chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: More than 35 days since patient received his first vaccine/Can patient receive 2nd dose? after 54 days is now been 3 month since the first dose; More than 35 days since patient received his first vaccine,is now been 3 month since the first dose; 17 and a half year old received the first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half year old received the first dose of the Moderna Covid-19 vaccine), PRODUCT DOSE OMISSION ISSUE (More than 35 days since patient received his first vaccine/Can patient receive 2nd dose? after 54 days is now been 3 month since the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since patient received his first vaccine,is now been 3 month since the first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half year old received the first dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days since patient received his first vaccine/Can patient receive 2nd dose? after 54 days is now been 3 month since the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since patient received his first vaccine,is now been 3 month since the first dose). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half year old received the first dose of the Moderna Covid-19 vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since patient received his first vaccine/Can patient receive 2nd dose? after 54 days is now been 3 month since the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since patient received his first vaccine,is now been 3 month since the first dose) outcome was unknown.        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.    Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Significant Follow up appended On 14-Jul-2021: Non significant follow up
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Little tired; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Little tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     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 an unknown date, the patient experienced FATIGUE (Little tired). At the time of the report, FATIGUE (Little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-122457 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Peripheral swelling
Clinical narrative: Feet are swollen; bottom of his feet are burning; round red marks on his leg and his knee cap (right leg)/ looks like a round mark like he hit something; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Feet are swollen), BURNING SENSATION (bottom of his feet are burning) and ERYTHEMA (round red marks on his leg and his knee cap (right leg)/ looks like a round mark like he hit something) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044321A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Feet are swollen), BURNING SENSATION (bottom of his feet are burning) and ERYTHEMA (round red marks on his leg and his knee cap (right leg)/ looks like a round mark like he hit something). At the time of the report, PERIPHERAL SWELLING (Feet are swollen), BURNING SENSATION (bottom of his feet are burning) and ERYTHEMA (round red marks on his leg and his knee cap (right leg)/ looks like a round mark like he hit something) had not resolved.            No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-122291 (Linked Report).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) outcome was unknown.        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 concomitant product was reported.  no treatment product was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-122517, US-MODERNATX, INC.-MOD-2021-122557, US-MODERNATX, INC.-MOD-2021-122588 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122588: US-MODERNATX, INC.-MOD-2021-122557:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Arms hurt really bad; red arm; swollen arm; hardened arm/it is hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), INDURATION (hardened arm/it is hard to touch), PAIN IN EXTREMITY (Arms hurt really bad) and ERYTHEMA (red arm) in a 48-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 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and INDURATION (hardened arm/it is hard to touch). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arms hurt really bad) and ERYTHEMA (red arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and INDURATION (hardened arm/it is hard to touch) had not resolved and PAIN IN EXTREMITY (Arms hurt really bad) and ERYTHEMA (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter information and additional events were provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Oropharyngeal pain, Somnolence, Vaccination site pain
Clinical narrative: missed the 2nd dose; Sore throat; Tiredness; Arm pain; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the 2nd dose), SOMNOLENCE (Sleepy), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Arm pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced SOMNOLENCE (Sleepy), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Arm pain). On 04-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the 2nd dose). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL (NYQUIL COLD & FLU) at an unspecified dose and frequency. On 13-Apr-2021, SOMNOLENCE (Sleepy), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Arm pain) had resolved. On 12-May-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment product was reported
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Dizzy; Magnet is attracted to injection site; sore arm; This spontaneous case was reported by an other caregiver and describes the occurrence of DIZZINESS (Dizzy), VACCINATION COMPLICATION (Magnet is attracted to injection site) and VACCINATION SITE PAIN (sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (Dizzy), VACCINATION COMPLICATION (Magnet is attracted to injection site) and VACCINATION SITE PAIN (sore arm). At the time of the report, DIZZINESS (Dizzy), VACCINATION COMPLICATION (Magnet is attracted to injection site) and VACCINATION SITE PAIN (sore arm) outcome was unknown.            Concomitant products were not provided.  Treatment medication were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back started hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back started hurting really bad) 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 01-Jan-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back started hurting really bad). At the time of the report, BACK PAIN (back started hurting really bad) outcome was unknown.            No concomitant medications was reported   No treatment medications was reported  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) outcome was unknown. Not Provided      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 concomitant medications were reported.  No treatment product were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-122781 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122781:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: May be the needle he got did not have enough solution in it; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (May be the needle he got did not have enough solution in it) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ACCIDENTAL UNDERDOSE (May be the needle he got did not have enough solution in it). At the time of the report, ACCIDENTAL UNDERDOSE (May be the needle he got did not have enough solution in it) outcome was unknown.            No concomitant medications was reported   No treatment medications was provided   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   This case was linked to MOD-2021-122406 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance
Clinical narrative: Cannot walk long distances; Started feeling fatigued; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Cannot walk long distances) and FATIGUE (Started feeling fatigued) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced GAIT DISTURBANCE (Cannot walk long distances) and FATIGUE (Started feeling fatigued). At the time of the report, GAIT DISTURBANCE (Cannot walk long distances) and FATIGUE (Started feeling fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-122480 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-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 VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter.  No treatment medications provided by the reporter.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Vaccination site pain
Clinical narrative: Sweating; Very sore arm; Nausea; Constant headache; Freezing with chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Very sore arm), NAUSEA (Nausea), HEADACHE (Constant headache) and CHILLS (Freezing with chills) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 040B71A) 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) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Very sore arm), NAUSEA (Nausea), HEADACHE (Constant headache) and CHILLS (Freezing with chills). The patient was treated with MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Very sore arm), NAUSEA (Nausea), HEADACHE (Constant headache) and CHILLS (Freezing with chills) outcome was unknown.            The concomitant medications were not provided.   The action taken with mRNA 1273 with the events was considered as not applicable.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance
Clinical narrative: Difficulty in walking; Fatigue aggravated; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficulty in walking) and FATIGUE (Fatigue aggravated) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 036B21A) 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) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced GAIT DISTURBANCE (Difficulty in walking) and FATIGUE (Fatigue aggravated). At the time of the report, GAIT DISTURBANCE (Difficulty in walking) and FATIGUE (Fatigue aggravated) had not resolved.            No concomitant medication was given.  The events patient experienced after first dose aggravated after second dose.  No treatment  was given for the events.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-122469 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back started hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back started hurting really bad) 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 BACK PAIN (Back started hurting really bad). At the time of the report, BACK PAIN (Back started hurting really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provider by the reporter.  Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Nausea, Skin exfoliation, Vaccination site pain
Clinical narrative: Blisters on the back of the right hand where fingers join the hand, later the blisters appeared on the Left hand exactly the same place as the right hand; Felt Queasy; Sore Injection Site; Scratched-off skin area on the right hand Dime Size; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Scratched-off skin area on the right hand Dime Size), BLISTER (Blisters on the back of the right hand where fingers join the hand, later the blisters appeared on the Left hand exactly the same place as the right hand), NAUSEA (Felt Queasy) and VACCINATION SITE PAIN (Sore Injection Site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced SKIN EXFOLIATION (Scratched-off skin area on the right hand Dime Size). On 22-Apr-2021, the patient experienced BLISTER (Blisters on the back of the right hand where fingers join the hand, later the blisters appeared on the Left hand exactly the same place as the right hand), NAUSEA (Felt Queasy) and VACCINATION SITE PAIN (Sore Injection Site). The patient was treated with TEA TREE OIL for Blisters, at an unspecified dose and frequency. On 25-Apr-2021, NAUSEA (Felt Queasy) and VACCINATION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, SKIN EXFOLIATION (Scratched-off skin area on the right hand Dime Size) and BLISTER (Blisters on the back of the right hand where fingers join the hand, later the blisters appeared on the Left hand exactly the same place as the right hand) had resolved.            Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-252354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information was received on 08-Jul-2021: significant Follow-up- Event Outcome for Blisters on hand and fingers, sore injection site were updated.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Severe cramping in the legs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Severe cramping in the legs) 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 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MUSCLE SPASMS (Severe cramping in the legs). At the time of the report, MUSCLE SPASMS (Severe cramping in the legs) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Some arm pain; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Some arm pain) and FATIGUE (Feeling tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 VACCINATION SITE PAIN (Some arm pain) and FATIGUE (Feeling tired). At the time of the report, VACCINATION SITE PAIN (Some arm pain) and FATIGUE (Feeling tired) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nightmare, Swelling
Clinical narrative: Had nightmares; Had a lump that grew to a softball size; Her right shoulder hurt; Right shoulder developed a golf ball-sized lump; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Had nightmares), SWELLING (Had a lump that grew to a softball size), SWELLING (Right shoulder developed a golf ball-sized lump) and ARTHRALGIA (Her right shoulder hurt) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 03-May-2021, the patient experienced SWELLING (Right shoulder developed a golf ball-sized lump). On 10-May-2021, the patient experienced NIGHTMARE (Had nightmares), SWELLING (Had a lump that grew to a softball size) and ARTHRALGIA (Her right shoulder hurt). On 06-May-2021, SWELLING (Right shoulder developed a golf ball-sized lump) had resolved. At the time of the report, NIGHTMARE (Had nightmares), SWELLING (Had a lump that grew to a softball size) and ARTHRALGIA (Her right shoulder hurt) outcome was unknown.        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.   On 03 May 2021 patient developed a golf ball-sized lump on her right shoulder which went away on 06 May 2021.On 10 May 2021,her right shoulder hurt and had a lump that grew to a softball size and also had nightmares.No concomitant medications were reported.No treatment information was provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Joint swelling, Vaccination site pain
Clinical narrative: Headache; Swallon ankle; Feeling tired; Arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (Swallon ankle), VACCINATION SITE PAIN (Arm pain), FATIGUE (Feeling tired) and HEADACHE (Headache) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS], PROBIOTICS NOS and FISH OIL for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm pain). On 07-Apr-2021, the patient experienced FATIGUE (Feeling tired). On 23-Apr-2021, the patient experienced JOINT SWELLING (Swallon ankle). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On 08-Apr-2021, VACCINATION SITE PAIN (Arm pain) had resolved. At the time of the report, JOINT SWELLING (Swallon ankle) and HEADACHE (Headache) outcome was unknown and FATIGUE (Feeling tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.    This case was linked to MOD-2021-122530 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) had 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.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-122422, US-MODERNATX, INC.-MOD-2021-122588, US-MODERNATX, INC.-MOD-2021-122557 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Cough, Oropharyngeal pain
Clinical narrative: COVID-19; Chills; Fever; Sore throat; Slight cough; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Slight cough), PAIN (Body ache), COVID-19 (COVID-19) and CHILLS (Chills) in a 23-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.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis, SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (Slight cough), PAIN (Body ache), CHILLS (Chills) and PYREXIA (Fever). On 16-Apr-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PAIN (Body ache), COVID-19 (COVID-19), CHILLS (Chills) and PYREXIA (Fever) had resolved and COUGH (Slight cough) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 102 (Inconclusive) 102F. On 15-Apr-2021, SARS-CoV-2 test: and posituve (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient is having possible delay in receiving the 2nd dose of Moderna vaccine.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; Chills; Fever; Sore throat; Slight cough; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Slight cough), PAIN (Body ache), COVID-19 (COVID-19) and CHILLS (Chills) in a 23-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.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis, SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (Slight cough), PAIN (Body ache), CHILLS (Chills) and PYREXIA (Fever). On 16-Apr-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PAIN (Body ache), COVID-19 (COVID-19), CHILLS (Chills) and PYREXIA (Fever) had resolved and COUGH (Slight cough) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 102 (Inconclusive) 102F. On 15-Apr-2021, SARS-CoV-2 test: and posituve (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient is having possible delay in receiving the 2nd dose of Moderna vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Joint swelling, Rash, Skin lesion, Urticaria
Clinical narrative: Trouble sleeping; Hives; Swollen ankle; Vaccination site pain; Break out on the whole body/ broke over the arm; Lesions over the arm; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Trouble sleeping), URTICARIA (Hives), JOINT SWELLING (Swollen ankle), SKIN LESION (Lesions over the arm) and VACCINATION SITE PAIN (Vaccination site pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 049B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (Three years before had a heart attack.). Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Blood pressure management. Concomitant products included AMMONIUM CHLORIDE, CAFFEINE (WATER [AMMONIUM CHLORIDE;CAFFEINE]) and POTASSIUM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN LESION (Lesions over the arm). On an unknown date, the patient experienced INSOMNIA (Trouble sleeping), URTICARIA (Hives), JOINT SWELLING (Swollen ankle), VACCINATION SITE PAIN (Vaccination site pain) and RASH (Break out on the whole body/ broke over the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Trouble sleeping), URTICARIA (Hives), JOINT SWELLING (Swollen ankle), SKIN LESION (Lesions over the arm), VACCINATION SITE PAIN (Vaccination site pain) and RASH (Break out on the whole body/ broke over the arm) outcome was unknown.            The concomitant medications also include blood pressure medications and heart medications.  Treatment also include putting iced bottle and steroids.   This case was linked to MOD-2021-122479 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Trouble sleeping; Hives; Swollen ankle; Vaccination site pain; Break out on the whole body/ broke over the arm; Lesions over the arm; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Trouble sleeping), URTICARIA (Hives), JOINT SWELLING (Swollen ankle), SKIN LESION (Lesions over the arm) and VACCINATION SITE PAIN (Vaccination site pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 049B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (Three years before had a heart attack.). Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Blood pressure management. Concomitant products included AMMONIUM CHLORIDE, CAFFEINE (WATER [AMMONIUM CHLORIDE;CAFFEINE]) and POTASSIUM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN LESION (Lesions over the arm). On an unknown date, the patient experienced INSOMNIA (Trouble sleeping), URTICARIA (Hives), JOINT SWELLING (Swollen ankle), VACCINATION SITE PAIN (Vaccination site pain) and RASH (Break out on the whole body/ broke over the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Trouble sleeping), URTICARIA (Hives), JOINT SWELLING (Swollen ankle), SKIN LESION (Lesions over the arm), VACCINATION SITE PAIN (Vaccination site pain) and RASH (Break out on the whole body/ broke over the arm) outcome was unknown.            The concomitant medications also include blood pressure medications and heart medications.  Treatment also include putting iced bottle and steroids.   This case was linked to MOD-2021-122479 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Myalgia; Excruciating joint pain in both knees; Chills; HEADACHE; feeling tired; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia   ), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Excruciating joint pain in both knees), CHILLS (Chills) and FATIGUE (feeling tired) in an 88-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.     Concurrent medical conditions included Arthritis. Concomitant products included VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS], PROBIOTICS NOS and FISH OIL for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 07-Apr-2021, the patient experienced FATIGUE (feeling tired). On 20-Apr-2021, the patient experienced HEADACHE (HEADACHE). On 28-Apr-2021, the patient experienced CHILLS (Chills). On 06-May-2021, the patient experienced MYALGIA (Myalgia   ) and ARTHRALGIA (Excruciating joint pain in both knees). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 08-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 11-May-2021, HEADACHE (HEADACHE) had resolved. At the time of the report, MYALGIA (Myalgia   ), ARTHRALGIA (Excruciating joint pain in both knees), CHILLS (Chills) and FATIGUE (feeling tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient used an ice pack for treatment.   This case was linked to MOD-2021-122507 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Myalgia; Excruciating joint pain in both knees; Chills; HEADACHE; feeling tired; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia   ), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Excruciating joint pain in both knees), CHILLS (Chills) and FATIGUE (feeling tired) in an 88-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.     Concurrent medical conditions included Arthritis. Concomitant products included VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS], PROBIOTICS NOS and FISH OIL for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 07-Apr-2021, the patient experienced FATIGUE (feeling tired). On 20-Apr-2021, the patient experienced HEADACHE (HEADACHE). On 28-Apr-2021, the patient experienced CHILLS (Chills). On 06-May-2021, the patient experienced MYALGIA (Myalgia   ) and ARTHRALGIA (Excruciating joint pain in both knees). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 08-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 11-May-2021, HEADACHE (HEADACHE) had resolved. At the time of the report, MYALGIA (Myalgia   ), ARTHRALGIA (Excruciating joint pain in both knees), CHILLS (Chills) and FATIGUE (feeling tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient used an ice pack for treatment.   This case was linked to MOD-2021-122507 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Migraine, Nausea
Clinical narrative: had migraine before but never like this; nauseous; felt tired; feeling dizzy / light headed; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (had migraine before but never like this), DIZZINESS (feeling dizzy / light headed), NAUSEA (nauseous) and FATIGUE (felt tired) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced DIZZINESS (feeling dizzy / light headed). On an unknown date, the patient experienced MIGRAINE (had migraine before but never like this), NAUSEA (nauseous) and FATIGUE (felt tired). At the time of the report, MIGRAINE (had migraine before but never like this), DIZZINESS (feeling dizzy / light headed), NAUSEA (nauseous) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 17 year old received Vaccine; Interval between 2 doses is more than 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between 2 doses is more than 42 days) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between 2 doses is more than 42 days). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between 2 doses is more than 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No conmeds and treatment history was reported .   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: dizziness; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VOMITING (vomiting) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced DIZZINESS (dizziness), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Drugs and treatment was reported.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative, Drug ineffective
Clinical narrative: Vaccine did not work for him/antibodies test came negative; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Vaccine did not work for him/antibodies test came negative) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 028B21A) for COVID-19 vaccination.     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 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DRUG INEFFECTIVE (Vaccine did not work for him/antibodies test came negative). At the time of the report, DRUG INEFFECTIVE (Vaccine did not work for him/antibodies test came negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Antibody test negative: negative (Negative) antibodies test = negative.         Concomitant product used was not provided by the reporter.  This patient has experienced no symptoms after vaccination administration.  No information regarding expiration date of vaccine reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.