chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Myalgia, Nasal congestion
Clinical narrative: nasal congestion; temperature of 100.1°F; achiness over sides; headache; she felt really bad; in bed early/sleeping on and off/did not get up till 1; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she felt really bad), SOMNOLENCE (in bed early/sleeping on and off/did not get up till 1), NASAL CONGESTION (nasal congestion), PYREXIA (temperature of 100.1°F) and MYALGIA (achiness over sides) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 939906, 028L20A and 013L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (three times a day). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2022, the patient experienced SOMNOLENCE (in bed early/sleeping on and off/did not get up till 1). On 26-Jun-2022, the patient experienced FEELING ABNORMAL (she felt really bad), NASAL CONGESTION (nasal congestion), PYREXIA (temperature of 100.1°F), MYALGIA (achiness over sides) and HEADACHE (headache). On 26-Jun-2022, FEELING ABNORMAL (she felt really bad), SOMNOLENCE (in bed early/sleeping on and off/did not get up till 1), NASAL CONGESTION (nasal congestion), PYREXIA (temperature of 100.1°F), MYALGIA (achiness over sides) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jun-2022, Body temperature: 100.1°f 100.1°F (Oral).         The first two dose did not effect hardly at all.  No treatment medications were reported.   This case was linked to MOD-2021-369076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Added the concomitant medication.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: nasal congestion; temperature of 100.1°F; achiness over sides; headache; she felt really bad; in bed early/sleeping on and off/did not get up till 1; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she felt really bad), SOMNOLENCE (in bed early/sleeping on and off/did not get up till 1), NASAL CONGESTION (nasal congestion), PYREXIA (temperature of 100.1°F) and MYALGIA (achiness over sides) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 939906, 028L20A and 013L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (three times a day). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2022, the patient experienced SOMNOLENCE (in bed early/sleeping on and off/did not get up till 1). On 26-Jun-2022, the patient experienced FEELING ABNORMAL (she felt really bad), NASAL CONGESTION (nasal congestion), PYREXIA (temperature of 100.1°F), MYALGIA (achiness over sides) and HEADACHE (headache). On 26-Jun-2022, FEELING ABNORMAL (she felt really bad), SOMNOLENCE (in bed early/sleeping on and off/did not get up till 1), NASAL CONGESTION (nasal congestion), PYREXIA (temperature of 100.1°F), MYALGIA (achiness over sides) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jun-2022, Body temperature: 100.1°f 100.1°F (Oral).         The first two dose did not effect hardly at all.  No treatment medications were reported.   This case was linked to MOD-2021-369076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Added the concomitant medication.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Tingling on feet. (Left and Right Foot); This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingling on feet. (Left and Right Foot)) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 13-May-2022.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2022 at 10:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (Tingling on feet. (Left and Right Foot)). At the time of the report, PARAESTHESIA (Tingling on feet. (Left and Right Foot)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. It was not asked if patient received any vaccine 1 month prior to Moderna COVID-19 vaccine. Batch number was asked but was unknown.  Patient reported that symptom started at around 10 pm and Nurse advised her to go to the Emergency room. No treatment medications were reported.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tingling on feet. (Left and Right Foot); This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingling on feet. (Left and Right Foot)) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 13-May-2022.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2022 at 10:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (Tingling on feet. (Left and Right Foot)). At the time of the report, PARAESTHESIA (Tingling on feet. (Left and Right Foot)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. It was not asked if patient received any vaccine 1 month prior to Moderna COVID-19 vaccine. Batch number was asked but was unknown.  Patient reported that symptom started at around 10 pm and Nurse advised her to go to the Emergency room. No treatment medications were reported.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Test positive for COVID; Lack of drug effect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Test positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced COVID-19 (Test positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Test positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient is not taking any concomitant medications. No treatment medications was reported.  Company Comment:  This is a spontaneous case concerning  a  19-year-old, female patient with no reported medical history, who experienced the unexpected AESI non-serious event of COviD-19 and Unexpected non-serious events of Drug ineffective. The events Covid-19 and Drug ineffective  occurred approximately 8 months after the second dose of mRNA-1273 COVID 19 Vaccine. The Paresthesia event was captured and linked to a sperate case. Patient tested positive for SARS-CoV-2 test: positive. No treatment medications was reported. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected b this report.   This case was linked to MOD-2022-595560 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  19-year-old, female patient with no reported medical history, who experienced the unexpected AESI non-serious event of COviD-19 and Unexpected non-serious events of Drug ineffective. The events Covid-19 and Drug ineffective  occurred approximately 8 months after the second dose of mRNA-1273 COVID 19 Vaccine. The Paresthesia event was captured and linked to a sperate case. Patient tested positive for SARS-CoV-2 test: positive. No treatment medications was reported. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected b this report.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Test positive for COVID; Lack of drug effect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Test positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced COVID-19 (Test positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Test positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient is not taking any concomitant medications. No treatment medications was reported.  Company Comment:  This is a spontaneous case concerning  a  19-year-old, female patient with no reported medical history, who experienced the unexpected AESI non-serious event of COviD-19 and Unexpected non-serious events of Drug ineffective. The events Covid-19 and Drug ineffective  occurred approximately 8 months after the second dose of mRNA-1273 COVID 19 Vaccine. The Paresthesia event was captured and linked to a sperate case. Patient tested positive for SARS-CoV-2 test: positive. No treatment medications was reported. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected b this report.   This case was linked to MOD-2022-595560 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  19-year-old, female patient with no reported medical history, who experienced the unexpected AESI non-serious event of COviD-19 and Unexpected non-serious events of Drug ineffective. The events Covid-19 and Drug ineffective  occurred approximately 8 months after the second dose of mRNA-1273 COVID 19 Vaccine. The Paresthesia event was captured and linked to a sperate case. Patient tested positive for SARS-CoV-2 test: positive. No treatment medications was reported. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected b this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received vaccine 20 hours after puncture; Patient received vaccine 20 hours after puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 20 hours after puncture) and PRODUCT STORAGE ERROR (Patient received vaccine 20 hours after puncture) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 939904, 017B21A and 040A21A) for COVID-19 vaccination.     The patient has ever had COVID + test or diagnosis from greater then 6 months. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose no) .  The patient's past medical history included Anemia. Concurrent medical conditions included Diabetes, Heart disorder, Kidney disorder and Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 20 hours after puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received vaccine 20 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 20 hours after puncture) and PRODUCT STORAGE ERROR (Patient received vaccine 20 hours after puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient is in a residential facility. Number of doses/vials: 1 Dose 1 vial. Date the vial was initially stored in the refrigerator was 21-Jun-2021. Date(s) and time(S) vial was first punctured was 21-Jun-2021 around 9 am. The vial was stored post puncture in Fridge. The vial did not undergo any temperature excursions. The vaccine was never at room temperature.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion occurred over the weekend; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred over the weekend) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 27-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred over the weekend). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred over the weekend) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   A refrigerator temperature excursion occurred over the weekend. The HCP would like to know if the two Moderna vials were still okay to be use. The vials went out of range for a little over one hour and then went back into range.The vial  was punctured and administered to a patient on  27Jun2022 and gave one dose to a patient that morning.   It was reported that, after use of online temperature excursion tool, the HCP stated the vials were okay to use as per tool.  No treatment information was reported.
Age: 1.25
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: state registry says 15 month old patient received full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (state registry says 15 month old patient received full dose) in a 15-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2022, the patient experienced ACCIDENTAL OVERDOSE (state registry says 15 month old patient received full dose). At the time of the report, ACCIDENTAL OVERDOSE (state registry says 15 month old patient received full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022; Dose administered to 2 patients 20 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 076C21A, 008B212A and 026A21A) for COVID-19 prophylaxis.     The had never had COVID and test or diagnosis.  Concurrent medical conditions included Sulfonamide allergy and Drug allergy (Oxycodone).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients 20 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that the 2/1 vial was initially stored in refrigerator on 17-Jun-2022, was first punctured on 23-Jun-2022 at 09:49 AM and was administered on 24-Jun-2022 at 09:25 AM and 09:30 AM. Post puncture the vial was left at room temperature for 23.5 hours. The vial did not undergo any temperature excursion. It was mentioned 3rd dose was administered on 03-Mar-2021.  Treatment medications were not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022; Dose administered to patient 20 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 939905, 021C21A and 026B21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Positive test on 06-Jan-2021. No hospitalization.) on 06-Jan-2021. Concurrent medical conditions included Drug allergy (Allergic to lisinopril), Allergy to NSAIDs and Drug allergy (Allergic to Statins).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 24-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 24-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient 20 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that the 2/1 vial was initially stored in refrigerator on 17-Jun-2022, was first punctured on 23-Jun-2022 at 09:49 AM and was administered on 24-Jun-2022 at 09:25 AM and 09:30 AM. Post puncture, the vial was left at room temperature for 23.5 hours. The vial did not undergo any temperature excursion. Treatment medications were not provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST PAIN (Chest pain) in an 18-year-old male patient 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 CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported that the patient went to the Hospital complaining of chest pain. They thought the patient was having a heart attack or something. No treatment details were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: First dose of Moderna vaccine administered to patient on 28-Apr-2021 and second dose administered on 06-May-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine administered to patient on 28-Apr-2021 and second dose administered on 06-May-2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (tested positive, no hospitalization) on 06-Jan-2021. Concurrent medical conditions included Drug allergy (Lisinopril allergy), Allergy to NSAIDs and Drug allergy (allergy to Statins).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine administered to patient on 28-Apr-2021 and second dose administered on 06-May-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine administered to patient on 28-Apr-2021 and second dose administered on 06-May-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     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 reported.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus started a week after the first dose in June 4; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (tinnitus started a week after the first dose in June 4) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu Vaccination. Past adverse reactions to the above products included Ear infection with Flu Vaccination. Concurrent medical conditions included Tinnitus.    On 04-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In June 2022,  after starting mRNA-1273 (Spikevax), the patient experienced TINNITUS (tinnitus started a week after the first dose in June 4). At the time of the report, TINNITUS (tinnitus started a week after the first dose in June 4) had not resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient had tinnitus for one year but not cured.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Therapeutic response unexpected
Clinical narrative: Sore arm; Headache; Fatigue; Break out at the time of the first shot and symptoms went away after receiving that dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Break out at the time of the first shot and symptoms went away after receiving that dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Lymphadenectomy (lymph node removed out of patient right leg prior to chemotherapy) and Chemotherapy. Concurrent medical conditions included Autoimmune disorder and Cancer (Finished treatment with rituximab, and Eulaxa a day before first dose of Moderna vaccine). Concomitant products included TRIAMCINOLONE and LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN EXTRA) for an unknown indication.    On 27-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Break out at the time of the first shot and symptoms went away after receiving that dose). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (Break out at the time of the first shot and symptoms went away after receiving that dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had an autoimmune problem where she broke out in an alligator skin-like blisters on her legs that itch. It was presumed to be Wells disease, and she was having a break out at the time of the first shot. The symptoms went away after receiving that dose. The patient received second dose on 24-FEB-2022. No treatment information was provided.   This case was linked to MOD-2022-595679 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received a booster dose instead of a third primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received a booster dose instead of a third primary dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J primary shot (primary shot) in March 2021. Past adverse reactions to the above products included No adverse event with J&J primary shot. Concurrent medical conditions included Immunocompromised.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In January 2022, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received a booster dose instead of a third primary dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received a booster dose instead of a third primary dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; sore arm; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: JNJ (received JNJ vaccine initially). Past adverse reactions to the above products included No adverse event with JNJ.    On 25-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION SITE PAIN (sore arm). On 25-Jan-2022, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In January 2022, HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) had resolved.            No concomitant medication was reported.  Patient got the Moderna booster dose. A couple hours after administration when she came home, she experienced the headaches. Both side effects lasted about a day.   This case was linked to MOD-2022-595774 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was administered with expired vaccine.; One day before the vial was used for administration, it was initially stored in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine.) and PRODUCT STORAGE ERROR (One day before the vial was used for administration, it was initially stored in the refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 067F21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine.) and PRODUCT STORAGE ERROR (One day before the vial was used for administration, it was initially stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine.) and PRODUCT STORAGE ERROR (One day before the vial was used for administration, it was initially stored in the refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the number of doses/vials used were unknown and the number of doses were administered to unknown number of patients on 5 separate days after the manufacturer date of expiry from 5 different vials.  The date(s) of administration of vaccine were reported as 18 Apr 2022, 25 Apr 2022, 26 Apr 2022, 16 May 2022 and 17 May 2022.The vial hadn't undergo any temperature excursions.  No treatment medication were reported.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: he was tired for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (he was tired for 24 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 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 FATIGUE (he was tired for 24 hours). At the time of the report, FATIGUE (he was tired for 24 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided by the reporter Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: he was tired for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (he was tired for 24 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 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 FATIGUE (he was tired for 24 hours). At the time of the report, FATIGUE (he was tired for 24 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided by the reporter Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: The injection site was aching & sore for 12 hours; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The injection site was aching & sore for 12 hours) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   In December 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. 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 VACCINATION SITE PAIN (The injection site was aching & sore for 12 hours). At the time of the report, VACCINATION SITE PAIN (The injection site was aching & sore for 12 hours) had resolved.            No concomitant medications were provided. Patient reported his experiences after receiving 2 primary doses (2nd dose lot unknown due to lost vaccination card in February of 2022) of the Moderna Covid-19 Vaccine both in the left arm. After the 1st dose in December of 2021 he was tired for 24 hours, After the 2nd dose when he got home the injection site was aching and sore for 12 hours.  No treatment medications were reported.   This case was linked to MOD-2022-595678 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: The injection site was aching & sore for 12 hours; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The injection site was aching & sore for 12 hours) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   In December 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. 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 VACCINATION SITE PAIN (The injection site was aching & sore for 12 hours). At the time of the report, VACCINATION SITE PAIN (The injection site was aching & sore for 12 hours) had resolved.            No concomitant medications were provided. Patient reported his experiences after receiving 2 primary doses (2nd dose lot unknown due to lost vaccination card in February of 2022) of the Moderna Covid-19 Vaccine both in the left arm. After the 1st dose in December of 2021 he was tired for 24 hours, After the 2nd dose when he got home the injection site was aching and sore for 12 hours.  No treatment medications were reported.   This case was linked to MOD-2022-595678 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: tired; Pain was just for 10 min; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tired) and VACCINATION SITE PAIN (Pain was just for 10 min) in a 69-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired) and VACCINATION SITE PAIN (Pain was just for 10 min). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and WATER at an unspecified dose and frequency. At the time of the report, FATIGUE (tired) outcome was unknown and VACCINATION SITE PAIN (Pain was just for 10 min) had resolved.            Patient was not on any concomitant medications. The patient had received all the previous doses of the Moderna COVID-19 vaccines and reported nothing big in terms of side effects, just being tired. The patient reported she had not been sick with COVID, even though she was around people with COVID. The treatment medication included: Gatorade
Sex: M
Vaccine: COVID19
Symptoms: Blood chloride, Blood chloride decreased, Blood creatinine, Blood creatinine increased, Blood glucose
Clinical narrative: glucose was 246; BUN is high; creatinine is high; sodium is low; potassium is low; chloride is low; This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low) and BLOOD POTASSIUM DECREASED (potassium is low) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (severe diabetic that takes insulin.). Concomitant products included INSULIN for Diabetes.   On 30-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low), BLOOD POTASSIUM DECREASED (potassium is low) and BLOOD CHLORIDE DECREASED (chloride is low). At the time of the report, BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low), BLOOD POTASSIUM DECREASED (potassium is low) and BLOOD CHLORIDE DECREASED (chloride is low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood chloride: low Low. On an unknown date, Blood creatinine: high High. On an unknown date, Blood glucose: 246 246. On an unknown date, Blood potassium: low Low. On an unknown date, Blood sodium: low Low. On an unknown date, Blood urea: high BUN is High.         No concomitant medication information provided. No treatment medication information provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood potassium, Blood potassium decreased, Blood sodium, Blood sodium decreased
Clinical narrative: glucose was 246; BUN is high; creatinine is high; sodium is low; potassium is low; chloride is low; This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low) and BLOOD POTASSIUM DECREASED (potassium is low) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (severe diabetic that takes insulin.). Concomitant products included INSULIN for Diabetes.   On 30-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low), BLOOD POTASSIUM DECREASED (potassium is low) and BLOOD CHLORIDE DECREASED (chloride is low). At the time of the report, BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low), BLOOD POTASSIUM DECREASED (potassium is low) and BLOOD CHLORIDE DECREASED (chloride is low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood chloride: low Low. On an unknown date, Blood creatinine: high High. On an unknown date, Blood glucose: 246 246. On an unknown date, Blood potassium: low Low. On an unknown date, Blood sodium: low Low. On an unknown date, Blood urea: high BUN is High.         No concomitant medication information provided. No treatment medication information provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Blood urea, Blood urea increased
Clinical narrative: glucose was 246; BUN is high; creatinine is high; sodium is low; potassium is low; chloride is low; This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low) and BLOOD POTASSIUM DECREASED (potassium is low) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (severe diabetic that takes insulin.). Concomitant products included INSULIN for Diabetes.   On 30-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low), BLOOD POTASSIUM DECREASED (potassium is low) and BLOOD CHLORIDE DECREASED (chloride is low). At the time of the report, BLOOD GLUCOSE ABNORMAL (glucose was 246), BLOOD UREA INCREASED (BUN is high), BLOOD CREATININE INCREASED (creatinine is high), BLOOD SODIUM DECREASED (sodium is low), BLOOD POTASSIUM DECREASED (potassium is low) and BLOOD CHLORIDE DECREASED (chloride is low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood chloride: low Low. On an unknown date, Blood creatinine: high High. On an unknown date, Blood glucose: 246 246. On an unknown date, Blood potassium: low Low. On an unknown date, Blood sodium: low Low. On an unknown date, Blood urea: high BUN is High.         No concomitant medication information provided. No treatment medication information provided.   Reporter did not allow further contact