleeping. I began to feel better on 3/4/2023. I was still extremely tired at this point, though, and I developed a slightly productive cough. I went to the doctor on 3/13/2023. I was given an albuterol inhaler, and I took Mucinex. Within another week or so, I began to feel better. It took a good three weeks before I was back to my old self. The cough persisted until about 3/20/2023.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Migraine, Oropharyngeal pain, Productive cough, Throat irritation
Clinical narrative: On the night of 2/26/2023, I had a scratchy throat. On 2/27/2023, I continued to have a scratchy throat. I took a home antigen test and got a negative result. On 2/28/2023, I began to have a severe sore throat. I took yet another home antigen test and got another negative result. I then developed a severe migraine. On 3/1/2023, I woke up feeling very sick. I had the sore throat and migraine. I took another home antigen test and got a positive result. I was sick for over two weeks. I also had severe fatigue and spent a lot of time sleeping. I began to feel better on 3/4/2023. I was still extremely tired at this point, though, and I developed a slightly productive cough. I went to the doctor on 3/13/2023. I was given an albuterol inhaler, and I took Mucinex. Within another week or so, I began to feel better. It took a good three weeks before I was back to my old self. The cough persisted until about 3/20/2023.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Two months after I received to vaccine I began experiencing ringing in my left ear which is now in both ears.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Dizziness, Hypertension
Clinical narrative: I was lightheaded and my blood pressure was really high, 200/120. It happened on April 10th and 11th, 2023. I went to the emergency department. I was in the emergency department for about 3 hours and was not treated with anything other than rest. My blood pressure came down on its own and I was discharged.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram, Dysgraphia, Feeling abnormal, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: I?m not sure of exact date but shortly after last booster . I wasn?t feeling right and my handwriting was bad .I kept thinking it would get better. I lived with it for awhile until my family noticed I wasn?t getting better . I didn?t want to deal with it during the holidays so waited until Jan 2023. My life has completely changed . I was going to be a traveling surgical tech in July and now I?m not even going to be a tech any more I?m moving near family as soon. I need help  with life things .I was so independent and now I?m not
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Allergy test negative, Blood test normal, COVID-19, Cough, Ear congestion
Clinical narrative: Prior to testing positive for COVID-19, I had had a cough that had persisted for several months. I took a home antigen test on 3/14/2023 and got a negative result. That night, I began to feel bad. I had fatigue, body aches, sore throat, and head congestion. I took a home antigen test on 3/15/2023 and got a positive result. I was prescribed Paxlovid on 3/16/2023. I stayed home and rested and took the medicine. The medication left a bad aftertaste, but I followed the doctor's orders. I steadily got better, and I was fine within a week. I then resumed my normal activities, and I continued to have the pre-existing cough. I saw my PCP about my cough, and I was referred to a pulmonologist, whom I saw on 4/3/2023. She also arranged for me to take a breathing test and prescribed an Advair inhaler, plus an albuterol inhaler to use in emergencies. When I underwent the breathing test, no anomalies were detected. When I saw the pulmonologist, he prescribed me montelukast. The pulmonologist also took me off the Advair inhaler and told me my lungs were clear. He suspected that my cough was caused by sinus issues, such as maybe sinusitis, rhinitis, or a deviated septum. Since I've been taking the montelukast, I have less sinus drainage. I still have a cough, but it's less severe now. I also have an infected upper right molar and am due to undergo a root canal in the near future. I suspect that the infected molar has something to do with the cough and sinus congestion (especially in the ears), but the doctors disagree. I was also put on amoxicillin/clavulanic acid, which is supposed to treat the infected tooth. The pulmonologist ordered blood tests for allergies, and nothing unusual was detected.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Feeling abnormal, Laboratory test normal, Loss of personal independence in daily activities, Oropharyngeal pain
Clinical narrative: Prior to testing positive for COVID-19, I had had a cough that had persisted for several months. I took a home antigen test on 3/14/2023 and got a negative result. That night, I began to feel bad. I had fatigue, body aches, sore throat, and head congestion. I took a home antigen test on 3/15/2023 and got a positive result. I was prescribed Paxlovid on 3/16/2023. I stayed home and rested and took the medicine. The medication left a bad aftertaste, but I followed the doctor's orders. I steadily got better, and I was fine within a week. I then resumed my normal activities, and I continued to have the pre-existing cough. I saw my PCP about my cough, and I was referred to a pulmonologist, whom I saw on 4/3/2023. She also arranged for me to take a breathing test and prescribed an Advair inhaler, plus an albuterol inhaler to use in emergencies. When I underwent the breathing test, no anomalies were detected. When I saw the pulmonologist, he prescribed me montelukast. The pulmonologist also took me off the Advair inhaler and told me my lungs were clear. He suspected that my cough was caused by sinus issues, such as maybe sinusitis, rhinitis, or a deviated septum. Since I've been taking the montelukast, I have less sinus drainage. I still have a cough, but it's less severe now. I also have an infected upper right molar and am due to undergo a root canal in the near future. I suspect that the infected molar has something to do with the cough and sinus congestion (especially in the ears), but the doctors disagree. I was also put on amoxicillin/clavulanic acid, which is supposed to treat the infected tooth. The pulmonologist ordered blood tests for allergies, and nothing unusual was detected.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Paranasal sinus hypersecretion, Respiratory tract congestion, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: Prior to testing positive for COVID-19, I had had a cough that had persisted for several months. I took a home antigen test on 3/14/2023 and got a negative result. That night, I began to feel bad. I had fatigue, body aches, sore throat, and head congestion. I took a home antigen test on 3/15/2023 and got a positive result. I was prescribed Paxlovid on 3/16/2023. I stayed home and rested and took the medicine. The medication left a bad aftertaste, but I followed the doctor's orders. I steadily got better, and I was fine within a week. I then resumed my normal activities, and I continued to have the pre-existing cough. I saw my PCP about my cough, and I was referred to a pulmonologist, whom I saw on 4/3/2023. She also arranged for me to take a breathing test and prescribed an Advair inhaler, plus an albuterol inhaler to use in emergencies. When I underwent the breathing test, no anomalies were detected. When I saw the pulmonologist, he prescribed me montelukast. The pulmonologist also took me off the Advair inhaler and told me my lungs were clear. He suspected that my cough was caused by sinus issues, such as maybe sinusitis, rhinitis, or a deviated septum. Since I've been taking the montelukast, I have less sinus drainage. I still have a cough, but it's less severe now. I also have an infected upper right molar and am due to undergo a root canal in the near future. I suspect that the infected molar has something to do with the cough and sinus congestion (especially in the ears), but the doctors disagree. I was also put on amoxicillin/clavulanic acid, which is supposed to treat the infected tooth. The pulmonologist ordered blood tests for allergies, and nothing unusual was detected.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tooth infection
Clinical narrative: Prior to testing positive for COVID-19, I had had a cough that had persisted for several months. I took a home antigen test on 3/14/2023 and got a negative result. That night, I began to feel bad. I had fatigue, body aches, sore throat, and head congestion. I took a home antigen test on 3/15/2023 and got a positive result. I was prescribed Paxlovid on 3/16/2023. I stayed home and rested and took the medicine. The medication left a bad aftertaste, but I followed the doctor's orders. I steadily got better, and I was fine within a week. I then resumed my normal activities, and I continued to have the pre-existing cough. I saw my PCP about my cough, and I was referred to a pulmonologist, whom I saw on 4/3/2023. She also arranged for me to take a breathing test and prescribed an Advair inhaler, plus an albuterol inhaler to use in emergencies. When I underwent the breathing test, no anomalies were detected. When I saw the pulmonologist, he prescribed me montelukast. The pulmonologist also took me off the Advair inhaler and told me my lungs were clear. He suspected that my cough was caused by sinus issues, such as maybe sinusitis, rhinitis, or a deviated septum. Since I've been taking the montelukast, I have less sinus drainage. I still have a cough, but it's less severe now. I also have an infected upper right molar and am due to undergo a root canal in the near future. I suspect that the infected molar has something to do with the cough and sinus congestion (especially in the ears), but the doctors disagree. I was also put on amoxicillin/clavulanic acid, which is supposed to treat the infected tooth. The pulmonologist ordered blood tests for allergies, and nothing unusual was detected.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Migraine, Rash, Rash pruritic, Skin irritation
Clinical narrative: The evening following the vaccination I began to develop itchy red bumps on my legs and arms. Since then, they have become more irritating and have spread to include most of my upper legs, arms, and hands. I have also developed migraines and weakness.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Herpes zoster, Laboratory test normal
Clinical narrative: Shingles outbreak 3 days after vaccine and 9 days after vaccine developed Bell?s palsy, which has not resolved as of now.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Bursitis, Hypoaesthesia, Impaired driving ability, Injected limb mobility decreased
Clinical narrative: Injection given to high up my arm near my shoulder, had intense pain.  When got home pain worsens and took ibuprofen and used ice pack considered going to ER but thought may subside as just got the injection and that the paperwork said pain at site expected.  So I continued self care rest, ice and ibuprofen at home until my stomach hurt.  However it progressively worsened and I was not able to have full function of my arm had painful range of motion. I could not turn my steering wheel or take off my shirt or fix my hair without pain with numbness and tingling going down my arm.  I called to complain to Clinic as I did not want another person to suffer the consequences that I have and I spoke with someone at clinic to complain and she instructed me to not wait until MD appt 3/6 but get immediate medical attention.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Injection given to high up my arm near my shoulder, had intense pain.  When got home pain worsens and took ibuprofen and used ice pack considered going to ER but thought may subside as just got the injection and that the paperwork said pain at site expected.  So I continued self care rest, ice and ibuprofen at home until my stomach hurt.  However it progressively worsened and I was not able to have full function of my arm had painful range of motion. I could not turn my steering wheel or take off my shirt or fix my hair without pain with numbness and tingling going down my arm.  I called to complain to Clinic as I did not want another person to suffer the consequences that I have and I spoke with someone at clinic to complain and she instructed me to not wait until MD appt 3/6 but get immediate medical attention.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Radicular pain, Radiculopathy, Vaccination complication
Clinical narrative: Injection given to high up my arm near my shoulder, had intense pain.  When got home pain worsens and took ibuprofen and used ice pack considered going to ER but thought may subside as just got the injection and that the paperwork said pain at site expected.  So I continued self care rest, ice and ibuprofen at home until my stomach hurt.  However it progressively worsened and I was not able to have full function of my arm had painful range of motion. I could not turn my steering wheel or take off my shirt or fix my hair without pain with numbness and tingling going down my arm.  I called to complain to Clinic as I did not want another person to suffer the consequences that I have and I spoke with someone at clinic to complain and she instructed me to not wait until MD appt 3/6 but get immediate medical attention.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abnormal loss of weight, Angiopathy, Arthralgia, Blood test
Clinical narrative: A few months after the Pfizer covid vaccine I started losing weight drastically and unintentionally. I developed swollen lymph nodes that aches, inflammation all over body, joint/muscle pain, stomach pain, swelling in my chest, constant tinnitus, left atrial enlargement, vascular issues, numbness, extreme fatigue and more. I have had numerous test and can not receive a diagnosis. I did NOT have ANY of these problems until after the vaccine and I am continuing to feel unwell.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Fatigue
Clinical narrative: A few months after the Pfizer covid vaccine I started losing weight drastically and unintentionally. I developed swollen lymph nodes that aches, inflammation all over body, joint/muscle pain, stomach pain, swelling in my chest, constant tinnitus, left atrial enlargement, vascular issues, numbness, extreme fatigue and more. I have had numerous test and can not receive a diagnosis. I did NOT have ANY of these problems until after the vaccine and I am continuing to feel unwell.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Inflammation, Left atrial enlargement, Lymph node pain
Clinical narrative: A few months after the Pfizer covid vaccine I started losing weight drastically and unintentionally. I developed swollen lymph nodes that aches, inflammation all over body, joint/muscle pain, stomach pain, swelling in my chest, constant tinnitus, left atrial enlargement, vascular issues, numbness, extreme fatigue and more. I have had numerous test and can not receive a diagnosis. I did NOT have ANY of these problems until after the vaccine and I am continuing to feel unwell.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging head, Malaise, Mammogram, Myalgia
Clinical narrative: A few months after the Pfizer covid vaccine I started losing weight drastically and unintentionally. I developed swollen lymph nodes that aches, inflammation all over body, joint/muscle pain, stomach pain, swelling in my chest, constant tinnitus, left atrial enlargement, vascular issues, numbness, extreme fatigue and more. I have had numerous test and can not receive a diagnosis. I did NOT have ANY of these problems until after the vaccine and I am continuing to feel unwell.