chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Mild ringing in the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Mild ringing in the ears) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 018821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced TINNITUS (Mild ringing in the ears). At the time of the report, TINNITUS (Mild ringing in the ears) outcome was unknown.            No relevant concomitant medications were reported. The patient reported that the event mild ringing in the ears would come and go but was minimal and the patient wasn't  sure if it ever went away completely or if it was just less noticeable because she was busy with other work. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-061186 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061186:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of SARS-CoV-2 positive test (tested positive for COVID-19) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On 1Mar 19, 2021, patient experienced SARS-CoV-2 positive test (tested positive for COVID-19). At the time of the report, SARS-CoV-2 positive test (tested positive for COVID-19) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Fatigue, Mass, Nausea, Neck pain
Clinical narrative: Small rash that lasted 3 hours; Lump on collarbone; Felt so tired and slept until 2 pm; Stabbing pain in back of right arm; Temperature of 99.9° F; Nausea; Stabbing pain in right hip; Stabbing pain in right foot; Pain on neck; Swollen left shoulder at the site of injection; Swollenness in ears; Swollenness in right shoulder; Swollenness in left rib cage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen left shoulder at the site of injection), EAR SWELLING (Swollenness in ears), FATIGUE (Felt so tired and slept until 2 pm), PAIN (Stabbing pain in back of right arm) and PYREXIA (Temperature of 99.9° F) in a 67-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 No adverse event. Concomitant products included Blood pressure medication, Cholesterol medication and Diabetes medication for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swollen left shoulder at the site of injection), EAR SWELLING (Swollenness in ears), SWELLING (Swollenness in right shoulder) and SWELLING (Swollenness in left rib cage). On 12-Mar-2021, the patient experienced FATIGUE (Felt so tired and slept until 2 pm), PAIN (Stabbing pain in back of right arm), PYREXIA (Temperature of 99.9° F), NAUSEA (Nausea), PAIN (Stabbing pain in right hip), PAIN IN EXTREMITY (Stabbing pain in right foot) and NECK PAIN (Pain on neck). On 13-Mar-2021, the patient experienced RASH (Small rash that lasted 3 hours) and MASS (Lump on collarbone). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 13-Mar-2021, RASH (Small rash that lasted 3 hours) had resolved. On 20-Mar-2021, MASS (Lump on collarbone) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swollen left shoulder at the site of injection), EAR SWELLING (Swollenness in ears), FATIGUE (Felt so tired and slept until 2 pm), PAIN (Stabbing pain in back of right arm), PYREXIA (Temperature of 99.9° F), NAUSEA (Nausea), SWELLING (Swollenness in right shoulder), SWELLING (Swollenness in left rib cage), PAIN (Stabbing pain in right hip), PAIN IN EXTREMITY (Stabbing pain in right foot) and NECK PAIN (Pain on neck) 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 products included Blood pressure medication, Cholesterol medication and Diabetes medication for an unknown indication.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Rash, Swelling
Clinical narrative: Small rash that lasted 3 hours; Lump on collarbone; Felt so tired and slept until 2 pm; Stabbing pain in back of right arm; Temperature of 99.9° F; Nausea; Stabbing pain in right hip; Stabbing pain in right foot; Pain on neck; Swollen left shoulder at the site of injection; Swollenness in ears; Swollenness in right shoulder; Swollenness in left rib cage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen left shoulder at the site of injection), EAR SWELLING (Swollenness in ears), FATIGUE (Felt so tired and slept until 2 pm), PAIN (Stabbing pain in back of right arm) and PYREXIA (Temperature of 99.9° F) in a 67-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 No adverse event. Concomitant products included Blood pressure medication, Cholesterol medication and Diabetes medication for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swollen left shoulder at the site of injection), EAR SWELLING (Swollenness in ears), SWELLING (Swollenness in right shoulder) and SWELLING (Swollenness in left rib cage). On 12-Mar-2021, the patient experienced FATIGUE (Felt so tired and slept until 2 pm), PAIN (Stabbing pain in back of right arm), PYREXIA (Temperature of 99.9° F), NAUSEA (Nausea), PAIN (Stabbing pain in right hip), PAIN IN EXTREMITY (Stabbing pain in right foot) and NECK PAIN (Pain on neck). On 13-Mar-2021, the patient experienced RASH (Small rash that lasted 3 hours) and MASS (Lump on collarbone). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 13-Mar-2021, RASH (Small rash that lasted 3 hours) had resolved. On 20-Mar-2021, MASS (Lump on collarbone) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swollen left shoulder at the site of injection), EAR SWELLING (Swollenness in ears), FATIGUE (Felt so tired and slept until 2 pm), PAIN (Stabbing pain in back of right arm), PYREXIA (Temperature of 99.9° F), NAUSEA (Nausea), SWELLING (Swollenness in right shoulder), SWELLING (Swollenness in left rib cage), PAIN (Stabbing pain in right hip), PAIN IN EXTREMITY (Stabbing pain in right foot) and NECK PAIN (Pain on neck) 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 products included Blood pressure medication, Cholesterol medication and Diabetes medication for an unknown indication.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Small rash that lasted 3 hours; Lump on collarbone; Felt so tired and slept until 2 pm; Stabbing pain in back of right arm; Temperature of 99.9° F; Nausea; Stabbing pain in right hip; Stabbing pain in right foot; Pain on neck; Swollen left shoulder at the site of injection; Swollenness in ears; Swollenness in right shoulder; Swollenness in left rib cage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen left shoulder at the site of injection), EAR SWELLING (Swollenness in ears), FATIGUE (Felt so tired and slept until 2 pm), PAIN (Stabbing pain in back of right arm) and PYREXIA (Temperature of 99.9° F) in a 67-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 No adverse event. Concomitant products included Blood pressure medication, Cholesterol medication and Diabetes medication for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swollen left shoulder at the site of injection), EAR SWELLING (Swollenness in ears), SWELLING (Swollenness in right shoulder) and SWELLING (Swollenness in left rib cage). On 12-Mar-2021, the patient experienced FATIGUE (Felt so tired and slept until 2 pm), PAIN (Stabbing pain in back of right arm), PYREXIA (Temperature of 99.9° F), NAUSEA (Nausea), PAIN (Stabbing pain in right hip), PAIN IN EXTREMITY (Stabbing pain in right foot) and NECK PAIN (Pain on neck). On 13-Mar-2021, the patient experienced RASH (Small rash that lasted 3 hours) and MASS (Lump on collarbone). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 13-Mar-2021, RASH (Small rash that lasted 3 hours) had resolved. On 20-Mar-2021, MASS (Lump on collarbone) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swollen left shoulder at the site of injection), EAR SWELLING (Swollenness in ears), FATIGUE (Felt so tired and slept until 2 pm), PAIN (Stabbing pain in back of right arm), PYREXIA (Temperature of 99.9° F), NAUSEA (Nausea), SWELLING (Swollenness in right shoulder), SWELLING (Swollenness in left rib cage), PAIN (Stabbing pain in right hip), PAIN IN EXTREMITY (Stabbing pain in right foot) and NECK PAIN (Pain on neck) 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 products included Blood pressure medication, Cholesterol medication and Diabetes medication for an unknown indication.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain, Pyrexia, Tinnitus
Clinical narrative: Breathing spasms which are now back as well.; Achiness; Bad fever; Headache; Tinnitus got worse especially in the right ear/tinnitus is really bad.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus got worse especially in the right ear/tinnitus is really bad.), DYSPNOEA (Breathing spasms which are now back as well.), PAIN (Achiness), PYREXIA (Bad fever) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 018821A) for COVID-19 immunisation.     The patient's past medical history included Breathing difficult since an unknown date.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Tinnitus got worse especially in the right ear/tinnitus is really bad.). On 28-Mar-2021, the patient experienced PAIN (Achiness), PYREXIA (Bad fever) and HEADACHE (Headache). On 29-Mar-2021, the patient experienced DYSPNOEA (Breathing spasms which are now back as well.). On 29-Mar-2021, PAIN (Achiness) and PYREXIA (Bad fever) was resolving. At the time of the report, TINNITUS (Tinnitus got worse especially in the right ear/tinnitus is really bad.) had not resolved and DYSPNOEA (Breathing spasms which are now back as well.) and HEADACHE (Headache) outcome was unknown.            No concomitant medication provided. Treatment information provided mentioned Tylenol and inhaler.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine.   This case was linked to MOD-2021-061183 (E2B Linked Report).; Sender's Comments:  MOD-2021-061183:1ST DOSE
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Feeding disorder, Migraine, Myalgia
Clinical narrative: periodic confusions; unable to eat; migraine; periodic fatigue; extreme nausea; periodic body ache; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (periodic confusions), FEEDING DISORDER (unable to eat), MIGRAINE (migraine), FATIGUE (periodic fatigue) and NAUSEA (extreme nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M2A and 08B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CONFUSIONAL STATE (periodic confusions), FEEDING DISORDER (unable to eat), MIGRAINE (migraine), FATIGUE (periodic fatigue), NAUSEA (extreme nausea) and MYALGIA (periodic body ache). At the time of the report, CONFUSIONAL STATE (periodic confusions), FEEDING DISORDER (unable to eat), MIGRAINE (migraine), FATIGUE (periodic fatigue), NAUSEA (extreme nausea) and MYALGIA (periodic body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The same symptoms started 30 min after receiving the second shot.  No concomitant medications were provided by reporter.  Patient undergoing therapy for cognitive decline which occurred (along with a host of other side effects).   This case was linked to MOD21-065091, MOD21-065092 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up has NNI.; Sender's Comments:  MOD21-065091:Crosslinked: Same reporter MOD21-065092:Crosslinked: Same reporter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: periodic confusions; unable to eat; migraine; periodic fatigue; extreme nausea; periodic body ache; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (periodic confusions), FEEDING DISORDER (unable to eat), MIGRAINE (migraine), FATIGUE (periodic fatigue) and NAUSEA (extreme nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M2A and 08B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CONFUSIONAL STATE (periodic confusions), FEEDING DISORDER (unable to eat), MIGRAINE (migraine), FATIGUE (periodic fatigue), NAUSEA (extreme nausea) and MYALGIA (periodic body ache). At the time of the report, CONFUSIONAL STATE (periodic confusions), FEEDING DISORDER (unable to eat), MIGRAINE (migraine), FATIGUE (periodic fatigue), NAUSEA (extreme nausea) and MYALGIA (periodic body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The same symptoms started 30 min after receiving the second shot.  No concomitant medications were provided by reporter.  Patient undergoing therapy for cognitive decline which occurred (along with a host of other side effects).   This case was linked to MOD21-065091, MOD21-065092 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up has NNI.; Sender's Comments:  MOD21-065091:Crosslinked: Same reporter MOD21-065092:Crosslinked: Same reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Very tired; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Very tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 25-Mar-2021, the patient experienced FATIGUE (Very tired). On 25-Mar-2021, DIZZINESS (Dizziness) had resolved. On 27-Mar-2021, FATIGUE (Very tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included high blood pressure medication. Treatment for the event included none.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received, TCR added. It does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Erythema, Feeling hot, Swelling, Vaccination site erythema
Clinical narrative: Soreness at injection site; both of her cheeks became hot; both of her cheeks became red; both of her cheeks became raised; evolved into a big circle (under her arm); a streak under her left arm; hot (red circle) at the injection site; big (red circle) at the injection site; raised red circle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (both of her cheeks became hot), VACCINATION SITE WARMTH (hot (red circle) at the injection site), ADVERSE REACTION (a streak under her left arm), ERYTHEMA (both of her cheeks became red) and SWELLING (both of her cheeks became raised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot (red circle) at the injection site), VACCINATION SITE ERYTHEMA (big (red circle) at the injection site) and VACCINATION SITE SWELLING (raised red circle at the injection site). On 12-Mar-2021, the patient experienced ADVERSE REACTION (a streak under her left arm) and ERYTHEMA (evolved into a big circle (under her arm)). On 25-Mar-2021, the patient experienced FEELING HOT (both of her cheeks became hot), ERYTHEMA (both of her cheeks became red) and SWELLING (both of her cheeks became raised). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 14-Mar-2021, VACCINATION SITE WARMTH (hot (red circle) at the injection site), ADVERSE REACTION (a streak under her left arm), ERYTHEMA (evolved into a big circle (under her arm)), VACCINATION SITE ERYTHEMA (big (red circle) at the injection site) and VACCINATION SITE SWELLING (raised red circle at the injection site) had resolved. At the time of the report, FEELING HOT (both of her cheeks became hot), ERYTHEMA (both of her cheeks became red) and SWELLING (both of her cheeks became raised) outcome was unknown and VACCINATION SITE PAIN (Soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient used topical sunscreen on face on 25Mar2021.   This case was linked to MOD-2021-125983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Outcome of event changed to Recovered/Resolved and Vaccination site pain event added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Soreness at injection site; both of her cheeks became hot; both of her cheeks became red; both of her cheeks became raised; evolved into a big circle (under her arm); a streak under her left arm; hot (red circle) at the injection site; big (red circle) at the injection site; raised red circle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (both of her cheeks became hot), VACCINATION SITE WARMTH (hot (red circle) at the injection site), ADVERSE REACTION (a streak under her left arm), ERYTHEMA (both of her cheeks became red) and SWELLING (both of her cheeks became raised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot (red circle) at the injection site), VACCINATION SITE ERYTHEMA (big (red circle) at the injection site) and VACCINATION SITE SWELLING (raised red circle at the injection site). On 12-Mar-2021, the patient experienced ADVERSE REACTION (a streak under her left arm) and ERYTHEMA (evolved into a big circle (under her arm)). On 25-Mar-2021, the patient experienced FEELING HOT (both of her cheeks became hot), ERYTHEMA (both of her cheeks became red) and SWELLING (both of her cheeks became raised). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 14-Mar-2021, VACCINATION SITE WARMTH (hot (red circle) at the injection site), ADVERSE REACTION (a streak under her left arm), ERYTHEMA (evolved into a big circle (under her arm)), VACCINATION SITE ERYTHEMA (big (red circle) at the injection site) and VACCINATION SITE SWELLING (raised red circle at the injection site) had resolved. At the time of the report, FEELING HOT (both of her cheeks became hot), ERYTHEMA (both of her cheeks became red) and SWELLING (both of her cheeks became raised) outcome was unknown and VACCINATION SITE PAIN (Soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient used topical sunscreen on face on 25Mar2021.   This case was linked to MOD-2021-125983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Outcome of event changed to Recovered/Resolved and Vaccination site pain event added.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: loss of appetite; lowenergy; body aches; fatigue; low grade fever; This spontaneous case was reported by an other health care professional and describes the occurrence of DECREASED APPETITE (loss of appetite), ASTHENIA (lowenergy), PAIN (body aches), FATIGUE (fatigue) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included UTI. Concomitant products included AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) for UTI.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DECREASED APPETITE (loss of appetite), ASTHENIA (lowenergy), PAIN (body aches), FATIGUE (fatigue) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 07-Mar-2021, DECREASED APPETITE (loss of appetite), ASTHENIA (lowenergy), PAIN (body aches), FATIGUE (fatigue) and PYREXIA (low grade fever) had resolved. 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.   Patient's second dose is schedule on 31MAR2021
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Rash, Rash pruritic, Urine odour abnormal
Clinical narrative: itchy rash; Body aches; Fowl urine smell; rash; Not feeling well today; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash), PAIN (Body aches), URINE ODOUR ABNORMAL (Fowl urine smell), MALAISE (Not feeling well today) and RASH (rash) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D20BEF1) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included LORATADINE for an unknown indication.   On 27-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 29-Mar-2021, the patient experienced MALAISE (Not feeling well today). On an unknown date, the patient experienced RASH PRURITIC (itchy rash), PAIN (Body aches), URINE ODOUR ABNORMAL (Fowl urine smell) and RASH (rash). At the time of the report, RASH PRURITIC (itchy rash), PAIN (Body aches), URINE ODOUR ABNORMAL (Fowl urine smell), MALAISE (Not feeling well today) and RASH (rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient had taken Claritin about 10/15 min after the injection.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Swelling of the face; hives; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of the face) and URTICARIA (hives) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced SWELLING FACE (Swelling of the face) and URTICARIA (hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 milligram; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milligram; PREDNISONE at a dose of 60 milligram and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Swelling of the face) and URTICARIA (hives) outcome was unknown.            No concomitant product use was reported  Action taken with mRNA-1273 Moderna COVID-19 Vaccine is not applicable   This case was linked to MOD-2021-033957 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Endometrial cancer and Blood pressure abnormal (Patient's blood pressure was going up and down and still  was not stable.). Concomitant products included LENVATINIB MESILATE (LENVIMA) from 11-Feb-2021 to 12-Feb-2021 for Endometrial cancer.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The patient mentioned he would get the second dose of Moderna vaccine on an unknown date in Mar-2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Mass excision, Myalgia
Clinical narrative: lump; redness; chills; muscle pain; Fatiguability and been lying on bed the whole afternoon; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), MASS EXCISION (lump), ERYTHEMA (redness), CHILLS (chills) and MYALGIA (muscle pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (Itching). On 20-Feb-2021, the patient experienced MASS EXCISION (lump), ERYTHEMA (redness), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (Fatiguability and been lying on bed the whole afternoon). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram twice a day. At the time of the report, PRURITUS (Itching), MASS EXCISION (lump), ERYTHEMA (redness), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (Fatiguability and been lying on bed the whole afternoon) outcome was unknown.            This case was linked to MOD-2021-019056 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: lump; redness; chills; muscle pain; Fatiguability and been lying on bed the whole afternoon; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), MASS EXCISION (lump), ERYTHEMA (redness), CHILLS (chills) and MYALGIA (muscle pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (Itching). On 20-Feb-2021, the patient experienced MASS EXCISION (lump), ERYTHEMA (redness), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (Fatiguability and been lying on bed the whole afternoon). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram twice a day. At the time of the report, PRURITUS (Itching), MASS EXCISION (lump), ERYTHEMA (redness), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (Fatiguability and been lying on bed the whole afternoon) outcome was unknown.            This case was linked to MOD-2021-019056 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin irritation, Vaccination site rash
Clinical narrative: irritation; itching; red; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (irritation), PRURITUS (itching), ERYTHEMA (red) and VACCINATION SITE RASH (rash at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced SKIN IRRITATION (irritation), PRURITUS (itching), ERYTHEMA (red) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, SKIN IRRITATION (irritation), PRURITUS (itching), ERYTHEMA (red) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  Treatment drug include Triamcinolone cream.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Syringe and needle separated; Liquid leaking out between syringe and needle; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe and needle separated) and UNDERDOSE (Liquid leaking out between syringe and needle) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had had COVID-19 90 days prior to vaccination.). Concurrent medical conditions included Penicillin allergy, Hypertension and Hypothyroidism. Concomitant products included LISINOPRIL and CARVEDILOL for Hypertension, LEVOTHYROXINE for Hypothyroidism.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe and needle separated) and UNDERDOSE (Liquid leaking out between syringe and needle). On 03-Feb-2021, DEVICE CONNECTION ISSUE (Syringe and needle separated) and UNDERDOSE (Liquid leaking out between syringe and needle) 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No new information was updated. On 14-Jun-2021: No new information updated.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pruritus, Rash, Skin exfoliation
Clinical narrative: rash all over his body(excluding the palms of his hands or soles of his feet) which was red like a sunburn; he still has itching on his back; peeling some what on arms; feeling chilled all day and fatigue; feeling chilled all day and fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash all over his body(excluding the palms of his hands or soles of his feet) which was red like a sunburn), PRURITUS (he still has itching on his back), SKIN EXFOLIATION (peeling some what on arms), CHILLS (feeling chilled all day and fatigue) and FATIGUE (feeling chilled all day and fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]), ATORVASTATIN, VITAMIN D NOS, METHOCARBAMOL, PARACETAMOL (EXTRA STRENGTH TYLENOL BACK PAIN), HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]), AMLODIPINE and METHOTREXATE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-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 RASH (rash all over his body(excluding the palms of his hands or soles of his feet) which was red like a sunburn), PRURITUS (he still has itching on his back), SKIN EXFOLIATION (peeling some what on arms), CHILLS (feeling chilled all day and fatigue) and FATIGUE (feeling chilled all day and fatigue). At the time of the report, RASH (rash all over his body(excluding the palms of his hands or soles of his feet) which was red like a sunburn), SKIN EXFOLIATION (peeling some what on arms), CHILLS (feeling chilled all day and fatigue) and FATIGUE (feeling chilled all day and fatigue) outcome was unknown and PRURITUS (he still has itching on his back) had not resolved. Not Provided          Treatment: Benadryl, Vistaril, Nivea lotion, Keri lotion.  Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus
Clinical narrative: itchy; took second dose less than 25 days apart from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took second dose less than 25 days apart from the first dose) and PRURITUS (itchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0478V18) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Uses Blood pressure medicine) and Arthritis (Uses Arthritis medicine).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took second dose less than 25 days apart from the first dose). On 27-Mar-2021, the patient experienced PRURITUS (itchy). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took second dose less than 25 days apart from the first dose) and PRURITUS (itchy) outcome was unknown.            Concomitant medicine include Blood Pressure medicine, arthritis medicine, potassium treatment medicine were not provided  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (UTI) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Nitrofurantoin and phenazopyridine
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Injection site pruritus
Clinical narrative: Joint pain; injection site Itching; Pain and itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain and itching at injection site), ARTHRALGIA (Joint pain) and INJECTION SITE PRURITUS (injection site Itching) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain and itching at injection site) and INJECTION SITE PRURITUS (injection site Itching). On 26-Mar-2021, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, INJECTION SITE PAIN (Pain and itching at injection site), ARTHRALGIA (Joint pain) and INJECTION SITE PRURITUS (injection site Itching) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.  Action taken with mRNA-1273 in response to the event was unknown
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Arm of injection painful; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm of injection painful) and FATIGUE (Exhausted) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, MONTELUKAST, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) and SALBUTAMOL (PROVENTIL [SALBUTAMOL]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 INJECTION SITE PAIN (Arm of injection painful) and FATIGUE (Exhausted). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and SALBUTAMOL (PROVENTIL [SALBUTAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Arm of injection painful) and FATIGUE (Exhausted) outcome was unknown. Not Provided          Concomitant medications reported were Amlodipine, Breonhaler, Montelukast, Claritin, Proventil inhaler  Treatment medicines include Advil, Prednisone, Massage, Bio Freeze cream, Tessalon Perles, Proventil inhaler   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to INC.-MOD-2021-061274 (E2B Linked Report).; Sender's Comments:   INC.-MOD-2021-061274:Second Dose
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Sleepy; tired and sleeps a lot; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and FATIGUE (tired and sleeps a lot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN, LISINOPRIL, GABAPENTIN, HYDROCODONE, ATORVASTATIN, VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ACETYLSALICYLIC ACID (ASPIRIN LOW), IRON and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced SOMNOLENCE (Sleepy) and FATIGUE (tired and sleeps a lot). At the time of the report, SOMNOLENCE (Sleepy) and FATIGUE (tired and sleeps a lot) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines include  Tamsulosin lisinopril, gabapentin, hydrocodone, atorvastin, vitaminC vitaminB12, l ow dose aspirin, iron, prenatal vitamin  Treatment drugs were not provided  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: 52 days interval between the doses; Fatigue/tired; Joint pain; Light fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days interval between the doses), FATIGUE (Fatigue/tired), ARTHRALGIA (Joint pain) and PYREXIA (Light fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Coronary artery disease from 26-Feb-2021 to 04-Mar-2021 and Open heart surgery on 08-Mar-2021. Concurrent medical conditions included Colon cancer since 20-Nov-2004, Blood pressure high since 2006, Borderline diabetes since February 2020 and Latex allergy. Concomitant products included AMLODIPINE, METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE, ATORVASTATIN, FERROUS SULFATE, SIMETHICONE, METHIMAZOLE, METFORMIN, ASCORBIC ACID, PARACETAMOL (TYLENOL), MULTIVITAMINS [VITAMINS NOS], LISINOPRIL from 2006 to an unknown date, VITAMIN C [ASCORBIC ACID] and METOPROLOL TARTRATE for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days interval between the doses) and PYREXIA (Light fever). 26-Mar-2021, the patient experienced FATIGUE (Fatigue/tired) and ARTHRALGIA (Joint pain). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days interval between the doses) had resolved. On 28-Mar-2021, FATIGUE (Fatigue/tired), ARTHRALGIA (Joint pain) and PYREXIA (Light fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.   Patient is concerned about effectiveness and efficacy of Moderna Covid-19 vaccine given 52-days apart. He wans to be part of clinical trials.   This case was linked to MOD-2021-061224 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 12-May-2021 .Patient demographics were updated, vaccine facility details were added, concomitant medications were added, event stop date was added, chronic long standing conditions were updated. On 15-Jul-2021: Follow-up information received on 15-JUL-2021 contains No New information.