chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Vaccination site pain
Clinical narrative: Arm hurt all night; Patient received 3rd dose of Moderna vaccine but is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt all night) and EXTRA DOSE ADMINISTERED (Patient received 3rd dose of Moderna vaccine but is not immunocompromised) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 032M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt all night). 07-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received 3rd dose of Moderna vaccine but is not immunocompromised). On 07-Oct-2021, EXTRA DOSE ADMINISTERED (Patient received 3rd dose of Moderna vaccine but is not immunocompromised) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm hurt all night) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: A patient was positive for covid after receiving 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (A patient was positive for covid after receiving 1st dose) 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 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced COVID-19 (A patient was positive for covid after receiving 1st dose). At the time of the report, COVID-19 (A patient was positive for covid after receiving 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Sep-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive..   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a female patient, unknown age, with no disclosed medical history, who experienced the non-serious, unexpected, AESI event of Covid-19. The event occurred  11 days after first dose of Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), PERIPHERAL SWELLING (arm was a little swollen) and PYREXIA (felt like having a little fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt), PERIPHERAL SWELLING (arm was a little swollen) and PYREXIA (felt like having a little fever). At the time of the report, PAIN IN EXTREMITY (arm hurt), PERIPHERAL SWELLING (arm was a little swollen) and PYREXIA (felt like having a little fever) outcome was unknown.            No treatment medications were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: receiving 2nd dose from a expired vaccine; wrong interval of days between doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving 2nd dose from a expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wrong interval of days between doses) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038c21a and 037c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving 2nd dose from a expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wrong interval of days between doses). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (receiving 2nd dose from a expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wrong interval of days between doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were provided. No treatment information were provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine as a 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received on 12-Oct-2021: Added facility type, Patient Initials and anatomical location of Suspect product.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spells) 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 DIZZINESS (dizzy spells). At the time of the report, DIZZINESS (dizzy spells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-346520 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Extra dose administered; fever; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and PYREXIA (fever) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 031M20A and 014F21A) for COVID-19 vaccination.     "No medical history was provided by the reporter.".  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and FENOFIBRATE for an unknown indication.   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 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered) and PYREXIA (fever). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) outcome was unknown and PYREXIA (fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were reported i.e., blood pressure medication No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: FU email includes NNI.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye pain, Eye pruritus, Fatigue, Headache
Clinical narrative: Still sick; Itchy throat; Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds; Eyes are crying/watery eyes; Itchy eyes; Sinus pressure; Eyes hurt; Teeth hurt; Ear hurt; severe allergic reaction; Felt like head was exploding; Swollen arm; Very tired/kind of tired; Pain in my arm/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), ILLNESS (Still sick) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Sinusitis (Sinus allergies).    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PAIN IN EXTREMITY (Pain in my arm/sore arm) and FATIGUE (Very tired/kind of tired). On 02-Oct-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). On 04-Oct-2021, the patient experienced RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), PARANASAL SINUS DISCOMFORT (Sinus pressure), EYE PAIN (Eyes hurt), TOOTHACHE (Teeth hurt), EAR PAIN (Ear hurt), HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (Felt like head was exploding). On 06-Oct-2021, the patient experienced THROAT IRRITATION (Itchy throat). On 08-Oct-2021, the patient experienced ILLNESS (Still sick). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 mg. On 02-Oct-2021, PAIN IN EXTREMITY (Pain in my arm/sore arm) and FATIGUE (Very tired/kind of tired) had resolved. On 04-Oct-2021, PERIPHERAL SWELLING (Swollen arm) had resolved. On 06-Oct-2021, THROAT IRRITATION (Itchy throat) had resolved. At the time of the report, RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), ILLNESS (Still sick), PARANASAL SINUS DISCOMFORT (Sinus pressure), EYE PAIN (Eyes hurt), TOOTHACHE (Teeth hurt), EAR PAIN (Ear hurt), HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (Felt like head was exploding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Illness, Lacrimation increased, Pain in extremity, Paranasal sinus discomfort
Clinical narrative: Still sick; Itchy throat; Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds; Eyes are crying/watery eyes; Itchy eyes; Sinus pressure; Eyes hurt; Teeth hurt; Ear hurt; severe allergic reaction; Felt like head was exploding; Swollen arm; Very tired/kind of tired; Pain in my arm/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), ILLNESS (Still sick) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Sinusitis (Sinus allergies).    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PAIN IN EXTREMITY (Pain in my arm/sore arm) and FATIGUE (Very tired/kind of tired). On 02-Oct-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). On 04-Oct-2021, the patient experienced RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), PARANASAL SINUS DISCOMFORT (Sinus pressure), EYE PAIN (Eyes hurt), TOOTHACHE (Teeth hurt), EAR PAIN (Ear hurt), HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (Felt like head was exploding). On 06-Oct-2021, the patient experienced THROAT IRRITATION (Itchy throat). On 08-Oct-2021, the patient experienced ILLNESS (Still sick). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 mg. On 02-Oct-2021, PAIN IN EXTREMITY (Pain in my arm/sore arm) and FATIGUE (Very tired/kind of tired) had resolved. On 04-Oct-2021, PERIPHERAL SWELLING (Swollen arm) had resolved. On 06-Oct-2021, THROAT IRRITATION (Itchy throat) had resolved. At the time of the report, RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), ILLNESS (Still sick), PARANASAL SINUS DISCOMFORT (Sinus pressure), EYE PAIN (Eyes hurt), TOOTHACHE (Teeth hurt), EAR PAIN (Ear hurt), HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (Felt like head was exploding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rhinorrhoea, Throat irritation, Toothache
Clinical narrative: Still sick; Itchy throat; Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds; Eyes are crying/watery eyes; Itchy eyes; Sinus pressure; Eyes hurt; Teeth hurt; Ear hurt; severe allergic reaction; Felt like head was exploding; Swollen arm; Very tired/kind of tired; Pain in my arm/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), ILLNESS (Still sick) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Sinusitis (Sinus allergies).    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PAIN IN EXTREMITY (Pain in my arm/sore arm) and FATIGUE (Very tired/kind of tired). On 02-Oct-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). On 04-Oct-2021, the patient experienced RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), PARANASAL SINUS DISCOMFORT (Sinus pressure), EYE PAIN (Eyes hurt), TOOTHACHE (Teeth hurt), EAR PAIN (Ear hurt), HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (Felt like head was exploding). On 06-Oct-2021, the patient experienced THROAT IRRITATION (Itchy throat). On 08-Oct-2021, the patient experienced ILLNESS (Still sick). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 mg. On 02-Oct-2021, PAIN IN EXTREMITY (Pain in my arm/sore arm) and FATIGUE (Very tired/kind of tired) had resolved. On 04-Oct-2021, PERIPHERAL SWELLING (Swollen arm) had resolved. On 06-Oct-2021, THROAT IRRITATION (Itchy throat) had resolved. At the time of the report, RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), ILLNESS (Still sick), PARANASAL SINUS DISCOMFORT (Sinus pressure), EYE PAIN (Eyes hurt), TOOTHACHE (Teeth hurt), EAR PAIN (Ear hurt), HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (Felt like head was exploding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Pain, Psoriasis
Clinical narrative: Pimples all over the body/Jingles; Psoriasis; Extreme pain; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Pimples all over the body/Jingles), PSORIASIS (Psoriasis) and PAIN (Extreme pain) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-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 ACNE (Pimples all over the body/Jingles), PSORIASIS (Psoriasis) and PAIN (Extreme pain). At the time of the report, ACNE (Pimples all over the body/Jingles), PSORIASIS (Psoriasis) and PAIN (Extreme pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (he had a sore arm) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG) and LISINOPRIL for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (he had a sore arm). On 09-Jan-2021, PAIN IN EXTREMITY (he had a sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2021-347110, MOD-2021-347111 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 15 patients were administered the Moderna COVID 19 vaccine after the 30 days use by date.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (15 patients were administered the Moderna COVID 19 vaccine after the 30 days use by date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (15 patients were administered the Moderna COVID 19 vaccine after the 30 days use by date.). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (15 patients were administered the Moderna COVID 19 vaccine after the 30 days use by date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported. Reporter did not have any information of patients, the vial was initially stored in the refrigerator on 24-Aug-2021, and the vial did not undergo any temperature excursions.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Product dose omission issue
Clinical narrative: I'm a little late for my 2nd shot.; I had minor soreness in my arm from the injection.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (I had minor soreness in my arm from the injection.) and PRODUCT DOSE OMISSION ISSUE (I'm a little late for my 2nd shot.) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced INJECTION SITE PAIN (I had minor soreness in my arm from the injection.). On 08-Oct-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I'm a little late for my 2nd shot.). At the time of the report, INJECTION SITE PAIN (I had minor soreness in my arm from the injection.) and PRODUCT DOSE OMISSION ISSUE (I'm a little late for my 2nd shot.) 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 medications were not provided by reporter. No Treatment medications were provided by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Chest pain, Crying, Dyspnoea
Clinical narrative: Afraid; Felt very sick; Weak; Chest pain; Short breath; Crying; Heart was bumping out of her breast (Chest)/Something wrong with my heart; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick), ASTHENIA (Weak), CHEST PAIN (Chest pain), DYSPNOEA (Short breath) and CRYING (Crying) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MALAISE (Felt very sick), ASTHENIA (Weak), CHEST PAIN (Chest pain), DYSPNOEA (Short breath), CRYING (Crying) and CARDIAC DISORDER (Heart was bumping out of her breast (Chest)/Something wrong with my heart). On 08-Oct-2021, the patient experienced FEELING ABNORMAL (Afraid). At the time of the report, MALAISE (Felt very sick), ASTHENIA (Weak), CHEST PAIN (Chest pain), DYSPNOEA (Short breath), CRYING (Crying), CARDIAC DISORDER (Heart was bumping out of her breast (Chest)/Something wrong with my heart) and FEELING ABNORMAL (Afraid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided. Patient refused EKG and lab works at ER and at the doctor's office because patient cannot afford it. Patient does not have insurance. Patient was Healthy (She has no previous medical history of any type of heart problems and did not have COVID-19 Disease).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Afraid; Felt very sick; Weak; Chest pain; Short breath; Crying; Heart was bumping out of her breast (Chest)/Something wrong with my heart; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick), ASTHENIA (Weak), CHEST PAIN (Chest pain), DYSPNOEA (Short breath) and CRYING (Crying) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MALAISE (Felt very sick), ASTHENIA (Weak), CHEST PAIN (Chest pain), DYSPNOEA (Short breath), CRYING (Crying) and CARDIAC DISORDER (Heart was bumping out of her breast (Chest)/Something wrong with my heart). On 08-Oct-2021, the patient experienced FEELING ABNORMAL (Afraid). At the time of the report, MALAISE (Felt very sick), ASTHENIA (Weak), CHEST PAIN (Chest pain), DYSPNOEA (Short breath), CRYING (Crying), CARDIAC DISORDER (Heart was bumping out of her breast (Chest)/Something wrong with my heart) and FEELING ABNORMAL (Afraid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided. Patient refused EKG and lab works at ER and at the doctor's office because patient cannot afford it. Patient does not have insurance. Patient was Healthy (She has no previous medical history of any type of heart problems and did not have COVID-19 Disease).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling abnormal, Feeling cold, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red) and PAIN IN EXTREMITY (Arm was painful) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 088Z21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle sprain in 2016.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021 at 7:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red), PAIN IN EXTREMITY (Arm was painful), FEELING ABNORMAL (Feeling bad/ Whole life has turned upside down), PAIN (Entire body ached), FEELING COLD (Feeling of being cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Just can't function), THINKING ABNORMAL (Not speaking or thinking clearly), SPEECH DISORDER (Not speaking or thinking clearly), CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose > 36 days after first dose). On 07-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose > 36 days after first dose) had resolved. On 08-Oct-2021, PAIN (Entire body ached) had resolved. At the time of the report, MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red), PAIN IN EXTREMITY (Arm was painful), FEELING ABNORMAL (Feeling bad/ Whole life has turned upside down), FEELING COLD (Feeling of being cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Just can't function), THINKING ABNORMAL (Not speaking or thinking clearly), SPEECH DISORDER (Not speaking or thinking clearly) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, X-ray: abnormal (abnormal) diagnosed  with tendonitis.         On 23-SEP-2021, patient had irritated her foot so she visited orthopedic doctor and she confirmed that the pain is 100 times worse what she is experiencing after she had gluteal pain.She is healthy and  works out 6 times a week and her ankle only hurts if she work out too hard. No treatment medications were provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red) and PAIN IN EXTREMITY (Arm was painful) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 088Z21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle sprain in 2016.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021 at 7:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red), PAIN IN EXTREMITY (Arm was painful), FEELING ABNORMAL (Feeling bad/ Whole life has turned upside down), PAIN (Entire body ached), FEELING COLD (Feeling of being cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Just can't function), THINKING ABNORMAL (Not speaking or thinking clearly), SPEECH DISORDER (Not speaking or thinking clearly), CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose > 36 days after first dose). On 07-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose > 36 days after first dose) had resolved. On 08-Oct-2021, PAIN (Entire body ached) had resolved. At the time of the report, MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red), PAIN IN EXTREMITY (Arm was painful), FEELING ABNORMAL (Feeling bad/ Whole life has turned upside down), FEELING COLD (Feeling of being cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Just can't function), THINKING ABNORMAL (Not speaking or thinking clearly), SPEECH DISORDER (Not speaking or thinking clearly) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, X-ray: abnormal (abnormal) diagnosed  with tendonitis.         On 23-SEP-2021, patient had irritated her foot so she visited orthopedic doctor and she confirmed that the pain is 100 times worse what she is experiencing after she had gluteal pain.She is healthy and  works out 6 times a week and her ankle only hurts if she work out too hard. No treatment medications were provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Thinking abnormal, X-ray
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red) and PAIN IN EXTREMITY (Arm was painful) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 088Z21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle sprain in 2016.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021 at 7:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red), PAIN IN EXTREMITY (Arm was painful), FEELING ABNORMAL (Feeling bad/ Whole life has turned upside down), PAIN (Entire body ached), FEELING COLD (Feeling of being cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Just can't function), THINKING ABNORMAL (Not speaking or thinking clearly), SPEECH DISORDER (Not speaking or thinking clearly), CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose > 36 days after first dose). On 07-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose > 36 days after first dose) had resolved. On 08-Oct-2021, PAIN (Entire body ached) had resolved. At the time of the report, MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red), PAIN IN EXTREMITY (Arm was painful), FEELING ABNORMAL (Feeling bad/ Whole life has turned upside down), FEELING COLD (Feeling of being cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Just can't function), THINKING ABNORMAL (Not speaking or thinking clearly), SPEECH DISORDER (Not speaking or thinking clearly) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, X-ray: abnormal (abnormal) diagnosed  with tendonitis.         On 23-SEP-2021, patient had irritated her foot so she visited orthopedic doctor and she confirmed that the pain is 100 times worse what she is experiencing after she had gluteal pain.She is healthy and  works out 6 times a week and her ankle only hurts if she work out too hard. No treatment medications were provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Intentional dose omission, Lung disorder, SARS-CoV-2 test, Tooth infection
Clinical narrative: caller stated he decided not to receive the second dose in the series; feeling tired/in bed for 4 days; he had a reaction; lungs started feeling weird/ lungs were filled with fluid/lungs had a sloshy feeling; infected tooth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (he had a reaction), LUNG DISORDER (lungs started feeling weird/ lungs were filled with fluid/lungs had a sloshy feeling), TOOTH INFECTION (infected tooth), INTENTIONAL DOSE OMISSION (caller stated he decided not to receive the second dose in the series) and FATIGUE (feeling tired/in bed for 4 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     The patient's past medical history included Walking pneumonia in 1992. Concurrent medical conditions included Asthma.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced TOOTH INFECTION (infected tooth). On 16-Jul-2021, the patient experienced VACCINATION COMPLICATION (he had a reaction), LUNG DISORDER (lungs started feeling weird/ lungs were filled with fluid/lungs had a sloshy feeling) and FATIGUE (feeling tired/in bed for 4 days). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (caller stated he decided not to receive the second dose in the series). The patient was treated with NAPROXEN SODIUM (ALEVE) in 2021 for Pain, at an unspecified dose and frequency. On 20-Jul-2021, FATIGUE (feeling tired/in bed for 4 days) had resolved. At the time of the report, VACCINATION COMPLICATION (he had a reaction) outcome was unknown and LUNG DISORDER (lungs started feeling weird/ lungs were filled with fluid/lungs had a sloshy feeling), TOOTH INFECTION (infected tooth) and INTENTIONAL DOSE OMISSION (caller stated he decided not to receive the second dose in the series) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported that, for treatment, the patient used his asthma inhalers (name not reported) frequently and took steroid pills daily.  About a month ago or so, the caller also reported an infected tooth and he had to have the tooth pulled out.  The caller mentioned he cannot tolerate chilis. The caller stated that he was a healthy individual. Stated that he just recently had a COVID-19 test and it was negative.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: caller stated he decided not to receive the second dose in the series; feeling tired/in bed for 4 days; he had a reaction; lungs started feeling weird/ lungs were filled with fluid/lungs had a sloshy feeling; infected tooth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (he had a reaction), LUNG DISORDER (lungs started feeling weird/ lungs were filled with fluid/lungs had a sloshy feeling), TOOTH INFECTION (infected tooth), INTENTIONAL DOSE OMISSION (caller stated he decided not to receive the second dose in the series) and FATIGUE (feeling tired/in bed for 4 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     The patient's past medical history included Walking pneumonia in 1992. Concurrent medical conditions included Asthma.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced TOOTH INFECTION (infected tooth). On 16-Jul-2021, the patient experienced VACCINATION COMPLICATION (he had a reaction), LUNG DISORDER (lungs started feeling weird/ lungs were filled with fluid/lungs had a sloshy feeling) and FATIGUE (feeling tired/in bed for 4 days). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (caller stated he decided not to receive the second dose in the series). The patient was treated with NAPROXEN SODIUM (ALEVE) in 2021 for Pain, at an unspecified dose and frequency. On 20-Jul-2021, FATIGUE (feeling tired/in bed for 4 days) had resolved. At the time of the report, VACCINATION COMPLICATION (he had a reaction) outcome was unknown and LUNG DISORDER (lungs started feeling weird/ lungs were filled with fluid/lungs had a sloshy feeling), TOOTH INFECTION (infected tooth) and INTENTIONAL DOSE OMISSION (caller stated he decided not to receive the second dose in the series) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported that, for treatment, the patient used his asthma inhalers (name not reported) frequently and took steroid pills daily.  About a month ago or so, the caller also reported an infected tooth and he had to have the tooth pulled out.  The caller mentioned he cannot tolerate chilis. The caller stated that he was a healthy individual. Stated that he just recently had a COVID-19 test and it was negative.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Neoplasm malignant, Pyrexia, Vaccination site erythema
Clinical narrative: COVID-19 infection/Hospitalization due to COVID-19; DRUG INEFFECTIVE; Cancer; left arm turned red; left arm was sore; fever of 102.5  degrees Farenheight.; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) and COVID-19 (COVID-19 infection/Hospitalization due to COVID-19) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm turned red), VACCINATION SITE PAIN (left arm was sore) and PYREXIA (fever of 102.5  degrees Farenheight.). On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant), COVID-19 (COVID-19 infection/Hospitalization due to COVID-19) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (DRUG INEFFECTIVE). At the time of the report, NEOPLASM MALIGNANT (Cancer), COVID-19 (COVID-19 infection/Hospitalization due to COVID-19), DRUG INEFFECTIVE (DRUG INEFFECTIVE), VACCINATION SITE ERYTHEMA (left arm turned red), VACCINATION SITE PAIN (left arm was sore) and PYREXIA (fever of 102.5  degrees Farenheight.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company Comment: This case concerns a  89 year-old, female subject  with no clinical history who experienced the unexpected events of COVID-19, and NEOPLASM MALIGNANT, DRUG INEFFECTIVE and other non-serious events. The events occurred on unknown days after two doses of [Spikevax]  The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of the vaccine is not affected by this report   This case was linked to MOD-2021-347627 (Patient Link).; Sender's Comments: This case concerns a  89 year-old, female subject  with no clinical history who experienced the unexpected events of COVID-19, and NEOPLASM MALIGNANT, DRUG INEFFECTIVE and other non-serious events. The events occurred on unknown days after two doses of [Spikevax]  The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of the vaccine is not affected by this report