chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a booster shot from an expired lot; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster shot from an expired lot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster shot from an expired lot). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received a booster shot from an expired lot) had resolved. Not Provided          No concomitants and treatment drugs were provided.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Any contact with my left arm vaccination site arm was very painful.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Any contact with my left arm vaccination site arm was very painful.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Any contact with my left arm vaccination site arm was very painful.). At the time of the report, VACCINATION SITE PAIN (Any contact with my left arm vaccination site arm was very painful.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-385869 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccines to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccines to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccines to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccines to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: COVID arm; itchiness arm pretty significantly; swelling arm pretty significantly; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (itchiness arm pretty significantly) and VACCINATION SITE SWELLING (swelling arm pretty significantly) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (itchiness arm pretty significantly) and VACCINATION SITE SWELLING (swelling arm pretty significantly). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (itchiness arm pretty significantly) and VACCINATION SITE SWELLING (swelling arm pretty significantly) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Vaccination Site Reaction and expected events of Vaccination Site Pruritus and Vaccination Site Swelling. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The events Vaccination Site Pruritus and Vaccination Site Swelling are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Vaccination Site Reaction and expected events of Vaccination Site Pruritus and Vaccination Site Swelling. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The events Vaccination Site Pruritus and Vaccination Site Swelling are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Day after second vaccine fever lasted for 24 hours/fever of 105 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Day after second vaccine fever lasted for 24 hours/fever of 105 degrees Farenheight) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Day after second vaccine fever lasted for 24 hours/fever of 105 degrees Farenheight). On 13-May-2021, PYREXIA (Day after second vaccine fever lasted for 24 hours/fever of 105 degrees Farenheight) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 105 (High) 105 degrees Fahrenheit.         Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-385864 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Fatigue, Headache, Injection site pain
Clinical narrative: Out of breath; Arm soreness; Headache; Felt tired; Got COVID-19 after 2 doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19 after 2 doses of Moderna COVID-19 vaccine), DYSPNOEA (Out of breath), INJECTION SITE PAIN (Arm soreness), HEADACHE (Headache) and FATIGUE (Felt tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypercholesterolemia and Prostate infection.   On an unknown date, the patient received first 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. In September 2021, the patient experienced COVID-19 (Got COVID-19 after 2 doses of Moderna COVID-19 vaccine). On an unknown date, the patient experienced DYSPNOEA (Out of breath), INJECTION SITE PAIN (Arm soreness), HEADACHE (Headache) and FATIGUE (Felt tired). In October 2021, COVID-19 (Got COVID-19 after 2 doses of Moderna COVID-19 vaccine) had resolved. At the time of the report, DYSPNOEA (Out of breath), INJECTION SITE PAIN (Arm soreness), HEADACHE (Headache) and FATIGUE (Felt tired) had resolved.            Concomitant medications include diabetic, cholesterol medicines, sugar pill, water pill, prostate medicine. All conditions are controlled. No treatment medications provided by the reporter.  Caller gotten both Moderna shots but his wife did not. Wife just got 1st Moderna shot on 10-Nov-2021. Mentioned that he got the shot about 8 months ago. Did not provide any information on the 2 shots he gotten (including the exact dates of vaccination, lot number and expiry date). Patient was quarantined for 10 days after diagnosed with COVID-19.  This spontaneous case concerns a 72-year-old male patient with no relevant medical history reported, who experienced non-serious unexpected event of special interest  COVID-19. The event occurred unspecified time after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a 72-year-old male patient with no relevant medical history reported, who experienced non-serious unexpected event of special interest  COVID-19. The event occurred unspecified time after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He had the first dose Moderna COVID19 Vaccine on 06Jan2021 and second dose on 16Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He had the first dose Moderna COVID19 Vaccine on 06Jan2021 and second dose on 16Feb2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013120A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He had the first dose Moderna COVID19 Vaccine on 06Jan2021 and second dose on 16Feb2021). On 16-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He had the first dose Moderna COVID19 Vaccine on 06Jan2021 and second dose on 16Feb2021) had resolved.            No concomitant medication information was reported.  No treatment medication information was reported.   This case was linked to MOD-2021-385844 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The contact is concerned she received the incorrect dose of vaccine.; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (The contact is concerned she received the incorrect dose of vaccine.) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 001B21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Metastatic breast cancer. Concomitant products included ANASTROZOLE, FULVESTRANT and DENOSUMAB for Metastatic breast cancer.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (The contact is concerned she received the incorrect dose of vaccine.). On 27-Oct-2021, INCORRECT DOSE ADMINISTERED (The contact is concerned she received the incorrect dose of vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She has not experienced any known symptoms. The contact has discussed the dosage with her infectious disease person who pointed out her medications are not immunosuppressive but are more hormonal.  Concomitant medication use was unknown Treatment information was unknown
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat,  12 hours after the vaccine,very painful sore throat, still haves it.; And when they take large breaths, deep breaths,  it hurts; Last night, was horrible, they had fever and chills, and all seem to be gone this mooring; Last night, was horrible, they had  fever and chills, and  all seem  to be gone this mooring; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat,  12 hours after the vaccine,very painful sore throat, still haves it.), DYSPNOEA (And when they take large breaths, deep breaths,  it hurts), PYREXIA (Last night, was horrible, they had fever and chills, and all seem to be gone this mooring) and CHILLS (Last night, was horrible, they had  fever and chills, and  all seem  to be gone this mooring) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034f22a and 039k20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to aspirin) and Penicillin allergy.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced PYREXIA (Last night, was horrible, they had fever and chills, and all seem to be gone this mooring) and CHILLS (Last night, was horrible, they had  fever and chills, and  all seem  to be gone this mooring). On 12-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat,  12 hours after the vaccine,very painful sore throat, still haves it.) and DYSPNOEA (And when they take large breaths, deep breaths,  it hurts). On 12-Nov-2021, PYREXIA (Last night, was horrible, they had fever and chills, and all seem to be gone this mooring) and CHILLS (Last night, was horrible, they had  fever and chills, and  all seem  to be gone this mooring) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat,  12 hours after the vaccine,very painful sore throat, still haves it.) had not resolved and DYSPNOEA (And when they take large breaths, deep breaths,  it hurts) 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 medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: got the full 0.5 ml instead of the booster dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (got the full 0.5 ml instead of the booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (got the full 0.5 ml instead of the booster dose). At the time of the report, ACCIDENTAL OVERDOSE (got the full 0.5 ml instead of the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.  This is a case of Accidental Overdose concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other adverse events. The event occurred the same day after receiving the third dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Accidental Overdose concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other adverse events. The event occurred the same day after receiving the third dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I had a boom, boom, boom that switching to a thumping noise.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (I had a boom, boom, boom that switching to a thumping noise.) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 025321A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (I had a boom, boom, boom that switching to a thumping noise.). At the time of the report, TINNITUS (I had a boom, boom, boom that switching to a thumping noise.) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain started kind of mild; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain started kind of mild) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced CHEST PAIN (Chest pain started kind of mild). At the time of the report, CHEST PAIN (Chest pain started kind of mild) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-385727 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cough, Headache, Malaise, Rhinorrhoea, Wheezing
Clinical narrative: been feeling sick ever since getting the Moderna vaccine; runny nose; Coughing; wheezing; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (been feeling sick ever since getting the Moderna vaccine ), RHINORRHOEA (runny nose), COUGH (Coughing), WHEEZING (wheezing) and HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (been feeling sick ever since getting the Moderna vaccine ), RHINORRHOEA (runny nose), COUGH (Coughing), WHEEZING (wheezing) and HEADACHE (headaches). At the time of the report, MALAISE (been feeling sick ever since getting the Moderna vaccine ), RHINORRHOEA (runny nose), COUGH (Coughing), WHEEZING (wheezing) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided by the reporter  It was reported that patient took multiple medications.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were give the dose of the Moderna COVID 19 vaccine that expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were give the dose of the Moderna COVID 19 vaccine that expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were give the dose of the Moderna COVID 19 vaccine that expired). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients were give the dose of the Moderna COVID 19 vaccine that expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. on 10-Sep-2021 vial was initially refrigerated. hadn't undergo any temperature excursions.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast tenderness
Clinical narrative: Bilateral breast tenderness; Lump in her armpit; This spontaneous case was reported by a consumer and describes the occurrence of BREAST TENDERNESS (Bilateral breast tenderness) and AXILLARY MASS (Lump in her armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST TENDERNESS (Bilateral breast tenderness) and AXILLARY MASS (Lump in her armpit). At the time of the report, BREAST TENDERNESS (Bilateral breast tenderness) and AXILLARY MASS (Lump in her armpit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Fully vaccinated with Moderna and contracted Covid19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Fully vaccinated with Moderna and contracted Covid19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Fully vaccinated with Moderna and contracted Covid19). At the time of the report, COVID-19 (Fully vaccinated with Moderna and contracted Covid19) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.  Company comment:This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) COVID-19. The event occurred unspecified time after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) COVID-19. The event occurred unspecified time after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: soreness; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness), PYREXIA (Fever) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, MYALGIA (soreness), PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that the Patient had experienced classic symptoms soreness, fever, headache for a day and a half
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received full dose of Moderna vaccine one month after booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received full dose of Moderna vaccine one month after booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (received full dose of Moderna vaccine one month after booster). At the time of the report, EXTRA DOSE ADMINISTERED (received full dose of Moderna vaccine one month after booster) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On Mar/2021, the patient received first dose of Johnson & Johnson vaccine (Intramuscular) 1 dosage form for COVID-19 vaccination.  Pharmacist states she and her husband received Johnson & Johnson 1 dose COVID-19 vaccine in March and a Moderna booster last month. They both then received a second full dose of Moderna 4 weeks later.  No concomitant medications were provided.  No treatment medications were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus, Vaccination site pain
Clinical narrative: light ringing in both ears; Pain in foot; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (light ringing in both ears), PAIN IN EXTREMITY (Pain in foot) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-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 TINNITUS (light ringing in both ears), PAIN IN EXTREMITY (Pain in foot) and VACCINATION SITE PAIN (arm was sore at the injection site). At the time of the report, TINNITUS (light ringing in both ears), PAIN IN EXTREMITY (Pain in foot) and VACCINATION SITE PAIN (arm was sore at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  The patient had pain in foot and ended up getting a steroid injection for foot. Might be because of it went away.   This case was linked to MOD-2021-386085, MOD-2021-386089 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 10/27/21 or 8 days after we received it / second patient booster dose of .25ml; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 10/27/21 or 8 days after we received it / second patient booster dose of .25ml) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 10/27/21 or 8 days after we received it / second patient booster dose of .25ml). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 10/27/21 or 8 days after we received it / second patient booster dose of .25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient received vaccine which was expired on 27-Oct-2021 or 8 days after the reporter received it. The patient did not have any adverse reactions.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: tested positive for Covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tested positive for Covid) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Completed treatment).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) positive. On 20-Sep-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  It was reported patient was 73 and just completed treatment for breast cancer  This case concerns a 73-year-old patient of unknown gender with a relevant medical history of Breast cancer with recent treatment, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 5 months after the second dose of mRNA- 1273 vaccine, exact schedule of vaccination was not reported. SARS-Co-2 test was positive. Very limited information regarding clinical course was provided. After 17 days, SARS-CoV-2 test turned negative. The rechallenge is not applicable due to the nature of the event.  Patient´s age and Breast cancer may be confounders, since they could be risk factors for severe COVID-19. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 73-year-old patient of unknown gender with a relevant medical history of Breast cancer with recent treatment, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 5 months after the second dose of mRNA- 1273 vaccine, exact schedule of vaccination was not reported. SARS-Co-2 test was positive. Very limited information regarding clinical course was provided. After 17 days, SARS-CoV-2 test turned negative. The rechallenge is not applicable due to the nature of the event.  Patient´s age and Breast cancer may be confounders, since they could be risk factors for severe COVID-19. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-386359 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis flared up again after the booster; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis flared up again after the booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019FZIA, 007BZIA and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Patient further stated that he has a history of arthritis as well.).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ARTHRITIS (Arthritis flared up again after the booster). At the time of the report, ARTHRITIS (Arthritis flared up again after the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  This spontaneous case concerns a male patient of unknown age with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) arthritis. The event occurred unspecified time after both the second and the booster dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was positive since the event reoccurred after the second and the booster dose.  The benefit-risk relationship of drug is not affected by this report.  Patient also stated he was a senior citizen and did not want to disclose his age or DOB   This case was linked to MOD-2021-386226 (Patient Link).; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) arthritis. The event occurred unspecified time after both the second and the booster dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was positive since the event reoccurred after the second and the booster dose.  The benefit-risk relationship of drug is not affected by this report.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Muscle aches; Fatigue; General pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at the site of injection) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) 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 MYALGIA (Muscle aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at the site of injection). At the time of the report, MYALGIA (Muscle aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Chills, Fall
Clinical narrative: Fell yesterday; Sinus pain; Watery eyes; Been in a fog since the shot; Fever alternating with chills; Muscle and joint aches/Ached all over; Pounding headache; Fever alternating with chills; Muscle and joint aches; My speech has been affected; Balance is off; Sinus drainage; Sore throat; Feels weak; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (My speech has been affected), BALANCE DISORDER (Balance is off), RHINORRHOEA (Sinus drainage), OROPHARYNGEAL PAIN (Sore throat) and ASTHENIA (Feels weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061F21A, 015M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced SPEECH DISORDER (My speech has been affected), BALANCE DISORDER (Balance is off), RHINORRHOEA (Sinus drainage), OROPHARYNGEAL PAIN (Sore throat), ASTHENIA (Feels weak), SINUS PAIN (Sinus pain), LACRIMATION INCREASED (Watery eyes), FEELING ABNORMAL (Been in a fog since the shot), PYREXIA (Fever alternating with chills), MYALGIA (Muscle and joint aches/Ached all over), HEADACHE (Pounding headache), CHILLS (Fever alternating with chills) and ARTHRALGIA (Muscle and joint aches). On 11-Nov-2021, the patient experienced FALL (Fell yesterday). At the time of the report, SPEECH DISORDER (My speech has been affected), BALANCE DISORDER (Balance is off), RHINORRHOEA (Sinus drainage), OROPHARYNGEAL PAIN (Sore throat), ASTHENIA (Feels weak), FALL (Fell yesterday), SINUS PAIN (Sinus pain), LACRIMATION INCREASED (Watery eyes), FEELING ABNORMAL (Been in a fog since the shot), PYREXIA (Fever alternating with chills), MYALGIA (Muscle and joint aches/Ached all over), HEADACHE (Pounding headache), CHILLS (Fever alternating with chills) and ARTHRALGIA (Muscle and joint aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient took Tylenol, but at 2 AM needed to take two more Tylenol.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lacrimation increased, Myalgia, Oropharyngeal pain
Clinical narrative: Fell yesterday; Sinus pain; Watery eyes; Been in a fog since the shot; Fever alternating with chills; Muscle and joint aches/Ached all over; Pounding headache; Fever alternating with chills; Muscle and joint aches; My speech has been affected; Balance is off; Sinus drainage; Sore throat; Feels weak; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (My speech has been affected), BALANCE DISORDER (Balance is off), RHINORRHOEA (Sinus drainage), OROPHARYNGEAL PAIN (Sore throat) and ASTHENIA (Feels weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061F21A, 015M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced SPEECH DISORDER (My speech has been affected), BALANCE DISORDER (Balance is off), RHINORRHOEA (Sinus drainage), OROPHARYNGEAL PAIN (Sore throat), ASTHENIA (Feels weak), SINUS PAIN (Sinus pain), LACRIMATION INCREASED (Watery eyes), FEELING ABNORMAL (Been in a fog since the shot), PYREXIA (Fever alternating with chills), MYALGIA (Muscle and joint aches/Ached all over), HEADACHE (Pounding headache), CHILLS (Fever alternating with chills) and ARTHRALGIA (Muscle and joint aches). On 11-Nov-2021, the patient experienced FALL (Fell yesterday). At the time of the report, SPEECH DISORDER (My speech has been affected), BALANCE DISORDER (Balance is off), RHINORRHOEA (Sinus drainage), OROPHARYNGEAL PAIN (Sore throat), ASTHENIA (Feels weak), FALL (Fell yesterday), SINUS PAIN (Sinus pain), LACRIMATION INCREASED (Watery eyes), FEELING ABNORMAL (Been in a fog since the shot), PYREXIA (Fever alternating with chills), MYALGIA (Muscle and joint aches/Ached all over), HEADACHE (Pounding headache), CHILLS (Fever alternating with chills) and ARTHRALGIA (Muscle and joint aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient took Tylenol, but at 2 AM needed to take two more Tylenol.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Sinus pain, Speech disorder
Clinical narrative: Fell yesterday; Sinus pain; Watery eyes; Been in a fog since the shot; Fever alternating with chills; Muscle and joint aches/Ached all over; Pounding headache; Fever alternating with chills; Muscle and joint aches; My speech has been affected; Balance is off; Sinus drainage; Sore throat; Feels weak; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (My speech has been affected), BALANCE DISORDER (Balance is off), RHINORRHOEA (Sinus drainage), OROPHARYNGEAL PAIN (Sore throat) and ASTHENIA (Feels weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061F21A, 015M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced SPEECH DISORDER (My speech has been affected), BALANCE DISORDER (Balance is off), RHINORRHOEA (Sinus drainage), OROPHARYNGEAL PAIN (Sore throat), ASTHENIA (Feels weak), SINUS PAIN (Sinus pain), LACRIMATION INCREASED (Watery eyes), FEELING ABNORMAL (Been in a fog since the shot), PYREXIA (Fever alternating with chills), MYALGIA (Muscle and joint aches/Ached all over), HEADACHE (Pounding headache), CHILLS (Fever alternating with chills) and ARTHRALGIA (Muscle and joint aches). On 11-Nov-2021, the patient experienced FALL (Fell yesterday). At the time of the report, SPEECH DISORDER (My speech has been affected), BALANCE DISORDER (Balance is off), RHINORRHOEA (Sinus drainage), OROPHARYNGEAL PAIN (Sore throat), ASTHENIA (Feels weak), FALL (Fell yesterday), SINUS PAIN (Sinus pain), LACRIMATION INCREASED (Watery eyes), FEELING ABNORMAL (Been in a fog since the shot), PYREXIA (Fever alternating with chills), MYALGIA (Muscle and joint aches/Ached all over), HEADACHE (Pounding headache), CHILLS (Fever alternating with chills) and ARTHRALGIA (Muscle and joint aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient took Tylenol, but at 2 AM needed to take two more Tylenol.