chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache
Clinical narrative: haven't even ate some nights; haven't eat last night and went to sleep at 7.00 pm extremely tired; felt like someone hit her over the head with a sledgehammer.; felt really tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (haven't even ate some nights), FATIGUE (felt really tired and fatigued), FATIGUE (haven't eat last night and went to sleep at 7.00 pm extremely tired) and HEADACHE (felt like someone hit her over the head with a sledgehammer.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     no medical history was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 20-Apr-2021, the patient experienced FATIGUE (felt really tired and fatigued) and HEADACHE (felt like someone hit her over the head with a sledgehammer.). On 23-Apr-2021, the patient experienced FATIGUE (haven't eat last night and went to sleep at 7.00 pm extremely tired). On an unknown date, the patient experienced DECREASED APPETITE (haven't even ate some nights). At the time of the report, DECREASED APPETITE (haven't even ate some nights), FATIGUE (felt really tired and fatigued), FATIGUE (haven't eat last night and went to sleep at 7.00 pm extremely tired) and HEADACHE (felt like someone hit her over the head with a sledgehammer.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant and treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR form appended on 26-MAY-2021:Patient stated AE from the firstvaccine resolved . Second dose information given and denied further follow-up
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: her neighbor got tired after 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (her neighbor got tired after 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (her neighbor got tired after 2nd dose). At the time of the report, FATIGUE (her neighbor got tired after 2nd dose) 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-2021-089114, MOD21-080986, US-MODERNATX, INC.-MOD-2021-089137 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089114:Patient case MOD21-080986: US-MODERNATX, INC.-MOD-2021-089137:
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over the body) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was reported.     On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced URTICARIA (hives all over the body). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no Concomitant products were provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: form added, patient email provided
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hyperhidrosis, Somnolence
Clinical narrative: weak; sleeping; headaches; sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), ASTHENIA (weak), SOMNOLENCE (sleeping) and HEADACHE (headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included TRIAMTERENE, ATORVASTATIN, NORTRIPTYLINE, METFORMIN, MELOXICAM, OMEPRAZOLE, GABAPENTIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and MULTIVITAMIN IRON for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced HYPERHIDROSIS (sweating) and HEADACHE (headaches). On 22-Apr-2021, the patient experienced ASTHENIA (weak) and SOMNOLENCE (sleeping). At the time of the report, HYPERHIDROSIS (sweating) and HEADACHE (headaches) outcome was unknown and ASTHENIA (weak) and SOMNOLENCE (sleeping) had not resolved.            Concomitant medications includes Stool softener daily along with above mentioned medications. No treatment drugs were reported. Consumer states he did not have any symptoms after his first dose that he received on 24-Mar-2021,Consumer calling in today, 23Apr2021, reporting symptoms her husband is having following his second dose. He received his second dose on 21Apr2021 in his right arm, lot number 030B21A, expiration unknown (01Jan1900), and that night began having sweating and headaches. Consumer states he had to call in to work yesterday and today because he is still having weakness and sleeping. States she is going to call his doctor today and he has not taken anything for symptoms, just his regular medication but has not taken that yet today.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness postural, Feeling abnormal, Orthostatic hypotension
Clinical narrative: Afraid of falling and braking a bone; Dizzy when changing from sitting to standing position; orthostatic hypotension; Balance issues/Balance issues are continuing /didn't have his legs under him; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizzy when changing from sitting to standing position), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), BALANCE DISORDER (Balance issues/Balance issues are continuing /didn't have his legs under him) and FEELING ABNORMAL (Afraid of falling and braking a bone) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Stroke on 11-Feb-2021, Rehabilitation therapy (post stroke), Surgery and Stent insertion NOS (stent procedure on right carotid artery.). Concomitant products included AMLODIPINE and LISINOPRIL for Blood pressure high, HYDROCHLOROTHIAZIDE for Hair loss, ATORVASTATIN for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS POSTURAL (Dizzy when changing from sitting to standing position), ORTHOSTATIC HYPOTENSION (orthostatic hypotension) and BALANCE DISORDER (Balance issues/Balance issues are continuing /didn't have his legs under him). On 07-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Afraid of falling and braking a bone). At the time of the report, DIZZINESS POSTURAL (Dizzy when changing from sitting to standing position), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), BALANCE DISORDER (Balance issues/Balance issues are continuing /didn't have his legs under him) and FEELING ABNORMAL (Afraid of falling and braking a bone) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were provided.  Patient undergone CT scans, skull sonograms w/o any new revelations (Results not provided.)  Patient Prior to 4/14 was successfully completed rehabilitation of a 2/12 stent procedure on my right carotid artery.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Significant Follow up received on 12-Aug-2021,  Updated medical history stent procedure details & Lab data details in INarrative Updated
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia, Vomiting
Clinical narrative: after an hour she vomited; joint pain; fever (maybe low grade fever did not took temperature since it was not significant); chills; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (after an hour she vomited), ARTHRALGIA (joint pain), PYREXIA (fever (maybe low grade fever did not took temperature since it was not significant)) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pancreatic cancer (Pancreatic cancer survivor 2019) in 2019. Concurrent medical conditions included Immune disorder (NOS), Psoriatic arthritis since 2011 and Allergy (General allergy (trees)). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and CLONAZEPAM for Anxiety, ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE (FIORINAL [ACETYLSALICYLIC ACID;BUTALBITAL;CAFFEINE]) for Migraine, OXYCODONE, PROMETHAZINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), PANCREATIN (CREON), METOPROLOL and OMEPRAZOLE for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VOMITING (after an hour she vomited), ARTHRALGIA (joint pain), PYREXIA (fever (maybe low grade fever did not took temperature since it was not significant)) and CHILLS (chills). At the time of the report, VOMITING (after an hour she vomited) had not resolved and ARTHRALGIA (joint pain), PYREXIA (fever (maybe low grade fever did not took temperature since it was not significant)) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient informed her doctor and was instructed to drink more water for now and may come tomorrow if she's still not ok and will do a lab test for that.   This case was linked to US-MODERNATX, INC.-MOD-2021-089305 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089305:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: shoulder rotating cuff is messed up in the arm; Feels like she is having arthritis and cannot even open bottles; Feet hurt, specifically her toes; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder rotating cuff is messed up in the arm), ARTHRALGIA (Feels like she is having arthritis and cannot even open bottles) and PAIN IN EXTREMITY (Feet hurt, specifically her toes) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ARTHRALGIA (shoulder rotating cuff is messed up in the arm), ARTHRALGIA (Feels like she is having arthritis and cannot even open bottles) and PAIN IN EXTREMITY (Feet hurt, specifically her toes). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (shoulder rotating cuff is messed up in the arm), ARTHRALGIA (Feels like she is having arthritis and cannot even open bottles) and PAIN IN EXTREMITY (Feet hurt, specifically her toes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: some of it spilled out during administration - about half of the vaccine was administered; some of it spilled out during administration - about half of the vaccine was administered; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (some of it spilled out during administration - about half of the vaccine was administered) and DEVICE CONNECTION ISSUE (some of it spilled out during administration - about half of the vaccine was administered) in a male 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (some of it spilled out during administration - about half of the vaccine was administered) and DEVICE CONNECTION ISSUE (some of it spilled out during administration - about half of the vaccine was administered). At the time of the report, UNDERDOSE (some of it spilled out during administration - about half of the vaccine was administered) and DEVICE CONNECTION ISSUE (some of it spilled out during administration - about half of the vaccine was administered) 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness
Clinical narrative: Feels sick; Having Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Feels sick) and CHILLS (Having Chills) in a 70-year-old female 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) (Intramuscular) 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 23-Apr-2021, the patient experienced ILLNESS (Feels sick) and CHILLS (Having Chills). At the time of the report, ILLNESS (Feels sick) and CHILLS (Having Chills) had resolved.            No treatment information was reported.  Concomitant product use was not provided by the reporter.   This case was linked to MOD21-066015 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information included, event outcome was updated.; Sender's Comments:  MOD21-066015:
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue
Clinical narrative: upset stomach; Having LBM; feels very tired; This spontaneous case was reported by an other caregiver and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (Having LBM) and FATIGUE (feels very tired) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (Having LBM) and FATIGUE (feels very tired). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (Having LBM) and FATIGUE (feels very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  The reporter stated that no treatment was received by the patient.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE, PRAVASTATIN and Trazadone for an unknown indication.    On 22-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 HEADACHE (headache). At the time of the report, HEADACHE (headache) 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.   Treatment medication include tylenol .
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient 90 days overdue for 2nd dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient 90 days overdue for 2nd dose of the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 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 (Patient 90 days overdue for 2nd dose of the Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient 90 days overdue for 2nd dose of the Moderna vaccine) outcome was unknown. 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.   Concomitant medication information was not reported. Treatment information as not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash morbilliform, Vaccination site pruritus, Vaccination site rash
Clinical narrative: morbilliform; skin is still red/skin is still splotchy with occasional flare ups; pretty severe rash on most of their trunk/rash on shoulders/ rash on neck; rash down the arms; itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (morbilliform), ERYTHEMA (skin is still red/skin is still splotchy with occasional flare ups), RASH (pretty severe rash on most of their trunk/rash on shoulders/ rash on neck), VACCINATION SITE RASH (rash down the arms) and VACCINATION SITE PRURITUS (itchy rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MORBILLIFORM (morbilliform), ERYTHEMA (skin is still red/skin is still splotchy with occasional flare ups), RASH (pretty severe rash on most of their trunk/rash on shoulders/ rash on neck), VACCINATION SITE RASH (rash down the arms) and VACCINATION SITE PRURITUS (itchy rash). At the time of the report, RASH MORBILLIFORM (morbilliform), ERYTHEMA (skin is still red/skin is still splotchy with occasional flare ups), RASH (pretty severe rash on most of their trunk/rash on shoulders/ rash on neck), VACCINATION SITE RASH (rash down the arms) and VACCINATION SITE PRURITUS (itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, Headache, Herpes zoster, Neuralgia
Clinical narrative: bumps near hairline; nerve pain; shingles; sharp pains in the head; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (bumps near hairline), NEURALGIA (nerve pain), HERPES ZOSTER (shingles) and HEADACHE (sharp pains in the head) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 037B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX (Patient had a shingles shot 2 years ago). Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), HYDROCHLOROTHIAZIDE, ATORVASTATIN, METOPROLOL and ADALIMUMAB (HUMIRA) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced FURUNCLE (bumps near hairline), NEURALGIA (nerve pain), HERPES ZOSTER (shingles) and HEADACHE (sharp pains in the head). At the time of the report, FURUNCLE (bumps near hairline), NEURALGIA (nerve pain), HERPES ZOSTER (shingles) and HEADACHE (sharp pains in the head) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had a shingles shot 2 years ago
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Arthralgia, Asthenia, Fatigue, Myalgia
Clinical narrative: Fatigue; Joint pain; muscle aches; swelling at the injection site; scar tissue; anemia; Erosion of energy; itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (scar tissue), ANAEMIA (anemia), ASTHENIA (Erosion of energy), VACCINATION SITE PRURITUS (itchiness at the injection site) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (few years ago). Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 07-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 SCAR (scar tissue), ANAEMIA (anemia), ASTHENIA (Erosion of energy), VACCINATION SITE PRURITUS (itchiness at the injection site), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (muscle aches) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, SCAR (scar tissue), ANAEMIA (anemia) and ASTHENIA (Erosion of energy) outcome was unknown and VACCINATION SITE PRURITUS (itchiness at the injection site), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (muscle aches) and VACCINATION SITE SWELLING (swelling at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient have been in the hospital for a blood transfusion.She was 3 units low.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received and added the events scar tissue,erosion of energy and anemia.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Scar, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Fatigue; Joint pain; muscle aches; swelling at the injection site; scar tissue; anemia; Erosion of energy; itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (scar tissue), ANAEMIA (anemia), ASTHENIA (Erosion of energy), VACCINATION SITE PRURITUS (itchiness at the injection site) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (few years ago). Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 07-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 SCAR (scar tissue), ANAEMIA (anemia), ASTHENIA (Erosion of energy), VACCINATION SITE PRURITUS (itchiness at the injection site), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (muscle aches) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, SCAR (scar tissue), ANAEMIA (anemia) and ASTHENIA (Erosion of energy) outcome was unknown and VACCINATION SITE PRURITUS (itchiness at the injection site), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (muscle aches) and VACCINATION SITE SWELLING (swelling at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient have been in the hospital for a blood transfusion.She was 3 units low.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received and added the events scar tissue,erosion of energy and anemia.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to patients between 16 and/or 17 years old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patients between 16 and/or 17 years old) in a 16-year-old patient of an unknown 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, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patients between 16 and/or 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patients between 16 and/or 17 years old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Spot is warm to the touch after second vaccine dose; Arm soreness after second vaccine dose; COVID Arm after second vaccine dose; Little redness on on the arm at the injection site after second vaccine dose; Little swelling on the arm at the injection site after second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Spot is warm to the touch after second vaccine dose), PAIN IN EXTREMITY (Arm soreness after second vaccine dose), VACCINATION SITE REACTION (COVID Arm after second vaccine dose), VACCINATION SITE ERYTHEMA (Little redness on on the arm at the injection site after second vaccine dose) and VACCINATION SITE SWELLING (Little swelling on the arm at the injection site after second vaccine dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 23-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Spot is warm to the touch after second vaccine dose), PAIN IN EXTREMITY (Arm soreness after second vaccine dose), VACCINATION SITE REACTION (COVID Arm after second vaccine dose), VACCINATION SITE ERYTHEMA (Little redness on on the arm at the injection site after second vaccine dose) and VACCINATION SITE SWELLING (Little swelling on the arm at the injection site after second vaccine dose). At the time of the report, VACCINATION SITE WARMTH (Spot is warm to the touch after second vaccine dose), PAIN IN EXTREMITY (Arm soreness after second vaccine dose), VACCINATION SITE REACTION (COVID Arm after second vaccine dose) and VACCINATION SITE SWELLING (Little swelling on the arm at the injection site after second vaccine dose) outcome was unknown and VACCINATION SITE ERYTHEMA (Little redness on on the arm at the injection site after second vaccine dose) had resolved.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Itchy redness spread to her abdomen; Itchiness; swelling on the injection site; Area around the injection site became intensely red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Itchy redness spread to her abdomen), PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Area around the injection site became intensely red) and VACCINATION SITE SWELLING (swelling on the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area around the injection site became intensely red). On 16-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling on the injection site). On 17-Apr-2021, the patient experienced PRURITUS (Itchiness). On 18-Apr-2021, the patient experienced ERYTHEMA (Itchy redness spread to her abdomen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Itchy redness spread to her abdomen), PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Area around the injection site became intensely red) and VACCINATION SITE SWELLING (swelling on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. Treatment information included- Benadryl capsules did not helped.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: received first dose of Moderna COVID-19 vaccine on 26APR2021 and she is about 8 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received first dose of Moderna COVID-19 vaccine on 26APR2021 and she is about 8 weeks pregnant) in a 29-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 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 29-Nov-2021. On 26-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (received first dose of Moderna COVID-19 vaccine on 26APR2021 and she is about 8 weeks pregnant). On 26-Apr-2021, EXPOSURE DURING PREGNANCY (received first dose of Moderna COVID-19 vaccine on 26APR2021 and she is about 8 weeks pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 26apr2021, post vaccination, the patient reported that she experienced symptoms of exposure during pregnancy  The patient was  8 weeks pregnant.  No treatment information was provided NO Concomitant information was provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: headache; fever; arm was swollen; arm was achy; arm was tender; tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), PAIN IN EXTREMITY (arm was achy), TENDERNESS (arm was tender), FATIGUE (tired) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), PAIN IN EXTREMITY (arm was achy), TENDERNESS (arm was tender) and FATIGUE (tired). On 27-Apr-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, PERIPHERAL SWELLING (arm was swollen), PAIN IN EXTREMITY (arm was achy), TENDERNESS (arm was tender), FATIGUE (tired), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 99.3f The patient had fever.. On an unknown date, Body temperature: 100.2f and 99.7f.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Crosslinked with MOD21-082836
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness
Clinical narrative: headache; fever; arm was swollen; arm was achy; arm was tender; tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), PAIN IN EXTREMITY (arm was achy), TENDERNESS (arm was tender), FATIGUE (tired) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), PAIN IN EXTREMITY (arm was achy), TENDERNESS (arm was tender) and FATIGUE (tired). On 27-Apr-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, PERIPHERAL SWELLING (arm was swollen), PAIN IN EXTREMITY (arm was achy), TENDERNESS (arm was tender), FATIGUE (tired), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 99.3f The patient had fever.. On an unknown date, Body temperature: 100.2f and 99.7f.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Crosslinked with MOD21-082836
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: burning sensation on left arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation on left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.     On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced BURNING SENSATION (burning sensation on left arm). At the time of the report, BURNING SENSATION (burning sensation on left arm) outcome was unknown. Unknown   Treatment medication was 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pain, Pharyngeal swelling, Swollen tongue
Clinical narrative: sore; Tongue began to swell/area below tongue began to swell; dizziness; felt her brain would explode; swelling in throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), SWOLLEN TONGUE (Tongue began to swell/area below tongue began to swell), DIZZINESS (dizziness), FEELING ABNORMAL (felt her brain would explode) and PHARYNGEAL SWELLING (swelling in throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B12A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Iodine allergy.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN (sore), SWOLLEN TONGUE (Tongue began to swell/area below tongue began to swell), DIZZINESS (dizziness), FEELING ABNORMAL (felt her brain would explode) and PHARYNGEAL SWELLING (swelling in throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (sore), SWOLLEN TONGUE (Tongue began to swell/area below tongue began to swell), DIZZINESS (dizziness), FEELING ABNORMAL (felt her brain would explode) and PHARYNGEAL SWELLING (swelling in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant  medications provided. Treatment included Benadryl liquigels taken one tablet every six hours Tylenol
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm is tiny bit sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is tiny bit sore) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy to antibiotic. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for Allergy NOS.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm is tiny bit sore). At the time of the report, VACCINATION SITE PAIN (arm is tiny bit sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitent medicines include Claritin D for his allergies every other day, protein powder for his shakes.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: diagnosed with covid-19; Was refused 2nd dose due to infusion and told to wait 60-90 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid-19) and PRODUCT DOSE OMISSION ISSUE (Was refused 2nd dose due to infusion and told to wait 60-90 days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was refused 2nd dose due to infusion and told to wait 60-90 days). On 27-Apr-2021, the patient experienced COVID-19 (diagnosed with covid-19). At the time of the report, COVID-19 (diagnosed with covid-19) and PRODUCT DOSE OMISSION ISSUE (Was refused 2nd dose due to infusion and told to wait 60-90 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment included antibody infusion.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Dyspnoea, Feeling hot, Injection site erythema, Vaccination site erythema
Clinical narrative: red target after the first shot; kept holding my left breast for a week; I feel aware of it, in my left breast., as of now.; red target after the second shot; a terrible pain in my left breast; intense heat right after the shot; shortness of the breath; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (a terrible pain in my left breast), FEELING HOT (intense heat right after the shot), DYSPNOEA (shortness of the breath), VACCINATION SITE ERYTHEMA (red target after the first shot) and VACCINATION SITE ERYTHEMA (red target after the second shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced FEELING HOT (intense heat right after the shot) and DYSPNOEA (shortness of the breath). On 01-Apr-2021, the patient experienced BREAST PAIN (a terrible pain in my left breast). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red target after the second shot) and BREAST PAIN (I feel aware of it, in my left breast., as of now.). On 08-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red target after the first shot) and BREAST PAIN (kept holding my left breast for a week). At the time of the report, BREAST PAIN (a terrible pain in my left breast), VACCINATION SITE ERYTHEMA (red target after the first shot), VACCINATION SITE ERYTHEMA (red target after the second shot), BREAST PAIN (kept holding my left breast for a week) and BREAST PAIN (I feel aware of it, in my left breast., as of now.) outcome was unknown and FEELING HOT (intense heat right after the shot) and DYSPNOEA (shortness of the breath) had resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Discomfort, Feeling abnormal, Headache
Clinical narrative: Feels Miserable; Chills; Fever; Headache; Aches and Pains all over; Horribly itchy; Wicked Rash (big welts); pain, Sore; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Horribly itchy), FEELING ABNORMAL (Feels Miserable), PAIN ( pain, Sore), DISCOMFORT (Discomfort) and RASH (Wicked Rash (big welts)) in a 69-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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN ( pain, Sore) and DISCOMFORT (Discomfort). On 23-Apr-2021, the patient experienced PRURITUS (Horribly itchy) and RASH (Wicked Rash (big welts)). On 26-Apr-2021, the patient experienced FEELING ABNORMAL (Feels Miserable), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Aches and Pains all over). On 23-Apr-2021, PAIN ( pain, Sore) and DISCOMFORT (Discomfort) had resolved. At the time of the report, PRURITUS (Horribly itchy), FEELING ABNORMAL (Feels Miserable), RASH (Wicked Rash (big welts)), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Aches and Pains all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 98.4. On an unknown date, Body temperature: 100.6f.     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 reported. No treatment information provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Feels Miserable; Chills; Fever; Headache; Aches and Pains all over; Horribly itchy; Wicked Rash (big welts); pain, Sore; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Horribly itchy), FEELING ABNORMAL (Feels Miserable), PAIN ( pain, Sore), DISCOMFORT (Discomfort) and RASH (Wicked Rash (big welts)) in a 69-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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN ( pain, Sore) and DISCOMFORT (Discomfort). On 23-Apr-2021, the patient experienced PRURITUS (Horribly itchy) and RASH (Wicked Rash (big welts)). On 26-Apr-2021, the patient experienced FEELING ABNORMAL (Feels Miserable), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Aches and Pains all over). On 23-Apr-2021, PAIN ( pain, Sore) and DISCOMFORT (Discomfort) had resolved. At the time of the report, PRURITUS (Horribly itchy), FEELING ABNORMAL (Feels Miserable), RASH (Wicked Rash (big welts)), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Aches and Pains all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 98.4. On an unknown date, Body temperature: 100.6f.     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 reported. No treatment information provided.