chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022; Patient administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial was initially stored in refrigerator on 17 Feb 2022 10:00 am. The vials did not undergo any temperature excursions. It was reported that no patients have come out with adverse events.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up information included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This spontaneous case was reported by a health care professional and describes the occurrence of TINNITUS (tinnitus) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient had not received any booster dose because of the event.  Treatment details were not reported by the reporter.   This case was linked to MOD-2021-009055 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Significant reduction in dysautonomia symptoms within days of the administration of a Moderna COVID-19 booster; This spontaneous case was reported by an other health care professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Significant reduction in dysautonomia symptoms within days of the administration of a Moderna COVID-19 booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dysautonomia.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Significant reduction in dysautonomia symptoms within days of the administration of a Moderna COVID-19 booster). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Significant reduction in dysautonomia symptoms within days of the administration of a Moderna COVID-19 booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   The patient took booster shot.  The patient experienced a clinically significant reduction in dysautonomia symptoms within days of the administration of Moderna COVID-19 booster shot on 03-Dec-2021. Unfortunately, the positive effects had begun to wear off. Patient was able to track and to actively participate in conversations during family's Christmas celebration. This was the first time since early 2015 that patient experienced a family gathering without fatigue, pain, or brain fog. But within the past 7 to 10 days, symptoms have resumed at the pre-booster frequency and intensity. Driving, walking the dog, and reading academic articles was a challenge once again. The patient was curious if the diminished benefit was related to the diminished efficacy of the booster or some other process.  No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022; 25 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Initially the vial was stored on the refrigerator on 17-Feb-2022. The vial did not undergo any temperature excursion. It was reported by the reporter that the vials likely did not maintain the activity necessary to fully protect against the SARSCoV-2 (COVID-19) virus at time of administration. No adverse events were reported by the patient.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: No new information added
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022; 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 and doses were administered 30 day use by date or after manufacturer date of expiry. The vials did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains no new information.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022; 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 and doses were administered 30 day use by date or after manufacturer date of expiry. The vials did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains no new information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: after her second shot, 24 hours later she had a lot of pain, felt like someone started beating on her; first dose on 5Feb2021, second dose on 15March2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (after her second shot, 24 hours later she had a lot of pain, felt like someone started beating on her) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 5Feb2021, second dose on 15March2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 041L20A) for COVID-19 vaccination.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 5Feb2021, second dose on 15March2021). On 16-Mar-2021, the patient experienced PAIN (after her second shot, 24 hours later she had a lot of pain, felt like someone started beating on her). At the time of the report, PAIN (after her second shot, 24 hours later she had a lot of pain, felt like someone started beating on her) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 5Feb2021, second dose on 15March2021) outcome was unknown.            No Medical History information was reported. Treatment information was reported as unknown.   This case was linked to MOD-2022-538477 (Patient Link).   Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was first punctured on 08-Apr-2022 and administered on 11-Apr-2022. The vial was stored in refrigerator post puncture.; Administer a vaccine after 12 hours of first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer a vaccine after 12 hours of first puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 08-Apr-2022 and administered on 11-Apr-2022. The vial was stored in refrigerator post puncture.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002m21a, 030b21a and 042b21a) for COVID-19 vaccination.     The patient allergies (medications, food and other products) was reported as unknown. The patient never had COVID positive test or diagnosed.  Concurrent medical conditions included Chronic kidney disease (Recent change in status such as improvement or worsening was unknown.).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022 at 1:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer a vaccine after 12 hours of first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 08-Apr-2022 and administered on 11-Apr-2022. The vial was stored in refrigerator post puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer a vaccine after 12 hours of first puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 08-Apr-2022 and administered on 11-Apr-2022. The vial was stored in refrigerator post puncture.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The vaccine was first punctured on 08-Apr-2022 at 9:38AM. The vial was stored in refrigerator post puncture.  It was reported that 8 minutes total the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F). The vial was not exposed to room temperature for >24 hours. The vial did not undergo any temperature excursions. Adverse event cause patient to seek medical care (office visit, Urgent care, ER, hospitalized) was reported as unknown.  No treatment medication was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: broke out in hives really bad; very bad pain in her arm for 5 or 6 days; itchy/ itching in all her body; arm swelling/each day got swollen; being really hot; each day got redder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy/ itching in all her body), PERIPHERAL SWELLING (arm swelling/each day got swollen), FEELING HOT (being really hot), ERYTHEMA (each day got redder) and URTICARIA (broke out in hives really bad) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 003j21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (positive and very bad) in November 2021, Epstein-Barr virus infection and Fibromyalgia. Concurrent medical conditions included Drug allergy (some medicines bother) and Milk allergy (milk constipate). Concomitant products included LISINOPRIL and METOPROLOL for an unknown indication.    On 01-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced PRURITUS (itchy/ itching in all her body), PERIPHERAL SWELLING (arm swelling/each day got swollen), FEELING HOT (being really hot) and ERYTHEMA (each day got redder). On an unknown date, the patient experienced URTICARIA (broke out in hives really bad) and PAIN IN EXTREMITY (very bad pain in her arm for 5 or 6 days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy/ itching in all her body) and URTICARIA (broke out in hives really bad) had not resolved, PERIPHERAL SWELLING (arm swelling/each day got swollen), FEELING HOT (being really hot) and ERYTHEMA (each day got redder) outcome was unknown and PAIN IN EXTREMITY (very bad pain in her arm for 5 or 6 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive, very bad.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient went to urgent care for hives, quitted steroids then for every 5 hours patient got hives.  Patient had bad pain in arm for 5 or 6 days.  Patient used prednisone and made itchiness, so patient started Benadryl. It was reported that the Benadryl runs out and then the hives came back.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: broke out in hives really bad; very bad pain in her arm for 5 or 6 days; itchy/ itching in all her body; arm swelling/each day got swollen; being really hot; each day got redder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy/ itching in all her body), PERIPHERAL SWELLING (arm swelling/each day got swollen), FEELING HOT (being really hot), ERYTHEMA (each day got redder) and URTICARIA (broke out in hives really bad) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 003j21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (positive and very bad) in November 2021, Epstein-Barr virus infection and Fibromyalgia. Concurrent medical conditions included Drug allergy (some medicines bother) and Milk allergy (milk constipate). Concomitant products included LISINOPRIL and METOPROLOL for an unknown indication.    On 01-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced PRURITUS (itchy/ itching in all her body), PERIPHERAL SWELLING (arm swelling/each day got swollen), FEELING HOT (being really hot) and ERYTHEMA (each day got redder). On an unknown date, the patient experienced URTICARIA (broke out in hives really bad) and PAIN IN EXTREMITY (very bad pain in her arm for 5 or 6 days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy/ itching in all her body) and URTICARIA (broke out in hives really bad) had not resolved, PERIPHERAL SWELLING (arm swelling/each day got swollen), FEELING HOT (being really hot) and ERYTHEMA (each day got redder) outcome was unknown and PAIN IN EXTREMITY (very bad pain in her arm for 5 or 6 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive, very bad.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient went to urgent care for hives, quitted steroids then for every 5 hours patient got hives.  Patient had bad pain in arm for 5 or 6 days.  Patient used prednisone and made itchiness, so patient started Benadryl. It was reported that the Benadryl runs out and then the hives came back.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 17 FEB 2022 and administered on 06  APR 2022; 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 17 FEB 2022 and administered on 06  APR 2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 17 FEB 2022 and administered on 06  APR 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 17 FEB 2022 and administered on 06  APR 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. No patients had come out with adverse events. Vial was stored in refrigerator on 17-Feb-2022 10:00 am and did not undergo temperature excursion. It was reported that the vaccine administered on 05-Apr-2022, 06-Apr-2022 and 07-Apr-2022 from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARSCoV- 2 (COVID-19) virus at time of administration. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received contains non significant information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 and doses were administered 30 day use by date or after manufacturer date of expiry. The vials did not undergo any temperature excursions. Treatment details were not reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains no new information.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.; 21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Vial was stored in refrigerator on 17-Feb-2022 at 10.00 am. The vial did not undergo any temperature excursion. The analysis of the vials associated with storage excursion was completed and it was reported that the vaccine administered on 05-Apr-2022, 06-Apr-2022 and 07-Apr-2022, from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  No adverse events were reported.  No treatment medications were provided.   This case was linked to MOD-2022-536013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received included event verbatim updated.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Pain in extremity
Clinical narrative: had a bad reaction and it went on for 3 weeks; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a bad reaction and it went on for 3 weeks) and PAIN IN EXTREMITY (Sore arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 012M20A and 011L210A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced VACCINATION COMPLICATION (had a bad reaction and it went on for 3 weeks) and PAIN IN EXTREMITY (Sore arm). On 18-Oct-2021, VACCINATION COMPLICATION (had a bad reaction and it went on for 3 weeks) and PAIN IN EXTREMITY (Sore arm) had resolved.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2022-538193 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Influenza like illness, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: had a bad reaction and it went on for 3 weeks; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a bad reaction and it went on for 3 weeks) and PAIN IN EXTREMITY (Sore arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 012M20A and 011L210A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced VACCINATION COMPLICATION (had a bad reaction and it went on for 3 weeks) and PAIN IN EXTREMITY (Sore arm). On 18-Oct-2021, VACCINATION COMPLICATION (had a bad reaction and it went on for 3 weeks) and PAIN IN EXTREMITY (Sore arm) had resolved.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2022-538193 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Pain in extremity
Clinical narrative: Sore Neck  after 2nd booster; Swelled up from left Ear to left Shoulder  after 2nd booster/Entire left arm swelled up after 2nd booster; Like I had a flu after 2nd booster; Red entire left arm  after 2nd booster; Sore Arm  after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore Neck  after 2nd booster), PERIPHERAL SWELLING (Swelled up from left Ear to left Shoulder  after 2nd booster/Entire left arm swelled up after 2nd booster), INFLUENZA LIKE ILLNESS (Like I had a flu after 2nd booster), ERYTHEMA (Red entire left arm  after 2nd booster) and PAIN IN EXTREMITY (Sore Arm  after 2nd booster) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M21A, 014F21A, 012M20A and 011L210A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced NECK PAIN (Sore Neck  after 2nd booster), PERIPHERAL SWELLING (Swelled up from left Ear to left Shoulder  after 2nd booster/Entire left arm swelled up after 2nd booster), INFLUENZA LIKE ILLNESS (Like I had a flu after 2nd booster), ERYTHEMA (Red entire left arm  after 2nd booster) and PAIN IN EXTREMITY (Sore Arm  after 2nd booster). On 10-Apr-2022, PERIPHERAL SWELLING (Swelled up from left Ear to left Shoulder  after 2nd booster/Entire left arm swelled up after 2nd booster), INFLUENZA LIKE ILLNESS (Like I had a flu after 2nd booster) and ERYTHEMA (Red entire left arm  after 2nd booster) had resolved. At the time of the report, NECK PAIN (Sore Neck  after 2nd booster) and PAIN IN EXTREMITY (Sore Arm  after 2nd booster) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not taken.   This case was linked to MOD-2022-538188 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Influenza like illness, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Sore Neck  after 2nd booster; Swelled up from left Ear to left Shoulder  after 2nd booster/Entire left arm swelled up after 2nd booster; Like I had a flu after 2nd booster; Red entire left arm  after 2nd booster; Sore Arm  after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore Neck  after 2nd booster), PERIPHERAL SWELLING (Swelled up from left Ear to left Shoulder  after 2nd booster/Entire left arm swelled up after 2nd booster), INFLUENZA LIKE ILLNESS (Like I had a flu after 2nd booster), ERYTHEMA (Red entire left arm  after 2nd booster) and PAIN IN EXTREMITY (Sore Arm  after 2nd booster) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M21A, 014F21A, 012M20A and 011L210A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced NECK PAIN (Sore Neck  after 2nd booster), PERIPHERAL SWELLING (Swelled up from left Ear to left Shoulder  after 2nd booster/Entire left arm swelled up after 2nd booster), INFLUENZA LIKE ILLNESS (Like I had a flu after 2nd booster), ERYTHEMA (Red entire left arm  after 2nd booster) and PAIN IN EXTREMITY (Sore Arm  after 2nd booster). On 10-Apr-2022, PERIPHERAL SWELLING (Swelled up from left Ear to left Shoulder  after 2nd booster/Entire left arm swelled up after 2nd booster), INFLUENZA LIKE ILLNESS (Like I had a flu after 2nd booster) and ERYTHEMA (Red entire left arm  after 2nd booster) had resolved. At the time of the report, NECK PAIN (Sore Neck  after 2nd booster) and PAIN IN EXTREMITY (Sore Arm  after 2nd booster) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not taken.   This case was linked to MOD-2022-538188 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022; 21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the vials were initially stored in the refrigerator on 17 Feb 2022 at 10 a.m.  It was reported that the vials had not undergone any temperature excursions.  It was reported that no patients had come out with adverse events.  vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received contains non significant information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022 , expired on 01-Apr-2022 and administered on 07-Apr-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 07-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. The vial was initially stored in refrigerator on 17 Feb 2022 10:00 am. The vials did not undergo any temperature excursions. It was reported that no patients have come out with adverse events. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Non Significant Follow up received analysis updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022; 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on  17-Feb-2022. The vial did not undergo any temperature excursions.  It was reported that no patients had come out with adverse events.  vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Non Significant Follow up appended
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 08-Apr-2022; 21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 08-Apr-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No adverse events were reported.  Vial was stored in refrigerator on 17-Feb-2022 at 10.00 am.  The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-536013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received includes no new information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 17-Feb-2022, expired on 01-Apr-2022 before the date of administration on 08-Apr-2022; Patient administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Feb-2022, expired on 01-Apr-2022 before the date of administration on 08-Apr-2022) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Feb-2022, expired on 01-Apr-2022 before the date of administration on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Feb-2022, expired on 01-Apr-2022 before the date of administration on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. It was reported that the 21 doses or vials were initially stored in refrigerator on 17-Feb-2022 at 10:00 am. The 21 patients had administered with expired vaccines and no patients had come out with adverse events. The vials had not undergone any temperature excursions. It was also reported that the 25 patient identifiers were updated for safety. Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received includes no significant information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 17 Feb 2022 and administerd on 08 Apr 2022 (BUD 30 days); 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17 Feb 2022 and administerd on 08 Apr 2022 (BUD 30 days)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17 Feb 2022 and administerd on 08 Apr 2022 (BUD 30 days)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17 Feb 2022 and administerd on 08 Apr 2022 (BUD 30 days)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expiry date of vaccine: 01 Apr 2022. Date the vial was initially stored in refrigerator is 17Feb2022, 10:00am. The vial didn't undergone any temperature excursions. No Concomitant Medications were provided by the Reporter. No Treatment Medications were provided by the Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received contains non significant information.