chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Lot 083J21A put in the fridge on 07-Feb-2022 and was administered on 06-Apr-2022; Expired dose of Moderna COVID-19 was adminsitered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna COVID-19 was adminsitered beyond the beyond use date) and PRODUCT STORAGE ERROR (Lot 083J21A put in the fridge on 07-Feb-2022 and was administered on 06-Apr-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     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 (Expired dose of Moderna COVID-19 was adminsitered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Lot 083J21A put in the fridge on 07-Feb-2022 and was administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna COVID-19 was adminsitered beyond the beyond use date) and PRODUCT STORAGE ERROR (Lot 083J21A put in the fridge on 07-Feb-2022 and was 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 of the patient was not reported.  The vial did not undergo any temperature excursion.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-584673 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Eye swelling, Orbital swelling, Vertigo, Vision blurred
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of vertigo, orbital swelling (bump under eye), blurred vision (sees blurry with the other eye), eye swelling (another bump in the eye) and blister (blisters popped under arms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 017B21A) for COVID-19 immunization. No medical history reported. On Mar 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced vertigo, orbital swelling (bump under eye), blurred vision (sees blurry with the other eye), eye swelling (another bump in the eye) and blister (blisters popped under arms). At the time of the report, vertigo, orbital swelling (bump under eye), blurred vision (sees blurry with the other eye), eye swelling (another bump in the eye) and blister (blisters popped under arms): not resolved. The reporter did not provide any causality assessments or concomitant medication. Treatment medication included unknown antibiotics. This case linked to MOD-2022-585296 (patient link).
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022; Expired doses of Moderna COVID-19 were administered beyond the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-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 by reporter.  Patient took booster dose of Moderna and took total 3 doses.Patient received vaccine on 07 Feb 2022. Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion.  No treatment medication was reported by reporter.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (administered expired dose) and product storage error (vial refrigerated Feb 7, 2022; administered Mar 29, 2022) in a 24-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 083J21A) for COVID-19 immunization. No medical history reported. On Mar 29, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 29, 2022, patient administered expired product (administered expired dose). On an unknown date, patient experienced product storage error (vial refrigerated Feb 7, 2022; administered Mar 29, 2022). At the time of the report, administered expired product (administered expired dose) and product storage error (vial refrigerated Feb 7, 2022; administered Mar 29, 2022) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Vial initially stored in refrigerator Feb 7, 2022, did not undergo any temperature excursions. This case linked to MOD-2022-584679 (patient link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 102 doses were given from LOT 026C21A. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non significant follow up. No new clinically significant information received.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received two primary doses of the Moderna covid19 vaccine, and is immunocompromised, and he did not got the third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received two primary doses of the Moderna covid19 vaccine, and is immunocompromised, and he did not got the third dose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received two primary doses of the Moderna covid19 vaccine, and is immunocompromised, and he did not got the third dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received two primary doses of the Moderna covid19 vaccine, and is immunocompromised, and he did not got the third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. The patient had no allergies and medical history related to AE, acute and chronic illnesses at the time of vaccination..  The patient choose to get the booster and now he wants to get the third dose.  No treatment medication was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no allergies. Patient was neither diagnosed nor tested positive for COVID.  The patient's past medical history included Coronary arterial stent insertion. Concurrent medical conditions included Blood pressure high and COPD.   On 07-Jun-2022 at 4:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2022 at 3:00 AM, the patient experienced CHILLS (Chills). The patient was treated with IBUPROFEN on 08-Jun-2022 for Chills, at a dose of 800 mg 1 tab. At the time of the report, CHILLS (Chills) had not resolved.      No concomitant medications were reported. It was reported that, the patient received his 1st dose of COVID 19 vaccine on Feb 2021, 2nd dose on Mar 2021, 1st booster dose on unknown date from unknown manufacturer. On the day of reporting, early morning 08 Jun-2022 at around 03am patient woke up with chills. the patient wanted to know if chills was a reaction to the booster dose.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of illness (really sick from the second) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19) for immunization. No medical history reported. On Mar 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 1, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (really sick from the second). At the time of the report, illness (really sick from the second) outcome: unknown.  No concomitant medication or treatment information provided. This case linked to MOD-2022-585451 (patient link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Illness, Mammogram, Nausea
Clinical narrative: Really sick from the second and booster.Even sicker from the booster; She had 102 fever, chills, aches, and nausea.; She had 102 fever, chills, aches, and nausea.; She had 102 fever, chills, aches, and nausea.; She had 102 fever, chills, aches, and nausea.; She ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine).; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Really sick from the second and booster.Even sicker from the booster), PAIN (She had 102 fever, chills, aches, and nausea.), PYREXIA (She had 102 fever, chills, aches, and nausea.), CHILLS (She had 102 fever, chills, aches, and nausea.) and NAUSEA (She had 102 fever, chills, aches, and nausea.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Flu vaccine. Past adverse reactions to the above products included Adverse drug reaction with Flu vaccine.    On 30-Oct-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 ILLNESS (Really sick from the second and booster.Even sicker from the booster), PAIN (She had 102 fever, chills, aches, and nausea.), PYREXIA (She had 102 fever, chills, aches, and nausea.), CHILLS (She had 102 fever, chills, aches, and nausea.), NAUSEA (She had 102 fever, chills, aches, and nausea.) and VACCINATION SITE LYMPHADENOPATHY (She ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine).). At the time of the report, ILLNESS (Really sick from the second and booster.Even sicker from the booster), PAIN (She had 102 fever, chills, aches, and nausea.), PYREXIA (She had 102 fever, chills, aches, and nausea.), CHILLS (She had 102 fever, chills, aches, and nausea.), NAUSEA (She had 102 fever, chills, aches, and nausea.) and VACCINATION SITE LYMPHADENOPATHY (She ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine).) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 fever (High) 102 fever. On an unknown date, Mammogram: the lymph node was swollen Ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine)..         It was reported that previously patient had received flu and pneumonia vaccine and got the similar events. Patient had never tested for Covid-19. No concomitant medication information was provided. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient states she powered through her symptoms. She didn't take any medications.   This case was linked to MOD-2022-585442 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site lymphadenopathy
Clinical narrative: Really sick from the second and booster.Even sicker from the booster; She had 102 fever, chills, aches, and nausea.; She had 102 fever, chills, aches, and nausea.; She had 102 fever, chills, aches, and nausea.; She had 102 fever, chills, aches, and nausea.; She ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine).; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Really sick from the second and booster.Even sicker from the booster), PAIN (She had 102 fever, chills, aches, and nausea.), PYREXIA (She had 102 fever, chills, aches, and nausea.), CHILLS (She had 102 fever, chills, aches, and nausea.) and NAUSEA (She had 102 fever, chills, aches, and nausea.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Flu vaccine. Past adverse reactions to the above products included Adverse drug reaction with Flu vaccine.    On 30-Oct-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 ILLNESS (Really sick from the second and booster.Even sicker from the booster), PAIN (She had 102 fever, chills, aches, and nausea.), PYREXIA (She had 102 fever, chills, aches, and nausea.), CHILLS (She had 102 fever, chills, aches, and nausea.), NAUSEA (She had 102 fever, chills, aches, and nausea.) and VACCINATION SITE LYMPHADENOPATHY (She ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine).). At the time of the report, ILLNESS (Really sick from the second and booster.Even sicker from the booster), PAIN (She had 102 fever, chills, aches, and nausea.), PYREXIA (She had 102 fever, chills, aches, and nausea.), CHILLS (She had 102 fever, chills, aches, and nausea.), NAUSEA (She had 102 fever, chills, aches, and nausea.) and VACCINATION SITE LYMPHADENOPATHY (She ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine).) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 fever (High) 102 fever. On an unknown date, Mammogram: the lymph node was swollen Ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine)..         It was reported that previously patient had received flu and pneumonia vaccine and got the similar events. Patient had never tested for Covid-19. No concomitant medication information was provided. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient states she powered through her symptoms. She didn't take any medications.   This case was linked to MOD-2022-585442 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19,Sickness; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19,Sickness) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19,Sickness). At the time of the report, COVID-19 (COVID-19,Sickness) outcome was unknown.            The co-suspect drug Humira was used for moderate to severe ulcerative colitis.  No concomitant medication was provided by the reporter.  It was unknown if patient was enrolled in COVID-19 vaccine trial.  No treatment medication was provided by the reporter.  Company Comment: This spontaneous case concerns an adult female patient (with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19  unspecified day after receiving a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns an adult female patient (with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19  unspecified day after receiving a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Reportedly, 168 doses or vials were initially stored in the refrigerator on an unknown date. It was reported that vials had not undergone any temperature excursion. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU was received with non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Tongue discomfort
Clinical narrative: her tongue was hanging out; couldn't breathe; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TONGUE DISCOMFORT (her tongue was hanging out) and DYSPNOEA (couldn't breathe) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TONGUE DISCOMFORT (her tongue was hanging out) and DYSPNOEA (couldn't breathe). At the time of the report, TONGUE DISCOMFORT (her tongue was hanging out) and DYSPNOEA (couldn't breathe) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication reported.  The reporter stated that she had to take her daughter (Patient) to ER after receiving the COVID-19 vaccine (unknown if vaccine administered was Moderna).  No treatment medication details reported.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses. Expiration date was reported as 24-Oct-2021.  Dates of administration of vaccine were reported as 25, 26, 27 and 29-Oct-2021.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up recieved contains non-significant information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator reported as unknown. Vaccine was expired on 07-APR-2022.  The vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 168 doses were given from LOT 048C21A. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non significant follow up. No new clinically significant information received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) 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 vials had not undergone any temperature excursion. Total of 168 doses/vials were given for LOT  048C21A.  Date the vial was initially stored in the refrigerator was reported as unknown.~  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document contain non-significant information was updated.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 168 doses were given from LOT 048C21A It was reported that the date vial initially stored in refrigerator was unknown  Treatment medication was not provided by the reporter    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant  follow up was received
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Spinal operation
Clinical narrative: Back surgery; COVID vaccine made sick; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL OPERATION (Back surgery) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SPINAL OPERATION (Back surgery) (seriousness criterion medically significant), ILLNESS (COVID vaccine made sick) and COVID-19 (COVID-19). At the time of the report, SPINAL OPERATION (Back surgery), ILLNESS (COVID vaccine made sick) and COVID-19 (COVID-19) outcome was unknown.            The indication of suspect drug Humira was reported as moderate to severe rheumatoid arthritis.  No concomitant product was reported. COMPANY COMMENT: This is an spontaneous case concerning an elderly female patient with medical history of Co-suspect product ADALIMUMAB for Rheumatoid arthritis who experienced the unexpected  events of SPINAL OPERATION (seriousness criterion medically significant), COVID-19 (AESI) and ILLNESS unknown days after  a dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   The reporter's causality for the events of Back surgery, Covid vaccine made sick and Covid with Humira (Adalimumab) was reported as not provided and the opinion was that there was no reasonable possibility that the events of Back surgery, Covid vaccine made sick and Covid are related to Humira (Adalimumab).  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an elderly female patient with medical history of Co-suspect product ADALIMUMAB for Rheumatoid arthritis who experienced the unexpected  events of SPINAL OPERATION (seriousness criterion medically significant), COVID-19 (AESI) and ILLNESS unknown days after  a dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU received with non significant information
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Patient reports that she was tired for 2 days after her second dose of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Patient reports that she was tired for 2 days after her second dose of the Moderna Covid-19 vaccine.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Patient reports that she was tired for 2 days after her second dose of the Moderna Covid-19 vaccine.). On 14-Mar-2021, FATIGUE (Patient reports that she was tired for 2 days after her second dose of the Moderna Covid-19 vaccine.) had resolved.            No Concomitant product use was reported.  No treatment information was provided.   This case was linked to MOD-2022-585875 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: felt tired for two days after reciving her Moderna Covid-19 vaccine booster dose; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (felt tired for two days after reciving her Moderna Covid-19 vaccine booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-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 FATIGUE (felt tired for two days after reciving her Moderna Covid-19 vaccine booster dose). At the time of the report, FATIGUE (felt tired for two days after reciving her Moderna Covid-19 vaccine booster dose) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient does not remember which arm that she received her Moderna Covid-19 vaccine in.   This case was linked to MOD-2022-585850 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Total of 102 doses/vials were given for LOT  026C21A. The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) 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 vials had not undergone any temperature excursion.Total of 168 doses/vials were given for LOT 048C21A.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in an 87-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 07-Apr-2022. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2022: Follow up received reporter address updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  It was unknown if the vial was initially stored in the refrigerator The vial did not undergo any temperature excursions    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non significant information.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Slight soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Slight soreness) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Slight soreness). At the time of the report, PAIN (Slight soreness) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired dose of the Moderna COVID-19 vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired dose of the Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired dose of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vaccine provided administer expired vaccine to the patient at a local jail. The vial was initially stored in the refrigerator was on 09-May-2022. The vial did not undergo any temperature excursions.  The patient did not report any adverse reactions to this expired dose.  No treatment information was provided by the reporter.