chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A full dose was given to a patient from a vial that has been out at room temperature for 25 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A full dose was given to a patient from a vial that has been out at room temperature for 25 hours.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B and 059H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for an unknown indication.   On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A full dose was given to a patient from a vial that has been out at room temperature for 25 hours.). On 04-Feb-2022, EXPIRED PRODUCT ADMINISTERED (A full dose was given to a patient from a vial that has been out at room temperature for 25 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was not experiencing any symptoms.  Patient was taking different medications.  No treatment information were given.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: SARS-COV-2 infection after first dose of the Moderna Covid19 vaccine; Sored arm; felt tired; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (SARS-COV-2 infection after first dose of the Moderna Covid19 vaccine), PAIN IN EXTREMITY (Sored arm) and FATIGUE (felt tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (SARS-COV-2 infection after first dose of the Moderna Covid19 vaccine), PAIN IN EXTREMITY (Sored arm) and FATIGUE (felt tired). At the time of the report, COVID-19 (SARS-COV-2 infection after first dose of the Moderna Covid19 vaccine), PAIN IN EXTREMITY (Sored arm) and FATIGUE (felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.  It was reported that the patient was received the Moderna Covid19 vaccine first primary dose in Jul2021 then she got a SARS-CoV-2 infection. And she still has not gotten the second primary dose.  Company Comment: This is a spontaneous case concerning a 61-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, and non serious events of pain in extremity and fatigue. The events occurred on an unknown date after the administration of the first dose of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 61-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, and non serious events of pain in extremity and fatigue. The events occurred on an unknown date after the administration of the first dose of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Feeling hot, Neck pain
Clinical narrative: Arm is hot; Back hurts; Neck hurts; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING HOT (Arm is hot), BACK PAIN (Back hurts) and NECK PAIN (Neck hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced FEELING HOT (Arm is hot), BACK PAIN (Back hurts) and NECK PAIN (Neck hurts). At the time of the report, FEELING HOT (Arm is hot), BACK PAIN (Back hurts) and NECK PAIN (Neck hurts) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Head discomfort, Limb discomfort, Malaise
Clinical narrative: Suddenly felt heavy, her arms and legs also felt so heavy; I felt my head, arms, and legs heavy; She thought she was going to pass out; She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.; I felt very sick; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Suddenly felt heavy, her arms and legs also felt so heavy), HEAD DISCOMFORT (I felt my head, arms, and legs heavy), PRESYNCOPE (She thought she was going to pass out), FEELING ABNORMAL (She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.) and MALAISE (I felt very sick) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced LIMB DISCOMFORT (Suddenly felt heavy, her arms and legs also felt so heavy), HEAD DISCOMFORT (I felt my head, arms, and legs heavy), PRESYNCOPE (She thought she was going to pass out) and FEELING ABNORMAL (She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.). In 2021, the patient experienced MALAISE (I felt very sick). In April 2021, LIMB DISCOMFORT (Suddenly felt heavy, her arms and legs also felt so heavy), HEAD DISCOMFORT (I felt my head, arms, and legs heavy), PRESYNCOPE (She thought she was going to pass out) and FEELING ABNORMAL (She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.) had resolved. At the time of the report, MALAISE (I felt very sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) Negative.         Concomitant medications include medications for high blood pressure and high cholesterol level.   Reporter stated that about 10 months ago she felt sick and thought it was COVID but the blood test came out negative.  Patient had experienced the events 15 days after the second dose and the whole episode lasted a few seconds.  No treatment information was provided.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Suddenly felt heavy, her arms and legs also felt so heavy; I felt my head, arms, and legs heavy; She thought she was going to pass out; She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.; I felt very sick; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Suddenly felt heavy, her arms and legs also felt so heavy), HEAD DISCOMFORT (I felt my head, arms, and legs heavy), PRESYNCOPE (She thought she was going to pass out), FEELING ABNORMAL (She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.) and MALAISE (I felt very sick) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced LIMB DISCOMFORT (Suddenly felt heavy, her arms and legs also felt so heavy), HEAD DISCOMFORT (I felt my head, arms, and legs heavy), PRESYNCOPE (She thought she was going to pass out) and FEELING ABNORMAL (She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.). In 2021, the patient experienced MALAISE (I felt very sick). In April 2021, LIMB DISCOMFORT (Suddenly felt heavy, her arms and legs also felt so heavy), HEAD DISCOMFORT (I felt my head, arms, and legs heavy), PRESYNCOPE (She thought she was going to pass out) and FEELING ABNORMAL (She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.) had resolved. At the time of the report, MALAISE (I felt very sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) Negative.         Concomitant medications include medications for high blood pressure and high cholesterol level.   Reporter stated that about 10 months ago she felt sick and thought it was COVID but the blood test came out negative.  Patient had experienced the events 15 days after the second dose and the whole episode lasted a few seconds.  No treatment information was provided.   Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna Covid19 vaccine administered to a patient younger than 18 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid19 vaccine administered to a patient younger than 18 years old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H2113) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid19 vaccine administered to a patient younger than 18 years old). On 27-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid19 vaccine administered to a patient younger than 18 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Caller reported she had a patient of 16 years who received the first dose of vaccine . The patient did not experience any symptoms after the vaccine and is not on concomitant medication. Concomitant medications was not reported.  Treatment medications was not reported.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.       Moderna booster vaccines were administered to patient around 490 to 500 people on the date last Oct 20.2021 to Nov 29, 2021, with lot numbers 006C21A (10-10-2021), 026B21A (09-17-2021),031B21A (9-22-2021).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, SARS-CoV-2 test
Clinical narrative: After the 1st shot I only had pain and little problems with my arm; After the 1st shot I only had little problems with my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After the 1st shot I only had pain and little problems with my arm) and LIMB DISCOMFORT (After the 1st shot I only had little problems with my arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Blood pressure high.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (After the 1st shot I only had pain and little problems with my arm) and LIMB DISCOMFORT (After the 1st shot I only had little problems with my arm). At the time of the report, PAIN IN EXTREMITY (After the 1st shot I only had pain and little problems with my arm) and LIMB DISCOMFORT (After the 1st shot I only had little problems with my arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) blood test came out negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned that one doctor diagnosed her with Lupus but that another doctor ruled out the condition.  Concomitant medication includes high cholesterol medication and high blood pressure medication.  No treatment details were reported.   This case was linked to MOD-2022-472812 (Patient Link).   Reporter did not allow further contact
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 12-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The pharmacist reported about the administration of expired moderna vaccine that was given as booster shot to patient. The vaccines was stored in freezer, which was taken out one to two vials and place in fridge each day as needed.  No treatment was given on the patient.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided. The expired vaccine was given as a booster dose to patients on the date last 20 Oct 2021 to 29 Nov 2021. The lot number of the vaccine was 026B21A(17 Sep 2021).The vaccines were stored in freezer, one to two vials were taken out  and placed in fridge each day as needed.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: Felt full head (after first or second AND after third); This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Felt full head (after first or second AND after third)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Adverse reaction with Flu shot. Concurrent medical conditions included Sjogren's syndrome (Patient is Immunocompromised). Concomitant products included LEVOTHYROXINE, POTASSIUM CHLORIDE;SODIUM BICARBONATE and BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Felt full head (after first or second AND after third)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (Felt full head (after first or second AND after third)) outcome was unknown.            Concomitant drugs include ARDES 2 vitamin daily.Treatment drugs include steroid.   This case was linked to MOD-2022-472950 (Patient Link).
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  The reporter stated the administration of expired vaccine were given as booster shot to patient.  The vaccines were stored in freezer, they take out one or two vials and placed it in fridge each day as needed.  No treatment given on the patient.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired vaccine) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported. It was reported that the vaccines were stored in freezer and one to two vials were taken out and placed in fridge each day as needed.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: receiving 2nd dose after 23 days of the first dose (instead of 28 days); This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose after 23 days of the first dose (instead of 28 days)) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 (receiving 2nd dose after 23 days of the first dose (instead of 28 days)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose after 23 days of the first dose (instead of 28 days)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2022: Non-significant follow up
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received booster instead of third dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster instead of third dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 027L20A and 031L20A) for COVID-19 immunisation.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included Reaction hypersensitivity (NOS) with flu shot. Concurrent medical conditions included Immunocompromised and Sjogren's. Concomitant products included LEVOTHYROXINE, SODIUM BICARBONATE and POTASSIUM CHLORIDE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster instead of third dose). On 17-Nov-2021, ACCIDENTAL UNDERDOSE (Received booster instead of third dose) had resolved.            On 13jan22 COVID19 IgG serum: negative, that is why the rheumatologist told her to take another dose. Patient reported within 30 minutes of getting the vaccine: head full, upper lip tingly  Patient to ER: heart beat and pressure fine, lungs fine. Gave her a steroid and Benadryl shot. Patient took treatment steroid and Benadryl shot.   This case was linked to MOD-2022-472923, MOD-2022-473001 (Patient Link).
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Nov-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        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.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Area where the shot was injected is sore/sore in the area on the injection; the area where the shot was injected swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Area where the shot was injected is sore/sore in the area on the injection) and VACCINATION SITE SWELLING (the area where the shot was injected swollen) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007521-28, 004s21a and 006o21a) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, 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 VACCINATION SITE PAIN (Area where the shot was injected is sore/sore in the area on the injection) and VACCINATION SITE SWELLING (the area where the shot was injected swollen). At the time of the report, VACCINATION SITE PAIN (Area where the shot was injected is sore/sore in the area on the injection) and VACCINATION SITE SWELLING (the area where the shot was injected swollen) had not resolved.            Concomitant product information was not provided.  The patient asked if it was safe to take something for pain and it did not work, and still sore and swollen.   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2022: Reporter details, patient demographics, suspect doses details were updated.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. Reporter stated that the vaccine was stored in freezer, and they take out one to two vials and place in fridge each day as needed. HCP was wanted to know next step after giving expired Moderna Vaccine. No treatment was given to patient.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Dec-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        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.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: arm was so sore, as if somebody beat me up but that's gone now; Under armpit is sore; Under armpit is a little bit swollen/ swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was so sore, as if somebody beat me up but that's gone now), AXILLARY PAIN (Under armpit is sore) and LYMPHADENOPATHY (Under armpit is a little bit swollen/ swollen lymph nodes) 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 02-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was so sore, as if somebody beat me up but that's gone now), AXILLARY PAIN (Under armpit is sore) and LYMPHADENOPATHY (Under armpit is a little bit swollen/ swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (arm was so sore, as if somebody beat me up but that's gone now), AXILLARY PAIN (Under armpit is sore) and LYMPHADENOPATHY (Under armpit is a little bit swollen/ swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment medication were provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, Cardiac stress test normal, Chest pain, Electrocardiogram abnormal, Sleep disorder
Clinical narrative: August 9, 4:30 am woke up due to chest pain. Took him to er and ekg was abnormal. Scheduled appointment for following month with cardiologist and ekg showed abnormal right branch blockage. ECG was also done and it showed everything was ok. A few months later (November), he had another episode?woke up with chest pain. This time we scheduled stress test with cardiologist. Result was everything normal/fine. Today, February 11, 2022, he woke up at 4:30 am with chest pain, again. Every time this happens, pain is in his left side (heart area). Pain increases when laying down, breathing out, or moving his arms as if hugging himself. Pain subsides when sitting up. It also helps alleviate pain if his left arm is lifted above his head while sitting up.  No treatments prescribed since they found nothing.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Head discomfort, Heart rate, Inappropriate schedule of product administration, Paraesthesia oral
Clinical narrative: head full; upper lip tingly; Received third dose after a booster/ vaccine in the incorrect order; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head full), PARAESTHESIA ORAL (upper lip tingly) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received third dose after a booster/ vaccine in the incorrect order) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 039F21A, 027L20A and 031L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU (Many years ago she had a reaction). Past adverse reactions to the above products included Vaccination adverse reaction with FLU. Concurrent medical conditions included Sjogren's and Immunocompromised. Concomitant products included LEVOTHYROXINE, SODIUM BICARBONATE, POTASSIUM CHLORIDE, PROBIOTICS NOS and ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, the patient experienced HEAD DISCOMFORT (head full) and PARAESTHESIA ORAL (upper lip tingly). 01-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received third dose after a booster/ vaccine in the incorrect order). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 01-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received third dose after a booster/ vaccine in the incorrect order) had resolved. At the time of the report, HEAD DISCOMFORT (head full) and PARAESTHESIA ORAL (upper lip tingly) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Blood pressure measurement: fine (normal) Pressure fine. In February 2022, Heart rate: fine (normal) heart beat fine.         Concomitant medications include AREDS2 vitamin daily.  It was reported that patient took the vaccine in the incorrect order and received third dose after a booster. Patient did test and had fine lungs.  Treatment medication include steroid.   This case was linked to MOD-2022-472950 (Patient Link).
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving dose greater than 12(US) hours post puncture: 04Feb2022 2:15 PM; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving dose greater than 12(US) hours post puncture: 04Feb2022 2:15 PM) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025l21b) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving dose greater than 12(US) hours post puncture: 04Feb2022 2:15 PM). On 04-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Receiving dose greater than 12(US) hours post puncture: 04Feb2022 2:15 PM) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP would like to know the validity of the doses and if the patient should be revaccinated, what to do next Dose administered 12 US 24 CA hours post puncture. Date the vial was initially stored in the refrigerator 8 PM 02 Feb 2022. Date s and time vial was first punctured 03Feb 2022 3PM. Date and time of administration of vaccine 04Feb2022  2:15 PM Total amount of time the vial was exposed to room temperature range 8 to 25 C= 46 to 77 F: 25 hours exposed to room temperature.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was reported that vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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. Treatment details was not reported by the reporter.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Treatment information was not provided.       Moderna booster vaccines were administered to patient around 490 to 500 people on the date last Oct 20.2021 to Nov 29, 2021, with lot numbers 006C21A (10-10-2021), 026B21A (09-17-2021),031B21A (9-22-2021).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Latanoprost Allergy), Drug allergy (Propylene glycol Allergy), Drug allergy (Sertraline Allergy), Hypertension, GERD, Asthma, Psoriatic arthritis and Hyperlipidemia. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Asthma, ATORVASTATIN for Hyperlipidemia, HYDROCHLOROTHIAZIDE and CANDESARTAN for Hypertension, ETANERCEPT for Psoriatic arthritis.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 8:18 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 8:18 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration). On 24-Jan-2022 at 8:18 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) to be not related.    Patient weight was reported as 79.4 kilograms. No Treatment information was reported. Reporter had stated that no adverse events were associated with the event and the patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date.   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 24-Jan-2022 at 12:26 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. Last menstrual period and estimated date of delivery were not provided. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, SARS-CoV-2 test: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details provided.   This case was linked to MOD-2022-473097 (Patient Link).