chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Sore arm; The vaccine from expired vial has been administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine from expired vial has been administered) and PAIN IN EXTREMITY (Sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine from expired vial has been administered). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine from expired vial has been administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. Treatment information were not provided.  Patient was administered vaccine from vial that was past the 12 hour puncture time.  Vial had been kept cold in the fridge.   This case was linked to US-MODERNATX, INC.-MOD-2021-153743, US-MODERNATX, INC.-MOD-2021-154363, US-MODERNATX, INC.-MOD-2021-154462, US-MODERNATX, INC.-MOD-2021-155107, US-MODERNATX, INC.-MOD-2021-155542 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Patient demographics and additional event (Sore arm) were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-153743:case: same reporter US-MODERNATX, INC.-MOD-2021-154363:case: same reporter US-MODERNATX, INC.-MOD-2021-154462:case: same reporter US-MODERNATX, INC.-MOD-2021-155107:case: same reporter US-MODERNATX, INC.-MOD-2021-155542:case: same reporter
Sex: F
Vaccine: COVID19
Symptoms: HIV test, HIV test false positive
Clinical narrative: False positive for HIV; This spontaneous case was reported by a nurse and describes the occurrence of HIV TEST FALSE POSITIVE (False positive for HIV) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HIV TEST FALSE POSITIVE (False positive for HIV). At the time of the report, HIV TEST FALSE POSITIVE (False positive for HIV) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HIV test: negative (Negative) false positive test for HIV.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment medications were not provided.  It was reported that patient had  initially tested positive for HIV1 and HIV2 reactive, the final interpretation was negative. The organization then notified her that they could not accept her blood donation.   `
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: slept all day; low fever; Tired; Patient got his 2nd dose on 41 day; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got his 2nd dose on 41 day), HYPERSOMNIA (slept all day), PYREXIA (low fever) and FATIGUE (Tired) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got his 2nd dose on 41 day) and FATIGUE (Tired). On 18-May-2021, the patient experienced HYPERSOMNIA (slept all day) and PYREXIA (low fever). On 17-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got his 2nd dose on 41 day) had resolved. On 19-May-2021, HYPERSOMNIA (slept all day), PYREXIA (low fever) and FATIGUE (Tired) had resolved.            No concomitant medications were reported.  Treatment Medication includes: Antibiotics and steroids   This case was linked to MOD-2021-155509 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19-Jul-2021 contains no significant information. Contact information updated, email added.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Moderna covid 19 vaccine administered 15 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna covid 19 vaccine administered 15 days after first dose) in a 79-year-old male elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 022C21A) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-May-2021, the elderly was diagnosed with INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna covid 19 vaccine administered 15 days after first dose). The Elderly was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna covid 19 vaccine administered 15 days after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine from expired vial has been administered to five patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered to five patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered to five patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered to five patients) 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.   No concomitant details were provided No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-154363, US-MODERNATX, INC.-MOD-2021-153743, US-MODERNATX, INC.-MOD-2021-154462, US-MODERNATX, INC.-MOD-2021-155107, US-MODERNATX, INC.-MOD-2021-155523 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154363: US-MODERNATX, INC.-MOD-2021-153743: US-MODERNATX, INC.-MOD-2021-154462: US-MODERNATX, INC.-MOD-2021-155107: US-MODERNATX, INC.-MOD-2021-155523:
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pyrexia
Clinical narrative: numbness in left thumb; high fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in left thumb) and PYREXIA (high fever) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPOAESTHESIA (numbness in left thumb) and PYREXIA (high fever). On 07-Feb-2021, HYPOAESTHESIA (numbness in left thumb) and PYREXIA (high fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-039663 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision is detreated) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 023M20A) for COVID-19 vaccination.  The patient's past medical history included Cataract operation (First cataract Surgery) on 22-Jun-2021.Previously administered products included for Product used for unknown indication: Prolia. Concomitant products included CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D), MATURE MULTIVITAMINS and LUTEIN [XANTOFYL] from 15-Mar-2021 to an unknown date for an unknown indication.On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VISUAL IMPAIRMENT (vision is detreated). At the time of the report, VISUAL IMPAIRMENT (vision is detreated) had not resolved. Concomitant included Bio flex was noted.No treatment medications were provided.Most recent FOLLOW-UP information incorporated above includes:On 20-Jul-2021: Significant follow up received included outcome of event updated unknown to not recovered. Concomitant and surgical procedure were added.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced MYALGIA (achy). At the time of the report, MYALGIA (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: would get the second dose more than 35 days after the first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (would get the second dose more than 35 days after the first) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (would get the second dose more than 35 days after the first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (would get the second dose more than 35 days after the first) had resolved.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: During administration the syringe barrel cracked; Lower-than-authorized dose volume administered (Leaked Out); This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (During administration the syringe barrel cracked) and UNDERDOSE (Lower-than-authorized dose volume administered (Leaked Out)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced DEVICE CONNECTION ISSUE (During administration the syringe barrel cracked) and UNDERDOSE (Lower-than-authorized dose volume administered (Leaked Out)). On 20-May-2021, DEVICE CONNECTION ISSUE (During administration the syringe barrel cracked) and UNDERDOSE (Lower-than-authorized dose volume administered (Leaked Out)) 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 concomitant medications was reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Ringing in her ear; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and TINNITUS (Ringing in her ear) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced DIZZINESS (Dizzy). On 18-Apr-2021, the patient experienced TINNITUS (Ringing in her ear). At the time of the report, DIZZINESS (Dizzy) and TINNITUS (Ringing in her ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-155644 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155644:friend of a friend
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: lips are swollen along with other areas on his face where he has fillers; lips are swollen along with other areas on his face where he has fillers; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips are swollen along with other areas on his face where he has fillers) and SWELLING FACE (lips are swollen along with other areas on his face where he has fillers) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced LIP SWELLING (lips are swollen along with other areas on his face where he has fillers) and SWELLING FACE (lips are swollen along with other areas on his face where he has fillers). At the time of the report, LIP SWELLING (lips are swollen along with other areas on his face where he has fillers) and SWELLING FACE (lips are swollen along with other areas on his face where he has fillers) outcome was unknown.      No treatment information was provided. No relevant concomitant medications reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Loud ringing in ears still happening; Got increasingly dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Got increasingly dizzy) and TINNITUS (Loud ringing in ears still happening) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced DIZZINESS (Got increasingly dizzy). On 18-Apr-2021, the patient experienced TINNITUS (Loud ringing in ears still happening). At the time of the report, DIZZINESS (Got increasingly dizzy) and TINNITUS (Loud ringing in ears still happening) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-155602 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: follow up received on 20-may-2021, it does not contain any new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155602:friend of a friend
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (2 other patients had a similar rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (2 other patients had a similar rash). At the time of the report, RASH (2 other patients had a similar rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medication were provided. This case was linked to US-MODERNATX, INC.-MOD-2021-155384 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow Up received on 30-JUN-2021 contains TCR form with No New Information; Sender's Comments: US-MODERNATX, INC.-MOD-2021-155384:Case of patient.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye
Clinical narrative: Dry eye syndrome; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry eye syndrome) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    Co-suspect product included non-company product MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) for Osteoporosis.    Family history included Sjogren's syndrome since an unknown date. Concurrent medical conditions included Leukemia. Concomitant products included MACROGOL 3350 (MIRALAX) for Digestion impaired, MAGNESIUM GLYCINATE for Leukemia, ACYCLOVIR [ACICLOVIR] for Shingles, ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient started MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) (unknown route) at an unspecified dose. In February 2021, the patient experienced DRY EYE (Dry eye syndrome). The patient was treated with DEXAMETHASONE, TOBRAMYCIN (TOBRAMYCIN + DEXAMETHASONE CELSUS) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DRY EYE (Dry eye syndrome) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Mother had a history of Lupus and Raynaud's syndrome. Patient is enrolled in Covid-19 clinical trial for SARS COVE 2 Anti-Body, blood drawn twice so far. Their recent Antibody test made only 1 spike protein antibody. They want to find out if their body will still make more antibodies.   This case was linked to MOD-2021-155690 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle twitching, Pyrexia, Vaccination site pain
Clinical narrative: Vaccination site pain; Twitch that now comes and goes; Fever was very intense; Very tired; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), MUSCLE TWITCHING (Twitch that now comes and goes), PYREXIA (Fever was very intense) and FATIGUE (Very tired) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-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 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), MUSCLE TWITCHING (Twitch that now comes and goes), PYREXIA (Fever was very intense) and FATIGUE (Very tired). The patient was treated with IBUPROFEN for Fever, at a dose of 1 dosage form. On 20-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain), MUSCLE TWITCHING (Twitch that now comes and goes), PYREXIA (Fever was very intense) and FATIGUE (Very tired) had resolved.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported   This case was linked to MOD-2021-054410 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Depressed mood, Fatigue, Feeling abnormal
Clinical narrative: Heavy sweating; Emotional sensitivity; Loss of Appetite; Lost weight like 2 sizes down; Horrible feeling; Sore at injection site; Chills; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Heavy sweating), DEPRESSED MOOD (Emotional sensitivity), DECREASED APPETITE (Loss of Appetite), WEIGHT DECREASED (Lost weight like 2 sizes down) and FEELING ABNORMAL (Horrible feeling) in a 58-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.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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 HYPERHIDROSIS (Heavy sweating), DEPRESSED MOOD (Emotional sensitivity), DECREASED APPETITE (Loss of Appetite), WEIGHT DECREASED (Lost weight like 2 sizes down), FEELING ABNORMAL (Horrible feeling), VACCINATION SITE PAIN (Sore at injection site), CHILLS (Chills) and FATIGUE (Tiredness). At the time of the report, HYPERHIDROSIS (Heavy sweating), DEPRESSED MOOD (Emotional sensitivity), DECREASED APPETITE (Loss of Appetite), WEIGHT DECREASED (Lost weight like 2 sizes down), FEELING ABNORMAL (Horrible feeling), VACCINATION SITE PAIN (Sore at injection site), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Vaccination site pain, Weight decreased
Clinical narrative: Heavy sweating; Emotional sensitivity; Loss of Appetite; Lost weight like 2 sizes down; Horrible feeling; Sore at injection site; Chills; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Heavy sweating), DEPRESSED MOOD (Emotional sensitivity), DECREASED APPETITE (Loss of Appetite), WEIGHT DECREASED (Lost weight like 2 sizes down) and FEELING ABNORMAL (Horrible feeling) in a 58-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.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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 HYPERHIDROSIS (Heavy sweating), DEPRESSED MOOD (Emotional sensitivity), DECREASED APPETITE (Loss of Appetite), WEIGHT DECREASED (Lost weight like 2 sizes down), FEELING ABNORMAL (Horrible feeling), VACCINATION SITE PAIN (Sore at injection site), CHILLS (Chills) and FATIGUE (Tiredness). At the time of the report, HYPERHIDROSIS (Heavy sweating), DEPRESSED MOOD (Emotional sensitivity), DECREASED APPETITE (Loss of Appetite), WEIGHT DECREASED (Lost weight like 2 sizes down), FEELING ABNORMAL (Horrible feeling), VACCINATION SITE PAIN (Sore at injection site), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Dizziness; Sweating; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received: Outcome is updated to recovered/resolved.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: itching at the injection site; Area was swollen; Area was swollen and it hurts; muscle was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE SWELLING (Area was swollen), INJECTION SITE PAIN (Area was swollen and it hurts) and MYALGIA (muscle was sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B214-1 and 038B21A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN HCL), SPIRONOLACTONE, IRBESARTAN and VERAPAMIL HYDROCHLORIDE (VERAPAMIL [VERAPAMIL HYDROCHLORIDE]) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 20-May-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE SWELLING (Area was swollen), INJECTION SITE PAIN (Area was swollen and it hurts) and MYALGIA (muscle was sore). At the time of the report, INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE SWELLING (Area was swollen), INJECTION SITE PAIN (Area was swollen and it hurts) and MYALGIA (muscle was sore) outcome was unknown.            Treatment details included cold and hot water to the area.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ANXIETY (Anxiety rate went up), ASTHENIA (Weakness), MYALGIA (Body aches) and NAUSEA (Serious nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DIZZINESS (Dizziness), ANXIETY (Anxiety rate went up), ASTHENIA (Weakness), MYALGIA (Body aches) and NAUSEA (Serious nausea). At the time of the report, DIZZINESS (Dizziness), ANXIETY (Anxiety rate went up), ASTHENIA (Weakness), MYALGIA (Body aches) and NAUSEA (Serious nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Missed the 2nd shot of Moderna vaccine; passed 36th days after receiving the 1st dose of vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot of Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (passed 36th days after receiving the 1st dose of vaccine.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history provided by the reporter.     On 15-Apr-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 DOSE OMISSION ISSUE (Missed the 2nd shot of Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (passed 36th days after receiving the 1st dose of vaccine.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot of Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (passed 36th days after receiving the 1st dose of vaccine.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       the patient had not experienced any side effect with first dose of vaccine ,further patient stated that he  missed the scheduled 2nd dose appointment on 13May2021.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine in the left arm of a patient of an unauthorized age; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine in the left arm of a patient of an unauthorized age) in a 16-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 05-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine in the left arm of a patient of an unauthorized age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine in the left arm of a patient of an unauthorized age) 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.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction to PEG (polyethylene glycol); This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (allergic reaction to PEG (polyethylene glycol)) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction to PEG (polyethylene glycol)). At the time of the report, HYPERSENSITIVITY (allergic reaction to PEG (polyethylene glycol)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   it was stated there was no known history of allergic reaction to PEG (polyethylene glycol). Concomitant and treatment medication was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: arm pain; headache; muscle pain; nausea; vomiting; fatigue; joint pain; fever of 100ºF; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), HEADACHE (headache), MYALGIA (muscle pain), NAUSEA (nausea) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C71A or 038C91A and 007C21A or 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain), HEADACHE (headache), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), ARTHRALGIA (joint pain) and PYREXIA (fever of 100ºF). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, PAIN IN EXTREMITY (arm pain), HEADACHE (headache), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), ARTHRALGIA (joint pain) and PYREXIA (fever of 100ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 100 (Inconclusive) fever of 100ºF.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: arm pain; headache; muscle pain; nausea; vomiting; fatigue; joint pain; fever of 100ºF; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), HEADACHE (headache), MYALGIA (muscle pain), NAUSEA (nausea) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C71A or 038C91A and 007C21A or 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain), HEADACHE (headache), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), ARTHRALGIA (joint pain) and PYREXIA (fever of 100ºF). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, PAIN IN EXTREMITY (arm pain), HEADACHE (headache), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), ARTHRALGIA (joint pain) and PYREXIA (fever of 100ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 100 (Inconclusive) fever of 100ºF.
Sex: U
Vaccine: COVID19
Symptoms: Abnormal behaviour
Clinical narrative: Patient started dancing two weeks after receiving their last Covid-19 vaccine; Med Info Agent:  Warm transfer from customer care, case: 00167431 Crosslinked with case: MOD21-092305 Consumer received both Moderna Covid-19 vaccines with no adverse events to report but has a question about why her bill states that she received Sars-Cov-2.  The consumer said son had some side effects and over in a day. The consumer also mentioned her sister got both vaccines and previously had Covid-19 before receiving the vaccines. Covid made her tired and her hair started to fall out. After receiving the vaccines the consumer reports her sister is no longer tired and her hair has grown back. The consumer also stated that one patient who also previously had Covid-19 prior to vaccine administration started dancing two weeks after receiving her second dose of the Covid-19 vaccine. The consumer also states that on news a patient was diagnosed with Covid-19 and did not have  smell or taste. After receiving the Covid-19 vaccine, the consumer reported the patient does not have smell or taste problem any more.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155334:Same reporter US-MODERNATX, INC.-MOD-2021-155275:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: tested positive for covid; Chills; fever; rash; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), RASH (rash), CHILLS (Chills) and PYREXIA (fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever). In April 2021, the patient experienced RASH (rash). On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for covid). In April 2021, RASH (rash) had resolved. On 24-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, COVID-19 (tested positive for covid) had not resolved and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 07-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was temporarily withheld on an unknown date.       No concomitant medications were reported.  It was reported that the patient tested positive for COVID-19 about 7 days after receiving the first vaccination dose. The patient quarantined for 2 weeks without any fever or sign of COVID-19 apart from fatigue and taking daily naps. The patient tested positive again on 07-May-2021 and has therefore not received the second dose.   No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: 6 styes on her right eye; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (6 styes on her right eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HORDEOLUM (6 styes on her right eye). At the time of the report, HORDEOLUM (6 styes on her right eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicine was not reported by the reporter  treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-067453 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067453:Case for dose 1
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Patients administered temperature excursion doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered temperature excursion doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered temperature excursion doses). On 23-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered temperature excursion doses) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-148248, US-MODERNATX, INC.-MOD-2021-148279, US-MODERNATX, INC.-MOD-2021-106651 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148248: US-MODERNATX, INC.-MOD-2021-148279: US-MODERNATX, INC.-MOD-2021-106651:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Sinus headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (extremely bad sinus headache) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SINUS HEADACHE (extremely bad sinus headache) and HEADACHE (headache). At the time of the report, SINUS HEADACHE (extremely bad sinus headache) and HEADACHE (headache) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment reported. Reporter did not allow further contact.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: I missed my 2nd dose because I got COVID-19; I got COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got COVID-19) and PRODUCT DOSE OMISSION ISSUE (I missed my 2nd dose because I got COVID-19) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced COVID-19 (I got COVID-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I missed my 2nd dose because I got COVID-19). At the time of the report, COVID-19 (I got COVID-19) and PRODUCT DOSE OMISSION ISSUE (I missed my 2nd dose because I got COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: The left arm was red at injection site; A bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (The left arm was red at injection site) and VACCINATION SITE SWELLING (A bump at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (The left arm was red at injection site) and VACCINATION SITE SWELLING (A bump at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (The left arm was red at injection site) and VACCINATION SITE SWELLING (A bump at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up received, contains event outcome as recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, SARS-CoV-2 antibody test
Clinical narrative: Headache; Fatigue; Tested postive for COVID 19 after 1st Dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested postive for COVID 19 after 1st Dose), HEADACHE (Headache) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced COVID-19 (Tested postive for COVID 19 after 1st Dose). On an unknown date, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested postive for COVID 19 after 1st Dose), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator     Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Follow up received and events outcome updated as recovered