chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID 19 infection), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION FAILURE (Vaccination failure) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033h21a and 076c21a) for Prophylactic vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination. No Medical History information was reported. On 07-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, the patient experienced COVID-19 (COVID 19 infection). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (COVID 19 infection), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION FAILURE (Vaccination failure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive. The concomitant medication was not reported by reporter. On 19-May-2022, the patient tested positive for Covid-19 and had runny nose at same time (dose number in series 2). This led to suspected clinical vaccination failure (dose number in series 1). The report was associated with product quality complaint. Janssen assessed the event of suspected COVID-19 infection to be possible. The treatment medication was not reported by reporter. Company comment: This case concerns a 46-year-old female patient with medical history of interchange of vaccine products, who experienced the adverse event of special interest of COVID-19 4 months after the third dose of mRNA-1273. Additionally, vaccination failure was also reported. Prior vaccination with JANSSEN COVID-19 vaccine is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a 46-year-old female patient with medical history of interchange of vaccine products, who experienced the adverse event of special interest of COVID-19 4 months after the third dose of mRNA-1273. Additionally, vaccination failure was also reported. Prior vaccination with JANSSEN COVID-19 vaccine is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Expired vaccine was administered to total of 24 patients including 15 males and 9 females. It was reported administrations were mostly for booster shots. No side effects were reported.  Treatment medication was not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID infection) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049121A) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol and Allergy NOS (Allergic reaction with an unknown drug). Concomitant products included ROSUVASTATIN from 21-May-2022 to an unknown date for High cholesterol. On 02-May-2022 at 3:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022 at 12:00 PM, the patient experienced COVID-19 (COVID  infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 for COVID-19 prophylaxis, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID  infection) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Race of the patient was reported as Caucasian. DOB for the patient is Apr-1961. The patient was taking any other medications or products within 2 weeks of starting COVID-19 treatment. The patient was on (Rosuvastatin, did not took during Paxlovid treatment days). Company comment: This spontaneous case concerns a 61-year-old, male patient with medical history of High cholesterol, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 32 days after administration of fourth dose of mRNA-1273. There was no information provided regarding the initial three doses. Patient was started on Paxlovid treatment regimen on May 24-29, 2022, 5 days later the symptoms runny nose and nasal congestion recurred. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. It was reported that Covid rebound- mild symptoms returned at 10 days after beginning of Paxlovid treatment, including runny nose, congestion, no fever. Rebound symptoms somewhat milder. Device Date was reported as 03 Jun 2022. Sender's Comments: This spontaneous case concerns a 61-year-old, male patient with medical history of High cholesterol, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 32 days after administration of fourth dose of mRNA-1273. There was no information provided regarding the initial three doses. Patient was started on Paxlovid treatment regimen on May 24-29, 2022, 5 days later the symptoms runny nose and nasal congestion recurred. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Surgery (from 30 years ago botched surgery). Concurrent medical conditions included Diarrhea (Since 1992, the patient had ongoing diarrhea).   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site) (seriousness criterion medically significant). In February 2021, VACCINATION SITE PAIN (sore arm at injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant details were provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment details were provided. Company comment: This spontaneous case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) event of Vaccination site pain. The exact date of onset of the event was not specified in respect to the administration of first dose of mRNA-1273, hence latency could not be assessed. Details of concomitant medications, clinical course and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per source document.   This case was linked to MOD-2022-584726, MOD-2022-584795, MOD-2022-584796 (Patient Link).; Sender's Comments: This spontaneous case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) event of Vaccination site pain. The exact date of onset of the event was not specified in respect to the administration of first dose of mRNA-1273, hence latency could not be assessed. Details of concomitant medications, clinical course and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per source document.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive home covid test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive home covid test) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Drug allergy.    On 19-May-2022 at 6:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive home covid test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 27-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive home covid test) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive home COVID-19 test.         Test was taken due to another family member who tested positive. No concomitant drug reported.  Company Comment: This spontaneous case reported by consumer concerns a patient of unknown age and gender, with no relevant medical history, who experienced unexpected, non-serious AESI Covid19 after receiving a fourth dose of mRNA-1273.  Around 4 days post-vaccination, the patient was treated with a 5-day course of Nirmatrelvir/Ritonavir (Paxlovid).  However, approximately 1 week later the patient had a family member who tested positive, hence the patient re-tested and was positive again on a home Covid19 test.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by consumer concerns a patient of unknown age and gender, with no relevant medical history, who experienced unexpected, non-serious AESI Covid19 after receiving a fourth dose of mRNA-1273.  Around 4 days post-vaccination, the patient was treated with a 5-day course of Nirmatrelvir/Ritonavir (Paxlovid).  However, approximately 1 week later the patient had a family member who tested positive, hence the patient re-tested and was positive again on a home Covid19 test.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Mobility decreased, Pyrexia
Clinical narrative: This spontaneous case reported by a patient's family member or friend, describes the occurrence of decreased mobility (doesn't feel like getting up to move about), pyrexia (temperature of 101.5ºF) and fatigue in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 8, 2022, patient experienced decreased mobility (doesn't feel like getting up to move about), pyrexia (he has a temperature of 101.5ºF) and fatigue. At the time of the report, decreased mobility (doesn't feel like getting up to move about), pyrexia (temperature of 101.5ºF) and fatigue outcome: unknown. Diagnostic results: Jun 8, 2022, body temperature: 101.5 (high) 101.5ºF. The action taken with mRNA-1273 (Moderna COVID-19 vaccine); intramuscular: unknown. No concomitant medication or treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Consumer also mentioned tinnitus and hearing problems One side of the head, it sounds like throbbing", "booming" and "whoosh"; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TINNITUS (Consumer also mentioned tinnitus and hearing problems One side of the head, it sounds like throbbing", "booming" and "whoosh") in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Consumer also mentioned tinnitus and hearing problems One side of the head, it sounds like throbbing", "booming" and "whoosh"). At the time of the report, TINNITUS (Consumer also mentioned tinnitus and hearing problems One side of the head, it sounds like throbbing", "booming" and "whoosh") outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. Patient had to get hearing aid and had to put it on.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound infection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 047B21A and 046A21A) for COVID-19 vaccination.     The patient had no known allergies.  Concurrent medical conditions included Cancer, Diabetes and Asplenia. Concomitant products included PANCREATIN (CREON) from 07-Nov-2017 to an unknown date, METFORMIN HCL from April 2018 to an unknown date and BENZONATATE from 26-May-2022 to 02-Jun-2022 for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Rebound infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 31-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2022, SARS-CoV-2 test: positive Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had rebound infection of COVID-19 on 06-Jun-2022.  Device Date was reported as 06-Jun-2022. Company comment This spontaneous case reported by a patient, concerns a 63-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 infection, on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine. Latency between vaccination and onset of the event could not be assessed. It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) from 26-May-2022 for COVID-19 treatment for 6 days. Details of the onset date, lab results and symptoms of this initial COVID-19 infection was not reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient, concerns a 63-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 infection, on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine. Latency between vaccination and onset of the event could not be assessed. It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) from 26-May-2022 for COVID-19 treatment for 6 days. Details of the onset date, lab results and symptoms of this initial COVID-19 infection was not reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: adverse effect because others had similar reaction/others are having the same symptoms; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (adverse effect because others had similar reaction/others are having the same symptoms) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (adverse effect because others had similar reaction/others are having the same symptoms). At the time of the report, IMMUNISATION REACTION (adverse effect because others had similar reaction/others are having the same symptoms) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No relevant concomitant medications were reported.  No treatment information was provided.  The patient states that she saw nothing online how to help, but now she was seeing articles that suggest this was an adverse effect because others had similar reaction. She was suspicious that this is an adverse effect, so she would like it reported. The patient stated she was happy that Moderna produced this vaccine. She was important that others are having the same symptoms and to report it to make it as safe as possible.   This case was linked to MOD-2021-261769, MOD-2022-585174 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0342F1A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Chronic fatigue, Restless legs, Post-traumatic stress disorder and Allergy to antibiotic (Vancomycin). Concomitant products included PACLITAXEL from 21-May-2022 to 29-May-2022 for an unknown indication.    On 07-Nov-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency; METHYLPREDNISOLONE at a dose of 4 milligram and DOXYCYCLINE MONOHYDRATE at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.            On 21-MAY-2022, Patient received Cough medicine and medicine was stopped on 27-MAY-2022. On 6-JUN-2022, the 16th day after start of COVID symptoms patient experienced fever, chills, body ache, diarrhea, headache, fatigue and appetite loss which were resolved. She became very fatigued and got a fever. She had issues with breathing.  Company Comment: This is a spontaneous case concerning a 72-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 4 days. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 4 days. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received dose 23 hours post puncture at room temperature; Expired dose administered (one patient); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered (one patient)) and PRODUCT STORAGE ERROR (Patient received dose 23 hours post puncture at room temperature) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE BESILATE (NORVASC) and CHLORTALIDONE (CHLORTHALIDONE) for an unknown indication.   On 11-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Jun-2022 at 8:00 AM, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2022 at 8:00 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered (one patient)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose 23 hours post puncture at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered (one patient)) and PRODUCT STORAGE ERROR (Patient received dose 23 hours post puncture at room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated about stability issues and informed that one patient received the vaccine 23 hours post puncture. On 24-May-2022, the vial was initially stored in the refrigerator. On 07-Jun-2022 at 8:30 am the vial was first punctured. Post puncture the vial was stored at room temperature. The vial did not undergo any temperature excursions. The expiration date for the 2nd dose was not provided. The beyond used date reported as 21Jun2022.  No treatment drug details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up contains Reporter email address, Patient details, 1st dose details of suspect product, concomitant medications.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine was stored in refrigerator on same date of Administration.; patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on same date of Administration.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on same date of Administration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on same date of Administration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Date of the vial initially stored was reported as same as administration date. The vial was pulled from freezer and thawed in room temperature on the day of vaccination, then discarded. It was reported that the vial did not undergo any temperature excursions. No treatment drug was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Vaccine beyond MFG Expiry Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond MFG Expiry Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond MFG Expiry Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond MFG Expiry Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.     The vial did not undergo any temperature excursions. The vaccine administered on 02-DEC-2021 involved only 1 patient.  No treatment information was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Dyspnoea
Clinical narrative: Blisters popping up; Patient was not breathing good and had to go to a pulmonary doctor; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters popping up) and DYSPNOEA (Patient was not breathing good and had to go to a pulmonary doctor) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 017BZIA) for COVID-19 vaccination.     The patient had no allergies and no illness.  The patient had not ever tested or diagnosed COVID-19.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BLISTER (Blisters popping up) and DYSPNOEA (Patient was not breathing good and had to go to a pulmonary doctor). At the time of the report, BLISTER (Blisters popping up) and DYSPNOEA (Patient was not breathing good and had to go to a pulmonary doctor) had not resolved. No Concomitant medications were reported. Patient stated he want to get to the bottom of this because patient still have side effects. patient had been to hospital twice. Treatment included antibiotics.   This case was linked to MOD-2022-585358 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of the Moderna Covid-19 vaccine on 07Oct2021. He came back 10May2022 & I started his regimen again & gave 0.5mL of Moderna Covid-19 vaccine/ He came back 10May2022 & I started his regimen again.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna Covid-19 vaccine on 07Oct2021. He came back 10May2022 & I started his regimen again & gave 0.5mL of Moderna Covid-19 vaccine/ He came back 10May2022 & I started his regimen again.) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 10-May-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 10-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna Covid-19 vaccine on 07Oct2021. He came back 10May2022 & I started his regimen again & gave 0.5mL of Moderna Covid-19 vaccine/ He came back 10May2022 & I started his regimen again.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna Covid-19 vaccine on 07Oct2021. He came back 10May2022 & I started his regimen again & gave 0.5mL of Moderna Covid-19 vaccine/ He came back 10May2022 & I started his regimen again.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had some soreness which was expected on arm with the first three arm injections; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Had some soreness which was expected on arm with the first three arm injections) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 024M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to chemicals (IV dye allergy), Drug allergy (Vicodin allergy), Blood pressure high (No recent changes in condition status), Thyroid disorder (No recent changes in condition status), High cholesterol (No recent changes in condition status), GERD (No recent changes in condition status) and Rheumatoid arthritis (No recent changes in condition status). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for Blood pressure high, OMEPRAZOLE for GERD, SIMVASTATIN for High cholesterol, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Had some soreness which was expected on arm with the first three arm injections). At the time of the report, VACCINATION SITE PAIN (Had some soreness which was expected on arm with the first three arm injections) outcome was unknown. Not Provided          Patient height was reported as 5 inch. Patient did not have any acute illness at the time of vaccination and up to one month before. Patient neither diagnosed with COVID-19 nor tested positive.  Treatment medications were not reported.   This case was linked to MOD-2022-580164, MOD-2022-585326, MOD-2022-585328, MOD-2022-580263 (Patient Link).
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022; Expired doses administered beyond the BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient took 2nd booster of Moderna and took total 4 doses. Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion. No treatment information was reported .
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired dose administered beyond-use-date) and product storage error (vial refrigerated Feb 7, 2022; administered Apr 18, 2022) in an 86-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 083J21A) for COVID-19  immunization. No medical history reported. On Apr 18, 2022, patient received the fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 18, 2022, patient administered expired product (expired dose administered beyond-use-date). On an unknown date, patient experienced product storage error (vial refrigerated Feb 7, 2022; administered Apr 18, 2022). At the time of the report, administered expired product (expired dose administered beyond-use-date) and product storage error (vial refrigerated Feb 7, 2022; administered Apr 18, 2022) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient received a total of 4 doses (second booster). The vial initially stored in the refrigerator Feb 7, 2022, did not undergo temperature excursions.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: had some soreness which was expected on arm with the first three arm injections; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (had some soreness which was expected on arm with the first three arm injections) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 prophylaxis.     The patient had not ever been diagnosed with/ tested positive for COVID-19.  Patient had no acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Penicillin allergy, Contrast media allergy (IV dye allergy), Drug allergy (Vicodin allergy), Blood pressure high (No recent changes in condition status), Thyroid disorder (No recent changes in condition status), High cholesterol (No recent changes in condition status), GERD (No recent changes in condition status), Rheumatoid arthritis (No recent changes in condition status) and Arthritis (No recent changes in condition status). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for Blood pressure high, OMEPRAZOLE for GERD, SIMVASTATIN for High cholesterol, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Rheumatoid arthritis and Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, AMLODIPINE BESYLATE, VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS], FISH OIL and UBIDECARENONE (COQ-10) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-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 VACCINATION SITE PAIN (had some soreness which was expected on arm with the first three arm injections). At the time of the report, VACCINATION SITE PAIN (had some soreness which was expected on arm with the first three arm injections) outcome was unknown.            Treatment medications were not reported.   This case was linked to MOD-2022-580164, MOD-2022-585302, MOD-2022-585328, MOD-2022-580263.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: had some soreness which was expected on arm with the first three arm injections; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (had some soreness which was expected on arm with the first three arm injections) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 prophylaxis.     The patient had not ever been diagnosed with/ tested positive for COVID-19.  Patient had no acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Penicillin allergy, Contrast media allergy (IV dye allergy), Drug allergy (Vicodin allergy), Blood pressure high (No recent changes in condition status), Thyroid disorder (No recent changes in condition status), High cholesterol (No recent changes in condition status), GERD (No recent changes in condition status), Rheumatoid arthritis (No recent changes in condition status) and Arthritis (No recent changes in condition status). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for Blood pressure high, OMEPRAZOLE for GERD, SIMVASTATIN for High cholesterol, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Rheumatoid arthritis and Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, AMLODIPINE BESYLATE, VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS], FISH OIL and UBIDECARENONE (COQ-10) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-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 VACCINATION SITE PAIN (had some soreness which was expected on arm with the first three arm injections). At the time of the report, VACCINATION SITE PAIN (had some soreness which was expected on arm with the first three arm injections) outcome was unknown.            Treatment medications were not reported.   This case was linked to MOD-2022-580164, MOD-2022-585302, MOD-2022-585328, MOD-2022-580263.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: some soreness which was expected on arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (some soreness which was expected on arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient was never been diagnosed with/ tested positive for COVID-19. The patient did not have any acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Penicillin allergy, Allergy to intravenous contrast media (IV dye), Drug allergy (vicodin), Blood pressure high (There was no recent changes), Thyroid disorder (There was no recent changes), High cholesterol (There was no recent changes), GERD (There was no recent changes) and Rheumatoid arthritis (There was no recent changes). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN, OMEPRAZOLE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), AMLODIPINE BESYLATE, ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), MULTIVITAMIN [VITAMINS NOS], FISH OIL and UBIDECARENONE (COQ 10) for an unknown indication.    On 28-Jan-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 (some soreness which was expected on arm). At the time of the report, PAIN IN EXTREMITY (some soreness which was expected on arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided by the reporter.   This case was linked to MOD-2022-580164, MOD-2022-585302, MOD-2022-585326, MOD-2022-580263 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: some soreness which was expected on arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (some soreness which was expected on arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient was never been diagnosed with/ tested positive for COVID-19. The patient did not have any acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Penicillin allergy, Allergy to intravenous contrast media (IV dye), Drug allergy (vicodin), Blood pressure high (There was no recent changes), Thyroid disorder (There was no recent changes), High cholesterol (There was no recent changes), GERD (There was no recent changes) and Rheumatoid arthritis (There was no recent changes). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN, OMEPRAZOLE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), AMLODIPINE BESYLATE, ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), MULTIVITAMIN [VITAMINS NOS], FISH OIL and UBIDECARENONE (COQ 10) for an unknown indication.    On 28-Jan-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 (some soreness which was expected on arm). At the time of the report, PAIN IN EXTREMITY (some soreness which was expected on arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided by the reporter.   This case was linked to MOD-2022-580164, MOD-2022-585302, MOD-2022-585326, MOD-2022-580263 (Patient Link).
Age: 91.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022; Expired doses administered beyond the BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) in a 91-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient took 2nd booster of Moderna and took total 4 doses. Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion. No treatment information was reported .
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials put in fridge on 07Feb2022 and administered on 13 Apr 2022; expired doses of Moderna COVID-19 administered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vials put in fridge on 07Feb2022 and administered on 13 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 administered beyond the beyond use date) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 administered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials put in fridge on 07Feb2022 and administered on 13 Apr 2022). At the time of the report, PRODUCT STORAGE ERROR (Vials put in fridge on 07Feb2022 and administered on 13 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 administered beyond the beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient had received total 4 doses. Total, 22 doses were administered from a few different vials.  The vial did not undergo any temperature excursions. Treatment medications were not reported.