chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 20-Jul-2022; Administered with the vaccine that has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 20-Jul-2022) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 20-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 20-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The patient received second booster on 20 Jul 2022. The vaccine was put in the refrigerator on 15 Jun 2022. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: Caller states that after receiving the Moderna vaccine, she developed blood clots in her brain; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL THROMBOSIS (Caller states that after receiving the Moderna vaccine, she developed blood clots in her brain) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBRAL THROMBOSIS (Caller states that after receiving the Moderna vaccine, she developed blood clots in her brain) (seriousness criterion medically significant). At the time of the report, CEREBRAL THROMBOSIS (Caller states that after receiving the Moderna vaccine, she developed blood clots in her brain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  After receiving the Moderna vaccine, patient developed blood clots in brain. Patient was working with MD at hospital to research trial associated with her condition. Caller did not disclose any other information as to when she received this information on her circumstances.  No treatment information was reported.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of cerebral thrombosis. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and event onset date were not provided; hence, the onset latency could not be assessed. It was reported that after vaccination, the patient developed blood clots in the brain. Treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2022: Additional follow-up document received contains no new information.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of cerebral thrombosis. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and event onset date were not provided; hence, the onset latency could not be assessed. It was reported that after vaccination, the patient developed blood clots in the brain. Treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022; administered with the vaccine that has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-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.  Patient had received first booster.  Pharmacist reported that they administered 7 doses of the COVID-19 vaccine that had been stored in the refrigerator for more than 30 days. The vaccine was initially stored in the refrigerator on 15-Jun-2022 and administered on two dates 3 doses on 19-Jul-2022 and 4 doses on 20-Jul-2022.  Treatment details were not reported by the reporter.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: he had a hive that was probably 3 inch x 2 inch on his arm that did not get the injection; A few hours later he started itching his right arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRURITUS (A few hours later he started itching his right arm) and URTICARIA (he had a hive that was probably 3 inch x 2 inch on his arm that did not get the injection) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced PRURITUS (A few hours later he started itching his right arm). On 22-Jul-2022 at 5:30 PM, the patient experienced URTICARIA (he had a hive that was probably 3 inch x 2 inch on his arm that did not get the injection). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) in July 2022 for Itchy upper limbs and Hives, at an unspecified dose and frequency. In July 2022, PRURITUS (A few hours later he started itching his right arm) and URTICARIA (he had a hive that was probably 3 inch x 2 inch on his arm that did not get the injection) had resolved.            Concomitant medication of the patient was not reported.   The patient received the injection around 12 pm.  The reporter also called the primary care provider of the patient to inform about the reaction. After giving Claritin, the itching stopped and hives disappeared. The patient had no additional issues after Claritin was given.
Sex: U
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: slight thrombocytopenia; This spontaneous case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA (slight thrombocytopenia) 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (slight thrombocytopenia) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (slight thrombocytopenia) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company comment-This spontaneous case concerns a patient of unspecified age and gender with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Thrombocytopenia which occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date and onset date of event was not disclosed. Patient had slight thrombocytopenia after administration with Moderna Covid-19 vaccine. Outcome of the event was not known at the time of report. No further information on risk factors, concurrent illness, detailed clinical course, investigations results, treatment of the event and details pertaining to the doses was available in the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Thrombocytopenia which occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date and onset date of event was not disclosed. Patient had slight thrombocytopenia after administration with Moderna Covid-19 vaccine. Outcome of the event was not known at the time of report. No further information on risk factors, concurrent illness, detailed clinical course, investigations results, treatment of the event and details pertaining to the doses was available in the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Potential Adverse event of Moderna COVID 19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Potential Adverse event of Moderna COVID 19 Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Potential Adverse event of Moderna COVID 19 Vaccine). At the time of the report, VACCINATION COMPLICATION (Potential Adverse event of Moderna COVID 19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The first dose was given on 25-Mar-2021 and the second dose on 3-May-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose was given on 25-Mar-2021 and the second dose on 3-May-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 044A21A) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose was given on 25-Mar-2021 and the second dose on 3-May-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose was given on 25-Mar-2021 and the second dose on 3-May-2021) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment reported   This case was linked to MOD-2022-613556 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 019b21a) for COVID-19 prophylaxis.     The patient had no known drug allergies. It was unknown if the patient was ever been diagnosed with or tested positive for COVID-19.  Concurrent medical conditions included Allergy (No recent changes in condition status) since 18-Aug-2020 and Rash (No recent changes in condition status) since 05-May-2020. Concomitant products included AZELASTINE from 18-Aug-2020 to an unknown date and BETAMETHASONE, CLOTRIMAZOLE (CLOTRIMAZOLE AND BETAMETHASONE) from 05-May-2020 to an unknown date for an unknown indication.   On 27-Apr-2021 at 4:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-May-2021 at 2:04 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 13-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itching). The patient was treated with CLOBETASOL ongoing from 13-Oct-2021 for Itching, at a dose of 0.05 % percent. At the time of the report, PRURITUS (itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Weight of the patient was reported as 217 (unit: unspecified).   This case was linked to MOD-2022-503402 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First booster on 27-Dec-2021 and second booster on 18-Apr-22; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster on 27-Dec-2021 and second booster on 18-Apr-22) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 0D2A21A, 013A21A and 078J21A) for COVID-19 prophylaxis.     Patient had no known drug allergy.  Patient has never been diagnosed with or tested positive for COVID-19.  Concurrent medical conditions included Vitamin D deficiency since 21-Feb-2022 and Gout. Concomitant products included ALLOPURINOL from 28-Dec-2018 to an unknown date and ERGOCALCIFEROL from 26-Jan-2019 to an unknown date for an unknown indication. On 04-Mar-2021 at 5:19 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Apr-2021 at 5:39 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Dec-2021 at 10:38 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Apr-2022 at 3:10 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster on 27-Dec-2021 and second booster on 18-Apr-22). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster on 27-Dec-2021 and second booster on 18-Apr-22) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Weight was reported as 204. No treatment medications were provided. This case was linked to MOD-2022-503273 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Type IIa hyperlipidaemia
Clinical narrative: Pure Hypercholesterolaemia; This spontaneous case was reported by an other health care professional and describes the occurrence of TYPE IIA HYPERLIPIDAEMIA (Pure Hypercholesterolaemia) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019b21a and 030A21A) for COVID-19 prophylaxis.     Patient had no known allergies to medications, food and other products.    On 19-Apr-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-May-2021 at 10:58 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Sep-2021, the patient experienced TYPE IIA HYPERLIPIDAEMIA (Pure Hypercholesterolaemia). The patient was treated with ROSUVASTATIN ongoing from 07-Sep-2021 at a dose of 5 milligram. At the time of the report, TYPE IIA HYPERLIPIDAEMIA (Pure Hypercholesterolaemia) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient height and weight was reported as 5'3 and 150.2.  No concomitant medication information was provided.   This case was linked to MOD-2022-503512 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030a21a, 002A21A and 069f21a) for COVID-19 prophylaxis.     Patient had no known allergies to medications, food and other products. Patient had never been diagnosed with or tested positive for COVID-19. It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Muscle spasm since 07-Jul-2020 and Pain since 20-Jul-2020. Concomitant products included CYCLOBENZAPRINE from 20-Jul-2020 to an unknown date, ERGOCALCIFEROL from 15-Apr-2021 to an unknown date, METHYLPREDNISOLONE from 25-Aug-2021 to an unknown date and NAPROXEN from 20-Jul-2020 to an unknown date for an unknown indication.   On 22-Mar-2021 at 8:03 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Apr-2021 at 3:40 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 01-Dec-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Aug-2021, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PAIN (Pain) to be not related.    The event did not cause the patient to seek medical care. There were no other potential causes. The patient had not experienced similar event in the past.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-503399 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Muscle injury, Nerve injury, Neuralgia, Pain, Pain in extremity
Clinical narrative: nerve pain in her left arm and her hand and the top of the shoulder; she have severe nerve and muscle damage; she have severe nerve and muscle damage; excruciating pain like live electricity running up from her arm to the fingers; excruciating pain like live electricity running up from her arm to the fingers; This spontaneous case was reported by a patient and describes the occurrence of NEURALGIA (nerve pain in her left arm and her hand and the top of the shoulder), NERVE INJURY (she have severe nerve and muscle damage), MUSCLE INJURY (she have severe nerve and muscle damage), PAIN (excruciating pain like live electricity running up from her arm to the fingers) and PAIN IN EXTREMITY (excruciating pain like live electricity running up from her arm to the fingers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, 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 NEURALGIA (nerve pain in her left arm and her hand and the top of the shoulder), NERVE INJURY (she have severe nerve and muscle damage), MUSCLE INJURY (she have severe nerve and muscle damage), PAIN (excruciating pain like live electricity running up from her arm to the fingers) and PAIN IN EXTREMITY (excruciating pain like live electricity running up from her arm to the fingers). At the time of the report, NEURALGIA (nerve pain in her left arm and her hand and the top of the shoulder), NERVE INJURY (she have severe nerve and muscle damage), MUSCLE INJURY (she have severe nerve and muscle damage), PAIN (excruciating pain like live electricity running up from her arm to the fingers) and PAIN IN EXTREMITY (excruciating pain like live electricity running up from her arm to the fingers) had not resolved.            Concomitant medications was not provided by the reporter. Patient mentioned she did not experience any symptoms after 1st and 2nd primary series. It was reported that the patient may require surgery in her spine. Treatment included physical therapy, unknown if any other treatment was given.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient received a half dose as the second primary dose instead of a full one; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patient received a half dose as the second primary dose instead of a full one) 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 UNDERDOSE (patient received a half dose as the second primary dose instead of a full one). At the time of the report, UNDERDOSE (patient received a half dose as the second primary dose instead of a full one) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture; received doses from a vial first punctured the day before the date of administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that 4 Patients received doses from a vial first punctured the day before the date of administration LOT 017b22a from the same vial. Date the vial was initially stored in the refrigerator was reported as 14Jul2022. Date and time of vial was first punctured was reported as 14 Jul 2022, time unknown estimation at 10:30 AM. Date and time of administration of vaccine was reported as 15Jul 2022 first administration 0:9 30 last administration 11:30. Vial did not undergo temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree celciu  to 25 degree celcius is equal to 46 degree celcius to 77 degree F) was between 10 minutes and 35 minutes. No Treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-614372, US-MODERNATX, INC.-MOD-2022-614373, US-MODERNATX, INC.-MOD-2022-614374 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614372:Patient 2 US-MODERNATX, INC.-MOD-2022-614373:Patient 3 US-MODERNATX, INC.-MOD-2022-614374:Patient 4
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received doses from a vial first punctured the day before the date of administration; Received doses from a vial first punctured the day before the date of administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Received doses from a vial first punctured the day before the date of administration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses from a vial first punctured the day before the date of administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received doses from a vial first punctured the day before the date of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Received doses from a vial first punctured the day before the date of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Patient received 4th dose. It was reported that 4 Patients received doses from a vial first punctured the day before the date of administration LOT 017b22a from the same vial. Date the vial was initially stored in the refrigerator was reported as 14Jul2022. Date and time of vial was first punctured was reported as 14 Jul 2022, time unknown estimation at 10:30 AM. Date and time of administration of vaccine was reported as 15Jul 2022 first administration 0:9 30 last administration 11:30. Vial did not undergo temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree Celcius to 25 degree Celcius is equal to 46 degree celcius to 77 degree F) was between 10 minutes and 35 minutes. No Treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-614374, US-MODERNATX, INC.-MOD-2022-614370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614374:Patient 4 US-MODERNATX, INC.-MOD-2022-614370:Patient 1
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture; received doses from a vial first punctured the day before the date of administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Date the vial was initially stored in the refrigerator was reported as 14-Jul-2022. Date and time of vial was first punctured was reported as 14-Jul-2022, time unknown estimation at 10:30 AM. Date and time of administration of vaccine was reported as 15-Jul-2022 first administration 09:30 last administration 11:30. Vial did not undergo temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree celciu  to 25 degree celcius is equal to 46 degree celcius to 77 degree F) was between 10 minutes and 35 minutes.  No treatment medications were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022; received doses from a vial first punctured the day before the date of administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received 1st booster dose. Concomitant drugs were not reported. It was reported that 4 doses from 1 vial was first punctured on 14-Jul-2022 at estimation 10:30 AM and were administered on 15-Jul-2022 first administration at 09:30 and last administration at 11:30. The vial was stored in fridge post puncture and did not undergo any temperature excursion. The vial was exposed to room temperature range between 10 minutes and 35 minutes. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-614370, US-MODERNATX, INC.-MOD-2022-614372, US-MODERNATX, INC.-MOD-2022-614373 (E2B Linked Report). This case was linked to MOD-2022-614370 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614370:Patient 1 US-MODERNATX, INC.-MOD-2022-614372:Patient 2 US-MODERNATX, INC.-MOD-2022-614373:Patient 3
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient inadvertently received a 5th shot of the Moderna Covid vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient inadvertently received a 5th shot of the Moderna Covid vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient inadvertently received a 5th shot of the Moderna Covid vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Patient inadvertently received a 5th shot of the Moderna Covid vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  The Nurse stated that One of their patient inadvertently received a 5th shot of the Moderna Covid vaccine.The patient had forgotten she had received 4 injections and the last one did not come across from state database into their system. So they only had 3 documented shots.Her Provider has been notified.  No Treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: nauseous; sore all over; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (nauseous) and MYALGIA (sore all over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced NAUSEA (nauseous) and MYALGIA (sore all over). At the time of the report, NAUSEA (nauseous) and MYALGIA (sore all over) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Caller wanted to report an adverse event; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Caller wanted to report an adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller wanted to report an adverse event). At the time of the report, IMMUNISATION REACTION (Caller wanted to report an adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator 23Jul2022; We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 23Jul2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 23Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 23Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The vial was initially stored in the refrigerator on 23-Jul-2022. The vial did not undergo any temperature excursions.     No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Hypokinesia, Inflammation, Joint swelling
Clinical narrative: Heat; Elbow swelling; She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck; A lot of inflammation; Redness; Arm swelling/shoulder swelling; Armpit swelling; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Heat), JOINT SWELLING (Elbow swelling), HYPOKINESIA (She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck), INFLAMMATION (A lot of inflammation) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was unknown whether patient has diagnosed/tested positive for COVID-19.  It was reported acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Heat), JOINT SWELLING (Elbow swelling), HYPOKINESIA (She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck), INFLAMMATION (A lot of inflammation), ERYTHEMA (Redness), PERIPHERAL SWELLING (Arm swelling/shoulder swelling) and LYMPHADENOPATHY (Armpit swelling). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING HOT (Heat), JOINT SWELLING (Elbow swelling), HYPOKINESIA (She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck), INFLAMMATION (A lot of inflammation), ERYTHEMA (Redness), PERIPHERAL SWELLING (Arm swelling/shoulder swelling) and LYMPHADENOPATHY (Armpit swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: Nothing wrong.         No concomitant medication were provided.  Patient received booster dose.  It was reported that patient had to rest in bed because patient couldn't move arm during 4 days, Patient felt like arm was stuck. Patient went to urgent care but there was nothing wrong when doctors checked x-ray studies, and was sent patient to an orthopedic doctor, who recommended physical therapy. It did not improve with Ibuprofen, and even ice did not resolved swelling. Patient visited a HCP and was told it might be due to an administration error, that vaccine was not administered intramuscularly, or maybe due to an autoimmune disease. It was unknown if patient was under any regular medications.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, X-ray
Clinical narrative: Heat; Elbow swelling; She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck; A lot of inflammation; Redness; Arm swelling/shoulder swelling; Armpit swelling; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Heat), JOINT SWELLING (Elbow swelling), HYPOKINESIA (She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck), INFLAMMATION (A lot of inflammation) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was unknown whether patient has diagnosed/tested positive for COVID-19.  It was reported acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Heat), JOINT SWELLING (Elbow swelling), HYPOKINESIA (She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck), INFLAMMATION (A lot of inflammation), ERYTHEMA (Redness), PERIPHERAL SWELLING (Arm swelling/shoulder swelling) and LYMPHADENOPATHY (Armpit swelling). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING HOT (Heat), JOINT SWELLING (Elbow swelling), HYPOKINESIA (She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck), INFLAMMATION (A lot of inflammation), ERYTHEMA (Redness), PERIPHERAL SWELLING (Arm swelling/shoulder swelling) and LYMPHADENOPATHY (Armpit swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: Nothing wrong.         No concomitant medication were provided.  Patient received booster dose.  It was reported that patient had to rest in bed because patient couldn't move arm during 4 days, Patient felt like arm was stuck. Patient went to urgent care but there was nothing wrong when doctors checked x-ray studies, and was sent patient to an orthopedic doctor, who recommended physical therapy. It did not improve with Ibuprofen, and even ice did not resolved swelling. Patient visited a HCP and was told it might be due to an administration error, that vaccine was not administered intramuscularly, or maybe due to an autoimmune disease. It was unknown if patient was under any regular medications.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine stored and then administered; We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.) and PRODUCT STORAGE ERROR (Expired vaccine stored and then administered) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.) and PRODUCT STORAGE ERROR (Expired vaccine stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   Confirmed expiration date was reported as 27-Mar-2022.  The vial was initially stored in the refrigerator on 23-Jul-2022. The vial did not undergo any temperature excursions.            No treatment information was provided by the reporter.